Skeletal muscle
relaxant adjunct—Diazepam; Lorazepam
Description
Benzodiazepines (ben-zoe-dye-AZ-e-peens) belong to
the group of medicines called central nervous system
(CNS) depressants (medicines that slow down the
nervous system).
Some benzodiazepines are used to relieve anxiety.
However, benzodiazepines should not be used to relieve
nervousness or tension caused by the stress of
everyday life.
Some benzodiazepines are used to treat insomnia
(trouble in sleeping). However, if used regularly (for
example, every day) for insomnia, they usually are not
effective for more than a few weeks.
Many of the benzodiazepines are used in the
treatment of other conditions, also. Diazepam is used
to help relax muscles or relieve muscle spasm.
Diazepam injection is used before some medical
procedures to relieve anxiety and to reduce memory of
the procedure. Chlordiazepoxide, clorazepate,
diazepam, and oxazepam are used to treat the symptoms
of alcohol withdrawal. Alprazolam and clonazepam are
used in the treatment of panic disorder. Clobazam,
clonazepam, clorazepate, diazepam, and lorazepam are
used in the treatment of certain convulsive (seizure)
disorders, such as epilepsy. The benzodiazepines may
also be used for other conditions as determined by
your doctor.
Benzodiazepines may be habit-forming (causing
mental or physical dependence), especially when taken
for a long time or in high doses.
These medicines are available only with your
doctor's prescription, in the following dosage forms:
- Oral
- Alprazolam
- Oral
solution (U.S.)
- Tablets (U.S. and Canada)
- Bromazepam
- Chlordiazepoxide
- Capsules
(U.S. and Canada)
- Clobazam
- Clonazepam
- Tablets
(U.S. and Canada)
- Clorazepate
- Capsules
(Canada)
- Tablets (U.S.)
- Extended-release tablets (U.S.)
- Diazepam
- Oral
solution (U.S. and Canada)
- Tablets (U.S. and Canada)
- Estazolam
- Flurazepam
- Capsules
(U.S. and Canada)
- Tablets (Canada)
- Halazepam
- Lorazepam
- Oral
concentrate (U.S.)
- Tablets (U.S. and Canada)
- Sublingual tablets (Canada)
- Nitrazepam
- Oxazepam
- Capsules
(U.S.)
- Tablets (U.S. and Canada)
- Quazepam
- Temazepam
- Capsules
(U.S. and Canada)
- Triazolam
- Tablets
(U.S. and Canada)
- Parenteral
- Chlordiazepoxide
- Diazepam
- Injection
(U.S. and Canada)
- Lorazepam
- Injection
(U.S. and Canada)
- Rectal
- Diazepam
- For
rectal solution (may be prepared in U.S. and
Canada from diazepam injection)
- Rectal gel (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 benzodiazepines, the following should be
considered:
Allergies—Tell your doctor if you have
ever had any unusual or allergic reaction to
benzodiazepines. Also tell your health care
professional if you are allergic to any other
substances, such as foods, preservatives, or dyes.
Certain benzodiazepine products may contain lactose,
parabens, or soybean oil.
Pregnancy—Chlordiazepoxide and diazepam
have been reported to increase the chance of birth
defects when used during the first 3 months of
pregnancy. Although similar problems have not been
reported with the other benzodiazepines, the chance
always exists since all of the benzodiazepines are
related.
Studies in animals have shown that clonazepam,
lorazepam, and temazepam cause birth defects or other
problems, including death of the animal fetus.
Too much use of a benzodiazepine during pregnancy
may cause the baby to become dependent on the
medicine. This may lead to withdrawal side effects
after birth. Also, use of benzodiazepines during
pregnancy, especially during the last weeks, may cause
body temperature problems, breathing problems,
difficulty in feeding, drowsiness, or muscle weakness
in the newborn infant.
Benzodiazepines given just before or during labor
may cause weakness in the newborn infant. When
diazepam is given in high doses (especially by
injection) within 15 hours before delivery, it may
cause breathing problems, muscle weakness, difficulty
in feeding, and body temperature problems in the
newborn infant.
Breast-feeding—Benzodiazepines may pass
into the breast milk and cause drowsiness, difficulty
in feeding, and weight loss in nursing babies of
mothers taking these medicines.
Children—Most of the side effects of these
medicines are more likely to occur in children,
especially the very young. These patients are usually
more sensitive than adults to the effects of
benzodiazepines.
It is possible that using clonazepam for long
periods of time may cause unwanted effects on physical
and mental growth in children. If such effects do
occur, they may not be noticed until many years later.
Before this medicine is given to children for long
periods of time, you should discuss its use with your
child's doctor.
Older adults—Most of the side effects of
these medicines are more likely to occur in the
elderly, who are usually more sensitive to the effects
of benzodiazepines.
Taking benzodiazepines for trouble in sleeping may
cause more daytime drowsiness in elderly patients than
in younger adults. In addition, falls and related
injuries are more likely to occur in elderly patients
taking benzodiazepines.
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 or receiving
benzodiazepines it is especially important that your
health care professional know if you are taking any of
the following:
- Central nervous system
(CNS) depressants (medicines that cause
drowsiness)—The CNS depressant effects of either
these medicines or benzodiazepines may be
increased; your doctor may want to change the dose
of either or both medicines
- Fluvoxamine (e.g., Luvox)
or
- Itraconazole (e.g.,
Sporanox) or
- Ketoconazole (e.g., Nizoral)
or
- Nefazodone (e.g., Serzone)—Higher
blood levels of benzodiazepines may occur,
increasing the chance that side effects will
occur; your doctor may want to change the dose of
either or both medicines, or give you a different
medicine
Other medical problems—The presence of
other medical problems may affect the use of
benzodiazepines. Make sure you tell your doctor if you
have any other medical problems, especially:
- Alcohol abuse (or history
of) or
- Drug abuse or dependence
(or history of)—Dependence on benzodiazepines
may be more likely to develop
- Brain disease—CNS
depression and other side effects of
benzodiazepines may be more likely to occur
- Difficulty in swallowing
(in children) or
- Emphysema, asthma,
bronchitis, or other chronic lung disease or
- Glaucoma or
- Hyperactivity or
- Mental depression or
- Mental illness (severe) or
- Myasthenia gravis or
- Porphyria or
- Sleep apnea (temporary
stopping of breathing during sleep)—Benzodiazepines
may make these conditions worse
- Epilepsy or history of
seizures—Although some benzodiazepines are used
in treating epilepsy, starting or suddenly
stopping treatment with these medicines may
increase seizures
- Kidney or liver
disease—Higher blood levels of benzodiazepines
may result, increasing the chance that side
effects will occur
Proper Use
For caregivers administering diazepam rectal gel
:
- Discuss with the patient's
medical doctor exactly when and how to use
diazepam rectal gel.
- Discuss with the patient's
medical doctor when you should call for emergency
help.
- Read the instructions that
you received with the medicine before you need to
use it.
- Stay with the patient
after administering diazepam rectal gel to check
his or her condition as instructed by the doctor.
For patients taking clorazepate extended-release
tablets :
- Swallow tablets whole.
- Do not crush, break, or
chew before swallowing.
For patients taking alprazolam, diazepam, or
lorazepam concentrated oral solution :
- Measure each dose
carefully using the dropper provided with the
medicine.
- It is recommended that
each dose be mixed with water, soda or soda-like
beverages, or semisolid food such as applesauce or
pudding, just before it is taken.
- Take the entire mixture
right away. It should not be saved to be used
later.
For patients taking lorazepam sublingual tablets
:
- Do not chew or swallow the
tablet. This medicine is meant to be absorbed
through the lining of the mouth. Place the tablet
under your tongue (sublingual) and let it slowly
dissolve there. Do not swallow for at least 2
minutes.
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. If too much is taken, it may
become habit-forming (causing mental or physical
dependence).
If you think this medicine is not working properly
after you have taken it for a few weeks, do not
increase the dose . Instead, check with your
doctor.
For patients taking this medicine on a regular
schedule for epilepsy or other seizure disorder
:
- In order for this
medicine to control your seizures, it must be
taken every day in regularly spaced doses as
ordered by your doctor . This is necessary to
keep a constant amount of the medicine in the
blood. To help keep the amount constant, do not
miss any doses.
For patients taking this medicine for insomnia
:
- Do not take this
medicine when your schedule does not permit you to
get a full night's sleep (7 to 8 hours) . If
you must wake up before this, you may continue to
feel drowsy and may experience memory problems,
because the effects of the medicine have not had
time to wear off.
For patients taking flurazepam :
- When you begin to take
this medicine, your sleeping problem will improve
somewhat the first night. However, 2 or 3 nights
may pass before you receive the full effects of
this medicine .
