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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.

What are the possible side effects of acetaminophen, butalbital, and caffeine?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication 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, stomach pain, low fever, 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 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.

Butalbital DRUG 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 Barbiturate-dependent patients can be withdrawn by using a number of different withdrawal regimens.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.

Fioricet 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.

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 thrombocytopenia 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. In adults hepatic toxicity has rarely been reported with acute overdoses of less than 10 grams, or fatalities with less than 15 grams.

Acute caffeine poisoning may cause insomnia, restlessness, tremor, and delirium, tachycardia and extrasystoles.

Treatment

A single or multiple overdose with Fioricet 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. Vomiting should be induced mechanically, or with syrup of ipecac, if the patient is alert (adequate pharyngeal and laryngeal reflexes). Oral activated charcoal (1 g/kg) should follow gastric emptying. The first dose should be accompanied by an appropriate cathartic. If repeated doses are used, the cathartic might be included with alternate doses as required. Hypotension is usually hypovolemic and should respond to fluids. Pressors should be avoided. A cuffed endotracheal tube should be inserted before gastric lavage of the unconscious patient and when necessary, to provide assisted respiration. If renal function is normal, forced diuresis may aid in the elimination of the barbiturate. Alkalinization of the urine increases renal excretion of some barbiturates, especially phenobarbital.

Meticulous attention should be given to maintaining adequate pulmonary ventilation. In severe cases of intoxication, peritoneal dialysis, or preferably hemodialysis may be considered. If hypoprothrombinemia occurs due to acetaminophen overdose, vitamin K should be administered intravenously.

If the dose of acetaminophen may have exceeded 140 mg/kg, acetylcysteine should be administered as early as possible. Serum acetaminophen levels should be obtained, since levels four or more hours following ingestion help predict acetaminophen toxicity. Do not await acetaminophen assay results before initiating treatment. Hepatic enzymes should be obtained initially, and repeated at 24-hour intervals.

Methemoglobinemia over 30% should be treated with methylene blue by slow intravenous administration.

Toxic Doses (for adults)

Butalbital:	toxic dose	1 g	(20 tablets)
Acetaminophen:	toxic dose	10 g	(30 tablets)
Caffeine:	toxic dose	1 g	(25 tablets)

In all cases of suspected overdosage, call your Regional Poison Control Center to obtain the most up-to-date information about the treatment of overdosage. Telephone numbers of certified Regional Poison Control Centers are listed in the Physicians’ Desk Reference®.

DOSAGE AND ADMINISTRATION

What is the most important information I should know about acetaminophen, butalbital, and caffeine?

Do not use this medication if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take acetaminophen, butalbital, and caffeine before the MAO inhibitor has cleared from your body.

Do not take more of this medication than is recommended. An overdose of acetaminophen can cause damage to your liver.

Do not use any other cold, allergy, pain, or sleep medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as “APAP”) is contained in many combination medicines. If you use certain products together you may accidentally use too much acetaminophen. Read the label of any other medicine you are using to see if it contains acetaminophen or APAP.

Avoid drinking alcohol. It can increase the risk of liver damage while you are taking acetaminophen. If you drink more than three alcoholic beverages per day, do not take acetaminophen without your doctor’s advice, and never take more than 2 grams (2000 mg) per day.

What should I discuss with my healthcare provider before taking acetaminophen, butalbital, and caffeine?

Butalbital may be habit-forming and should be used only by the person it was prescribed for. This medication should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Do not take this medication without first talking to your doctor if you drink more than three alcoholic beverages per day or if you have had alcoholic liver disease (cirrhosis). You may not be able to take medication that contains acetaminophen.

You should not take this medication if you are allergic to acetaminophen, butalbital, or caffeine, or if you have porphyria.

Before using acetaminophen, butalbital, and caffeine, tell your doctor if you are allergic to any drugs, or if you have:

kidney disease,
liver disease; or
a history of mental illness or suicidal thoughts.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

FDA pregnancy category C. It is not known whether acetaminophen, butalbital, and caffeine is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.

Acetaminophen, butalbital, and caffeine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take acetaminophen, butalbital, and caffeine?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Take the medicine with food or milk if it upsets your stomach.

An overdose of acetaminophen can cause serious harm. The maximum amount of acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Taking more acetaminophen could cause damage to your liver. One tablet may contain up to 750 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking.

Store this medication at room temperature away from moisture and heat.

Keep track of how much medicine has been used from each new bottle. Butalbital is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

What happens if I miss a dose?

Since this medication is usually taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include insomnia, restlessness, tremor, dizziness, drowsiness, nausea, vomiting, diarrhea, stomach pain, loss of appetite, increased sweating, shallow breathing, confusion, uneven heartbeats, seizure (convulsions), or coma.

What should I avoid while taking acetaminophen, butalbital, and caffeine?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

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.

While you are taking this medication, avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor’s advice.

What other drugs will affect acetaminophen, butalbital, and caffeine?

The following drugs can interact with acetaminophen, butalbital, and caffeine. Tell your doctor if you are using any of these:

an antibiotic;
a blood thinner such as warfarin (Coumadin);
isoniazid;
zidovudine (Retrovir, AZT);
seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton);
gout medications such as probenecid (Benemid) or sulfinpyrazone;
an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate);
steroids such as prednisone, fluticasone (Advair), mometasone (Asmanex, Nasonex), dexamethasone (Decadron, Hexadrol) and others; or
an antidepressant such as amitriptyline (Elavil, Etrafon), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Janimine, Tofranil), and others.

This list is not complete and there may be other drugs that can interact with acetaminophen, butalbital, and caffeine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

HOW SUPPLIED

Fioricet® (Butalbital, Acetaminophen, and Caffeine Tablets USP)

Containing 50 mg butalbital, 325 mg acetaminophen, and 40 mg caffeine. Available as light-blue, speckled, round uncoated tablets, engraved “FIORICET (butalbital, acetaminophen and caffeine) ” on one side, and a three-head profile on other side. Bottles of 100 (NDC 52544-957-01) and 500 (NDC 52544-957-05).