Benztropine

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Benztropine
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Adeel Jamil, M.D. [2]

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Overview

Benztropine is an anticholinergic that is FDA approved for the treatment of postencephalitic and idiopathic parkinsonism and drug-induced|extrapyramidal disorders. Common adverse reactions include tachycardia, constipation, nausea, xerostomia, blurred vision, dysuria, and urinary retention.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

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 accordingto 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. In highly sensitive patients, therapy may be initiated with 0.5 mg at bedtime, and increased as necessary.
  • Some patients experience greatest relief by taking the entire dose at bedtime; others react more favorably to divided doses, two to four times a day. Frequently, one dose a day is sufficient, and divided doses may be unnecessary or undesirable.
  • The long duration of action of this drug makes it particularly suitable for bedtime medication when its effects may last throughout the night, enabling patients to turn in bed during the night more easily, and to rise in the morning.
  • When benztropine mesylate is started, do not terminate therapy with other antiparkinsonian agents abruptly. If the other agents are to be reduced or discontinued, it must be done gradually. Many patients obtain greatest relief with combination therapy.
  • Benztropine mesylate may be used concomitantly with Carbidopa-Levodopa, or with levodopa, in which case periodic dosage adjustment may be required in order to maintain optimum response.
Drug-Induced Extrapyramidal Disorders
  • In treating extrapyramidal disorders due to neuroleptic drugs (e.g., phenothiazines), the recommended dosage is 1 to 4 mg once or twice a day orally. Dosage must be individualized according to the need of the patient. Some patients require more than recommended; others do not need as much.
  • In acute dystonic reactions, 1 to 2 mL of the injection usually relieves the condition quickly. After that, the tablets 1 to 2 mg twice a day, usually prevents recurrence.
  • When extrapyramidal disorders develop soon after initiation of treatment with neuroleptic drugs (e.g., phenothiazines), they are likely to be transient. One to 2 mgof benztropine mesylate tablets two or three times a day usually provides relief within one or two days. After one or two weeks the drug should be withdrawn to determine the continued need for it. If such disorders recur, benztropine mesylate can be reinstituted.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Benztropine in adult patients.

Non–Guideline-Supported Use

Excessive salivation, Medical condition-associated; Prophylaxis
  • Benztropine daily doses of 3.8 mg.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Benztropine in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Benztropine in pediatric patients.

Non–Guideline-Supported Use

Excessive salivation, Medical condition-associated; Prophylaxis
  • Benztropine daily doses of 3.8 mg.

Contraindications

  • 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.

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 motorvehicle.
  • 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 thechronically 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.

Precautions

  • Since benztropine mesylate has cumulative action, continued supervision is advisable. Patients with a tendency to tachycardia and patients with prostatic hypertrophy should be observed closely during treatment.
  • Dysuria may occur, but rarely becomes a problem. Urinary retention has been reported with benztropine mesylate.
  • The drug may cause complaints of weakness and inability to move particular muscle groups, especially in large doses. For example, if the neck has been rigid and suddenly relaxes, it may feel weak, causing some concern. In this event, dosage adjustment is required.
  • The physician should be aware of the possible occurrence of glaucoma. Although the drug does not appear to have any adverse effect on simple glaucoma, it probably should not be used in angle-closure glaucoma.

Adverse Reactions

Clinical Trials Experience

  • 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 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.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Benztropine in the drug label.

Drug Interactions

There is limited information regarding Benztropine Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on use of Benztropine in women who are pregnant.
Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Benztropine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Benztropine during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Benztropine with respect to nursing mothers.

Pediatric Use

  • Because of the atropine-like side effects, benztropine mesylate should be used with caution in pediatric patients over three years of age.

Geriatic Use

There is no FDA guidance on the use of Benztropine with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Benztropine with respect to specific gender populations.

Race

There is no FDA guidance on the use of Benztropine with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Benztropine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Benztropine in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Benztropine in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Benztropine in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Benztropine in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Benztropine in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

Management

Chronic Overdose

There is limited information regarding Chronic Overdose of Benztropine in the drug label.

Pharmacology

Benzatropine00.png
Benzatropine
Systematic (IUPAC) name
(3-endo)-3-(Diphenylmethoxy)-8-methyl-8-azabicyclo[3.2.1]octane
Identifiers
CAS number 86-13-5
ATC code N04AC01
PubChem 1201549
DrugBank DB00245
Chemical data
Formula C21H25NO 
Mol. mass 307.429 g/mol
SMILES eMolecules & PubChem
Synonyms Benztropine
Pharmacokinetic data
Bioavailability ?
Metabolism Hepatic
Half life 12-24 hours
Excretion Urine
Therapeutic considerations
Pregnancy cat.

