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Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules Indications and Usage (1) 12/2016 Safely and Effectively

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Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules Indications and Usage (1) 12/2016 Safely and Effectively HIGHLIGHTS OF PRESCRIBING INFORMATION ---------------------------RECENT MAJOR CHANGES-------------------------­ These highlights do not include all the information needed to use Boxed Warning 8/2017 Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules Indications and Usage (1) 12/2016 safely and effectively. See full prescribing information for Butalbital, Dosage and Administration (2) 12/2016 Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Contraindications (4) 8/2017 Warnings and Precautions (5) 8/2017 Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII ----------------------------INDICATIONS AND USAGE--------------------------- Initial U.S. Approval: 1992 Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsule is a combination product of butalbital, a barbiturate; acetaminophen; caffeine, a methylxanthine; and codeine phosphate, an opioid agonist; and is indicated for the management of the symptom complex of tension (or muscle contraction) headache, when other non-opioid analgesic and alternative treatments are WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE­ inadequate. (1) THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; RISKS FROM CONCOMITANT USE WITH Limitations of Use BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; ULTRA­ Because of the risks of addiction, abuse, and misuse with opioids, even at RAPID METABOLISM OF CODEINE AND OTHER RISK recommended doses, reserve Butalbital, Acetaminophen, Caffeine, and FACTORS FOR LIFE THREATENING RESPIRATORY Codeine Phosphate Capsules for use in patients for whom alternative DEPRESSION IN CHILDREN; NEONATAL OPIOID treatment options (e.g., non-opioid, non-barbiturate analgesics): WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS • Have not been tolerated, or are not expected to be tolerated, AFFECTING CYTOCHROME P450 ISOENZYMES; and • Have not provided adequate analgesia, or are not expected to provide HEPATOTOXICITY adequate analgesia. See full prescribing information for complete boxed warning. ----------------------DOSAGE AND ADMINISTRATION----------------------­ • Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate • Use the lowest effective dosage for the shortest duration consistent with Capsules expose users to the risks of addiction, abuse, and misuse, individual patient treatment goals. (2.1) which can lead to overdose and death. Assess patient's risk before • prescribing and monitor regularly for these behaviors and Individualize dosing based on the severity of pain, patient response, prior conditions. (5.1) analgesic experience, and risk factors for addiction, abuse, and misuse. (2.1) • Serious, life-threatening, or fatal respiratory depression may • occur. Monitor closely, especially upon initiation or following a Initiate treatment with one or two capsules every 4 hours as needed for dose increase. (5.2) pain. Total daily dosage should not exceed 6 capsules. (2.2) • • Accidental ingestion of Butalbital, Acetaminophen, Caffeine, and Do not stop Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Codeine Phosphate Capsules, especially by children, can result in Capsules abruptly in a physically dependent patient. (2.3) fatal overdose. Keep out of reach of children. (5.2) ---------------------DOSAGE FORMS AND STRENGTHS---------------------­ • Concomitant use of opioids or a barbiturate with benzodiazepines • or other central nervous system (CNS) depressants, including Capsules: 50 mg butalbital, 325 mg acetaminophen, 40 mg caffeine, and alcohol, may result in profound sedation, respiratory depression, 30 mg codeine phosphate. coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; -------------------------------CONTRAINDICATIONS----------------------------­ limit dosages and durations to the minimum required; and follow • Children younger than 12 years of age. (4) patients for signs and symptoms of respiratory depression and • Post-operative management in children younger than 18 years of age sedation. (5.3, 7) following tonsillectomy and/or adenoidectomy. (4) • Life-threatening respiratory depression and death have occurred • Significant respiratory depression. (4) in children who received codeine; most cases followed • Acute or severe bronchial asthma in an unmonitored setting or in absence tonsillectomy and/or adenoidectomy, and many of the children had of resuscitative equipment. (4) evidence of being an ultra-rapid metabolizer of codeine due to a • Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of CYP2D6 polymorphism. (5.4). Butalbital, Acetaminophen, MAOIs within the last 14 days. (4) Caffeine, and Codeine Phosphate Capsules are contraindicated in • Known or suspected gastrointestinal obstruction, including paralytic ileus. children younger than 12 years of age and in children younger (4) than 18 years of age following tonsillectomy and/or adenoidectomy • Intolerance or hypersensitivity to acetaminophen, caffeine, butalbital or (4). Avoid the use of Butalbital, Acetaminophen, Caffeine, and codeine, or components of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules in adolescents 12 to 18 years of age Codeine Phosphate Capsules. (4) who have other risk factors that may increase their sensitivity to • Porphyria. (4) the respiratory depressant effects of codeine. • Prolonged use of Butalbital, Acetaminophen, Caffeine, and -----------------------WARNINGS AND PRECAUTIONS-----------------------­ Codeine Phosphate Capsules during pregnancy can result in • Life-Threatening Respiratory Depression in Patients with Chronic neonatal opioid withdrawal syndrome, which may be life- Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: threatening if not recognized and treated. If prolonged opioid use Monitor closely, particularly during initiation and titration. (5.8) is required in a pregnant woman, advise the patient of the risk of • Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of neonatal opioid withdrawal syndrome and ensure that appropriate corticosteroids, and wean patient off of the opioid. (5.10) treatment will be available. (5.5) • Severe Hypotension: Monitor during dosage initiation and titration. Avoid • The effects of concomitant use or discontinuation of cytochrome use of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with codeine Capsules in patients with circulatory shock. (5.11) are complex. Use of cytochrome P450 3A4 inducers, 3A4 • Risks of Use in Patients with Increased Intracranial Pressure, Brain inhibitors, or 2D6 inhibitors with Butalbital, Acetaminophen, Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation Caffeine, and Codeine Phosphate Capsules requires careful and respiratory depression. Avoid use of Butalbital, Acetaminophen, consideration of the effects on codeine, and the active metabolite, Caffeine, and Codeine Phosphate Capsules in patients with impaired morphine. (5.6, 7) consciousness or coma. (5.12) • Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the ------------------------------ADVERSE REACTIONS------------------------------­ cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen-containing product. (5.7) 1 Reference ID: 4145187 Frequently reported adverse reactions are drowsiness, lightheadedness, Acetaminophen, Caffeine, and Codeine Phosphate Capsules or precipitate dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, withdrawal symptoms. (7) and intoxicated feeling. (6) -----------------------USE IN SPECIFIC POPULATIONS-----------------------­ To report SUSPECTED ADVERSE REACTIONS, contact Actavis • Pregnancy: May cause fetal harm. (8.1) Pharma, Inc. at 1-800-272-5525 or FDA at 1-800-FDA-1088 or • Lactation: Breastfeeding not recommended. (8.2) www.fda.gov/medwatch. • Geriatric: Respiratory depression has occurred after large initial doses were administered. Increase dosage slowly. (8.5) ------------------------------DRUG INTERACTIONS------------------------------­ • Serotonergic Drugs: Concomitant use may result in serotonin syndrome. See 17 for PATIENT COUNSELING INFORMATION and Medication Discontinue Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Guide Capsules if serotonin syndrome is suspected. (7) • Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics: Avoid Revised: 8/2017 use with Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules because they may reduce analgesic effect of Butalbital, 2 Reference ID: 4145187 FULL PRESCRIBING INFORMATION: CONTENTS* 5.13 Risks of Use in Patients with Gastrointestinal Conditions 5.14 Increased Risk of Seizures in Patients with Seizure Disorders WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE­ 5.15 Withdrawal THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL 5.16 Risks of Driving and Operating Machinery INGESTION; RISKS FROM CONCOMITANT USE WITH 5.17 Serious Skin Reactions BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; 5.18 Hypersensitivity/Anaphylaxis ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK 5.19 Drug/Laboratory Test Interactions FACTORS FOR LIFE-THREATENING RESPIRATORY 6 ADVERSE REACTIONS DEPRESSION IN CHILDREN; NEONATAL OPIOID WITHDRAWAL 7 DRUG INTERACTIONS SYNDROME; INTERACTIONS WITH DRUGS AFFECTING 8 USE IN SPECIFIC POPULATIONS CYTOCHROME P450 ISOENZYMES;
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