Benztropine: uses, appearance and warnings

Benztropine mesylate tablets 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).

Benztropine Mesylate Tablets, USP are available as follows: 0.5 mg: White, biconvex, round tablets, debossed with “337” on one side, and plain with a bisect on the other side, in bottles of 100 (NDC 50228- 225-01), and 1,000 (NDC 50228-225-10). 1 mg: Light yellow, round, biconvex tablets debossed with “338” on one side and plain with a bisect on the other side, in bottles of 100 (NDC 50228-226-01) and 1,000 (NDC 50228-226-10). 2 mg: Light red, round, biconvex tablets debossed with “339” on one side and plain with a bisect on the other side, in bottles of 100 (NDC 50228-227-01) and 1,000 (NDC 50228-227-10). Dispense in well-closed containers as defined in the USP. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children. For more details please call 1-855-724-3436. Dispense the Prescribing Information at: https://sciegenpharm.com/medication-guide/ * Duvoisin, R.C.; Katz, R.J.; Amer. Med. Ass. 206 : 1963–1965, Nov. 25, 1968. Manufactured by: A&Z Pharmaceutical, Inc., 180 Oser Ave. Suite 300 Hauppauge, NY 11788 Manufactured for: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Revised: 12/2025 LB8080

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.

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 mesylate 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 mesylate, in combination with phenothiazines and/or tricyclic antidepressants. Since benztropine mesylate 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.

The adverse reactions below, most of which are anticholinergic in nature, have been reported and within each category are listed in order of decreasing severity. Cardiovascular Tachycardia. Digestive Paralytic ileus, constipation, vomiting, nausea, dry mouth. If dry mouth is so severe that there is difficulty in swallowing or speaking, or loss of appetite and weight, reduce dosage, or discontinue the drug temporarily. Slight reduction in dosage may control nausea and still give sufficient relief of symptoms. Vomiting may be controlled by temporary discontinuation, followed by resumption at a lower dosage. Nervous System Toxic psychosis, including confusion, disorientation, memory impairment, visual hallucinations; exacerbation of pre-existing psychotic symptoms; nervousness; depression; listlessness; numbness of fingers. Special Senses Blurred vision, dilated pupils. …

Antipsychotic drugs such as phenothiazines or haloperidol; tricyclic antidepressants (see WARNINGS ).