ACETAMINOPHEN AND CODEINE phosphate tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)

Disponibil de la:

Preferred Pharmaceuticals, Inc.

INN (nume internaţional):

CODEINE PHOSPHATE

Compoziție:

CODEINE PHOSPHATE 60 mg

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

ACETAMINOPHEN AND CODEINE- ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET
PREFERRED PHARMACEUTICALS, INC.
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ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP
(300 MG/30 MG AND 300 MG/60 MG)
CIII
RX ONLY
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; NEONATAL OPIOID
WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING
CYTOCHROME P450 ISOENZYMES; HEPATOTOXICITY; AND RISKS FROM
CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
ADDICTION, ABUSE AND MISUSE
ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS EXPOSE PATIENTS AND OTHER
USERS TO THE RISKS
OF OPIOID ADDICTION, ABUSE AND MISUSE, WHICH CAN LEAD TO OVERDOSE AND
DEATH. ASSESS EACH
PATIENT’S RISK PRIOR TO PRESCRIBING ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLETS, AND
MONITOR ALL PATIENTS REGULARLY FOR THE DEVELOPMENT OF THESE BEHAVIORS
AND CONDITIONS [SEE
WARNINGS].
LIFE-THREATENING RESPIRATORY DEPRESSION
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR
WITH USE OF
ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS. MONITOR FOR RESPIRATORY
DEPRESSION,
ESPECIALLY DURING INITIATION OF ACETAMINOPHEN AND CODEINE PHOSPHATE
TABLETS OR FOLLOWING A
DOSE INCREASE [SEE WARNINGS].
ACCIDENTAL INGESTION
ACCIDENTAL INGESTION OF ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS,
ESPECIALLY BY
CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLETS [SEE
WARNINGS].
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
ULTRA-RAPID METABOLIZERS OF
CODEINE DUE TO A CYP2D6 POLYMORPHISM [SEE WARNINGS, PRECAUTIONS;
INFORMATION
FOR PATIENTS/CAREGIVERS, NURSING MOTHERS]. ACETAMINOPHEN AND CO