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Drug Interactions

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.

Adverse Reactions

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

Signs and Symptoms

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.

Dosage

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.

How Supplied

Tablets:

Each film-coated tablet contains paroxetine hydrochloride equivalent to paroxetine as follows: 10 mg, 20 mg, 30 mg, 40 mg.

Suspension for Oral Administration:

Each 5 mL of orange-colored, orange-flavored liquid contains paroxetine hydrochloride equivalent to paroxetine, 10mg.

 
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