Fiorinal® with Codeine (Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP)
Revised: January 2007
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)
Headaches Quiz: Test Your Headache Pain IQ
Source: MedicineNet Headache Specialty [2015.02.20]
Title: Headaches Quiz: Test Your Headache Pain IQ
Category: MedicineNet Quiz
Created: 9/28/2010 11:09:00 AM
Last Editorial Review: 2/20/2015 5:14:04 PM
Source: MedicineNet Brain Aneurysm Specialty [2015.02.02]
Title: Cluster Headaches
Category: Diseases and Conditions
Created: 2/4/2005 12:00:00 AM
Last Editorial Review: 2/2/2015 12:00:00 AM
Study suggests worsening trends in headache management
Source: Headache / Migraine News From Medical News Today [2015.01.12]
Each year more than 12 million Americans visit their doctors complaining of headaches, which result in lost productivity and costs of upward of $31 billion annually.
Salt, not high blood pressure, may be to blame for that headache
Source: Headache / Migraine News From Medical News Today [2014.12.15]
Departing from the belief that a special diet aimed at lowering high blood pressure can ease headaches, a new study suggests it is simply salt intake that is the culprit.
The Worst Headache of Your Life: Brain Hemorrhage Symptoms
Source: MedicineNet Brain Aneurysm Specialty [2014.12.01]
Title: The Worst Headache of Your Life: Brain Hemorrhage Symptoms
Category: Doctor's Views
Created: 4/23/2010 12:00:00 AM
Last Editorial Review: 12/1/2014 12:00:00 AM
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)
Efficacy and Safety of Sinutab on Subjects in the Setting of a Common Cold [Recruiting]