PROMETHAZINE WITH CODEINE- promethazine hydrochloride and codeine phosphate syrup

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494), CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)

MAH:

Atlantic Biologicals Corps

INN:

PROMETHAZINE HYDROCHLORIDE

composition:

PROMETHAZINE HYDROCHLORIDE 6.25 mg in 5 mL

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Promethazine with codeine syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold. The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population. Codeine sulfate is contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy. Codeine is contraindicated in patients with a known hypersensitivity to the drug. Promethazine is 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 and codeine are both contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma. The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less

authorization_status:

Abbreviated New Drug Application

SPC

PROMETHAZINE WITH CODEINE- PROMETHAZINE HYDROCHLORIDE AND CODEINE
PHOSPHATE SYRUP
ATLANTIC BIOLOGICALS CORPS
----------
PROMETHAZINE WITH CODEINE SYRUP (PROMETHAZINE HYDROCHLORIDE, USP
AND CODEINE PHOSPHATE, USP)
CV
RX ONLY
WARNING: RESPIRATORY DEPRESSION IN CHILDREN ANDDEATH RELATED TO
ULTRA-RAPID
METABOLISM OF CODEINE TO MORPHINE
RESPIRATORY DEPRESSION IN CHILDREN
THE COMBINATION OF PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE IS
CONTRAINDICATEDIN PEDIATRIC PATIENTS LESS THAN 6 YEARS OF AGE.
CONCOMITANT ADMINISTRATION OF
PROMETHAZINEPRODUCTS WITH OTHER RESPIRATORY DEPRESSANTS HAS AN
ASSOCIATION WITH
RESPIRATORY DEPRESSION,AND SOMETIMES DEATH, IN PEDIATRIC PATIENTS.
POSTMARKETING CASES OF RESPIRATORY DEPRESSION, INCLUDING FATALITIES,
HAVE BEEN REPORTED
WITHUSE OF PROMETHAZINE HYDROCHLORIDE IN PEDIATRIC PATIENTS LESS THAN
2 YEARS OF AGE. A
WIDERANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HYDROCHLORIDE HAVE
RESULTED IN
RESPIRATORYDEPRESSION IN THESE PATIENTS.
DEATH RELATED TO ULTRA-RAPID METABOLISM OF CODEINE TO MORPHINE
RESPIRATORY DEPRESSION AND DEATH HAVE OCCURRED IN CHILDREN WHO
RECEIVED CODEINEFOLLOWING
TONSILLECTOMY AND/OR ADENOIDECTOMY AND HAD EVIDENCE OF BEING
ULTRA-RAPIDMETABOLIZERS OF
CODEINE DUE TO A CYP2D6 POLYMORPHISM.
DESCRIPTION
Each 5 mL (one teaspoonful), for oral administration contains:
Promethazine hydrochloride 6.25 mg;
codeine phosphate 10 mg. Alcohol 7%.
Inactive Ingredients: Ascorbic acid, citric acid, FD&C blue #1, FD&C
red #3, grape blend flavor,
menthol, methylparaben, propylene glycol, propylparaben, purified
water, saccharin sodium, sodium
benzoate, sodium citrate and sucrose.
Codeine is one of the naturally occurring phenanthrene alkaloids of
opium derived from the opium
poppy; it is classified pharmacologically as a narcotic analgesic.
Codeine phosphate may be chemically
designated as
7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol
phosphate (1:1)(salt)
hemihydrate.
The phosphate salt of codeine occurs as white, needle-shaped crystals
or white crystalline powder.
Cod