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)
Teens Likely to Get Opioid Rx for Headaches
Source: MedPage Today Emergency Medicine [2014.03.06]
(MedPage Today) -- Nearly half of teens who visit a doctor complaining of headache pain walk away with a prescription for a narcotic painkiller, researchers found.
High stress levels 'increase frequency of headaches'
Source: Anxiety / Stress News From Medical News Today [2014.02.20]
Whether a result of our work, home or social lives, all of us go through stressful periods. Now, new research has linked high stress levels to increased occurrence of headaches - an association that has long been suspected.The study findings are due to be presented at the American Academy of Neurology's 66th Annual Meeting in Philadelphia, PA, in April.
Source: MedicineNet Antiphospholipid Syndrome Specialty [2014.01.31]
Title: Migraine Headache
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 1/31/2014 7:06:51 PM
Source: MedicineNet Common Cold Specialty [2014.01.28]
Title: Sinus Headache
Category: Diseases and Conditions
Created: 1/11/2010 2:35:00 PM
Last Editorial Review: 1/28/2014 12:00:00 AM
Chewing gum is often the culprit for migraine headaches in teens - 87 percent who quit experience significant relief
Source: Headache / Migraine News From Medical News Today [2013.12.30]
Teenagers are notorious for chewing a lot of gum. The lip smacking, bubble popping, discarded gum stuck to the sole give teachers and parents a headache.Now, Dr. Nathan Watemberg of Tel Aviv University-affiliated Meir Medical Center has found that gum-chewing teenagers, and younger children as well, are giving themselves headaches too.
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]