PROMETHAZINE WITH CODEINE- promethazine hydrochloride and codeine phosphate solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Lohxa

INN (Nome Internazionale):

PROMETHAZINE HYDROCHLORIDE

Composizione:

PROMETHAZINE HYDROCHLORIDE 6.25 mg in 5 mL

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Promethazine HCl and Codeine Phosphate Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold. Promethazine HCl and Codeine Phosphate Oral Solution is contraindicated in all children younger than 12 years of age. (See WARNINGS - Ultra- Rapid Metabolism of Codeine and Respiratory Depression ). Promethazine HCl and Codeine Phosphate Oral Solution is contraindicated for postoperative management in children younger than 18 years who have undergone tonsillectomy and/or adenoidectomy. (See WARNINGS - Ultra- Rapid Metabolism of Codeine and Respiratory Depression ). 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 r

Dettagli prodotto:

Promethazine with Codeine Oral Solution contains promethazine hydrochloride 6.25 mg/5 mL, codeine phosphate 10 mg/5 mL and alcohol 7 percent. Single Use Pre-Filled Unit Dose Syringe. Store at 20° – 25°C (68° – 77°F) [see USP Controlled Room Temperature]. Protect from light.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

PROMETHAZINE WITH CODEINE- PROMETHAZINE HYDROCHLORIDE AND CODEINE
PHOSPHATE SOLUTION
LOHXA
----------
PROMETHAZINE WITH CODEINE ORAL SOLUTION
CV
(PROMETHAZINE HYDROCHLORIDE 6.25 MG/5 ML &
CODEINE PHOSPHATE 10 MG/5ML)
RX ONLY
WARNING: ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK
FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN
AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS
ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK FACTORS FOR
LIFE-THREATENING
RESPIRATORY DEPRESSION IN CHILDREN
LIFE-THREATENING RESPIRATORY DEPRESSION AND DEATH HAVE OCCURRED IN
CHILDREN WHO RECEIVED
CODEINE. MOST OF THE REPORTED CASES OCCURRED FOLLOWING TONSILLECTOMY
AND/OR
ADENOIDECTOMY, AND MANY OF THE CHILDREN HAD EVIDENCE OF BEING AN
ULTRA-RAPID METABOLIZER
OF CODEINE DUE TO A CYP2D6 POLYMORPHISM. PROMETHAZINE HCL AND CODEINE
PHOSPHATE
ORAL SOLUTION IS CONTRAINDICATED IN CHILDREN YOUNGER THAN 12 YEARS OF
AGE AND IN CHILDREN
YOUNGER THAN 18 YEARS OF AGE FOLLOWING TONSILLECTOMY AND/OR
ADENOIDECTOMY (SEE
CONTRAINDICATIONS). AVOID THE USE OF PROMETHAZINE HCL AND CODEINE
PHOSPHATE
ORAL SOLUTION IN ADOLESCENTS 12 TO 18 YEARS OF AGE WHO HAVE OTHER RISK
FACTORS THAT MAY
INCREASE THEIR SENSITIVITY TO THE RESPIRATORY DEPRESSANT EFFECTS OF
CODEINE. (SEE WARNINGS
- ULTRA-RAPID METABOLISM OF CODEINE AND RESPIRATORY DEPRESSION).
PROMETHAZINE AND RESPIRATORY DEPRESSION IN CHILDREN
POSTMARKETING CASES OF RESPIRATORY DEPRESSION, INCLUDING FATALITIES
HAVE BEEN REPORTED WITH
USE OF PROMETHAZINE IN PEDIATRIC PATIENTS. CHILDREN MAY BE
PARTICULARLY SENSITIVE TO THE
ADDITIVE RESPIRATORY DEPRESSANT EFFECTS WHEN PROMETHAZINE IS COMBINED
WITH OTHER
RESPIRATORY DEPRESSANTS, INCLUDING CODEINE. (SEE WARNINGS –
PROMETHAZINE AND
RESPIRATORY DEPRESSION IN CHILDREN).
RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS
CONCOMITANT USE OF OPIOIDS WITH BENZODIAZEPINES OR OTHER CENTRAL
NERVOUS SYSTEM (CNS)
DEPRESSANTS, INCLUDING ALCOHOL, MAY RESULT IN PROFOUND SEDATION,
RESPIRATORY DEPRESSION,
COMA, AND