מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
BUTALBITAL (UNII: KHS0AZ4JVK) (BUTALBITAL - UNII:KHS0AZ4JVK), ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E), CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)
Bryant Ranch Prepack
BUTALBITAL
BUTALBITAL 50 mg
ORAL
PRESCRIPTION DRUG
ASCOMP with Codeine is indicated for the management of the symptom complex of tension (or muscle contraction) headache, when non-opioid analgesic and alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids and butalbital, even at recommended doses [see Warnings and Precautions (5.1)] , reserve ASCOMP with Codeine for use in patients for whom alternative treatment options (e.g., non-opioid, non-barbiturate 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. ASCOMP with Codeine is contraindicated for: - All children younger than 12 years of age [see Warnings and Precautions (5.5)] - Postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see Warnings and Precautions (5.5)] . ASCOMP with Codeine is also contraindicated in patients with: - Significant respiratory depression [se
ASCOMP with Codeine (Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP ) have a plain blue opaque cap with a yellow opaque body imprinted with "B 074" in black ink. NDC: 63629-2952-1: 30 Capsules in a BOTTLE NDC: 63629-2952-2: 20 Capsules in a BOTTLE NDC: 63629-2952-3: 90 Capsules in a BOTTLE NDC: 63629-2952-4: 60 Capsules in a BOTTLE NDC: 63629-2952-5: 40 Capsules in a BOTTLE NDC: 63629-2952-6: 18 Capsules in a BOTTLE Store below 25°C (77°F) in a tight, light-resistant container. Protect from moisture. Store ASCOMP with Codeine securely and dispose of properly [see PATIENT COUNSELING INFORMATION (17)]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
Abbreviated New Drug Application
BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE- BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE Bryant Ranch Prepack ---------- MEDICATION GUIDE MEDICATION GUIDE ASCOMP WITH CODEINE (AZ-KOMP) (BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE, USP) CAPSULES, CIII ASCOMP with Codeine is: • A strong prescription pain medicine that contains an opioid (narcotic) that is indicated for the relief of the symptom complex of tension (or muscle contraction) headache, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them. • An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death. Important information about ASCOMP with Codeine: • Get emergency help right away if you take too much ASCOMP with Codeine (overdose). When you first start taking ASCOMP with Codeine, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. • Taking ASCOMP with Codeine with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death. • Never give anyone else your ASCOMP with Codeine. They could die from taking it. Selling or giving away ASCOMP with Codeine is against the law. • Store ASCOMP with Codeine securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. Important Information Guiding Use in Pediatric Patients: • Do not give ASCOMP with Codeine to a child younger than 12 years of age. • Do not give ASCOMP with Codeine to a child younger than 18 years of age after surgery to remove the tonsils and/or adenoids. • Avoid giving ASCOMP with Codeine to children between 12 to 18 years of age who have risk facto קרא את המסמך השלם
BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE- BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE BRYANT RANCH PREPACK ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ASCOMP WITH CODEINE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ASCOMP WITH CODEINE. ASCOMP WITH CODEINE (BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE, USP) CAPSULES, FOR ORAL USE, CIII INITIAL U.S. APPROVAL: 1990 WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; NEONATAL OPIOID WITHDRAWAL SYNDROME; AND INTERACTION WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ ASCOMP WITH CODEINE EXPOSES USERS TO THE RISKS OF ADDICTION, ABUSE, AND MISUSE, WHICH CAN LEAD TO OVERDOSE AND DEATH. ASSESS PATIENT'S RISK BEFORE PRESCRIBING AND MONITOR REGULARLY FOR THESE BEHAVIORS AND CONDITIONS. (5.1) 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 RISK EVALUATION AND MITIGATION STRATEGY (REMS) FOR THESE PRODUCTS. (5.2) SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR. MONITOR CLOSELY, ESPECIALLY UPON INITIATION OR FOLLOWING A DOSE INCREASE. (5.3) ACCIDENTAL INGESTION OF ASCOMP WITH CODEINE, ESPECIALLY BY CHILDREN, CAN RESULT IN FATAL OVERDOSE. (5.3) CONCOMITANT USE OF OPIOIDS OR A BARBITURATE WITH BENZODIAZEPINES OR OTHER CENTRAL NERVOUS SYSTEM (CNS) DEPRESSANTS, INCLUDING ALCOHOL, MAY RESULT IN PROFOUND SEDATION, RESPIRATORY DEPRESSION, COMA, AND DEATH. RESERVE CONCOMITANT PRESCRIBING FOR USE IN PATIENTS FOR WHOM ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE; LIMIT DOSAGES AND DURATIONS TO THE M קרא את המסמך השלם