Dosing—The dose of benzodiazepines 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 benzodiazepines. 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
solution that you take, or the number of injections
you receive, 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 benzodiazepines .
- For alprazolam
- For oral dosage
form (solution or tablets):
- For
anxiety:
- Adults—At
first, 0.25 to 0.5 milligram (mg) three times
a day. Your doctor may increase your dose if
needed. However, the dose usually is not more
than 4 mg a day.
- Children younger than 18 years
of age—Use and dose must be determined by
your doctor.
- Older adults—At first, 0.25 mg
two or three times a day. Your doctor may
increase your dose if needed.
- For panic disorder:
- Adults—At
first, 0.5 mg three times a day. Your doctor
may increase your dose if needed. However, the
dose usually is not more than 10 mg a day.
- Children younger than 18 years
of age—Use and dose must be determined by
your doctor.
- For bromazepam
- For oral dosage
form (tablets):
- For
anxiety:
- Adults—6
to 30 milligrams (mg) a day, taken in smaller
doses during the day.
- Children younger than 18 years
of age—Use and dose must be determined by
your doctor.
- Older adults—At first, up to 3
mg a day. Your doctor may change your dose if
needed.
- For chlordiazepoxide
- For oral dosage
form (capsules):
- For
anxiety:
- Adults—5
to 25 milligrams (mg) three or four times a
day.
- Children 6 years of age and
older—5 mg two to four times a day. Your
doctor may increase your dose if needed.
- Children younger than 6 years of
age—Use and dose must be determined by your
doctor.
- Older adults—At first, 5 mg
two to four times a day. Your doctor may
increase your dose if needed.
- For sedation during withdrawal
from alcohol:
- Adults—At
first, 50 to 100 mg, repeated if needed.
However, the dose usually is not more than 400
mg a day.
- Children—Use and dose must be
determined by your doctor.
- For injection
dosage form:
- For
anxiety:
- Adults—At
first, 50 to 100 mg, injected into a muscle or
vein. Then, if needed, 25 to 50 mg three or
four times a day.
- Teenagers—25 to 50 mg,
injected into a muscle or vein.
- Children younger than 12 years
of age—Use and dose must be determined by
your doctor.
- Older adults—25 to 50 mg,
injected into a muscle or vein.
- For sedation during withdrawal
from alcohol:
- Adults—At
first, 50 to 100 mg, injected into a muscle or
vein. If needed, the dose may be repeated in
two to four hours.
- Children—Use and dose must be
determined by your doctor.
- For clobazam
- For oral dosage form
(tablets):
- For
control of seizures:
- Adults—At
first, 5 to 15 milligrams (mg) a day. Your
doctor may increase your dose if needed.
However, the dose usually is not more than 80
mg a day.
- Children 2 to 16 years of
age—At first, 5 mg a day. Your doctor may
increase your dose if needed. However, the
dose usually is not more than 40 mg a day.
- Children younger than 2 years of
age—Dose is based on body weight and must be
determined by your doctor.
- For clonazepam
- For oral dosage
form (tablets):
- For
control of seizures:
- Adults—At
first, 0.5 milligram (mg) three times a day.
Your doctor may increase your dose if needed.
However, the dose usually is not more than 20
mg a day.
- Infants and children younger
than 10 years of age—Dose is based on body
weight and must be determined by your doctor.
- For panic disorder:
- Adults—At
first, 0.25 mg two times a day. Your doctor
may increase your dose if needed. However, the
dose usually is not more than 4 mg a day.
- Children—Use and dose must be
determined by your doctor.
- For clorazepate
- For oral dosage
form (capsules or tablets):
- For
anxiety:
- Adults
and teenagers—7.5 to 15 mg two to four times
a day. Or your doctor may want you to start by
taking 15 mg at bedtime.
- Children younger than 12 years
of age—Use and dose must be determined by
your doctor.
- Older adults—At first, 3.75 to
15 mg a day. Your doctor may increase your
dose if needed.
- For sedation during withdrawal
from alcohol:
- Adults
and teenagers—At first, 30 mg. Your doctor
will set up a schedule that will gradually
reduce your dose.
- Children younger than 12 years
of age—Use and dose must be determined by
your doctor.
- For control of seizures:
- Adults
and teenagers—At first, up to 7.5 mg taken
three times a day. Your doctor may increase
your dose if needed. However, the dose usually
is not more than 90 mg a day.
- Children 9 to 12 years of
age—At first, up to 7.5 mg two times a day.
Your doctor may increase your dose if needed.
However, the dose usually is not more than 60
mg a day.
- Children younger than 9 years of
age—Use and dose must be determined by your
doctor.
- For oral dosage
form (extended-release tablets):
- For
anxiety:
- Adults
and teenagers—Your doctor may change your
dosage form to the extended-release tablet if
you are already taking 3.75 or 7.5 milligrams
(mg) of clorazepate three times a day. The
extended-release tablet is taken one time each
day.
- Children younger than 12 years
of age—Use and dose must be determined by
your doctor.
- For control of seizures:
- Adults,
teenagers, and children 9 to 12 years of
age—Your doctor may change your dosage form
to the extended-release tablet if you are
already taking 3.75 or 7.5 milligrams (mg) of
clorazepate three times a day. The
extended-release tablet is taken one time each
day.
- Children younger than 9 years of
age—Use and dose must be determined by your
doctor.
- For diazepam
- For oral dosage form
(solution or tablets):
- For
anxiety:
- Adults—2
to 10 mg two to four times a day.
- Children 6 months of age and
older—Dose is based on body weight or size
and must be determined by your doctor.
- Children younger than 6 months of
age—Use is not recommended.
- Older adults—2 to 2.5 mg one or
two times a day. Your doctor may increase your
dose if needed.
- For sedation during withdrawal
from alcohol:
- Adults—At
first, 10 mg three or four times a day. Your
doctor will set up a schedule that will
gradually decrease your dose.
- Children—Use and dose must be
determined by your doctor.
- For control of seizures:
- Adults—2
to 10 mg two to four times a day.
- Children 6 months of age and
older—Dose is based on body weight or size
and must be determined by your doctor.
- Children younger than 6 months of
age—Use is not recommended.
- Older adults—2 to 2.5 mg one or
two times a day. Your doctor may increase your
dose if needed.
- For relaxing muscles:
- Adults—2
to 10 mg three or four times a day.
- Children 6 months of age and
older—Dose is based on body weight or size
and must be determined by your doctor.
- Children younger than 6 months of
age—Use is not recommended.
- Older adults—2 to 2.5 mg one or
two times a day. Your doctor may increase your
dose if needed.
- For injection dosage
form:
- For
anxiety:
- Adults—2
to 10 mg, injected into a muscle or vein.
- Children—Use and dose must be
determined by your doctor.
- For older adults—2 to 5 mg,
injected into a muscle or vein.
- For sedation during withdrawal
from alcohol:
- Adults—At
first, 10 mg injected into a muscle or vein.
If needed, 5 to 10 mg may be given three or
four hours later.
- Children—Use and dose must be
determined by your doctor.
- For sedation before surgery or
other procedures:
- Adults—5
to 20 mg, injected into a muscle or vein.
- Children—Use and dose must be
determined by your doctor.
- Older adults—2 to 5 mg,
injected into a muscle or vein.
- For control of seizures:
- Adults—At
first, 5 to 10 mg, usually injected into a
vein every ten to fifteen minutes, stopping if
the total dose reaches 30 mg. If needed, this
treatment may be repeated in two to four
hours.
- Children 5 years of age and
older—At first, 1 mg, usually injected into
a vein every two to five minutes, stopping if
the total dose reaches 10 mg. This treatment
may be repeated in two to four hours.
- Infants older than 30 days of age
and children younger than 5 years of age—At
first, 0.2 to 0.5 mg, usually injected into a
vein every two to five minutes, stopping if
the total dose reaches 5 mg. This treatment
may be repeated in two to four hours.
- Newborns and infants 30 days of
age and younger—Use and dose must be
determined by your doctor.
- Older adults—2 to 5 mg,
injected into a muscle or vein.
- For relaxing muscle spasms:
- Adults—At
first, 5 to 10 mg injected into a muscle or
vein. The dose may be repeated in three or
four hours.
- Children—Use and dose must be
determined by your doctor.
- Older adults—2 to 5 mg,
injected into a muscle or vein.
- For relaxing muscles in tetanus:
- Adults—At
first, 5 to 10 mg injected into a muscle or
vein. Your doctor may increase your dose if
needed.
- Children 5 years of age and
older—5 to 10 mg, injected into a muscle or
vein. The dose may be repeated every three to
four hours if needed.
- Infants older than 30 days of age
and children younger than 5 years of age—1
to 2 mg, injected into a muscle or vein. The
dose may be repeated every three to four hours
if needed.
