International reference: 1 US FDA recall for this ingredient

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penici (benztropine)

US-market enforcement records (OpenFDA), shown for reference - not specific to this product in Ghana.

Valid Ghana · FDA Ghana

TROPINEROS TABLETS

BENZTROPINE MESYLATE

FDA/SD.255-010090 2MG nervous system INN generic

What it does

Benztropine is a medication used to help manage certain movement disorders.

Commonly used for: tremors (shaking), muscle stiffness (rigidity), Parkinson's disease, extrapyramidal symptoms caused by antipsychotic drugs

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
FDA/SD.255-010090
Registration date
2025-01-21
Expiry date
2030-02-01
Status
Valid
Active ingredient
BENZTROPINE MESYLATE
Dosage form
-
Strength
2MG
Pack size
-
Therapeutic class
-
ATC class (WHO)
N04AC - Ethers of tropine or tropine derivatives
Drug group
NERVOUS SYSTEM
RxNorm RxCUI
1424
Manufacturer / MAH
Infocus Remedies
Applicant / LTR
ROSTRUM PHARAMCY LIMITED
Country of origin
-
Manufacturer location
704/C, 704/C, Gayatri Mandir Rd, Phase 4, GIDC Estate, GIDC Naroda, Ahmedabad, Gujarat 382330, India

Source: Food and Drugs Authority · fetched 2026-04-18 08:33:04 · updated 2026-10-27 04:00:05

Disclaimer: This information is sourced from Food and Drugs Authority (Ghana). Always consult a qualified healthcare professional before using any medication.

About this medicine

Benztropine is a medication used to help manage certain movement disorders.

What it treats

  • tremors (shaking)
  • muscle stiffness (rigidity)
  • Parkinson's disease
  • extrapyramidal symptoms caused by antipsychotic drugs

How it works

Benztropine works by balancing chemicals in the brain that help control movement.

Who it's for

This medication is for people experiencing movement problems or side effects from certain mental health medications.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: benztropine

BNF-referenced

Benztropine is an anticholinergic medication primarily used to treat symptoms of Parkinson's disease and to manage drug-induced extrapyramidal symptoms. It works by restoring the balance between acetylcholine and dopamine in the central nervous system, which is often disrupted in these conditions.

Indications

  • Parkinson's disease
  • Drug-induced extrapyramidal symptoms
  • Acute dystonia

Dosage

Children: For children, the dosage must be determined by a healthcare professional, and it is recommended to refer to the BNF for Children for specific dosing guidance.

Adults: The usual dose for adults is 0.5 to 6 mg daily, given in one or two doses. The maximum recommended dose is typically 6 mg per day.

Mechanism of action

Benztropine acts as an antagonist of muscarinic acetylcholine receptors. By inhibiting acetylcholine activity, it helps to reduce the tremors and rigidity associated with Parkinson's disease and counteracts the side effects of antipsychotic medications that block dopamine receptors.

Pharmacodynamics

The drug exhibits anticholinergic properties, leading to reduced activity of the neurotransmitter acetylcholine in the brain. This results in decreased muscle rigidity and tremors. The therapeutic effects are often seen in the control of motor symptoms in Parkinson's disease and in alleviating drug-induced movement disorders.

Pharmacokinetics

Benztropine is well-absorbed following oral administration, with peak plasma concentrations occurring within 1 to 2 hours. It is widely distributed in body tissues, and its effects may last for several hours. The drug undergoes hepatic metabolism and is excreted primarily in the urine, with a half-life that typically ranges from 12 to 24 hours.

Contra-indications

  • Hypersensitivity to benztropine or any component of the formulation
  • Glaucoma
  • Prostatic hypertrophy
  • Myasthenia gravis
  • Tachycardia
  • Severe constipation

Adverse effects

  • Dry mouth
  • Blurred vision
  • Constipation
  • Urinary retention
  • Drowsiness
  • Confusion
  • Nausea
  • Vomiting

Interactions

  • Antihistamines may enhance anticholinergic effects
  • Concurrent use with other anticholinergic agents may increase the risk of side effects
  • CNS depressants may enhance drowsiness

Precautions

  • Use with caution in patients with a history of seizures
  • May impair the ability to drive or operate machinery
  • Monitor for signs of urinary retention
  • Caution in elderly patients due to increased sensitivity to anticholinergic effects

Pregnancy

Benztropine should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Limited data on human pregnancy outcomes are available.

Breast-feeding

It is not known whether benztropine is excreted in human milk. Caution should be exercised when administering to breastfeeding women.

Storage

Store in a cool, dry place away from light. Keep out of reach of children.

Formulations

  • Tablets
  • Injection solution
PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: benztropine

PubChem CID 1201549

Molecular formula: C21H25NO

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.