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Fioricet® 50/325/40 mg for Migraine


Medical uses

Fioricet, introduced in the US in the 1960s, is a pain reliever and sedative used to relieve tension headaches, and sometimes other types of pain. Fioricet is often prescribed for abortive treatment of chronic headache unresponsive to “over the counter” analgesics or NSAIDs. Fioricet can be used with an NSAID (e.g. naproxen, ibuprofen) for complementary relief of inflammatory pain.

This analgesic consists of a fixed combination of butalbital 50 mg, acetaminophen 325 mg and caffeine 40 mg. Acetaminophen is a pain reliever and fever reducer (antipyretic). Butalbital is in a class of drugs called barbiturates that slow down central nervous system causing relaxation. Caffeine is believed to constrict dilated blood vessels that may contribute to tension headaches.

Fioricet Efficacy for Migraine Headaches

The role of Fioricet in migraines is controversial, but is crucial when circumstances preclude other analgesics. Practically 14-36% of diagnosed migraineurs are prescribed butalbital compounds.

For many migraineurs the trick is to take Fioricet as soon as a headache is coming on. If you wait until the migraine has gotten too far it does not help much, though will make the headache more tolerable.

The overuse of Fioricet may trigger rebound headache. So you have to be careful about how much and how long you take it. The best pattern is set Fioricet aside as a "last resort" remedy.

Butalbital/Acetaminophen/Caffeine vs Sumatriptan/Naproxen

Recent large high quality study4 compared sumatriptan/naproxen with butalbital/acetaminophen/caffeine in the treatment of moderate to severe migraine headache in patients who in the past had used a butalbital-containing medication. Compared with the butalbital/apap/caffeine the patients who took sumatriptan/naproxen achieved better relief of migraine pain and associated symptoms. More patients treated with sumatriptan/naproxen reported being pain free. Both sumatriptan/ naproxen and the butalbital combination were well tolerated.

Dosage regimen

1-2 tablets every 4 hours as needed. Total daily dosage should not exceed 6 tablets. Fioricet should be taken no more than 2 days per week. Prolonged continuous use of Fioricet is not recommended because of the potential for rebound headache and physical dependence.

Fioricet works within 15-20 minutes. Most headaches go away within an hour.

Benefits

  • Effective acute medications for migraine and different types of headaches
  • Proven efficacy in relieving tension headache 2
  • May be effective as reserve medication or when other medicines are ineffective or cannot be used 2
  • Important alternative antimigraine treatment for those patients who cannot take vasoconstricting medications (e.g. ergot derivatives, triptans) or opioids.
  • Superior to acetaminophen with codeine in alleviating emotional or psychic tension 3. Also, Fioricet is suggested to have faster and more long analgesic effect than acetaminophen with codeine.

Concerns

  • Butalbital analgesics are not recommended as first-line therapies for migraine.
  • Barbiturates are habit-forming and potentially abusable.
  • Not suitable for extended use in chronic migraines.
  • Risk of drug-induced headache and headache chronification
  • Butalbital is a central nervous system depressant, so its combination products often cause sedation and drowsiness, which can contribute to driving impairment5
  • Risk of toxicity
  • Withdrawal syndrome 1

Pharmacological characteristics

  • Elimination half-life:
    Butalbital: 35 hours
    Acetaminophen: 1.25-3 hours, may be increased by liver damage and following overdosage
    Caffeine: 3 hours

Mode of action

Butalbital has generalized depressant effect on CNS and, in very high doses, has peripheral effects. Acetaminophen has analgesic and antipyretic effects; its analgesic effects may be mediated through inhibition of prostaglandin synthetase enzyme complex. Caffeine is thought to produce constriction of cerebral blood vessels.

References

  • 1. Romero CE, Baron JD, Knox AP, Hinchey JA, Ropper AH. Barbiturate withdrawal. Arch Neurol. 2004 Jul;61(7):1111-2.
  • 2. Solomon S. Butalbital-containing compounds: should they be banned? No. Curr Pain Headache Rep. 2002 Apr;6(2):147-50. PubMed
  • 3. Friedman AP, DiSerio FJ. Chronically recurring tension headache: a placebo-controlled, multicenter investigation of Fioricet and acetaminophen with codeine. Clin Ther. 1987;10(1):69-81. PubMed
  • 4. Derosier F, Sheftell F, Silberstein S, Cady R, Ruoff G, Krishen A, Peykamian M. Sumatriptan-naproxen and butalbital: a double-blind, placebo-controlled crossover study. Headache. 2012 Apr;52(4):530-43 PubMed
  • 5. Yeakel JK, Logan BK. Butalbital and driving impairment. J Forensic Sci. 2013 Jul;58(4):941-5. PubMed

By HealthyStock Research Group, September 2009
Medical resources reviewed: August 2018

Interesting facts

fioricet
watson

  • Generic name: Butalbital/Acetaminophen/Caffeine
  • Trade names: Alagesic, Geone, Fioricet, Margesic, Repan
  • Dosages: 50-325-40 mg tablets
  • Pharmacologic category: Combined Analgesic
  • Habit forming? Yes
  • Pregnancy risk factor: C
  • In 2003 Watson Pharmaceuticals, a maker of generic and brand-name drugs, acquired the U.S. marketing rights to the Fioricet and Fiorinal product lines, for $178 million from Novartis.
  • The divested products achieved combined sales of approximately USD 60 million in 2002.

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