- Newborns and infants 30 days of
age and younger—Use and dose must be
determined by your doctor.
- For rectal dosage
form (gel or solution):
- For
control of seizures:
- Adults
and teenagers—Dose is based on body weight
and must be determined by your doctor.
- Children—Dose is based on body
weight and must be determined by your doctor.
- For estazolam
- For oral dosage
form (tablets):
- For
trouble in sleeping:
- Adults—1
milligram (mg) at bedtime. Your doctor may
increase your dose if needed. However, the
dose usually is not more than 2 mg.
- Children younger than 18 years
of age—Use and dose must be determined by
your doctor.
- For flurazepam
- For oral dosage
form (capsules or tablets):
- For
trouble in sleeping:
- Adults—15
or 30 milligrams (mg) at bedtime.
- Children younger than 15 years
of age—Use and dose must be determined by
your doctor.
- Older adults—At first, 15 mg
at bedtime. Your doctor may increase your dose
if needed.
- For halazepam
- For oral dosage
form (tablets):
- For
anxiety:
- Adults—20
to 40 milligrams (mg) three or four times a
day.
- Children younger than 18 years
of age—Use and dose must be determined by
your doctor.
- Older adults—20 mg one or two
times a day.
- For lorazepam
- For oral dosage form
(concentrate or tablets):
- For
anxiety:
- Adults
and teenagers—1 to 3 milligrams (mg) two or
three times a day.
- Children younger than 12 years of
age—Use and dose must be determined by your
doctor.
- Older adults—0.5 to 2 mg a day,
taken in smaller doses during the day.
- For trouble in sleeping:
- Adults
and teenagers—2 to 4 mg taken at bedtime.
- Children younger than 12 years of
age—Use and dose must be determined by your
doctor.
- For sublingual tablet
dosage form:
- For
anxiety:
- Adults—2
to 3 mg a day, in smaller doses placed under
the tongue during the day. Your doctor may
increase your dose if needed. However, the
dose usually is not more than 6 mg a day.
- Children younger than 18 years of
age—Use and dose must be determined by your
doctor.
- Older adults—At first, 0.5 mg a
day. Your doctor may increase your dose if
needed.
- For sedation before surgery:
- Adults—Dose
is based on body weight and will be determined
by your doctor. However, the dose usually is
not more than 4 mg, placed under the tongue,
one to two hours before surgery.
- Children—Use and dose must be
determined by your doctor.
- For injection dosage
form:
- For
sedation before surgery or other procedures:
- Adults—Dose
is based on body weight and will be determined
by your doctor. However, the dose usually is
not more than 4 mg, injected into a muscle or
vein.
- Children younger than 18 years of
age—Use and dose must be determined by your
doctor.
- For control of seizures:
- Adults—At
first, 4 mg slowly injected into a vein. The
dose may be repeated after ten to fifteen
minutes if needed.
- Children younger than 18 years of
age—Use and dose must be determined by your
doctor.
- For nitrazepam
- For oral dosage form
(tablets):
- For
trouble in sleeping:
- Adults—5
to 10 milligrams (mg) at bedtime.
- Children—Use and dose must be
determined by your doctor.
- Older adults—At first, 2.5 mg
taken at bedtime. Your doctor may increase
your dose if needed.
- For control of seizures:
- Children
less than 30 kilograms (66 pounds) of body
weight—Dose is based on body weight and will
be determined by your doctor.
- For oxazepam
- For oral dosage
form (capsules or tablets):
- For
anxiety:
- Adults—10
to 30 milligrams (mg) three or four times a
day.
- Children younger than 12 years
of age—Use and dose must be determined by
your doctor.
- Older adults—At first, 5 mg
one or two times a day or 10 mg three times a
day. Your doctor may increase your dose if
needed. However, the dose usually is not more
than 15 mg four times a day.
- For sedation during withdrawal
from alcohol:
- Adults—15
to 30 mg three or four times a day.
- Children younger than 12 years
of age—Use and dose must be determined by
your doctor.
- For quazepam
- For oral dosage
form (tablets):
- For
trouble in sleeping:
- Adults—7.5
to 15 milligrams (mg) at bedtime.
- Children younger than 18 years
of age—Use and dose must be determined by
your doctor.
- For temazepam
- For oral dosage
form (capsules):
- For
trouble in sleeping:
- Adults—15
milligrams (mg) at bedtime. Your doctor may
change your dose if needed.
- Children younger than 18 years
of age—Use and dose must be determined by
your doctor.
- Older adults—At first, 7.5 mg
at bedtime. Your doctor may increase your dose
if needed.
- For triazolam
- For oral dosage
form (tablets):
- For
trouble in sleeping:
- Adults—0.125
to 0.25 milligram (mg) at bedtime.
- Children younger than 18 years
of age—Use and dose must be determined by
your doctor.
- Older adults—At first, 0.125
mg at bedtime. Your doctor may increase your
dose if needed.
Missed dose—If you are taking this
medicine regularly (for example, every day as for
epilepsy) and you miss a dose, take it right away if
you remember within an hour or so of the missed dose.
However, if you do not remember until later, 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. Overdose of benzodiazepines may be
especially dangerous in 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
If you will be taking a benzodiazepine regularly
for a long time :
- Your doctor should check
your progress at regular visits to make sure that
this medicine does not cause unwanted effects. If
you are taking a benzodiazepine for convulsions
(seizures), this is also important during the
first few months of treatment.
- Check with your doctor at
regular visits to see if you need to continue
taking this medicine.
If you are taking a benzodiazepine for epilepsy
or another seizure disorder :
- Your doctor may want you
to carry a medical identification card or bracelet
stating that you are taking this medicine.
If you are taking a benzodiazepine for insomnia
(trouble in sleeping):
- If you think you need this
medicine for more than 7 to 10 days, be sure to
discuss it with your doctor. Insomnia that lasts
longer than this may be a sign of another medical
problem.
- You may have difficulty
sleeping (rebound insomnia) for the first few
nights after you stop taking this medicine.
Benzodiazepines may be habit-forming (causing
mental or physical dependence) , especially when
taken for a long time or in high doses. Some signs of
dependence on benzodiazepines are:
- A strong desire or need to
continue taking the medicine.
- A need to increase the
dose to receive the effects of the medicine.
- Withdrawal effects (for
example, irritability, nervousness, trouble in
sleeping, abdominal or stomach cramps, trembling
or shaking) occurring after the medicine is
stopped.
If
you think you may have become mentally or physically
dependent on this medicine, check with your doctor
. Do not stop taking it suddenly.
If you have been taking this medicine in large
doses or for a long time, do not stop taking it
without first checking with your doctor . Your
doctor may want you to reduce gradually the amount you
are taking before stopping completely. Stopping this
medicine suddenly may cause withdrawal side effects,
including seizures. Stopping this medicine suddenly is
most likely to cause seizures if you have been taking
it for epilepsy or another seizure disorder.
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. This effect may last for a few days after
you stop taking this medicine. Check with your
doctor before taking any of the above while you are
taking this medicine .
If you think you or someone else may have taken
an overdose of this medicine, get emergency help at
once . Taking an overdose of a benzodiazepine or
taking alcohol or other CNS depressants with the
benzodiazepine may lead to unconsciousness and
possibly death. Some signs of an overdose are
continuing slurred speech or confusion, severe
drowsiness, severe weakness, and staggering.
Before you have any medical tests, tell the medical
doctor in charge that you are taking this medicine.
The results of the metyrapone test may be affected by
chlordiazepoxide.
If you develop any unusual and strange thoughts or
behavior while you are taking this medicine, be sure
to discuss it with your doctor. Some changes that have
occurred in people taking this medicine are like those
seen in people who drink alcohol and then act in a
manner that is not normal. Other changes may be more
unusual and extreme, such as confusion, agitation, and
hallucinations (seeing, hearing, or feeling things
that are not there).
This medicine may cause some people, especially
older persons, to become drowsy, dizzy, lightheaded,
clumsy or unsteady, or less alert than they are
normally. Even if taken 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 dizzy or are not alert
.
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:
Less common
Anxiety; confusion (may
be more common in the elderly); fast, pounding, or
irregular heartbeat; lack of memory of events taking
place after benzodiazepine is taken (may be more
common with triazolam); mental depression
Rare
Abnormal thinking,
including disorientation, delusions (holding false
beliefs that cannot be changed by facts), or loss of
sense of reality; agitation; behavior changes,
including aggressive behavior, bizarre behavior,
decreased inhibition, or outbursts of anger;
convulsions (seizures); hallucinations (seeing,
hearing, or feeling things that are not there);
hypotension (low blood pressure); muscle weakness;
skin rash or itching; sore throat, fever, and chills;
trouble in sleeping; ulcers or sores in mouth or
throat (continuing); uncontrolled movements of body,
including the eyes; unusual bleeding or bruising;
unusual excitement, nervousness, or irritability;
unusual tiredness or weakness (severe); yellow eyes or
skin
Symptoms of overdose
Confusion (continuing);
convulsions (seizures); drowsiness (severe) or coma;
shakiness; slow heartbeat; slow reflexes; slurred
speech (continuing); staggering; troubled breathing;
weakness (severe)
For patients having chlordiazepoxide, diazepam,
or lorazepam injected :
- Check with your doctor if
there is redness, swelling, or pain at the place
of injection.
