Fioricet and Esgic are brand name drugs made from a combination of butalbital (a barbiturate, 50 mg), acetaminophen (325 mg), and caffeine (40 mg). They are indicated for the treatment of tension headaches and muscle contraction headaches. Although not indicated, they are commonly used to treat migraines and other pain related ailments. Note that Fioricet (and some other pain medications) are implicated as causing repeat headaches with over-use (see NYT citation below)
Fioricet is indicated for the treatment of complex and muscle contraction headaches. It is also commonly prescribed for migraines although it is not FDA indicated for this use. The usual adult dose is 1-2 tablets every four hours as needed, not exceeding six tablets in a 24 hour period.
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 half-life of about 35 hours. Acetaminophen half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Caffeine half-life is about 3 hours.
Side effects
Side effects for any drug are difficult to predict, but commonly reported side effects for Fioricet include:
Dizziness
Drowsiness
Intoxicated feeling
Light-headedness
Nausea
Vomiting
Sedation
Addiction
Shortness of breath
Abdominal pain
Variations
Phrenilin is an equivalent combination of butalbital and acetaminophen, without the caffeine (325/50).
Esgic Plus and Phrenilin Forte contains 500 and 650 miligrams of acetaminophen respectively, instead of 325 milligrams. Additionally, Esgic Plus contains 40 milligrams of caffeine.
Fiorinal contains aspirin instead of acetaminophen.
Fiorinal and Fioricet also come as a combination drug with codeine called Fiorinal with Codeine and Fioricet with Codeine which adds 30 milligrams of codeine phosphate to each mixture.
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Fioricet
Generic Name: acetaminophen, butalbital, and caffeine (oral) (a seet a MIN oh fen, bue TAL bi tal, and KAF een)
Brand Names: Anolor 300, Dolgic LQ, Esgic, Fioricet, Geone, Margesic, Medigesic, Repan, Zebutal
What is acetaminophen, butalbital, and caffeine?
Acetaminophen is a pain reliever and fever reducer.
Butalbital is in a group of drugs called barbiturates. It relaxes muscle contractions involved in a tension headache.
Caffeine is a central nervous system stimulant. It relaxes muscle contractions in blood vessels to improve blood flow.
The combination of acetaminophen, butalbital, and caffeine is used to treat tension headaches that are caused by muscle contractions.
Acetaminophen, butalbital, and caffeine may also be used for other purposes not listed in this medication guide.
What is the most important information I should know about acetaminophen, butalbital, and caffeine?
Do not use this medication if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take acetaminophen, butalbital, and caffeine before the MAO inhibitor has cleared from your body. Do not take more of this medication than is recommended. An overdose of acetaminophen can cause damage to your liver. Do not use any other over-the-counter cough, cold, allergy, or menstrual pain medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains acetaminophen or caffeine. Avoid drinking alcohol. It can increase the risk of liver damage while you are taking acetaminophen. If you drink more than three alcoholic beverages per day, do not take acetaminophen without your doctor's advice, and never take more than 2 grams (2000 mg) per day.
What should I discuss with my healthcare provider before taking acetaminophen, butalbital, and caffeine?
Butalbital may be habit-forming and should be used only by the person it was prescribed for. This medication 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 this medication 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 this medication if you are allergic to acetaminophen, butalbital, or caffeine, or if you have porphyria.
Before using acetaminophen, butalbital, and caffeine, 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 condition, s you may need a dose adjustment or special tests to safely take this medication.
FDA pregnancy category C. This medication may be harmful to an unborn baby. 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 this medication without telling your doctor if you are breast-feeding a baby.
How should I take acetaminophen, butalbital, and caffeine?
Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.
Take the medicine with food or milk if it upsets your stomach. An overdose of acetaminophen can cause serious harm. The maximum amount of acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Taking more acetaminophen could cause damage to your liver. One tablet may contain up to 750 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking. Store this medication at room temperature away from moisture and heat.
Keep track of how much medicine has been used from each new bottle. Butalbital is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.
What happens if I miss a dose?
Since this medication is usually taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine.
Overdose symptoms may include insomnia, restlessness, tremor, dizziness, drowsiness, nausea, vomiting, diarrhea, stomach pain, loss of appetite, increased sweating, shallow breathing, confusion, uneven heartbeats, seizure (convulsions), or coma.
What should I avoid while taking acetaminophen, butalbital, and caffeine?
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. 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. Avoid drinking alcohol. It can increase the risk of liver damage while you are taking acetaminophen. If you drink more than three alcoholic beverages per day, do not take acetaminophen without your doctor's advice, and never take more than 2 grams (2000 mg) of acetaminophen per day. Do not use any other over-the-counter cough, cold, allergy, or menstrual pain medication without first asking your doctor or pharmacist. Acetaminophen or caffeine are contained in many product over-the-counter medicines. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains acetaminophen or caffeine.
While you are taking this medication, avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice.
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Why is Fioricet 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 Fioricet
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 Fioricet?
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.
Side effects may include:
Abdominal pain, dizziness, drowsiness, intoxicated feeling, light-headedness, nausea, sedation, shortness of breath, vomiting
Why should Fioricet 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 Fioricet
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 Fioricet
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 diphenhydramineDrugs known as monoamine oxidase inhibitors, including the antidepressants phenelzine and tranylcypromineDrugs to treat depression such as amitriptylineMajor tranquilizers such as chlorpromazine and haloperidolMuscle relaxants such as cyclobenzaprineNarcotic pain relievers such as propoxypheneSleep aids such as triazolamTranquilizers such as alprazolam and diazepam
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 for Fioricet
ADULTS
The usual dose of Fioricet is 1 or 2 tablets taken every 4 hours as needed. Do not exceed a total dose of 6 tablets per day.
The usual dose of Esgic-Plus is 1 tablet every 4 hours as needed. Do not take more than 6 tablets a day.
CHILDREN
The safety and effectiveness of Fioricet have not been established in children under 12 years of age.
OLDER ADULTS
Fioricet may cause excitement, depression, and confusion in older people. Therefore, your doctor will prescribe a dose individualized to suit your needs.
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.
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