国: アメリカ合衆国
言語: 英語
ソース: 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)
Mayne Pharma Inc.
Butalbital
Butalbital 50 mg
ORAL
PRESCRIPTION DRUG
Butalbital, aspirin, caffeine, and codeine phosphate capsules are 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 butalbital, aspirin, caffeine, and codeine phosphate capsules 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 Butalbital, aspirin, caffeine, and codeine phosphate capsules are 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
Butalbital, aspirin, caffeine, and codeine phosphate capsules Each capsule has a yellow body and a purple cap. The yellow body is imprinted with "312" in black. NDC 68308-312-10 Bottles of 100 capsules Store and Dispense Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature] Protect from moisture. Store butalbital, aspirin, caffeine, and codeine phosphate capsules securely and dispose of properly [see Patient Counseling Information (17)] . Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Abbreviated New Drug Application
CODEINE PHOSPHATE CAPSULE Mayne Pharma Inc. ---------- MEDICATION GUIDE BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULES, CIII (BUE-TAL-BE-TAL, AS-PRIN, KAF-EEN, KOE-DEEN FOS-FATE) CAPSULES, CIII This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 11/2019 Butalbital, aspirin, caffeine, and codeine phosphate capsules are: • 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 butalbital, aspirin, caffeine, and codeine phosphate capsules: • Get emergency help right away if you take too much butalbital, aspirin, caffeine, and codeine phosphate capsules (overdose). When you first start taking butalbital, aspirin, caffeine, and codeine phosphate capsules, 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 butalbital, aspirin, caffeine, and codeine phosphate capsules 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 butalbital, aspirin, caffeine, and codeine phosphate capsules. They could die from taking it. Selling or giving away butalbital, aspirin, caffeine, and codeine phosphate capsules is against the law. • Store butalbital, aspirin, caffeine, and codeine phosphate capsules securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. I 完全なドキュメントを読む
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE- BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE MAYNE PHARMA INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULES. BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE 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 INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULES EXPOSE 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 BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULES, 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. RESE 完全なドキュメントを読む