Class: Analgesic Combination
Dosage Forms. Capsule: (Acetaminophen/Butalbital/Caffeine) 325 mg/50 mg/40 mg; Tablet: (Acetaminophen/Butalbital/Caffeine) 325 mg/50 mg/40 mg, 500 mg/50 mg/40 mg; Solution: Each 15 mL contains (Acetaminophen/Butalbital/Caffeine) 325 mg/50 mg/40 mg
Common FDA Label Indication, Dosing, and Titration.
1. Headache, complex tension or muscle contraction: Adults and Children >12 y, acetaminophen 325 mg/butalbital 50 mg/caffeine 40 mg po q4h prn; max 6 doses/d
Off-Label Uses. None
MOA. Butalbital is a barbiturate while caffeine is a stimulant. Mechanism of action in headache is unknown.
Drug Characteristics: Butalbital
Medication Safety Issues: Butalbital
Drug Interactions: Butalbital
Adverse Reactions: Butalbital
Efficacy Monitoring Parameters. Relief of pain.
Toxicity Monitoring Parameters. Seek medical attention if severe skin rash, excessive drowsiness, decreased breathing, severe constipation, black tarry stools, yellowing of eyes and skin.
Key Patient Counseling Points. May cause drowsiness; avoid driving or other tasks requiring motor coordination. Avoid alcohol and other CNS depressants. Avoid caffeine containing products.
Clinical Pearls. Use caution in elderly, appear more sensitive to the effects. Contains butalbital, but not scheduled as a controlled substance. Butalbital also available in formulation with aspirin replacing acetaminophen; brand name Fiorinal, but is a Schedule III controlled substance. Use caution and do not exceed 4 g/d of acetaminophen.