C(US)

Legal status

-only(US)

Routes Oral, IM, IV

Mechanism of Action

Structure

  • Benztropine Mesylate is a synthetic compound containing structural features found in atropine and diphenhydramine.
  • It is a crystalline white powder, very soluble in water, designated as 3α-(Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate, with the following structural formula:
File:Benztropine01.png
This image is provided by the National Library of Medicine.
  • Each tablet, for oral administration, contains 0.5 mg, 1 mg or 2 mg of benztropine mesylate.
  • Each tablet contains the following inactive ingredients: dibasic calcium phosphate lactose monohydrate, lactose anhydrous, microcrystalline cellulose, cornstarch,talc and hydrogenated vegetable oil.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Benztropine in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Benztropine in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Benztropine in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Benztropine in the drug label.

How Supplied

  • Benztropine Mesylate Tablets, USP are available as follows:
  • 0.5 mg white, round, bisected, compressed tablets, debossed “EP 136”, in bottles of 100 (NDC 64125-136-01) and 1000 (NDC 64125-136-10) tablets.
  • 1 mg white, oval, bisected, compressed tablets debossed “EP 137”, in bottles of 100 (NDC 64125-137-01) and 1000 (NDC 64125-137-10) tablets.
  • 2 mg white, round, bisected, compressed tablets, debossed “EP 138”, in bottles of100 (NDC 64125-138-01) and 1000 (NDC 64125-138-10) tablets.
  • Dispense in a well-closed container as defined in the USP, with a child-resistant closure.
  • Store at 20°-25°C (68°-77°F).

Storage

There is limited information regarding Benztropine Storage in the drug label.

Images

Drug Images

BENZTROPINE MESYLATE NDC 09041055.jpg

Drug Name: BENZTROPINE MESYLATE
Ingredient(s): BENZTROPINE MESYLATE[BENZTROPINE]
Imprint: cor;143
Dosage: 0.5 mg
Color(s): White
Shape: Round
Size (mm): 6
Score: 2
NDC:09041055

Drug Label Author: Major Pharmaceuticals

This pill image is provided by the National Library of Medicine's PillBox.
BENZTROPINE MESYLATE NDC 09041056.jpg

Drug Name: BENZTROPINE MESYLATE
Ingredient(s): BENZTROPINE MESYLATE[BENZTROPINE]
Imprint: cor;144
Dosage: 1 mg
Color(s): White
Shape: Oval
Size (mm): 8
Score: 2
NDC:09041056

Drug Label Author: Major Pharmaceuticals

This pill image is provided by the National Library of Medicine's PillBox.
BENZTROPINE MESYLATE NDC 09041057.jpg

Drug Name: BENZTROPINE MESYLATE
Ingredient(s): BENZTROPINE MESYLATE[BENZTROPINE]
Imprint: cor;145
Dosage: 2 mg
Color(s): White
Shape: Round
Size (mm): 8
Score: 2
NDC:09041057

Drug Label Author: Major Pharmaceuticals

This pill image is provided by the National Library of Medicine's PillBox.
BENZTROPINE MESYLATE NDC 649800111.jpg

Drug Name: BENZTROPINE MESYLATE
Ingredient(s): BENZTROPINE MESYLATE[BENZTROPINE]
Imprint: cor;143
Dosage: 0.5 mg
Color(s): White
Shape: Round
Size (mm): 6
Score: 2
NDC:649800111

Drug Label Author: Rising Pharmaceuticals Inc

This pill image is provided by the National Library of Medicine's PillBox.
BENZTROPINE MESYLATE NDC 649800112.jpg

Drug Name: BENZTROPINE MESYLATE
Ingredient(s): BENZTROPINE MESYLATE [BENZTROPINE]
Imprint: cor;144
Dosage: 1 mg
Color(s): White
Shape: Oval
Size (mm): 8
Score: 2
NDC:649800112

Drug Label Author: Rising Pharmaceuticals Inc

This pill image is provided by the National Library of Medicine's PillBox.
Benztropine Mesylate NDC 06032433.jpg

