BENZTROPINE MESYLATE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENZTROPINE MESYLATE (UNII: WMJ8TL7510) (BENZTROPINE - UNII:1NHL2J4X8K)

Available from:

Hikma Pharmaceuticals USA Inc.

INN (International Name):

BENZTROPINE MESYLATE

Composition:

BENZTROPINE MESYLATE 1 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

For use as an adjunct in the therapy of all forms of parkinsonism (see DOSAGE AND ADMINISTRATION ). Useful also in the control of extrapyramidal disorders (except tardive dyskinesia — see PRECAUTIONS ) due to neuroleptic drugs (e.g., phenothiazines). Hypersensitivity to any component of benztropine mesylate. 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.

Product summary:

Benztropine Mesylate Injection, USP, 1 mg per mL, is a clear, colorless solution and is supplied as follows: NDC 0143-9729-05 in boxes of 5 x 2 mL ampules. Storage Conditions: Store at 25°C (77°F); excursions permitted to 15º to 30°C (59º to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BENZTROPINE MESYLATE- BENZTROPINE MESYLATE INJECTION
HIKMA PHARMACEUTICALS USA INC.
----------
BENZTROPINE MESYLATE INJECTION, USP
Rx Only
DESCRIPTION
Benztropine Mesylate, USP 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
H
NO•CH O 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 q.s:
......................................................................................................1
mL
CLINICAL PHARMACOLOGY
Benztropine mesylate possesses both anticholinergic and antihistaminic
effects,
21
25
4
3
although only the former have been established as therapeutically
significant in the
management of parkinsonism.
In the isolated guinea pig ileum, the anticholinergic activity of this
drug is about equal to
that of atropine; however, when administered orally to unanesthetized
cats, it is only
about half as active as atropine.
In laboratory animals, its antihistaminic activity and duration of
action approach those of
pyrilamine maleate.
INDICATIONS AND USAGE
For use as an adjunct in the therapy of all forms of parkinsonism (see
DOSAGE AND
ADMINISTRATION).
Useful also in the control of extrapyramidal disorders (except tardive
dyskinesia — see
PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazines).
CONTRAINDICATIONS
Hypersensitivity to any component of benztropine mesylate.
Because of its atropine-like side effects, thi