byū/tal’ bi/täl, a/sēt’ə/mēn’ ō/fen, kaf’ ēn

Brand Names: Fioricet®

  • Generic Available

Common Dosage Forms:

  • Tablets: Each tablet contains 50 mg butalbital, 325 mg acetaminophen, and 40 mg caffeine
  • Capsules*: Each capsule contains 50 mg butalbital, 300 mg acetaminophen, and 40 mg caffeine

*also available with codeine

FDA Indications/Dosages:

  • Relief of the symptom complex of tension (or muscle contraction) headache:
    One to two tabs/caps every four hours as needed (not to exceed six tabs/caps per day).
  • Not recommended for children under 12.

Pharmacology/Pharmacokinetics:

Acetaminophen produces analgesia by inhibiting prostaglandin synthesis in the CNS and through a peripheral action of blocking pain impulse generation. Butalbital produces sensory cortex depression through inhibition of conduction in the reticular formation at the level of the thalamus. Caffeine produces CNS stimulation by inhibition of phosphodiesterase which increases the accumulation of c-AMP.

Drug Interactions:

May decrease the pharmacological effects of oral anticoagulants, corticosteroids, estrogens, griseofulvin, doxycycline, theophyllines, quinidine, and beta-adrenergic blockers. May increase the toxic effects of methoxyflurane. Hepatotoxicity potential increases when used with hydantoins or sulfinpyrazone. May have an additive toxic effect with alcohol and other CNS depressants.

Contraindications/Precautions:

Contraindicated in patients hypersensitive to any component or with porphyria. Use with caution in patients with increased intracranial pressure, head injury, severe hepatic or renal impairment, Addison’s disease, hypothyroidism, and prostatic hypertrophy or urethral stricture. Pregnancy Category C.

Adverse Effects:

Dizziness, drowsiness, and lightheadedness.

Patient Consultation:

  • May cause drowsiness. Use caution while operating machinery or when mental alertness is required.
  • Avoid alcohol while taking this medication.
  • May take with food or milk to avoid GI upset.
  • Do not exceed prescribed dosage.
  • WARNING: This medication may be habit-forming.
  • Store in a cool, dry place away from sunlight and children.
  • Contact a physician if the above side effects are severe or persistent.
  • If a dose is missed, skip it and return to normal dosing schedule.