Drug Name: Benztropine Mesylate Oral (patient information)
Ingredient(s): BENZTROPINE MESYLATE[BENZTROPINE]
Imprint: 2325;V
Dosage: 0.5 mg
Color(s): White
Shape: Round
Size (mm): 6
Score: 2
NDC:06032433

Drug Label Author: Qualitest Pharmaceuticals

This pill image is provided by the National Library of Medicine's PillBox.
Benztropine Mesylate NDC 06032434.jpg

Drug Name: Benztropine Mesylate Oral (patient information)
Ingredient(s): BENZTROPINE MESYLATE[BENZTROPINE]
Imprint: 2326;V
Dosage: 1 mg
Color(s): White
Shape: Oval
Size (mm): 10
Score: 2
NDC:06032434

Drug Label Author: Qualitest Pharmaceuticals

This pill image is provided by the National Library of Medicine's PillBox.
Benztropine Mesylate NDC 06032435.jpg

Drug Name: Benztropine Mesylate Oral (patient information)
Ingredient(s): BENZTROPINE MESYLATE[BENZTROPINE]
Imprint: 2327;V
Dosage: 2 mg
Color(s): White
Shape: Round
Size (mm): 7
Score: 2
NDC:06032435

Drug Label Author: Qualitest Pharmaceuticals

This pill image is provided by the National Library of Medicine's PillBox.
Benztropine Mesylate NDC 08321080.jpg

Drug Name: Benztropine Mesylate Oral (patient information)
Ingredient(s): benztropine mesylate[benztropine]
Imprint: 832;BM05
Dosage: 0.5 mg
Color(s): White
Shape: Round
Size (mm): 6
Score: 2
NDC:08321080

Drug Label Author: Upsher-Smith Laboratories, Inc.

This pill image is provided by the National Library of Medicine's PillBox.
Benztropine Mesylate NDC 08321081.jpg

Drug Name: Benztropine Mesylate Oral (patient information)
Ingredient(s): benztropine mesylate[benztropine]
Imprint: 832;BM1
Dosage: 1 mg
Color(s): White
Shape: Oval
Size (mm): 11
Score: 2
NDC:08321081

Drug Label Author: Upsher-Smith Laboratories, Inc.

This pill image is provided by the National Library of Medicine's PillBox.
Benztropine Mesylate NDC 08321082.jpg

Drug Name: Benztropine Mesylate Oral (patient information)
Ingredient(s): benztropine mesylate[benztropine]
Imprint: 832;BM2
Dosage: 2 mg
Color(s): White
Shape: Round
Size (mm): 7
Score: 2
NDC:08321082

Drug Label Author: Upsher-Smith Laboratories, Inc.

This pill image is provided by the National Library of Medicine's PillBox.
Benztropine Mesylate NDC 501110393.jpg

Drug Name: Benztropine Mesylate Oral (patient information)
Ingredient(s): BENZTROPINE MESYLATE[BENZTROPINE]
Imprint: b;1114
Dosage: 0.5 mg
Color(s): White
Shape: Round
Size (mm): 6
Score: 2
NDC:501110393

Drug Label Author: Pliva Inc.

This pill image is provided by the National Library of Medicine's PillBox.
Benztropine Mesylate NDC 501110395.jpg

Drug Name: Benztropine Mesylate Oral (patient information)
Ingredient(s): BENZTROPINE MESYLATE[BENZTROPINE]
Imprint: b;1116
Dosage: 2 mg
Color(s): White
Shape: Round
Size (mm): 6
Score: 2
NDC:501110395

Drug Label Author: Pliva Inc.

This pill image is provided by the National Library of Medicine's PillBox.

Package and Label Display Panel

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC 17478-012-02

Benztropine Mesylate

Injection, USP

2 mg/2 mL (1 mg/mL)

2 mL Ampule

Rx only Akorn Logo


This image is provided by the National Library of Medicine.
Principal Display Panel Text for Carton Label:

NDC 17478-012-02

Benztropine Mesylate

Injection, USP

2 mg/2 mL

(1 mg/mL)

For Intravenous or Intramuscular Use

5 Ampules (2 mL each)

Rx only Akorn Logo

This image is provided by the National Library of Medicine.
This image of the FDA label is provided by the National Library of Medicine.

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Benztropine in the drug label.

Precautions with Alcohol

  • Alcohol-Benztropine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

  • BENZTROPINE MESYLATE®[1]

Look-Alike Drug Names

There is limited information regarding Benztropine Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. "BENZTROPINE MESYLATE- benztropine mesylate tablet".

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