Paroxetine instructions for administration

Instructions for administration
Major depressive disorder Obsessive compulsive disorder Panic disorder Social anxiety disorder Generalized anxiety disorder Special populations Switching patients to/from a monoamine oxidase inhibitor''' Discontinuation of treatment with paroxetine tablets'''
 * Initial dosage (MDD)
 * Maintenance therapy (MDD)
 * Initial dosage (OCD)
 * Maintenance therapy (OCD)
 * Initial dosage (PD)
 * Maintenance therapy (PD)
 * Initial dosage (SAD)
 * Maintenance therapy (SAD)
 * Initial dosage (GAD)
 * Maintenance therapy (GAD)
 * Treatment of pregnant women (3rd trimester)
 * Dosage for elderly/debilitated patients/patients with severe renal or hepatic impairment

Initial dosage (MDD)
Paroxetine tablets 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 Paroxetine hydrochloride 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. Return to top

Maintenance therapy (MDD)
There is no body of evidence available to answer the question of how long the patient treated with Paroxetine tablets should remain on them. 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 Paroxetine hydrochloride has shown that efficacy is maintained for periods of up to 1 year with doses that averaged about 30 mg. Return to top

Initial dosage (OCD)
Paroxetine tablets should be administered as a single daily dose with or without food, usually in the morning. The recommended dose of Paroxetine tablets 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 Paroxetine hydrochloride in the treatment of OCD. The maximum dosage should not exceed 60 mg/day. Return to top

Maintenance therapy (OCD)
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. 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. Return to top

Initial dosage (PD)
Paroxetine tablets should be administered as a single daily dose with or without food, usually in the morning. The target dose of Paroxetine tablets 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 Paroxetine hydrochloride. The maximum dosage should not exceed 60 mg/day. Return to top

Maintenance therapy (PD)
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. 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. Return to top

Initial dosage (SAD)
Paroxetine tablets 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 Paroxetine hydrochloride was demonstrated in patients dosed in a range of 20 to 60 mg/day. While the safety of Paroxetine hydrochloride 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. Return to top

Maintenance therapy (SAD)
There is no body of evidence available to answer the question of how long the patient treated with Paroxetine tablets should remain on them. Although the efficacy of Paroxetine hydrochloride 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. Return to top

Initial dosage (GAD)
Paroxetine tablets should be administered as a single daily dose with or without food, usually in the morning. In clinical trials the effectiveness of Paroxetine 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. Return to top

Maintenance therapy (GAD)
Systematic evaluation of continuing Paroxetine hydrochloride for periods of up to 24 weeks in patients with Generalized Anxiety Disorder who had responded while taking Paroxetine hydrochloride during an 8 week acute treatment phase has demonstrated a benefit of such maintenance. Nevertheless, patients should be periodically reassessed to determine the need for maintenance treatment. Return to top

Treatment of pregnant women (3rd trimester)
Neonates exposed to Paroxetine hydrochloride and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. When treating pregnant women with Paroxetine during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering Paroxetine in the third trimester. Return to top

Dosage for elderly/debilitated patients/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. Return to top

Switching patients to/from a monoamine oxidase inhibitor
At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with Paroxetine tablets. Similarly, at least 14 days should be allowed after stopping Paroxetine tablets before starting a MAOI. Return to top

Discontinuation of treatment with paroxetine tablets
Symptoms associated with discontinuation of Paroxetine hydrochloride have been reported. Patients should be monitored for these symptoms when discontinuing treatment, regardless of the indication for which Paroxetine tablets are 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. Return to top