Uses for Fioricet

This combination medication 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

See also Warning section.

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

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. Report any withdrawal reactions immediately.

Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.

Tell your doctor if you notice increased use of this medication, a worsening of headaches, an increase in the number of headaches, the medication not working as well, or use of this medication for more than 2 headache episodes a week. Do not take more than recommended. Your doctor may need to change your medication and/or add a separate medication to prevent the headaches.

Fioricet Side Effectst

Nervous System

Nervous system side effects including drowsiness, lightheadedness, dizziness, sedation, and an intoxicated feeling have been reported frequently from the use of butalbital. Headache and seizures have been reported infrequently. Mental confusion, excitement, or depression have also been reported due to either intolerance (primarily in elderly or debilitated patients) or due to an overdose of butalbital.

General

General side effects including caffeinism have been reported. Consumption of higher doses of caffeine (>600 mg/day) has been reported to have lead to caffeinism. Caffeinism is a syndrome characterized by anxiety, restlessness, and sleep disorders (similar to anxiety states). It has also been reported that chronic, heavy caffeine ingestion may be associated with depression. Caffeine may cause anxiety and panic in panic disorder patients and may aggravate PMS.

Hepatic

Hepatic side effects including severe and sometimes fatal dose dependent hepatitis has been reported with the use of acetaminophen in alcoholic patients. Hepatotoxicity has been increased during fasting. Alcoholic patients may develop hepatotoxicity after even modest doses of acetaminophen. In healthy patients, approximately 15 grams of acetaminophen is necessary to deplete liver glutathione stores by 70% in a 70 kg person. However, hepatotoxicity has been reported following smaller doses. Glutathione concentrations may be repleted by the antidote N-acetylcysteine. One case report has suggested that hypothermia may also be beneficial in decreasing liver damage during overdose. In a recent retrospective study of 306 patients admitted for acetaminophen overdose, 6.9% had severe liver injury but all recovered. None of the 306 patients died. One study has suggested that acetaminophen may precipitate acute biliary pain and cholestasis. The mechanism of this effect may be related to inhibition of prostaglandin and alterations in the regulation of the sphincter of Oddi. Cases of acute pancreatitis have been reported rarely with the use of acetaminophen. A 19-year-old female developed hepatotoxicity, reactive plasmacytosis and agranulocytosis followed by a leukemoid reaction after acute acetaminophen toxicity.

Gastrointestinal

Gastrointestinal side effects are rare with acetaminophen use, except in alcoholics and after overdose. Nausea, vomiting, and abdominal pain have been reported frequently with the use of butalbital. In clinical trials of caffeine citrate, five cases of necrotizing enterocolitis were reported among the 46 infants exposed to the caffeine citrate injection.

Renal

Acute tubular necrosis usually occurs in conjunction with liver failure, but has been observed as an isolated finding in rare cases. A possible increase in the risk of renal cell carcinoma has been associated with chronic acetaminophen use as well. A recent case-control study of patients with end-stage renal disease suggested that long term consumption of acetaminophen may significantly increase the risk of end-stage renal disease particularly in patients taking more than two pills per day. Renal side effects are rare with acetaminophen and include acute tubular necrosis and interstitial nephritis. Adverse renal effects are most often observed after overdose, after chronic abuse (often with multiple analgesics), or in association with acetaminophen-related hepatotoxicity.

Precautions for Fioricet

Before taking this medication, tell your doctor or pharmacist if you are allergic to acetaminophen, caffeine, or butalbital; or to other barbiturates (such as phenobarbital) or xanthine derivatives (such as theophylline); or if you have any other allergies.

This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

severe breathing problems (such as bronchopneumonia)

a certain enzyme disorder (porphyria)

liver disease

kidney disease

personal or family history of regular use/abuse of drugs/alcohol

mental/mood disorders

abdominal/stomach problems (such as stomach ulcer)

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages. Liquid products may contain alcohol, sugar and/or aspartame.

Caution is advised if you have diabetes, alcohol dependence, liver disease, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely. Before having surgery, tell your doctor or dentist about all the products you use. During pregnancy, this medication should be used only when clearly needed.

Using it for long periods or in high doses near the expected delivery date is not recommended because of possible harm to the unborn baby.

Discuss the risks and benefits with your doctor. Infants born to mothers who have used this medication for an extended time may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, seizures, or diarrhea. Tell your doctor immediately if you notice any of these symptoms in your newborn.

This drug passes into breast milk and could have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Drug Interactions 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 over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Fioricet Indications & Dosage

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 r/equired because butalbital is habit-forming and potentially abusable.

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 this product is not recommended because of the potential for physical dependence.

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” on one side, and a three-head profile “