pharmacopeia
GET
/api/v1/drug/benztropine

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Cholinergic Antagonists; Cholinergic Muscarinic Antagonists; Dopamine Receptor Interactions; Histamine Receptor Antagonists.

CholinergicCholinergic MuscarinicHistamine Receptor

Indications

Sourced from openFDA
  • Benztropine mesylate tablets, USP 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).

Contraindications

Sourced from openFDA
  • Hypersensitivity to benztropine mesylate tablets or to any component of the 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.contraindicated

Dosage & administration

Sourced from openFDA

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 the 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. Postencephalitic and Idiopathic Parkinsonism - The usual daily dose is 1 to 2 mg, with a range of 0.5 to 6 mg orally or parentally. 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. Patients with a poor mental outlook are usually poor candidates for therapy. In idiopathic parkinsonism, therapy may be initiated with a single daily dose of 0.5 to 1 mg at bedtime. In some patients, this will be adequate; in others 4 to 6 mg a day may be required. In postencephalitic parkinsonism, therapy may be initiated in most patients with 2 mg a day in one or more doses.

Warnings & precautions

Sourced from openFDA

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.

Adverse reactions

Sourced from openFDA

The adverse reactions below, most of which are antichlolinergic 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 preexisting psychotic symptoms; nervousness; depression; listlessness; numbness of fingers. Special Senses Blurred vision, dilated pupils. Urogenital Urinary retention, dysuria. Metabolic/Immune or Skin Occasionally, an allergic reaction, e.g., skin rash, develops. If this cannot be controlled by dosage reduction, the medication should be discontinued. Other Heat stroke, hyperthermia, fever.

Overdosage

Sourced from openFDA

Manifestations - May be any of those seen in atropine poisoning or antihistamine overdosage: CNS depression, preceded or followed by stimulation; confusion; nervousness; listlessness; intensification of mental symptoms or toxic psychosis in patients with mental illness being treated with neuroleptic drugs (e.g., phenothiazines); hallucinations (especially visual); dizziness; muscle weakness; ataxia; dry mouth; mydriasis; blurred vision; palpitations; tachycardia; elevated blood pressure; nausea; vomiting; dysuria; numbness of fingers; dysphagia; allergic reactions, e.g., skin rash; headache; hot, dry, flushed skin; delirium; coma; shock; convulsions; respiratory arrest; anhidrosis; hyperthermia; glaucoma; constipation. Treatment - Physostigmine salicylate, 1 to 2 mg, SC or IV, reportedly will reverse symptoms of anticholinergic intoxication. * A second injection may be given after 2 hours if required. Otherwise treatment is symptomatic and supportive. Induce emesis or perform gastric lavage (contraindicated in precomatose convulsive, or psychotic states). Maintain respiration.

Approval history

Sourced from openFDA
  • Jan 23, 1992ANDAANDA081265Chartwell Rx
  • Dec 12, 1996ANDAANDA040103Aiping Pharm Inc
  • Aug 27, 2007ANDAANDA040715Ph Health
  • Jul 28, 2009ANDAANDA090233Fresenius Kabi Usa
  • Aug 31, 2009ANDAANDA090287Hikma Farmaceutica
  • Mar 29, 2010ANDAANDA090294Invagen Pharms
  • Nov 28, 2012ANDAANDA090168Leading
  • Feb 5, 2013ANDAANDA091525Navinta Llc

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
7,140 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective4516.3%
  2. 2Completed Suicide4356.1%
  3. 3Toxicity To Various Agents3945.5%
  4. 4Off Label Use3595.0%
  5. 5Death3274.6%
  6. 6Drug Interaction3264.6%
  7. 7Tremor3144.4%
  8. 8Fall2423.4%
  9. 9Fatigue2383.3%
  10. 10Nausea2363.3%
  11. 11Weight Increased2363.3%
  12. 12Confusional State2323.2%
  13. 13Dizziness2263.2%
  14. 14Depression2092.9%
  15. 15Constipation2032.8%

Literature

View JSON

Recent PubMed references pinned to Benztropine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

View JSON

The 10 most recently updated of 17 ClinicalTrials.gov registrations naming Benztropine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Benztropine work?
Mechanism-of-action classes: Cholinergic Antagonists; Cholinergic Muscarinic Antagonists; Dopamine Receptor Interactions; Histamine Receptor Antagonists.
What is Benztropine used for?
According to FDA labeling, Benztropine carries indications including: Benztropine mesylate tablets, USP 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).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Benztropine?
Benztropine is classified as Ethers of tropine or tropine derivatives, Anticholinergic, Antihistamine, Cholinergic Antagonists, Cholinergic Muscarinic Antagonists, Dopamine Receptor Interactions, Histamine Receptor Antagonists, Decreased Parasympathetic Acetylcholine Activity, Decreased Respiratory Secretions, Dopamine Activity Alteration, Positive Chronotropy, Pupillary Dilation, Salivation Inhibition.
What are the contraindications for Benztropine?
Benztropine labeling lists contraindications including: Hypersensitivity to benztropine mesylate tablets or to any component of the 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.. Always consult the full prescribing information and a clinician.
Note. Data for benztropine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

Search pharmacopeia

Search drugs, classes, and ingredients