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Fioricet is an effective headache prescription and can relief headache immediately.
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
Butalbital (5-allyl-5-isobutylbarbituric acid) is a short- to intermediate-acting barbiturate. It has the following structural formula:
C11H16N2O3 Mol. wt. 224.26
Acetaminophen (4´-hydroxyacetanilide) is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:
C8H9NO2 Mol. wt. 151.16
Caffeine (1,3,7-trimethylxanthine) is a central nervous system stimulant. It has the following structural formula:
C8H10N4O2 Mol. wt. 194.19
Inactive Ingredients: crospovidone, FD&C Blue #1 (aluminum lake), magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid.
Fioricet contains a combination of acetaminophen, butalbital, and caffeine. Acetaminophen is a pain reliever and fever reducer.
Butalbital is in a group of drugs called barbiturates. It relaxes muscle contractions involved in a tension headache. Caffeine is a central nervous system stimulant. It relaxes muscle contractions in blood vessels to improve blood flow.
Fioricet is used to treat tension headaches that are caused by muscle contractions.
Important information about Fioricet
Do not use Fioricet if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.
Tell your doctor if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen. Do not take more Fioricet than is recommended. An overdose of acetaminophen can damage your liver or cause death. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.
Avoid drinking alcohol. It may increase your risk of liver damage while taking Fioricet due to the acetaminophen component.
Before taking Fioricet
Do not use Fioricet if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Tell your doctor if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen. You should not take Fioricet if you are allergic to acetaminophen, butalbital, or caffeine, or if you have porphyria.
To make sure you can safely take Fioricet, tell your doctor if you have any of these other conditions:
- kidney disease,
- liver disease; or
- a history of mental illness or suicidal thoughts.
Butalbital may be habit forming and should be used only by the person it was prescribed for. Never share Fioricet with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.
FDA pregnancy category C. It is not known whether Fioricet will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Acetaminophen, butalbital, and caffeine can pass into breast milk and may harm a nursing baby. Do not use Fioricet without telling your doctor if you are breast-feeding a baby.
Fioricet DRUG ABUSE AND DEPENDENCE
Fioricet Abuse and Dependence
Barbiturates may be habit-forming: Tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. The average daily dose for the barbiturate addict is usually about 1500 mg. As tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than two-fold. As this occurs, the margin between an intoxication dosage and fatal dosage becomes smaller. The lethal dose of a barbiturate is far less if alcohol is also ingested. Major withdrawal symptoms (convulsions and delirium) may occur within 16 hours and last up to 5 days after abrupt cessation of these drugs. Intensity of withdrawal symptoms gradually declines over a period of approximately 15 days. Treatment of barbiturate dependence consists of cautious and gradual withdrawal of the drug. Barbiturate-dependent patients can be withdrawn by using a number of different withdrawal regimens. One method involves initiating treatment at the patient’s regular dosage level and gradually decreasing the daily dosage as tolerated by the patient.
OVERDOSAGE
Following an acute overdosage of butalbital, acetaminophen, and caffeine, toxicity may result from the barbiturate or the acetaminophen. Toxicity due to caffeine is less likely, due to the relatively small amounts in this formulation.
A lot of patients think fioricet over dosage will make them additive. Never use fioricet over dosage and follow your doctor’s instruction. Following are some patient reviews about fioricet. 80% headache patient think it is helpful but 20% patient think it doesnot work for them and some patients think it may additive.
I have been using Fioricet for 10 years for Migraines and have found it to be the best treatment for me. It can sometimes make me feel a little “stoned” but that passes within half an hour and I can move on with my day.
The only reason I am NOT satisfied is my own fault…I got soooo addicted several yrs ago & had to get help! It works like a miracle for migraines but be very careful to take it only when needed for pain.
