Why is this drug prescribed?

Fioricet, a strong, non-narcotic pain reliever and relaxant, is prescribed for the relief of tension headache symptoms caused by muscle contractions in the head, neck, and shoulder area. It combines a sedative barbiturate (butalbital), a non-aspirin pain reliever (acetaminophen), and caffeine.

Most important fact about this drug

Mental and physical dependence can occur with the use of barbiturates such as butalbital when these drugs are taken in higher than recommended doses over long periods of time.

How should you take this medication?

Take Fioricet exactly as prescribed. Do not increase the amount you take without your doctor's approval.

--If you miss a dose...

Take it as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Never take 2 doses at the same time.

--Storage instructions...

Store at room temperature in a tight, light-resistant container.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Fioricet.

• More common side effects may include:
  Abdominal pain, dizziness, drowsiness, intoxicated feeling, light-headedness, nausea, sedation, shortness of breath, vomiting

• Less common or rare side effects may include:
  Agitation, allergic reactions, constipation, depression, difficulty swallowing, dry mouth, earache, exaggerated feeling of well-being, excessive sweating, excessive urination, excitement, fainting, fatigue, fever, flatulence, headache, heartburn, heavy eyelids, high energy, hot spells, itching, leg pain, mental confusion, muscle fatigue, numbness, rapid heartbeat, ringing in the ears, seizure, shaky feeling, skin redness and/or peeling, sluggishness, stuffy nose, tingling

Why should this drug not be prescribed?

If you are sensitive to or have ever had an allergic reaction to barbiturates, acetaminophen, or caffeine, you should not take this medication. Make sure that your doctor is aware of any drug reactions that you have experienced.

Unless you are directed to do so by your doctor, do not take this medication if you have porphyria (an inherited metabolic disorder affecting the liver or bone marrow).

Special warnings about this medication

Fioricet may cause you to become drowsy or less alert; therefore, driving or operating dangerous machinery or participating in any hazardous activity that requires full mental alertness is not recommended until you know your response to this drug.

If you are being treated for severe depression or have a history of severe depression or drug abuse, consult with your doctor before taking Fioricet.

Use this drug with caution if you are elderly or in a weakened condition, if you have liver or kidney problems, or if you have severe abdominal trouble.

Possible food and drug interactions when taking this medication

Butalbital slows the central nervous system (CNS) and intensifies the effects of alcohol and other CNS depressants. Use of alcohol with this drug may also cause overdose symptoms. Avoid alcoholic beverages while taking Fioricet.

If Fioricet is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Fioricet with the following:

Antihistamines such as Benadryl
Drugs known as monoamine oxidase inhibitors, including the antidepressants Nardil and Parnate
Drugs to treat depression such as Elavil
Major tranquilizers such as Haldol and Thorazine
Muscle relaxants such as Flexeril
Narcotic pain relievers such as Darvon
Sleep aids such as Halcion
Tranquilizers such as Xanax and Valium

Special information if you are pregnant or breastfeeding

If you are pregnant or plan to become pregnant, inform your doctor immediately. Fioricet can affect a developing baby. It also appears in breast milk. If this medication is essential to your health, your doctor may advise you to discontinue breastfeeding your baby until your treatment is finished.

Recommended dosage

ADULTS

The usual dose of Esgic-Plus is 1 tablet every 4 hours as needed. Do not take more than 6 tablets a day.

CHILDREN

OLDER ADULTS

Overdosage

Symptoms of Fioricet overdose can be due to its barbiturate or its acetaminophen component.

• Symptoms of barbiturate poisoning may include:
  Coma, confusion, drowsiness, low blood pressure, shock, slow or troubled breathing

Overdose due to the acetaminophen component of Fioricet may cause kidney and liver damage, blood disorders, or coma due to low blood sugar. Massive doses may cause liver failure.

• Symptoms of liver damage include:
  Excess perspiration, feeling of bodily discomfort, nausea, vomiting

If you suspect an overdose, seek emergency medical treatment immediately.