国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
BENZTROPINE MESYLATE (UNII: WMJ8TL7510) (BENZTROPINE - UNII:1NHL2J4X8K)
Cardinal Health 107, LLC
ORAL
PRESCRIPTION DRUG
Benztropine mesylate tablets USP are indicated 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 or to any component of the 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, for oral use, are supplied in the following forms: 1 mg: Compressed tablet, white oval tablets debossed “N” left of bisect “10” on one side and plain on other side. Available: Overbagged with 10 tablets per bag, NDC 55154-8095-0 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in well-closed containers as defined in the USP. Keep out of reach of children. *Duvoisin, R.C.; Katz, R.J.; Amer. Med. Ass. 206 : 1963–1965, Nov. 25, 1968.
Abbreviated New Drug Application
BENZTROPINE MESYLATE- BENZTROPINE MESYLATE TABLET CARDINAL HEALTH 107, LLC ---------- BENZTROPINE MESYLATE TABLETS USP RX ONLY DESCRIPTION Benztropine mesylate is a synthetic compound containing structural features found in atropine and diphenhydramine. 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: Benztropine mesylate is a crystalline white powder, very soluble in water, and has a molecular weight of 403.54. Each benztropine mesylate tablet USP for oral administration contains benztropine mesylate USP 0.5 mg, 1 mg or 2 mg. Inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch. 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. 21 25 4 3 INDICATIONS AND USAGE Benztropine mesylate tablets USP are indicated 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 or to any component of the 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 hazardo 阅读完整的文件