benztropine mesylate
Benztropine Mesylate is an anticholinergic used to treat Drug-Induced Abnormalities, Parkinson Disease.
Anticholinergic · by Navinta LLC
Generic of Cogentin
Key facts
- Active ingredient
- Benztropine Mesylate
- Drug class
- Anticholinergic
- Form
- Injectable, Solution, Tablet
- Strength
- Benztropine Mesylate 1MG/ML
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- May treat
- drug-induced abnormalities, parkinson disease
- Manufacturer
- Navinta LLC
- FDA application
- ANDA091525
What is Benztropine Mesylate?
From the FDA label:Benztropine mesylate is a synthetic compound containing structural features found in atropine and diphenhydramine. It is designated chemically as 8-azabicyclo[3.2.1] octane, 3-(diphenylmethoxy)-, endo , methanesulfonate. Its empirical formula is C 21 H 25 NO•CH 4 O 3 S, and its structural formula is: Benztropine mesylate is a crystalline white powder, very soluble in water, and has a molecular weight of 403.54. Benztropine mesylate injection, USP is supplied as a sterile injection for intravenous and intramuscular use. Each milliliter of the injection contains: Benztropine mesylate USP----------------------------------------------------------------------------------1 mg Sodium chloride USP----------------------------------------------------------------------------------------9 mg Water for injection USP q.s.--------------------------------------------------------------------------------1 mL benztropine-fig-01
How to use
Benztropine Mesylate is sold in more than one form (Injectable, Solution and Tablet), and each is dosed differently. The instructions below come from the FDA label for application ANDA091525 — follow the label that came with the product you were actually prescribed.
Since there is no significant difference in onset of effect after intravenous or intramuscular injection, usually there is no need to use the intravenous route. The drug is quickly effective after either route, with improvement sometimes noticeable a few minutes after injection. In emergency situations, when the condition of the patient is alarming, 1 to 2 mL of the injection normally will provide quick relief. If the parkinsonian effect begins to return, the dose can be repeated. 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 following dosing guidelines were written in reference to both benztropine mesylate tablets and Benztropine mesylate injection, USP. Benztropine mesylate tablets should be used when patients are able to take oral medication. The usual daily dose is 1 to 2 mg, with a range of 0.5 to 6 mg parenterally. 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…
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. 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. To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals USA Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Warnings
Important safety information
Safe use in pregnancy has not been established. Benztropine mesylate injection, USP 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 injection, USP 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 injection, USP in combination with phenothiazines and/or tricyclic antidepressants. Since Benztropine mesylate injection, USP 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.
Who should not take Benztropine Mesylate
Hypersensitivity to any component of Benztropine mesylate injection, USP. 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.
Overdose — what happens if you take too much
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. Maintain respiration. A short-acting barbiturate may be used for CNS excitement, but with caution to avoid subsequent depression; supportive care for depression (avoid convulsant stimulants such as picrotoxin, pentylenetetrazol, or bemegride); artificial respiration for severe respiratory depression; a local miotic for mydriasis and cycloplegia; ice bags or other cold applications and alcohol sponges for hyperpyrexia, a vasopressor…
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Drug class
How this class works, per Muscarinic Antagonists - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Benztropine Mesylate ranks — best-rated anticholinergic for:
Dosage forms
Injectable, Solution and Tablet
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- What does Benztropine Mesylate treat?
- Benztropine Mesylate (Benztropine Mesylate) may be used to treat drug-induced abnormalities, parkinson disease, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Benztropine Mesylate work?
- Benztropine Mesylate is a anticholinergic. Anticholinergic drugs block acetylcholine, the chemical messenger of the body's "rest and digest" nervous system, by occupying its muscarinic receptors. This eases muscle spasms, dries up secretions, relaxes the bladder and airways, and speeds the heart, depending on the tissue.
- Is there a coupon or discount for Benztropine Mesylate?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Benztropine Mesylate. To pay less, Benztropine Mesylate is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Benztropine Mesylate?
- Benztropine Mesylate is marketed by Navinta LLC. You can see Navinta LLC's full profile, rating, and other products on pharmaranks.
- Is Benztropine Mesylate a brand-name or generic drug?
- Benztropine Mesylate is a generic medication; its active ingredient is Benztropine Mesylate. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Benztropine Mesylate available over the counter?
- No. Benztropine Mesylate is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Benztropine Mesylate come in?
- Benztropine Mesylate is currently marketed as injectable, solution and tablet, per the FDA's National Drug Code Directory.
- What class of drug is Benztropine Mesylate?
- Benztropine Mesylate is classified as anticholinergic, antihistamine, per the FDA's Established Pharmacologic Class.
- Is Benztropine Mesylate FDA-registered?
- Benztropine Mesylate is on record with the U.S. FDA under application number ANDA091525. You can verify this on its official FDA label.
- Is Benztropine Mesylate safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Benztropine Mesylate. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Benztropine Mesylate?
- Benztropine Mesylate's side effects are taken directly from its FDA label. From the label: 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.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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