What is Fioricet and What is Fioricet Side Effects ?

Fioricet and Esgic are brand names of a combination of butalbital (a barbiturate), acetaminophen and caffeine which is indicated for the treatment of tension headaches, muscle contraction headaches and post-dural puncture headaches. Although not indicated, they are commonly used to treat migraines and other pain related ailments.

Fioricet® (Butalbital, Acetaminophen, and Caffeine Tablets USP) is supplied in tablet form for oral administration.

Each tablet contains the following active ingredients:
butalbital USP . . . . . . . . . . . .50 mg
acetaminophen USP . . . . . . 325 mg
caffeine USP . . . . . . . . . . . . .40 mg

Inactive Ingredients: crospovidone, FD&C Blue #1, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid.

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.

Before taking Fioricet

Do not use Fioricet if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

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 sever

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

Get emergency medical help if you have signs of an allergic reaction to Fioricet: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.

Stop using this medicine and call your doctor at once if you have:

confusion, seizure (convulsions);
shortness of breath;
a light-headed feeling, like you might pass out; or
nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common Fioricet side effects may include:

drowsiness, dizziness;
feeling anxious or restless;
drunk feeling; or
sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Fioricet?

Taking this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking Fioricet with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with acetaminophen, butalbital, and caffeine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Fioricet only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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You have a history of alcoholism or drug addiction;
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What is Fioricet and why it can relieve headaches ?

Fioricet (Butalbital, Acetaminophen, and Caffeine Tablets, USP) is supplied in tablet form for oral administration.

Each tablet contains the following active ingredients:
butalbital USP . . . . . . . . . .50 mg
acetaminophen USP . . . . 325 mg
caffeine USP . . . . . . . . . . .40 mg

Fioricet contains Butalbital, Acetaminophen, 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.

Butalbital

Butalbital is well absorbed from the gastrointestinal tract and is expected to distribute to most tissues in the body. Barbiturates in general may appear in breast milk and readily cross the placental barrier. They are bound to plasma and tissue proteins to a varying degree and binding increases directly as a function of lipid solubility.

Elimination of butalbital is primarily via the kidney (59% to 88% of the dose) as unchanged drug or metabolites. The plasma half-life is about 35 hours. Urinary excretion products include parent drug (about 3.6% of the dose), 5-isobutyl-5-(2, 3-dihydroxypropyl) barbituric acid (about 24% of the dose), 5-allyl-5(3-hydroxy-2-methyl-1-propyl) barbituric acid (about 4.8% of the dose), products with the barbituric acid ring hydrolyzed with excretion of urea (about 14% of the dose), as well as unidentified materials. Of the material excreted in the urine, 32% is conjugated.

The in vitro plasma protein binding of butalbital is 45% over the concentration range of 0.5-20 mcg/mL. This falls within the range of plasma protein binding (20%-45%) reported with other barbiturates such as phenobarbital, pentobarbital, and secobarbital sodium. The plasma-to-blood concentration ratio was almost unity, indicating that there is no preferential distribution of butalbital into either plasma or blood cells.

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.

What is the most important information I should know about Fioricet?

- Butalbital, one of the drugs found in Fioricet, is habit-forming and has potential for abuse. Extended use is not recommended.Fioricet can affect your ability to drive a car or operate machinery. Do not drive a car or operate machinery while taking Fioricet until you know how this drug affects you.Avoid alcohol and other drugs that affect your central nervous system (brain and spinal cord) because they can further affect your ability to concentrate.
- Who should not take Fioricet?Do not take Fioricet if you are allergic to butalbital, acetaminophen, or caffeine.Do not take Fioricet if you have an inherited disorder that affects the liver or bone marrow (porphyria).

What should I tell my doctor before I take the first dose of Fioricet?

- Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Fioricet. Also, talk to your doctor about your complete medical history, especially if you have porphyria, kidney or liver disease, a history of prior substance abuse, if you drink alcohol, are pregnant, plan to become pregnant, or are breastfeeding.

What is the usual dosage?

The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor’s approval.Adults: The usual dose of Fioricet is 1 or 2 tablets taken every 4 hours as needed. One tablet contains 50 milligrams (mg) of butalbital, 325 mg of acetaminophen, and 40 mg of caffeine. Do not take more than 6 tablets per day.Elderly: Your doctor may prescribe a lower dose than the usual recommended dose to suit your needs.Children: Fioricet is not recommended in children <12 years old.

How should I take Fioricet?

Take Fioricet exactly as prescribed. Do not increase the amount you take without your doctor’s approval. Do not take more than 6 tablets per day.

What should I avoid while taking Fioricet?

- - Fioricet can cause drowsiness or dizziness. Avoid driving, operating machinery, or performing other hazardous activities while taking Fioricet.Avoid taking Fioricet with medications that affect your concentration, such as other narcotic pain relievers, general anesthetics, sleeping pills, anti-allergy medications, sedative-hypnotics, and tranquilizers (such as chlordiazepoxide). These may cause further drowsiness.Do not drink alcohol while taking Fioricet. Doing so may result in increased drowsiness and dizziness.Avoid taking other medications that contain acetaminophen, such as Tylenol. Avoid taking too much caffeine.

