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

 
 



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.


See all Fiorinal with Codeine indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Fiorinal with Codeine (Codeine / Butalbital / Caffeine / Aspirin)

Migraine Headaches Pictures Slideshow: 14 Non-Drug Treatments for Migraines
Source: MedicineNet Headache Specialty [2015.06.26]
Title: Migraine Headaches Pictures Slideshow: 14 Non-Drug Treatments for Migraines
Category: Slideshows
Created: 6/25/2012 12:00:00 AM
Last Editorial Review: 6/26/2015 12:00:00 AM

Pediatric Primary Headache From A to Z
Source: Medscape Emergency Medicine Headlines [2015.06.24]
A special symposium at this year's PAS addressed pediatric headache and migraine, emphasizing the need to approach them as functional problems.
Medscape Pediatrics

Consensus Criteria for Refractory Chronic Cluster Headache
Source: Medscape NeurologyHeadlines [2015.06.23]
The European Headache Federation has developed a consensus statement on what constitutes refractory chronic cluster headache.
Medscape Medical News

NeuroBreak: Opioid Overload in Headache, A-Beta Still Drawing Big Bucks
Source: MedPage Today Neurology [2015.06.23]
(MedPage Today) -- News and commentary from the world of neurology and neuroscience

Tension Headache
Source: MedicineNet Cauliflower Ear Specialty [2015.06.22]
Title: Tension Headache
Category: Diseases and Conditions
Created: 2/4/2005 12:00:00 AM
Last Editorial Review: 6/22/2015 12:00:00 AM

more news >>

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)

Efficacy and Safety of Sinutab on Subjects in the Setting of a Common Cold [Recruiting]

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Page last updated: 2015-06-26

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