BENZTROPINE MESYLATE tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

REMEDYREPACK INC.

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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., phenothiazine's). 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. Because of the atropine-like side effects, benztropine mesylate should be used with caution in pediatric patients over three years of age (see CONTRAINDICATIONS ).

Ürün özeti:

Benztropine Mesylate Tablets, USP are available as follows: 0.5 mg white, round, bisected, compressed tablets, debossed “EP 136” NDC: 70518-0720-00 NDC: 70518-0720-01 NDC: 70518-0720-02 PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 28 in 1 BLISTER PACK PACKAGING: 60 in 1 BLISTER PACK Rx Only Dispense in a well-closed container as defined in the USP, with a child-resistant closure. Store at 20°-25°C (68°-77°F). [See USP controlled room temperature]. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

BENZTROPINE MESYLATE- BENZTROPINE MESYLATE TABLET
REMEDYREPACK INC.
----------
BENZTROPINE MESYLATE TABLETS USP
0.5 MG, 1 MG AND 2 MG
BAYSHORE PHARMACEUTICALS LLC
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, designated as
3α-
(Diphenylmethoxy)-1 α H, 5αH-tropane methanesulfonate, with the
following structural
formula:
Each tablet, for oral administration, contains 0.5 mg, 1 mg or 2 mg of
benztropine
mesylate.
Each tablet contains the following inactive ingredients: dibasic
calcium phosphate
anhydrous, lactose monohydrate, lactose anhydrous, microcrystalline
cellulose,
cornstarch, talc and hydrogenated vegetable oil.
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
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., phenothiazine's).
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.
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 mes