BUTALBITALAND ASPIRIN (Systemic)

Some commonly used brand names are:

In the U.S.?

• Axotal ¹
• Butalgen ²
• Fiorgen ²
• Fiorinal ²
• Fiormor ²
• Fortabs ²
• Isobutal ²
• Isobutyl ²
• Isolin ²
• Isollyl ²
• Laniroif ²
• Lanorinal ²
• Marnal ²
• Vibutal ²

In Canada?

• Fiorinal ²
• Tecnal ²

Other commonly used names for the butalbital, aspirin,and caffeine combination medicine are butalbital-AC and butalbital compound.

Category

• Analgesic

Description

Butalbital and aspirin combination is a pain reliever andrelaxant. It is used to treat tension headaches. Butalbital belongs to thegroup of medicines called barbiturates . Barbiturates act in the central nervoussystem (CNS) to produce their effects.

When you use butalbital for a long time, your body may get used to it sothat larger amounts are needed to produce the same effects. This is calledtolerance to the medicine. Also, butalbital may become habit-forming (causingmental or physical dependence) when it is used for a long time or in largedoses. Physical dependence may lead to withdrawal side effects when you stoptaking the medicine. In patients who get headaches, the first symptom of withdrawalmay be new (rebound) headaches.

Some of these medicines also contain caffeine. Caffeine may help to relieveheadaches. However, caffeine can also cause physical dependence when it isused for a long time. This may lead to withdrawal (rebound) headaches whenyou stop taking it.

Butalbital and aspirin combination is sometimes also used for other kindsof headaches or other kinds of pain, as determined by your doctor.

Butalbital and aspirin combination is available only with your doctor'sprescription, in the following dosage forms:

Oral
• Butalbital and Aspirin
  • Tablets (U.S.)
• Butalbital, Aspirin, and Caffeine
  • Capsules (U.S. and Canada)
  • Tablets (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For butalbital and aspirincombinations, the following should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to butalbital or other barbiturates; aspirin or other salicylates,including methyl salicylate (oil of wintergreen); caffeine; or any of thefollowing medicines:

• Diclofenac (e.g., Voltaren)
• Diflunisal (e.g., Dolobid)
• Etodolac (e.g., Lodine)
• Fenoprofen (e.g., Nalfon)
• Floctafenine (e.g., Idarac)
• Flurbiprofen, oral (e.g., Ansaid)
• Ibuprofen (e.g., Motrin)
• Indomethacin (e.g., Indocin)
• Ketoprofen (e.g., Orudis)
• Ketorolac (e.g., Toradol)
• Meclofenamate (e.g., Meclomen)
• Mefenamic acid (e.g., Ponstel)
• Nabumetone (e.g., Relafen)
• Naproxen (e.g., Naprosyn)
• Oxaprozin (e.g., Daypro)
• Oxyphenbutazone (e.g., Tandearil)
• Phenylbutazone (e.g., Butazolidin)
• Piroxicam (e.g., Feldene)
• Sulindac (e.g., Clinoril)
• Suprofen (e.g., Suprol)
• Tenoxicam (e.g., Mobiflex)
• Tiaprofenic acid (e.g., Surgam)
• Tolmetin (e.g., Tolectin)
• Zomepirac (e.g., Zomax)

Also tell your health care professional if you are allergic to any othersubstances, such as foods, preservatives, or dyes.

Pregnancy?

• For butalbital: Barbiturates such as butalbitalhave been shown to increase the chance of birth defects in humans. Also, onestudy in humans has suggested that barbiturates taken during pregnancy mayincrease the chance of brain tumors in the baby. Butalbital may cause breathingproblems in the newborn baby if taken just before or during delivery.
• For aspirin: Although studies in humanshave not shown that aspirin causes birth defects, it has caused birth defectsin animal studies.
  Do not take aspirin during the last 3 months of pregnancyunless it has been ordered by your doctor. Some reports have suggestedthat use of aspirin late in pregnancy may cause a decrease in the newborn'sweight and possible death of the fetus or newborn baby. However, the mothersin these reports had been taking much larger amounts of aspirin than are usuallyrecommended. Studies of mothers taking aspirin in the doses that are usuallyrecommended did not show these unwanted effects.
  There is a chance that regular use of aspirin late in pregnancy may causeunwanted effects on the heart or blood flow in the fetus or in the newbornbaby. Also, use of aspirin during the last 2 weeks of pregnancy may causebleeding problems in the fetus before or during delivery or in the newbornbaby. In addition, too much use of aspirin during the last 3 months of pregnancymay increase the length of pregnancy, prolong labor, cause other problemsduring delivery, or cause severe bleeding in the mother before, during, orafter delivery.
• For caffeine: Studies in humans have notshown that caffeine causes birth defects. However, use of large amounts ofcaffeine during pregnancy may cause problems with the heart rhythm and thegrowth of the fetus. Also, studies in animals have shown that caffeine causesbirth defects when given in very large doses (amounts equal to the amountin 12 to 24 cups of coffee a day).

