BENZTROPINE MESYLATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aphena Pharma Solutions - Tennnessee, LLC

INN (International Name):

BENZTROPINE MESYLATE

Composition:

BENZTROPINE MESYLATE 0.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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). 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.

Product summary:

Benztropine Mesylate Tablets USP, for oral use, are supplied in the following forms: 0.5 mg: Compressed tablet, white, round, flat-faced beveled edge tablets debossed “N” left of bisect “9” on one side and plain on other side, in bottles of 100 (NDC 0603-2437-21), and 1000 (NDC 0603-2437-32). 1 mg: Compressed tablet, white oval tablets debossed “N” left of bisect “10” on one side and plain on other side, in bottles of 100 (NDC 0603-2438-21) and 1000 (NDC 0603-2438-32). 2 mg: Compressed tablet, white, round, flat-faced beveled edge tablets debossed “N” left of bisect “11” on one side and plain on other side, in bottles of 100 (NDC 0603-2439-21) and 1000 (NDC 0603-2439-32). Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in well-closed containers as defined in the USP. Keep out of reach of children. *Duvoisin, R.C.; Katz, R.J.; Amer. Med. Ass. 206 : 1963–1965, Nov. 25, 1968.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BENZTROPINE MESYLATE- BENZTROPINE MESYLATE TABLET
APHENA PHARMA SOLUTIONS - TENNNESSEE, LLC
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BENZTROPINE MESYLATE TABLETS USP
RX ONLY
DESCRIPTION
Benztropine mesylate is a synthetic compound containing structural
features found in
atropine and diphenhydramine.
It is designated chemically as 3α-(Diphenylmethoxy)-1αH,
5αH-tropane
methanesulfonate. Its molecular 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.
Each benztropine mesylate tablet USP for oral administration contains
benztropine
mesylate USP 0.5 mg, 1 mg or 2 mg.
Inactive ingredients: colloidal silicon dioxide, magnesium stearate,
microcrystalline
cellulose, pregelatinized starch.
CLINICAL PHARMACOLOGY
Benztropine mesylate possesses both anticholinergic and antihistaminic
effects,
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
21
25
4
3
pyrilamine maleate.
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).
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.
WARNINGS
Safe use in pregnancy has not been established.
Benztropine mesylate may impair mental and/or physical abilities
required for
perfo