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
Clumsiness or
unsteadiness; dizziness or lightheadedness;
drowsiness; slurred speech
Less common or rare
Abdominal or stomach
cramps or pain; blurred vision or other changes in
vision; changes in sexual desire or ability;
constipation; diarrhea; dryness of mouth or increased
thirst; false sense of well-being; headache; increased
bronchial secretions or watering of mouth; muscle
spasm; nausea or vomiting; problems with urination;
trembling or shaking; unusual tiredness or weakness
Not all of the side effects listed above have been
reported for each of these medicines, but they have
been reported for at least one of them. All of the
benzodiazepines are similar, so any of the above side
effects may occur with any of these medicines.
After you stop using this medicine, your body may
need time to adjust. During this time, check with your
doctor if you notice any of the following side
effects:
More common
Irritability;
nervousness; trouble in sleeping
Less common
Abdominal or stomach
cramps; confusion; fast or pounding heartbeat;
increased sense of hearing; increased sensitivity to
touch and pain; increased sweating; loss of sense of
reality; mental depression; muscle cramps; nausea or
vomiting; sensitivity of eyes to light; tingling,
burning, or prickly sensations; trembling or shaking
Rare
Confusion as to time,
place, or person; convulsions (seizures); feelings of
suspicion or distrust; hallucinations (seeing,
hearing, or feeling things that are not there)
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, some of the
benzodiazepines are used in certain patients with the
following medical conditions:
- Nausea and vomiting caused
by cancer chemotherapy
- Tension headache
- Tremors
Other than the above information, there is no
additional information
In the U.S.—
In Canada—
Category
Description
Buspirone (byoo-SPYE-rone) is used to treat certain
anxiety disorders or to relieve the symptoms of
anxiety. However, buspirone usually is not used for
anxiety or tension caused by the stress of everyday
life.
It is not known exactly how buspirone works to
relieve the symptoms of anxiety. Buspirone is thought
to work by decreasing the amount and actions of a
chemical known as serotonin in certain parts of the
brain.
Buspirone 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 buspirone, the following should be considered:
Allergies—Tell your doctor if you have
ever had any unusual or allergic reaction to buspirone.
Also tell your health care professional if you are
allergic to any other substances, such as foods,
preservatives, or dyes.
Pregnancy—Buspirone has not been studied
in pregnant women. However, buspirone has not been
shown to cause birth defects or other problems in
animal studies.
Breast-feeding—It is not known whether
buspirone passes into the breast milk of humans.
Children—Studies on this medicine have
been done only in adult patients, and there is no
specific information comparing use of buspirone in
children up to 18 years of age with use in other age
groups.
Older adults—This medicine 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.
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 buspirone, it is
especially important that your health care
professional know if you are taking any of the
following:
- Erythromycin (e.g., ERYC,
E.E.S.) or
- Itraconazole (e.g.,
Sporanox)—Higher blood levels of buspirone may
occur, increasing the chance of side effects. Your
doctor may change the dose of buspirone that you
take
- Monoamine oxidase (MAO)
inhibitors (furazolidone [e.g., Furoxone],
phenelzine [e.g., Nardil], procarbazine [e.g.,
Matulane], selegiline at doses more than 10 mg a
day [e.g., Eldepryl], tranylcypromine [e.g.,
Parnate])—Taking buspirone while you are taking
monoamine oxidase (MAO) inhibitors may cause high
blood pressure
Other medical problems—The presence of
other medical problems may affect the use of buspirone.
Make sure you tell your doctor if you have any other
medical problems, especially:
- Kidney disease or
- Liver disease—Buspirone
may be removed from your body more slowly, which
may increase the chance of side effects. Your
doctor may need to adjust your dose
Proper Use
Take buspirone 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 unwanted
effects.
After you begin taking buspirone, 1 to 2 weeks may
pass before you begin to feel the effects of this
medicine.
Dosing—The dose of buspirone 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 buspirone. 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
forms (tablets):
- Adults:
To start, 5 milligrams (mg) two or three times a
day, or 7.5 mg two times a day. Your doctor may
increase your dose by 5 mg a day every few days
if needed. However, the dose usually is not more
than 60 mg a day.
- Children up to 18 years of age:
Use and dose must be determined by the doctor.
- Older adults: To start, 5
milligrams (mg) two or three times a day, or 7.5
mg two times a day. Your doctor may increase
your dose by 5 mg a day every few days if
needed.
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 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
If you will be using buspirone regularly for a long
time, your doctor should check your progress at
regular visits to make sure the medicine does not
cause unwanted effects.
Buspirone may cause some people to become dizzy,
lightheaded, 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 dizzy
or are not alert .
If you think you or someone else may have taken
an overdose of buspirone, get emergency help at once
. Some symptoms of an overdose are dizziness or
lightheadedness; severe drowsiness or loss of
consciousness; stomach upset, including nausea or
vomiting; or very small pupils of the eyes.
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:
Rare
Chest pain; confusion;
fast or pounding heartbeat; fever; incoordination;
mental depression; muscle weakness; numbness,
tingling, pain, or weakness in hands or feet; skin
rash or hives; stiffness of arms or legs; sore throat;
uncontrolled movements of the body
Symptoms of
overdose—may be more severe than side effects seen
at regular doses or several may occur together
Dizziness or
lightheadedness; drowsiness (severe) or loss of
consciousness; stomach upset, including nausea or
vomiting; very small pupils of the eyes
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
Dizziness or
lightheadedness, especially when getting up from a
sitting or lying position; headache; nausea;
restlessness, nervousness, or unusual excitement
Less common or rare
Blurred vision;
clamminess or sweating; decreased concentration;
diarrhea; drowsiness (more common with doses of more
than 20 mg per day); dryness of mouth; muscle pain,
spasms, cramps, or stiffness; ringing in the ears;
trouble in sleeping, nightmares, or vivid dreams;
unusual tiredness or weakness
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.—
Category
Description
Citalopram (si-TAL-oh-pram) is used to treat mental
depression.
Citalopram 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 form:
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 citalopram, the following should be considered:
Allergies—Tell your doctor if you have
ever had any unusual or allergic reaction to
citalopram. 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. However, studies in animals have shown
that citalopram may cause decreased survival rates and
slowed growth in offspring when given to the mother in
doses many times higher than the usual human dose.
Before taking this medicine, make sure your doctor
knows if you are pregnant or if you may become
pregnant.
Breast-feeding—Citalopram passes into
breast milk and may cause unwanted effects, such as
drowsiness, decreased feeding, and weight loss in the
breast-fed baby. 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 citalopram in
children with use in other age groups.
Older adults—This medicine has been tested
and has not been shown to cause different side effects
or problems in older people than it does in younger
adults. However, citalopram is removed from the body
more slowly in older people and an older person 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 citalopram, it is
especially important that your health care
professional know if you are taking any of the
following:
- Bromocriptine (e.g.,
Parlodel) or
- Buspirone (e.g., BuSpar)
or
- Certain tricyclic
antidepressants (amitriptyline [e.g., Elavil],
clomipramine [e.g., Anafranil], or imipramine
[e.g., Tofranil]) or
- Dextromethorphan (cough
medicine) 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], fluvoxamine [e.g., Luvox], 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 citalopram 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
- Monoamine oxidase (MAO)
inhibitors (furazolidone [e.g., Furoxone],
isocarboxazid [e.g., Marplan], phenelzine [e.g.,
Nardil], procarbazine [e.g., Matulane], selegiline
[e.g., Eldepryl], tranylcypromine [e.g., Parnate])—
Do not take citalopram while you are taking or
within 2 weeks of taking an MAO inhibitor. 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. At least 14 days should pass between
stopping treatment with one medicine (citalopram
or the MAO inhibitor) and starting treatment with
the other
Other medical problems—The presence of
other medical problems may affect the use of
citalopram. Make sure you tell your doctor if you have
any other medical problems, especially:
- Kidney disease, severe or
- Liver disease—Higher
blood levels of citalopram may occur, increasing
the chance of having unwanted effects. You may
need to take a lower dose than a person without
kidney or liver disease
- Mania (history of)—May
be activated
- Seizure disorders (history
of)—The risk of having seizures may be increased
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.
