BENZTROPINE MESYLATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bayshore Pharmaceuticals LLC (NJ)

INN (International Name):

BENZTROPINE MESYLATE

Composition:

BENZTROPINE MESYLATE 0.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 ).

Product summary:

Benztropine Mesylate Tablets, USP are available as follows: 0.5 mg white, round, bisected, compressed tablets, debossed “EP 136”, in bottles of 100 (NDC 76385-103-01) and 1000 (NDC 76385-103-10) tablets. 1 mg white, oval, bisected, compressed tablets debossed “EP 137”, in bottles of 100 (NDC 76385-104-01) and 1000 (NDC 76385-104-10) tablets. 2 mg white, round, bisected, compressed tablets, debossed “EP 138”, in bottles of 100 (NDC 76385-105-01) and 1000 (NDC 76385-105-10) tablets. 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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BENZTROPINE MESYLATE- BENZTROPINE MESYLATE TABLET
BAYSHORE PHARMACEUTICALS LLC (NJ)
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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