BENZTROPINE MESYLATE tablet

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

BENZTROPINE MESYLATE (UNII: WMJ8TL7510) (BENZTROPINE - UNII:1NHL2J4X8K)

Доступно од:

REMEDYREPACK INC.

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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., phenothiazine's). 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. Because of the atropine-like side effects, benztropine mesylate should be used with caution in pediatric patients over three years of age (see CONTRAINDICATIONS ).

Резиме производа:

Benztropine Mesylate Tablets, USP are available as follows: 2 mg white, round, bisected, compressed tablets, debossed “EP 138”, in NDC: 70518-0649-00 30 in 1 BLISTER PACK Dispense in a well-closed container as defined in the USP, with a child-resistant closure. Store at 20°-25°C (68°-77°F). [See USP controlled room temperature]. Duvoisin, R.C.; Katz, R.J; Amer. Med. Ass. 206.1963-1965, Nov. 25, 1968. Rx Only Call your doctor for medical advice about the side effects. You may report side effects to FDA at 1-800-FDA-1088. Manufactured For: Bayshore Pharmaceuticals LLC Short Hills, NJ 07078 1-800-246-6028 Issued 11/2017 Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

BENZTROPINE MESYLATE- BENZTROPINE MESYLATE TABLET
REMEDYREPACK INC.
----------
BENZTROPINE MESYLATE TABLETS USP
0.5 MG, 1 MG AND 2 MG
BAYSHORE PHARMACEUTICALS LLC
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)-1 α H, 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: dibasic
calcium phosphate anhydrous, lactose
monohydrate, lactose anhydrous, microcrystalline cellulose,
cornstarch, talc and hydrogenated
vegetable oil.
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., phenothiazine's).
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 mes