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Zebutal (Butalbital / Acetaminophen / Caffeine) - Summary

 
 



BOXED WARNING

Hepatotoxicity
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.

 

ZEBUTAL SUMMARY

ZEBUTAL™ Capsules brand of Butalbital, Acetaminophen, and Caffeine is supplied in capsule form for oral administration. Each ZEBUTAL™ Capsule contains:

  • Butalbital, USP...........................................50 mg
  • Acetaminophen, USP...............................500 mg
  • Caffeine, USP.............................................40 mg

Butalbital (5-allyl-5-isobutylbarbituric acid), a white, odorless, crystalline powder having a slightly bitter taste, is a short to intermediate-acting barbiturate.

Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic.

Caffeine (1,3,7,-trimethylxanthine), a bitter, white crystalline powder or white-glistening needles, is a central nervous system stimulant.

ZEBUTAL™ Capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.

Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.


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NEWS HIGHLIGHTS

Published Studies Related to Zebutal (Butalbital / Acetaminophen / Caffeine)

Butalbital in the treatment of headache: history, pharmacology, and efficacy. [2001.11]
Analgesics containing butalbital compounded with aspirin, acetaminophen, and/or caffeine are widely used for the treatment of migraine and tension-type headache. The butalbital-containing compounds are efficacious in placebo-controlled trials among patients with episodic tension-type headaches.Because of concerns about overuse, medication-overuse headache, and withdrawal, their use should be limited and carefully monitored.

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Clinical Trials Related to Zebutal (Butalbital / Acetaminophen / Caffeine)

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)

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Page last updated: 2006-01-31

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