Since I have suffered migraines since the age of 6, I have been through a huge amount of treatments and medications to try to help with my migraines. After several stays overnight at the hospital hooked up to IV’s being given the strong medication DHE(if anyone has ever gone through taking this I am sure you understand the horricfic experience I had with it), a few years ago I finally came into contact with a doctor who had enough sense to prescribe Fioricet for me…and ever since then it has been the number one thing to relieve my pain. I understand that doctors have to take precautions when prescribing Fioricet, but when there are only so many days supply there, and I have to make it last a month or so it can become hard at times, especially when I have the really really bad attacks…making sure that I have enough to relieve the migraine, and enough just incase I have another attack before I am able to get a refill…so that can be extemely frustrating at times! But, overall this has been the best thing I have found, and the list of meds I have been through consists of 3 long pages. Only being 22yrs old it can be scary having to deal with these consistant headaches, but I feel that as long as I am cautious with my use of Fioricet and use it as I am supposed to I will make it through, and those of you who suffer from migraines and feel the same, I strongly reccomend giving Fioricet a try.
I”ve had migraines since age 8, finally went to my DR. at age of 23 and this is what he gave me. It changed my life completly, and I was able to live a fun, full life… Then at age29-30 iwas blessed with a beutifully large baby boy.11.5oz !The headaches drasticly changed 4days after his birth. so I now have Chronic Daily migraine Headaches, and have pain 24//7 for 19yrs,now, Nothing else I have tried works to help the pain. I juggle life around my headaches.It has been a very useful med. for my needs.
I have been using Fioricet for 10 years for Migraines and have found it to be the best treatment for me. It can sometimes make me feel a little “stoned” but that passes within half an hour and I can move on with my day.
Signs and Symptoms
Toxicity from barbiturate poisoning include drowsiness, confusion, and coma; respiratory depression; hypotension; and hypovolemic shock.
In acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necroses, hypoglycemic coma, and coagulation defects may also occur. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis, and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.
Acute caffeine poisoning may cause insomnia, restlessness, tremor, and delirium, tachycardia and extrasystoles.
Treatment
A single or multiple drug overdose with this combination product is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended. Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption.
Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Assisted or controlled ventilation should also be considered.
Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation. Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration.
Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication.
DOSAGE AND ADMINISTRATION
One or 2 tablets every 4 hours as needed. Total daily dosage should not exceed 6 tablets.
Extended and repeated use of Fioricet is not recommended because of the potential for physical dependence.
HOW SUPPLIED
Fioricet Tablets
Containing 50 mg butalbital, 325 mg acetaminophen, and 40 mg caffeine.
Available as light-blue, speckled, round uncoated tablets, engraved “FIORICET” on one side, and a three-head profile
on other side. Bottles of 100 (NDC 52544-957-01) and 500 (NDC 52544-957-05). Bottles of 100 are supplied with child-resistant closures.
Store below 30°C (86°F); dispense in a tight container.
Fioricet side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Fioricet: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using Fioricet and call your doctor at once if you have any of these serious side effects:
- fast, pounding, or uneven heartbeat;
- feeling light-headed or short of breath;
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
- easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms.
Less serious Fioricet side effects may include:
- drowsiness;
- dizziness, confusion or lightheadedness;
- dry mouth;
- nausea, vomiting, stomach pain, loss of appetite;
- feeling anxious or jittery;
- drunk feeling; or
- headache.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Fioricet?
Tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by butalbital.
Tell your doctor about all other medicines you use, especially:
- an antibiotic;
- a blood thinner such as warfarin (Coumadin, Jantoven);
- isoniazid (for treating tuberculosis);
- zidovudine (Retrovir, AZT);
- seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton);
- gout medications such as probenecid (Benemid) or sulfinpyrazone;
- steroids such as prednisone, fluticasone (Advair), mometasone (Asmanex, Nasonex), dexamethasone (Decadron, Hexadrol) and others; or
- an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Janimine, Tofranil), and others.
This list is not complete and other drugs may interact with Fioricet. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
