In the U.S.—

• Luvox

In Canada—

• Luvox

Category  

• Antiobsessional agent
• antidepressant

Description  

Fluvoxamine (floo-VOX-a-meen) is used to treat obsessive-compulsive disorder.

This medicine may also be used for other conditions as determined by your doctor.

Fluvoxamine belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). These medicines are thought to work by increasing the activity of a chemical called serotonin in the brain.

This medicine is available only with your doctor's prescription, in the following dosage form:

• Oral
• Tablets (U.S. and Canada)

Before Using This Medicine  

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For fluvoxamine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to fluvoxamine. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Fluvoxamine has not been studied in pregnant women. However, studies in animals have shown that fluvoxamine may cause lower survival rates in offspring when given to the mother in doses less than the maximum recommended human dose. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—Fluvoxamine passes into breast milk. However, the effects of this medicine in nursing babies are not known.

Children—This medicine has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults. Because fluvoxamine may cause weight loss or a decrease in appetite, children who will be taking fluvoxamine for a long time should have their weight and growth measured by the doctor regularly.

Older adults—Fluvoxamine has been tested in a limited number of older adults and has not been shown to cause different side effects or problems in older people than it does in younger adults. However, fluvoxamine may be removed from the body more slowly in older adults and an older adult may receive a lower dose than a younger adult.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking fluvoxamine, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Alprazolam (e.g., Xanax) or
• Bromazepam (e.g., Lectopam) or
• Clozapine (e.g., Clozaril) or
• Metoprolol (e.g., Lopressor) or
• Midazolam (e.g., Versed) or
• Propranolol (e.g., Inderal) or
• Theophylline (e.g., Theo-Dur) or
• Triazolam (e.g., Halcion) or
• Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Pertofrane], doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g., Aventyl], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil]) or
• Warfarin (e.g., Coumadin)—Higher blood levels of these medicines may occur, causing unwanted effects. Your doctor may want to see you more often if you are taking one of these medicines with fluvoxamine. Your doctor may also change the dose of these medicines or may change you to a different medicine.

• Astemizole (e.g., Hismanal) or
• Cisapride (e.g., Propulsid) or
• Terfenadine (e.g., Seldane)— Do not take any of these medicines while you are taking fluvoxamine or a very serious heart problem may occur.

• Buspirone (e.g., BuSpar) or
• Bromocriptine (e.g., Parlodel) or
• Dexfenfluramine (e.g., Redux) or
• Dextromethorphan (e.g., Robitussin DM) or
• Dihydroergotamine (e.g., D.H.E. 45) or
• Fenfluramine (e.g., Pondimin) or
• Levodopa (e.g., Sinemet) or
• Lithium (e.g., Eskalith) or
• Meperidine (e.g., Demerol) or
• Moclobemide (e.g., Manerex) or
• Nefazodone (e.g., Serzone) or
• Pentazocine (e.g., Talwin) or
• Selective serotonin reuptake inhibitors, other (fluoxetine [e.g., Prozac], paroxetine [e.g., Paxil], sertraline [e.g., Zoloft]) or
• Street drugs (LSD, MDMA [e.g., ecstasy], marijuana) or
• Sumatriptan (e.g., Imitrex) or
• Tramadol (e.g., Ultram) or
• Trazodone (e.g., Desyrel) or
• Tryptophan or
• Venlafaxine (e.g., Effexor)—Using these medicines with fluvoxamine may increase the chance of developing a rare, but very serious, unwanted effect known as the serotonin syndrome. Symptoms of this syndrome include agitation, confusion, diarrhea, fever, overactive reflexes, poor coordination, restlessness, shivering, sweating, talking or acting with excitement you cannot control, trembling or shaking, or twitching. If you develop these symptoms (usually three or more occur together) check with your doctor as soon as possible

• Diazepam (e.g., Valium)—Higher blood levels of diazepam may occur, causing unwanted effects. Taking diazepam while you are taking fluvoxamine is not recommended

• Monoamine oxidase (MAO) inhibitors (furazolidone [e.g., Furoxone], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate])— Do not take fluvoxamine while you are taking or within 2 weeks of taking an MAO inhibitor , or you may develop agitation, coma, severe muscle stiffness, sudden high body temperature, or extremely high blood pressure. At least 14 days should be allowed between stopping treatment with one medicine and starting treatment with the other

Other medical problems—The presence of other medical problems may affect the use of fluvoxamine. Make sure you tell your doctor if you have any other medical problems, especially:

• Brain disease or mental retardation or
• Seizures, history of—The risk of seizures may be increased

• Liver disease—Higher blood levels of fluvoxamine may occur, increasing the chance of side effects

• Mania or hypomania, history of—The condition may be activated

Proper Use  

Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Fluvoxamine may be taken with or without food or on a full or empty stomach. However, if your doctor tells you to take the medicine a certain way, take it exactly as directed.

If you are taking fluvoxamine for obsessive-compulsive disorder, you may have to take it for up to 10 or 12 weeks before you begin to feel better . Your doctor should check your progress at regular visits during this time.

Dosing—The dose of fluvoxamine will be different for different patients. Follow your doctor's orders or the directions on the label . The following information includes only the average doses of fluvoxamine. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets that you take depends on the strength of the medicine.

• For oral dosage form (tablets):
• For treatment of obsessive-compulsive disorder:
• Adults—At first, 50 milligrams (mg) once a day at bedtime. Your doctor may increase your dose if needed. However, the dose usually is not more than 300 mg a day. If your daily dose is higher than 100 mg, your doctor may want you to take it in two divided doses.
• Children younger than 8 years of age—Use and dose must be determined by your doctor.
• Children 8 to 17 years of age—At first, 25 mg once a day at bedtime. Your doctor may increase your dose if needed. However, the dose usually is not more than 200 mg a day. If your daily dose is higher than 50 mg, your doctor may want you to take it in two divided doses.

Missed dose—If you miss a dose of fluvoxamine and your dosing schedule is:

• One time a day—Take the missed dose as soon as possible if remembered the same day and go back to your regular dosing schedule. Do not double doses.
• Two times a day—Skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions  

It is important that your doctor check your progress at regular visits , to allow for changes in your dose and to help reduce any side effects.

Do not take astemizole, cisapride, or terfenadine while you are taking fluvoxamine . If you do, you may develop a very serious heart problem.

Do not take fluvoxamine if you have taken a monoamine oxidase (MAO) inhibitor in the past 14 days. Do not start taking an MAO inhibitor within 14 days of stopping fluvoxamine . If you do, you may develop agitation, coma, extreme muscle stiffness, sudden high body temperature, or other severe unwanted effects.

Avoid drinking alcohol while taking fluvoxamine.

Check with your doctor as soon as possible if you develop a skin rash, hives, or itching while you are taking fluvoxamine.

Fluvoxamine may cause some people to become drowsy or less able to think clearly, or to have blurred vision or poor muscle control. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert, able to see clearly, or able to control your movements well .

Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely. This is to decrease the chance of having discontinuation symptoms.

Side Effects  

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Change in sexual performance or desire

Less common

Behavior, mood, or mental changes; trouble in breathing; trouble in urinating; twitching

Rare

Absence of or decrease in body movements; blurred vision; clumsiness or unsteadiness; convulsions (seizures); inability to move eyes; increase in body movements; menstrual changes; nose bleeds; red or irritated eyes; redness, tenderness, itching, burning or peeling of skin; skin rash; sore throat, fever, and chills; unusual bruising; unusual, incomplete, or sudden body or facial movements; unusual secretion of milk, in females; weakness

Rare—Symptoms of serotonin syndrome (usually three or more occur together)

Agitation; confusion; diarrhea; fever; overactive reflexes; poor coordination; restlessness; shivering; sweating; talking or acting with excitement you cannot control; trembling or shaking; twitching

Symptoms of overdose—may be more severe than usual side effects, or two or more may occur together

Coma; convulsions (seizures); diarrhea; dizziness; drowsiness; dryness of mouth; fast or slow heartbeat; large pupils; low blood pressure; nausea; trembling or shaking; trouble in urinating; twitching; vomiting

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

More common

Constipation; dizziness; drowsiness; headache; nausea; trouble in sleeping; unusual tiredness; vomiting

Less common

Abdominal pain; change in sense of taste; decreased appetite; diarrhea; dryness of mouth; feeling of constant movement of self or surroundings; feeling of fast or irregular heartbeat; frequent urination; heartburn; increased sweating; trembling or shaking; unusual weight gain or loss

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time check with your doctor if you notice any of the following side effects:

Confusion; decreased energy; dizziness; headache; irritability; nausea; problems with memory; weakness

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Additional Information  

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, fluvoxamine is used in certain patients with the following medical condition:

• Mental depression

If you are taking fluvoxamine for mental depression, you may have to take it for 3 weeks or longer before you begin to feel better . Your doctor should check your progress at regular visits during this time.

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for this use.

In the U.S.—

• Chlorpromazine Hydrochloride Intensol ¹
• Compazine ⁸
• Compazine Spansule ⁸
• Mellaril ¹¹
• Mellaril Concentrate ¹¹
• Mellaril-S ¹¹
• Permitil ²
• Permitil Concentrate ²
• Prolixin ²
• Prolixin Concentrate ²
• Prolixin Decanoate ²
• Prolixin Enanthate ²
• Serentil ³
• Serentil Concentrate ³
• Stelazine ¹²
• Stelazine Concentrate ¹²
• Thorazine ¹
• Thorazine Spansule ¹
• `s
• Trilafon Concentrate ⁶
• Vesprin ¹³

In Canada—

• Apo-Fluphenazine ²
• Apo-Perphenazine ⁶
• Apo-Thioridazine ¹¹
• Apo-Trifluoperazine ¹²
• Chlorpromanyl-20 ¹
• Chlorpromanyl-40 ¹
• Largactil ¹
• Largactil Liquid ¹
• Largactil Oral Drops ¹
• Majeptil ¹⁰
• Mellaril ¹¹
• Modecate ²
• Modecate Concentrate ²
• Moditen Enanthate ²
• Moditen HCl ²
• Neuleptil ⁵
• Novo-Chlorpromazine ¹
• Novo-Trifluzine ¹²
• Novo-Ridazine ¹¹
• Nozinan ⁴
• Nozinan Liquid ⁴
• Nozinan Oral Drops ⁴
• Nu-Prochlor ⁸
• Piportil L ₄ ⁷
• PMS Fluphenazine ²
• PMS Perphenazine ⁶
• PMS Prochlorperazine ⁸
• PMS Thioridazine ¹¹
• PMS Trifluoperazine ¹²
• Serentil ³
• Stelazine ¹²
• Stemetil ⁸
• Stemetil Liquid ⁸

Category  

• Analgesic—Methotrimeprazine
• Anesthetic adjunct—Chlorpromazine; Methotrimeprazine, intravenous
• Antidyskinetic, Huntington's chorea—Chlorpromazine; Thioridazine
• Antiemetic—Chlorpromazine; Methotrimeprazine; Perphenazine; Prochlorperazine; Trifluoperazine; Triflupromazine
• Antineuralgia adjunct—Fluphenazine
• Antipsychotic—Chlorpromazine; Fluphenazine; Mesoridazine; Methotrimeprazine; Perphenazine; Pipotiazine; Prochlorperazine; Promazine; Thioproperazine; Thioridazine; Trifluoperazine; Triflupromazine
• Antipsychotic adjunct—Pericyazine
• Sedative—Chlorpromazine; Methotrimeprazine; Thioridazine

Description  

Phenothiazines (FEE-noe-THYE-a-zeens) are used to treat serious mental and emotional disorders, including schizophrenia and other psychotic disorders. Some are used also to control agitation in certain patients, severe nausea and vomiting, severe hiccups, and moderate to severe pain in some hospitalized patients. Chlorpromazine is used also in the treatment of certain types of porphyria, and with other medicines in the treatment of tetanus. Phenothiazines may also be used for other conditions as determined by your doctor.

Phenothiazines may cause unwanted, unattractive, and uncontrolled face or body movements that may not go away when you stop taking the medicine. They may also cause other serious unwanted effects. You and your doctor should talk about the good this medicine will do as well as the risks of using it. Also, your doctor should look for early signs of these effects at regular visits. Your doctor may be able to stop or decrease some unwanted effects, if they do occur, by changing your dose or by making other changes in your treatment.

Phenothiazines are available only with your doctor's prescription in the following dosage forms:

• Oral
• Chlorpromazine
• Extended-release capsules (U.S.)
• Oral concentrate (U.S. and Canada)
• Syrup (U.S. and Canada)
• Tablets (U.S. and Canada)
• Fluphenazine
• Elixir (U.S. and Canada)
• Oral solution (U.S.)
• Tablets (U.S. and Canada)
• Mesoridazine
• Oral solution (U.S.)
• Tablets (U.S. and Canada)
• Methotrimeprazine
• Oral solution (Canada)
• Tablets (Canada)
• Pericyazine
• Capsules (Canada)
• Oral solution (Canada)
• Perphenazine
• Oral solution (U.S. and Canada)
• Tablets (U.S. and Canada)
• Prochlorperazine
• Extended-release capsules (U.S.)
• Oral solution (U.S. and Canada)
• Tablets (U.S. and Canada)
• Thioproperazine
• Tablets (Canada)
• Thioridazine
• Oral solution (U.S. and Canada)
• Oral suspension (U.S. and Canada)
• Tablets (U.S. and Canada)
• Trifluoperazine
• Syrup (U.S. and Canada)
• Tablets (U.S. and Canada)

• Parenteral
• Chlorpromazine
• Injection (U.S. and Canada)
• Fluphenazine
• Injection (U.S. and Canada)
• Mesoridazine
• Injection (U.S.)
• Methotrimeprazine
• Injection (Canada)
• Perphenazine
• Injection (U.S.)
• Pipotiazine
• Injection (Canada)
• Prochlorperazine
• Injection (U.S. and Canada)
• Promazine
• Injection (Canada)
• Trifluoperazine
• Injection (U.S.)
• Triflupromazine
• Injection (U.S.)

• Rectal
• Chlorpromazine
• Suppositories (U.S. and Canada)
• Prochlorperazine
• Suppositories (U.S. and Canada)

Before Using This Medicine  

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For phenothiazines, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to phenothiazines. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes. Some of the phenothiazine dosage forms contain parabens, sulfites, or tartrazine.

Pregnancy—Although studies have not been done in pregnant women, some side effects, such as jaundice and movement disorders, have occurred in a few newborns whose mothers received phenothiazines during pregnancy. Studies in animals have shown that, when given to the mother during pregnancy, these medicines can decrease the number of successful pregnancies and cause problems with bone development in the offspring. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—Phenothiazines pass into breast milk and may cause drowsiness or unusual muscle movements in the nursing baby. It may be necessary for you to take a different medicine or to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Children—Certain side effects, such as muscle spasms of the face, neck, and back, tic-like or twitching movements, inability to move the eyes, twisting of the body, or weakness of the arms and legs, are more likely to occur in children, especially those with severe illness or dehydration. Children are usually more sensitive than adults to the effects of phenothiazines.

