Tryptophan: As with other serotonin reuptake
inhibitors, an interaction between paroxetine and tryptophan may occur when
they are co-administered. Adverse experiences, consisting primarily of
headache, nausea, sweating and dizziness, have been reported when tryptophan
was administered to patients taking Paxil (paroxetine hydrochloride).
Consequently, concomitant use of Paxil with tryptophan is not
recommended.
Monoamine Oxidase Inhibitors: Paroxetine should
not be used in combination with MAO inhibitors or within 2 weeks of terminating
treatment with MAO inhibitors. Treatment with paroxetine should then be
initiated cautiously and dosage increased gradually until optimal response is
reached. MAO inhibitors should not be introduced within 2 weeks of cessation of
therapy with paroxetine.
Warfarin: Preliminary data suggest that there may
be a pharmacodynamic interaction (that causes an increased bleeding diathesis
in the face of unaltered prothrombin time) between paroxetine and warfarin.
Since there is little clinical experience, the concomitant administration of
Paxil and warfarin should be undertaken with caution.
Sumafriptan: There have been rare postmarketing
reports describing patients with weakness, hyperreflexia, and incoordination
following the use of a selective serotonin reuptake inhibitor (SSRI) and
sumatriptan. If concomitant treatment with sumatriptan and an SSRI (e.g.,
fluoxetine, fluvoxamine, paroxetine, sertraline) is clinically warranted,
appropriate observation of the patient is advised.
Drugs Affecting Hepatic Metabolism: The metabolism
and pharmacokinetics of paroxetine may be affected by the induction or
inhibition of drug-metabolizing enzymes. Cimetidine, Phenobarbital,
Phenytoin.
Drugs Metabolized by Cytochrome P450IID6: Many
drugs, including most antidepressants (paroxetine, other SSRls and many
tricyclics), are metabolized by the cytochrome P450 isozyme P45011D6.
Concomitant use of Paxil with other drugs metabolized by cytochrome P45011D6
has not been formally studied but may require lower doses than usually
prescribed for either Paxil or the other drug.
Therefore, co-administration of Paxil with other drugs
that are metabolized by this isozyme, including certain antidepressants (e.g.,
nortriptyline, amitriptyline, imipramine, desipramine and fluoxetine),
phenothiazines (e.g., thioridazine) and Type iC antiarrhythmics (e.g.,
propafenone, flecainide and encainide), or that inhibit this enzyme (e.g.,
quinidine), should be approached with caution.
Tricyclic Antidepressants (TCA): Caution is
indicated in the co-administration of tricyclic antidepressants (TCAs) with
Paxil, because paroxetine may inhibit TCA metabolism. Plasma TCA concentrations
may need to be monitored, and the dose of TCA may need to be reduced, if a TCA
is co-administered with Paxil (see above—Drugs Metabolized by Cytochrome
P45011D6).
Lithium, Digoxin, Diazapam: Since there is little
clinical experience, the concurrent administration of paroxetine and the above
drugs should be undertaken with caution.
BEFORE USING THIS MEDICINE: INFORM YOUR DOCTOR OR
PHARMACIST of all prescription and over-the-counter medicine that you are
taking. This includes cyproheptadine, clozapine, dexfenfluramine, fenfluramine,
astemizole, terfenadine, lithium, selegiline, tramadol, and medicines used to
treat depression. Inform your doctor of any other medical conditions,
allergies, pregnancy, or breast-feeding.
When Used for Depression: The most commonly
observed adverse events associated with the use of paroxetine (Paxil) were:
asthenia, sweating, nausea, decreased appetite, somnolence, dizziness,
insomnia, tremor, nervousness, ejaculatory disturbance and other male genital
disorders.
When Used for OCD: The most commonly observed
adverse events associated with the use of paroxetine were: nausea, dry mouth,
decreased appetite, constipation. dryness, somnolence, tremor, sweating,
impotence and abnormal ejaculation.
When Used for Panic Disorder: The most commonly
observed adverse events associated with the use of paroxetine were: asthenia,
sweating, decreased appetite, libido decreased, tremor, abnormal ejaculation,
female genital disorders and impotence.
Other rarer side effects that should be reported
immediately to your doctor: Diarrhea; difficulty in speaking; drowsiness;
dryness of mouth; fever; inability to move eyes; increased sweating; increased
thirst; lack of energy; loss of or decrease in body movements; mood or behavior
changes; overactive reflexes; racing heartbeat; restlessness; shivering or
shaking; sudden or unusual body or face movements; talking, feeling, and acting
with excitement and activity you cannot control.
Other possible side effects: Constipation;
decreased sexual ability; dizziness; headache; nausea; problems in urinating;
tremor; trouble in sleeping; unusual tiredness or weakness; vomiting; anxiety
or nervousness; blurred vision; change in your sense of taste; decreased or
increased appetite; decreased sexual desire; fast or irregular heartbeat;
tingling, burning, or prickly sensations; weight loss or gain
DO NOT DRINK ALCOHOL while you are taking this medicine.
Dependence & Withdrawl: Paxil (paroxetine
hydrochloride) is not a controlled substance. Paxil has not been systematically
studied in animals or humans for its potential for abuse, tolerance or physical
dependence. While the clinical trials did not reveal any tendency for any
drug-seeking behavior, these observations were not systematic and it is not
possible to predict on the basis of this limited experience the extent to which
a CNS-active drug will be misused, diverted and/or abused once marketed.
