You should not use Fioricet if you are allergic to acetaminophen, butalbital, or caffeine, if you have porphyria, or if you have recently used alcohol, sedatives, tranquilizers, or other narcotic medications.

To make sure Fioricet is safe for you, tell your doctor if you have:

• • • liver disease, cirrhosis, a history of alcoholism or drug addiction, or if you drink more than 3 alcoholic beverages per day;
    • kidney disease;
    • asthma, sleep apnea, or other breathing disorder;
    • stomach ulcer or bleeding;
    • a history of skin rash caused by any medication;
    • a history of mental illness or suicidal thoughts; or
    • if you use medicine to prevent blood clots.

It is not known whether Fioricet will harm an unborn baby. If you use butalbital while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

This medicine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take Fioricet?

Take Fioricet exactly as prescribed. Follow all directions on your prescription label. Do not take more of this medication than recommended. An overdose can damage your liver or cause death. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Butalbital may be habit-forming. Never share Fioricet with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away Fioricet is against the law.

Take Fioricet with food or milk if it upsets your stomach.

Store Fioricet at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Butalbital is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Fioricet dosing information

Usual Adult Dose of Fioricet for Headache:

Acetaminophen 300 mg, butalbital 50 mg, and caffeine 40 mg: 1 or 2 capsule(s) orally every 4 hours as needed. Maximum daily dose: 6 doses. Acetaminophen 325 mg, butalbital 50 mg, and caffeine 40 mg: 1 or 2 tablet(s), capsule(s), or tablespoonful(s) orally every 4 hours. Maximum daily dose: 6 doses Acetaminophen 500 mg, butalbital 50 mg, and caffeine 40 mg: 1 tablet or capsule orally every 4 hours. Maximum daily dose: 6 doses Acetaminophen 750 mg, butalbital 50 mg, and caffeine 40 mg: 1 tablet orally every 4 hours. Maximum daily dose: 5 tablets

Usual Pediatric Dose of Fioricet for Headache:

12 years and older: Acetaminophen 300 mg, butalbital 50 mg, and caffeine 40 mg: 1 or 2 capsule(s) orally every 4 hours as needed. Maximum daily dose: 6 doses.

What happens if I miss a dose?

Since this medicine is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Fioricet can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include insomnia, restlessness, tremor, diarrhea, increased shallow breathing, uneven heartbeats, seizure (convulsions), or fainting.

What should I avoid while taking Fioricet?

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.

Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

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

Fioricet Side Effects

Fioricet is a prescription medication used to relieve tension headaches. It works by relaxing muscle contractions that can result in mild to moderate head pain.

Fioricet (butalbital, acetaminophen, and caffeine capsule) is a combination of a barbiturate, a non-salicylate analgesic and antipyretic, and a central nervous system stimulant indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Common side effects of Esgic include:

• • drowsiness
  • lightheadedness
  • dizziness, sedation
  • shortness of breath
  • nausea
  • vomiting
  • abdominal pain, and
  • intoxicated feeling

The dose of Fioricet is one or two capsules every four hours. The total daily dosage of Fioricet  should not exceed 6 capsules.

Fioricet may interact with monoamine oxidase (MAO) inhibitors, other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants. Tell your doctor all medications and supplements you use. During pregnancy, Fioricet should be taken only if prescribed. It is unknown if it would affect a fetus. All the drugs in Fioricet pass into breast milk, and breastfeeding while taking Fioricet is not recommended. Withdrawal symptoms may occur if you suddenly stop taking Fioricet.

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.

Acetaminophen

Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug.

Caffeine

Like most xanthines, caffeine is rapidly absorbed and distributed in all body tissues and fluids, including the CNS, fetal tissues, and breast milk.

Caffeine is cleared through metabolism and excretion in the urine. The plasma half-life is about 3 hours. Hepatic biotransformation prior to excretion, results in about equal amounts of 1-methylxanthine and 1-methyluric acid. Of the 70% of the dose that is recovered in the urine, only 3% is unchanged drug.

 

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