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What is aspirin/butalbital/caffeine?
Aspirin is a pain reliever, as well as an anti-inflammatory and a fever reducer. Butalbital is in a class of drugs called barbiturates that slow down your central nervous system (brain and nerve impulses) and cause relaxation. Caffeine is believed to constrict dilated blood vessels (veins and arteries) that may contribute to tension headaches. Aspirin/butalbital/caffeine is used to relieve complex tension headaches, although precisely how it works is unknown. Aspirin/butalbital/caffeine may also be used for purposes other than those listed in this medication guide.

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What are the possible side effects of aspirin/butalbital/caffeine?

If you experience any of the following serious side effects, stop taking aspirin/butalbital/caffeine and seek emergency medical attention:

• an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);

• slow, weak breathing;

• severe weakness or dizziness; or

• black, bloody, or tarry stools or blood in your urine or vomit.

Other, less serious side effects may be more likely to occur. Continue to take aspirin/butalbital/caffeine and talk to your doctor if you experience

• dry mouth, nausea, vomiting, or decreased appetite;

• dizziness, tiredness, or lightheadedness; or

• ringing in your ears.

Butalbital may be habit forming.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

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How should I take aspirin/butalbital/caffeine?
Take aspirin/butalbital/caffeine exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you. Take each dose with a full glass of water. Take aspirin/butalbital/caffeine with food or milk if it upsets your stomach. Never take more of this medication than is prescribed for you. Too much aspirin/butalbital/caffeine could be very harmful. Never take more than six tablets or capsules per day. Do not share this medication with anyone else.

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What is the most important information I should know about aspirin/butalbital/caffeine?
Use caution when driving, operating machinery, or performing other hazardous activities. Butalbital may cause drowsiness or dizziness. If you experience drowsiness or dizziness, avoid these activities. Avoid alcohol. Alcohol taken during therapy with aspirin/butalbital/caffeine can increase the risk of stomach bleeding and can increase drowsiness and dizziness. Never take more aspirin/butalbital/caffeine than is prescribed for you. If your pain is not being adequately treated, talk to your doctor.

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What happens if I miss a dose?
Take the missed dose as soon as you remember. Do not take a double dose of this medication. Wait the prescribed amount of time before taking your next dose.

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What other drugs will affect aspirin/butalbital/caffeine?
Do not take aspirin/butalbital/caffeine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. Dangerous sedation could result. Aspirin/butalbital/caffeine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), pain relievers, anxiety medicines, and muscle relaxants. Tell your doctor about all medicines that you are taking, and do not take any medicine unless your doctor approves.

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Can I take this if I am pregnant or trying to get pregnant or if I am breastfeeding?

Aspirin has not been formally assigned to a pregnancy category by the FDA. The frequency of fetal exposure to aspirin reported in many studies may be underestimated because aspirin (and other salicylates) occur in many over-the-counter preparations and women may fail to recall taking aspirin and over-the-counter drugs. NSAID use during the third trimester of pregnancy should be avoided due to effects on the fetal cardiovascular system (closure of the ductus arteriosus). Aspirin use in pregnancy has been associated with alterations in both maternal and fetal hemostasis. In addition, high doses have been associated with increased perinatal mortality, intrauterine growth retardation, and teratogenic effects. Aspirin should only be given during pregnancy when benefit outweighs risk. Increased maternal bleeding can occur during delivery when aspirin is used 1 week prior to and/or during labor and delivery. Prolonged gestation and labor have been reported due to aspirin's inhibition of prostaglandin. Butalbital has been assigned to pregnancy category C by the FDA. 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. There are no controlled data in human pregnancy. Butalbital should be used during pregnancy only if the potential benefit justifies the potential risk to the infant. Caffeine has been assigned to pregnancy category B by the FDA. Both human and animal studies 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. Aspirin-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 on this combination product in human pregnancy. Aspirin-butalbital-caffeine should only be given during pregnancy when need has been clearly established.

A study of the use of low-dose aspirin (60 mg per day) to prevent and treat preeclampsia in 9364 pregnant women (the Collaborative Low-dose Aspirin Study in Pregnancy--CLASP) did "not support routine prophylactic or therapeutic administration of antiplatelet therapy in pregnancy to all women at increased risk of preeclampsia or IUGR." In that study, no excess of intraventricular hemorrhage, neonatal bleeds, or mortality attributable to bleeding were observed. The investigators did identify a possible role for low-dose aspirin in the treatment of early-onset preeclampsia severe enough to need very preterm delivery. Another study of low-dose aspirin (follow-up from the Italian Study of Aspirin in Pregnancy) has suggested that "low dose aspirin in pregnancy is safe with respect to the risks of malformation and of major impairment in development at 18 months of age." High-dose aspirin (2 g per day) has been associated with stillbirths, cerebral hemorrhage, oculoauriculovertebral dysplasia, neonatal salicylate toxicity, constricted ductus arteriosus, cyclopia, and neonatal acidosis. Some cases of congenital heart defects have been reported. However, a case control study of aspirin use in the first trimester concluded that aspirin "does not increase the risk of congenital heart defects in relation to that of other structural malformations." 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.

Aspirin is excreted into human milk in small amounts. Peak milk salicylate levels have been reported at nine hours after maternal dosing (and measured at 1.1 mg/dL). Use of large doses of aspirin can result in rashes, platelet abnormalities, and bleeding in nursing infants. Because of a single case report of metabolic acidosis, the American Academy of Pediatrics characterizes aspirin as a drug that has been "associated with significant effects on some nursing infants and should be given to nursing mothers with caution." 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.

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What does my medication look like?
Aspirin/butalbital/caffeine is available with a prescription generically and under the brand name Fiorinal. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you. Aspirin/butalbital/caffeine strengths are as follows: Fiorinal 325 mg/50 mg/40 mg--white, round tablets Fiorinal 325 mg/50 mg/40 mg-dark green and lime green capsules

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What happens if I overdose?
Seek emergency medical attention. Symptoms of an aspirin/butalbital/caffeine overdose include slow breathing, seizures, dizziness, weakness, loss of consciousness, coma, confusion, tiredness, cold and clammy skin, fast heartbeat, small pupils, nausea, vomiting, ringing in your ears, and sweating.

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What should I discuss with my healthcare provider before taking aspirin/butalbital/caffeine?
Do not take aspirin/butalbital/caffeine without first talking to your doctor if you drink more than three alcoholic beverages per day, if you have a stomach ulcer, if you have a bleeding or platelet disorder, or if you have recently had surgery. Before taking this medication, tell your doctor if you have kidney disease; liver disease; porphyria; asthma or another respiratory disease; fluid retention; congestive heart disease or another type of heart disease; or high blood pressure. You may not be able to take aspirin/butalbital/caffeine, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.

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Can I stop taking the medication if I feel better?
If you are taking an analgesic for pain and you are no longer experiencing the pain you may stop using the medication. In general, pain medications are to be used on an as needed basis.

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I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

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