देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
BUTALBITAL (UNII: KHS0AZ4JVK) (BUTALBITAL - UNII:KHS0AZ4JVK), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E), CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)
Nexgen Pharma, Inc.
BUTALBITAL
BUTALBITAL 50 mg
ORAL
PRESCRIPTION DRUG
Butalbital, Acetaminophen, 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, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for use in patients for whom alternative treatment options [e.g., non-opioid, non-barbiturate analgesics]: Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are contraindicated for: Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are also contraindicated in patients with: Risk Summary Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.6)] . Available data with Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsu
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules 50 mg/300 mg/ 40 mg/30 mg with a dark green opaque body and a black opaque cap. Cap is imprinted with “AP” and “661” in white. Bottles of 100 (NDC 0722-7028-01) Bottles of 500 (NDC 0722-7028-05) Store at 20° to 25C (68° to 77F). [See USP Controlled Room Temperature.]; and dispense in a tight container. Store Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules securely and dispose of properly [see Patient Counseling Information (17)] .
Abbreviated New Drug Application
ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE Nexgen Pharma, Inc. ---------- MEDICATION GUIDE Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, CIII Butalbital, Acetaminophen, 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, Acetaminophen, Caffeine, and Codeine Phosphate Capsules: • Get emergency help right away if you take too much Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules (overdose). When you first start taking Butalbital, Acetaminophen, 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, Acetaminophen, 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, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. They could die from taking it. Selling or giving away Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules is against the law. • Store Butalbital, Acetaminophen, 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. • Get emergency help right away if you take more than 4,000 mg of acetaminophen i पूरा दस्तावेज़ पढ़ें
BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE- BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE NEXGEN PHARMA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULES FOR ORAL USE, CIII. INITIAL U.S. APPROVAL: 1992 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; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; AND HEPATOTOXICITY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • • • • • • • • • RECENT MAJOR CHANGES BUTALBITAL, ACETAMINOPHEN, 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, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULES, ESPECIALLY BY CHILDREN, CAN RESULT IN FATAL OVERDOSE. KEEP OUT OF REACH OF CHILDREN. (5.3) CONCOMITANT USE OF OPIOIDS OR A BARBITURATE WITH BENZODIAZEPINES OR OTHER CENTRAL NERVOUS SYSTEM (CNS) DEPRESSANTS, INCLUDING ALCOHOL पूरा दस्तावेज़ पढ़ें