Pajjiż: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
CARISOPRODOL (UNII: 21925K482H) (CARISOPRODOL - UNII:21925K482H), ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E), CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)
Rising Pharmaceuticals, Inc.
CARISOPRODOL
CARISOPRODOL 200 mg
ORAL
PRESCRIPTION DRUG
Carisoprodol, Aspirin and Codeine Phosphate Tablets, USP are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses (seeWARNINGS ), reserve Carisoprodol, Aspirin and Codeine Phosphate Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): - Have not been tolerated, or are not expected to be tolerated, - Have not provided adequate analgesia, or are not expected to provide adequate analgesia Carisoprodol, Aspirin and Codeine Phosphate Tablets,USP should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration (see DOSAGE AND ADMINISTRATION ). Carisoprodol, Aspirin and Codeine Phosphate Tablets are contraindicated for: - All children
Carisoprodol, Aspirin and Codeine Phosphate Tablets, USP are supplied as: Yellow and white color, round unscored convex, two layered tablets debossed on yellow layer with “CL” over “024” and plain on the white layer. The tablets are available in bottles of 100, NDC 64980-176-01. Storage Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401 USA Manufactured by: Ingenus Pharmaceuticals NJ, LLC Fairfield, NJ 07004 USA 5508 Rev.07/2018
Abbreviated New Drug Application
CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE- CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE TABLET RISING PHARMACEUTICALS, INC. ---------- CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE TABLETS USP, CIII RX ONLY WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); 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; 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). OPIOID ANALGESIC RISK EVALUATION AND MITIGATION STRATEGY (REMS) TO ENSURE THAT THE BENEFITS OF OPIOID ANALGESICS OUTWEIGH THE RISKS OF ADDICTION, ABUSE, AND MISUSE, THE FOOD AND DRUG ADMINISTRATION (FDA) HAS REQUIRED A REMS FOR THESE PRODUCTS (SEE WARNINGS). UNDER THE REQUIREMENTS OF THE REMS, DRUG COMPANIES WITH APPROVED OPIOID ANALGESIC PRODUCTS MUST MAKE REMS-COMPLIANT EDUCATION PROGRAMS AVAILABLE TO HEALTHCARE PROVIDERS. HEALTHCARE PROVIDERS ARE STRONGLY ENCOURAGED TO COMPLETE A REMS-COMPLIANT EDUCATION PROGRAM, COUNSEL PATIENTS AND/OR THEIR CAREGIVERS, WITH EVERY PRESCRIPTION, ON SAFE USE, SERIOUS RISKS, STORAGE, AND DISPOSAL OF THESE PRODUCTS, EMPHASIZE TO PATIENTS AND THEIR CAREGIVERS THE IMPORTANCE OF READING THE MEDICATION GUIDE EVERY TIME IT IS PROVIDED BY THEIR PHARMACIST, AND CONSIDER OTHER TOOLS TO IMPROVE PATIENT, HOUSEHOLD, AND COMMUNITY SAFETY. LIFE-THREATENING RESPIRATORY DEPRESSION SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR WITH USE O Aqra d-dokument sħiħ