Codeine / Promethazine (Codeine cough syrup)

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Description

Codeine / Promethazine – Codeine cough syrup

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 has 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 ultrarapid metabolizers of codeine due to a CYP2D6 polymorphism.

DESCRIPTION of Codeine / Promethazine.

Each 5 mL (one teaspoonful), for oral administration contains Promethazine hydrochloride 6.25 mg; codeine phosphate 10 mg in a flavored syrup base with a pH between 4.8 and 5.4. Alcohol 7%.

Inactive ingredients: Artificial and natural flavors, citric acid, D&C Red 33, FD&C Blue 1, FD&C Yellow 6, glycerin, saccharin sodium, sodium benzoate, sodium citrate, sodium propionate, water, and other ingredients.

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-epoxy3-methoxy-17-methylmorphinan6-α-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 C18H21NO3H3PO4  ½ H2O, and the following structural formula:

 

Additional information

Quantity

1pint, 8oz

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