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  Major Depressive Disorder Usual Initial Dosage

  Paroxetine Hydrochloride Controlled-Release Tablets should be administered as a single daily dose, usually in the morning, with or without food. The recommended initial dose is 25 mg/day. Patients were dosed in a range of 25 mg to 62.5 mg/day in the clinical trials demonstrating the effectiveness of Paroxetine Hydrochloride Controlled-Release Tablets in the treatment of major depressive disorder. As with all drugs effective in the treatment of major depressive disorder, the full effect may be delayed. Some patients not responding to a 25-mg dose may benefit from dose increases, in 12.5-mg/day increments, up to a maximum of 62.5 mg/day. Dose changes should occur at intervals of at least 1 week.

  Patients should be cautioned that Paroxetine Hydrochloride Controlled-Release Tablets should not be chewed or crushed, and should be swallowed whole.

  Maintenance Therapy

  There is no body of evidence available to answer the question of how long the patient should be treated with Paroxetine Hydrochloride Controlled-Release Tablets. It is generally agreed that acute episodes of major depressive disorder 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 euthymia is unknown.

  Systematic evaluation of the efficacy of immediate-release paroxetine hydrochloride has shown that efficacy is maintained for periods of up to 1 year with doses that averaged about 30 mg, which corresponds to a 37.5-mg dose of Paroxetine Hydrochloride Controlled-Release Tablets, based on relative bioavailability considerations (see CLINICAL PHARMACOLOGY: Pharmacokinetics).

  Panic Disorder Usual Initial Dosage

  Paroxetine Hydrochloride Controlled-Release Tablets should be administered as a single daily dose, usually in the morning. Patients should be started on 12.5 mg/day. Dose changes should occur in 12.5-mg/day increments and at intervals of at least 1 week. Patients were dosed in a range of 12.5 to 75 mg/day in the clinical trials demonstrating the effectiveness of Paroxetine Hydrochloride Controlled-Release Tablets. The maximum dosage should not exceed 75 mg/day.

  Patients should be cautioned that Paroxetine Hydrochloride Controlled-Release Tablets should not be chewed or crushed, and should be swallowed whole.

  Maintenance Therapy

  Long-term maintenance of efficacy with the immediate-release formulation of paroxetine was demonstrated in a 3-month relapse prevention trial. In this trial, patients with panic disorder assigned to immediate-release paroxetine demonstrated a lower relapse rate compared to patients on placebo. 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.

  Social Anxiety Disorder Usual Initial Dosage

  Paroxetine Hydrochloride Controlled-Release Tablets should be administered as a single daily dose, usually in the morning, with or without food. The recommended initial dose is 12.5 mg/day. Patients were dosed in a range of 12.5 mg to 37.5 mg/day in the clinical trial demonstrating the effectiveness of Paroxetine Hydrochloride Controlled-Release Tablets in the treatment of social anxiety disorder. If the dose is increased, this should occur at intervals of at least 1 week, in increments of 12.5 mg/day, up to a maximum of 37.5 mg/day.

  Patients should be cautioned that Paroxetine Hydrochloride Controlled-Release Tablets should not be chewed or crushed, and should be swallowed whole.

  Maintenance Therapy

  There is no body of evidence available to answer the question of how long the patient should be treated with Paroxetine Hydrochloride Controlled-Release Tablets. Although the efficacy of Paroxetine Hydrochloride Controlled-Release Tablets beyond 12 weeks of dosing has not been demonstrated in controlled clinical trials, social anxiety disorder is recognized as a chronic condition, and it is reasonable to consider continuation of treatment 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.

  Premenstrual Dysphoric Disorder Usual Initial Dosage

  Paroxetine Hydrochloride Controlled-Release Tablets should be administered as a single daily dose, usually in the morning, with or without food. Paroxetine Hydrochloride Controlled-Release Tablets may be administered either daily throughout the menstrual cycle or limited to the luteal phase of the menstrual cycle, depending on physician assessment. The recommended initial dose is 12.5 mg/day. In clinical trials, both 12.5 mg/day and 25 mg/day were shown to be effective. Dose changes should occur at intervals of at least 1 week.

  Patients should be cautioned that Paroxetine Hydrochloride Controlled-Release Tablets should not be chewed or crushed, and should be swallowed whole.

  Maintenance/Continuation Therapy

  The effectiveness of Paroxetine Hydrochloride Controlled-Release Tablets for a period exceeding 3 menstrual cycles has not been systematically evaluated in controlled trials. However, women commonly report that symptoms worsen with age until relieved by the onset of menopause. Therefore, it is reasonable to consider continuation of a responding patient. Patients should be periodically reassessed to determine the need for continued treatment.

  Special Populations Treatment of Pregnant Women During the Third Trimester

  Neonates exposed to Paroxetine Hydrochloride Controlled-Release Tablets and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see WARNINGS: Usage in Pregnancy). When treating pregnant women with paroxetine during the third trimester, the physician should carefully consider the potential risks and benefits of treatment.

  Dosage for Elderly or Debilitated Patients, and Patients With Severe Renal or Hepatic Impairment

  The recommended initial dose of Paroxetine Hydrochloride Controlled-Release Tablets is 12.5 mg/day for elderly patients, debilitated patients, and/or patients with severe renal or hepatic impairment. Increases may be made if indicated. Dosage should not exceed 50 mg/day.

  Switching a Patient to or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders

  At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with Paroxetine Hydrochloride Controlled-Release Tablets. Conversely, at least 14 days should be allowed after stopping Paroxetine Hydrochloride Controlled-Release Tablets before starting an MAOI intended to treat psychiatric disorders (see CONTRAINDICATIONS).

  Use of Paroxetine Hydrochloride Controlled-Release Tablets With Other MAOIs, Such as Linezolid or Methylene Blue

  Do not start Paroxetine Hydrochloride Controlled-Release Tablets in a patient who is being treated with linezolid or intravenous methylene blue because there is increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered (see CONTRAINDICATIONS).

  In some cases, a patient already receiving therapy with Paroxetine Hydrochloride Controlled-Release Tablets may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, Paroxetine Hydrochloride Controlled-Release Tablets should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with Paroxetine Hydrochloride Controlled-Release Tablets may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS).

  Discontinuation of Treatment With Paroxetine Hydrochloride Controlled-Release Tablets

  Symptoms associated with discontinuation of immediate-release paroxetine hydrochloride or Paroxetine Hydrochloride Controlled-Release Tablets have been reported (see PRECAUTIONS: Discontinuation of Treatment with Paroxetine Hydrochloride Controlled-Release Tablets). Patients should be monitored for these symptoms when discontinuing treatment, regardless of the indication for which Paroxetine Hydrochloride Controlled-Release Tablets is being prescribed. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.

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