PROMETHAZINE WITH CODEINE- promethazine hydrochloride and codeine phosphate solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Proficient Rx LP

INN (International Name):

PROMETHAZINE HYDROCHLORIDE

Composition:

PROMETHAZINE HYDROCHLORIDE 6.25 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Promethazine with Codeine Syrup, a clear purple syrup with odor of grape menthol, contains promethazine hydrochloride 6.25 mg/5 mL, codeine phosphate 10 mg/5 mL and alcohol 7 percent, and is available in 4 fluid ounce (118 mL), 8 fluid ounce (237 mL) and pint (473 mL).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROMETHAZINE WITH CODEINE- PROMETHAZINE HYDROCHLORIDE AND CODEINE
PHOSPHATE SOLUTION
PROFICIENT RX LP
----------
PROMETHAZINE WITH CODEINE SYRUP (PROMETHAZINE HYDROCHLORIDE, USP
AND CODEINE PHOSPHATE, USP)
CV
RX ONLY
WARNING: RESPIRATORY DEPRESSION IN CHILDREN AND DEATH RELATED TO
ULTRA-RAPID
METABOLISM OF CODEINE TO MORPHINE
RESPIRATORY DEPRESSION IN CHILDREN
THE COMBINATION OF PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE IS
CONTRAINDICATED
IN PEDIATRIC PATIENTS LESS THAN 6 YEARS OF AGE. CONCOMITANT
ADMINISTRATION OF PROMETHAZINE
PRODUCTS 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 WITH
USE OF PROMETHAZINE HYDROCHLORIDE IN PEDIATRIC PATIENTS LESS THAN 2
YEARS OF AGE. A WIDE
RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HYDROCHLORIDE HAVE
RESULTED IN RESPIRATORY
DEPRESSION IN THESE PATIENTS.
DEATH RELATED TO ULTRA-RAPID METABOLISM OF CODEINE TO MORPHINE
RESPIRATORY DEPRESSION AND DEATH HAVE OCCURRED IN CHILDREN WHO
RECEIVED CODEINE
FOLLOWING TONSILLECTOMY AND/OR ADENOIDECTOMY AND HAD EVIDENCE OF BEING
ULTRA-RAPID
METABOLIZERS 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%.
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.
Codeine phosphate is freely soluble in water and slightly soluble in
alcohol. It has a molecular weight
of 406.37, a molecular formula of C
H NO •H PO •½H O, and the following structural formula:
18
21
3
3
4
2
Promethazine hydroc