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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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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