Permax (Pergolide Mesylate) - Indications and Dosage

INDICATIONS AND USAGE

Permax is indicated as adjunctive treatment to levodopa/carbidopa in the management of the signs and symptoms of Parkinson's disease.

Evidence to support the efficacy of pergolide as an antiparkinsonian adjunct was obtained in a multicenter study enrolling 376 patients with mild to moderate Parkinson's disease who were intolerant to l -dopa/carbidopa as manifested by moderate to severe dyskinesia and/or on-off phenomena. On average, the patients evaluated had been on l -dopa/carbidopa for 3.9 years (range, 2 days to 16.8 years). The administration of pergolide permitted a 5% to 30% reduction in the daily dose of l -dopa. On average, these patients treated with pergolide maintained an equivalent or better clinical status than they exhibited at baseline.

DOSAGE AND ADMINISTRATION

Administration of Permax should be initiated with a daily dosage of 0.05 mg for the first 2 days. The dosage should then be gradually increased by 0.1 or 0.15 mg/day every third day over the next 12 days of therapy. The dosage may then be increased by 0.25 mg/day every third day until an optimal therapeutic dosage is achieved.

Permax is usually administered in divided doses 3 times per day. During dosage titration, the dosage of concurrent l- dopa/carbidopa may be cautiously decreased.

In clinical studies, the mean therapeutic daily dosage of Permax was 3 mg/day. The average concurrent daily dosage of l- dopa/carbidopa (expressed as l- dopa) was approximately 650 mg/day. The efficacy of Permax at doses above 5 mg/day has not been systematically evaluated.  Doses of pergolide above 5 mg/day are not recommended (see WARNINGS).

HOW SUPPLIED

Tablets (modified rectangle shape, scored):

0.05 mg, ivory, debossed with A 024, in bottles of 30 (UC5336) — NDC 0187-0839-01

0.25 mg, green, debossed with A 025, in bottles of 100 (UC5337) — NDC 0187-0840-02

1 mg, pink, debossed with A 026, in bottles of 100 (UC5338) — NDC 0187-0841-02

Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].

PERMAX is a registered trademark of Eli Lilly and Company, and licensed in the US to Valeant Pharmaceuticals International.

Literature revised August 18, 2004

Manufactured for:
Valeant Pharmaceuticals International
3300 Hyland Ave.
Costa Mesa, CA 92626 U.S.A.

Part Number 3083900EX00
PRINTED IN USA