Class: Anticholinergic Agents
VA Class: AU350
CAS Number: 132-17-2
Brands: Cogentin
Introduction
Antimuscarinic antiparkinsonian agent.
Uses for Benztropine Mesylate
Parkinsonian Syndrome
Adjunctive treatment of all forms of parkinsonian syndrome.a
May be used as monotherapy or combined with other antiparkinsonian agents (e.g., carbidopa-levodopa).a b
Drug-Induced Extrapyramidal Reactions
Control of extrapyramidal reactions (e.g., acute dystonia) induced by antipsychotic agents (e.g., phenothiazines).a
Does not alleviate symptoms of tardive dyskinesia, and in some instances may aggravate them.a b c Use not recommended.a b c
Benztropine Mesylate Dosage and Administration
Administration
Administered orally or by IM injection.a b
Also may be given IV.b Onset is rapid after either IM or IV injection, with no important difference in onset.b Manufacturer states there usually is no need to administer IV and does not provide specific instructions for IV administration.b
Oral Administration
Administered as a single dose at bedtime or in divided doses 2–4 times daily.a b
IM Administration
Reserve for patients who cannot take oral medication or for emergency situations (e.g., acute dystonia).a b
Dosage
Available as benztropine mesylate; dosage is expressed in terms of the salt.a b
Geriatric patients or those with less than average body weight generally cannot tolerate high dosages of the drug.a b
Pediatric Patients
Manufacturers make no specific dosage recommendations for children ≥ 3 years of age.a b (See Pediatric Use under Cautions.)
Adults
Parkinsonian Syndrome
May require periodic dosage adjustments to maintain optimum symptomatic relief in patients receiving concomitant levodopa or combination levodopa-carbidopa therapy.a
If used to replace or supplement other antiparkinsonian drugs, change should be gradual, with dosage of previous medication reduced as benztropine dosage is increased.a
Avoid abrupt discontinuance of concomitantly administered antiparkinsonian drugs.a
Idiopathic Parkinsonian Syndrome
Oral
Initially, 0.5–1 mg as a single dose at bedtime.b Dosages may be increased by 0.5-mg increments at 5–6 day intervals up to a maximum of 6 mg daily.b
Usual dosage: 1–2 mg daily (range: 0.5–6 mg daily).b
IM
Initially, 0.5–1 mg as a single dose at bedtime.a Dosages may be increased by 0.5-mg increments at 5- to 6-day intervals up to a maximum of 6 mg daily.a
Usual dosage: 1–2 mg daily (range: 0.5–6 mg daily).a b
Postencephalitic Parkinsonian Syndrome
Oral
Initially, 2 mg daily, given in 1 or more divided doses.b In highly sensitive patients, may give instead as a single 0.5 mg dose at bedtime.b Dosages may be increased by 0.5-mg increments at 5- to 6-day intervals up to a maximum of 6 mg daily.b
Usual dosage: 1–2 mg daily (range: 0.5–6 mg daily).b
IM
Initially, 2 mg daily, given in 1 or more divided doses.a In highly sensitive patients, may give instead as a single 0.5 mg dose at bedtime.a Dosages may be increased by 0.5-mg increments at 5–6 day intervals up to a maximum of 6 mg daily.a
Usual dosage: 1–2 mg daily (range: 0.5–6 mg daily).a
Drug-Induced Extrapyramidal Reactions
Oral
1–4 mg once or twice daily.b
For extrapyramidal disorders that develop shortly after initiation of antipsychotic therapy, 1–2 mg 2 or 3 times daily usually provides relief within 1 or 2 days.b Evaluate need for continued therapy after 1–2 weeks.b
IM
1–4 mg once or twice daily.a
For extrapyramidal disorders that develop shortly after initiation of antipsychotic therapy, 1–2 mg 2 or 3 times daily usually provides relief within 1 or 2 days.a Evaluate need for continued therapy after 1–2 weeks.a
Acute Dystonia
IM
1–2 mg, as a single dose.a
Prescribing Limits
Adults
Parkinsonian Syndrome
Oral
Maximum 6 mg daily.b
IM
Maximum 6 mg daily.a
Cautions for Benztropine Mesylate
Contraindications
Known hypersensitivity to benztropine or any ingredient in the formulation.a b
Children < 3 years of age.a b
Warnings/Precautions
Warnings
Pregnancy
Safe use during pregnancy has not been established.a b
Cognitive/Physical Impairment
Risk of impaired mental alertness or physical coordination required for performing hazardous tasks (e.g., driving or operating machinery).a b
Drug Interactions
Concomitant use with phenothiazines or tricyclic antidepressants associated with potentially fatal paralytic ileus, hyperthermia, or heat stoke.a b Advise patients to promptly notify clinicians if adverse GI effects, fever, or heat intolerance occur if used concomitantly with these drugs or other drugs with anticholinergic or antidopaminergic (e.g., haloperidol) effects.a b (See Interactions.)
Anhidrosis
Possibly severe anhidrosis and fatal hyperthermia.a b Use with caution in hot weather, particularly when given concomitantly with other anticholinergic drugs to chronically ill or alcoholic patients, those who have CNS disease, and those engaged in manual labor.a b Decrease dosages as needed to maintain ability to perspire.a b
General Precautions
Adequate Patient Monitoring
Has cumulative effects; continue to monitor patients, particularly those with tendency toward tachycardia or with prostatic hypertrophy.a b
Musculoskeletal Effects
Possible complaints of weakness and inability to move particular muscle groups, particularly at large dosages; adjust dosages as required.a b
CNS Effects
Possible mental confusion and excitement, particularly with large dosages or in susceptible patients.a b Visual hallucinations also possible.a b (See Dosage and Administration: Dosage.)
