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Fioricet contains a combination of 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.

Fioricet is used to treat tension headaches that are caused by muscle contractions. Fioricet may also be used for purposes not listed in this medication guide.

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

Fioricet Mechanism of Action

Fioricet is a brand name consisting of a combination of butalbital (a barbiturate), APAP and caffeine which is indicated for the treatment of tension headaches, muscle contraction headaches and post-dural puncture headaches. 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.

Each tablet contains the following active ingredients:

• • • butalbital USP . . . . . . . . . .50 mg
    • acetaminophen USP . . . . 325 mg caffeine USP . . . . . . . . . . .40 mg
    • Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate.

Butalbital belongs to the group of medicines called barbiturates. Barbiturates act in the central nervous system (CNS) to produce their effects. When butalbital is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain.

Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.  It has the following structural formula:

  Acetaminophen (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. Acetaminophen is used to relieve pain and reduce fever in patients.

It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when taken in large doses, including liver damage. 

It has the following structural formula: Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant.Caffeine is a CNS stimulant that is used with pain relievers to increase their effect. It has also been used for migraine headaches. However, caffeine can also cause physical dependence when it is used for a long time. This may lead to withdrawal (rebound) headaches when you stop taking it. It has the following structural formula: Inactive Ingredients: crospovidone, FD&C Blue #1 (aluminum lake), magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid.

Fioricet Precautions

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 several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

Pregnancy Category C

Animal reproduction studies have not been conducted with this combination product. It is also not known whether butalbital, acetaminophen and caffeine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product should be given to a pregnant woman only when clearly needed.

Nonteratogenic Effects

Withdrawal seizures were reported in a two-day-old male infant whose mother had taken a butalbitalcontaining drug during the last two months of pregnancy. Butalbital was found in the infant’s serum. The  infant was given phenobarbital 5 mg/kg, which was tapered without further seizure or other withdrawal symptoms.

Nursing Mothers

Caffeine, barbiturates and acetaminophen are excreted in breast milk in small amounts, but the significance of their effects on nursing infants is not known. Because of potential for serious adverse reactions in nursing infants from butalbital, acetaminophen and caffeine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

What you should know before you buy fioricet online ?

This medicine may be habit-forming. If you or your child feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loose skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

This medicine may make you dizzy or drowsy. 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 not alert.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Also, there may be a greater risk of liver damage if you drink three or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages, and check with your doctor before taking any of these medicines while you are using this medicine.

Before you have any medical tests, tell the medical doctor in charge that you or your child are taking this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Acetaminophen Warnings

Acetaminophen is an active ingredient in hundreds of over-the-counter (OTC) and prescription medicines. It relieves pain and fever. And, it is also combined with other active ingredients in medicines that treat allergy, cough, colds, flu, and sleeplessness. In prescription medicines, acetaminophen is found with other active ingredients to treat moderate to severe pain. Acetaminophen can cause serious liver damage if more than directed is used.

One Fioricet pill contains 325mg acetaminophen. The max dosage of acetaminophen per day is 3000mg, but the most reliable amount should be 2000mg acetaminophen. It means you can take the max dosage of fioricet is six pills per day.

If you take other OTC medicines that contains acetaminophen, you must count the total amount of fioricet, never exceed the max dosage 2000mg.

Fioricet Drug Interactions

Severe Interactions

These medications are not usually taken together. Consult your healthcare professional (e.g., doctor or pharmacist) for more in formation.

• • • SEDATIVE HYPNOTICS; ALCOHOL/SODIUM OXYBATE
    • XANTHINE DERIVATIVES/DIPYRIDAMOLE INJECTABLE

Serious Interactions

These medications may interact and cause very harmful effects. Consult your healthcare professional (e.g., doctor or pharmacist) for more in formation.

• • • THEOPHYLLINE DERIVATIVES/CIMETIDINE
    • SELECTED ANTICONVULSANTS; BARBITURATES/CONTRACEPTIVES
    • STRONG CYP3A4 INDUCERS/ARIPIPRAZOLE LAUROXIL SUBMICRONIZED
    • SELECTED BARBITURATES/SELECTED ANTICONVULSANTS
    • SELECTED BARBITURATES/LAMOTRIGINE
    • SELECTED BARBITURATES/ESLICARBAZEPINE
    • SELECTED BARBITURATES/CARBAMAZEPINE
    • STRONG CYP3A4 INDUCERS/TRABECTEDIN
    • STRONG CYP3A4 INDUCERS/FLIBANSERIN
    • STRONG CYP3A4 INDUCERS/QUETIAPINE (> 150 MG)
    • STRONG CYP3A4 INDUCERS/TOLVAPTAN
    • STRONG CYP3A4 INDUCERS/SELECTED IMMUNOSUPPRESSANTS
    • ACETAMINOPHEN/SODIUM FUSIDATE
    • XANTHINE DERIVATIVES/ADENOSINE; HEXOBENDINE; REGADENOSON
    • BARBITURATES/METHOXYFLURANE
    • BARBITURATES/SELECTED ANTICOAGULANTS (VIT K ANTAGONISTS)

Moderate Interactions

These medications may cause some risk when taken together. Consult your healthcare professional (e.g., doctor or pharmacist) for more in formation.

