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Important information about Fioricet

Do not use Fioricet if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Tell your doctor if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen. Do not take more Fioricet than is recommended. An overdose of acetaminophen can damage your liver or cause death. 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.

Avoid drinking alcohol. It may increase your risk of liver damage while taking Fioricet due to the acetaminophen component.

Before taking Fioricet

Do not use Fioricet if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Tell your doctor if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen. You should not take Fioricet if you are allergic to acetaminophen, butalbital, or caffeine, or if you have porphyria.

To make sure you can safely take Fioricet, tell your doctor if you have any of these other conditions:

• • kidney disease,
  • liver disease; or
  • a history of mental illness or suicidal thoughts.

Butalbital may be habit forming and should be used only by the person it was prescribed for. 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.

FDA pregnancy category C. It is not known whether Fioricet will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Acetaminophen, butalbital, and caffeine can pass into breast milk and may harm a nursing baby. Do not use Fioricet without telling your doctor if you are breast-feeding a baby.

Is Fioricet Addictive?

Although it’s only a prescription headache medication, Fioricet has the potential to cause addiction. If a person follows their prescription guidelines and uses the medication correctly, the risks of addiction are low. However, if someone takes too much Fioricet, they may develop tolerance to its effects. A person with tolerance to a certain dose of Fioricet will require higher doses of the medication to alleviate their headaches.

When a person with tolerance starts to take more Fioricet, possibly by obtaining more prescriptions, they may eventually become dependent on it. In other words, they may feel unable to get through the day without taking Fioricet, and if they stop, they will experience symptoms of withdrawal. These symptoms arise because their body has grown accustomed to Fioricet in high doses.

If a Fioricet-dependent person attempts to weather withdrawal alone, it’s likely they will take Fioricet again just to relieve the symptoms. This is a hallmark characteristic of addiction. Anyone who compulsively abuses Fioricet to avoid withdrawal likely has an addiction to Fioricet. Additionally, people with an addiction to Fioricet will experience cravings for the medication which further compel them to keeping using it.

Moreover, the ingredient butalbital is an addictive substance in its own right. Butalbital can cause someone to “get high” because it’s a central nervous system depressant. Since butalbital is part of Fioricet, it is possible for someone to abuse Fioricet as a recreational drug. At high doses, Fioricet can intoxicate a person in a manner similar to alcohol. People who abuse Fioricet for this purpose have as much of a risk of developing an addiction as they would have if they repeatedly use an illegal drug.

The Symptoms of Withdrawal

In most cases, Fioricet withdrawal lasts anywhere from 8 hours to three days after the last dose. Withdrawal is the biggest obstacle to overcoming dependence on Fioricet, which is why rehab centers provide detox programs so that people can safely undergo the withdrawal cycle without the risk of relapse. It is best to undergo withdrawal under medical supervision because some withdrawal symptoms are dangerous.

Rebound headaches are the most common symptoms of Fioricet withdrawal. Other symptoms of withdrawal include:

• • • Anxiety
    • Dizziness
    • Insomnia
    • Muscle spasms
    • Nausea and vomiting
    • Rapid emotional changes
    • Seizures (in rare cases)
    • Tremors
    • Weakness

Acetaminophen / butalbital / caffeine Pregnancy Warnings

Acetaminophen-butalbital-caffeine has been assigned to pregnancy category C by the FDA. Animal reproduction studies have not been conducted on this combination product. There are no controlled data in human pregnancy. Acetaminophen-butalbital-caffeine is only recommended for use during pregnancy when benefit outweighs risk.

Acetaminophen is routinely used for short term pain relief and fever in all stages of pregnancy. Acetaminophen is believed to be safe in pregnancy when used intermittently for short durations. Two cases of acetaminophen overdose in late pregnancy have been reported. In both cases neither the neonate nor the mother suffered hepatic toxicity. Investigations have revealed conflicting results with regards to the pharmacokinetic disposition of acetaminophen in pregnant women. One study has suggested that the oral clearance of acetaminophen is 58% higher and the elimination half-life is 28% longer in pregnant women compared to nonpregnant women. Another study has suggested that the elimination half-life is not different in patients who are pregnant. That study also suggested that the volume of distribution of acetaminophen may be higher in pregnant women. One study has suggested that acetaminophen in typical oral doses may result in a reduced production of prostacyclin in pregnant women. That study also suggested that acetaminophen does not affect thromboxane production. Barbiturates in general have been reported to readily cross the placental barrier. Withdrawal seizures have been reported in a two day old infant whose mother had taken a butalbital containing drug during the last two months of pregnancy. Butalbital was found in the infant’s serum. Animal reproduction studies have not been conducted on butalbital. Caffeine has been assigned to pregnancy category B by the FDA. Both human and animal studies on caffeine have failed to reveal evidence of significant mutagenic or carcinogenic effects. Caffeine crosses the placenta. Fetal blood and tissue levels in the fetus are similar to those in the mother. Caffeine has been reported to be an animal teratogen only with doses high enough to cause toxicity in the mother. In 1980, the Food and Drug Administration issued an advisory (based primarily on animal evidence) which stated that pregnant women should limit there intake of caffeine to a minimum. In a study of 2817 fertile women, no evidence of adverse effects from caffeine was found. The fecundability ratio (adjusted for known risk factors for time to conceive) was 1.03 between fertile women who consumed more than 7000 mg caffeine per month and those who consumed 500 mg or less per month. Furthermore, caffeine was not associated with infertility in 1818 infertile women and their primiparous controls. In another study (n=441) no evidence was found that moderate caffeine use increased the risk of spontaneous abortion, intrauterine growth retardation, or microcephaly.

