Fiorinal with Codeine (Codeine Phosphate / Butalbital / Caffeine / Aspirin) - Summary

SUMMARY

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...

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Clinical Trials Related to Fiorinal with Codeine (Codeine / Butalbital / Caffeine / Aspirin)

Metabolomic Fingerprint After Bariatric Surgery [Completed]
Background: Obesity is associated with multiple diseases. Bariatric surgery is the most effective therapy for severe obesity that cannot only reduce body weight but also obesity-associated morbidity. Objective: The metabolic alterations associated with obesity and respective changes after bariatric surgery are incompletely understood. Design: In the longitudinal observational study, the investigator applied a 1H-NMR-based global, untargeted metabolomics strategy on human serum samples that were collected before and repeatedly up to one year after distinct bariatric procedures (sleeve gastrectomy, proximal and distal Roux-en Y gastric bypass; RYGB). For comparison, the investigator also analyzed serum samples from normal-weight and less obesity obese subjects that were matched for 1-year postoperative BMI values of the surgical groups.

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