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The efficacy of PAXIL in longer-term treatment of PTSD, i. e., for more than 12 weeks, has not been systematically evaluated in placebo-controlled trials. Therefore, the physician who elects to prescribe PAXIL for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). DOSAGE AND ADMINISTRATION Major Depressive Disorder Text Continues Below
Usual Initial Dosage: PAXIL should be administered as a single daily dose with or without food, 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 effectiveness of PAXIL 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 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 major depressive disorder require several months or longer of sustained pharmacologic therapy. Whether the dose needed to induce remission is identical to the dose needed to maintain and/ or sustain euthymia is unknown. Systematic evaluation of the efficacy of PAXIL has shown that efficacy is maintained for periods of up to 1 year with doses that averaged about 30 mg.
Obsessive Compulsive Disorder Usual Initial Dosage: PAXIL should be administered as a single daily dose with or without food, 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. The maximum dosage should not exceed 60 mg/ day.
Maintenance Therapy Long-term maintenance of efficacy was demonstrated in a 6-month relapse prevention trial. In this trial, patients with OCD assigned to paroxetine demonstrated a lower relapse rate compared to patients on placebo (see CLINICAL PHARMACOLOGY— Clinical Trials). OCD 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.
Panic Disorder Usual Initial Dosage: PAXIL should be administered as a single daily dose with or without food, 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/ day 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 Long-term maintenance of efficacy was demonstrated in a 3-month relapse prevention trial. In this trial, patients with panic disorder assigned to paroxetine demonstrated a lower relapse rate compared to patients on placebo (see CLINICAL PHARMACOLOGY— Clinical Trials). 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: PAXIL should be administered as a single daily dose with or without food, usually in the morning. The recommended and initial dosage is 20 mg/ day. In clinical trials the effectiveness of PAXIL was demonstrated in patients dosed in a range of 20 to 60 mg/ day. While the safety of PAXIL has been evaluated in patients with social anxiety disorder at doses up to 60 mg/ day, available information does not suggest any additional benefit for doses above 20 mg/ day (see CLINICAL PHARMACOLOGY— Clinical Trials). 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. Although the efficacy of PAXIL 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. Generalized Anxiety Disorder: Usual Initial Dosage: PAXIL should be administered as a single daily dose with or without food, usually in the morning. In clinical trials the effectiveness of PAXIL was demonstrated in patients dosed in a range of 20 to 50 mg/ day. The recommended starting dosage and the established effective dosage is 20 mg/ day. There is not sufficient evidence to suggest a greater benefit to doses higher than 20 mg/ day. Dose changes should occur in 10 mg/ day increments and at intervals of at least 1 week. Maintenance Therapy Systematic evaluation of continuing PAXIL for periods of up to 24 weeks in patients with Generalized Anxiety Disorder who had responded while taking PAXIL during an 8-week acute treatment phase has demonstrated a benefit of such maintenance (see CLINICAL PHARMACOLOGY . Clinical Trials). Nevertheless, patients should be periodically reassessed to determine the need for maintenance treatment. Posttraumatic Stress Disorder Usual Initial Dosage: PAXIL should be administered as a single daily dose with or without food, usually in the morning. The recommended starting dosage and the established effective dosage is 20 mg/ day. In 1 clinical trial, the effectiveness of PAXIL was demonstrated in patients dosed in a range of 20 to 50 mg/ day. However, in a fixed dose study, there was not sufficient evidence to suggest a greater benefit for a dose of 40 mg/ day compared to 20 mg/ day. Dose changes, if indicated, should occur in 10 mg/ day increments and 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. Although the efficacy of PAXIL beyond 12 weeks of dosing has not been demonstrated in controlled clinical trials, PTSD 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. Dosage for Elderly or Debilitated Patients, and Patients With Severe Renal or Hepatic Impairment: The recommended initial dose is 10 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 40 mg/ day. Switching Patients to or From a Monoamine Oxidase Inhibitor: At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with PAXIL. Similarly, at least 14 days should be allowed after stopping PAXIL before starting an MAOI. Discontinuation of Treatment With PAXIL Symptoms associated with discontinuation of PAXIL have been reported (see PRECAUTIONS). Patients should be monitored for these symptoms when discontinuing treatment, regardless of the indication for which PAXIL 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. NOTE: SHAKE SUSPENSION WELL BEFORE USING. HOW SUPPLIED Tablets: Film-coated, modified-oval as follows: 10-mg yellow, scored tablets engraved on the front with PAXIL and on the back with 10. NDC 0029-3210-13 Bottles of 30
20-mg pink, scored tablets engraved on the front with PAXIL and on the back with 20.
NDC 0029-3211-13 Bottles of 30
NDC 0029-3211-20 Bottles of 100
NDC 0029-3211-21 SUP 100s (intended for institutional use only)
30-mg blue tablets engraved on the front with PAXIL and on the back with 30.
NDC 0029-3212-13 Bottles of 30
40-mg green tablets engraved on the front with PAXIL and on the back with 40.
NDC 0029-3213-13 Bottles of 30
Store tablets between 15 and 30 C (59 and 86 F).
Oral Suspension: Orange-colored, orange-flavored, 10 mg/ 5 mL, in 250 mL white bottles. NDC 0029-3215-48 Store suspension at or below 25 C (77 F).
PAXIL is a registered trademark of GlaxoSmithKline.
GlaxoSmithKline
Research Triangle Park, NC 27709
©2003, GlaxoSmithKline. All rights reserved.
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