Citalopram may be taken with or without food on a
full or empty stomach. If your doctor tells you to
take it a certain way, follow your doctor's
instructions.
You may have to take citalopram for 4 weeks
before you begin to feel better . Your doctor
should check your progress at regular visits during
this time. Also, you may need to keep taking
citalopram for 6 months or longer to help prevent the
return of the depression.
Dosing—The dose of citalopram 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 citalopram. 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
mental depression:
- Adults—To
start, usually 20 milligrams (mg) once a day,
taken either in the morning or evening. Your
doctor may increase your dose gradually if
needed. However, the dose usually is not more
than 60 mg a day.
- Children—Use and dose must be
determined by the doctor.
- Older adults—Usually 20
milligrams (mg) once a day, taken either in
the morning or evening. Your doctor may
increase your dose gradually if needed.
However, the dose usually is not more than 40
mg a day.
Missed dose—Because citalopram may be
taken by different patients at different times of the
day, you and your doctor should discuss what to do if
you miss any 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 citalopram with or within 14 days of
taking an MAO inhibitor (furazolidone, isocarboxazid,
phenelzine, procarbazine, selegiline, tranylcypromine).
Do not take an MAO inhibitor within 14 days of taking
citalopram . If you do, you may develop extremely
high blood pressure or convulsions (seizures).
Avoid drinking alcoholic beverages while you are
taking citalopram.
This medicine may cause some people to become
drowsy, to have trouble thinking, or to have problems
with movement. Make sure you know how you react to
citalopram before you drive, use machines, or do
anything else that could be dangerous if you are not
alert or well-coordinated.
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. One rare, but very serious, effect
that may occur is the serotonin syndrome. This
syndrome (group of symptoms) is more likely to occur
shortly after an increase in citalopram dose.
Check with your doctor
as soon as possible if any of the following side
effects occur:
More common
Decrease in sexual desire
or ability
Less common
Agitation; blurred
vision; confusion; fever; increase in frequency of
urination or amount of urine produced; lack of
emotion; loss of memory; menstrual changes; skin rash
or itching; trouble in breathing
Rare
Bleeding gums; breast
tenderness or enlargement or unusual secretion of milk
(in females); dizziness or fainting; irregular
heartbeat; low blood sodium (confusion, convulsions
[seizures], drowsiness, dryness of mouth, increased
thirst, lack of energy); mood or mental changes; nose
bleed; painful urination; purple or red spots on skin;
sore throat, fever, and chills; red or irritated eyes;
redness, tenderness, itching, burning, or peeling of
skin; serotonin syndrome (agitation, confusion,
diarrhea, fever, overactive reflexes, poor
coordination, restlessness, shivering, sweating,
talking or acting with excitement you cannot control,
trembling or shaking, twitching); trouble in holding
or releasing urine; unusual or sudden body or facial
movements or postures
Symptoms of
overdose—more common
Dizziness; drowsiness;
fast heartbeat; nausea; sweating; trembling or
shaking; vomiting
Symptoms of
overdose—rare
Bluish colored skin or
lips; confusion; convulsions (seizures); coma; deep or
fast breathing with dizziness; fainting; general
feeling of discomfort or illness; loss of memory;
muscle pain; slow or irregular heartbeat; weakness
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
Drowsiness; dryness of
mouth; nausea; trouble in sleeping
Less common
Abdominal pain; anxiety;
change in sense of taste; diarrhea; gas; headache;
heartburn; increased sweating; increased yawning; loss
of appetite; pain in muscles or joints; stuffy or
runny nose; tingling, burning, or prickly feelings on
skin; tooth grinding; trembling or shaking; unusual
increase or decrease in weight; unusual tiredness or
weakness; vomiting; watering of mouth
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:
Anxiety; dizziness;
nervousness; trembling or shaking
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.—
Generic name product may be available.
In Canada—
Other—
Generic name product may be available in the U.S.
Category
Description
Clozapine (KLOE-za-peen) is used to treat
schizophrenia in patients who have not been helped by
or are unable to take other medicines.
Clozapine is available only from pharmacies that
agree to participate with your doctor in a plan to
monitor your blood tests. You will need to have blood
tests done every week for at least 6 months. After
that, your doctor will decide if it is safe for you to
have blood tests every other week. You will receive
enough clozapine to last until your next blood test,
but only if the results of your blood tests show that
it is safe for you to take this medicine. If any of
your blood tests are not normal, you may need to have
blood tests more often than every week until they
return to normal.
Clozapine is available 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 clozapine, the following should be considered:
Allergies—Tell your doctor if you have
ever had any unusual or allergic reaction to clozapine.
Also tell your health care professional if you are
allergic to any other substances, such as foods,
preservatives, or dyes.
Pregnancy—Clozapine has not been studied
in pregnant women. However, clozapine has not been
shown to cause birth defects or other problems in
animal studies.
Breast-feeding—Clozapine may pass into
breast milk and cause drowsiness, trouble in nursing,
restlessness or irritability, convulsions (seizures),
or heart or blood vessel problems in nursing babies.
Children—Studies on this medicine have
been done only in adult patients, and there is no
specific information comparing use of clozapine in
children with use in other age groups.
Older adults—Many medicines have not been
tested in older people. Therefore, it may not be known
whether they work exactly the same way they do in
younger adults. Clozapine may be more likely to cause
side effects in the elderly, including dizziness and
fainting, low blood pressure, and confusion or
excitement.
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 clozapine, it is
especially important that your health care
professional know if you are taking any of the
following:
- Alcohol or
- Central nervous system
(CNS) depressants (medicines that cause
drowsiness) 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 or alcohol with clozapine may
cause increased drowsiness, low blood pressure, or
trouble in breathing
- Amantadine (e.g.,
Symmetrel) or
- Antihypertensives (high
blood pressure medicine) or
- Antipsychotics (medicine
for mental illness) or
- Bromocriptine (e.g.,
Parlodel) or
- Certain eye drops used to
treat glaucoma (carteolol [e.g., Ocupress],
levobunolol [e.g., Betagan], metipranolol [e.g.,
OptiPranolol], timolol [e.g., Timoptic]) or
- Diuretics (water pills) or
- Levodopa (e.g., Dopar) or
- Medicine for heart disease
or
- Nabilone (e.g., Cesamet)
(with high doses) or
- Narcotic pain medicine or
- Pentamidine (e.g., Pentam)
or
- Pimozide (e.g., Orap) or
- Promethazine (e.g.,
Phenergan) or
- Trimeprazine (e.g.,
Temaril)—Using these medicines with clozapine
may cause low blood pressure, which can cause
dizziness or fainting
- Amphotericin B by
injection (e.g., Fungizone) or
- Antineoplastics (cancer
medicine) or
- Antithyroid agents
(medicine for overactive thyroid) or
- Azathioprine (e.g., Imuran)
or
- Chlorambucil (e.g.,
Leukeran) or
- Chloramphenicol (e.g.,
Chloromycetin) or
- Colchicine or
- Cyclophosphamide (e.g.,
Cytoxan) or
- Flucytosine (e.g., Ancobon)
or
- Ganciclovir (e.g.,
Cytovene) or
- Interferon (e.g., Intron
A, Roferon-A) or
- Mercaptopurine (e.g.,
Purinethol) or
- Methotrexate (e.g., Mexate)
or
- Plicamycin (e.g.,
Mithracin) or
- Zidovudine (e.g., AZT,
Retrovir)—Taking clozapine with any of these
medicines may increase the chance that very
serious blood problems will occur
- Lithium—Using clozapine
with lithium may increase the chance that
convulsions (seizures), confusion or problems with
movement will occur
- Selective serotonin
reuptake inhibitors (fluoxetine [e.g., Prozac],
fluvoxamine [e.g., Luvox], paroxetine [e.g., Paxil],
sertraline [e.g., Zoloft])—These medicines can
increase the blood levels of clozapine, which
increases the chance that unwanted effects will
occur
Other medical problems—The presence of
other medical problems may affect the use of clozapine.
Make sure you tell your doctor if you have any other
medical problems, especially:
- Blood diseases or
- Enlarged prostate or
difficult urination or
- Gastrointestinal problems
or
- Glaucoma, narrow angle or
- Heart or blood vessel
problems—Clozapine may make these conditions
worse
- Epilepsy or other seizure
disorder—Clozapine may increase the chance that
seizures will occur
- Kidney or liver
disease—Higher blood levels of clozapine may
occur, increasing the chance that unwanted effects
will occur
Proper Use
Take this medicine exactly as directed . Do
not take more of this medicine and do not take it more
often than your doctor ordered. Do not miss any doses.
This medicine has been prescribed for your
current medical problem only . It must not be
given to other people or used for other problems
unless you are directed to do so by your doctor.