Breast-feeding?Although this combination medicine has not beenreported to cause problems, the chance always exists, especially if the medicineis taken for a long time or in large amounts.

• For butalbital: Barbiturates such as butalbitalpass into the breast milk and may cause drowsiness, unusually slow heartbeat,shortness of breath, or troubled breathing in nursing babies.
• For aspirin: Aspirin passes into the breastmilk. However, taking aspirin in the amounts present in these combinationmedicines has not been reported to cause problems in nursing babies.
• For caffeine: The caffeine in some ofthese combination medicines passes into the breast milk in small amounts.Taking caffeine in the amounts present in these medicines has not been reportedto cause problems in nursing babies. However, studies have shown that nursingbabies may appear jittery and have trouble in sleeping when their mothersdrink large amounts of caffeine-containing beverages. Therefore, breast-feedingmothers who use caffeine-containing medicines should probably limit the amountof caffeine they take in from other medicines or from beverages.

Children?

• For butalbital: Although barbituratessuch as butalbital often cause drowsiness, some children become excited aftertaking them.
• For aspirin: Do not give a medicine containingaspirin to a child with fever or other symptoms of a virus infection, especiallyflu or chickenpox, without first discussing its use with your child's doctor. This is very important because aspirin may cause a serious illnesscalled Reye's syndrome in children with fever caused by a virus infection,especially flu or chickenpox. Children who do not have a virus infection mayalso be more sensitive to the effects of aspirin, especially if they havea fever or have lost large amounts of body fluid because of vomiting, diarrhea,or sweating. This may increase the chance of side effects during treatment.
• For caffeine: There is no specific informationcomparing use of caffeine in children up to 12 years of age with use in otherage groups. However, caffeine is not expected to cause different side effectsor problems in children than it does in adults.

Older adults?

• For butalbital: Confusion, depression,or excitement may be especially likely to occur in elderly patients, who areusually more sensitive than younger adults to the effects of butalbital.
• For aspirin: Elderly patients are moresensitive than younger adults to the effects of aspirin. This may increasethe chance of side effects during treatment.
• For caffeine: Many medicines have notbeen studied specifically in older people. Therefore, it may not be knownwhether they work exactly the same way they do in younger adults or if theycause different side effects or problems in older people. There is no specificinformation comparing use of caffeine in the elderly with use in other agegroups.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takinga butalbital and aspirin combination, it is especially important that yourhealth care professional know if you are taking any of the following:

• Antacids, large amounts taken regularly, especially calcium- and/ormagnesium-containing antacids or sodium bicarbonate (baking soda), or
• Urinary alkalizers (medicine that makes the urine less acid, suchas acetazolamide [e.g., Diamox], dichlorphenamide [e.g., Daranide], methazolamide[e.g., Neptazane], potassium or sodium citrate and/or citric acid)?Thesemedicines may cause aspirin to be removed from the body faster than usual,which may shorten the time that aspirin is effective; acetazolamide, dichlorphenamide,and methazolamide may also increase the chance of side effects when takentogether with aspirin

• Anticoagulants (blood thinners) or
• Heparin?Use of these medicines together with aspirin may increasethe chance of bleeding; also, butalbital may cause anticoagulants to be lesseffective

• Antidepressants, tricyclic (amitriptyline [e.g., Elavil], amoxapine[e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Pertofrane],doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g.,Aventyl], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil])or
• Central nervous system (CNS) depressants (medicines that often causedrowsiness)?These medicines may add to the effects of butalbital andincrease the chance of drowsiness or other side effects

• Carbamazepine (e.g., Tegretol) or
• Contraceptives, oral (birth control pills), containing estrogen or
• Corticosteroids (cortisone-like medicines) or
• Corticotropin (e.g., ACTH)?Butalbital may make these medicinesless effective

• Divalproex (e.g., Depakote) or
• Methotrexate (e.g., Folex, Mexate) or
• Valproic acid (e.g., Depakene) or
• Vancomycin (e.g., Vancocin)?The chance of serious side effectsmay be increased

• Probenecid (e.g., Benemid) or
• Sulfinpyrazone (e.g., Anturane)?Aspirin can keep these medicinesfrom working properly for treating gout

Other medical problems?The presence of other medicalproblems may affect the use of butalbital and aspirin combinations. Make sureyou tell your doctor if you have any other medical problems, especially:

• Alcohol abuse (or history of) or
• Drug abuse or dependence (or history of)?Dependence on butalbitalmay develop

