PROMETHAZINE WITH CODEINE- promethazine hydrochloride and codeine phosphate solution

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

ATLANTIC BIOLOGICALS CORP.

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Promethazine with Codeine Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older. Important Limitations of Use - Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4) ]. - Contraindicated in pediatric patients under 12 years of age [see Contraindications (4), Use in Specific Populations (8.4) ]. - Contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy [see Contraindications (4), Use in Specific Populations (8.4) ]. - Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1) ], reserve Promethazine with Codeine Oral Solution for use in adult  patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made. -   Promethazine with Codei

Produkto santrauka:

Promethazine with Codeine Oral Solution, 6.25 mg and 10 mg per 5 mL, is a clear, purple solution, supplied as: NDC Number              Size 60432-606-16             16 fl. oz. (473 mL) bottle Keep bottles tightly closed. Store at 20° to 25°C (68° to 77°F).  [See USP Controlled Room Temperature.] Protect from light. Dispense in tight, light-resistant container (USP/NF) with a child-resistant closure. Ensure that patients have an oral dosing dispenser that measures the appropriate volume in milliliters. Counsel patients on how to utilize an oral dosing dispenser and correctly measure the oral suspension as prescribed.

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

PROMETHAZINE WITH CODEINE- PROMETHAZINE HYDROCHLORIDE AND CODEINE
PHOSPHATE SOLUTION
ATLANTIC BIOLOGICALS CORP.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PROMETHAZINE WITH CODEINE ORAL
SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
PROMETHAZINE WITH CODEINE
ORAL SOLUTION INITIAL U.S. APPROVAL:1952
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY
DEPRESSION;
ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK
FACTORS
FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; PROMETHAZINE
AND
RESPIRATORY DEPRESSION IN CHILDREN; MEDICATION ERRORS; INTERACTIONS
WITH DRUGS
AFFECTING CYTOCHROME P450 ISOENZYMES; CONCOMITANT USE WITH
BENZODIAZEPINES OR
OTHER CNS DEPRESSANTS; NEONATAL OPIOID WITHDRAWAL SYNDROME
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
PROMETHAZINE WITH CODEINE ORAL SOLUTION EXPOSES USERS TO RISKS OF
ADDICTION, ABUSE, AND MISUSE,
WHICH CAN LEAD TO OVERDOSE AND DEATH. ASSESS PATIENT'S RISK BEFORE
PRESCRIBING AND MONITOR CLOSELY FOR
THESE BEHAVIORS AND CONDITIONS. (5.1)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR CLOSELY, ESPECIALLY UPON
INITIATION OR WHEN USED IN PATIENTS AT HIGHER RISK. (5.2)
ACCIDENTAL INGESTION OF PROMETHAZINE WITH CODEINE ORAL SOLUTION,
ESPECIALLY BY CHILDREN, CAN RESULT IN
A FATAL OVERDOSE OF CODEINE. (5.2)
LIFE-THREATENING RESPIRATORY DEPRESSION AND DEATH HAVE OCCURRED IN
CHILDREN WHO RECEIVED CODEINE;
MOST CASES FOLLOWED TONSILLECTOMY AND/OR ADENOIDECTOMY, AND MANY OF
THE CHILDREN HAD EVIDENCE OF
BEING AN ULTRA-RAPID METABOLIZER OF CODEINE DUE TO A CYP2D6
POLYMORPHISM. (5.3) PROMETHAZINE WITH
CODEINE 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. (4) AVOID THE USE OF
PROMETHAZINE WITH CODEINE ORAL SOLUTION IN ADOLESCENTS 12 TO 18 YEARS
OF AGE WHO HAVE OTHER RISK
FACTORS THAT MAY INCR