DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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

 
 



WARNING: DEATH RELATED TO ULTRA-RAPID METABOLISM OF CODEINE TO MORPHINE

Respiratory depression and death have occurred in children who received codeine following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine due to a CYP2D6 polymorphism.

 

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.


See all Fiorinal with Codeine indications & dosage >>

NEWS HIGHLIGHTS

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

'Mutant' Lice More Hype Than Headache
Source: MedPageToday.com - medical news plus CME for physicians [2015.08.21]
(MedPage Today) -- Treatment failure doesn't equal clinical resistance

Severe Headache During Pregnancy May Signal Trouble
Source: MedicineNet Headache 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...

Headaches in Pregnancy May Signal Serious Illness (CME/CE)
Source: MedPageToday.com - medical news plus CME for physicians [2015.08.20]
(MedPage Today) -- Hypertension, preeclampsia most likely culprits

Health Tip: Soothing a Tension Headache
Source: MedicineNet Headache Specialty [2015.08.18]
Title: Health Tip: Soothing a Tension Headache
Category: Health News
Created: 8/18/2015 12:00:00 AM
Last Editorial Review: 8/18/2015 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...

more studies >>

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]

more trials >>


Page last updated: 2015-08-21

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2015