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.
Butalbital, acetaminophen and caffeine is supplied in capsule form for oral administration. Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter, white, odorless, crystalline powder, is a short to intermediate-acting barbiturate.
Butalbital, Acetaminophen and Caffeine 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.
Clinical Trials Related to Esgic-Plus (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´┐Ż 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)
Page last updated: 2013-09-02