Drug Profiles:
Fioricet® (butalbital, acetaminophen, caffeine)*

Fioricet® is for mild to moderate Migraine pain management. Migraineurs find Fioricet® is a useful therapy when taken before lying down in a dark room because it is compounded with a barbiturate (used for its sedative effects).

CAUTION: Federal law prohibits dispensing without prescription.

* Fioricet is also available with Codeine.

Allergies-
Be certain to tell your doctor if you have ever had any unusual or allergic reaction to butalbital or other barbiturates, or to acetaminophen, aspirin, or caffeine. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy-
FDA pregnancy category C. This means that its effects on an unborn baby are not known. Do not take this medication without first talking to your doctor if you are pregnant.

Breast-feeding-
This drug combination passes into breast milk and may harm a nursing infant. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

Children-

• For butalbital: Although barbiturates such as butalbital often cause drowsiness, some children become excited after taking them.
• For acetaminophen: Acetaminophen has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.
• For caffeine: There is no specific information comparing use of caffeine in children up to 12 years of age with use in other age groups. However, caffeine is not expected to cause different side effects or problems in children than it does in adults.

Older adults-

• For butalbital: Certain side effects, such as confusion, excitement, or mental depression, may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of the butalbital in this combination medicine.
• For acetaminophen: Acetaminophen has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.
• For caffeine: Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of caffeine in the elderly with use in other age groups.

Other medicines-
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. It is especially important to tell your doctor if you are taking:

• Anticoagulants (blood thinners)
• Carbamazepine (Tegretol)
• Contraceptives containing estrogen
• Corticosteroids (cortisone-like medicines)
• Corticotropin (ACTH)
• Tricyclic Antidepressants
• Central nervous system (CNS) depressants (medicines that often cause drowsiness)
• Divalproex (Depakote) or Valproic acid (Depakene)
• Drugs other than those listed here may also interact with Acetaminophen/butalbital/caffeine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Other medical problems-
The presence of other medical problems may affect the use of frovatriptan. Make sure you tell your doctor if you have any other medical problems, especially:

• alcohol abuse (or history of)
• drug abuse or dependence (or history of)
• Asthma, emphysema, or other chronic lung disease
• hepatitis or other liver disease
• typeractivity (in children)
• kidney disease
• diabetes mellitus
• mental depression
• overactive thyroid
• porphyria (or history of)
• heart disease (severe)

Proper Use of This Medicine

• Take Acetaminophen/butalbital/caffeine exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
• Take each dose with a full glass of water.
• Take Acetaminophen/butalbital/caffeine with food or milk if it upsets your stomach.
• Never take more of this medication than is prescribed for you. Too much Acetaminophen/butalbital/caffeine could be very harmful. Never take more than six tablets or capsules per day.
• Do not share this medication with anyone else.
• Avoid alcohol. Alcohol taken during therapy with acetaminophen and butalbital can be very damaging to your liver and can increase drowsiness and dizziness.
• This medicine will relieve a head pain best if you take it as soon as the pain begins. If you get warning signs of a migraine, take this medicine as soon as you are sure that the migraine is coming. This may even stop the head pain from occurring. Lying down in a quiet, dark room for a while after taking the medicine also helps to relieve head pain.
• People who who have frequent head pain episodes may need to take a different medicine to help prevent headaches or Migraines. It is important that you follow your doctor's directions about taking the other medicine, even if your headaches or Migraines continue to occur. Preventive medicines may take several weeks to start working. Even after they do start working, your headaches or Migraines may not go away completely. However, they should occur less often, and should be less severe and easier to relieve than before.

Dosing-
The dose of Fioricet will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses. If your dose is different, do not change it unless your doctor tells you to do so.

• Adults—One or 2 capsules or tablets every four hours as needed. If your medicine contains 325 or 500 milligrams (mg) of acetaminophen in each capsule or tablet, you should not take more than six capsules or tablets a day. If your medicine contains 650 mg of acetaminophen in each capsule or tablet, you should not take more than four capsules or tablets a day.
• Children—Dose must be determined by your doctor.

Storage-
To store this medicine:

• Keep out of the reach of children since overdose is especially dangerous in children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

• Check with your doctor if the medicine stops working as well as it did when you first started using it. This may mean that you are in danger of becoming dependent on the medicine. Do not try to get better pain relief by increasing the dose.
• Check with your doctor if you are having headaches or Migraines more often than you did before you started using this medicine. This is especially important if a new episode occurs within 1 day after you took your last dose of medicine, episodes begin to occur every day, or an episode continues for several days in a row. This may mean that you are dependent on the headache medicine. Continuing to take this medicine will cause even more headaches later on. Your doctor can give you advice on relief.
• Check the acetaminophen content of other over-the-counter and prescription products while taking this medication. You should not exceed 4 grams (4000 mg) of acetaminophen per day.
• The butalbital in this medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; other barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Also, stomach problems may be more likely to occur if you drink alcoholic beverages while you are taking Acetaminophen. Therefore, do not drink alcoholic beverages, and check with your doctor before taking any of the medicines listed above, while you are using this medicine.
• This medicine may cause some people to become drowsy, dizzy, or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert and clearheaded.
• Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine. Serious side effects may occur if your medical doctor or dentist gives you certain other medicines without knowing that you have taken butalbital.
• Before you have any medical tests, tell the person in charge that you are taking this medicine. Caffeine (present in some butalbital and Acetaminophen combinations) interferes with the results of certain tests that use dipyridamole (e.g., Persantine) to help show how well blood is flowing to your heart. Caffeine should not be taken for 8 to 12 hours before the test. The results of some other tests may also be affected by butalbital and Acetaminophen combinations.
• If you have been taking large amounts of this medicine, or if you have been taking it regularly for several weeks or more, do not suddenly stop using it without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely, to lessen the chance of withdrawal side effects.
• If you think you or anyone else may have taken an overdose of this medicine, get emergency help at once.

Side Effects of This Medicine
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur, especially if several of them occur together:

• Rare: Bleeding or crusting sores on lips; chest pain; fever with or without chills; hive-like swellings (large) on eyelids, face, lips, and/or tongue; muscle cramps or pain; red, thickened, or scaly skin; shortness of breath, troubled breathing, tightness in chest, or wheezing; skin rash, itching, or hives; sores, ulcers, or white spots in mouth (painful); sore throat

Also, check with your doctor as soon as possible if any of the following side effects occur:

• Less comon: confusion (mild); mental depression; unusual excitement (mild)
• Rare: bloody or black, tarry stools; bloody urine; pinpoint red spots on skin; swollen or painful glands; unusual bleeding or bruising ; unusual tiredness or weakness (mild)

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common: Bloated or "gassy'" feeling; dizziness or lightheadedness (mild); drowsiness (mild); nausea, vomiting, or stomach pain
   

Some commonly used brand names are:

In the U.S.-

In Canada- not commercially available