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.
Media Articles Related to Fiorinal with Codeine (Codeine / Butalbital / Caffeine / Aspirin)
Source: MedicineNet Anthrax Specialty [2015.11.13]
Category: Diseases and Conditions
Created: 5/31/2002 12:00:00 AM
Last Editorial Review: 11/13/2015 12:00:00 AM
Source: MedicineNet Allergy Specialty [2015.10.30]
Title: Sinus Headache
Category: Diseases and Conditions
Created: 1/11/2010 12:00:00 AM
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Severe Headache During Pregnancy May Signal Trouble
Source: MedicineNet Pregnancy Induced Hypertension Specialty [2015.08.21]
Title: Severe Headache During Pregnancy May Signal Trouble
Category: Health News
Created: 8/20/2015 12:00:00 AM
Last Editorial Review: 8/21/2015 12:00:00 AM
Severe headache in pregnant women: When to worry
Source: Headache / Migraine News From Medical News Today [2015.08.20]
New findings by Montefiore and Einstein researchers offer first clinical recommendationsIf a pregnant woman with high blood pressure and no history of headache suddenly develops a headache that...
More evidence that kids' headaches increase at back-to-school time
Source: Headache / Migraine News From Medical News Today [2015.08.17]
Findings from Nationwide Children's Hospital physicians demonstrate that headaches increase in fall in children, a trend that may be due to back-to-school changes in stress, routines and sleep.
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. 
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)
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
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.