Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
BENZTROPINE MESYLATE (UNII: WMJ8TL7510) (BENZTROPINE - UNII:1NHL2J4X8K)
Rebel Distributors Corp
BENZTROPINE MESYLATE
BENZTROPINE MESYLATE 2 mg
ORAL
PRESCRIPTION DRUG
INDICATIONS AND USAGE: For use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia - see PRECAUTIONS ) due to neuroleptic drugs (e.g., phenothiazines). CONTRAINDICATIONS: Hypersensitivity to benztropine mesylate tablets. Because of its atropine-like side effects, this drug is contraindicated in pediatric patients under three years of age and should be used with caution in older pediatric patients. Pediatric Use: Because of the atropine-like side effects, benztropine mesylate should be used with caution in pediatric patients over three years of age (see CONTRADICTIONS ).
HOW SUPPLIED: Benztropine mesylate tablets USP 2 mg - Each white, round compressed tablet is scored and debossed with identification logo cor and 145 on one side. NDC 21695-286-30 in bottles of 30 tablets Store at controlled room temperature 15° - 30°C (59° - 86°F) (see USP). Dispense in well-closed container as defined in the USP. Manufactured by: Corepharma LLC Middlesex, NJ 08846 MF # 276-03 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401 Rev. July 2009 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320
Abbreviated New Drug Application
BENZTROPINE MESYLATE- BENZTROPINE MESYLATE TABLET REBEL DISTRIBUTORS CORP ---------- BENZTROPINE MESYLATE TABLETS USP 0.5 MG, 1 MG AND 2 MG RX ONLY DESCRIPTION: Benztropine mesylate is a synthetic compound containing structural features found in atropine and diphenhydramine. It is a crystalline white powder, very soluble in water. It is designated chemically as 3α- (Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate. Its molecular formula is C H NO • CH O S, and its structural formula is: Each tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg of benztropine mesylate. Each tablet contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch. CLINICAL PHARMACOLOGY: Benztropine possesses both anticholinergic and antihistaminic effects, although only the former have been established as therapeutically significant in the management of parkinsonism. In the isolated guinea pig ileum, the anticholinergic activity of this drug is about equal to that of atropine; however, when administered orally to unanesthetized cats, it is only about half as active as atropine. In laboratory animals, its antihistaminic activity and duration of action approach those of pyrilamine maleate. INDICATIONS AND USAGE: For use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia - see PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazines). CONTRAINDICATIONS: Hypersensitivity to benztropine mesylate tablets. Because of its atropine-like side effects, this drug is contraindicated in pediatric patients under three years of age and should be used with caution in older pediatric patients. WARNINGS: Safe use in pregnancy has not been established. Benztropine mesylate may impair mental and/or physical abilities required for performance of hazardous 21 25 4 3 tasks such as operating machinery or driving a motor vehicle. When benztropine is given concomitantly with phenothiazine Đọc toàn bộ tài liệu