ZEBUTAL SUMMARY
ZEBUTAL™ CAPSULES BRAND OF
BUTALBITAL, ACETAMINOPHEN, AND
CAFFEINE CAPSULES, USP
ZEBUTAL™ Capsules brand of Butalbital, Acetaminophen, and Caffeine is supplied in capsule form for oral administration. Each ZEBUTAL™ Capsule contains:
- Butalbital, USP...........................................50 mg
- Acetaminophen, USP...............................500 mg
- Caffeine, USP.............................................40 mg
Butalbital (5-allyl-5-isobutylbarbituric acid), a white, odorless, crystalline powder having a slightly bitter taste, 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.
Caffeine (1,3,7,-trimethylxanthine), a bitter, white crystalline powder or white-glistening needles, is a central nervous system stimulant.
ZEBUTAL™ 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.
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NEWS HIGHLIGHTS
Published Studies Related to Zebutal (Butalbital / Acetaminophen / Caffeine)
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 Zebutal (Butalbital / Acetaminophen / Caffeine)
Effect of PACAP38/VIP on Migraineurs Measured by Magnetic Resonance [Recruiting]
The purpose of this study is to examine and compare the effect of pituitary adenylate
cyclase-activating polypeptide-38 (PACAP38) and vasoactive intestinal polypeptide (VIP) on
intracranial arteries and neuronal activity in patients with migraine without aura using a
high resolution magnetic resonance imaging (MRI), including MR angiography (MRA) and
functional MRI (fMRI).
MRA will be used to detect changes in intracranial artery circumferences before and after
PACAP38 and VIP.
fMRI will be used oo detect changes in blood-oxygenation-level-dependent-signal
(BOLD-signal).
PACAP38 but not VIP induces migraine like attacks in migraine patients. The migraine
specific drug sumatriptan will be given to relieve pain and the effect will also be
registered using MRA and fMRI.
Assessment of Pituitary Adenylate Cyclase Activating Polypeptide-Brain Derived Neurotrophic Factor (PACAP-BDNF) Signaling System Involvement in Etiology and Treatment of Major Depression [Recruiting]
The neuropeptide Pituitary Adenylate Cyclase Activating Polypeptide (PACAP) and its
receptors PAC1 and VPAC2 are widely expressed in the nervous system. The investigators found
that PACAP treatment of neuronal cell cultures increases expression of Brain Derived
Neurotrophic Factor (BDNF) that plays an important role in the etiology of psychiatric
disorders and action of antidepressants. For the first time, the investigators demonstrated
that treatment by Paroxetine and Citalopram significantly decreases PAC1 and VPAC2 and
upregulates PACAP mRNA expression, whereas Imipramine shows an opposite effect. Moreover,
PACAP, PAC1 and VPAC2 expression is highly correlated with BDNF expression. Their in vivo
studies show that Imipramine reduces BDNF and increases PAC1 mRNA expression in murine
hippocampus, suggesting that antidepressants may affect neuronal plasticity through
PACAP-BDNF interactions. Based on their observations in experimental systems, the
investigators hypothesize that PACAP signaling system may be involved in the etiology of
depression and mechanism of antidepressant action. The investigators will evaluate this
hypothesis by examining serum PACAP levels, effect of antidepressants on PACAP levels, and
gene polymorphisms of PACAP and its receptors in major depressive disorder patients. This
study will enhance the investigators' understanding of PACAP's role in the etiology of
depression and antidepressant treatment and will provide a basis to evaluate PACAP pathway
as a potential target for diagnostics and novel antidepressants drug discovery.
A Study in Type 1 Diabetic Patients With Repeated Doses of E1 in Combination With G1 [Active, not recruiting]
The purpose of the study is to determine whether E1 and G1 are safe and effective in the
treatment of type 1 diabetes.
Type 1 diabetes is an autoimmune disease, in which the immune system attacks pancreatic beta
cells. These cells produce insulin, which regulates blood glucose. The mainstay of current
treatment for type 1 diabetes is dietary control and daily parenteral administration of
insulin.