• • • BARBITURATES; HYDANTOINS/QUINIDINE
    • THEOPHYLLINE DERIVATIVES/LITHIUM
    • SELECTED ANTICONVULSANTS/ESTROGENS
    • SELECTED XANTHINE DERIVATIVES/FLUVOXAMINE
    • ACETAMINOPHEN/ISONIAZID
    • BARBITURATES/PHENOTHIAZINES
    • BARBITURATES/RIFAMPIN
    • ACETAMINOPHEN/BUSULFAN
    • ACETAMINOPHEN/SELECTED ANTICOAGULANTS
    • STRONG CYP3A4 INDUCERS/SELECTED ANTIPSYCHOTICS
    • SELECTED ANTICONVULSANTS/FELODIPINE
    • BARBITURATES/METRONIDAZOLE
    • BARBITURATES; HYDANTOINS/THEOPHYLLINE
    • CYP3A4 INDUCERS/DOXYCYCLINE
    • SELECTED CYP3A4 INDUCERS/CORTICOSTEROIDS
    • BARBITURATES/SELECTED BETA-BLOCKERS

The CNS effects of butalbital may be enhanced by monoamine oxidase (MAO) inhibitors.

Butalbital, acetaminophen, and caffeine may enhance the effects of: other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression.

 

Overdose Signs and Symptoms

Toxicity from barbiturate poisoning include drowsiness, confusion, and coma; respiratory depression; hypotension; and hypovolemic shock.

In acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necroses, hypoglycemic coma, and thrombocytopenia may also occur. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis, and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion. In adults hepatic toxicity has rarely been reported with acute overdoses of less than 10 grams, or fatalities with less than 15 grams. Acute caffeine poisoning may cause insomnia, restlessness, tremor, and delirium, tachycardia and extrasystoles.

 

Fioricet Overdose Treatment

A single or multiple overdose with Fioricet is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended.

Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption. Vomiting should be induced mechanically, or with syrup of ipecac, if the patient is alert (adequate pharyngeal and laryngeal reflexes). Oral activated charcoal (1 g/kg) should follow gastric emptying. The first dose should be accompanied by an appropriate cathartic. If repeated doses are used, the cathartic might be included with alternate doses as required.

 

Hypotension is usually hypovolemic and should respond to fluids. Pressors should be avoided. A cuffed endotracheal tube should be inserted before gastric lavage of the unconscious patient and when necessary, to provide assisted respiration. If renal function is normal, forced diuresis may aid in the elimination of the barbiturate.

 

Alkalinization of the urine increases renal excretion of some barbiturates, especially phenobarbital. Meticulous attention should be given to maintaining adequate pulmonary ventilation. In severe cases of intoxication, peritoneal dialysis, or preferably hemodialysis may be considered.

 

If hypoprothrombinemia occurs due to acetaminophen overdose, vitamin K should be administered intravenously. If the dose of acetaminophen may have exceeded 140 mg/kg, acetylcysteine should be administered as early as possible. Serum acetaminophen levels should be obtained, since levels four or more hours following ingestion help predict acetaminophen toxicity.

 

Do not await acetaminophen assay results before initiating treatment. Hepatic enzymes should be obtained initially, and repeated at 24-hour intervals. Methemoglobinemia over 30% should be treated with methylene blue by slow intravenous administration.

 

Toxic Doses (for adults)

Butalbital:	toxic dose	1 g	(20 tablets)
Acetaminophen:	toxic dose	10 g	(30 tablets)
Caffeine:	toxic dose	1 g	(25 tablets)

In all cases of suspected overdosage, call your Regional Poison Control Center to obtain the most up-to-date information about the treatment of overdosage. Telephone numbers of certified Regional Poison Control Centers are listed in the Physicians’ Desk Reference®.

Fioricet Drug Active Ingrdients and Inactive Ingrdients

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.

For More fioricet side effect information, please check Fioricet side effects

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