Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate

BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE

Manufacturer: Actavis Pharma, Inc.

Score: 144.0

Quick Summary

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. The capsules contain a combination of a barbiturate, an opioid agonist, a non-opioid analgesic, and a CNS stimulant. Key clinical findings indicate the capsules can produce sedation, respiratory depression, and euphoria, and are associated with risks such as addiction, abuse, and misuse. Important safety information includes warnings about life-threatening respiratory depression, interactions with other CNS depressants, and the potential for neonatal opioid withdrawal syndrome. Initial dosing and titration recommendations are provided, and dose adjustments may be necessary based on individual patient response. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

Management of tension (or muscle contraction) headaches
Contains a combination of butalbital, acetaminophen, caffeine, and codeine phosphate
Produces sedation, respiratory depression, and euphoria

Important Safety Information

Warning

Addiction, abuse, and misuse, life-threatening respiratory depression, and interactions with other CNS depressants

Contraindications

All children younger than 12 years of age
Post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy
Significant respiratory depression
Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment
Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days

Adverse Reactions

Drowsiness
Lightheadedness
Dizziness
Sedation
Shortness of breath
Nausea
Vomiting
Abdominal pain
Intoxicated feeling

Dosing Recommendations

General Guidance

Titrate the dose based on individual patient response, and consider dose reductions in patients with impaired renal or hepatic function

Tension headaches

Adult Dose

One or two capsules every 4 hours as needed for pain, not to exceed 6 capsules per day

Pediatric Dose

Not recommended for pediatric patients

Special Population Considerations

Pregnancy

Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are not recommended for use in pregnant women during or immediately prior to labor

Nursing Mothers

Butalbital and codeine are excreted in breast milk, and caution should be exercised when administering to nursing mothers

Pediatric Use

The safety and effectiveness of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules in pediatric patients have not been established
Life-threatening respiratory depression and deaths have occurred in children who received codeine

Geriatric Use

Elderly patients may have increased sensitivity to Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules
Use caution when selecting a dosage for an elderly patient, and titrate the dosage slowly