Acetaminophen / butalbital / caffeine Breastfeeding Warnings

One small study has reported that following a 1000 mg dose of acetaminophen to nursing mothers, nursing infants receive less than 1.85% of the weight-adjusted maternal oral dose.

Acetaminophen is excreted into human milk in small concentrations. One case of a rash has been reported in a nursing infant. Acetaminophen is considered compatible with breast-feeding by the American Academy of Pediatrics. Barbiturates are excreted in breast milk in small amounts. The significance of the effects on nursing infants has not been reported.

Because of the potential for serious adverse reactions in nursing infants from butalbital, 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. Caffeine is excreted into human milk in small amounts. Adverse effects in the nursing infant are unlikely. However, irritability and poor sleep patterns have been reported in nursing infants. The amount of caffeine generally found in caffeinated beverages is considered to usually be compatible with breast-feeding by the American Academy of Pediatrics. Because caffeine is excreted into human milk and because caffeine is metabolized slowly by nursing infants, consumption of more than moderate levels of caffeine by nursing mothers is not recommended.

Fioricet side effects

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

Stop using Fioricet and call your doctor at once if you have any of these serious side effects:

• fast, pounding, or uneven heartbeat;
• feeling light-headed or short of breath;
• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms.

Less serious Fioricet side effects may include:

• • • drowsiness;
    • dizziness, confusion or lightheadedness;
    • dry mouth;
    • nausea, vomiting, stomach pain, loss of appetite;
    • feeling anxious or jittery;
    • drunk feeling; or
    • headache.

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?

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.

Tell your doctor about all other medicines you use, especially:

• • • an antibiotic;
    • a blood thinner such as warfarin (Coumadin, Jantoven);
    • isoniazid (for treating tuberculosis);
    • zidovudine (Retrovir, AZT);
    • seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton);
    • gout medications such as probenecid (Benemid) or sulfinpyrazone;
    • steroids such as prednisone, fluticasone (Advair), mometasone (Asmanex, Nasonex), dexamethasone (Decadron, Hexadrol) and others; or
    • an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Janimine, Tofranil), and others.

This list is not complete and other drugs may interact with Fioricet. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

What are the Symptoms of a Fioricet Overdose?

While butalbital is the addictive ingredient in Fioricet, acetaminophen is the ingredient which is liable to cause an overdose. Unfortunately, people who misuse Fioricet as a recreational drug or as a way to suppress withdrawal are most likely to suffer an overdose.

When a person overdoses on Fioricet, the acetaminophen will damage their liver. In severe cases, an overdose can even provoke fatal liver failure. For this reason, it is dangerous to take Fioricet together with another medication which contains acetaminophen because it increases the risk of overdose and death. Furthermore, drinking alcohol while taking Fioricet may also inflict liver damage.

A Fioricet overdose is a medical emergency, so it’s important to know the symptoms. An overdose on Fioricet and all other forms of liver failure cause jaundice, the yellowing of the skin and eyes. Other symptoms of an overdose include:

• • • Confusion
    • Convulsions and seizures
    • Fainting
    • Irregular heartbeat
    • Lack of appetite
    • Nausea and vomiting
    • Restlessness
    • Stomach pain
    • Sweating
    • Tremors

Adults and children of 12 years of age and older

• • • 50/325/40 mg tablets or capsules: Take 1 to 2 tablets by mouth every 4 hours. Maximum of 6 doses per day. Not to exceed 4000 mg of acetaminophen per day to avoid liver injury.
    • Dolgic Plus (50/750/40 mg): Take 1 tablet by mouth every 4 hours. Maximum of 5 tablets per day.
    • Alagesic LQ: Take 1 to 2 tablespoons (15-30 ml) by mouth every 4 hours. Maximum daily dose of 6 tablespoons (180 ml) per day.
    • Safe and effective use of butalbital/acetaminophen/caffeine is not established in children under 12 years of age.