Older adults—Constipation, trouble urinating, dryness of mouth, confusion, problems with memory, dizziness or fainting, drowsiness, trembling of the hands and fingers, and problems with muscle movement, such as decreased or unusual movements, are especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of phenothiazines.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking phenothiazines, it is especially important that your health care professional know if you are taking any of the following:

• Amantadine (e.g., Symmetrel) or
• Antihypertensives (high blood pressure medicine) or
• Bromocriptine (e.g., Parlodel) or
• Deferoxamine (e.g., Desferal) or
• Diuretics (water pills) or
• Levobunolol (e.g., Betagan) or
• Medicine for heart disease or
• Metipranolol (e.g., OptiPranolol) or
• Nabilone (e.g., Cesamet) (with high doses) or
• Narcotic pain medicine or
• Pentamidine (e.g., Pentam)—Severe low blood pressure may occur

• Antidepressants (medicine for depression)—The risk of developing serious side effects, including severe constipation, low blood pressure, severe drowsiness, unusual body or facial movements, and changes in heart rhythm, may be increased

• Antipsychotics, other (medicine for mental illness) or
• Promethazine (e.g., Phenergan) or
• Trimeprazine (e.g., Temaril)—Severe low blood pressure or unusual body or facial movements may occur

• Antithyroid agents (medicine for overactive thyroid)—The risk of developing serious blood problems may be increased

• Astemizole (e.g., Hismanal) or
• Cisapride (e.g., Propulsid) or
• Disopyramide (e.g., Norpace) or
• Erythromycin (e.g., E.E.S., EryPed) or
• Probucol (e.g., Lorelco) or
• Procainamide (e.g., Procan SR) or
• Quinidine (e.g., Duraquin)—Serious changes in heart rhythm may occur

• Central nervous system (CNS) depressants (medicines that cause drowsiness)—Severe drowsiness and trouble in breathing may occur

• Epinephrine (e.g., Adrenalin)—Severe low blood pressure and fast heartbeat may occur

• Levodopa (e.g., Dopar)—Phenothiazines may prevent levodopa from working properly in the treatment of Parkinson's disease

• Lithium (e.g., Lithane, Lithizine, Lithobid)—Some unwanted effects, such as decreased or unusual body or facial movements, may be increased. The blood levels of the phenothiazine and/or lithium may be changed, so the medicines may not work properly. Your doctor may need to change your dose of either or both medicines

• Metoclopramide (e.g., Reglan) or
• Metyrosine (e.g., Demser) or
• Pemoline (e.g., Cylert) or
• Rauwolfia alkaloids (deserpidine [e.g., Harmonyl], rauwolfia serpentina [e.g., Raudixin], reserpine [e.g., Serpasil])—Taking these medicines with phenothiazines may increase the chance of having decreased or unusual body or facial movements or may make the movement problems worse

• Pimozide (e.g., Orap)—Serious changes in heart rhythm, severe low blood pressure, or unusual body or facial movements may occur

Other medical problems—The presence of other medical problems may affect the use of phenothiazines. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse—Certain unwanted effects, such as heatstroke and liver disease, may be more likely to occur

• Blood disease or
• Breast cancer or
• Difficult urination or
• Glaucoma or
• Heart or blood vessel disease or
• Parkinson's disease or
• Seizure disorders, or history of or
• Stomach ulcers—Phenothiazines may make the condition worse

• Brain damage or
• Blood vessel disease in the brain—Serious increase in body temperature may occur

• Enlarged prostate—Difficulty in urinating may occur or may become more severe

• Liver disease—Phenothiazines may make the condition worse. Higher blood levels of phenothiazines may occur, increasing the chance of having unwanted effects

• Lung disease—Difficulty in breathing may become more severe. Decrease in cough reflex caused by phenothiazines may increase the risk of developing complications, such as pneumonia

• Pheochromocytoma or
• Kidney disease—Severe low blood pressure may occur

• Reye's syndrome—The risk that the phenothiazine will have unwanted effects on the liver may be increased

Proper Use  

For patients taking this medicine by mouth :

• This medicine may be taken with food or a full glass (8 ounces) of water or milk to reduce stomach irritation.
• If your medicine comes in a dropper bottle , measure each dose with the special dropper provided with your prescription and dilute it in a small glass (4 ounces) of orange or grapefruit juice or water just before taking it.
• If you are taking the extended-release capsule form of this medicine, each dose should be swallowed whole. Do not break, crush, or chew before swallowing .

For patients using the suppository form of this medicine:

• If the suppository is too soft to insert, chill it in the refrigerator for 30 minutes or run cold water over it before removing the foil wrapper.
• To insert the suppository: First remove the foil wrapper and moisten the suppository with cold water. Lie down on your side and use your finger to push the suppository well up into the rectum.

Do not take more or less of this medicine and do not take it more or less often than your doctor ordered . Not taking more than your doctor ordered is particularly important for children or elderly patients, since they may react very strongly to this medicine.

This medicine must be taken for several weeks before its full effect is reached when it is used to treat mental and emotional conditions .

Dosing—The dose of phenothiazines will be different for different patients. Follow your doctor's orders or the directions on the label . The following information includes only the average doses of phenothiazines. If your dose is different, do not change it unless your doctor tells you to do so.

The number of capsules, tablets, or teaspoonfuls of elixir, solution, suspension, or syrup that you take, or the number of injections you receive or suppositories that you use, depends on the strength of the medicine. Also, the number of doses you use each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking phenothiazines .

• For chlorpromazine
• For oral extended-release capsule dosage form:
• For mental or emotional disorders:
• Adults—30 to 300 milligrams (mg) one to three times a day. Your doctor may increase your dose if needed.
• Children—This dosage form is not recommended for use in children.
• For oral concentrate, syrup, or tablet dosage forms:
• For mental or emotional disorders:
• Adults and teenagers—At first, 10 to 25 mg two to four times a day. Your doctor may increase your dose if needed.
• Children up to 6 months of age—Dose must be determined by your doctor.
• Children 6 months to 12 years of age—Dose is based on body weight or size, and must be determined by your doctor. The usual dose is 0.55 mg per kilogram (kg) (0.25 mg per pound) of body weight, every four to six hours.
• For nausea and vomiting:
• Adults and teenagers—10 to 25 mg every four to six hours as needed.
• Children up to 6 months of age—Dose must be determined by your doctor.
• Children 6 months to 12 years of age—Dose is based on body weight or size, and must be determined by your doctor. The usual dose is 0.55 mg per kg (0.25 mg per pound) of body weight, every four to six hours.
• For sedation before surgery:
• Adults and teenagers—25 to 50 mg two to three hours before surgery.
• Children—Dose is based on body weight or size, and must be determined by your doctor. The usual dose is 0.55 mg per kg (0.25 mg per pound) of body weight, two to three hours before surgery.
• For treatment of hiccups:
• Adults and teenagers—25 to 50 mg three or four times a day. If hiccups remain after two to three days of oral treatment, treatment by injection may be needed.
• Children—Dose must be determined by your doctor.
• For porphyria:
• Adults and teenagers—25 to 50 mg three or four times a day.
• Children—Dose must be determined by your doctor.
• For injection dosage form:
• For severe mental or emotional disorders:
• Adults—At first, 25 to 50 mg, injected into a muscle. The dose may be repeated in one hour, and every three to twelve hours thereafter. Your doctor may increase your dose if needed.
• Children up to 6 months of age—Dose must be determined by your doctor.
• Children 6 months to 12 years of age—Dose is based on body weight or size and must be determined by your doctor. The usual dose is 0.55 mg per kg (0.25 mg per pound) of body weight, injected into a muscle every six to eight hours as needed.
• For nausea and vomiting:
• Adults—At first, 25 mg injected into a muscle. If needed, doses of 25 to 50 mg may be given every three to four hours.
• Children up to 6 months of age—Dose must be determined by your doctor.
• Children 6 months to 12 years of age—Dose is based on body weight or size and must be determined by your doctor. The usual dose is 0.55 mg per kg (0.25 mg per pound) of body weight, injected into a muscle every six to eight hours as needed.
• For nausea and vomiting during surgery:
• Adults—At first, 12.5 mg injected into a muscle. The dose may be repeated if needed. Or up to 25 mg may be diluted and injected slowly into a vein.
• Children up to 6 months of age—Dose must be determined by your doctor.
• Children 6 months to 12 years of age—Dose is based on body weight or size and must be determined by your doctor. The usual dose is 0.275 mg per kg (0.125 mg per pound) of body weight injected into a muscle or diluted and injected slowly into a vein.
• For sedation before surgery:
• Adults—12.5 to 25 mg, injected into a muscle one to two hours before surgery.
• Children up to 6 months of age—Dose must be determined by your doctor.
• Children 6 months to 12 years of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 0.55 mg per kg (0.25 mg per pound) of body weight, injected into a muscle one to two hours before surgery.
• For treatment of hiccups:
• Adults—25 to 50 mg, injected into a muscle three or four times a day. If hiccups remain after treatment by injection into muscle, 25 to 50 mg may be diluted and injected slowly into a vein.
• Children—Dose must be determined by your doctor.
• For porphyria:
• Adults—25 mg injected into a muscle every six to eight hours.
• Children—Dose must be determined by your doctor.
• For tetanus:
• Adults—25 to 50 mg, injected into a muscle three or four times a day. Or 25 to 50 mg, diluted and injected slowly into a vein. Your doctor may increase your dose if needed.
• Children up to 6 months of age—Dose must be determined by your doctor.
• Children 6 months to 12 years of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 0.55 mg per kg (0.25 mg per pound) of body weight, injected into a muscle every six to eight hours or diluted and injected slowly into a vein.
• For rectal dosage form (suppositories):
• For nausea and vomiting:
• Adults and teenagers—50 to 100 mg, inserted into the rectum every six to eight hours as needed.
• Children up to 6 months of age—Dose must be determined by your doctor.
• Children 6 months to 12 years of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 1 mg per kg (0.45 mg per pound) of body weight, inserted into the rectum every six to eight hours as needed.

• For fluphenazine
• For oral dosage form (elixir, solution, or tablets):
• For mental or emotional disorders:
• Adults—At first, a total of 2.5 to 10 milligrams (mg) a day, taken in smaller doses every six to eight hours during the day. Your doctor may increase your dose if needed. However, the dose usually is not more than 20 mg a day.
• Children—0.25 to 0.75 mg one to four times a day.
• Older adults—1 to 2.5 mg a day. Your doctor may increase your dose if needed.
• For long-acting decanoate injection dosage form:
• For mental or emotional disorders:
• Adults—At first, 12.5 to 25 mg, injected into a muscle or under the skin every one to three weeks. Your doctor may increase your dose if needed. However, the dose usually is not more than 100 mg.
• Children 5 to 12 years of age—3.125 to 12.5 mg, injected into a muscle or under the skin every one to three weeks.
• Children 12 years of age and older—At first, 6.25 to 18.75 mg, injected into a muscle or under the skin once a week. Your doctor may increase your dose if needed. However, the dose usually is not more than 25 mg every one to three weeks.
• For long-acting enanthate injection dosage form:
• For mental or emotional disorders:
• Adults and teenagers—At first, 25 mg, injected into a muscle or under the skin every two weeks. Your doctor may adjust your dose if needed. However, the dose usually is not more than 100 mg.
• Children up to 12 years of age—Dose must be determined by your doctor.
• For short-acting hydrochloride injection dosage form:
• For mental or emotional disorders:
• Adults and teenagers—At first, 1.25 mg, injected into a muscle. Your doctor may repeat and increase your dose if needed. However, the dose usually is not more than 10 mg a day.
• Children up to 12 years of age—Dose must be determined by your doctor.
• Older adults—1 to 2.5 mg a day, injected into a muscle. Your doctor may increase your dose if needed.

• For mesoridazine
• For oral dosage form (solution or tablets):
• For mental or emotional disorders:
• Adults and teenagers—A total of 30 to 150 milligrams (mg) a day, taken in smaller doses two or three times during the day.
• Children up to 12 years of age—Dose must be determined by your doctor.
• For injection dosage form:
• For mental or emotional disorders:
• Adults and teenagers—25 mg injected into a muscle. The dose may be repeated in thirty to sixty minutes if needed.
• Children up to 12 years of age—Dose must be determined by your doctor.

• For methotrimeprazine
• For oral dosage form (solution or tablets):
• For mental or emotional disorders:
• Adults and teenagers—At first, a total of 50 to 75 milligrams (mg) a day, taken in smaller doses two or three times a day with meals. Your doctor may increase your dose if needed.
• Children—Dose is based on body weight and must be determined by your doctor. At first, the usual dose is a total of 0.25 mg per kilogram (kg) (0.11 mg per pound) of body weight a day, taken in smaller doses two or three times a day with meals. Your doctor may increase your dose if needed.
• For pain:
• Adults and teenagers—For moderate pain, at first a total of 6 to 25 mg a day, taken in smaller doses three times a day with meals. For severe pain, at first a total of 50 to 75 mg a day, taken in smaller doses two or three times a day with meals. Your doctor may increase your dose if needed.
• Children—Dose is based on body weight and must be determined by your doctor. At first, the usual dose is a total of 0.25 mg per kg (0.11 mg per pound) of body weight a day, taken in smaller doses two or three times a day with meals. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg a day.
• For sedation:
• Adults and teenagers—At first, a total of 6 to 25 mg a day, taken in smaller doses three times a day with meals. Your doctor may increase your dose if needed.
• Children—Dose is based on body weight and must be determined by your doctor. At first, the usual dose is a total of 0.25 mg per kg (0.11 mg per pound) of body weight a day, taken in smaller doses two or three times a day with meals. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg a day.
• For injection dosage form:
• For mental or emotional disorders:
• Adults and teenagers—At first, 10 to 20 mg, injected into a muscle every four to six hours. Your doctor may increase your dose if needed.
• Children—Dose is based on body weight and must be determined by your doctor. The usual dose is a total of 0.062 to 0.125 mg per kg (0.028 to 0.057 mg per pound) of body weight a day, injected into a muscle in one dose or in a few smaller doses.
• For pain:
• Adults and teenagers—At first, 2.5 to 20 mg, injected into a muscle. Your doctor may repeat or increase your dose if needed.
• Children—Dose is based on body weight and must be determined by your doctor. The usual dose is a total of 0.062 to 0.125 mg per kg (0.028 to 0.057 mg per pound) of body weight a day, injected into a muscle in one dose or in a few smaller doses.
• Older adults—At first, 5 to 10 mg injected into a muscle every four to six hours. Your doctor may increase your dose if needed.
• For sedation before surgery:
• Adults and teenagers—2 to 20 mg, injected into a muscle forty-five minutes to three hours before surgery.
• Children—Dose must be determined by your doctor.

• For pericyazine
• For oral dosage form (capsules or solution):
• For mental or emotional disorders:
• Adults—At first, 5 milligrams (mg) taken in the morning, and 10 mg taken in the evening. Your doctor may change your dose if needed. However, the dose usually is not more than 20 mg taken in the morning and 40 mg taken in the evening.
• Children up to 5 years of age—Dose must be determined by your doctor.
• Children 5 years of age and older—2.5 to 10 mg taken in the morning, and 5 to 30 mg taken in the evening.
• Older adults—At first, 5 mg a day. Your doctor may increase your dose if needed. However, the dose usually is not more than 30 mg a day.

