SUMMARY
Fiorinal® with Codeine (Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP)
C-III
Revised: January 2007
Rx only
Watson
Fiorinal® with Codeine (butalbital, aspirin, caffeine, and codeine phosphate) is supplied in capsule form for oral administration.
Each capsule contains:
codeine phosphate, USP............................30 mg
butalbital, USP...........................................50 mg
caffeine, USP.............................................40 mg
aspirin, USP.............................................325 mg
Codeine phosphate [morphine-3-methyl ether phosphate (1:1) (salt) hemihydrate. C18H24NO7P, anhydrous mw 397.37], is a narcotic analgesic and antitussive.
Butalbital (5-allyl-5-isobutylbarbituric acid, C11H16N2O3, mw 224.26), is a short- to intermediate-acting barbiturate.
Caffeine (1,3,7-trimethylxanthine, C8H10N4O2, mw 194.19), is a central nervous system stimulant.
Aspirin is benzoic acid, 2-(acetyloxy)-, C9H8O4, mw 180.16, is an analgesic, antipyretic, anti-inflammatory.
Fiorinal® with Codeine (butalbital, aspirin, caffeine, and codeine phosphate) is indicated for the relief of the symptom complex of tension (or muscle contraction) headache.
Evidence supporting the efficacy of Fiorinal® with Codeine (butalbital, aspirin, caffeine, and codeine phosphate) is derived from 2 multi-clinic trials that compared patients with tension headache randomly assigned to 4 parallel treatments: Fiorinal® with Codeine (butalbital, aspirin, caffeine, and codeine phosphate), codeine, Fiorinal® (butalbital, aspirin, and caffeine), and placebo. Response was assessed over the course of the first 4 hours of each of 2 distinct headaches, separated by at least 24 hours. Fiorinal® with Codeine (butalbital, aspirin, caffeine, and codeine phosphate) proved statistically significantly superior to each of its components (Fiorinal®, codeine) and to placebo on measures of pain relief.
Evidence supporting the efficacy and safety of Fiorinal® with Codeine (butalbital, aspirin, caffeine, and codeine phosphate) in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because codeine and butalbital are habitforming and potentially abusable.
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NEWS HIGHLIGHTSMedia Articles Related to Fiorinal with Codeine (Codeine / Butalbital / Caffeine / Aspirin)
For Severe Migraine Headaches, Surgery Potentially The Best Option
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The disability from migraine headaches is an enormous health burden affecting over 30 million Americans. In newly released research, 79 migraine sufferers were followed for at least five years after having undergone detection of migraine "trigger sites" and surgery. The new data finds promising outcomes for treating trigger sites surgically for migraine headaches resulting in elimination of pain for those afflicted with the condition.
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Source: Headache / Migraine News From Medical News Today [2009.10.19]
Migraine sufferers, beware. You may be more prone to an alcohol-induced headache after a night of drinking, according to researchers from the Jefferson Headache Center. The research will be presented at Neuroscience 2009, the Annual Meeting of the Society for Neuroscience, in Chicago. Until now, studying the mechanism behind migraine and other forms of recurrent headaches has not been possible in an animal model, according to Michael Oshinsky, Ph.D.
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Source: MedicineNet Migraine Headache Specialty [2009.09.04]
Title: School Days Give Some Kids a Headache
Category: Health News
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Last Editorial Review: 9/4/2009
NovaDel Article Published In Headache: The Journal Of Head And Face Pain
Source: Headache / Migraine News From Medical News Today [2009.09.03]
NovaDel Pharma Inc. (NYSE AMEX: NVD) announced that an article titled "Rapid Oral Transmucosal Absorption of Sumatriptan, and Pharmacodynamics in Acute Migraine" was published online on June 22, 2009 in the peer-reviewed journal Headache: The Journal of Head and Face Pain. NovaDel conducted two clinical trials evaluating sumatriptan administered via its oral spray drug delivery technology.
Leading International Headache Journal Cephalalgia To Be Published By SAGE
Source: Headache / Migraine News From Medical News Today [2009.09.03]
SAGE, the world's leading independent academic and professional publisher is delighted to announce a new agreement with the International Headache Society (IHS) to publish their official journal, Cephalalgia. Now in its 29th volume, Cephalalgia provides an international forum for original research papers, review articles and short communications on all aspects of headache.
Published Studies Related to Fiorinal with Codeine (Codeine / Butalbital / Caffeine / Aspirin)
Comparison of butorphanol nasal spray and fiorinal with codeine in the treatment of migraine. [1998.07]
Butorphanol tartrate is a synthetic mixed agonist-antagonist opioid analgesic. Its transnasal dosage form, which may be self-administered when the use of an opioid analgesic is appropriate, was previously shown to provide rapid relief of migraine pain... Butorphanol patients had more side effects, less improvement in digestive symptoms, and less improvement in functional ability than Fiorinal with Codeine patients.
Fiorinal with codeine in the treatment of tension headache--the contribution of components to the combination drug. [1988]
The contribution of the Fiorinal and codeine phosphate components to the effectiveness of the Fiorinal with Codeine combination in the treatment of tension headache symptoms was evaluated in a randomized, placebo-controlled, multicenter double-blind study...
Clinical Trials Related to Fiorinal with Codeine (Codeine / Butalbital / Caffeine / Aspirin)
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