Dosing—The dose of clozapine 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 clozapine. 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
your special needs .
- For oral dosage
form (tablets):
- For
schizophrenia:
- Adults—At
first, 12.5 milligrams (mg) (one half of a
25-mg tablet) once or twice a day. Your doctor
may increase your dose as needed. However, the
dose usually is not more than 900 mg a day.
- Children younger than 16 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 almost time for your next dose, skip the missed
dose and go back to your regular dosing schedule. Do
not double doses.
If you miss 2 or more days of clozapine doses, talk
to your doctor before you start taking it again. You
may need to restart this medicine at a lower dose than
you were taking before.
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 you have your blood tests
done when they are scheduled, and that your doctor
check your progress at regular visits . Clozapine
can cause some very serious blood problems that you
may not be able to feel or see. The pharmacy will give
you this medicine only if your blood tests show that
it is safe for you to take clozapine. Also, your
doctor will make sure the medicine is working properly
and change the dosage if needed.
If you do not take clozapine for 2 or more days,
talk to your doctor about what to do . You may
need to take a lower dose when you first start taking
this medicine again.
If you have been using this medicine regularly, do
not stop taking it 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 help prevent the illness from suddenly
returning.
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 .
Contact your doctor as soon as possible if you
develop unusual tiredness or weakness, fever, sore
throat, or other symptoms of infection. These can be
symptoms of a very serious blood problem.
Clozapine may cause drowsiness, blurred vision or
convulsions (seizures). Do not drive, climb, swim,
operate machines or do anything else that could be
dangerous while you are taking this medicine.
Dizziness, lightheadedness, or fainting may occur,
especially when you get up from a lying or sitting
position. Getting up slowly may help. If this problem
continues or gets worse, check with your doctor.
In some patients, clozapine may cause increased
watering of the mouth. Other patients, however, may
get dryness of the mouth. For temporary relief of
mouth dryness, 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, a medicine may cause
some unwanted effects. Some side effects may not have
signs or symptoms that you can see or feel. Clozapine
can cause some very serious blood problems. Your
doctor will watch for these by doing blood tests every
week or two for as long as you are taking clozapine
and for 4 weeks after you stop taking it. Although not
all of these side effects may occur, if they do occur
they may need medical attention.
Check with your doctor
immediately if any of the following side effects
occur:
More common
Fast or irregular
heartbeat; fever; low blood pressure
Less common
High blood pressure
(severe or continuing headache)
Rare
Chest pain; chills;
convulsions (seizures); cough; difficult or fast
breathing or sudden shortness of breath; fainting;
increased sweating; loss of bladder control; muscle
stiffness (severe); sore throat; sores, ulcers, or
white spots on lips or in mouth; swelling or pain in
leg; unusual bleeding or bruising; unusual tiredness
or weakness; unusually pale skin
Check with your doctor
as soon as possible if any of the following side
effects occur:
More common
Dizziness, especially
when getting up from a lying or sitting position
Less common
Blurred vision;
confusion; restlessness or need to keep moving;
unusual anxiety, nervousness, or irritability
Rare
Absence of or decrease in
movement; decreased sexual ability; high blood sugar
(increased appetite, increased thirst, increased
urination, weakness); lip smacking or puckering; liver
problems (dark urine, decreased appetite, nausea,
vomiting, yellow eyes or skin); mental depression;
puffing of cheeks; rapid or worm-like movements of
tongue; trembling or shaking; trouble in sleeping;
trouble in urinating; uncontrolled chewing movements;
uncontrolled movements of arms and legs
Symptoms of overdose
Convulsions (seizures);
dizziness or fainting; drowsiness (severe) or coma;
fast, slow, or irregular heartbeat; hallucinations
(seeing, hearing, or feeling things that are not
there); increased watering of mouth (severe); slow,
irregular, or troubled breathing; unusual excitement,
nervousness, or restlessness
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
or lightheadedness (mild); drowsiness; headache
(mild); increased watering of mouth; nausea or
vomiting; unusual weight gain
Less common
Abdominal discomfort or
heartburn; 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.
In the U.S.—
In Canada—
Category
- Stimulant, central
nervous system
Description
Pemoline (PEM-oh-leen) belongs to the group of
medicines called central nervous system (CNS)
stimulants. It is used to treat children with
attention-deficit hyperactivity disorder (ADHD).
Pemoline increases attention and decreases
restlessness in children who are overactive, cannot
concentrate for very long or are easily distracted,
and are emotionally unstable. This medicine is used as
part of a total treatment program that also includes
social, educational, and psychological treatment.
Rarely, pemoline has caused serious liver problems.
You and your doctor should talk about the good this
medicine will do as well as the risks of using it. In
addition, you will be asked to sign an informed
consent form stating that you understand and agree to
accept the risk of liver problems.
Pemoline is available only with your doctor's
prescription, in the following dosage forms:
- Oral
- Tablets (U.S. and Canada)
- Chewable 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 pemoline, the following should be considered:
Allergies—Tell your doctor if you have
ever had any unusual or allergic reaction to pemoline.
Also tell your health care professional if you are
allergic to any other substances, such as foods,
preservatives, or dyes.
Pregnancy—Pemoline has not been shown to
cause birth defects or other problems in humans.
However, studies in animals given large doses of
pemoline have shown that pemoline causes an increase
in stillbirths and decreased survival of the offspring
after birth.
Breast-feeding—It is not known whether
pemoline passes into breast milk.
Children—Slowed growth rate in children
who received medicines like pemoline for a long period
of time has been reported. Some doctors recommend
medicine-free periods during treatment with pemoline
to help prevent slowed growth.
Pemoline may make behavior worse in children with
serious mental illness.
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 pemoline, it is
especially important that your health care
professional know if you are taking any of the
following:
- Amantadine (e.g.,
Symmetrel) or
- Amphetamines or
- Appetite suppressants
(diet pills)
- Caffeine (e.g., NoDoz) or
- Chlophedianol (e.g., Ulone)
or
- Cocaine or
- Medicine for asthma or
other breathing problems or
- Medicine for colds, sinus
problems, hay fever or other allergies (including
nose drops or sprays) or
- Methylphenidate (e.g.,
Ritalin) or
- Nabilone (e.g., Cesamet)—Using
these medicines with pemoline may cause severe
nervousness, irritability, trouble in sleeping, or
possibly irregular heartbeat or seizures
- Anticonvulsants (medicine
to control seizures)—Pemoline may increase the
chance of having seizures; your doctor may change
the dose of your anticonvulsant medicine
- Monoamine oxidase (MAO)
inhibitors (furazolidone [e.g., Furoxone],
isocarboxazid [e.g., Marplan], phenelzine [e.g.,
Nardil], procarbazine [e.g., Matulane], selegiline
[e.g., Eldepryl], tranylcypromine [e.g., Parnate])—
Taking pemoline while you are taking or within
2 weeks of taking an MAO inhibitor may result in
sudden extremely high blood pressure or fever,
irregular heartbeat, or seizures
Other medical problems—The presence of
other medical problems may affect the use of pemoline.
Make sure you tell your doctor if you have any other
medical problems, especially:
- Drug abuse or dependence
(or history of)—Dependence on pemoline may
develop
- Gilles de la Tourette's
syndrome or other tics or
- Liver disease or
- Mental illness (severe)—Pemoline
may make the condition worse
- Kidney disease—Higher
blood levels of pemoline may occur, increasing the
chance of side effects
Proper Use
For patients taking the chewable tablet form
of this medicine:
- These tablets must be
chewed before swallowing. Do not swallow whole.
Sometimes this medicine must be taken for 3 to 4
weeks before improvement is noticed .
Take pemoline 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. If too much is taken, it may become
habit-forming.
Dosing—The dose of pemoline 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 pemoline. 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 or chewable
dosage forms (tablets):
- Children
6 years of age and over: To start, 37.5
milligrams (mg) every morning. Your doctor may
increase your dose if needed. However, the dose
is usually not more than 112.5 mg a day.
- Children up to 6 years of age:
Use and dose must be determined by the doctor.
Missed dose—If you miss a dose of this
medicine, take it as soon as possible and go back to
your regular dosing schedule. If you do not remember
the missed dose until the next 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
Your doctor should check your progress at regular
visits to make sure that this medicine does not cause
unwanted effects.In addition, you must have your blood
tested every other week to see if this medicine is
affecting your liver.
Dark urine or yellow eyes or skin may be a sign of
a serious unwanted effect on your liver. Check with
your doctor immediately if you develop dark urine or
yellow eyes or skin .
This medicine may cause some people to become dizzy
or less alert than they are normally. Make sure you
know how you react to this medicine before you ride a
bicycle or do anything else that could be dangerous if
you are dizzy or are not alert .