• For perphenazine
• For oral solution dosage form:
• For mental or emotional disorders in hospitalized patients:
• Adults and teenagers—8 to 16 milligrams (mg) two to four times a day.
• Children up to 12 years of age—Dose must be determined by your doctor.
• For oral tablet dosage form:
• For mental or emotional disorders:
• Adults and teenagers—4 to 16 mg two to four times a day.
• Children up to 12 years of age—Dose must be determined by your doctor.
• For nausea and vomiting:
• Adults and teenagers—A total of 8 to 16 mg a day, taken in smaller doses during the day. Your doctor will lower your dose as soon as possible.
• Children up to 12 years of age—Dose must be determined by your doctor.
• For injection dosage form:
• For mental or emotional disorders:
• Adults and teenagers—5 to 10 mg injected into a muscle every six hours.
• Children up to 12 years of age—Dose must be determined by your doctor.
• For nausea and vomiting:
• Adults and teenagers—At first, 5 to 10 mg injected into a muscle, or 5 mg diluted and injected slowly into a vein. Your doctor may adjust your dose if needed.
• Children up to 12 years of age—Dose must be determined by your doctor.

• For pipotiazine
• For injection dosage form:
• For mental or emotional disorders:
• Adults and teenagers—At first, 50 to 100 milligrams (mg) injected into a muscle every two to three weeks. Your doctor may increase your dose if needed. However, the dose usually is not more than 150 mg every four weeks.
• Children up to 12 years of age—Dose must be determined by your doctor.

• For prochlorperazine
• For oral extended-release capsule dosage form:
• For mental or emotional disorders:
• Adults and teenagers—Dose must be determined by your doctor.
• Children—This dosage form is not recommended for use in children.
• For nausea and vomiting:
• Adults and teenagers—At first, 15 mg taken once a day in the morning, or 10 mg taken every twelve hours. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg a day.
• Children—This dosage form is not recommended for use in children.
• For oral dosage form (solution or tablets):
• For mental or emotional disorders:
• Adults and teenagers—At first, 5 to 10 milligrams (mg) three or four times a day. Your doctor may increase your dose if needed. However, the dose usually is not more than 150 mg a day.
• Children up to 2 years of age—Dose must be determined by your doctor.
• Children 2 to 12 years of age—2.5 mg two or three times a day. Your doctor may increase your dose if needed. However, for children 2 through 5 years of age, the dose usually is not more than 20 mg a day. For children 6 to 12 years of age, the dose usually is not more than 25 mg a day.
• For nausea and vomiting:
• Adults and teenagers—5 to 10 mg three or four times a day.
• Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2.5 mg taken one to three times a day.
• For injection dosage form:
• For mental or emotional disorders:
• Adults and teenagers—At first, 10 to 20 mg injected into a muscle. The dose may be repeated if needed. Later, the dose is usually 10 to 20 mg every four to six hours. However, the dose usually is not more than 200 mg a day.
• Children up to 2 years of age—Dose must be determined by your doctor.
• Children 2 to 12 years of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 0.132 mg per kilogram (kg) (0.06 mg per pound) of body weight, injected into a muscle. However, the dose for children 2 through 5 years of age usually is not more than 20 mg a day. The dose for children 6 to 12 years of age usually is not more than 25 mg a day.
• For nausea and vomiting:
• Adults and teenagers—5 to 10 mg, injected into a muscle every three to four hours as needed. Or 2.5 to 10 mg injected slowly into a vein. The dose usually is not more than 40 mg a day.
• Children up to 2 years of age—Dose must be determined by your doctor.
• Children 2 to 12 years of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 0.132 mg per kg (0.06 mg per pound) of body weight, injected into a muscle. However, the dose for children 2 through 5 years of age usually is not more than 20 mg a day. The dose for children 6 to 12 years of age usually is not more than 25 mg a day.
• For nausea and vomiting in surgery:
• Adults and teenagers—5 to 10 mg, injected into a muscle or injected slowly into a vein. The dose may be repeated if needed. However, the total dose usually is not more than 40 mg a day.
• Children—Dose must be determined by your doctor.
• For rectal dosage form (suppositories):
• For mental or emotional disorders:
• Adults and teenagers—10 mg inserted into the rectum three or four times a day. Your doctor may increase your dose if needed.
• Children 2 to 12 years of age—2.5 mg inserted into the rectum two or three times a day. Your doctor may increase your dose if needed. However, for children 2 through 5 years of age, the dose usually is not more than 20 mg a day. For children 6 to 12 years of age, the dose usually is not more than 25 mg a day.
• For nausea and vomiting:
• Adults and teenagers—25 mg inserted into the rectum two times a day.
• Children up to 2 years of age—Dose must be determined by your doctor.
• Children 2 to 12 years of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 2.5 mg inserted into the rectum one to three times a day.

• For promazine
• For injection dosage form:
• For mental or emotional disorders:
• Adults—At first, 50 to 150 mg, injected into a muscle or, in hospitalized patients, diluted and injected into a vein. Later, 10 to 200 mg, injected into a muscle every four to six hours.
• Children up to 12 years of age—Dose must be determined by your doctor.
• Children 12 years of age and older—10 to 25 mg, injected into a muscle, every four to six hours.

• For thioproperazine
• For oral dosage form (tablets):
• For mental or emotional disorders:
• Adults and teenagers—At first, 5 milligrams (mg) a day. Your doctor may increase your dose if needed.
• Children 3 through 10 years of age—Dose must be determined by your doctor.
• Children 11 years of age and older—At first, a total of 1 to 3 mg a day taken all at one time in a single dose each day or divided and taken in smaller doses several times during the day. Your doctor may increase your dose if needed.

• For thioridazine
• For oral dosage form (suspension, solution, or tablets):
• For mental or emotional disorders:
• Adults and teenagers—At first, 50 to 100 milligrams (mg) one to three times a day. Your doctor may adjust your dose if needed. However, the dose usually is not more than 800 mg a day.
• Children up to 2 years of age—Dose must be determined by your doctor.
• Children 2 to 12 years of age—At first, 10 to 25 mg two or three times a day. Your doctor may adjust your dose, if needed, based on body weight or size.

• For trifluoperazine
• For oral dosage form (syrup or tablets):
• For mental or emotional disorders:
• Adults and teenagers—At first, 2 to 5 milligrams (mg) one or two times a day. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg a day.
• Children up to 6 years of age—Dose must be determined by your doctor.
• Children 6 to 12 years of age—At first, 1 mg one or two times a day. Your doctor may increase your dose if needed.
• For injection dosage form:
• For mental or emotional disorders:
• Adults and teenagers—1 to 2 mg, injected into a muscle every four to six hours as needed. However, the dose usually is not more than 10 mg a day.
• Children up to 6 years of age—Dose must be determined by your doctor.
• Children 6 to 12 years of age—1 mg injected into a muscle one or two times a day.

• For triflupromazine
• For injection dosage form:
• For mental or emotional disorders:
• Adults and teenagers—60 milligrams (mg) injected into a muscle as needed. However, the dose usually is not more than 150 mg a day.
• Children up to 21/2 years of age—Dose must be determined by your doctor.
• Children 21/2 years of age and older—Dose is based on body weight and must be determined by your doctor. The usual dose is 0.2 to 0.25 mg per kilogram (kg) (0.09 to 0.11 mg per pound) of body weight, injected into a muscle. However, the dose usually is not more than 10 mg a day.
• For nausea and vomiting:
• Adults and teenagers—5 to 15 mg injected into a muscle every four hours, as needed. However, the dose usually is not more than 60 mg a day injected into a muscle. Or 1 mg injected into a vein, the dose being repeated as needed. However, the dose usually is not more than 3 mg a day injected into a vein.
• Children up to 21/2 years of age—Dose must be determined by your doctor.
• Children 21/2 years of age and older—Dose is based on body weight and must be determined by your doctor. The usual dose is 0.2 to 0.25 mg per kg (0.09 to 0.11 mg per pound) of body weight, injected into a muscle. However, the dose usually is not more than 10 mg a day.

Missed dose—If you miss a dose of this medicine and your dosing schedule is:

• One dose a day—Take the missed dose as soon as possible. Then go back to your regular dosing schedule. However, if you do not remember the missed dose until the next day, skip it and go back to your regular dosing schedule. Do not double doses.
• More than one dose a day—If you remember within an hour or so of the missed dose, take it right away. However, if you do not remember until later, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you have any questions about this, check with your doctor.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store the capsule or tablet form of this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the liquid form of this medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions  

Your doctor should check your progress at regular visits, especially during the first few months of treatment with this medicine. This will allow your dosage to be changed if necessary to meet your needs.

Do not stop taking this medicine without first checking with your doctor . Your doctor may want you to reduce gradually the amount you are taking before stopping completely. This is to prevent side effects and to keep your condition from becoming worse.

Do not take this medicine within 2 hours of taking antacids or medicine for diarrhea. Taking these products too close together may make this medicine less effective.

This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine .

Before using any prescription or over-the-counter (OTC) medicine for colds or allergies, check with your doctor. These medicines may increase the chance of developing heatstroke or other unwanted effects, such as dizziness, dry mouth, blurred vision, and constipation, while you are taking a phenothiazine.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests (such as electrocardiogram [ECG or EKG] readings, the gonadorelin test, the metyrapone test, tests for phenylketonurea, and urine bilirubin tests) may be affected by this medicine.

Before having any kind of surgery, dental treatment, or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine . Taking phenothiazines together with medicines that are used during surgery, dental treatments, or emergency treatments may increase CNS depression or cause low blood pressure.

This medicine may cause some people to become drowsy or less alert than they are normally. Even if this medicine is taken only at bedtime, it may cause some people to feel drowsy or less alert on arising. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert .

Phenothiazines may cause blurred vision, difficulty in reading, or other changes in vision, especially during the first few weeks of treatment. Do not drive, use machines, or do anything else that could be dangerous if you are not able to see well. If the problem continues or gets worse, check with your doctor .

Dizziness, lightheadedness, or fainting may occur , especially when you get up from a lying or sitting position. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.

This medicine may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are taking this medicine , since overheating may result in heatstroke. Also, hot baths or saunas may make you feel dizzy or faint while you are taking this medicine.

This medicine also may make you more sensitive to cold temperatures. Dress warmly during cold weather. Be careful during prolonged exposure to cold, such as in winter sports or swimming in cold water.

Phenothiazines may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute . However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Phenothiazines may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Apply a sunblock product that has a skin protection factor (SPF) of at least 15. You may require a product with a higher SPF number, especially if you have a fair complexion. If you have any questions about this, check with your health care professional.
• Apply a sunblock lipstick that has an SPF of at least 15 to protect your lips.
• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor .

Phenothiazines may cause your eyes to be more sensitive to sunlight than they are normally . Exposure to sunlight over a period of time (several months to years) may cause blurred vision, change in color vision, or difficulty in seeing at night. When you go out during the daylight hours, even on cloudy days, wear sunglasses that block ultraviolet (UV) light. Ordinary sunglasses may not protect your eyes. If you have any questions about the kind of sunglasses to wear, check with your medical doctor or eye doctor.

If you are taking a liquid form of this medicine , avoid getting it on your skin or clothing because it may cause a skin rash or other irritation.

If you are receiving this medicine by injection:

• The effects of the long-acting injection form of this medicine may last for 6 to 12 weeks. The precautions and side effects information for this medicine applies during this time .

Side Effects  

Along with their needed effects, phenothiazines can sometimes cause serious unwanted effects. Tardive dyskinesia or tardive dystonia (muscle movement disorders) may occur and may not go away after you stop using the medicine. Signs of tardive dyskinesia or tardive dystonia include worm-like movements of the tongue, or other uncontrolled movements of the mouth, tongue, cheeks, jaw, body, arms, or legs. Another possible serious unwanted effect is the neuroleptic malignant syndrome (NMS). Signs and symptoms of NMS include severe muscle stiffness, fever, fast heartbeat, difficult breathing, increased sweating, and loss of bladder control. You and your doctor should discuss the good this medicine will do as well as the risks of taking it .

Stop taking this medicine and check with your doctor immediately if any of the following side effects occur:

Rare—Symptoms of neuroleptic malignant syndrome

Confusion (severe) or coma; difficult or fast breathing; drooling; fast heartbeat; fever; high or low (irregular) blood pressure; increased sweating; loss of bladder control; muscle stiffness (severe); trembling or shaking; trouble in speaking or swallowing

Check with your doctor immediately if any of the following side effects occur:

More common

Inability to move eyes; increased blinking or spasms of eyelid; lip smacking or puckering; muscle spasms of face, neck, body, arms, or legs causing unusual postures or unusual expressions on face; puffing of cheeks; rapid or worm-like movements of tongue; sticking out of tongue; tic-like or twitching movements; trouble in breathing, speaking, or swallowing; uncontrolled chewing movements; uncontrolled movements of arms or legs; uncontrolled twisting movements of neck, trunk, arms, or legs

Also, check with your doctor as soon as possible if any of the following side effects occur:

More common

Blurred vision, change in color vision, or difficulty in seeing at night; fainting; loss of balance control; mask-like face; restlessness or need to keep moving; shuffling walk; stiffness of arms or legs; trembling and shaking of hands and fingers

Less common

Difficulty in urinating; skin rash; sunburn (severe)

Rare

Abdominal or stomach pains; aching muscles and joints; agitation, bizarre dreams, excitement, or trouble in sleeping; bleeding or bruising (unusual); chest pain; clumsiness; confusion (mild); constipation (severe); convulsions (seizures); dark urine; fever and chills; hair loss; headaches; hot, dry skin or lack of sweating; itchy skin (severe); muscle weakness; nausea, vomiting, or diarrhea; pain in joints; prolonged, painful, inappropriate erection of the penis; redness of hands; shivering; skin discoloration (tan or blue-gray); sore throat and fever; sores in mouth; unusual bleeding or bruising; unusual tiredness or weakness; yellow eyes or skin

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

More common

Constipation (mild); decreased sweating; dizziness; drowsiness; dryness of mouth; nasal congestion

Less common

Changes in menstrual period; decreased sexual ability; increased sensitivity of eyes to light; rough or "fuzzy" tongue; secretion of milk (unusual); swelling or pain in breasts; watering of mouth; weight gain (unusual)

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this time, check with your doctor if you notice dizziness, nausea and vomiting, stomach pain, trembling of the fingers and hands, or any of the following signs of tardive dyskinesia or tardive dystonia:

Inability to move eyes; lip smacking or puckering; muscle spasms of face, neck, body, arms, or legs, causing unusual body positions or unusual expressions on face; puffing of cheeks; rapid or worm-like movements of tongue; sticking out of tongue; tic-like or twitching movements; trouble in breathing, speaking, or swallowing; uncontrolled chewing movements; uncontrolled twisting or other movements of neck, trunk, arms, or legs

Although not all of the side effects listed above have been reported for all of the phenothiazines, they have been reported for at least one of them. However, since all of the phenothiazines are very similar, any of the above side effects may occur with any of these medicines.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Additional Information  

Once a medicine has been approved for marketing for a certain use, experience may show that it also is useful for other medical problems. Although these uses are not included in product labeling, phenothiazines are used in certain patients with the following medical conditions:

• Chronic neurogenic pain (certain continuing pain conditions)
• Huntington's chorea (hereditary movement disorder)

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.