Consequently, patients should be evaluated carefully for history of drug abuse,
and such patients should be observed closely for signs of Paxil misuse or abuse
(e.g., development of tolerance, incrementations of dose drug-seeking
behavior).
Overdose with Paxil (up to 2000 mg) alone and in
combination with other drugs has been reported. Signs and symptoms of overdose
with Paxil include nausea, vomiting, sedation, dizziness, sweating, and facial
flush. There are no reports of coma or convulsions following overdosage with
Paxil alone. A fatal outcome has been reported rarely when Paxil was taken in
combination with other agents, or when taken alone. Other symptoms of overdose
may include fast heartbeat and dilated pupils.
Treatment
If you or someone you know may have used more than the
recommended dose of this medicine, contact your local poison control center or
emergency room immediately.
Maintain adequate airway, empty stomach contents, and
treat symptomatically.
Treatment should be supportive and in response to
clinical signs and symptoms. Respiration, pulse and blood pressure should be
monitored and supported by general measures when necessary. Immediate gastric
lavage should be performed followed by administration of activated charcoal.
Do not exceed the recommended dosage or take this
medicine for longer than prescribed. Continue to take this medicine even if you
feel better. Do not miss any doses.
At least 1-2 weeks, and sometimes up to 4 weeks, may pass
before this medicine reaches its full effect.
Follow the directions for using this medicine provided
by your doctor.
Store this medicine at room temperature, away from heat
and light.
This medicine may be taken on an empty stomach or with
food.
If you miss a dose of this medicine, and you are taking
it in the morning, take it during the afternoon if you remember. If you do not
remember until the next morning, skip the missed dose and go back to your
regular dosing schedule. If you miss a dose and you are taking a daily dose at
bedtime and do not remember until the next day, skip the missed dose and go
back to your regular dosing schedule. Do not take 2 doses at once.
Additional Information: Do not share this medicine
with others for whom it was not prescribed. Do not use this medicine for other
health conditions. Keep this medicine out of the reach of children.
IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME,
obtain refills before your supply runs out.
For Depression:
Adults: Usual Initial Dosage: Paxil (paroxetine
hydrochloride) should be administered as a single daily dose, usually in the
morning. The recommended initial dose is 20 mg/day. Patients were dosed in a
range of 20 to 50 mg/day in the clinical trials demonstrating the
antidepressant effectiveness of Paxil. As with all antidepressants, the full
antidepressant effect may be delayed. Some patients not responding to a 20 mg
dose may benefit from dose increases, in 10 mg/day increments, up to a maximum
of 50 mg/day. Dose changes should occur at intervals of at least 1 week.
Maintenance Therapy: There is no body of evidence
available to answer the question of how long the patient treated with Paxil
should remain on it. It is generally agreed that acute episodes of depression
require several months or longer of sustained pharmacologic therapy. Whether
the dose of an antidepressant needed to induce remission is identical to the
dose needed to maintain and/or sustain euthyrnia is unknown. Systematic
evaluation of the efficacy of Paxil (paroxetine hydrochloride) has shown that
efficacy is maintained for periods of up to 1 year with doses that averaged
about 30 mg.
For Obsessive-Compulsive Disorder (OCD):
Adults: Paxil (paroxetine hydrochloride) should be
administered as a single daily dose, usually in the morning. The recommended
dose of Paxil in the treatment of OCD is 40 mg daily. Patients should be
started on 20 mg/day and the dose can be increased in 10 mg/day increments.
Dose changes should occur at intervals of at least 1 week. Patients were dosed
in a range of 20 to 60 mg/day in the clinical trials demonstrating the
effectiveness of Paxil in the treatment of OCD.
Maintenance Therapy: It is reasonable to consider
continuation for a responding patient. Dosage adjustments should be made to
maintain the patient on the lowest effective dosage, and patients should be
periodically reassessed to determine the need for continued treatment.
For Panic Disorder:
Adults: Paxil should be administered as a single
daily dose, usually in the morning. The target dose of Paxil in the treatment
of panic disorder is 40 mg/day. Patients should be started on 10 mg/day. Dose
changes should occur in 10 mg/week increments and at intervals of at least 1
week. Patients were dosed in a range of 10 to 60 mg/day in the clinical trials
demonstrating the effectiveness of Paxil. The maximum dosage should not exceed
60 mg/day.
Maintenance Therapy: Panic disorder is a chronic
condition, and it is reasonable to consider continuation for a responding
patient. Dosage adjustments should be made to maintain the patient on the
lowest effective dosage, and patients should be periodically reassessed to
determine the need for continued treatment.
Elderly or Debilitated, and Patients with Severe Renal
or Hepatic Impairment: The recommended initial dose is 10 mg/ day for
elderly patients, debilitated patients, and/o( patients with, severe renal or
hepatic impairment. Increases may be made if indicated. Dosage should not
exceed 40 mg/day. Switching Patients to or from a Monoamine Oxidese Inhbitor:
At least 14 days should elapse between discontinuation of a MACI and initiation
of Paxil therapy. Similarly, at least 14 days should be allowed after stopping
Paxil before starting a MAOI.
Children under 18 years of age: The use of
paroxetine in children under 18 years of age is not recommended as safety and
efficacy have not been established in this population.
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