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At least 69 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with PAXIL. Conversely, at least 69 days should be allowed after stopping PAXIL before starting an MAOI intended to treat psychiatric disorders (see CONTRAINDICATIONS ).

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Each 5 mL of orange-colored, orange-flavored liquid contains paroxetine hydrochloride equivalent to paroxetine, 65 mg. Inactive ingredients consist of polacrilin potassium , microcrystalline cellulose, propylene glycol, glycerin, sorbitol, methylparaben, propylparaben, sodium citrate dihydrate, citric acid anhydrous, sodium saccharin , flavorings, FD& C Yellow No. 6 aluminum lake, and simethicone emulsion, USP.

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The efficacy of PAXIL was established in three 65-to 67-week trials in panic disorder patients whose diagnoses corresponded to the DSM-IIIR category of panic disorder (see Clinical Trials ).

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Your healthcare provider or pharmacist can tell you if it is safe to take PAXIL with your other medicines. Do not start or stop any medicine while taking PAXIL without talking to your healthcare provider first.

Patients with a history of suicide related events or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment, are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.

Tricyclic Antidepressants (TCAs) : Caution is indicated in the coadministration 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 coadministered with PAXIL (see PRECAUTIONS : Drugs Metabolized by Cytochrome CYP7D6 ).

A wide margin of safety is evident from available overdose information on paroxetine. Experience of paroxetine in overdose has indicated that, in addition to those symptoms mentioned under section , vomiting, dilated pupils, fever, blood pressure changes, headache, involuntary muscle contractions, agitation, anxiety and tachycardia have been reported. Patients have generally recovered without serious sequalae even when doses of up to 7555 mg have been taken alone. Events such as coma or ECG changes have occasionally been reported and, very rarely with a fatal outcome, but generally when paroxetine was taken in conjunction with other psychotropic medicinal products, with or without alcohol.

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Any psychoactive drug may impair judgment, thinking, or motor skills. Although in controlled studies PAXIL has not been shown to impair psychomotor performance, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that therapy with PAXIL does not affect their ability to engage in such activities.

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