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Molecule

Benztropine

Also known as benztropine mesylate
Available on requestNeurology
Presentations
4
Brands
0
Manufacturers
0
Available from stock
0

Benztropine is an anticholinergic. It is available as tablets and injection for oral, intramuscular and intravenous use. MedsAcross supplies Benztropine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Anticholinergic, Antihistamine, Cholinergic Antagonists, Histamine Receptor Antagonists
ATC classification
N04AC01 Benztropine · Anticholinergic, subgroup N04AC
US FDA first approval
5 March 1954
EU status
Not recorded
Orphan designation
Not recorded
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral, Intramuscular, Intravenous
Dosage forms
Tablet, Injection
Identifiers
UNII 1NHL2J4X8KRxCUI 1424CAS 86-13-5DrugBank DB00245Q415026

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

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).

Source: US FDA prescribing information

Dosing overview

Benztropine mesylate tablets should be used when patients are able to take oral medication. 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. Postencephalitic and Idiopathic Parkinsonism The usual daily dose is 1 to 2 mg with a range of 0.5 to 6 mg orally. As with any agent used in parkinsonism, dosage must be individualized according to age and weight, and the type of parkinsonism being treated. Generally, older patients, and thin patients cannot tolerate large doses. Most patients with postencephalitic parkinsonism need fairly large doses and tolerate them well.

Source: US FDA prescribing information

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.

Source: US FDA prescribing information

Warnings and precautions

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.

Source: US FDA prescribing information

Side effects

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.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

4 presentations of Benztropine, sorted by availability.

MedicineManufacturerRegisterAvailability
Benztropine 1 mg tabletOralGeneric name—US FDAAvailable on request
Benztropine 2 mg tabletOralGeneric name—US FDAAvailable on request
Benztropine 0.5 mg tabletOralGeneric name—US FDAAvailable on request
Benztropine 2 mg/2 mL injectionIntramuscular, intravenousGeneric name—US FDAAvailable on request

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 5 March 1954Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Benztropine available for export from India?

Yes, on request. MedsAcross lists 4 presentations of Benztropine and sources them for licensed hospitals, importers and physicians against valid import documents.

Is Benztropine approved by the US FDA?

Yes. The US FDA first approved Benztropine on 5 March 1954, according to Drugs@FDA.

Does Benztropine need cold chain shipping?

No listed presentation of Benztropine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Benztropine in?

Benztropine is classified under ATC code N04AC01 (Benztropine).

References

  1. Benztropine Mesylate prescribing information (Par Health). U.S. National Library of Medicine, DailyMed. Retrieved 20 August 2026

Request Benztropine for export supply

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