CODEINE AND CHLORPHENIRAMINE MALEATE ER tablet, extended release

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J), CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)

Prieinama:

Nexgen Pharma, Inc.

INN (Tarptautinis Pavadinimas):

CODEINE PHOSPHATE

Sudėtis:

CODEINE PHOSPHATE 54.3 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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

Produkto santrauka:

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.

Autorizacija statusas:

New Drug Application

Prekės savybės

CODEINE AND CHLORPHENIRAMINE MALEATE ER- CODEINE AND CHLORPHENIRAMINE
MALEATE ER TABLET, EXTENDED RELEASE
NEXGEN PHARMA, INC.
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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_)