BUTALBITALAND ACETAMINOPHEN (Systemic)?

Some commonly used brand names are:

In the U.S.?

• Amaphen ²
• Anolor-300 ²
• Anoquan ²
• Arcet ²
• Bancap ¹
• Bucet ¹
• Butace ²
• Conten ¹
• Dolmar ²
• Endolor ²
• Esgic ²
• Esgic-Plus ²
• Ezol ²
• Femcet ²
• Fioricet ²
• Isocet ²
• Medigesic ²
• Pacaps ²
• Pharmagesic ²
• Phrenilin ¹
• Phrenilin Forte ¹
• Repan ²
• Sedapap ¹
• Tencet ²
• Tencon ¹
• Triad ²
• Triaprin ¹
• Two-Dyne ²

? Not commercially available in Canada.

Category

• Analgesic

Description

Butalbital and acetaminophen (byoo-TAL-bi-tal and a-seat-a-MIN-oh-fen) combination is a pain reliever and relaxant. It is used to treat tensionheadaches. Butalbital belongs to the group of medicines called barbiturates (bar-BI-tyoo-rates).Barbiturates act in the central nervous system (CNS) to produce their effects.

When you take butalbital for a long time, your body may get used to itso that 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 butalbital and acetaminophen combinations also contain caffeine (KAF-een). 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 acetaminophen combination may also be used for other kindsof headaches or other kinds of pain as determined by your doctor.

Butalbital and acetaminophen combinations are available only with yourdoctor's prescription in the following dosage forms:

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

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 acetaminophencombinations, the following should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to butalbital or other barbiturates, or to acetaminophen,aspirin, or caffeine. Also tell your health care professional if you are allergicto any other substances, 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 breathing problems in the newborn baby if taken justbefore or during delivery.
• For acetaminophen: Although studies onbirth defects with acetaminophen have not been done in pregnant women, ithas not been reported to cause birth defects or other problems.
• For caffeine: Studies in humans have notshown that caffeine (contained in some of these combination medicines) causesbirth defects. However, use of large amounts of caffeine during pregnancymay cause problems with the heart rhythm and the growth of the fetus. Also,studies in animals have shown that caffeine causes birth defects when givenin very large doses (amounts equal to those present in 12 to 24 cups of coffeea day).

Breast-feeding?

• 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 acetaminophen: Although acetaminophenhas not been shown to cause problems in nursing babies, it passes into thebreast milk in small amounts.
• For caffeine: Caffeine (present in somebutalbital and acetaminophen combinations) passes into the breast milk insmall amounts. Taking caffeine in the amounts present in these medicines hasnot been shown to cause problems in nursing babies. However, studies haveshown that nursing babies may appear jittery and have trouble in sleepingwhen their mothers drink large amounts of caffeine-containing beverages. Therefore,breast-feeding mothers who use caffeine-containing medicines should probablylimit the amount of 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 acetaminophen: Acetaminophen has beentested in children and, in effective doses, has not been shown to cause differentside effects or problems than it does in adults.
• 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: Certain side effects,such as confusion, excitement, or mental depression, may be especially likelyto occur in elderly patients, who are usually more sensitive than youngeradults to the effects of the butalbital in this combination medicine.
• For acetaminophen: Acetaminophen has beentested and has not been shown to cause different side effects or problemsin older people than it does in younger adults.
• 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 acetaminophen combination, it is especially important thatyour health care professional know if you are taking any of the following:

• Anticoagulants (blood thinners), or
• 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

• 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

• Divalproex (e.g., Depakote) or
• Valproic acid (e.g., Depakene)?The chance of side effects maybe increased

Other medical problems?The presence of other medicalproblems may affect the use of butalbital and acetaminophen combinations.Make sure you 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; also, acetaminophen may cause liver damage in people who abusealcohol

• Asthma (or history of), emphysema, or other chronic lung diseaseor
• Hepatitis or other liver disease or
• Hyperactivity (in children) or
• Kidney disease?The chance of serious side effects may be increased

• Type 2 diabetes mellitus or
• Mental depression or
• Overactive thyroid or
• Porphyria (or history of)?Butalbital can make these conditionsworse

• Heart disease (severe)?The caffeine in some butalbital andacetaminophen combinations can make some kinds of heart disease worse

Proper Use of This Medicine

Take this medicine only as directed by your doctor. Do not take moreof it, do not take it more often, and do not take it for a longer time thanyour doctor ordered. If butalbital and acetaminophen combination is takenregularly (for example, every day), it may become habit-forming (causing mentalor physical dependence). The caffeine in some butalbital and acetaminophencombinations can also increase the chance of dependence. Dependence is especiallylikely to occur in patients who take these medicines to relieve frequent headaches.Taking too much of this medicine may also lead to liver damage or other medicalproblems.

