Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J), CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)
Nexgen Pharma, Inc.
CODEINE PHOSPHATE
CODEINE PHOSPHATE 54.3 mg
ORAL
PRESCRIPTION DRUG
CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE is indicated for the relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults 18 years of age and older. Important Limitations of Use Not indicated for pediatric patients under 18 years of age [see Use in Special Population (8.4)] Patients with known hypersensitivity to codeine, chlorpheniramine or any of the inactive ingredients of CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE. Persons known to be hypersensitive to certain other opioids may exhibit cross-sensitivity to codeine. Teratogenic Effects Pregnancy Category C There are no adequate and well-controlled studies of CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE in pregnant women. Reproductive toxicity studies have not been conducted with CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE; however, studies are available with individual active ingredients or related active ingredients. Because animal reproduction studies are not always predictive of human response, CO
CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE is supplied as white to off-white, uncoated, standard round tablet, debossed with NXG on one side and CC on the other side. Supplied in bottles of 100 tablets: NDC 0722-7184-01. 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, with a child-resistant closure. Keep this and all medicine out of reach of children.
New Drug Application
CODEINE AND CHLORPHENIRAMINE MALEATE ER- CODEINE AND CHLORPHENIRAMINE MALEATE ER TABLET, EXTENDED RELEASE NEXGEN PHARMA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE™ SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE. CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE (CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE) EXTENDED RELEASE TABLETS, CIII INITIAL U.S. APPROVAL: 1985 WARNING DEATH RELATED TO ULTRA-RAPID METABOLISM OF CODEINE TO MORPHINE AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS ULTRA-RAPID METABOLISM 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. (5.1) CONCOMITANT USE WITH BENZODIAZEPINES, 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 DEATH _[SEE WARNING_ _AND PRECAUTIONS (5.2) DRUG INTERACTIONS (7.1). _AVOID USE OF OPIOID COUGH MEDICATIONS IN PATIENTS TAKING BENZODIAZEPINES, OTHER CNS DEPRESSANTS, OR ALCOHOL. RECENT MAJOR CHANGES INDICATIONS AND USAGE CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE is a combination of codeine phosphate, an opiate agonist antitussive, and chlorpheniramine maleate, a histamine-1 (H1) receptor antagonist indicated for the relief of cough and symptoms associated with upper respiratory allergies or a common cold. (_1_) IMPORTANT LIMITATIONS OF USE Not indicated for pediatric patients under 18 years of age _(8.4))_ DOSAGE AND ADMINISTRATION DOSAGE FORMS AND STRENGTHS Extended release (ER) tablet: contains 54.3 mg of codeine phosphate (equivalent to 40 mg of codeine) and 8 mg of chlorpheniramine maleate (equivalent to 5.6 mg of chlorpheniramine). (_3_) Baca dokumen lengkap