PROMETHAZINE HYDROCHLORIDE suppository

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

A-S Medication Solutions

관리 경로:

RECTAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Promethazine HCl Suppositories, USP are useful for: 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 other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients. Promethazine HCl Suppositories are contraindicated for

제품 요약:

Product: 50090-5362 NDC: 50090-5362-1 1 SUPPOSITORY in a BLISTER PACK / 4 in a CARTON NDC: 50090-5362-2 1 SUPPOSITORY in a BLISTER PACK / 12 in a CARTON

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

PROMETHAZINE HYDROCHLORIDE- PROMETHAZINE HYDROCHLORIDE SUPPOSITORY
A-S MEDICATION SOLUTIONS
----------
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, glyceryl monostearate, hard fat,
and white wax.
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.
17
20
2
1
INDICATIONS AND USAGE
Promethazine HCl Suppositories, USP are useful for:
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 other
standard
measure