SUMMARY
BUTAPAP TABLETS
BUTALBITAL AND ACETAMINOPHEN TABLETS
50 mg/325 mg
Butalbital and acetaminophen is supplied in tablet form for oral administration.
Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter, white, odorless, crystalline powder, 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.
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 habit-forming and potentially abusable.
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NEWS HIGHLIGHTSMedia Articles Related to Butalbital and Acetaminophen (Butalbital / Acetaminophen)
Headache
Source: MedicineNet Angina Specialty [2013.05.16]
Title: Headache
Category: Diseases and Conditions
Created: 5/31/2002 12:00:00 AM
Last Editorial Review: 5/16/2013 12:00:00 AM
The Worst Headache of Your Life: Brain Hemorrhage Symptoms
Source: MedicineNet Brain Aneurysm Specialty [2013.04.19]
Title: The Worst Headache of Your Life: Brain Hemorrhage Symptoms
Category: Doctor's Views
Created: 4/23/2010 4:52:00 PM
Last Editorial Review: 4/19/2013 12:00:00 AM
Tension Headache
Source: MedicineNet Headache Specialty [2013.04.12]
Title: Tension Headache
Category: Diseases and Conditions
Created: 2/4/2005 4:30:00 PM
Last Editorial Review: 4/12/2013 12:00:00 AM
New Medical Device Shown To Be Highly Effective In Cluster Headache
Source: Headache / Migraine News From Medical News Today [2013.02.06]
Results showed that patients experienced clinically significant improvements in headache disability and quality of life, and demonstrated that SPG stimulation may reduce the frequency of cluster attacks. Autonomic Technologies, Inc...
Lightning Linked To Some Headaches, Migraines
Source: Headache / Migraine News From Medical News Today [2013.01.28]
University of Cincinnati (UC) researchers have found that lightning may affect the onset of headache and migraines. These results, published in the online edition of the journal Cephalalgia, are the first tying lightning to headache and could help chronic sufferers more efficiently anticipate headache and migraine arrival and begin preventive treatment immediately...
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)
TREXIMA Versus Butalbital-Containing Combination Medications for the Acute Treatment of Migraine in Adults [Recruiting]
This study is a multicenter, randomized, double-blind, double-dummy, placebo-controlled,
crossover, three-attack, outpatient study in which TREXIMA will be compared to a
butalbital-containing combination medication (BCM; acetaminophen 325mg, caffeine 40mg, and
butalbital 50mg [Fioricet]) for the acute treatment of migraine headaches. Subjects will be
randomized to one of 6 possible treatment sequences (TPB, TBP, BTP, BPT, PTB, PBT).
Subjects will treat each of the 3 migraine attacks when pain is moderate to severe. (T =
TREXIMA; P = placebo; B = butalbital) The study will include 4 visits: (1) a Screening
visit at study entry, (2) a Drug Screen visit, (3) a Randomization visit, (4) a Final visit.
The Final visit occurs either (A) upon withdrawal, or (B), after treatment of 3 migraine
attacks, or C) if the study concludes prior to the subject treating 3 attacks. The primary
objective is to evaluate the efficacy of TREXIMA versus BCM for the acute treatment of
moderate/severe migraine.
Study TRX109013, TREXIMA™ (Sumatriptan + Naproxen Sodium) Versus Butalbital-Containing Combination Medications (BCM) for the Acute Treatment of Migraine [Recruiting]
This study is a multicenter, randomized, double-blind, double-dummy, placebo-controlled,
crossover, three-attack, outpatient study in which TREXIMA will be compared to a
butalbital-containing combination medication (BCM; acetaminophen 325mg, caffeine 40mg, and
butalbital 50mg [Fioricet]) for the acute treatment of migraine headaches. Subjects will be
randomized to one of 6 possible treatment sequences (TPB, TBP, BTP, BPT, PTB, PBT).
Subjects will treat each of the 3 migraine attacks when pain is moderate to severe. (T =
TREXIMA; P = placebo; B = butalbital) The study will include 4 visits: (1) a Screening
visit at study entry, (2) a Drug Screen visit, (3) a Randomization visit, (4) a Final visit.
The Final visit occurs either (A) upon withdrawal, or (B), after treatment of 3 migraine
attacks, or C) if the study concludes prior to the subject treating 3 attacks. The primary
objective is to evaluate the efficacy of TREXIMA versus BCM for the acute treatment of
moderate/severe migraine.
Idiopathic Intracranial Hypertension Treatment Trial [Recruiting]
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 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: 2013-05-16
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