• Asthma, especially if occurring together with other allergies andnasal polyps (or history of), or
• Emphysema or other chronic lung disease or
• Hyperactivity (in children) or
• Kidney disease or
• Liver disease?The chance of serious side effects may be increased

• Diabetes mellitus (sugar diabetes) or
• Mental depression or
• Overactive thyroid or
• Porphyria (or history of)?Butalbital may make these conditionsworse

• Gout?Aspirin can make this condition worse and can also lessenthe effects of some medicines used to treat gout

• Heart disease (severe)?The caffeine in some of these combinationmedicines can make some kinds of heart disease worse

• Hemophilia or other bleeding problems or
• Vitamin K deficiency?Aspirin increases the chance of seriousbleeding

• Stomach ulcer, especially with a history of bleeding, or other stomachproblems?Aspirin can make your condition worse

Proper Use of This Medicine

Take this medicine with food or a full glass (8 ounces) of water tolessen stomach irritation.

Do not take this medicine if it has a strong vinegar-likeodor. This odor means the aspirin in it is breaking down. If you haveany questions about this, check with your health care professional.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not takeit for a longer time than your doctor ordered. If butalbital and aspirin combinationis taken regularly (for example, every day), it may become habit-forming (causingmental or physical dependence). The caffeine in some butalbital and aspirincombinations can also increase the chance of dependence. Dependence is especiallylikely to occur in patients who take this medicine to relieve frequent headaches.Taking too much of this combination medicine can also lead to stomach problemsor to other medical problems.

This medicine will relieve a headache best if you take it as soon as the headache begins. If you get warning signs ofa migraine, take this medicine as soon as you are sure that the migraine iscoming. This may even stop the headache pain from occurring. Lying down in a quiet, dark room for a while after taking the medicine alsohelps to relieve headaches.

People who get a lot of headaches may need to take a different medicineto help prevent headaches. It is important that you followyour doctor's directions about taking the other medicine, even if your headachescontinue to occur. Headache-preventing medicines may take several weeksto start working. Even after they do start working, your headaches may notgo away completely. However, your headaches should occur less often, and theyshould be less severe and easier to relieve than before. This will reducethe amount of headache relievers that you need. If you do not notice any improvementafter several weeks of headache-preventing treatment, check with your doctor.

Dosing?The dose of butalbital and aspirin combinationmedicines will be different for different patients. Follow your doctor's orders or the directions on the label. The followinginformation includes only the average doses of the medicine. If your dose is different, do not change it unless your doctor tellsyou to do so.

For Butalbital and Aspirin combination
• For oral dosage form (tablets):
  • For tension headaches:
    • Adults?One tablet every four hours as needed. You should nottake more than six tablets a day.
    • Children?Dose must be determined by your doctor.

For Butalbital, Aspirin, and Caffeine combination
• For oral dosage forms (capsules or tablets):
  • For tension headaches:
    • Adults?One or 2 capsules or tablets every four hours as needed.You should not take more than six capsules or tablets a day.
    • Children?Dose must be determined by your doctor.

Missed dose?If your doctor has ordered you to take this medicineaccording to a regular schedule and you miss a dose, take it as soon as youremember. However, if it is almost time for your next dose, skip the misseddose and go back to your regular dosing schedule. Do not double doses.

Storage?To store this medicine:

• Keep out of the reach of children. Overdose is especially dangerousin young children.
• Store away from heat and direct light.
• Do not store this medicine in the bathroom, near the kitchen sink,or in other damp places. Heat or moisture may cause the medicine to breakdown.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Check with your doctor:

• If the medicine stops working as well as it did when you first startedusing it. This may mean that you are in danger of becoming dependent on themedicine. Do not try to get better pain relief by increasingthe dose.
• If you are having headaches more often than youdid before you started using this medicine. This is especially importantif a new headache occurs within 1 day after you took your last dose of headachemedicine, headaches begin to occur every day, or a headache continues forseveral days in a row. This may mean that you are dependent on the headachemedicine. Continuing to take this medicine will causeeven more headaches later on. Your doctor can give you advice on howto relieve the headaches.

Check the labels of all nonprescription (over-the-counter[OTC]) and prescription medicines you now take. If any contain a barbiturate,aspirin, or other salicylates, including diflunisal, check with your healthcare professional. Taking them together with this medicine may causean overdose.

The butalbital in this medicine will add to the effects of alcohol andother CNS depressants (medicines that slow down the nervous system, possiblycausing drowsiness). Some examples of CNS depressants are antihistamines ormedicine for hay fever, other allergies, or colds; sedatives, tranquilizers,or sleeping medicine; other prescription pain medicine or narcotics; otherbarbiturates; medicine for seizures; muscle relaxants; or anesthetics, includingsome dental anesthetics. Also, stomach problems may be more likely to occurif you drink alcoholic beverages while you are taking aspirin. Therefore, do not drink alcoholic beverages, and check with yourdoctor before taking any of the medicines listed above, while you are usingthis medicine.

