Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
BENZTROPINE MESYLATE (UNII: WMJ8TL7510) (BENZTROPINE - UNII:1NHL2J4X8K)
Nexus Pharmaceuticals Inc
BENZTROPINE MESYLATE
BENZTROPINE MESYLATE 1 mg in 1 mL
PARENTERAL
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 any component of benztropine mesylate injection. 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. Because of the atropine-like side effects, benztropine mesylate should be used with caution in pediatric patients over three years of age (see CONTRAINDICATIONS).
Injection benztropine mesylate, 1 mg per mL, is a clear, colorless solution and is supplied in boxes of 5 x 2 mL vials. Store at 25°C (77°F): excursions permitted to 15° to 30°C (59 to 86°F) [see USP Controlled room temperature], protect from light, retain in carton until time of use. NDC Number 14789-300-02 Manufactured in the USA for: Nexus Pharmaceuticals, Inc., Lincolnshire, IL 60069 May 2009 PM-30100 1 Duvoisin, R.C.; Katz, R.J.; Amer. Med. Ass. 206:1963-1965, Nov.25, 1968 * Registered trademark of MERCK & CO., Inc.
Abbreviated New Drug Application
BENZTROPINE MESYLATE INJECTION, USP- BENZTROPINE MESYLATE INJECTION NEXUS PHARMACEUTICALS INC ---------- BENZTROPINE MESYLATE INJECTION, USP RX ONLY DESCRIPTION Benztropine mesylate is a synthetic compound containing structural features found in atropine and diphenhydramine. It is designated chemically as 8-azabicyclo[3.2.1] octane, 3-(diphenylmethoxy)-, _endo_, methanesulfonate. Its empirical 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. Benztropine mesylate Injection is supplied as a sterile injection for intravenous and intramuscular use. Each milliliter of the injection contains: Benztropine mesylate 1 mg/mL Sodium chloride 9 mg/mL Water for injection q.s. 1 mL 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, it s 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). 21 25 4 3 CONTRAINDICATIONS Hypersensitivity to any component of benztropine mesylate injection. 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 m Đọc toàn bộ tài liệu