PROMETHAZINE HYDROCHLORIDE suppository

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Physicians Total Care, Inc.

INN (International Name):

PROMETHAZINE HYDROCHLORIDE

Sammensætning:

PROMETHAZINE HYDROCHLORIDE 12.5 mg

Indgivelsesvej:

RECTAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Promethazine is useful for: Promethazine HCl suppositories are contraindicated for use in pediatric patients less than two years of age. Promethazine HCl suppositories are contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma.

Produkt oversigt:

Promethazine HCl Suppositories are available as follows: 12.5 mg, white bullet shaped suppositories sealed in white PVC/PE shells, 25 mg, white bullet shaped suppositories sealed in white PVC/PE shells, Store refrigerated between 2°-8°C (36°-46°F). Dispense in well-closed container. Use carton to protect contents from light. Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1 Dist. by: Taro Pharmaceuticals U.S.A., Inc. , Hawthorne, NY 10532 Issued: May, 2005 PK-4710-0  350 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, OK     74146

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

PROMETHAZINE HYDROCHLORIDE - PROMETHAZINE HYDROCHLORIDE SUPPOSITORY
PHYSICIANS TOTAL CARE, INC.
----------
RX ONLY
PROMETHAZINE HCL SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS
THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL
RESPIRATORY DEPRESSION.
POSTMARKETING CASES OF RESPIRATORY DEPRESSION, INCLUDING
FATALITIES, HAVE BEEN REPORTED WITH USE OF PROMETHAZINE HCL
SUPPOSITORIES IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE
RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HCL SUPPOSITORIES
HAS RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS.
CAUTION SHOULD BE EXERCISED WHEN ADMINISTEREING PROMETHAZINE
HCL SUPPOSITORIES TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER.
IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF
PROMETHAZINE HCL SUPPOSITORY BE USED IN PEDIATRIC PATIENTS 2 YEARS
OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS
WITH RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED.
DESCRIPTION
Each rectal suppository of promethazine hydrochloride contains 12.5 mg
or 25 mg promethazine HCl
with ascorbyl palmitate, cocoa butter, colloidal silicon dioxide, and
white wax. Promethazine
Hydrochloride Suppositories 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 a 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
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
properti