Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate is one of 8,063 medications in the MedPlain dataset. Key details — Brand name: Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate; Generic name: BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE; Drug class: Barbiturate [EPC].
| Brand name | Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate |
|---|---|
| Generic name | BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE |
| Drug class | Barbiturate [EPC] |
| Manufacturer | LGM PHARMA SOLUTIONS, LLC |
| Used for | 1 INDICATIONS AND USAGE 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]: Have not been tolerated, or are not expected to be tolerated, Have not provided adequate |
| Dosage | 2 DOSAGE AND ADMINISTRATION Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. ( 2.1 ) Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse. ( 2.1 ) Discuss availability of naloxone with the patient and caregiver and assess each patient’s need for access to naloxone, both when initiating and renewing treatment with Butalbital, Acetaminophen, Ca |
| Warnings | 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 Addiction, Abuse, and Misuse Butalbital, Ace |
| Active ingredient(s) | ACETAMINOPHEN |
| Route | ORAL |
| Official label | https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=180d20a5-78a8-4faa-98ad-3196cdd5663a |