Generic Fioricet
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Fioricet and Esgic is 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.
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. 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 a half-life of about 35 hours. Acetaminophen has a half-life of about 1.25 to 3 hours, but may be increased by liver damage and after an overdose. Caffeine has a half-life of about 3 hours.
Generic Name: acetaminophen, butalbital, and caffeine (a SEET a MIN oh fen, bue TAL bi tal, and KAF een); Brand Names: Alagesic, Anolor 300, Dolgic LQ, Dolgic Plus, Esgic, Esgic-Plus, Fioricet, Geone, Margesic, Medigesic, Repan, Zebutal. 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.
Important information about Fioricet
Do not use Fioricet 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 Fioricet before the MAO inhibitor has cleared from your body.
Do not take more Fioricet than is recommended. An overdose of acetaminophen can cause damage to your liver. Do not use any other cold, allergy, pain, or sleep medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as “APAP”) is contained in many combination medicines. If you use certain products together with Fioricet you may accidentally use too much acetaminophen. Read the label of any other medicine you are using to see if it contains acetaminophen or APAP. 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 Fioricet?
Butalbital may be habit-forming and should be used only by the person it was prescribed for. Fioricet 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 Fioricet 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 Fioricet if you are allergic to acetaminophen, butalbital, or caffeine, or if you have porphyria. Before using Fioricet, 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 conditions, you may need a dose adjustment or special tests to safely take Fioricet.
FDA pregnancy category C. It is not known whether Fioricet is harmful to an unborn baby. Before taking Fioricet, 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 Fioricet without telling your doctor if you are breast-feeding a baby.
How should I take Fioricet?
Take Fioricet 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 Fioricet 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 Fioricet 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 should I avoid while taking Fioricet?
Fioricet 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 cold, allergy, pain, or sleep medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as “APAP”) is contained in many combination medicines. If you use certain products together you may accidentally use too much acetaminophen. Read the label of any other medicine you are using to see if it contains acetaminophen or APAP. While you are taking Fioricet, avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor’s advice.
Butalbital Abuse and Dependence
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.
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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.