What are possible food and drug interactions associated with 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 any of the following: alcohol, general anesthetics, antidepressant medications in a class called monoamine oxidase (MAO) inhibitors such as phenelzine and tranylcypromine, narcotic pain relievers such as codeine or propoxyphene, other medicines that affect your brain and spinal cord (CNS depressants), sedative-hypnotics, and tranquilizers such as chlordiazepoxide.

What are the possible side effects of Fioricet?

- Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.Side effects may include: fatal skin reactions, seizure, confusion, depression, excitement, stomach pain, dizziness, drowsiness, intoxicated feeling, lightheadedness, nausea, sedation, shortness of breath, vomiting, excessive sweating

Can I receive Fioricet if I am pregnant or breastfeeding?

- The effects of Fioricet during pregnancy and breastfeeding are unknown. Do not breastfeed while taking Fioricet. Tell your doctor immediately if you are pregnant, plan to become pregnant, or are breastfeeding.

What should I do if I miss a dose of Fioricet?

- 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 dosing schedule. Do not take two doses at once.

How should I store Fioricet?

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

Fioricet Pharmacokinetics

The behavior of the individual components is described below.

Butalbital

Acetaminophen

Caffeine

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

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Forms of Fioricet available to treat migraines

Fioricet, which is a brand-name medication, is available only as a tablet. Other medications containing the same active ingredients are available as liquids and may contain different strengths of acetaminophen.

Other names for this combination of drugs:

Amaphen^®
Anoquan^®
Butace^®
Endolor^®
Esgic^®
Fioricet^®
Medigesic^®
Repan^®

Most common side effects of Fioricet tablets

Fioricet is a combination of three drugs, therefore each ingredient may result in different side effects.

The most common side effects seen from butalbital are:

Dizziness
Sedation
Drowsiness
Lightheadedness
Shortness of breath
Dulled senses
Abdominal pain
Nausea and/or Vomiting

Possible side effects from the acetaminophen:

Allergic reactions
Rash
Low blood cell count

Possible side effects from the caffeine:

Rapid heart rate
Irritability
Dependence
Shaking
Poisonous effect on the kidneys
Increased blood sugar

Serious side effects

Some people may experience serious side effects when they take Fioricet. The maximum daily dose of acetaminophen for adults without liver problems is 4,000 mg or 4 grams per day. Seek immediate medical attention immediately if you have any of the following symptoms of liver damage:

Persistent nausea or vomiting
Yellowing of the eyes or skin
Dark-colored urine
Severe abdominal pain or stomach pain
Extreme fatigue

Barbiturates, including Fioricet, can cause dangerous and potentially life-threatening dependency. Consuming alcohol while taking Fioricet is dangerous. Because Fioricet can be addictive, it should only be taken while under a doctor’s supervision and the medicine should be stopped gradually, not abruptly.

Like many painkillers used for treating migraines, if Fioricet is taken often over a long time it can lead to a rebound headache, which is also called medication overuse headache. This results in headaches worsening.

Who should not take Fioricet for migraines

Fioricet may interact with other medicines you are taking. Therefore, as always, you must inform your doctor of all other medications you are currently taking including over-the-counter drugs and any natural remedies.

Let your doctor know if you are taking certain antidepressants called MAO inhibitors, drugs that act on the central nervous system, alcohol, antihistamines, sleep aids, anti-anxiety medications, muscle relaxants, narcotic pain killers or drugs for mental illness.

Fioricet should not be used if you take sodium oxylate, a drug for narcolepsy, if you suffer from porphyria or if you drink alcohol.

Fioricet interacts with several other drugs including:

Adenosine
Anti-seizure drugs
Beta agonists (such as albuterol) used to treat asthma
Birth control pills (oral contraceptives)

Fioricet also interacts with drugs that affect liver enzymes, including:

Erythromycin
Cimetidine
Disulfiram
Valproic acid
Fluvoxamine
Isoniazid
Lithium
Methoxyflurane
Phenothiazines (such as chlorpromazine)

Fioricet can also speed up the removal of other drugs from your body by affecting your liver enzymes including:

Blood thinners (such as warfarin)
Cyclosporine (used for organ transplant)
Corticosteroids (such as prednisone)
Estrogen (a female sex hormone)
Felodipine (a calcium-channel blocker)
Metronidazole (an antibiotic)
Quinidine (used to treat irregular heart rate)
Certain beta blockers (such as metoprolol)
Theophylline (used for asthma)
Doxycycline ( a type of tetracycline antibiotic)

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Fioricet is used to treat migraine and various forms of headache. Many doctors prescribe it to their patients because it is a sedative and a pain killer wrapped in one. When you have a prescription, you can buy Fioricet anywhere, but you should know that you should not exceed dosage prescribed by your doctor. However, if you have exceeded the dosage, you should call your doctor and tell him what side effects you are experiencing so he can help you out.

When you order Fioricet next day, you will get it in form of pills for oral usage of various shapes and colors. Usually it’s made in white or blue color, and the shape might be round or oval. Dosage is same for any of mentioned, 40mg, only shapes and colors are different.

Before taking this medicine

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.

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