Recent diabetes research has increasingly focused on pancreatic islet cell replacement,
either by islet cell transplantation or by endogenous regeneration of islet cells. During
fetal development, islet precursor cells proliferate and differentiate into mature beta cells
capable of producing insulin. This process is known as islet cell neogenesis. Islet cell
neogenesis normally ceases around birth, however, the adult pancreas still retains
significant potential for islet regeneration, as shown by tissue repair following pancreatic
injury. Pre-clinical studies have shown that E1 and G1 can re-establish islet cell neogenesis
and increase pancreatic insulin production in diabetic animal models. It is therefore
postulated that treatment with E1 and G1 may produce islet cell regeneration in type 1
diabetic patients.
A Study in Type 2 Diabetic Patients With Repeated Doses of E1 in Combination With G1 [Active, not recruiting]
The purpose of the study is to determine whether E1 and G1 are safe and effective in the
treatment of type 2 diabetes.
Type 2 diabetes is the most common form of diabetes. The disease is characterised by insulin
resistance and a compensated state of hyperinsulinemia. In most individual, hyperglycemia
results from a failure of pancreatic beta cells insulin secretory capacity to adequately
compensate for insulin resistance in peripheral tissues. Treatment for type 2 diabetes is
achieved by dietary control, or a combination of diet and oral hypoglycemic agents or
insulin. As the disease progress, many type 2 diabetic patients eventually require insulin
as primary therapy to achieve glycemic control.
Recent diabetic research has increasingly focused on pancreatic islet cell replacement,
either by islet cell transplantation or by endogenous regeneration of islet cells. During
fetal development, islet precursor cells proliferate and differentiate into mature beta cells
capable of producing insulin. This process is known as islet cell neogenesis. Islet cell
neogenesis normally ceases around birth, however, the adult pancreas still retains
significant potential for islet regeneration, as shown by tissue repair following pancreatic
injury. Pre-clinical studies have shown that E1 and G1 can re-establish islet cell
neogenesis and increase insulin production in diabetic animal models. In type 2 diabetic
patients, treatment with E1 and G1 may result in islet cell regeneration. This therapeutic
approach may improve beta cell function, restore the loss of insulin secretory capacity and
also benefit patients on oral hypoglycemic agents by delaying insulin use.
Safety and Effectiveness of h5G1.1-mAb for Dermatomyositis [Completed]
This study will evaluate the safety and effectiveness of the experimental drug h5G1. 1-mAb in
treating patients with dermatomyositis. This disease, which causes skin rash, muscle
weakness, and sometimes various other symptoms, may be due to an immune system abnormality.
Drugs currently used to treat dermatomyositis, such as prednisone and various anticancer
drugs, often have serious side effects and may not work in all patients. h5G1. 1-mAb is a
genetically engineered antibody that blocks the activity of certain proteins involved in the
immune reaction that produces inflammation.
Patients age 18 years and older who have had dermatomyositis for at least 6 months and who
have not improved with prednisone or other therapies, or who cannot tolerate prednisone or
other therapies, may be eligible for this 12-week study. Candidates will have a history and
physical examination, including blood and urine tests, throat culture, and muscle strength
testing. Participants will be randomly assigned to receive either h5G1. 1-mAb or placebo (an
inactive substance). The drug or placebo will be given intravenously (through a thin tube
inserted into a vein) once a week for five doses and then every other week for two more
doses.
Participants will undergo the following additional tests at various intervals during the
study as follows:
1. Complete physical examination ( visit 9)
2. Blood and urine tests (various intervals)
3. Muscle strength testing, assessment of ability to perform daily tasks, and completion of
questionnaire regarding functional abilities (visits 2, 6 and 9)
4. Ultrasound imaging of muscle (during certain muscle exercises) (visits 2, 6 and 9)
5. Electrocardiogram (EKG) (visits 2 and 9)
6. Throat swab (culture) (visit 6)
7. Examination and photography of skin lesions (visits 2 and 9)
8. Skin biopsy - removal of small sample of skin tissue under local anesthetic (visits 2
and 9)
9. Magnetic resonance imaging (MRI) scan of muscles (visits 2 and 9)
10. Possible muscle biopsy - removal of small sample of muscle tissue under local anesthetic
(visits 2 and 9).
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