BENZTROPINE MESYLATE .5 mg/1
benztropine mesylate · TABLET · Marlex PHARMACEUTICAL, INC
BENZTROPINE MESYLATE is a tablet containing benztropine mesylate at .5 mg/1, taken oral. Manufactured by Marlex PHARMACEUTICAL, INC.
Key Facts
- Brand Name
- BENZTROPINE MESYLATE
- Generic Name
- benztropine mesylate
- NDC Code (Product)
10135-813- Manufacturer
- Marlex PHARMACEUTICAL, INC
- Strength
- .5 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA204713
- Marketing Start
- 03/01/2025
Recall History
Attix Pharmaceuticals
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 penicillin.
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Fresenius Kabi USA, LLC
Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination observed in reserve sample vials
Nexus Pharmaceuticals Inc
Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE 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).
Dosage & Administration
DOSAGE AND ADMINISTRATION 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 usuall…
Warnings
WARNINGS 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.…
Contraindications
CONTRAINDICATIONS 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.
Drug Interactions
Drug Interactions Antipsychotic drugs such as phenothiazines or haloperidol; tricyclic antidepressants (see WARNINGS ).
Adverse Reactions
ADVERSE REACTIONS 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.
Frequently Asked Questions
What is BENZTROPINE MESYLATE used for?
BENZTROPINE MESYLATE contains benztropine mesylate. It is a tablet taken oral. Consult your doctor for specific uses.
Is BENZTROPINE MESYLATE a controlled substance?
BENZTROPINE MESYLATE is not classified as a controlled substance by the DEA.
What is the generic name for BENZTROPINE MESYLATE?
The generic name for BENZTROPINE MESYLATE is benztropine mesylate. There are 6 other brand versions of benztropine mesylate.
What is the NDC code for BENZTROPINE MESYLATE .5 mg/1?
The NDC (National Drug Code) for BENZTROPINE MESYLATE .5 mg/1 is 10135-813, listed by Marlex PHARMACEUTICAL, INC.