permax- Pergolide tablet

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

pergolide (UNII: 24MJ822NZ9) (pergolide - UNII:24MJ822NZ9)

Pieejams no:

Valeant Pharmaceuticals, Inc.

SNN (starptautisko nepatentēto nosaukumu):

Pergolide

Zāļu forma:

TABLET

Kompozīcija:

0.05 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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. Pergolide is contraindicated in patients who are hypersensitive to this drug or other ergot derivatives.

Produktu pārskats:

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

Produkta apraksts

PERMAX- PERGOLIDE TABLET
VALEANT PHARMACEUTICALS, INC.
----------
PERMAX
PERGOLIDE TABLETS, USP
®
WARNING
_CARDIAC VALVULOPATHY AND FIBROTIC COMPLICATIONS_
CARDIAC VALVULOPATHY
THE USE OF PERGOLIDE HAS BEEN SHOWN TO INCREASE THE RISK OF CARDIAC
VALVULAR DISEASE
INVOLVING ONE OR MORE VALVES. SOME PATIENTS HAVE REQUIRED VALVE
REPLACEMENT, AND DEATHS
HAVE BEEN REPORTED. CASES HAVE BEEN REPORTED AFTER EXPOSURES TO
PERGOLIDE RANGING FROM
SEVERAL MONTHS TO SEVERAL YEARS. THE HISTOPATHOLOGY OF EXPLANTED
VALVES IS SIMILAR TO THAT OF
OTHER DRUG-INDUCED VALVULOPATHIES. PRECISE RISK ESTIMATES OF
PERGOLIDE-INDUCED CARDIAC
VALVULAR DISEASE ARE NOT AVAILABLE.
SPECIFIC RISK FACTORS PREDISPOSING PATIENTS TO DEVELOPING CARDIAC
VALVULAR DISEASE WITH
PERGOLIDE HAVE NOT BEEN IDENTIFIED. CARDIAC VALVULOPATHY HAS BEEN
REPORTED WITH ALL DOSES OF
PERGOLIDE; HOWEVER, AVAILABLE DATA SUGGEST THAT THE RISK MAY BE
GREATER WITH HIGHER DOSES.
DOSES OF PERGOLIDE ABOVE 5 MG/DAY ARE NOT RECOMMENDED (_SEE_DOSAGE &
ADMINISTRATION).
PERGOLIDE IS NOT RECOMMENDED FOR USE IN PATIENTS WITH A HISTORY OF
CARDIAC VALVULOPATHY.
BEFORE INITIATING TREATMENT WITH PERGOLIDE, ALL PATIENTS SHOULD
UNDERGO A CARDIOVASCULAR
EVALUATION, INCLUDING AN ECHOCARDIOGRAM, TO DETERMINE WHETHER VALVULAR
DISEASE IS PRESENT
AND TO PROVIDE A BASELINE FOR SUBSEQUENT MONITORING. ALTHOUGH THE RISK
OF DISEASE
PROGRESSION IN PATIENTS WITH ASYMPTOMATIC VALVULAR DISEASE IS UNKNOWN,
PERGOLIDE
ORDINARILY SHOULD NOT BE INITIATED IF VALVULOPATHY IS DETECTED AT
SCREENING.
ALL PATIENTS TAKING PERGOLIDE SHOULD UNDERGO PERIODIC ECHOCARDIOGRAMS
TO SCREEN FOR THE
DEVELOPMENT OF VALVULOPATHY. PATIENTS SHOULD ALSO BE MONITORED FOR
SIGNS AND SYMPTOMS OF
VALVULOPATHY, INCLUDING DYSPNEA, EDEMA, CONGESTIVE HEART FAILURE AND
NEW CARDIAC
MURMURS. IF A PATIENT DEVELOPS THESE SIGNS OR SYMPTOMS, CONSIDERATION
SHOULD BE GIVEN TO
SUSPENDING TREATMENT WITH PERGOLIDE UNTIL A FULL DIAGNOSTIC
EVALUATION, INCLUDING
ECHOCARDIOGRAM, HAS BEEN PERFORMED. PERGOLIDE SHOULD ORDINARILY BE
DISCONTINUED IF A
PATIENT IS DI