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.
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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.
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NEWS HIGHLIGHTSMedia 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
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.
Clinical Trials Related to Butalbital and Acetaminophen (Butalbital / Acetaminophen)
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)
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).
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)
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Page last updated: 2017-09-19
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