In the U.S.—

• Moban
• Moban Concentrate

** Not commercially available in Canada.

Category  

• Antipsychotic

Description  

Molindone (moe-LIN-done) is used to treat nervous, mental, and emotional conditions.

Molindone is available only with your doctor's prescription, in the following dosage forms:

• Oral
• Solution (U.S.)
• Tablets (U.S.)

Before Using This Medicine  

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For molindone, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to molindone, phenothiazines, thioxanthenes, haloperidol, or loxapine. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Molindone has not been shown to cause birth defects or other problems in humans. However, studies in mice have shown a slight decrease in successful pregnancies.

Breast-feeding—It is not known if molindone passes into breast milk.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of molindone in children with use in other age groups.

Older adults—Elderly patients are usually more sensitive than younger adults to the effects of molindone. Constipation, dizziness or lightheadedness, drowsiness, dryness of mouth, trembling of the hands and fingers, and symptoms of tardive dyskinesia (such as rapid, worm-like movements of the tongue or any other uncontrolled movements of the mouth, tongue, or jaw, and/or arms and legs) are especially likely to occur in elderly patients.

Other medicines—Although certain medicines should not be used together at all, in other cases 2 different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking molindone, it is especially important that your health care professional know if you are taking any of the following:

• Amoxapine (e.g., Asendin) or
• Methyldopa (e.g., Aldomet) or
• Metoclopramide (e.g., Reglan) or
• Metyrosine (e.g., Demser) or
• Other antipsychotics (medicine for mental illness) or
• Pemoline (e.g., Cylert) or
• Pimozide (e.g., Orap) or
• Promethazine (e.g., Phenergan) or
• Rauwolfia alkaloids (alseroxylon [e.g., Rauwiloid], deserpidine [e.g., Harmonyl], rauwolfia serpentina [e.g., Raudixin], reserpine [e.g., Serpasil]) or
• Trimeprazine (e.g., Temaril)—Taking these medicines with molindone may increase the chance and seriousness of some side effects

• Central nervous system (CNS) depressants (medicine that causes drowsiness) or
• Tricyclic antidepressants (medicine for depression)—Taking these medicines with molindone may increase the CNS depressant effects

• Lithium (e.g., Eskalith, Lithane)—The chance of serious side effects may be increased

Other medical problems—The presence of other medical problems may affect the use of molindone. Make sure you tell your doctor if you have any other medical problems, especially:

• Brain tumor or
• Intestinal blockage—Molindone may interfere with the diagnosis of these conditions

• Difficult urination or
• Enlarged prostate or
• Glaucoma or
• Liver disease or
• Parkinson's disease—Molindone may make the condition worse

Proper Use  

Molindone should be taken with food or a full glass (8 ounces) of water or milk to reduce stomach irritation.

The liquid form of molindone may be taken undiluted or mixed with milk, water, fruit juice, or carbonated beverages.

Take this medicine only as directed by your doctor . Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Sometimes this medicine must be taken for several weeks before its full effect is reached in the treatment of certain mental and emotional conditions .

Dosing—The dose of molindone will be different for different patients. Follow your doctor's orders or the directions on the label . The following information includes only the average doses of molindone. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets or amount of solution that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using molindone .

• For oral dosage forms (solution or tablets):
• Adults: To start, 50 to 75 milligrams a day, taken in smaller doses three or four times during the day. For maintenance, the dose you take will depend on your condition and may be from 15 to 225 milligrams a day, taken in smaller doses three or four times during the day.
• Children up to 12 years of age: The dose must be determined by the doctor.

Missed dose—If you miss a dose of this medicine, take it as soon as possible. However, if it is within 2 hours of your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store the tablets in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the liquid form of this medicine from freezing
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions  

Your doctor should check your progress at regular visits. This will allow the dosage of the medicine to be adjusted when necessary and also will reduce the possibility of side effects.

Do not stop taking this medicine without first checking with your doctor . Your doctor may want you to reduce gradually the amount you are taking before stopping completely.

Do not take molindone within 1 or 2 hours of taking antacids or medicine for diarrhea . Taking them too close together may make molindone less effective.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine .

Molindone may cause some people to become drowsy or less alert than they are normally, especially during the first few weeks the medicine is being taken. Even if you take this medicine only at bedtime, you may feel drowsy or less alert on arising. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert .

Dizziness or lightheadedness may occur , especially when you get up from a lying or sitting position. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.

These medicines may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are taking this medicine, since overheating may result in heat stroke . Also, hot baths or saunas may make you feel dizzy or faint while you are taking this medicine.

Molindone may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infection.

Side Effects  

Along with its needed effects, molindone can sometimes cause serious side effects. Tardive dyskinesia (a movement disorder) may occur and may not go away after you stop using the medicine. Symptoms of tardive dyskinesia include fine, worm-like movements of the tongue, or other uncontrolled movements of the mouth, tongue, cheeks, jaw, or arms and legs. Other serious but rare side effects may also occur. These include severe muscle stiffness, fever, unusual tiredness or weakness, fast heartbeat, difficult breathing, increased sweating, loss of bladder control, and seizures (neuroleptic malignant syndrome). You and your doctor should discuss the good this medicine will do as well as the risks of taking it .

Stop taking molindone and get emergency help immediately if any of the following side effects occur:

Rare

Convulsions (seizures); difficult or fast breathing; fast heartbeat or irregular pulse; fever (high); high or low (irregular) blood pressure; increased sweating; loss of bladder control; muscle stiffness (severe); unusually pale skin; unusual tiredness or weakness

Also, check with your doctor as soon as possible if any of the following side effects occur:

More common

Difficulty in talking or swallowing; inability to move eyes; lip smacking or puckering; loss of balance control; mask-like face; muscle spasms, especially of the neck and back; puffing of cheeks; rapid or worm-like movements of tongue; restlessness or need to keep moving (severe); shuffling walk; stiffness of arms and legs; trembling and shaking of hands; twisting movements of body; uncontrolled movements of arms and legs; unusual chewing movements

Less common

Mental depression

Rare

Confusion; hot, dry skin, or lack of sweating; muscle weakness; skin rash; yellow eyes or skin

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

More common

Blurred vision; constipation; decreased sweating; difficult urination; dizziness or lightheadedness, especially when getting up suddenly from a lying or sitting position; drowsiness; dryness of mouth; headache; nausea; stuffy nose

Less common

Changes in menstrual periods; decreased sexual ability; false sense of well-being; swelling of breasts; unusual secretion of milk

Some side effects may occur after you have stopped taking this medicine. Check with your doctor as soon as possible if you notice any of the following effects:

Lip smacking or puckering; puffing of cheeks; rapid or worm-like movements of tongue; uncontrolled chewing movements; uncontrolled movements of arms and legs

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

In the U.S.—

• Nardil ¹
• Parnate ²

In Canada—

• Nardil ¹
• Parnate ²

Category  

• Antidepressant—Phenelzine; Tranylcypromine
• Antipanic agent—Phenelzine; Tranylcypromine
• Headache, tension, prophylactic—Phenelzine; Tranylcypromine
• Vascular headache prophylactic—Phenelzine; Tranylcypromine

Description  

Monoamine oxidase (MAO) inhibitors are used to relieve certain types of mental depression. They work by blocking the action of a chemical substance known as monoamine oxidase (MAO) in the nervous system.

Although these medicines are very effective for certain patients, they may also cause some unwanted reactions if not taken in the right way. It is very important to avoid certain foods, beverages, and medicines while you are being treated with an MAO inhibitor. Your health care professional will help you obtain a list to carry in your wallet or purse as a reminder of which products you should avoid.

MAO inhibitors are available only with your doctor's prescription, in the following dosage forms:

• Oral
• Phenelzine
• Tablets (U.S. and Canada)
• Tranylcypromine
• Tablets (U.S. and Canada)

Before Using This Medicine  

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For monoamine oxidase (MAO) inhibitors, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to any MAO inhibitor. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Diet—Dangerous reactions such as sudden high blood pressure may result when MAO inhibitors are taken with certain foods or drinks. The following foods should be avoided:

• Foods that have a high tyramine content (most common in foods that are aged or fermented to increase their flavor), such as cheeses; fava or broad bean pods; yeast or meat extracts; smoked or pickled meat, poultry, or fish; fermented sausage (bologna, pepperoni, salami, summer sausage) or other fermented meat; sauerkraut; or any overripe fruit. If a list of these foods and beverages is not given to you, ask your health care professional to provide one.
• Alcoholic beverages or alcohol-free or reduced-alcohol beer and wine.
• Large amounts of caffeine-containing food or beverages such as coffee, tea, cola, or chocolate.

Pregnancy—A limited study in pregnant women showed an increased risk of birth defects when these medicines were taken during the first 3 months of pregnancy. In animal studies, MAO inhibitors caused a slowing of growth and increased excitability in the newborn when very large doses were given to the mother during pregnancy.

Breast-feeding—Tranylcypromine passes into the breast milk; it is not known whether phenelzine passes into breast milk. Problems in nursing babies have not been reported.

Children—Studies on these medicines have been done only in adult patients, and there is no specific information comparing use of MAO inhibitors in children with use in other age groups. However, animal studies have shown that these medicines may slow growth in the young. Therefore, be sure to discuss with your doctor the use of these medicines in children.

Older adults—Dizziness or lightheadedness may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to these effects of MAO inhibitors.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking MAO inhibitors, it is especially important that your health care professional know if you are taking any of the following:

• Amphetamines or
• Antihypertensives (high blood pressure medicine) or
• Appetite suppressants (diet pills) or
• Cyclobenzaprine (e.g., Flexeril) or
• Fluoxetine (e.g., Prozac) or
• Levodopa (e.g., Dopar, Larodopa) or
• Maprotiline (e.g., Ludiomil) or
• Medicine for asthma or other breathing problems or
• Medicines for colds, sinus problems, or hay fever or other allergies (including nose drops or sprays) or
• Meperidine (e.g., Demerol) or
• Methylphenidate (e.g., Ritalin) or
• Monoamine oxidase (MAO) inhibitors, other, including furazolidone (e.g., Furoxone), procarbazine (e.g., Matulane), or selegiline (e.g., Eldepryl), or
• Paroxetine (e.g., Paxil), or
• Sertraline (e.g., Zoloft), or
• Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Pertofrane], doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g., Aventyl], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil])—Using these medicines while you are taking or within 2 weeks of taking MAO inhibitors may cause serious side effects such as sudden rise in body temperature, extremely high blood pressure, severe convulsions, and death; however, sometimes certain of these medicines may be used with MAO inhibitors under close supervision by your doctor

• Antidiabetics, oral (diabetes medicine you take by mouth) or
• Insulin—MAO inhibitors may change the amount of antidiabetic medicine you need to take

• Bupropion (e.g., Wellbutrin)—Using bupropion while you are taking or within 2 weeks of taking MAO inhibitors may cause serious side effects such as seizures

• Buspirone (e.g., BuSpar)—Use with MAO inhibitors may cause high blood pressure

• Carbamazepine (e.g., Tegretol)—Use with MAO inhibitors may increase seizures

• Central nervous system (CNS) depressants (medicines that cause drowsiness)—Using these medicines with MAO inhibitors may increase the CNS and other depressant effects

• Cocaine—Cocaine use by persons taking MAO inhibitors, including furazolidone and procarbazine, may cause a severe increase in blood pressure

• Dextromethorphan—Use with MAO inhibitors may cause excitement, high blood pressure, and fever

• Trazodone or
• Tryptophan used as a food supplement or a sleep aid—Use of these medicines by persons taking MAO inhibitors, including furazolidone and procarbazine, may cause mental confusion, excitement, shivering, trouble in breathing, or fever

Other medical problems—The presence of other medical problems may affect the use of MAO inhibitors. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse—Drinking alcohol while you are taking an MAO inhibitor may cause serious side effects

• Angina (chest pain) or
• Headaches (severe or frequent)—These conditions may interfere with warning signs of serious side effects of MAO inhibitors

• Asthma or bronchitis—Some medicines used to treat these conditions may cause serious side effects when used while you are taking an MAO inhibitor

• Diabetes mellitus (sugar diabetes)—These medicines may change the amount of insulin or oral antidiabetic medication that you need

• Epilepsy—Seizures may occur more often

• Heart or blood vessel disease or
• Liver disease or
• Mental illness (or history of) or
• Parkinson's disease or
• Recent heart attack or stroke—MAO inhibitors may make the condition worse

• High blood pressure—Condition may be affected by these medicines

• Kidney disease—Higher blood levels of MAO inhibitors may occur, which increases the chance of side effects

• Overactive thyroid or
• Pheochromocytoma (PCC)—Serious side effects may occur

Proper Use  

Sometimes this medicine must be taken for several weeks before you begin to feel better. Your doctor should check your progress at regular visits, especially during the first few months of treatment, to make sure that this medicine is working properly and to check for unwanted effects .

Take this medicine only as directed by your doctor . Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

MAO inhibitors may be taken with or without food or on a full or empty stomach. However, if your doctor tells you to take the medicine a certain way, take it exactly as directed.

Dosing—The dose of MAO inhibitors will be different for different patients. Follow your doctor's orders or the directions on the label . The following information includes only the average doses of phenelzine and tranylcypromine. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using an MAO inhibitor .

• For phenelzine
• For oral dosage form (tablets):
• For treatment of depression:
• Adults—Dose is based on your body weight. To start, the usual dose is 1 milligram (mg) per kilogram (kg) of body weight (0.45 mg per pound) a day. Your doctor may decrease or increase your dose as needed. However, the dose usually is not more than 90 mg a day.
• Children younger than 16 years of age—Use and dose must be determined by the doctor.
• Older adults—To start, 15 mg in the morning. Your doctor may increase your dose gradually as needed. However, the dose usually is not more than 60 mg a day.

• For tranylcypromine
• For oral dosage form (tablets):
• For treatment of depression:
• Adults—To start, 30 milligrams (mg) a day. Your doctor may increase your dose gradually as needed. However, the dose usually is not more than 60 mg a day.
• Children younger than 16 years of age—Use and dose must be determined by the doctor.
• Older adults—To start, 2.5 to 5 mg a day. The doctor may increase your dose as needed. However, the dose usually is not more than 45 mg a day.

Missed dose—If you miss a dose of this medicine, take it as soon as possible. However, if it is within 2 hours of your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions  

When taken with certain foods, drinks, or other medicines, MAO inhibitors can cause very dangerous reactions such as sudden high blood pressure (also called hypertensive crisis). To avoid such reactions, obey the following rules of caution :

• Do not eat foods that have a high tyramine content (most common in foods that are aged or fermented to increase their flavor), such as cheeses; fava or broad bean pods; yeast or meat extracts; smoked or pickled meat, poultry, or fish; fermented sausage (bologna, pepperoni, salami, and summer sausage) or other fermented meat; sauerkraut; or any overripe fruit. If a list of these foods is not given to you, ask your health care professional to provide one.
• Do not drink alcoholic beverages or alcohol-free or reduced-alcohol beer and wine.
• Do not eat or drink large amounts of caffeine-containing food or beverages such as coffee, tea, cola, or chocolate.
• Do not take any other medicine unless approved or prescribed by your doctor. This especially includes nonprescription (over-the-counter [OTC]) medicine, such as that for colds (including nose drops or sprays), cough, asthma, hay fever, and appetite control; ``keep awake'' products; or products that make you sleepy.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine .