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 acetaminophen 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 these medicines. If your dose is different, do not change it unless your doctor tellsyou to do so.

The number of capsules or tablets that you take depends on the strengthof the medicine.

• For oral dosage forms (capsules or tablets):
  • For tension headaches:
    • Adults?One or 2 capsules or tablets every four hours as needed.If your medicine contains 325 or 500 milligrams (mg) of acetaminophen in eachcapsule or tablet, you should not take more than six capsules or tablets aday. If your medicine contains 650 mg of acetaminophen in each capsule ortablet, you should not take more than four 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. Donot 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 taking this medicine. This is especially importantif a new headache occurs within 1 day after you took your last dose of thismedicine, headaches begin to occur every day, or a headache continues forseveral days in a row. This may mean that you are dependent on the medicine. Continuing to take this medicine will cause even moreheadaches later on. Your doctor can give you advice on how to relievethe headaches.

Check the labels of all nonprescription (over-the-counter[OTC]) or prescription medicines you now take. If any contain a barbiturateor acetaminophen, check with your health care professional. Takingthem together with this medicine may cause an 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; narcotics; other barbiturates;medicine for seizures; muscle relaxants; or anesthetics, including some dentalanesthetics. Also, drinking large amounts of alcoholic beverages regularlywhile taking this medicine may increase the chance of liver damage, especiallyif you take more of this medicine than your doctor ordered or if you takeit regularly for a long time. Therefore, do not drinkalcoholic beverages, and check with your doctor before taking any of the medicineslisted above, while you are using this 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 you have any medical tests, tell the person in charge that you aretaking this medicine. Caffeine (present in some butalbital and acetaminophencombinations) 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 othertests may also be affected by butalbital and acetaminophen combinations.

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 can occur if your medical doctor or dentistgives you certain medicines without knowing that you have taken butalbital.

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 taking it without first checking with your doctor.Your doctor may want you to reduce gradually the amount you are taking beforestopping completely in order 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 possibly death. Signs of butalbital overdose includesevere drowsiness, confusion, severe weakness, shortness of breath or unusuallyslow or troubled breathing, slurred speech, staggering, and unusually slowheartbeat. Signs of severe acetaminophen poisoning may not occur until 2 to4 days after the overdose is taken, but treatment to prevent liver damageor death must be started within 24 hours or less after the overdose is taken.

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.

Check with your doctorimmediately if any of the following side effects occur, especiallyif several of them occur together:

Rare

Bleeding or crusting sores on lips; chest pain; fever with or without chills; hive-like swellings (large) on eyelids, face, lips, and/or tongue; muscle cramps or pain; red, thickened, or scaly skin; shortness of breath,troubled breathing, tightness in chest, or wheezing; skin rash, itching, or hives; sores, ulcers, or whitespots in mouth (painful); sore throat

Symptoms of overdose

Anxiety, confusion, excitement, irritability, nervousness, restlessness,or trouble in sleeping (severe, especially with products containing caffeine); convulsions (seizures) (for products containingcaffeine); diarrhea, especially if occurring togetherwith increased sweating, loss of appetite, and stomach cramps or pain; 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); muscletrembling or twitching (for products containing caffeine); nausea or vomiting, sometimes with blood; ringingor other sounds in ears (for products containing caffeine); seeing flashes of ``zig-zag'' lights (for products containing caffeine); shortness of breath or unusually slow or troubled breathing; slow, fast, or irregular heartbeat; slurred speech; staggering; swelling, pain, or tenderness in the upper abdomen or stomach area; unusual movements of the eyes

Also, check with your doctoras soon as possible if any of the following side effects occur:

Less common

Confusion (mild); mental depression; unusual excitement (mild)

Rare

Bloody or black, tarry stools; bloodyurine; pinpoint red spots on skin; swollen or painful glands; unusual bleeding or bruising; unusual tiredness or weakness (mild)

Other side effects may occur that usually do not need medical attention.These side effects may go away during treatment as your body adjusts to themedicine. However, check with your doctor if any of the following side effectscontinue or are bothersome:

More common

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

Other sideeffects not listed above may also occur in some patients. If you notice anyother effects, check with your doctor.