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Fioricet with Codeine (Codeine Phosphate / Butalbital / Caffeine / Acetaminophen) - Summary

 
 



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

  • Fioricet with Codeine contains butalbital, acetaminophen, caffeine, and codeine phosphate. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product.
  • 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

Fioricet® with Codeine (butalbital, acetaminophen, 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
acetaminophen, 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.

Acetaminophen (4´-hydroxyacetanilide, C8H9NO2, mw 151.16), is a non-opiate, non-salicylate analgesic and antipyretic.

Active Ingredients: codeine phosphate, USP, butalbital, USP, caffeine, USP, and acetaminophen, USP.

Fioricet® with Codeine (butalbital, acetaminophen, caffeine, and codeine phosphate) is indicated for the relief of the symptom complex of tension (or muscle contraction) headache.

Evidence supporting the efficacy and safety of Fioricet® with Codeine (butalbital, acetaminophen, caffeine, and codeine phosphate) in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because codeine and butalbital are habit-forming and potentially abusable.


See all Fioricet with Codeine indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Fioricet with Codeine (Codeine / Butalbital / Caffeine / Acetaminophen)

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...

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 evidence that kids' headaches increase at back-to-school time
Source: Anxiety / Stress News From Medical News Today [2015.08.17]
Findings from Nationwide Children's Hospital physicians demonstrate that headaches increase in fall in children, a trend that may be due to back-to-school changes in stress, routines and sleep.

Headaches Are Common in Kids, Teens
Source: MedicineNet Headache Specialty [2015.08.17]
Title: Headaches Are Common in Kids, Teens
Category: Health News
Created: 8/14/2015 12:00:00 AM
Last Editorial Review: 8/17/2015 12:00:00 AM

more news >>

Published Studies Related to Fioricet with Codeine (Codeine / Butalbital / Caffeine / Acetaminophen)

Symptomatic treatment of chronically recurring tension headache: a placebo-controlled, multicenter investigation of Fioricet and acetaminophen with codeine. [1987]
A double-blind, randomized, multicenter investigation was conducted to compare the efficacy and safety of Fioricet, acetaminophen with codeine, and placebo for the symptomatic treatment of tension headache. At the onset of a typical headache, the patients took two capsules of their assigned study medication and rated responses over the next four hours in three target symptoms areas: pain, emotional or psychic tension, and muscle contractions or stiffness in the head and neck...

more studies >>

Clinical Trials Related to Fioricet with Codeine (Codeine / Butalbital / Caffeine / Acetaminophen)

Dissonance Inpatient Relapse Prevention Program for Anorexia Nervosa [Recruiting]
Anorexia Nervosa inpatient treatment has often a short-term success as weight is restored to a healthy level, but high percentage of patients relapse during the first year following the discharge. The development of strategies to overcome this problem represents a priority for clinicians. Aim of this trial is to evaluate the effects of a relapse prevention program based on cognitive dissonance theory developed for hospitalized patients.

TREXIMET� Versus Butalbital-containing Combination Medications for the Acute Treatment of Migraine in Adults [Completed]
Study TRX109011/TRX109013, A Randomized, Double-blind, Double-dummy, Placebo-controlled, Crossover Study to Evaluate the Efficacy of TREXIMET (Sumatriptan + Naproxen Sodium) versus Butalbital-containing Combination Medications (BCM) for the Acute Treatment of Migraine when administered during the Moderate-Severe Pain Phase of the Migraine (Studies 1 and 2 of 2)

more trials >>


Page last updated: 2015-08-21

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