Fioricet

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Fioricet
Combination of
Butalbital Barbiturate
Acetaminophen misc analgesic
Caffeine Xanthine
Clinical data
Trade names Fioricet
AHFS/Drugs.com entry
Pregnancy cat. C (US)
Legal status Schedule III (US)
Routes Oral
Identifiers
ATC code ?
Generic Fioricet (50/40/325)

Fioricet and Esgic are brand names of a combination of butalbital (a barbiturate), acetaminophen and caffeine which is indicated for the treatment of tension headaches, muscle contraction headaches and post-dural puncture headaches. Although not indicated, they are commonly used to treat migraines and other pain related ailments.

New Fioricet Formulation[edit]

Per FDA guidelines[1] recommending that manufacturers limit the dose of acetaminophen in prescription products, the formulation of fioricet has changed. "Old formulations"[2] of fioricet contained 50 mg of butalbital, 325 mg of acetaminophen and 40 mg caffeine; "new formulations"[3] contain 50 mg of butalbital, 300 mg of acetaminophen and 40 mg caffeine. Manufacturers were allowed to make the "old formulation" of fioricet until January 1, 2014. Currently there is no move to remove or destroy the "old formulation", allowing for an odd situation in which there could be two different formulations of fioricet in pharmacies.

Formulation DEA Schedule Butalbital (mg) Acetaminophen (mg) Caffeine (mg) Form
Old fioricet none[2] 50 325[2] 40 tablet[2]
New fioricet CIII[3] 50 300[3] 40 capsule[3]

Confusion over Control status[edit]

Confusion has arisen about the controlled substance status of this medication. Per DEA listing, Fioricet is a DEA exempt prescription product.[4] There is no logical rationale for why this is an exempted as a controlled substance, but it has been postulated that the concentration of butalbital with the acetaminophen (and caffeine) allows this to be an analgesic combination that the DEA allows exemption to. However peculiar it may be, Fioricet's sister product, Fiorinal, contains the same amount of butalbital per dose, combined with aspirin (and caffeine) instead of acetaminophen (and caffeine) but it is in fact a DEA Schedule III item.[5]

Per the FDA National Drug Code Directory,[6] "new formulations" of fioricet are listed as DEA Schedule III:

Labeller NDC DEA Schedule form strength (Butalbital, Acetaminophen, Caffeine) note
Watson Pharma 52544-080-01 CIII capsule 300 mg, 50 mg, 40 mg new formulation
Rx Pak Division of McKesson 65084-454-10 CIII capsule 300 mg, 50 mg, 40 mg new formulation
Cardinal Health 55154-3416-1 none tablet 325 mg, 50 mg, 40 mg old formulation

Potential Problems of two formulations[edit]

This change in designation affects mid-level providers, such as ARNPs and PAs, who are not allowed to prescribe controlled substances in some jurisdictions. Ostensibly, prescribers that are affected by this change could clearly indicate on the prescription that they would like the "old formulation" (perhaps by writing out the mg combination) until the "old formulation" is no longer available. Pharmacists dispensing or verifying this medication need to be keenly aware of the difference in formulation and CSA scheduling, as a misfill of the scheduled "new formulation" for the "old formulation" could have legal ramifications. Delays in verification and dispensing, or invalidation of a prescription due to a mid-level provider not having the ability to prescribe the controlled "newer formulation" could likewise affect patients through delays and hassles.

Usage and dosage[edit]

Fioricet is indicated for the treatment of muscle tension or muscle contraction headaches. It is also commonly prescribed for migraines although it is not FDA indicated for this use in the United States. The usual adult dose is 1-2 tablets every four hours as needed, not exceeding six tablets in a 24 hour period.[7][8]

Mechanism of action[edit]

Butalbital has generalized depressant effect on central nervous system 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.

Butalbital has a half-life of about 35 hours. Acetaminophen has a half-life of about 1.25 to 3 hours, but may be increased by liver damage and after an overdose. Caffeine has a half-life of about 5 to 7 hours.[9]

Side effects[edit]

Commonly reported side effects for Fioricet include:

Fioricet is implicated as causing repeat headaches with over-use.[10]

Rare side-effects[edit]

Variations[edit]

Name DEA Schedule Acetaminophen (mg) Aspirin (mg) Butalbital (mg) Caffeine (mg) Codeine (mg) Labeller Form End Marketing Date
Esgic[11][12] CIII 325 50 40 Forrest Laboratories, Inc[11][12] capsule,[11] tablet[12]
Esgic Plus[13][14][15] CIII 500 50 40 Forrest Laboratories, Inc;[13][14] A-S Medication Solutions LLC[15] capsule,[13] tablet[14][15] 6/29/2014;[14][15] 8/10/2015[13]
Fioricet (new formulation)[3] CIII 300 50 40 Watson Pharma, Inc.[3] capsule
Fioricet (old formulation)[2] none 325 50 40 Cardinal Health[2] tablet 1/1/2014
Fioricet with codeine[16] CIII 300 50 40 30 Watson Pharma, Inc.[16] capsule
Fiorinal[17] CIII 325 50 40 Watson Pharma, Inc.[17] capsule
Fiorinal with codeine[18] CIII 325 50 40 30 Watson Pharma, Inc.[18] capsule
Phrenilin[19] CIII 325 50 Valeant Pharmaceuticals International[19] tablet
Phrenilin Forte[20] CIII 650 50 Valeant Pharmaceuticals International[20] capsule
Phrenilin with caffeine and codeine[21] CIII 325 50 40 30 Valeant Pharmaceuticals North America[21] capsule

References[edit]

  1. ^ Food and Drug Administration. FDA drug safety communication: prescription acetaminophen products to be limited to 325 mg per dosage unit; boxed warning will highlight potential for severe liver failure.
  2. ^ a b c d e f (Old formulation) Fioricet package insert, Cardinal Health, Inc.
  3. ^ a b c d e f (New formulation) Fioricet package insert, Watson Pharma, Inc.
  4. ^ http://www.deadiversion.usdoj.gov/schedules/exempt/exempt_rx_list.pdf
  5. ^ http://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf
  6. ^ FDA National Drug Code Directory
  7. ^ Fioricet at RxList
  8. ^ http://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=4417
  9. ^ http://www.webmd.com/balance/caffeine-myths-and-facts
  10. ^ A Hidden Cause of Headache Pain - New York Times
  11. ^ a b c Esgic tablet package insert, Forest Laboratories, Inc
  12. ^ a b c Esgic capsule package insert, Forest Laboratories, Inc
  13. ^ a b c d Esgic Plus capsule package insert, Forest Laboratories, Inc
  14. ^ a b c d Esgic Plus tablet package insert, Forest Laboratories, Inc
  15. ^ a b c d Esgic Plus tablet package insert, A-S Medication Solutions LLC
  16. ^ a b Fioricet with codeine capsule package insert, Watson Pharma, Inc
  17. ^ a b Fiorinal capsule package insert, Watson Pharma, Inc
  18. ^ a b Fiorinal with codeine capsule package insert, Watson Pharma, Inc
  19. ^ a b Phrenilin tablet package insert, Valeant Pharmaceuticals North America
  20. ^ a b Phrenilin Forte capsule package insert, Valeant Pharmaceuticals International
  21. ^ a b Phrenilin (butalbital, acetaminophen, caffeine, and codeine phosphate) capsule package insert, Valeant Pharmaceuticals North America

External links[edit]