Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)

Prieinama:

A-S Medication Solutions

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (see WARNINGS ), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics). - Have not provided adequate analgesia, or are not expected to provide adequate analgesia, Have not provided adequate analgesia, or are not expected to provide adequate analgesia, - Have not been tolerated, or are not expected to be tolerated. Have not been tolerated, or are not expected to be tolerated. Acetaminophen and codeine phosphate tablets are contraindicated for: - All children younger than 12 years of age (see WARNINGS ). All children younger than 12 years of age (see WARNINGS ). - Post-operative management in children younger

Produkto santrauka:

Product: 50090-1572 NDC: 50090-1572-0 10 TABLET in a BOTTLE NDC: 50090-1572-1 12 TABLET in a BOTTLE NDC: 50090-1572-2 15 TABLET in a BOTTLE NDC: 50090-1572-3 20 TABLET in a BOTTLE NDC: 50090-1572-4 30 TABLET in a BOTTLE NDC: 50090-1572-7 100 TABLET in a BOTTLE

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

ACETAMINOPHEN AND CODEINE- ACETAMINOPHEN AND CODEINE TABLET
A-S MEDICATION SOLUTIONS
----------
ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP CIII
300 MG/30 MG
RX ONLY BOXED WARNING
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 CODEINE
PHOSPHATE TABLET