PROMETHAZINE HYDROCHLORIDE tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494)

Tilgængelig fra:

McKesson Contract Packaging

INN (International Name):

PROMETHAZINE HYDROCHLORIDE

Sammensætning:

PROMETHAZINE HYDROCHLORIDE 25 mg

Recept type:

PRESCRIPTION DRUG

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

PROMETHAZINE HYDROCHLORIDE- PROMETHAZINE HYDROCHLORIDE TABLET
MCKESSON CONTRACT PACKAGING
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DESCRIPTION
Promethazine hydrochloride, a phenothiazine derivative, is designated
chemically as 10_H_-
Phenothiazine-10-ethanamine, _N,N,_α-trimethyl-, monohydrochloride,
(±)- with the following structural
formula:
Promethazine hydrochloride is a racemic compound; the molecular
formula is C
H N S • HCl and its
molecular weight is 320.88.
Promethazine hydrochloride occurs as a white to faint yellow,
practically odorless, crystalline powder
which slowly oxidizes and turns blue on prolonged exposure to air. It
is freely soluble in water and
soluble in alcohol.
Each tablet for oral administration contains 12.5 mg, 25 mg or 50 mg
promethazine hydrochloride, USP.
The inactive ingredients include: hypromellose, lactose monohydrate,
magnesium stearate, and
microcrystalline cellulose. The 12.5 mg contains FD&C Yellow No.6
aluminum lake. The 50 mg
contains D&C Red Lake Blend No.27 aluminum lake and D & C Red No. 30
aluminum lake.
CLINICAL PHARMACOLOGY
Promethazine is a phenothiazine derivative which differs structurally
from the antipsychotic
phenothiazines by the presence of a branched side chain and no ring
substitution. It is thought that this
configuration is responsible for its relative lack (1/10 that of
chlorpromazine) of dopamine antagonist
properties.
Promethazine is an H receptor blocking agent. In addition to its
antihistaminic action, it provides
clinically useful sedative and antiemetic effects.
Promethazine is well absorbed from the gastrointestinal tract.
Clinical effects are apparent within 20
minutes after oral administration and generally last four to six
hours, although they may persist as long
as 12 hours. Promethazine is metabolized by the liver to a variety of
compounds; the sulfoxides of
promethazine and N-demethylpromethazine are the predominant
metabolites appearing in the urine.
INDICATIONS AND USAGE
Promethazine hydrochloride tablets are useful for:
Perennial and seasonal allergic rhinitis.
Va