BENZTROPINE MESYLATE tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International ime):

BENZTROPINE MESYLATE

Sastav:

BENZTROPINE MESYLATE 0.5 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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

Proizvod sažetak:

Benztropine Mesylate Tablets, USP, for oral use, are supplied in the following forms: As 0.5 mg: White color, round, flat face beveled edge, bisected, compressed tablets, debossed "EP” above the bisect and "136" below the bisect, on one side and plain on the other side, in blister cards of 30 (NDC 0615-8088-39) tablets. As 1 mg: White color, oval, bisected, compressed tablets, debossed "EP" on the left side and "137" on the right side of the bisect, on one side and plain on the other side, in blister cards of 30 (NDC 0615-8089-39)  tablets. As 2 mg: White color, round, flat face beveled edge, bisected, compressed tablets, debossed "EP" above bisect and "138" below bisect on one side and plain on the other side. Store at controlled room temperature 20°-25° C (68°-77° 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. Manufactured by: Leading Pharma, LLC Fairfield, NJ 07004 Rev 01 01/17

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

BENZTROPINE MESYLATE- BENZTROPINE MESYLATE TABLET
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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BENZTROPINE MESYLATE TABLETS USP
0.5 MG, 1 MG AND 2 MG
DESCRIPTION
Benztropine mesylate, USP is a synthetic compound containing
structural features found in atropine and
diphenhydramine.
It is designated chemically as 3α-(Diphenylmethoxy) -1α-H,5 α
H-tropane methanesulfonate. Its
molecular formula is C
H NO•CH O S, and its structural formula is:
Benztropine mesylate, USP 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 0.5 mg, 1
mg or 2 mg.
Inactive ingredients: corn starch, dicalcium phosphate anhydrous,
hydrogenated vegetable oil, lactose
anhydrous, lactose monohydrate, microcrystalline cellulose, talc.
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