If you have been using this medicine for a long
time and you think you may have become mentally or
physically dependent on it, check with your doctor
. Some signs of dependence on pemoline are:
- a strong desire or need to
continue taking the medicine.
- a need to increase the
dose to receive the effects of the medicine.
- withdrawal side effects
(for example, mental depression, unusual behavior,
or unusual tiredness or weakness) occurring after
the medicine is stopped.
If you take this medicine in large doses for a long
time, do not stop taking it without first checking
with your doctor. Your doctor may want you to reduce
gradually the amount you are taking before stopping
completely.
Side Effects
Along with its needed effects, a medicine may cause
some unwanted effects. Some side effects will have
signs or symptoms that you can see or feel. Your
doctor may watch for others by doing certain tests.
Pemoline may cause some serious side effects,
including liver problems. Also, medicines like
pemoline, when used for a long time, have been
reported to slow the growth rate of children. Some
doctors recommend medicine-free periods during
treatment with pemoline. Pemoline may also cause
unwanted effects on behavior in children with severe
mental illness.
Although not all of these side effects may occur,
if they do occur they may need medical attention.
Check with your doctor
immediately if either of the following side effects
occurs:
Rare
Dark urine; yellow eyes
or skin
Check with your doctor
as soon as possible if any of the following side
effects occur:
Rare
Convulsions (seizures);
hallucinations (seeing, hearing, or feeling things
that are not there); nausea and vomiting; shortness of
breath, troubled breathing, wheezing, or tightness in
chest; skin rash; sores, ulcers, or white spots on
lips or in mouth; swollen or painful glands;
uncontrolled movements of eyes, tongue, lips, face,
arms, or legs; unusual bleeding or bruising; unusual
tiredness; vocal sounds you cannot control
Symptoms of overdose
Agitation; confusion;
convulsions (seizures)—may be followed by coma;
false sense of well-being; fast heartbeat;
hallucinations (seeing, hearing, or feeling things
that are not there); headache (severe); high blood
pressure; high fever; large pupils; muscle trembling
or twitching; restlessness; sweating; vomiting
This medicine may also
cause the following side effects that your doctor will
watch for:
Rare
Liver problems; slow
growth in children
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
Loss of appetite;
trouble in sleeping; weight loss
Less common
Dizziness; drowsiness;
headache; increased irritability; mental depression;
stomachache
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:
Abdominal pain; convulsions (seizures); headache;
mental depression; nausea; unusual behavior; unusual
tiredness or weakness; vomiting
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.—
Generic name product may be available.
In Canada—
Generic name product may be available in the U.S.
Category
- Antidepressant
- Antineuralgic
Description
Trazodone (TRAZ-oh-done) belongs to the group of
medicines known as antidepressants or ``mood
elevators.'' It is used to relieve mental depression
and depression that sometimes occurs with anxiety.
Trazodone 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 trazodone, the following should be considered:
Allergies—Tell your doctor if you have
ever had any unusual or allergic reaction to trazodone.
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. However, studies in animals have shown
that trazodone causes birth defects and a decrease in
the number of successful pregnancies when given in
doses many times larger than human doses.
Breast-feeding—Trazodone 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 trazodone in
children with use in other age groups.
Older adults—Drowsiness, dizziness,
confusion, vision problems, dryness of mouth, and
constipation may be more likely to occur in the
elderly, who are usually more sensitive to the effects
of trazodone.
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 trazodone, it is
especially important that your health care
professional know if you are taking any of the
following:
- Antihypertensives (high
blood pressure medicine)—Taking these medicines
with trazodone may result in low blood pressure (hypotension);
the amount of medicine you need to take may change
- Central nervous system
(CNS) depressants (medicine that causes
drowsiness) or
- Tricyclic antidepressants
(medicine for depression)—Taking these medicines
with trazodone may add to the CNS depressant
effects
Other medical problems—The presence of
other medical problems may affect the use of trazodone.
Make sure you tell your doctor if you have any other
medical problems, especially:
- Alcohol abuse (or history
of)—Drinking alcohol with trazodone will
increase the central nervous system (CNS)
depressant effects
- Heart disease—Trazodone
may make the condition worse
- Kidney disease or
- Liver disease—Higher
blood levels of trazodone may occur, increasing
the chance of side effects
Proper Use
To lessen stomach upset and to reduce dizziness and
lightheadedness, take this medicine with or shortly
after a meal or light snack, even for a daily bedtime
dose, unless your doctor has told you to take it on an
empty stomach.
Take trazodone only as directed by your doctor
, to benefit your condition as much as possible.
Sometimes trazodone must be taken for up to 4
weeks before you begin to feel better , although
most people notice improvement within 2 weeks.
Dosing—The dose of trazodone 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 trazodone. If your dose is different, do
not change it unless your doctor tells you to do
so:
- Adults—Oral, to start,
50 milligrams per dose taken three times a day, or
75 milligrams per dose taken two times a day. Your
doctor may increase your dose if needed.
- Children 6 to 18 years of
age—Oral. Your doctor will tell you what dose to
take based on your body weight.
- Children up to 6 years of
age—Dose must be determined by the doctor.
- Elderly patients—Oral,
to start, 25 milligrams per dose taken three times
a day. Your doctor may increase your dose if
needed.
Missed dose—If you miss a dose of this
medicine, take it as soon as possible. However, if it
is within 4 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
It is very important that your doctor check your
progress at regular visits. This will allow your
doctor to check the medicine's effects and to change
the dose if needed.
Do not stop taking this medicine without first
checking with your doctor . To prevent a possible
return of your medical problem, your doctor may want
you to reduce gradually the amount of medicine you are
using before you stop completely.
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 trazodone together with
medicines that are used during surgery or dental or
emergency treatments may increase the CNS depressant
effects.
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 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 not alert .
Dizziness, lightheadedness, or fainting may
occur , especially when you get up from a lying or
sitting position. Getting up slowly may help. If this
problem continues or gets worse, check with your
doctor.
Trazodone 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, 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 check with your doctor immediately if
the following side effect occurs:
Rare
Painful, inappropriate
erection of the penis, continuing
Also, check with your
doctor as soon as possible if any of the following
side effects occur:
Less common
Confusion; muscle tremors
Rare
Fainting; fast or slow
heartbeat; skin rash; unusual excitement
Symptoms of overdose
Drowsiness; loss of
muscle coordination; nausea and 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
Dizziness or
lightheadedness; drowsiness; dryness of mouth (usually
mild); headache; nausea and vomiting; unpleasant taste
Less common
Blurred vision;
constipation; diarrhea; muscle aches or pains; unusual
tiredness or weakness
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.—
In Canada—
Category
Description
Venlafaxine (ven-la-FAX-een) is used to treat
mental depression.
This medicine is available only with your doctor's
prescription, in the following dosage forms:
- Oral
- Extended-release capsules
(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 venlafaxine, the following should be considered:
Allergies—Tell your doctor if you have
ever had any unusual or allergic reaction to
venlafaxine. 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. However, when pregnant rats were given
venlafaxine in doses much larger than the usual human
dose, some of their pups died before or soon after
birth. Before taking this medicine, make sure your
doctor knows if you are pregnant or if you may become
pregnant.
Breast-feeding—It is not known whether
venlafaxine passes into breast milk. Although most
medicines pass into breast milk in small amounts, many
of them may be used safely while breast-feeding.
Mothers who are taking this medicine and who wish to
breast-feed should discuss this with their doctor.
Children—Studies on this medicine have
been done only in adult patients, and there is no
specific information comparing use of venlafaxine in
children with use in other age groups.
Older adults—In studies done to date that
have included elderly people, venlafaxine did not
cause different side effects or problems in older
people than it did in younger adults.
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 venlafaxine, it is
especially important that your health care
professional know if you are taking the following:
- Buspirone (e.g., BuSpar) or
- Bromocriptine (e.g.,
Parlodel) or
- Certain tricyclic
antidepressants (amitriptyline [e.g., Elavil],
clomipramine [e.g., Anafranil], or imipramine
[e.g., Tofranil]) 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 (fluoxetine [e.g., Prozac], fluvoxamine
[e.g., Luvox], 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—Using these
medicines with venlafaxine may increase the chance
of developing a rare, but very serious, unwanted
effect known as the serotonin syndrome; symptoms
of this syndrome include confusion, diarrhea,
fever, poor coordination, restlessness, shivering,
sweating, talking or acting with excitement you
cannot control, trembling or shaking, or
twitching; if you experience these symptoms
contact your doctor as soon as possible
- Moclobemide (e.g., Manerex)—Taking
moclobemide and venlafaxine together or less than
3 days apart may increase the chance of developing
serious unwanted effects, including the serotonin
syndrome, and 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
venlafaxine while you are taking or within 2 weeks
of taking an MAO inhibitor; if you do, you may
develop confusion, agitation, restlessness,
stomach or intestinal symptoms, sudden high body
temperature, extremely high blood pressure, and
severe convulsions; at least 14 days should be
allowed between stopping treatment with an MAO
inhibitor and starting treatment with venlafaxine,
and at least 7 days should be allowed between
stopping treatment with venlafaxine and starting
treatment with an MAO inhibitor
Other medical problems—The presence of
other medical problems may affect the use of
venlafaxine. 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
- Heart disease or
- High or low blood
pressure—Venlafaxine may make these conditions
worse
- Kidney disease or
- Liver disease—Higher
blood levels of venlafaxine may occur, increasing
the chance of side effects; your doctor may need
to adjust your venlafaxine dose
- Mania (history of)—The
risk of developing mania may be increased
- Weight loss—Venlafaxine
may cause weight loss; this weight loss is usually
small, but if a large weight loss occurs, it may
be harmful in some patients
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.
