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)
For Severe Migraine Headaches, Surgery Potentially The Best Option
Source: Headache / Migraine News From Medical News Today [2009.10.26]
The disability from migraine headaches is an enormous health burden affecting over 30 million Americans. In newly released research, 79 migraine sufferers were followed for at least five years after having undergone detection of migraine "trigger sites" and surgery. The new data finds promising outcomes for treating trigger sites surgically for migraine headaches resulting in elimination of pain for those afflicted with the condition.
Migraine Sufferers More Prone To Hangover Headache
Source: Headache / Migraine News From Medical News Today [2009.10.19]
Migraine sufferers, beware. You may be more prone to an alcohol-induced headache after a night of drinking, according to researchers from the Jefferson Headache Center. The research will be presented at Neuroscience 2009, the Annual Meeting of the Society for Neuroscience, in Chicago. Until now, studying the mechanism behind migraine and other forms of recurrent headaches has not been possible in an animal model, according to Michael Oshinsky, Ph.D.
School Days Give Some Kids a Headache
Source: MedicineNet Migraine Headache Specialty [2009.09.04]
Title: School Days Give Some Kids a Headache
Category: Health News
Created: 9/3/2009 4:10:00 PM
Last Editorial Review: 9/4/2009
NovaDel Article Published In Headache: The Journal Of Head And Face Pain
Source: Headache / Migraine News From Medical News Today [2009.09.03]
NovaDel Pharma Inc. (NYSE AMEX: NVD) announced that an article titled "Rapid Oral Transmucosal Absorption of Sumatriptan, and Pharmacodynamics in Acute Migraine" was published online on June 22, 2009 in the peer-reviewed journal Headache: The Journal of Head and Face Pain. NovaDel conducted two clinical trials evaluating sumatriptan administered via its oral spray drug delivery technology.
Leading International Headache Journal Cephalalgia To Be Published By SAGE
Source: Headache / Migraine News From Medical News Today [2009.09.03]
SAGE, the world's leading independent academic and professional publisher is delighted to announce a new agreement with the International Headache Society (IHS) to publish their official journal, Cephalalgia. Now in its 29th volume, Cephalalgia provides an international forum for original research papers, review articles and short communications on all aspects of headache.
Published Studies Related to Butalbital and Acetaminophen (Butalbital / Acetaminophen)
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.
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Page last updated: 2009-10-26
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