Check with your doctor or hospital emergency room immediately if severe headache, stiff neck, chest pains, fast heartbeat, or nausea and vomiting occur while you are taking this medicine. These may be symptoms of a serious side effect that should have a doctor's attention.

Do not stop taking this medicine without first checking with your doctor . Your doctor may want you to reduce gradually the amount you are using before stopping completely.

Dizziness, lightheadedness, or fainting may occur , especially when you get up from a lying or sitting position. Getting up slowly may help . When you get up from lying down, sit on the edge of the bed with your feet dangling for 1 or 2 minutes. Then stand up slowly. If the problem continues or gets worse, check with your doctor.

This medicine may cause blurred vision or make some people drowsy or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are unable to see well or are not alert .

Before having any kind of surgery, dental treatment, or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine or have used it within the past 2 weeks . Taking MAO inhibitors together with medicines that are used during surgery or dental or emergency treatments may increase the risk of serious side effects.

Your doctor may want you to carry an identification card stating that you are using this medicine.

For patients with angina (chest pain):

• This medicine may cause you to have an unusual feeling of good health and energy. However, do not suddenly increase the amount of exercise you get without discussing it with your doctor . Too much activity could bring on an attack of angina.

For diabetic patients:

• This medicine may affect blood sugar levels. While you are using this medicine, be especially careful in testing for sugar in your blood or urine. If you have any questions about this, check with your doctor.

After you stop using this medicine, you must continue to obey the rules of caution for at least 2 weeks concerning food, drink, and other medicine, since these things may continue to react with MAO inhibitors.

Side Effects  

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Stop taking this medicine and get emergency help immediately if any of the following side effects occur:

Symptoms of unusually high blood pressure (hypertensive crisis)

Chest pain (severe); enlarged pupils; fast or slow heartbeat; headache (severe); increased sensitivity of eyes to light; increased sweating (possibly with fever or cold, clammy skin); nausea and vomiting; stiff or sore neck

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Dizziness or lightheadedness (severe), especially when getting up from a lying or sitting position

Less common

Diarrhea; fast or pounding heartbeat; swelling of feet or lower legs; unusual excitement or nervousness

Rare

Dark urine; fever; skin rash; slurred speech; sore throat; staggering walk; yellow eyes or skin

Symptoms of overdose

Anxiety (severe); confusion; convulsions (seizures); cool, clammy skin; dizziness (severe); drowsiness (severe); fast and irregular pulse; fever; hallucinations (seeing, hearing, or feeling things that are not there); headache (severe); high or low blood pressure; muscle stiffness; sweating; troubled breathing; trouble in sleeping (severe); unusual irritability

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

More common

Blurred vision; decreased amount of urine; decreased sexual ability; dizziness or lightheadedness (mild), especially when getting up from a lying or sitting position; drowsiness; headache (mild); increased appetite (especially for sweets) or weight gain; increased sweating; muscle twitching during sleep; restlessness; shakiness or trembling; tiredness and weakness; trouble in sleeping

Less common or rare

Chills; constipation; decreased appetite; dryness of mouth

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Additional Information  

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, phenelzine and tranylcypromine are used in certain patients with the following medical conditions:

• Headache
• Panic disorder

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.

In the U.S.—

• Navane ³
• Taractan ¹
• Thiothixene HCl Intensol ³

In Canada—

• Fluanxol ²
• Fluanxol Depot ²
• Navane ³

Category  

• Antipsychotic—Chlorprothixene; Flupenthixol; Thiothixene

Description  

This medicine belongs to the family of medicines known as thioxanthenes (thye-oh-ZAN-theens) . It is used in the treatment of nervous, mental, and emotional conditions. Improvement in such conditions is thought to result from the effect of the medicine on nerve pathways in specific areas of the brain.

Thioxanthene medicines are available only with your doctor's prescription, in the following dosage forms:

• Oral
• Chlorprothixene
• Suspension (U.S.)
• Tablets (U.S.)
• Flupenthixol
• Tablets (Canada)
• Thiothixene
• Capsules (U.S. and Canada)
• Solution (U.S.)

• Parenteral
• Chlorprothixene
• Injection (U.S.)
• Flupenthixol
• Injection (Canada)
• Thiothixene
• Injection (U.S.)

Before Using This Medicine  

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For thioxanthenes, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to thioxanthene or to phenothiazine medicines. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies have not been done in pregnant women. Although animal studies have not shown that thioxanthenes cause birth defects, the studies have shown that these medicines cause a decrease in fertility and fewer successful pregnancies.

Breast-feeding—It is not known if thioxanthenes pass into the breast milk. However, similar medicines for nervous, mental, or emotional conditions do pass into breast milk and may cause drowsiness and increase the risk of other problems in the nursing baby. Be sure you have discussed the risks and benefits of this medicine with your doctor.

Children—Certain side effects, such as muscle spasms of the face, neck, and back, tic-like or twitching movements, inability to move the eyes, twisting of the body, or weakness of the arms and legs, are more likely to occur in children, who are usually more sensitive than adults to the side effects of thioxanthenes.

Older adults—Constipation, dizziness or fainting, drowsiness, dryness of mouth, trembling of the hands and fingers, and symptoms of tardive dyskinesia (such as rapid, worm-like movements of the tongue or any other uncontrolled movements of the mouth, tongue, or jaw, and/or arms and legs) are especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of thioxanthenes.

Other medicines—Although certain medicines should not be used together at all, in other cases 2 different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking thioxanthenes, it is especially important that your health care professional know if you are taking any of the following:

• Amoxapine (e.g., Asendin) or
• Methyldopa (e.g., Aldomet) or
• Metoclopramide (e.g., Reglan) or
• Metyrosine (e.g., Demser) or
• Other antipsychotics (medicine for mental illness) or
• Pemoline (e.g., Cylert) or
• Pimozide (e.g., Orap) or
• Promethazine (e.g., Phenergan) or
• Rauwolfia alkaloids (alseroxylon [e.g., Rauwiloid], deserpidine [e.g., Harmonyl], rauwolfia serpentina [e.g., Raudixin], reserpine [e.g., Serpasil]) or
• Trimeprazine (e.g., Temaril)—Taking these medicines with thioxanthenes may increase the chance and severity of certain side effects

• Central nervous system (CNS) depressants (medicine that causes drowsiness) or
• Tricyclic antidepressants (medicine for depression)—Taking these medicines with thioxanthenes may add to the CNS depressant effects

• Epinephrine (e.g., Adrenalin)—Severe low blood pressure (hypotension) and fast heartbeat may occur if epinephrine is used with thioxanthenes

• Levodopa (e.g., Sinemet)—Thioxanthenes may keep levodopa from working properly in the treatment of Parkinson's disease

• Quinidine (e.g., Quinidex)—Unwanted effects on your heart may occur

Other medical problems—The presence of other medical problems may affect the use of thioxanthenes. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse—Drinking alcohol will add to the central nervous system (CNS) depressant effects of thioxanthenes

• Blood disease or
• Enlarged prostate or
• Glaucoma or
• Heart or blood vessel disease or
• Lung disease or
• Parkinson's disease or
• Stomach ulcers or
• Urination problems—Thioxanthenes may make the condition worse

• Liver disease—Higher blood levels of thioxanthenes may occur, increasing the chance of side effects

• Reye's syndrome—The risk of liver problems may be increased

• Seizure disorders—The risk of seizures may be increased

Proper Use  

This medicine may be taken with food or a full glass (8 ounces) of water or milk to reduce stomach irritation.

For patients taking thiothixene oral solution :

• This medicine must be diluted before you take it. Just before taking, measure the dose with the specially marked dropper. Mix the medicine with a full glass of water, milk, tomato or fruit juice, soup, or carbonated beverage.

Do not take more of this medicine or take it more often than your doctor ordered . This is particularly important when this medicine is given to children, since they may react very strongly to its effects.

Sometimes this medicine must be taken for several weeks before its full effect is reached .

Dosing—The dose of these medicines will be different for different patients. Follow your doctor's orders or the directions on the label . The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The number of capsules or tablets or the amount of liquid that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking thioxanthenes.

• For chlorprothixene
• For treatment of psychosis:
• Oral dosage forms (suspension or tablets):
• Adults and teenagers—25 to 50 milligrams (mg) three or four times a day.
• Children 6 to 12 years of age—10 to 25 mg three or four times a day.
• Children up to 6 years of age—Use and dose must be determined by your doctor.
• Injection dosage form:
• Adults and teenagers—25 to 50 mg, injected into a muscle, three or four times a day.
• Children up to 12 years of age—Use and dose must be determined by your doctor.

• For flupenthixol
• For treatment of psychosis:
• Oral dosage form (tablets):
• Adults—To start, 1 milligram (mg) three times a day. Your doctor may increase your dose if needed, depending on your condition.
• Children—Use and dose must be determined by your doctor.
• Long-acting injection dosage form:
• Adults—To start, 20 to 40 milligrams (mg) injected into a muscle. Your doctor will determine whether your dose needs to be changed, depending on your condition.
• Children—Use and dose must be determined by your doctor.

• For thiothixene
• For treatment of psychosis:
• Oral dosage forms (capsules and solution):
• Adults and teenagers—To start, 2 milligrams (mg) three times a day, or 5 mg two times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 60 mg a day.
• Children up to 12 years of age—Use and dose must be determined by your doctor.
• Injection dosage form:
• Adults and teenagers—4 milligrams (mg), injected into a muscle, two to four times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 30 mg a day.
• Children up to 12 years of age—Use and dose must be determined by your doctor.

Missed dose—If you miss a dose of this medicine, take it as soon as possible. However, if it is within 2 hours of your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store the capsule or tablet form of this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the liquid form of this medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions  

Your doctor should check your progress at regular visits. This will allow the dosage of the medicine to be adjusted when necessary and also will reduce the possibility of side effects.

Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping completely. This is to prevent side effects and to prevent your condition from becoming worse.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any such depressants while you are using this medicine .

Do not take this medicine within an hour of taking antacids or medicine for diarrhea. Taking them too close together may make this medicine less effective.

Before having any kind of surgery, dental treatment, or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine . Taking thioxanthenes together with medicines that are used during surgery or dental or emergency treatments may increase the CNS depressant effects.

This medicine may cause some people to become drowsy or less alert than they are normally, especially during the first few weeks the medicine is being taken. Even if you take this medicine only at bedtime, you may feel drowsy or less alert on arising. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert .

Dizziness, lightheadedness, or fainting may occur while you are taking this medicine , especially when you get up from a lying or sitting position. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.

This medicine may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are taking this medicine , since overheating may result in heat stroke. Also, hot baths or saunas may make you feel dizzy or faint while you are taking this medicine.

Thioxanthenes may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.
• Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.
• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor .

This medicine may cause dryness of the mouth. For temporary relief, use sugarless gum or candy, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

If you are taking a liquid form of this medicine, try to avoid spilling it on your skin or clothing . Skin rash and irritation have been caused by similar medicines.

If you are receiving this medicine by injection:

• The effects of the long-acting injection form of this medicine may last for up to 3 weeks. The precautions and side effects information for this medicine applies during this period of time .

Side Effects  

Along with their needed effects, thioxanthenes can sometimes cause serious side effects. Tardive dyskinesia (a movement disorder) may occur and may not go away after you stop using the medicine. Signs of tardive dyskinesia include fine, worm-like movements of the tongue, or other uncontrolled movements of the mouth, tongue, cheeks, jaw, or arms and legs. Other serious but rare side effects may also occur. Some of these side effects, including severe muscle stiffness, fever, unusual tiredness or weakness, fast heartbeat, difficult breathing, increased sweating, loss of bladder control, and seizures, may be the sign of a condition called neuroleptic malignant syndrome. You and your doctor should discuss the good this medicine will do as well as the risks of taking it .

Although not all of these side effects may occur, if they do occur they may need medical attention.

Stop taking this medicine and get emergency help immediately if any of the following side effects occur:

Rare

Convulsions (seizures); difficulty in breathing; fast heartbeat; high fever; high or low (irregular) blood pressure; increased sweating; loss of bladder control; muscle stiffness (severe); unusually pale skin; unusual tiredness

Also, check with your doctor as soon as possible if any of the following side effects occur:

More common

Difficulty in talking or swallowing; inability to move eyes; lip smacking or puckering; loss of balance control; mask-like face; muscle spasms, especially of the neck and back; puffing of cheeks; rapid or worm-like movements of tongue; restlessness or need to keep moving (severe); shuffling walk; stiffness of arms and legs; trembling and shaking of fingers and hands; twisting movements of body; uncontrolled chewing movements; uncontrolled movements of the arms and legs

Less common

Blurred vision or other eye problems; difficult urination; fainting; skin discoloration; skin rash

Rare

Hot, dry skin or lack of sweating; increased blinking or spasms of eyelid; muscle weakness; sore throat and fever; uncontrolled twisting movements of neck, trunk, arms, or legs; unusual bleeding or bruising; unusual facial expressions or body positions; yellow eyes or skin

Symptoms of overdose

Difficulty in breathing (severe); dizziness (severe); drowsiness (severe); muscle trembling, jerking, stiffness, or uncontrolled movements (severe); small pupils; unusual excitement; unusual tiredness or weakness (severe)

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

More common

Constipation; decreased sweating; dizziness, lightheadedness, or fainting; drowsiness (mild); dryness of mouth; increased appetite and weight; increased sensitivity of skin to sunlight (skin rash, itching, redness or other discoloration of skin, or severe sunburn); stuffy nose

Less common

Changes in menstrual period; decreased sexual ability; swelling of breasts (in males and females); unusual secretion of milk

After you stop taking this medicine your body may need time to adjust, especially if you took this medicine in high doses or for a long time. If you stop taking it too quickly, the following withdrawal effects may occur and should be reported to your doctor:

Dizziness; nausea and vomiting; stomach pain; trembling of fingers and hands; uncontrolled, continuing movements of mouth, tongue, or jaw

Although not all of the side effects listed above have been reported for all thioxanthenes, they have been reported for at least one of them. However, since these medicines are very similar, any of the above side effects may occur with any of them.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Generic name: Desipramine hydrochloride

Brand name: Norpramin

Why is this drug prescribed?

Desipramine hydrochloride is used in the treatment of depression. It is one of a family of drugs called tricyclic antidepressants. Drugs in this class are thought to work by affecting the levels of the brain's natural chemical messengers (called neurotransmitters), and adjusting the brain's response to them.

Desipramine hydrochloride has also been used to treat bulimia and attention deficit disorders, and to help with cocaine withdrawal.