Risk of intensification of mental symptoms or precipitation of toxic psychosis in patients with mental disorders receiving phenothiazines, especially at beginning of therapy or during dosage adjustment; monitor closely.a b (See Specific Drugs under Interactions.)
Tardive Dyskinesia
Not recommended for use in patients with tardive dyskinesia.a b (See Drug-Induced Extrapyramidal Reactions under Uses.)
Renal Effects
Possible dysuria or urinary retention.a b
Glaucoma
Consider risks of glaucoma.a b Probably should not be used in patients with angle-closure glaucoma.a b e
Specific Populations
Pregnancy
Category C.d See Warnings under Cautions.
Pediatric Use
Safety and efficacy not established in children <3 years of age.a b (See Cautions: Contraindications.)
Use with caution in children >3 years of age because of adverse anticholinergic effects.a b
Common Adverse Effects
Dry mouth, blurred vision, mydriasis, nausea, nervousness, tachycardia, paralytic ileus, constipation.c e
Interactions for Benztropine Mesylate
Specific Drugs
Drug | Interaction | Comments |
|---|---|---|
Anticholinergic agents | Increased risk of adverse anticholinergic effectsa b | |
Antidepressants, tricyclics | Potentially fatal paralytic ileus, hyperthermia, or heat intolerancea b | Advise patients to promptly notify clinicians if adverse GI effects, fever, or heat intolerance occursa b |
Haloperidol | Potentially fatal paralytic ileus, hyperthermia, or heat intolerancea b | Advise patients to promptly notify clinicians if adverse GI effects, fever, or heat intolerance occursa b |
Phenothiazines | Potentially fatal paralytic ileus, hyperthermia, or heat intolerancea b Possible intensification of mental symptoms or precipitation of toxic psychosis in patients with mental disordersa b | Advise patients to promptly notify clinicians if adverse GI effects, fever, or heat intolerance occursa b Observe carefully, especially at beginning of therapy or during dosage adjustmenta b |
Stability
Storage
Oral
Tablets
< 30°C.b
Parenteral
Solution
< 40°C, preferably between 15–30°C; avoid freezing.c
Compatibility
For information on systemic interactions resulting from concomitant use, see Interactions.
Drug Compatibility
For information on IV injection of benztropine, see Administration under Dosage and Administration.
Compatible |
|---|
Fluconazole |
Tacrolimus |
Compatible |
|---|
Chlorpromazine HCl |
Fluphenazine HCl |
Metoclopramide HCl |
Perphenazine |
Variable |
Haloperidol lactate |
ActionsActions
Possesses both anticholinergic and antihistaminic effects, although only the former have been established as therapeutically important in management of parkinsonism.a
Advice to Patients
Potential for drug to impair mental alertness or physical coordination; use caution when driving or operating machinery until effects on individual are known.a b
Risk of hyperthermia.a b
Importance of promptly notifying clinicians of adverse GI effects, fever, or heat intolerance, particularly if also receiving phenothiazines, haloperidol, or other drugs with anticholinergic or antidopaminergic activity.a b
Importance of women informing their clinician if they are or plan to become pregnant or paln to breast-feed.a b
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses.a b
Importance of informing patients of other important precautionary information.a b (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets | 0.5 mg* | Benztropine Mesylate Tablets | Corepharma, Par, Pliva, Rising Pharmaceuticals, Upsher-Smith |
1 mg* | Benztropine Mesylate Tablets | Corepharma, Par, Pliva, Rising Pharmaceuticals, Upsher-Smith | ||
2 mg* | Benztropine Mesylate Tablets | Corepharma, Par, Pliva, Rising Pharmaceuticals, Upsher-Smith | ||
Parenteral | Injection | 1 mg/mL | Cogentin (with sodium chloride 9 mg/mL) | Ovation |
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Benztropine Mesylate 0.5MG Tablets (TEVA PHARMACEUTICALS USA): 60/$15.99 or 90/$17.99
Benztropine Mesylate 1MG Tablets (UPSHER-SMITH): 60/$15.99 or 90/$17.99
Benztropine Mesylate 2MG Tablets (UPSHER-SMITH): 90/$22.99 or 180/$45.97
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
References
a. Merck & Co., Inc., Cogentin (benztropine mesylate) injection prescribing information. Whitehouse Station, NJ; 2001 Oct.
b. Par pharmaceuticals, Inc., Benztropine mesylate tablets, USP prescribing information. Spring Valley, NY; 2001 Oct.
c. AHFS drug information 2003. McEvoy GK, ed. Benztropine mesylate. Bethesda, MD: American Society of Health-System Pharmacists; 2003:1185-6.
d. Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 6th ed. Baltimore, MD: Williams & Wilkins; 2002:125-6.
e. AHFS drug information 2003. McEvoy GK, ed. Antimuscarinics/Antispasmodics General Statement. Bethesda, MD: American Society of Health-System Pharmacists; 2003:1188-96.
HID. Trissel LA. Handbook on injectable drugs. 14th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2007:205-6.
More Benztropine Mesylate resources
- Benztropine Mesylate Side Effects (in more detail)
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