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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. It is designated chemically as 3α-(Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate. Its molecular formula is C21H25NO • CH4O3S, and its structural formula is:
Each tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg of benztropine mesylate. Each tablet contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch.
CLINICAL PHARMACOLOGY: Benztropine 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 any component of 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 is given concomitantly with phenothiazines, haloperidol, or other drugs with anticholinergic or antidopaminergic activity, patients should be advised to report gastrointestinal complaints, fever or heat intolerance promptly. Paralytic ileus, hyperthermia and heat stroke, all of which have sometimes been fatal, have occurred in patients taking anticholinergic-type antiparkinsonism drugs, including benztropine in combination with phenothiazines and/or tricyclic antidepressants.
Since benztropine contains structural features of atropine, it may produce anhidrosis. For this reason, it should be administered with caution during hot weather, especially when given concomitantly with other atropine-like drugs to the chronically ill, the alcoholic, those who have central nervous system disease, and those who do manual labor in a hot environment. Anhidrosis may occur more readily when some disturbance of sweating already exists. If there is evidence of anhidrosis, the possibility of hyperthermia should be considered. Dosage should be decreased at the discretion of the physician so that the ability to maintain body heat equilibrium by perspiration is not impaired. Severe anhidrosis and fatal hyperthermia have occurred.
PRECAUTIONS:
ADVERSE REACTIONS: The adverse reactions below, most of which are anticholinergic in nature, have been reported and within each category are uled in order of decreasing severity.
OVERDOSAGE:
DOSAGE AND ADMINISTRATION: Benztropine mesylate tablets should be used when patients are able to take oral medication.
The injection is especially useful for psychotic patients with acute dystonic reactions or other reactions that make oral medication difficult or impossible. It is recommended also when a more rapid response is desired than can be obtained with tablets.
Because of cumulative action, therapy should be initiated with a low dose which is increased gradually at five or six-day intervals to the smallest amount necessary for optimal relief. Increases should be made in increments of 0.5 mg to a maximum of 6 mg or until optimal results are obtained without excessive adverse reactions.
HOW SUPPLIED: Benztropine mesylate tablets USP 0.5 mg - Each white, round compressed tablet is scored and debossed with identification logo cor and 143 on one side.
NDC 64980-111-01 in bottles of 100 tablets
NDC 64980-111-10 in bottles of 1000 tablets
Benztropine mesylate tablets USP 1 mg - Each white, oval shaped compressed tablet is scored and debossed with identification logo cor and 144 on one side.
NDC 64980-112-01 in bottles of 100 tablets
NDC 64980-112-10 in bottles of 1000 tablets
Benztropine mesylate tablets USP 2 mg - Each white, round compressed tablet is scored and debossed with identification logo cor and 145 on one side.
NDC 64980-113-01 in bottles of 100 tablets
NDC 64980-113-10 in bottles of 1000 tablets
Store at controlled room temperature 15° - 30°C (59° - 86°F) (see USP).
Dispense in well-closed container as defined in the USP.
Manufactured by:
Corepharma LLC
Middlesex, NJ 08846
MF # 276-02
Manufactured for:
Rising Pharmaceuticals, Inc.
Allendale, NJ 07401
Rev. January 2007