Fioricet (Butalbital / Acetaminophen / Caffeine) - Summary

FIORICET SUMMARY

Fioricet^® (Butalbital, Acetaminophen, and Caffeine Tablets USP) is supplied in tablet form for oral administration.

Each tablet contains the following active ingredients:
butalbital USP. .. .. .. .. .. .50 mg
acetaminophen USP. .. .. . 325 mg
caffeine USP. .. .. .. .. .. . .40 mg

Fioricet^® (Butalbital, Acetaminophen, and Caffeine Tablets USP) is 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.

See all Fioricet indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Fioricet (Butalbital / Acetaminophen / Caffeine)

Symptomatic treatment of chronically recurring tension headache: a placebo-controlled, multicenter investigation of Fioricet and acetaminophen with codeine. [1987]
A double-blind, randomized, multicenter investigation was conducted to compare the efficacy and safety of Fioricet, acetaminophen with codeine, and placebo for the symptomatic treatment of tension headache. At the onset of a typical headache, the patients took two capsules of their assigned study medication and rated responses over the next four hours in three target symptoms areas: pain, emotional or psychic tension, and muscle contractions or stiffness in the head and neck...

Barbiturate withdrawal following Internet purchase of Fioricet. [2004.07]
CONCLUSIONS: The withdrawal state from barbiturates is similar to that from ethanol. Tolerance can develop with prolonged abuse, leading to escalating drug doses to achieve the desired effect. The suggested management of both types of withdrawal syndromes is similar, but the relative resistance of the behavioral and autonomic features in patients was remarkable. Physicians should be aware of the ease with which medications can be purchased without supervision from Internet pharmacies. The magnitude of the number of drugs that are made available through this means creates a proclivity to withdrawal states.

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.

more studies >>

Clinical Trials Related to Fioricet (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).

more trials >>

Reports of Suspected Fioricet (Butalbital / Acetaminophen / Caffeine) Side Effects

Drug Ineffective (7),  Headache (4),  Pain (3),  Hallucination (3),  Insomnia (3),  Agitation (2),  Vomiting Projectile (2),  Constipation (2),  Influenza Like Illness (2),  Haemorrhoidal Haemorrhage (2), more >>

PATIENT REVIEWS / RATINGS / COMMENTS

Fioricet review by 50 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		migraines
Dosage & duration:		l tablet taken onset of migraine for the period of still taking it at onsets
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		treatment benefits include migrain pain subsiding in about 20 minutes. No lingering fuzziness from taking this medication. Did not make me sleepy. If migrain pain appeared hours later another dose taken. This drug is especially handy for anyone with pre-menstural migrain headaches
Side effects:		for me there w4ere no treatment side effects. This medication did not cause drowsiness and I was able to keep doing my daily activiites. I also found that if I drank some coffee it would work even faster. It works in about 20 minutes after taking the medication.
Comments:		I take one tablet at the onset of of any migrain. After taking the tablet in about 20 minutes depending upon how fast I got to the pain. The medication started to work and within about 20 minutes the headache was all but forgotten. This is a safe great medication for anyone who suffers from migrain pain

Fioricet review by 34 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		migraines
Dosage & duration:		one to two tablets every four hours taken a copule times a month for the period of about 6 months
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		It effectively stopped migraine at the "aura" stage. No need to take any additional medications.
Side effects:		Massive dizziness/ "drugged" feeling. A feeling of being "out of it" --- unable to focus eyes, exhausted, etc. Impossible to function until the effect wore off. Not convinced this is the best option for migraine treatment. Although it was effective, the side effects were almost not worth it. There have got to be better options out there.
Comments:		Every time more than one pill was taken (where one was ineffective in stopping the progression of a migraine), massive dizziness and drugged feeling would result.

Fioricet review by 34 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		migraines
Dosage & duration:		one to two tablets every four hours taken a copule times a month for the period of about 6 months
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		It effectively stopped migraine at the "aura" stage. No need to take any additional medications.
Side effects:		Massive dizziness/ "drugged" feeling. A feeling of being "out of it" --- unable to focus eyes, exhausted, etc. Impossible to function until the effect wore off. Not convinced this is the best option for migraine treatment. Although it was effective, the side effects were almost not worth it. There have got to be better options out there.
Comments:		Every time more than one pill was taken (where one was ineffective in stopping the progression of a migraine), massive dizziness and drugged feeling would result.