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

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.

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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...

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