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This combination medication Fioricet (Acetaminophen, Butalbital, and Caffeine) is used to treat tension headaches. Acetaminophen helps to decrease the pain from the headache. Caffeine helps increase the effects of acetaminophen. Butalbital is a sedative that helps to decrease anxiety and cause sleepiness and relaxation.

How to use Fioricet Oral

Take this medication by mouth with or without food, usually every 4 hours as needed or as directed by your doctor.

If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

The dosage is based on your medical condition and response to therapy. This medication works best if it is used as the first signs of a headache occur. If you wait until the headache has worsened, the medication may not work as well.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as nausea/vomiting, mental/mood changes, seizures) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.

Though very unlikely, abnormal drug-seeking behavior (addiction) is possible with this medication. To lessen the risk of becoming addicted, do not increase your dose, take it more frequently, or take it for a longer time than prescribed. Properly stop the medication when so directed.

This medication contains acetaminophen. Do not take more acetaminophen than recommended.

What should I discuss with my healthcare provider before taking Fioricet?

Butalbital may be habit-forming and should be used only by the person it was prescribed for. Fioricet 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 Fioricet 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 Fioricet if you are allergic to acetaminophen, butalbital, or caffeine, or if you have porphyria.

Before using Fioricet, 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 Fioricet.

FDA pregnancy category C. It is not known whether Fioricet is harmful to an unborn baby. Before taking Fioricet, 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 Fioricet without telling your doctor if you are breast-feeding a baby.

Fioricet Mechanism of action

Butalbital has generalized depressant effect on central nervous system and, in very high doses, has peripheral effects. Acetaminophen has analgesic and antipyretic effects; its analgesic effects may be mediated through inhibition of prostaglandin synthetase enzyme complex. Caffeine is thought to produce constriction of cerebral blood vessels.

Butalbital has a half-life of about 35 hours. Acetaminophen has a half-life of about 1.25 to 3 hours, but may be increased by liver damage and after an overdose. Caffeine has a half-life of about 3 hours.

What side effects can this medication cause?

Acetaminophen, Butalbital, Caffeine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• drowsiness
• upset stomach
• vomiting
• stomach pain
• depression
• lightheadedness
• confusion

If you experience any of the following symptoms, call your doctor immediately:

• skin rash
• itching
• difficulty breathing

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

Brand names of combination products

• Medigesic^® (containing Acetaminophen, Butalbital, Caffeine)
• Minotal^® (containing Acetaminophen, Butalbital, Caffeine)
• Mygracet^® (containing Acetaminophen, Butalbital, Caffeine)
• Nonbac^® (containing Acetaminophen, Butalbital, Caffeine)
• Orbivan^® (containing Acetaminophen, Butalbital, Caffeine)
• Pacaps^® (containing Acetaminophen, Butalbital, Caffeine)
• Pharmagesic^® (containing Acetaminophen, Butalbital, Caffeine)
• Quala Cet^® (containing Acetaminophen, Butalbital, Caffeine)
• Repan^® (containing Acetaminophen, Butalbital, Caffeine)
• Tenake^® (containing Acetaminophen, Butalbital, Caffeine)
• Tencet^® (containing Acetaminophen, Butalbital, Caffeine)
• Triad^® (containing Acetaminophen, Butalbital, Caffeine)
• Two-Dyne^® (containing Acetaminophen, Butalbital, Caffeine)
• Zebutal^® (containing Acetaminophen, Butalbital, Caffeine)
• Fioricet^® with Codeine (containing Acetaminophen, Butalbital, Caffeine, Codeine)
• Phrenilin^® with Caffeine and Codeine (containing Acetaminophen, Butalbital, Caffeine, Codeine)

What other drugs will affect Fioricet?

The following drugs can interact with Fioricet. 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.

Acetaminophen is routinely used for short term pain relief and fever in all stages of pregnancy. Acetaminophen is believed to be safe in pregnancy when used intermittently for short durations. Two cases of acetaminophen overdose in late pregnancy have been reported. In both cases neither the neonate nor the mother suffered hepatic toxicity. Investigations have revealed conflicting results with regards to the pharmacokinetic disposition of acetaminophen in pregnant women.

 One study has suggested that the oral clearance of acetaminophen is 58% higher and the elimination half-life is 28% longer in pregnant women compared to nonpregnant women. Another study has suggested that the elimination half-life is not different in patients who are pregnant. That study also suggested that the volume of distribution of acetaminophen may be higher in pregnant women. One study has suggested that acetaminophen in typical oral doses may result in a reduced production of prostacyclin in pregnant women. That study also suggested that acetaminophen does not affect thromboxane production.

Barbiturates in general have been reported to readily cross the placental barrier. Withdrawal seizures have been reported in a two day old infant whose mother had taken a butalbital containing drug during the last two months of pregnancy. Butalbital was found in the infant’s serum. Animal reproduction studies have not been conducted on butalbital. Caffeine has been assigned to pregnancy category B by the FDA. Both human and animal studies on caffeine have failed to reveal evidence of significant mutagenic or carcinogenic effects. Caffeine crosses the placenta.

Fetal blood and tissue levels in the fetus are similar to those in the mother. Caffeine has been reported to be an animal teratogen only with doses high enough to cause toxicity in the mother. In 1980, the Food and Drug Administration issued an advisory (based primarily on animal evidence) which stated that pregnant women should limit there intake of caffeine to a minimum. In a study of 2817 fertile women, no evidence of adverse effects from caffeine was found.

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The fecundability ratio (adjusted for known risk factors for time to conceive) was 1.03 between fertile women who consumed more than 7000 mg caffeine per month and those who consumed 500 mg or less per month. Furthermore, caffeine was not associated with infertility in 1818 infertile women and their primiparous controls. In another study (n=441) no evidence was found that moderate caffeine use increased the risk of spontaneous abortion, intrauterine growth retardation, or microcephaly.