CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CARISOPRODOL (UNII: 21925K482H) (CARISOPRODOL - UNII:21925K482H)

Available from:

Ingenus Pharmaceuticals NJ, LLC

INN (International Name):

CARISOPRODOL

Composition:

CARISOPRODOL 200 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE- CARISOPRODOL, ASPIRIN AND
CODEINE
PHOSPHATE TABLET
INGENUS PHARMACEUTICALS NJ, LLC
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CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE TABLETS USP, 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
CYTROCHROME P450 ISOENZYMES; AND RISKS FROM CONCOMITANT USE WITH
BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
ADDICTION, ABUSE AND MISUSE
CARISOPRODOL, ASPIRIN 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 CARISOPRODOL,
ASPIRIN 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
CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE TABLETS. MONITOR FOR
RESPIRATORY DEPRESSION,
ESPECIALLY DURING INITIATION OF CARISOPRODOL, ASPIRIN AND CODEINE
PHOSPHATE TABLETS OR
FOLLOWING A DOSE INCREASE (SEE WARNINGS).
ACCIDENTAL INGESTION
ACCIDENTAL INGESTION OF EVEN ONE DOSE OF CARISOPRODOL, ASPIRIN AND
CODEINE PHOSPHATE
TABLETS, ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF
CARISOPRODOL, ASPIRIN 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 AN
ULTRA-RAPID METABOLIZER
OF CODEINE DUE TO A CYP2D6 POLYMORPHISM (SEE WARNINGS). CARISOPRODOL,
ASPIRIN AND
CODEI