PHENERGAN promethazine hydrochloride suppository

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

Promethazine Hydrochloride (UNII: R61ZEH7I1I) (Promethazine - UNII:FF28EJQ494)

Доступна с:

Prestium Pharma, Inc.

ИНН (Международная Имя):

Promethazine Hydrochloride

состав:

Promethazine Hydrochloride 12.5 mg

Тип рецепта:

PRESCRIPTION DRUG

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

PHENERGAN - PROMETHAZINE HYDROCHLORIDE SUPPOSITORY
PRESTIUM PHARMA, INC.
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PHENERGAN™
(PROMETHAZINE HYDROCHLORIDE)
SUPPOSITORIES, USP
RX ONLY
DESCRIPTION
Each rectal suppository contains 12.5 mg or 25 mg promethazine HCl
with ascorbyl palmitate, colloidal
silicon dioxide, white wax, hard fat, and glyceryl monostearate.
Phenergan (Promethazine HCl)
Suppositories, USP are for rectal administration only.
Promethazine HCl is a racemic compound; the empirical formula is C
H N S•HCl and its molecular
weight is 320.88.
Promethazine HCl, a phenothiazine derivative, is designated chemically
as 10_H_-Phenothiazine, 10-
ethanamine, _N,N α_-trimethyl-, monohydrochloride, (±)- with the
following structural formula:
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
soluble in water and freely 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 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
Phenergan (Promethazine HCl) Suppositories, USP are useful for:
17
20
2
1
Perennial and seasonal allergic rhinitis.
Vasomotor rhinitis.
Allergic conjunctivitis due to inhalant allergens and foods.
Mild, uncomplicated allergic skin manifestations of urticaria and
angioedema.
Amelioration of allergic reactions to blood or plasma.
Dermographism.
Anaphylactic reactions, as adjunctive therapy to epinephrine and oth