Most important fact about this drug

Serious, sometimes fatal, reactions have been known to occur when drugs such as desipramine hydrochloride are taken with another type of antidepressant called an MAO inhibitor. Drugs in this category include Nardil and Parnate. Do not take desipramine hydrochloride within two weeks of taking one of these drugs. Make sure your doctor and pharmacist know of all the medications you are taking.

How should you take this medication?

Desipramine hydrochloride should be taken exactly as prescribed.

Do not stop taking desipramine hydrochloride if you feel no immediate effect. It can take up to 2 or 3 weeks for improvement to begin.

Desipramine hydrochloride can cause dry mouth. Sucking hard candy or chewing gum can help this problem.

• If you miss a dose...

If you take several doses per day, take the forgotten dose as soon as you remember, then take any remaining doses for the day at evenly spaced intervals. If you take desipramine hydrochloride once a day at bedtime and don't remember until morning, skip the missed dose. Never try to "catch up" by doubling the dose.

• Storage instructions...

Desipramine hydrochloride can be stored at room temperature. Protect it from excessive heat.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking desipramine hydrochloride.

• Side effects may include:
  Abdominal cramps, agitation, anxiety, black tongue, black, red, or blue spots on skin, blurred vision, breast development in males, breast enlargement in females, confusion, constipation, delusions, diarrhea, dilated pupils, disorientation, dizziness, drowsiness, dry mouth, excessive or spontaneous flow of milk, fatigue, fever, flushing, frequent urination or difficulty or delay in urinating, hallucinations, headache, heart attack, heartbeat irregularities, hepatitis, high or low blood pressure, high or low blood sugar, hives, impotence, increased or decreased sex drive, inflammation of the mouth, insomnia, intestinal blockage, lack of coordination, light-headedness (especially when rising from lying down), loss of appetite, loss of hair, mild elation, nausea, nightmares, odd taste in mouth, painful ejaculation, palpitations, purplish spots on the skin, rapid heartbeat, restlessness, ringing in the ears, seizures, sensitivity to light, skin itching and rash, sore throat, stomach pain, stroke, sweating, swelling due to fluid retention (especially in face or tongue), swelling of testicles, swollen glands, tingling, numbness and pins and needles in hands and feet, tremors, urinating at night, visual problems, vomiting, weakness, weight gain or loss, worsening of psychosis, yellowed skin and whites of eyes

Why should this drug not be prescribed?

Desipramine hydrochloride should not be used if you are known to be hypersensitive to it, or if you have had a recent heart attack.

People who take antidepressant drugs known as MAO inhibitors (including Nardil and Parnate) should not take desipramine hydrochloride.

Special warnings about this medication

Before using desipramine hydrochloride, tell your doctor if you have heart or thyroid disease, a seizure disorder, a history of being unable to urinate, or glaucoma.

Nausea, headache, and uneasiness can result if you suddenly stop taking desipramine hydrochloride. Consult your doctor and follow instructions closely when discontinuing desipramine hydrochloride.

This drug may impair your ability to drive a car or operate potentially dangerous machinery. Do not participate in any activities that require full alertness if you are unsure about your ability.

Desipramine hydrochloride may increase your skin's sensitivity to sunlight. Overexposure could cause rash, itching, redness, or sunburn. Avoid direct sunlight or wear protective clothing.

If you are planning to have elective surgery, make sure that your doctor is aware that you are taking desipramine hydrochloride. It should be discontinued as soon as possible prior to surgery.

Tell your doctor if you develop a fever and sore throat while you are taking desipramine hydrochloride. He may want to do some blood tests.

Possible food and drug interactions when taking this medication

People who take antidepressant drugs known as MAO inhibitors (including Nardil and Parnate) should not take desipramine hydrochloride.

If desipramine hydrochloride is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Norpramin with the following:

• Cimetidine (Tagamet)
• Drugs that improve breathing, such as Proventil
• Drugs that relax certain muscles, such as Bentyl
• Fluoxetine (Prozac)
• Guanethidine (Ismelin)
• Paroxetine (Paxil)
• Sedatives/hypnotics (Halcion, Valium)
• Sertraline (Zoloft)
• Thyroid medications (Synthroid)

Extreme drowsiness and other potentially serious effects can result if desipramine hydrochloride is combined with alcohol or other depressants, including narcotic painkillers such as Percocet and Demerol, sleeping medications such as Halcion and Nembutal, and tranquilizers such as Valium and Xanax.

Special information if you are pregnant or breastfeeding

Pregnant women or mothers who are nursing an infant should use desipramine hydrochloride only when the potential benefits clearly outweigh the potential risks. If you are pregnant or planning to become pregnant, inform your doctor immediately.

Recommended dosage

• ADULTS

The usual dose ranges from 100 to 200 milligrams per day, taken in 1 dose or divided into smaller doses. If needed, dosages may gradually be increased to 300 milligrams a day. Dosages above 300 milligrams per day are not recommended.

• CHILDREN

Norpramin is not recommended for children.

• OLDER ADULTS AND ADOLESCENTS

The usual dose ranges from 25 to 100 milligrams per day. If needed, dosages may gradually be increased to 150 milligrams a day. Doses above 150 milligrams per day are not recommended.

Overdosage

Any medication taken in excess can have serious consequences. An overdosage of desipramine hydrochloride can be fatal. If you suspect an overdose, seek medical help immediately.

• Symptoms of overdose may include:

Agitation, coma, confusion, convulsions, dilated pupils, disturbed concentration, drowsiness, extremely low blood pressure, hallucinations, high fever, irregular heart rate, low body temperature, overactive reflexes, rigid muscles, stupor, vomiting.

In the U.S.—

• Orap

In Canada—

• Orap

Category  

• Antidyskinetic, Gilles de la Tourette's syndrome
• Antipsychotic

Description  

Pimozide (PIM-oh-zide) is used to treat the symptoms of Tourette's syndrome. It is meant only for patients with severe symptoms who cannot take or have not been helped by other medicine.

Pimozide works in the central nervous system to help control the vocal outbursts and uncontrolled, repeated movements of the body (tics) that interfere with normal life. It will not completely cure the tics, but will help to reduce their number and severity.

Pimozide may also be used for other conditions as determined by your doctor.

This medicine is available only with your doctor's prescription, in the following dosage form:

• Oral
• Tablets (U.S. and Canada)

Before Using This Medicine  

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For pimozide, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to pimozide, haloperidol, or other medicines used to treat mental illness. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies in rats and rabbits given more than the highest recommended human dose of pimozide have shown fewer pregnancies, slowed development of the fetus, and toxic effects in the mother and fetus.

Breast-feeding—It is not known whether pimozide passes into breast milk.

Children—Children are especially sensitive to the effects of pimozide. This may increase the chance of side effects during treatment. Pimozide usually is not used in children for any condition other than Tourette's syndrome.

Older adults—Constipation, dizziness or fainting, drowsiness, dryness of mouth, and trembling of the hands and fingers, and symptoms of tardive dyskinesia (such as rapid, worm-like movements of the tongue or any other uncontrolled movements of the mouth, tongue, or jaw, and/or arms and legs) may be especially likely to occur in the elderly, who are usually more sensitive than younger adults to the effects of pimozide.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking pimozide, it is especially important that your health care professional know if you are taking any of the following:

• Amoxapine (e.g., Asendin) or
• Antipsychotics (medicine for mental illness) or
• Metoclopramide (e.g., Reglan) or
• Metyrosine (e.g., Demser) or
• Paroxetine (e.g., Paxil) or
• Promethazine (e.g., Phenergan) or
• Rauwolfia alkaloids (deserpidine [e.g., Harmonyl], rauwolfia serpentina [e.g., Raudixin], reserpine [e.g., Serpalan]) or
• Tacrine (e.g., Cognex)—Taking these medicines with pimozide may increase the chance of developing unusual movements

• Amphetamines or
• Methylphenidate (e.g., Ritalin) or
• Pemoline (e.g., Cylert)—These medicines may cause tics and pimozide is not used to treat tics caused by other medicines

• Anticholinergics (medicine for abdominal or stomach spasms or cramps)—Taking these medicines with pimozide may increase the chance of certain side effects, such as dryness of mouth, constipation, and unusual excitement

• Azithromycin (e.g., Zithromax) or
• Clarithromycin (e.g., Biaxin) or
• Dirithromycin (e.g., Dynabac) or
• Disopyramide (e.g., Norpace) or
• Erythromycin (e.g., Erybid) or
• Maprotiline (e.g., Ludiomil) or
• Phenothiazines (chlorpromazine [e.g., Thorazine], fluphenazine [e.g., Prolixin], mesoridazine [e.g., Serentil], methotrimeprazine [e.g., Nozinan], pericyazine [e.g., Neuleptil], perphenazine [e.g., Trilafon], pipotiazine [e.g., Piportil L ₄ ], prochlorperazine [e.g., Compazine], promazine [e.g., Sparine], thiopropazate [e.g., Dartal], thioproperazine [e.g., Majeptil], thioridazine [e.g., Mellaril], trifluoperazine [e.g., Stelazine], triflupromazine [e.g., Vesprin]) or
• Probucol (e.g., Lorelco) or
• Procainamide (e.g., Pronestyl) or
• Quinidine (e.g., Quinidex) or
• Ritonavir (e.g., Norvir) or
• Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Pertofrane], doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g., Aventyl], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil])— Do not take any of these medicines while you are taking pimozide . Taking these medicines with pimozide may increase the chance of developing serious changes in the rhythm of your heart

• Central nervous system (CNS) depressants (medicines that cause drowsiness)—Using these medicines with pimozide may increase the CNS depressant effects

Other medical problems—The presence of other medical problems may affect the use of pimozide. Make sure you tell your doctor if you have any other medical problems, especially:

• Breast cancer (history of) or
• Glaucoma, narrow angle or
• Heart disease or
• Intestinal blockage or
• Urinary tract blockage or difficult urination—Pimozide may make the condition worse

• Kidney disease or
• Liver disease—Higher blood levels of pimozide may occur, increasing the chance of side effects

• Low blood potassium—Pimozide may increase the chance of developing serious changes in heart rhythm

• Seizures, history of—Pimozide may increase the chance of having seizures

• Tics other than those caused by Tourette's syndrome—Pimozide should not be used because of the risk of serious side effects

Proper Use  

Use pimozide only as directed by your doctor . Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Dosing—The dose of pimozide will be different for different patients. Follow your doctor's orders or the directions on the label . The following information includes only the average doses of pimozide. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using pimozide .

• For oral dosage form (tablets):
• For Tourette's syndrome:
• Adults—To start, 1 to 2 milligrams (mg) a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 10 mg a day.
• Children up to 12 years of age—Dose must be determined by the doctor.
• Children 12 years of age and older—To start, 0.05 mg per kilogram (0.023 mg per pound) of body weight a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 10 mg a day.

Missed dose—If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions  

Your doctor should check your progress at regular visits, especially during the first few months of treatment with this medicine. The amount of pimozide you take may be changed often to meet the needs of your condition and to help avoid unwanted effects.

Do not take azithromycin, clarithromycin, dirithromycin, disopyramide, erythromycin, maprotiline, phenothiazines, probucol, procainamide, quinidine, ritonavir, or tricyclic antidepressants while you are taking pimozide , or you may develop a very serious irregular heartbeat.

Do not suddenly stop taking this medicine without first checking with your doctor . Your doctor may want you to reduce gradually the amount you are taking before stopping completely. This will allow your body time to adjust and help to avoid worsening of your medical condition.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine .

This medicine may cause some people to become drowsy or less alert or to have blurred vision or muscle stiffness, especially as the amount of medicine is increased. Even if you take pimozide at bedtime, you may feel drowsy or less alert on arising. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to see well or if you do not have good muscle control .

Although not a problem for many patients, dizziness, lightheadedness, or fainting may occur when you get up from a sitting or lying position. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.

Before having any kind of surgery, dental treatment, or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine . Taking pimozide together with medicines that are used during surgery or dental or emergency treatment may increase the CNS depressant effects.

Pimozide may cause dryness of the mouth. For temporary relief, use sugarless gum or candy, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Side Effects  

Along with its needed effects, pimozide can sometimes cause serious unwanted effects. Tardive dyskinesia (a movement disorder) may occur and may not go away after you stop using the medicine. Signs of tardive dyskinesia include fine, worm-like movements of the tongue, or other uncontrolled movements of the mouth, tongue, cheeks, jaw, or arms and legs. Other serious but rare side effects, such as abnormal heart rhythm or the neuroleptic malignant syndrome, may also occur. You and your doctor should discuss the good this medicine will do as well as the risks of taking it .

Stop taking pimozide and get emergency help immediately if any of the following side effects occur:

Rare—Signs of the neuroleptic malignant syndrome (usually two or more occur together)

Convulsions (seizures); difficult or unusually fast breathing; fast heartbeat or irregular pulse; fever (high); high or low (irregular) blood pressure; increased sweating; loss of bladder control; muscle stiffness (severe)

Symptoms of overdose

Coma; convulsions (seizures); dizziness (severe); muscle trembling, jerking, or stiffness (severe); troubled breathing (severe); uncontrolled movements (severe)

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Difficulty in speaking; dizziness or fainting; fast or irregular heartbeat; loss of balance control; lack of facial expression; mood or behavior changes; restlessness or need to keep moving; shuffling walk; slowed movements; stiffness of arms and legs; swelling or soreness of breasts (less common in males); trembling and shaking of fingers and hands; unusual secretion of milk (rare in males)

Less common or rare

Difficulty in swallowing; inability to move eyes; increased blinking or spasms of eyelid; lip smacking or puckering; menstrual changes; muscle spasms, especially of the face, neck, or back; puffing of cheeks; rapid or worm-like movements of tongue; skin rash and itching; sore throat and fever; swelling of face; uncontrolled chewing movements; uncontrolled movements of neck, trunk, arms, or legs, including twisting movements; unusual bleeding or bruising; unusual facial expressions or body positions; yellow eyes or skin

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

More common

Blurred vision or other vision problems; constipation; dizziness, lightheadedness, or fainting when getting up from a lying or sitting position; drowsiness; dryness of mouth; skin discoloration

Less common

Decreased sexual ability; diarrhea; headache; loss of appetite and weight; mental depression; nausea and vomiting; tiredness or weakness

After you stop using pimozide, it may still produce some side effects that need attention. During this period of time, check with your doctor as soon as possible if you notice any of the following side effects:

Lip smacking or puckering; puffing of cheeks; rapid or worm-like movements of the tongue; uncontrolled chewing movements; uncontrolled movements of the arms and legs

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Additional Information  

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, pimozide is used in certain patients with the following medical condition:

• Psychotic disorders, such as schizophrenia

In the U.S.—

• Paxil

In Canada—

• Paxil

Category  

• Antianxiety agent
• antidepressant
• antiobsessional agent
• antipanic agent

Description  

Paroxetine (pa-ROX-uh-teen) is used to treat mental depression, obsessive-compulsive disorder, panic disorder, and social anxiety disorder (also known as social phobia).

Paroxetine belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). These medicines are thought to work by increasing the activity of the chemical serotonin in the brain.