You may have to take venlafaxine for 4 weeks or
longer before you begin to feel better. Also, you
will probably need to keep taking this medicine for at
least 6 months, even if you feel better, to help
prevent your depression from returning. Your doctor
should check your progress at regular visits during
this time.
Venlafaxine should be taken with food or on a full
stomach to lessen the chance of stomach upset.
However, if your doctor tells you to take the medicine
a certain way, take it exactly as directed.
If you are taking the extended-release capsule
dosage form, swallow the capsule whole with fluid;
do not break, crush, chew, or place the capsule in
liquid.
Dosing—The dose of venlafaxine 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 venlafaxine. If your dose is different, do
not change it unless your doctor tells you to do
so.
The number of capsules or 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 your special needs.
- For mental depression:
- For
oral extended-release capsule dosage
form:
- Adults—At
first, 75 milligrams (mg) a day, taken in one
dose in the morning or evening. Your doctor
may increase your dose if needed. However, the
dose is usually not more than 225 mg a day.
- Children—Use and dose must be
determined by your doctor.
- For oral tablet dosage
form:
- Adults—At
first, a total of 75 mg a day, taken in
smaller doses two or three times during the
day. Your doctor may increase your dose if
needed. However, the dose is usually not more
than 375 mg a day.
- Children up to 18 years of
age—Use and dose must be determined by your
doctor.
Missed dose—If you are taking the
tablet form of venlafaxine and you miss a dose,
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.
If you are taking the extended-release capsule
form of venlafaxine and you miss a dose, take it
as soon as possible. However, if you do not remember
the missed dose until the next 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.
Tell your doctor right away if you develop any
allergic reactions, such as skin rash or hives, while
taking venlafaxine.
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
side effects.
It is not known how venlafaxine will interact with
alcohol and other central nervous system (CNS)
depressants (medicines that may make 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.
Venlafaxine 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.
Dizziness, lightheadedness, or fainting may
occur, especially when you get up from a lying or
sitting position. Getting up slowly may help. If this
problem continues or gets worse, check with your
doctor.
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
Changes in vision, such
as blurred vision; decrease in sexual desire or
ability; headache
Less common
Chest pain; feeling of
fast or irregular heartbeat; mood or mental changes;
ringing or buzzing in ears
Rare
Convulsions (seizures);
itching or skin rash; lightheadedness or fainting,
especially when getting up suddenly from a sitting or
lying position; lockjaw; menstrual changes; problems
in urinating or in holding urine; swelling; talking,
feeling, and acting with excitement and activity you
cannot control; trouble in breathing
Symptoms of overdose
Agitation; convulsions
(seizures); drowsiness; extreme tiredness or weakness;
fast heartbeat; tingling, burning, or prickling
sensations; trembling or shaking
This medicine may also cause the following side
effect that your doctor will watch for:
More common
High blood pressure
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
Abnormal dreams; anxiety
or nervousness; chills; constipation; diarrhea;
dizziness; drowsiness; dryness of mouth; heartburn;
increased sweating; loss of appetite; nausea; stuffy
or runny nose; stomach pain or gas; tingling, burning,
or prickly sensations; trembling or shaking; trouble
in sleeping; unusual tiredness or weakness; vomiting;
weight loss
Less common
Change in sense of
taste; muscle tension; yawning
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:
Changes in dreaming; dizziness; dryness of mouth;
headache; increased sweating; nausea; nervousness;
trouble in sleeping; unusual tiredness or weakness
Other side effects not listed above may also occur
in some patients. If you notice any other effects,
check with your doctor.
Generic name:
Amitriptyline hydrochloride
Brand names: Elavil
Why is this drug
prescribed?
Amitriptyline
hydrochloride is prescribed for the relief of symptoms
of mental depression. It is a member of the group of
drugs called tricyclic antidepressants. Some doctors
also prescribe amitriptyline hydrochloride to treat
bulimia (an eating disorder), to control chronic pain,
to prevent migraine headaches, and to treat a
pathological weeping and laughing syndrome associated
with multiple sclerosis.
Most important fact
about this drug
You may
need to take amitriptyline hydrochloride regularly for
several weeks before it becomes fully effective. Do
not skip doses, even if they seem to make no
difference or you feel you don't need them.
How should you take
this medication?
Take
amitriptyline hydrochloride exactly as prescribed. You
may experience side effects, such as mild drowsiness,
early in therapy. However, they usually disappear
after a few days.
Amitriptyline
hydrochloride may cause dry mouth. Sucking a hard
candy, chewing gum, or melting bits of ice in your
mouth can provide relief.
If you miss a dose...
Take it as soon as you
remember. If it is almost time for your next dose,
skip the one you missed and go back to your regular
schedule. Never take 2 doses at the same time.
If you take a single daily
dose at bedtime, do not make up for it in the morning.
It may cause side effects during the day.
Storage instructions...
Keep amitriptyline
hydrochloride in a tightly closed container. Store at
room temperature. Protect from light and 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 amitriptyline
hydrochloride.
- Side effects may
include:
Abnormal movements, anxiety, black tongue, blurred
vision, breast development in males, breast
enlargement, coma, confusion, constipation,
delusions, diarrhea, difficult or frequent
urination, difficulty in speech, dilation of
pupils, disorientation, disturbed concentration,
dizziness on getting up, dizziness or
light-headedness, drowsiness, dry mouth, excessive
or spontaneous flow of milk, excitement, fatigue,
fluid retention, hair loss, hallucinations,
headache, heart attack, hepatitis, high blood
pressure, high fever, high or low blood sugar,
hives, impotence, inability to sleep, increased or
decreased sex drive, increased perspiration,
increased pressure within the eye, inflammation of
the mouth, intestinal obstruction, irregular
heartbeat, lack or loss of coordination, loss of
appetite, low blood pressure, nausea, nightmares,
numbness, rapid and/or fast, fluttery heartbeat,
rash, red or purple spots on skin, restlessness,
ringing in the ears, seizures, sensitivity to
light, stomach upset, strange taste, stroke,
swelling due to fluid retention in the face and
tongue, swelling of testicles, swollen glands,
tingling and pins and needles in the arms and
legs, tremors, vomiting, weakness, weight gain or
loss, yellowed eyes and skin
- Side effects due to
rapid decrease or abrupt withdrawal from Elavil
include:
Headache, nausea, vague feeling of bodily
discomfort
- Side effects due to
gradual dosage reduction may include:
Dream and sleep disturbances, irritability,
restlessness
These side effects do not
signify an addiction to the drug.
Why should this drug
not be prescribed?
If you
are sensitive to or have ever had an allergic reaction
to amitriptyline hydrochloride or similar drugs such
as Norpramin and Tofranil, you should not take this
medication. Make sure your doctor is aware of any drug
reactions you have experienced.
Do not
take amitriptyline hydrochloride while taking other
antidepressants known as MAO inhibitors. Drugs in this
category include Nardil and Parnate.
Unless
you are directed to do so by your doctor, do not take
this medication if you are recovering from a heart
attack.
Special warnings
about this medication
Do not
stop taking amitriptyline hydrochloride abruptly,
especially if you have been taking large doses for a
long time. Your doctor probably will want to decrease
your dosage gradually. This will help prevent a
possible relapse and will reduce the possibility of
withdrawal symptoms.
Amitriptyline
hydrochloride may make your skin more sensitive to
sunlight. Try to stay out of the sun, wear protective
clothing, and apply a sun block.
Amitriptyline
hydrochloride may cause you to become drowsy or less
alert; therefore, you should not drive or operate
dangerous machinery or participate in any hazardous
activity that requires full mental alertness until you
know how this drug affects you.
While
taking this medication, you may feel dizzy or
light-headed or actually faint when getting up from a
lying or sittin