This medicine may cause some people to become drowsy, dizzy, or lightheaded. Make sure you know how you react to this medicine beforeyou drive, use machines, or do anything else that could be dangerous if youare dizzy or are not alert and clearheaded.

Before having any kind of surgery (including dental surgery) or emergencytreatment, tell the medical doctor or dentist in charge that you are takingthis medicine. Serious side effects may occur if your medical doctor or dentistgives you certain other medicines without knowing that you have taken butalbital.

Do not take this medicine for 5 days before any planned surgery, includingdental surgery, unless otherwise directed by your medical doctor or dentist.Taking aspirin during this time may cause bleeding problems.

Before you have any medical tests, tell the person in charge that you aretaking this medicine. Caffeine (present in some butalbital and aspirin combinations)interferes with the results of certain tests that use dipyridamole (e.g.,Persantine) to help show how well blood is flowing to your heart. Caffeineshould not be taken for 8 to 12 hours before the test. The results of someother tests may also be affected by butalbital and aspirin combinations.

If you have been taking large amounts of this medicine, or if you havebeen taking it regularly for several weeks or more, do not suddenly stop using it without first checking with your doctor.Your doctor may want you to reduce gradually the amount you are taking beforestopping completely, to lessen the chance of withdrawal side effects.

If you think you or anyone else may have taken an overdoseof this medicine, get emergency help at once. Taking an overdose ofthis medicine or taking alcohol or CNS depressants with this medicine maylead to unconsciousness or death. Symptoms of overdose of this medicine includeconvulsions (seizures); hearing loss; confusion; ringing or buzzing in theears; severe excitement, nervousness, or restlessness; severe dizziness; severedrowsiness; shortness of breath or troubled breathing; and severe weakness.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects.Although not all of these side effects may occur, if they do occur they mayneed medical attention.

The following side effectsmay mean that a serious allergic reaction is occurring. Check with your doctoror get emergency help immediately if they occur, especially if severalof them occur at the same time.

Less common or rare

Bluish discoloration or flushing or redness of skin (occurringtogether with other effects listed in this section); coughing, shortness of breath, troubled breathing, tightness in chest, orwheezing; difficulty in swallowing; dizziness or feeling faint (severe); hive-like swellings (large) on eyelids, face, lips, or tongue; skin rash, itching, or hives; stuffynose (occurring together with other effects listed in this section)

Also check with your doctor immediately if any of the following sideeffects occur, especially if several of them occur together:

Rare

Bleeding or crusting sores on lips; chest pain; fever with or without chills; red, thickened, or scaly skin; sores,ulcers, or white spots in mouth (painful); sore throat(unexplained); tenderness, burning, or peeling ofskin

Symptoms of overdose

Anxiety, confusion, excitement, irritability, nervousness, restlessness,or trouble in sleeping (severe, especially with products containing caffeine); convulsions (seizures, with products containingcaffeine); diarrhea (severe or continuing); dizziness, lightheadedness, drowsiness, or weakness (severe); frequent urination (for products containing caffeine); hallucinations (seeing, hearing, or feeling thingsthat are not there); increased sensitivity to touchor pain (for products containing caffeine); increasedthirst; muscle trembling or twitching (for productscontaining caffeine); nausea or vomiting (severeor continuing), sometimes with blood; ringing orbuzzing in ears (continuing) or hearing loss; seeingflashes of ``zig-zag'' lights (for products containing caffeine); slow, fast, or irregular heartbeat; slow, fast, irregular, or troubled breathing; slurredspeech; staggering; stomachpain (severe); uncontrollable flapping movementsof the hands, especially in elderly patients; unusualmovements of the eyes; vision problems

Also, checkwith your doctor as soon as possible if any of the following side effectsoccur:

Less common or rare

Bloody or black, tarry stools; bloodyurine; confusion or mental depression; muscle cramps or pain; pinpoint redspots on skin; swollen or painful glands; unusual bleeding or bruising; unusualexcitement (mild)

Other side effects may occur that usually donot need medical attention. These side effects may go away during treatmentas your body adjusts to the medicine. However, check with your doctor if anyof the following side effects continue or are bothersome:

More common

Bloated or ``gassy'' feeling; dizzinessor lightheadedness (mild); drowsiness (mild); heartburn or indigestion; nausea, vomiting,or stomach pain (occurring without other symptoms of overdose)

Other side effects not listed abovemay also occur in some patients. If you notice any other effects, check withyour doctor.