This medicine is available only with your doctor's prescription, in the following dosage forms:

• Oral
• Extended-release Tablets (U.S.)
• Oral Suspension (U.S.)
• Tablets (U.S. and Canada)

Before Using This Medicine  

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For paroxetine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to paroxetine. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—One study looked at the babies of 97 women who took paroxetine either at the beginning of pregnancy or through the entire pregnancy. This study found no harmful effects of paroxetine on the babies. However, more study is needed to be sure that paroxetine is safe to use during pregnancy. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—Paroxetine passes into the breast milk. However, the effects of this medicine in nursing babies are not known.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of paroxetine in children with use in other age groups.

Older adults—In studies that have included elderly people, paroxetine did not cause different side effects or problems in older people than it did in younger adults. However, paroxetine may be removed from the body more slowly in elderly people. An older adult may need a lower dose than a younger adult.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking paroxetine, it is especially important that your health care professional know if you are taking any of the following:

• Astemizole (e.g., Hismanal)—Taking astemizole while you are using paroxetine may lead to a serious change in the rhythm of your heartbeat

• Buspirone (e.g., BuSpar) or
• Bromocriptine (e.g., Parlodel) or
• Dextromethorphan (cough medicine) or
• Levodopa (e.g., Sinemet) or
• Lithium (e.g., Eskalith) or
• Meperidine (e.g., Demerol) or
• Nefazodone (e.g., Serzone) or
• Pentazocine (e.g., Talwin) or
• Selective serotonin reuptake inhibitors, other (citalopram [e.g., Celexa], fluoxetine [e.g., Prozac], fluvoxamine [e.g., Luvox], sertraline [Zoloft]) or
• Street drugs (LSD, MDMA [e.g., ecstasy], marijuana) or
• Sumatriptan (e.g., Imitrex) or
• Tramadol (e.g., Ultram) or
• Trazodone (e.g., Desyrel) or
• Tryptophan or
• Venlafaxine (e.g., Effexor)—Using these medicines with paroxetine may increase the chance of developing a rare, but very serious, unwanted effect known as the serotonin syndrome. This syndrome may cause confusion, diarrhea, fever, poor coordination, restlessness, shivering, sweating, talking or acting with excitement you cannot control, trembling or shaking, or twitching. If you develop these symptoms, contact your doctor as soon as possible. Using tryptophan with paroxetine is not recommended

• Moclobemide (e.g., Manerex)—The risk of developing serious unwanted effects, including the serotonin syndrome, is increased. Use of moclobemide with paroxetine is not recommended. Also, it is recommended that 3 to 7 days be allowed between stopping treatment with moclobemide and starting treatment with paroxetine, and that 2 weeks be allowed between stopping treatment with paroxetine and starting treatment with moclobemide

• Monoamine oxidase (MAO) inhibitors (furazolidone [e.g., Furoxone], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate])— Do not take paroxetine while you are taking or within 2 weeks of taking an MAO inhibitor , or you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, sudden high body temperature, extremely high blood pressure, severe convulsions, or the serotonin syndrome. At least 14 days should be allowed between stopping treatment with one medicine (paroxetine or the MAO inhibitor) and starting treatment with the other

• Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Pertofrane], doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g., Aventyl], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil])—Taking a tricyclic antidepressant together with paroxetine may increase the risk of side effects. Your doctor may need to adjust the dose of either medicine or check blood levels of the tricyclic antidepressant. Also, taking paroxetine with amitriptyline, clomipramine, or imipramine may increase the chance that the serotonin syndrome will develop

• Warfarin (e.g., Coumadin)—Taking this medicine together with paroxetine may cause bleeding problems; your doctor may need to adjust the dosage of either medicine

Other medical problems—The presence of other medical problems may affect the use of paroxetine. Make sure you tell your doctor if you have any other medical problems, especially:

• Brain disease or damage, or mental retardation or
• Seizures (history of)—The risk of seizures may be increased

• Kidney disease, severe, or
• Liver disease, severe—Higher blood levels of paroxetine may occur, increasing the chance of side effects

• Mania (history of)—The condition may be activated

Proper Use  

Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Paroxetine may be taken with or without food or on a full or empty stomach. However, if your doctor tells you to take the medicine a certain way, take it exactly as directed.

You may have to take paroxetine for several weeks before you begin to feel better . Your doctor should check your progress at regular visits during this time. Also, if you are taking paroxetine for depression, you will probably need to continue taking it for at least 6 months to help prevent the depression from returning.

If you are taking the oral suspension form of paroxetine, shake the bottle well before measuring each dose. Use a small measuring cup or a measuring spoon to measure each dose. The teaspoons and tablespoons that are used for serving and eating food do not measure exact amounts.

If you are taking the extended-release tablet form of this medicine, swallow the tablet whole. Do not crush, break, or chew before swallowing.

Dosing—The dose of paroxetine will be different for different patients. Follow your doctor's orders or the directions on the label . The following information includes only the average doses of paroxetine. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral suspension dosage form:
• For treatment of depression:
• Adults—At first, 20 milligrams (mg) (10 milliliters [mL]) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 50 mg (25 mL) a day.
• Children—Use and dose must be determined by your doctor.
• Older adults—At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg (20 mL) a day.
• For treatment of obsessive-compulsive disorder:
• Adults—At first, 20 milligrams (mg) (10 milliliters [mL]) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 60 mg (30 mL) a day.
• Children—Use and dose must be determined by your doctor.
• Older adults—At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg (20 mL) a day.
• For treatment of panic disorder:
• Adults—At first, 10 milligrams (mg) (5 milliliters [mL]) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 60 mg (30 mL) a day.
• Children—Use and dose must be determined by your doctor.
• Older adults—At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg (20 mL) a day.
• For treatment of social anxiety disorder:
• Adults—At first, 20 milligrams (mg) (10 milliliters [mL]) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not not more than 60 mg (30 mL) a day.
• Children—Use and dose must be determined by your doctor.
• Older adults—At first, 10 mg once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg a day.

• For oral tablet dosage form:
• For treatment of depression:
• Adults—At first, 20 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 50 mg a day.
• Children—Use and dose must be determined by your doctor.
• Older adults—At first, 10 mg once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg a day.
• For treatment of obsessive-compulsive disorder:
• Adults—At first, 20 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 60 mg a day.
• Children—Use and dose must be determined by your doctor.
• Older adults—At first, 10 mg once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg a day.
• For treatment of panic disorder:
• Adults—At first, 10 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 60 mg a day.
• Children—Use and dose must be determined by your doctor.
• Older adults—At first, 10 mg once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg a day.
• For treatment of social anxiety disorder:
• Adults—At first, 20 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 60 mg a day.
• Children—Use and dose must be determined by your doctor.
• Older adults—At first, 10 mg once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg a day.

• For oral extended-release tablet dosage form:
• For treatment of depression:
• Adults—At first, 25 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 62.5 mg a day.
• Children—Use and dose must be determined by your doctor.
• Older adults—At first, 12.5 mg once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 50 mg a day.

Missed dose—If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store the tablet form of this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the oral suspension form of this medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions  

It is important that your doctor check your progress at regular visits, to allow for changes in your dose and to help reduce any side effects.

Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely. This is to decrease the chance of having discontinuation symptoms such as agitation, confusion, diarrhea, dizziness or lightheadedness, headache, increased sweating, muscle pain, nausea, restlessness, runny nose, trouble in sleeping, trembling or shaking, unusual tiredness or weakness, vision changes, or vomiting.

Do not take paroxetine if you have taken a monoamine oxidase (MAO) inhibitor (furazolidone, phenelzine, procarbazine, selegiline, tranylcypromine) in the past 2 weeks. Do not start taking an MAO inhibitor within 2 weeks of stopping paroxetine . If you do, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, sudden high body temperature, extremely high blood pressure, severe convulsions, or the serotonin syndrome.

Paroxetine has not been shown to add to the effects of alcohol. However, use of alcohol is not recommended in patients who are taking paroxetine.

Paroxetine may cause some people to become drowsy or have blurred vision. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to see clearly .

Side Effects  

Along with its needed effects, a medicine may cause some unwanted effects. One rare but serious unwanted effect that may occur with paroxetine use is the serotonin syndrome. This syndrome (group of symptoms) is more likely to occur shortly after the dose of paroxetine is increased.

Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Less common

Agitation; fast or irregular heartbeat; muscle pain or weakness; skin rash

Rare

Absence of or decrease in body movements; difficulty in speaking; inability to move eyes; incomplete, sudden, or unusual body or facial movements; low blood sodium (confusion, convulsions [seizures], drowsiness, dryness of mouth, increased thirst, lack of energy); red or purple patches on skin; serotonin syndrome (confusion, diarrhea, fever, poor coordination, restlessness, shivering, sweating, talking and acting with excitement you cannot control, trembling or shaking, twitching); talking, feeling, and acting with excitement and activity you cannot control

Symptoms of overdose

Dizziness; drowsiness; dryness of mouth; flushing of face; irritability; large pupils; nausea; racing heartbeat; trembling or shaking; vomiting

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

More common

Constipation; decreased sexual ability; diarrhea; dizziness; drowsiness; dryness of mouth; headache; increased sweating; nausea; problems in urinating; trembling or shaking; trouble in sleeping; unusual tiredness or weakness; vomiting

Less common

Anxiety or nervousness; blurred vision; change in sense of taste; decreased or increased appetite; decreased sexual desire; tingling, burning, or prickling sensations; weight loss or gain

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time check with your doctor if you notice any of the following side effects:

Agitation, confusion, or restlessness; diarrhea; dizziness or lightheadedness; headache; increased sweating; muscle pain; nausea or vomiting; runny nose; trembling or shaking; trouble in sleeping; unusual tiredness or weakness; vision changes

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Generic name: Fluoxetine hydrochloride

Brand name: Prozac

Why is this drug prescribed?

Fluoxetine hydrochloride is prescribed for the treatment of depression--that is, a continuing depression that interferes with daily functioning. The symptoms of major depression often include changes in appetite, sleep habits, and mind/body coordination; decreased sex drive; increased fatigue; feelings of guilt or worthlessness; difficulty concentrating; slowed thinking; and suicidal thoughts.

Fluoxetine hydrochloride is also prescribed to treat obsessive-compulsive disorder. An obsession is a thought that won't go away; a compulsion is an action done over and over to relieve anxiety.

Fluoxetine hydrochloride is thought to work by adjusting the balance of the brain's natural chemical messengers. It has also been used to treat obesity and eating disorders.

Most important fact about this drug

Serious, sometimes fatal, reactions have been known to occur when Fluoxetine hydrochloride is used in combination with other antidepressant drugs known as MAO inhibitors, including Nardil and Parnate; and when Fluoxetine hydrochloride is discontinued and an MAO inhibitor is started. Never take Fluoxetine hydrochloride with one of these drugs or within 14 days of discontinuing therapy with one of them; and allow 5 weeks or more between stopping Fluoxetine hydrochloride and starting an MAO inhibitor. Be especially cautious if you have been taking Fluoxetine hydrochloride in high doses or for a long time.

If you are taking any prescription or nonprescription drugs, notify your doctor before taking Fluoxetine hydrochloride.

How should you take this medication?

Fluoxetine hydrochloride should be taken exactly as prescribed by your doctor.

Fluoxetine hydrochloride usually is taken once or twice a day. To be effective, it should be taken regularly. Make a habit of taking it at the same time you do some other daily activity.

• If you miss a dose...

Take the forgotten dose as soon as you remember. If several hours have passed, skip the dose. Never try to "catch up" by doubling the dose.

• Storage instructions...

Store at room temperature.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Fluoxetine hydrochloride.

• More common side effects may include
  Abnormal dreams, abnormal thinking, agitation, allergic reaction, anxiety, bronchitis, chest pain, chills, cough, diarrhea, dizziness, drowsiness and fatigue, dry mouth, flu symptoms, frequent urination, hay fever, headache, inability to fall or stay asleep, increased appetite, indigestion, itching, joint pain, lack or loss of appetite, light-headedness, limb pain, muscle pain, nausea, nervousness, sinus inflammation, sore throat, stomach/intestinal disorder, sweating, tremors, weakness, weight loss, yawning
• Less common side effects may include:
  Abnormal ejaculation, abnormal gait, abnormal stoppage of menstrual flow, acne, altered sense of taste, amnesia, apathy, arthritis, asthma, bone pain, breast cysts, breast pain, brief loss of consciousness, bursitis, chills and fever, confusion, conjunctivitis, convulsions, dark, tarry stool, decreased sex drive, difficulty in swallowing, dilation of pupils, dry skin, ear pain, eye pain, exaggerated feeling of well-being, excessive bleeding, facial swelling due to fluid retention, fever, fluid retention, fluttery heartbeat, gas, hair loss, hallucinations, hangover effect, hiccups, high or low blood pressure, hives, hostility, infection, inflammation of the esophagus, inflammation of the gums, inflammation of the stomach lining, inflammation of the tongue, inflammation of the vagina, intolerance of light, involuntary movement, irrational ideas, irregular heartbeat, jaw or neck pain, lack of muscle coordination, low blood pressure upon standing, low blood sugar, migraine headache, mouth inflammation, muscle spasm, neck pain and rigidity, nosebleed, ovarian disorders, paranoid reaction, pelvic pain, pneumonia, rapid breathing, rapid heartbeat, ringing in the ears, severe chest pain, skin inflammation, skin rash, thirst, tooth problems, twitching, uncoordinated movements, urinary disorders, vague feeling of bodily discomfort, vertigo, vision disturbances, vomiting, weight gain
• Rare side effects may include:
  Antisocial behavior, blood in urine, bloody diarrhea, bone disease, breast enlargement, cataracts, colitis, coma, deafness, decreased reflexes, dehydration, double vision, drooping of eyelids, duodenal ulcer, enlarged abdomen, enlargement of liver, enlargement or increased activity of thyroid gland, excess growth of coarse hair on face, chest, etc., excess uterine or vaginal bleeding, extreme muscle tension, eye bleeding, female milk production, fluid accumulation and swelling in the head, fluid buildup in larynx and lungs, gallstones, glaucoma, gout, heart attack, hepatitis, high blood sugar, hysteria, inability to control bowel movements, increased salivation, inflammation of eyes and eyelids, inflammation of fallopian tubes, inflammation of testes, inflammation of the gallbladder, inflammation of the small intestine, inflammation of tissue below skin, kidney disorders, lung inflammation, menstrual disorders, miscarriage, mouth sores, muscle inflammation or bleeding, muscle spasms, painful sexual intercourse for women, psoriasis, rashes, reddish or purplish spots on the skin, reduction of body temperature, rheumatoid arthritis, seborrhea, shingles, skin discoloration, skin inflammation and disorders, slowing of heart rate, slurred speech, spitting blood, stomach ulcer, stupor, suicidal thoughts, taste loss, temporary cessation of breathing, tingling sensation around the mouth, tongue discoloration and swelling, urinary tract disorders, vomiting blood, yellow eyes and skin

Why should this drug not be prescribed?

If you are sensitive to or have ever had an allergic reaction to Fluoxetine hydrochloride or similar drugs such as Paxil and Zoloft, you should not take this medication. Make sure that your doctor is aware of any drug reactions that you have experienced.

Do not take this drug while using an MAO inhibitor. (See "Most important fact about this drug.")

