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Butalbital and Acetaminophen (Butalbital / Acetaminophen) - Summary

 
 



BOX 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.

 

SUMMARY

Each Butalbital and Acetaminophen Tablet for oral administration, contains Butalbital, USP 50 mg, Acetaminophen, USP 300 mg.

Butalbital and Acetaminophen Tablets 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 habitforming and potentially abusable.


See all Butalbital and Acetaminophen indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Butalbital and Acetaminophen (Butalbital / Acetaminophen)

Headaches Quiz: Learn About Headache Pain
Source: MedicineNet Facial Nerve Problems Specialty [2017.09.19]
Title: Headaches Quiz: Learn About Headache Pain
Category: MedicineNet Quiz
Created: 9/28/2010 12:00:00 AM
Last Editorial Review: 9/19/2017 4:58:09 PM

Headache
Source: MedicineNet Anthrax Specialty [2017.08.16]
Title: Headache
Category: Diseases and Conditions
Created: 5/31/2002 12:00:00 AM
Last Editorial Review: 8/16/2017 12:00:00 AM

Migraine vs. Headache: Differences and Similarities
Source: MedicineNet Analgesics, Antipyretics Specialty [2017.06.26]
Title: Migraine vs. Headache: Differences and Similarities
Category: Diseases and Conditions
Created: 6/21/2017 12:00:00 AM
Last Editorial Review: 6/26/2017 12:00:00 AM

Migraine Headache
Source: MedicineNet Antiphospholipid Syndrome Specialty [2017.03.13]
Title: Migraine Headache
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 3/13/2017 12:00:00 AM

Cluster Headaches
Source: MedicineNet Cauliflower Ear Specialty [2016.08.25]
Title: Cluster Headaches
Category: Diseases and Conditions
Created: 2/4/2005 12:00:00 AM
Last Editorial Review: 8/25/2016 12:00:00 AM

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Published Studies Related to Butalbital and Acetaminophen (Butalbital / Acetaminophen)

Sumatriptan-Naproxen and Butalbital: A Double-Blind, Placebo-Controlled Crossover Study. [2011.11.21]
Objectives.- The primary objective was to compare the efficacy of a sumatriptan and naproxen combination medication (SumaRT/Nap-85 mg sumatriptan and 500 mg naproxen sodium), a butalbital-containing combination medication (BCM-50 mg butalbital, 325 mg acetaminophen, 40 mg caffeine), and placebo when used to treat moderate to severe migraine headache pain in subjects who used BCMs in the past.

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 Butalbital and Acetaminophen (Butalbital / Acetaminophen)

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)

Idiopathic Intracranial Hypertension Treatment Trial [Completed]
Idiopathic intracranial hypertension (IIH), also called pseudotumor cerebri, is a disorder of elevated intracranial pressure of unknown cause [Corbett, et al., 1982; Wall, et al., 1991]. Its incidence is 22. 5 new cases each year per 100,000 overweight women of childbearing age, and is rising [Garrett, et al., 2004] in parallel with the obesity epidemic. It affects about 100,000 Americans. Most patients suffer debilitating headaches. Because of pressure on the optic nerve (papilledema), 86% have some degree of permanent visual loss and 10% develop severe visual loss [Wall, et al., 1991]. Interventions to prevent loss of sight, all with unproven efficacy, include diet, diuretics such as acetazolamide, repeated spinal taps, optic nerve sheath fenestration surgery, and cerebrospinal fluid (CSF) shunting procedures. The purported goal of these therapies is to lower intracranial pressure; however, it is unclear which treatments work and by what mechanism. None of these strategies has been verified by properly designed clinical trials. Thus, there is confusion, uncertainty, and weak scientific rationales to guide treatment decisions. This trial will study subjects who have mild visual loss from IIH to (1) establish convincing, evidence-based treatment strategies for IIH to restore and protect vision, (2) follow subjects up to 4 years to observe the long-term treatment outcomes and (3) determine the cause of IIH. To meet those aims, the trial will be divided into a 12-month intervention phase and a 3-year observational phase. Subjects are not required to complete the observational phase of the study, but will be asked to do so and consented for the observational phase of the study at the conclusion of the intervention phase (12 months).

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Reports of Suspected Butalbital and Acetaminophen (Butalbital / Acetaminophen) Side Effects

Completed Suicide (3)Dyskinesia (2)Intentional Drug Misuse (2)Somnolence (2)Multiple Drug Overdose (2)Hyperhidrosis (1)Abdominal Discomfort (1)Vomiting (1)Nausea (1)Impaired Gastric Emptying (1)


Page last updated: 2017-09-19

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