PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE syrup

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Apotheca Inc

INN（国際名）:

CODEINE PHOSPHATE

構図:

CODEINE PHOSPHATE 10 mg in 5 mL

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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 Substance

製品概要:

Promethazine Hydrochloride and Codeine Phosphate Syrup contains promethazine hydrochloride 6.25 mg/5 mL, codeine phosphate 10 mg/5 mL and alcohol 7 percent. It is supplied as follows: NDC 12634-909-02 60 mL Bottle NDC 12634-909-04 120mL Bottle NDC 12634-909-06 178mL Bottle NDC 12634-909-08 237 mL Bottle NDC 12634-909-16 473 mL Bottle NDC 12634-909-28 3785 mL Bottle NDC 12634-909-32 946 mL Bottle Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Manufactured by Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701 Rev. 804:08 05/15 Repackged and Distributed by: Apotheca Inc. Phoenix, AZ 85006

認証ステータス:

Abbreviated New Drug Application

製品の特徴

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE- PROMETHAZINE
HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP
APOTHECA INC
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PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP
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
ISCONTRAINDICATED
IN PEDIATRIC PATIENTS LESS THAN 6 YEARS OF AGE.
CONCOMITANTADMINISTRATION OF PROMETHAZINE
PRODUCTS WITH OTHER RESPIRATORY DEPRESSANTSHAS AN ASSOCIATION WITH
RESPIRATORY DEPRESSION,
AND SOMETIMES DEATH, INPEDIATRIC PATIENTS.
POSTMARKETING CASES OF RESPIRATORY DEPRESSION, INCLUDING FATALITIES,
HAVEBEEN REPORTED WITH
USE OF PROMETHAZINE HYDROCHLORIDE IN PEDIATRIC PATIENTSLESS THAN 2
YEARS OF AGE. A WIDE
RANGE OF WEIGHT-BASED DOSES OFPROMETHAZINE HYDROCHLORIDE HAVE RESULTED
IN RESPIRATORY
DEPRESSION INTHESE PATIENTS.
DEATH RELATED TO ULTRA-RAPID METABOLISM OF CODEINE TO MORPHINE
RESPIRATORY DEPRESSION AND DEATH HAVE OCCURRED IN CHILDREN WHO
RECEIVEDCODEINE FOLLOWING
TONSILLECTOMY AND/OR ADENOIDECTOMY AND HAD EVIDENCEOF BEING
ULTRA-RAPID METABOLIZERS OF
CODEINE DUE TO A CYP2D6POLYMORPHISM.
DESCRIPTION
Each 5 mL (one teaspoonful), for oral administration contains:
Promethazine hydrochloride 6.25 mg;
codeine phosphate 10 mg. Alcohol 7%.
Inactive Ingredients: Artificial boysenberry flavor, ascorbic acid,
citric acid, D&C Red No. 33, FD&C
Blue No. 1, FD&C Yellow No. 6, methylparaben, propylene glycol,
propylparaben, purified water,
saccharin sodium, sodium benzoate, sodium citrate, and sucrose syrup.
Codeine is one of the naturally occurring phenanthrene alkaloids of
opium derived from the nopium
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.