PROMETHAZINE HYDROCHLORIDE solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Preferred Pharmaceuticals, Inc.

INN (Kansainvälinen yleisnimi):

PROMETHAZINE HYDROCHLORIDE

Koostumus:

PROMETHAZINE HYDROCHLORIDE 6.25 mg in 5 mL

Prescription tyyppi:

PRESCRIPTION DRUG

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

PROMETHAZINE HYDROCHLORIDE- PROMETHAZINE HYDROCHLORIDE SOLUTION
PREFERRED PHARMACEUTICALS, INC.
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PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION
DESCRIPTION
Each teaspoonful (5 mL) of Promethazine HCl Oral Solution contains
6.25 mg promethazine HCl in a
flavored syrup base with a pH between 4.7 and 5.2. Alcohol 7%. The
inactive ingredients present are
ascorbic acid, citric acid, D&C Yellow No. 10, edetate disodium, ethyl
alcohol, FD&C Blue No. 1,
FD&C Red No. 40, glycerin, methylparaben, pineapple flavor, purified
water, sodium benzoate, sodium
citrate, sucralose, and sucrose.
Promethazine HCl is a racemic compound; the molecular formula is C
H N S•HCl and its molecular
weight is 320.89.
Promethazine HCl, a phenothiazine derivative, is chemically designated
as 10-[2-
(Dimethylamino)propyl] phenothiazine monohydrochloride. Its structural
formula is:
Promethazine HCl 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.
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-desmethylpromethazine are the predominant
metabolites appearing in the urine.
INDICATIONS AND USAGE
Promethazine HCl Oral Solution is useful for:
Perenni