Special warnings about this medication

Unless you are directed to do so by your doctor, do not take this medication if you are recovering from a heart attack or if you have kidney or liver disease or diabetes.

Fluoxetine hydrochloride may cause you to become drowsy or less alert and may affect your judgment. Therefore, driving or operating dangerous machinery or participating in any hazardous activity that requires full mental alertness is not recommended.

While taking this medication, you may feel dizzy or light-headed or actually faint when getting up from a lying or sitting position. If getting up slowly doesn't help or if this problem continues, notify your doctor.

If you develop a skin rash or hives while taking Fluoxetine hydrochloride, discontinue use of the medication and notify your doctor immediately.

Fluoxetine hydrochloride should be used with caution if you have a history of seizures. You should discuss all of your medical conditions with your doctor before taking this medication.

The safety and effectiveness of Fluoxetine hydrochloride have not been established in children.

Possible food and drug interactions when taking this medication

Combining Fluoxetine hydrochloride with MAO inhibitors is dangerous.

Do not drink alcohol while taking this medication.

If Fluoxetine hydrochloride is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Fluoxetine hydrochloride with the following:

• Carbamazepine (Tegretol)
• Diazepam (Valium)
• Digitoxin (Crystodigin)
• Drugs that impair brain function, such as Xanax
• Flecainide (Tambocor)
• Lithium (Eskalith)
• Other antidepressants (Elavil)
• Phenytoin (Dilantin)
• Tryptophan
• Vinblastine (Velban)
• Warfarin (Coumadin)

Special information if you are pregnant or breastfeeding

The effects of Fluoxetine hydrochloride during pregnancy have not been adequately studied. If you are pregnant or plan to become pregnant, inform your doctor immediately. This medication appears in breast milk, and breastfeeding is not recommended while you are taking Fluoxetine hydrochloride.

Recommended dosage

• ADULTS

The usual starting dose is 20 milligrams per day, taken in the morning. Your doctor may increase your dose after several weeks if no improvement is observed. People with kidney or liver disease, the elderly, and those taking other drugs may have their dosages adjusted by their doctor.

Dosages above 20 milligrams daily should be taken once a day in the morning or in 2 smaller doses taken in the morning and at noon.

The usual daily dose for depression ranges from 20 to 60 milligrams. For obsessive-compulsive disorder the customary range is 20 to 60 milligrams per day, though a maximum of 80 milligrams is sometimes prescribed.

Overdosage

Any medication taken in excess can have serious consequences. In addition, combining Fluoxetine hydrochloride with certain other drugs can cause symptoms of overdose. If you suspect an overdose, seek medical attention immediately.

• Symptoms of Fluoxetine hydrochloride overdose include:

Agitation, nausea, restlessness, vomiting

Older people often need less lithium carbonate and may show signs of overdose at a dosage younger people can handle well.

Generic name: Mirtazapine

Brand name: Remeron

Why is this drug prescribed?

Mirtazapine is prescribed for the treatment of major depression--that is, a continuous depressed mood that interferes with everyday life. The symptoms of major depression often include changes in appetite and weight, difficulty sleeping, loss of interest in pleasurable activities, constant fidgeting or a slowdown in movement, fatigue, feelings of guilt or worthlessness, difficulty concentrating, slowed thinking, and suicidal thoughts.

Mirtazapine is thought to work by adjusting the balance of the brain's natural chemical messengers, especially norepinephrine and serotonin.

Most important fact about this drug

Mirtazapine makes some people drowsy or less alert, and may affect judgment and thinking. Don't drive or participate in any hazardous activity that requires full mental alertness until you know whether mirtazapine has this effect on you.

How should you take this medication?

Mirtazapine may be taken with or without food. It is preferable to take it in the evening before you go to sleep. Even though you may begin to feel better in 1 to 4 weeks, continue taking this medication exactly as prescribed. Regular daily doses are needed for the drug to work properly.

• If you miss a dose...

Take the forgotten dose if you remember within a few hours. Otherwise, skip the dose. Never try to "catch up" by doubling the dose.

• Storage instructions...

Store at room temperature in a tight, light-resistant container.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking mirtazapine.

• More common side effects may include:
  Abnormal dreams and thinking, constipation, dizziness, dry mouth, "flu-like" symptoms, increased appetite, sleepiness, weakness, weight gain
• Less common side effects may include:
  Back pain, confusion, difficult or labored breathing, fluid retention, frequent urination, muscle pain, nausea, swelling of ankles or hands, tremors

Why should this drug not be prescribed?

If you have ever had an allergic reaction to mirtazapine or similar drugs such as Ludiomil and Desyrel, you should not take this medication. Be sure to tell your doctor about any drug reactions you have experienced.

You should also avoid mirtazapine if you are taking the antidepressants Nardil or Parnate (see "Special warnings about this medication").

Special warnings about this medication

Serious, sometimes fatal reactions have been known to occur when drugs such as mirtazapine are taken in combination with other drugs known as MAO inhibitors, including the antidepressants Nardil and Parnate. Never take mirtazapine with one of these drugs or within 14 days of discontinuing therapy with one of them; and allow at least 14 days between stopping mirtazapine and starting an MAO inhibitor.

If you develop "flu-like" symptoms, a sore throat, chills or fever, mouth sores, or any other signs of infection, call your doctor; these symptoms may signal a serious underlying condition.

Mirtazapine tends to raise cholesterol levels in some people. If you have a cholesterol problem, be sure to mention it to your doctor before starting therapy with mirtazapine.

Mirtazapine should be used with caution if you have active liver or kidney disease, or heart or blood pressure problems. Also be sure to tell your doctor if you have a history of seizures, mania (extremely high spirits), hypomania (mild excitability), drug use, or any other physical or emotional problems.

While first taking this medication you may feel dizzy or light-headed, especially when getting up from a lying or sitting position. If getting up slowly doesn't help, or if this problem continues, notify your doctor.

Possible food and drug interactions when taking this medication

Never combine mirtazapine with an MAO inhibitor; and do not drink alcohol while taking this medication. If mirtazapine is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining mirtazapine with tranquilizers such as Valium, Xanax, and Ativan.

Special information if you are pregnant or breastfeeding

The effects of mirtazapine during pregnancy have not been adequately studied. If you are pregnant or plan to become pregnant, tell your doctor immediately. It is not known whether mirtazapine appears in breast milk. However, because many drugs do make their way into breast milk, you should tell your doctor if you are breastfeeding or plan to breastfeed.

Recommended dosage

• ADULTS

The usual starting dose is 15 milligrams taken daily before going to sleep. Depending upon your response, your dosage may be increased to as much as 45 milligrams a day.

• CHILDREN

The safety and effectiveness of mirtazapine have not been established in children..

Overdosage

Any medication taken in excess can have serious consequences. If you suspect an overdose, seek medical attention immediately.

• Symptoms of mirtazapine overdose include:

Drowsiness, impaired memory, mental confusion, rapid heartbeat

In the U.S.—

• Risperdal

In Canada—

• Risperdal

Category  

• Antipsychotic

Description  

Risperidone (ris-PER-i-done) is used to treat the symptoms of psychotic disorders, such as schizophrenia.

Risperidone is available only with your doctor's prescription, in the following dosage forms:

• Oral
• Oral solution (U.S. and Canada)
• Tablets (U.S. and Canada)

Before Using This Medicine  

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For risperidone, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to risperidone. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies with risperidone have not been done in pregnant women. One baby whose mother took risperidone during pregnancy was born with a serious brain problem. However, it is not known whether this problem was caused by risperidone. Some unwanted effects have been reported in animal studies, but the risk to human babies is not clear. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—Risperidone has been shown to pass into the milk of nursing animals. It may also pass into human milk and may cause unwanted effects, such as behavior changes, in nursing babies. It may be necessary for you to take another medicine or to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of risperidone in children with use in other age groups.

Older adults—Elderly people may be especially sensitive to the effects of risperidone. This may increase the chance of having side effects during treatment.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking risperidone, it is especially important that your health care professional know if you are taking any of the following:

• Antihypertensives (high blood pressure medicine) or
• Central nervous system (CNS) depressants (medicine that makes you drowsy or less alert) or
• Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Pertofrane], doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g., Aventyl], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil])—Risperidone may add to the effects of these medicines, causing unwanted effects such as increased drowsiness or low blood pressure

• Bromocriptine (e.g., Parlodel) or
• Levodopa (e.g., Dopar, Larodopa) or
• Pergolide (e.g., Permax)—Risperidone may interfere with the effects of these medicines so that they do not work properly

• Carbamazepine (e.g., Epitol, Tegretol) or
• Clozapine (e.g., Clozaril)—These medicines may affect the blood levels of risperidone so that risperidone does not work properly or causes unwanted effects. Your doctor may need to change your dose of risperidone

Other medical problems—The presence of other medical problems may affect the use of risperidone. Make sure you tell your doctor if you have any other medical problems, especially:

• Breast cancer or
• Heart or blood vessel problems, including stroke or
• Parkinson's disease—Risperidone may make these conditions worse

• Epilepsy or other seizure disorders—Risperidone may increase the risk of having seizures

• Kidney disease or
• Liver disease—Higher blood levels of risperidone may occur, increasing the chance of side effects

Proper Use  

Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more or less of it, do not take it more or less often, and do not take it for a longer or shorter time than your doctor ordered.

Dosing—The dose of risperidone will be different for different patients. Follow your doctor's orders or the directions on the label . The following information includes only the average doses of risperidone. If your dose is different, do not change it unless your doctor tells you to do so.

• For symptoms of psychotic disorder:
• For oral solution dosage form—
• Adults—At first, 1 milligram (mg) [1 milliliter (mL)] two times a day. Your doctor may increase your dose as needed. However, the dose usually is not more than 16 mg (16 mL) a day.
• Children younger than 18 years of age—Use and dose must be determined by the doctor.
• Older adults—At first, 0.5 mg (0.5 mL) two times a day. Your doctor may increase your dose as needed. However, the dose usually is not more than 3 mg (3 mL) a day.
• For oral tablet dosage form—
• Adults—At first, 1 milligram (mg) two times a day. Your doctor may increase your dose as needed. However, the dose usually is not more than 16 mg a day.
• Children younger than 18 years of age—Use and dose must be determined by the doctor.
• Older adults—At first, 0.5 mg two times a day. Your doctor may increase your dose as needed. However, the dose usually is not more than 3 mg a day.

For patients taking the oral solution form of risperidone:

• Measure the dose with the measuring device provided with your medicine. Stir the dose into a small glass (3 to 4 ounces) of water, coffee, orange juice, or low-fat milk just before taking it. Do not mix this medicine with cola or tea.
• Rinse the empty measuring device with water and place it back in its storage case. Put the plastic cap back on the bottle of medicine.

Missed dose—If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store the tablet form of this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the solution form of this medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions  

Your doctor should check your progress at regular visits , especially during the first few months of treatment with this medicine. This will allow the dosage to be changed if necessary to meet your needs.

Do not stop taking this medicine without first checking with your doctor . Your doctor may want you to reduce gradually the amount you are taking before stopping completely. This is to prevent side effects and to keep your condition from becoming worse.

This medicine may add to the effects of alcohol and other CNS depressants (medicine that makes you drowsy or less alert) . Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine .

Before having any kind of surgery, dental treatment, or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine . Taking risperidone together with medicines that are used during surgery, dental, or emergency treatments may increase the CNS depressant effects.

This medicine may cause blurred vision, dizziness, or drowsiness. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to see clearly .

Dizziness, lightheadedness, or fainting may occur , especially when you get up from a lying or sitting position. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.

Risperidone may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Apply a sun block product that has a skin protection factor (SPF) of at least 15. You may require a product with a higher SPF number, especially if you have a fair complexion. If you have any questions about this, check with your health care professional.
• Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.
• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor .

This medicine may make it more difficult for your body to keep a constant temperature. Use extra care not to become overheated during exercise or hot weather while you are taking this medicine, since overheating may result in heatstroke. Hot baths or saunas may make you feel dizzy or faint while you are taking this medicine. Also, use extra care not to become too cold while you are taking risperidone. If you become too cold, you may feel drowsy, confused, or clumsy.

Side Effects  

Along with its needed effects, risperidone can sometimes cause serious side effects. Tardive dyskinesia (a movement disorder) may occur and may not go away after you stop using the medicine. Signs of tardive dyskinesia include fine, worm-like movements of the tongue, or other uncontrolled movements of the mouth, tongue, cheeks, jaw, or arms and legs. Other serious but rare side effects may also occur. These include neuroleptic malignant syndrome (NMS), which may cause severe muscle stiffness, fever, severe tiredness or weakness, fast heartbeat, difficult breathing, increased sweating, loss of bladder control, or seizures. You and your doctor should discuss the good this medicine will do as well as the risks of taking it .

Stop taking risperidone and get emergency help immediately if any of the following side effects occur:

Rare

Convulsions (seizures); difficult or fast breathing; fast heartbeat or irregular pulse; fever (high); high or low blood pressure; increased sweating; loss of bladder control; muscle stiffness (severe); unusually pale skin; unusual tiredness or weakness (severe)

Check with your doctor immediately if any of the following side effects occur:

More common

Difficulty in speaking or swallowing; inability to move eyes; muscle spasms of face, neck, and back; twisting movements of body

Rare

High body temperature (dizziness; fast, shallow breathing; fast, weak heartbeat; headache; muscle cramps; pale, clammy skin; increased thirst); lip smacking or puckering; low body temperature (confusion, drowsiness, poor coordination, shivering); prolonged, painful, inappropriate erection of the penis; puffing of cheeks; rapid or worm-like movements of tongue; uncontrolled chewing movements; uncontrolled movements of arms and legs

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Anxiety or nervousness; changes in vision, including blurred vision; decreased sexual desire or performance; loss of balance control; mask-like face; menstrual changes; mood or mental changes, including aggressive behavior, agitation, difficulty in concentration, and memory problems; problems in urination or increase in amount of urine; restlessness or need to keep moving (severe); shuffling walk; skin rash or itching; stiffness or weakness of arms or legs; tic-like or twitching movements; trembling and shaking of fingers and hands; trouble in sleeping

Less common

Back pain; chest pain; seborrhea (skin condition that may include dandruff and oily skin); unusual secretion of milk

Rare

Extreme thirst; increased blinking or spasms of eyelid; loss of appetite; talking, feeling, and acting with excitement and activity that cannot be controlled; uncontrolled twisting movements of neck, trunk, arms, or legs; unusual bleeding or bruising; unusual facial expressions or body positions

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

More common

Constipation; coughing; diarrhea; drowsiness; dryness of mouth; headache; heartburn; increased dream activity; increased length of sleep; nausea; sore throat; stuffy or runny nose; unusual tiredness or weakness; weight gain

Less common

Darkening of skin color; dry skin; increased sensitivity of the skin to sun; increased watering of mouth; joint pain; stomach pain; vomiting; weight loss

Some side effects, such as uncontrolled movements of the mouth, tongue, and jaw, or uncontrolled movements of arms and legs, may occur after you have stopped taking this medicine. If you notice any of these effects, check with your doctor as soon as possible.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

In the U.S.—

• Ritalin