BENZTROPINE MESYLATE tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Par Pharmaceutical, Inc.

INN (Διεθνής Όνομα):

BENZTROPINE MESYLATE

Σύνθεση:

BENZTROPINE MESYLATE 0.5 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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.

Περίληψη προϊόντος:

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.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

BENZTROPINE MESYLATE- BENZTROPINE MESYLATE TABLET
PAR PHARMACEUTICAL, INC.
----------
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 pyrilamine
maleate.
INDICATIONS AND USAGE
Benztropine mesylate tablets USP are indicated for use as an adjunct
in the therapy of all forms of
parkinsonism.
21
25
4
3
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 performance of hazardo