Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494), CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)
Proficient Rx LP
PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE 6.25 mg in 5 mL
ORAL
PRESCRIPTION DRUG
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
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
Abbreviated New Drug Application
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 Baca dokumen lengkapnya