PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE syrup

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Pharmaceutical Associates, Inc.

SNN (starptautisko nepatentēto nosaukumu):

PROMETHAZINE HYDROCHLORIDE

Kompozīcija:

PROMETHAZINE HYDROCHLORIDE 6.25 mg in 5 mL

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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 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. Codein

Produktu pārskats:

Promethazine hydrochloride and codeine phosphate syrup (clear purple color, grape flavor) contains promethazine hydrochloride 6.25 mg/5 mL, codeine phosphate 10 mg/5 mL and alcohol 7%, and is available in the following oral dosage form: NDC 0121-0547-05 (unit dose cups of 5 mL, 10 × 10's). 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.

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE- PROMETHAZINE
HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP
PHARMACEUTICAL ASSOCIATES, INC.
----------
PROMETHAZINE HCL AND
CODEINE PHOSPHATE
SYRUP
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, and alcohol 7%.
Inactive Ingredients: Citric acid, D&C Red No. 33, FD&C Blue No.1,
FD&C Red No. 40, flavoring,
glycerin, purified water, sodium benzoate, sodium citrate, saccharin,
and sorbitol solution.
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 slight