国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
BENZTROPINE MESYLATE (UNII: WMJ8TL7510) (BENZTROPINE - UNII:1NHL2J4X8K)
Par Pharmaceutical, Inc.
BENZTROPINE MESYLATE
BENZTROPINE MESYLATE 0.5 mg
ORAL
PRESCRIPTION DRUG
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). 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.
Benztropine Mesylate Tablets, USP are available as follows: 0.5 mg: white, round, flat-faced beveled edge, scored tablets, debossed "2325" on one side and debossed "V" on the reverse side, supplied in bottles of 10, 100 and 1000. 1 mg: white, oval, scored tablets, debossed "2326" on one side and debossed "V" on the reverse side, supplied in bottles of 10, 100 and 1000. 2 mg: white, round, flat-faced beveled edge, scored tablets, debossed "2327" on one side and debossed "V" on the reverse side, supplied in bottles of 10, 100 and 1000. Dispense in a well-closed container as defined in the USP. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. *Duvoisin, R.C.; Katz, R.J.; Amer. Med. Ass. 206:1963–1965, Nov. 25, 1968.
Abbreviated New Drug Application
BENZTROPINE MESYLATE- BENZTROPINE MESYLATE TABLET PAR PHARMACEUTICAL, INC. ---------- 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, designated as 3α- (Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate, with the following structural formula: Each tablet, for oral administration, contains 0.5 mg, 1 mg or 2 mg of benztropine mesylate. Each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate, lactose monohydrate, magnesium stearate and microcrystalline cellulose. CLINICAL PHARMACOLOGY Benztropine mesylate 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 tasks, such as operating machinery or driving a motor vehicle. When benztropine mesylate is given concomitantly with phenothiazines, halo 阅读完整的文件