Fioricet
From Pharmacopedia
More actions
Barbiturate (butalbital), Non-opioid analgesic (acetaminophen), Methylxanthine (caffeine), Fixed-dose combination
Butalbital / Acetaminophen / Caffeine
Fioricet, Esgic; with codeine as Fioricet with Codeine (Schedule III)
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Summary
Classes
Common uses
Tension-type headache (limited evidence; falling out of favor due to medicine-overuse headache and barbiturate dependence risk)0, Migraine (off-label, rescue use)0
Pharmacy
Starting dose
1-2 capsules (50 mg butalbital / 325 mg acetaminophen / 40 mg caffeine each) PO every 4 hours as needed; maximum 6 capsules/d
Preparations
50/325/40 mg capsules and tablets; oral solution
US FDA Max
6 capsules/d (300 mg butalbital, 1950 mg acetaminophen, 240 mg caffeine)
Pharmacology
Routes
Oral
Onset
30-60 minutes
Duration
4-6 hours
Half-life
Butalbital ~35 hours (long; cumulative effects with frequent use); acetaminophen 1-3 hours; caffeine 3-7 hours[1]
Bioavailability
Butalbital well-absorbed; caffeine ~100%; acetaminophen 85-98%[1]
Pregnancy
Generally avoided; barbiturate exposure in late pregnancy can produce neonatal withdrawal and respiratory depression.[citation needed]
Legal status
Plain Fioricet is uncontrolled federally (the small butalbital dose was historically deemed insufficient for scheduling), but DEA-scheduled in some states. Fioricet with Codeine is Schedule III. Fiorinal (aspirin instead of acetaminophen) is Schedule III federally
Purported mechanism
Butalbital is a short-to-intermediate-acting barbiturate that positively modulates GABA-A receptors, producing sedation and muscle relaxation that may relieve tension-type headache. Acetaminophen provides non-opioid analgesia. Caffeine provides mild vasoconstriction (mechanistically attractive for vasodilatory headache) plus an enhancing effect on analgesic absorption.0 Concerns: barbiturate physical dependence with regular use, medicine-overuse headache (especially with >2 doses/week), and the seemingly persistent absence of high-quality RCT support for the combination's headache efficacy. Modern headache guidelines discourage routine use[1].
References
- ↑ 1.0 1.1 1.2 FDA Prescribing Information, Fioricet (butalbital / acetaminophen / caffeine), Allergan, current revision. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/088762s019lbl.pdf