BENZTROPINE MESYLATE tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

State of Florida DOH Central Pharmacy

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

INDICATIONS AND USAGE: 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. 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. Pediatric Use: Because of the atropine-like side effects, benztropine mesylate should be used with caution in pediatric patients over three years of age (see CONTRADICTIONS ).

Dettagli prodotto:

HOW SUPPLIED: Benztropine mesylate tablets USP 0.5 mg - Each white, round compressed tablet is scored and debossed with identification logo cor and 143 on one side. Benztropine mesylate tablets USP 1 mg - Each white, oval shaped compressed tablet is scored and debossed with identification logo cor and 144 on one side. Benztropine mesylate tablets USP 2 mg - Each white, round compressed tablet is scored and debossed with identification logo cor and 145 on one side. They are supplied by State of Florida DOH Central Pharmacy as follows: Store at controlled room temperature 15° - 30°C (59° - 86°F) (see USP). Dispense in well-closed container as defined in the USP. Manufactured by: Corepharma LLC Middlesex, NJ 08846 MF # 276-03 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401 And Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

BENZTROPINE MESYLATE - BENZTROPINE MESYLATE TABLET
STATE OF FLORIDA DOH CENTRAL PHARMACY
----------
BENZTROPINE MESYLATE TABLETS USP
0.5 MG, 1 MG AND 2 MG
RX ONLY
DESCRIPTION: Benztropine mesylate is a synthetic compound containing
structural features found in
atropine and diphenhydramine.
It is a crystalline white powder, very soluble in water. 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:
Each tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg
of benztropine mesylate. Each tablet
contains the following inactive ingredients: magnesium stearate,
microcrystalline cellulose, povidone
and pregelatinized starch.
CLINICAL PHARMACOLOGY: Benztropine 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: 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.
Because of its atropine-like side effects, this drug is
contraindicated in pediatric patients under three
21
25
4
3
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 motor vehicle.
When benztropine is given concomitantly wit