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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)

Health Tip: What May Trigger Tension Headaches
Source: MedicineNet Headache Specialty [2014.04.11]
Title: Health Tip: What May Trigger Tension Headaches
Category: Health News
Created: 4/11/2014 7:35:00 AM
Last Editorial Review: 4/11/2014 12:00:00 AM

Dizziness and headache can be symptoms of stroke, especially in women, minorities and younger patients
Source: Headache / Migraine News From Medical News Today [2014.04.08]
Doctors overlook or discount the early signs of potentially disabling strokes in tens of thousands of American women each year, a large number of them visitors to emergency rooms complaining of...

More ERs Treating Headaches With Narcotics, Study Finds
Source: MedicineNet acetaminophen Specialty [2014.04.03]
Title: More ERs Treating Headaches With Narcotics, Study Finds
Category: Health News
Created: 4/2/2014 5:36:00 PM
Last Editorial Review: 4/3/2014 12:00:00 AM

$1 billion a year is spent on brain scans for headache sufferers
Source: Headache / Migraine News From Medical News Today [2014.03.18]
Contrary to guidelines, 12% of patients going to their doctor with headache are given brain scans. A new study in JAMA Internal Medicine warns of the substantial health care costs.

Study finds high utilization of neuroimaging for headaches despite guidelines
Source: Headache / Migraine News From Medical News Today [2014.03.18]
Neuroimaging for headaches is frequently ordered by physicians during outpatient visits, despite guidelines that recommend against such routine procedures.

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: 2014-04-11

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