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Bipolar Mania Usual Dose Risperidone should be administered on a once daily schedule, starting with 2 mg to 3 mg per day. Dosage adjustments, if indicated, should occur at intervals of not less than 24 hours and in dosage increments/ decrements of 1 mg per day, as studied in the short-term, placebo-controlled trials. In these trials, short-term ( 3 week) anti-manic efficacy was demonstrated in a flexible dosage range of 1-6 mg per day ( see CLINICAL PHARMACOLOGY Clinical Trials) . RISPERDAL ® doses higher than 6 mg per day were not studied. Text Continues Below
Maintenance Therapy There is no body of evidence available from controlled trials to guide a clinician in the longer-term management of a patient who improves during treatment of an acute manic episode with risperidone. While it is generally agreed that pharmacological treatment beyond an acute response in mania is desirable, both for maintenance of the initial response and for prevention of new manic episodes, there are no systematically obtained data to support the use of risperidone in such longer-term treatment
( i. e. , beyond 3 weeks) . Pediatric Use Safety and effectiveness of RISPERDAL ® in pediatric patients with schizophrenia or acute mania associated with Bipolar I Disorder have not been established. Dosage in Special Populations The recommended initial dose is 0.5 mg BID in patients who are elderly or debilitated, patients with severe renal or hepatic impairment, and patients either predisposed to hypotension or for whom hypotension would pose a risk. Dosage increases in these patients should be in ncrements of no more than 0.5 mg BID. Increases to dosages above 1.5 mg BID should generally occur at intervals of at least 1 week. In some patients, slower titration may be medically appropriate. Elderly or debilitated patients, and patients with renal impairment, may have less ability to eliminate RISPERDAL ® than normal adults. Patients with impaired hepatic function may have increases in the free fraction of risperidone, possibly resulting in an enhanced effect ( see CLINICAL PHARMACOLOGY) . Patients with a predisposition to hypotensive reactions or for whom such reactions would pose a particular risk likewise need to be titrated cautiously and carefully monitored ( see PRECAUTIONS) . If a once-a-day dosing regimen in the elderly or debilitated patient is being considered, it is recommended that the patient be titrated on a twice-a-day regimen for 2-3 days at the target dose. Subsequent switches to a once-a-day dosing regimen can be done thereafter. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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