PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE- promethazine hydrochloride and codeine phosphate syrup

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Proficient Rx LP

Designación común internacional (DCI):

PROMETHAZINE HYDROCHLORIDE

Composición:

PROMETHAZINE HYDROCHLORIDE 6.25 mg in 5 mL

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Promethazine hydrochloride and codeine phosphate 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.   Promethazine hydrochloride and codeine phosphate syrup is a Schedule V Controlled S

Resumen del producto:

Promethazine Hydrochloride and Codeine Phosphate Syrup contains promethazine hydrochloride, USP 6.25 mg/5 mL, codeine phosphate, USP 10 mg/5 mL and alcohol 7 percent. It is supplied in a clear green, pineapple flavored syrup and is available as follows: NDC 63187-595-04 4 fl. oz. (118 mL) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries, Inc. Bryan, OH 43506 Relabeled By: Proficient Rx LP Thousand Oaks, CA 91320 5981T05                                                                                          Iss: 03/15

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE- PROMETHAZINE
HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP
PROFICIENT RX LP
----------
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP 6.25 MG AND
10MG/5 ML RX ONLY CV
BOXED WARNING
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%.
Inactive Ingredients: ascorbic acid, citric acid, D & C yellow #10,
edetate disodium, ethyl alcohol,
FD&C Blue #1, FD&C Red #40, glycerin, methylparaben, pineapple flavor,
purified water, sodium
benzoate, sodium citrate, sucralose, 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 crysta