Երկիր: Ամերիկայի Միացյալ Նահանգներ
Լեզու: անգլերեն
Աղբյուրը: 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)
LGM Pharma Solutions, LLC
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 are dark blue, opaque cap with a gray, opaque body, and body is imprinted with “B 073” in black ink. Bottles of 100 (NDC 79739-6670-1 ) Store at 20° to 25°C (68° to 77°F); and dispense in a tight, light-resistant container. Store Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules securely and dispose of properly [see Patient Counseling Information (17)]. Rx only Keep this and all medication out of the reach of children.
Abbreviated New Drug Application
acetaminophen, caffeine, and codeine phosphate capsule LGM Pharma Solutions, LLC ---------- 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 or call 911if 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. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose. • 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 accessibl Կարդացեք ամբողջական փաստաթուղթը
BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE- BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE LGM PHARMA SOLUTIONS, LLC ---------- 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 Dosage and Administration (2.2) 03/2021 Warnings and Precautions (5.1, 5.3, 5.4) 03/2021 INDICATIONS AND USAGE Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsule is a combination product of 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 B Կարդացեք ամբողջական փաստաթուղթը