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|Butalbital Compound with Codeine

BARBITURATES, ASPIRIN, AND CODEINE (Systemic)

Some commonly used brand names are:

In the U.S.—

• Ascomp with Codeine No.3 ¹
• Butalbital Compound with Codeine ¹
• Butinal with Codeine No.3 ¹
• Fiorinal with Codeine No.3 ¹
• Idenal with Codeine ¹
• Isollyl with Codeine ¹

In Canada—

• Fiorinal-C 1/4 ¹
• Fiorinal-C 1/2 ¹
• Phenaphen with Codeine No.3 ²
• Tecnal-C 1/4 ¹
• Tecnal-C 1/2 ¹

Category

• Analgesic—Butalbital, Aspirin, Caffeine, and Codeine; Phenobarbital, Aspirin, and Codeine

‡ In Canada, Aspirin is a brand name. Acetylsalicylic acid is the generic name in Canada. ASA, a synonym for acetylsalicylic acid, is the term that commonly appears on Canadian product labels.

Description

Barbiturate (bar-BI-tyoo-rate) , aspirin, and codeine combinations are used to relieve headaches and other kinds of pain. These combination medicines may provide better pain relief than either aspirin or codeine used alone. In some cases, relief of pain may come at lower doses of each medicine.

Codeine is a narcotic analgesic (nar-KOT-ik an-al-JEE-zik) that acts in the central nervous system (CNS) to relieve pain. Many of its side effects are also caused by actions in the CNS. Butalbital and phenobarbital belong to the group of medicines called barbiturates. Barbiturates also act in the CNS to produce their effects.

When you use a barbiturate or codeine for a long time, your body may get used to the medicine so that larger amounts are needed to produce the same effects. This is called tolerance to the medicine. Also, barbiturates and codeine may become habit-forming (causing mental or physical dependence) when they are used for a long time or in large doses. Physical dependence may lead to withdrawal symptoms when you stop taking the medicine. In patients who get headaches, the first symptom of withdrawal may be new (rebound) headaches.

The butalbital, aspirin, and codeine combination also contains caffeine (kaf-EEN). Caffeine may help to relieve headaches. However, caffeine can also cause physical dependence when it is used for a long time. This may lead to withdrawal (rebound) headaches when you stop taking it.

Aspirin is not a narcotic and does not cause physical dependence. However, it may cause other unwanted effects if too much is taken.

These combination medicines are available only with your doctor"s prescription, in the following dosage forms:

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

Before Using This Medicine

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

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to aspirin or other salicylates including methyl salicylate (oil of wintergreen); butalbital, phenobarbital, or other barbiturates; caffeine; codeine; or any of the following 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 other substances, such as foods, preservatives, or dyes.

Pregnancy—

• For butalbital or phenobarbital : Barbiturates have been shown to increase the chance of birth defects in humans. Also, one study in humans has suggested that barbiturates taken during pregnancy may increase the chance of brain tumors in the baby. Barbiturates may cause breathing problems in the newborn baby if taken just before or during delivery.
• For aspirin : Although studies in humans have not shown that aspirin causes birth defects, aspirin has caused birth defects in animal studies.
  Do not take aspirin during the last 3 months of pregnancy unless it has been ordered by your doctor . Some reports have suggested that use of aspirin late in pregnancy may cause a decrease in the newborn"s weight and possible death of the fetus or newborn baby. However, the mothers in these reports had been taking much larger amounts of aspirin than are usually recommended. Studies of mothers taking aspirin in the doses that are usually recommended did not show these unwanted effects.
  There is a chance that regular use of aspirin late in pregnancy may cause unwanted effects on the heart or blood flow in the fetus or in the newborn baby. Also, use of aspirin during the last 2 weeks of pregnancy may cause bleeding problems in the fetus before or during delivery or in the newborn baby. In addition, too much use of aspirin during the last 3 months of pregnancy may increase the length of pregnancy, prolong labor, cause other problems during delivery, or cause severe bleeding in the mother before, during, or after delivery.
• For codeine : Although studies on birth defects with codeine have not been done in pregnant women, it has not been reported to cause birth defects. However, it may cause breathing problems in the newborn baby if taken just before or during delivery. Codeine did not cause birth defects in animal studies, but it caused slower development of bones and other harmful effects in the fetus.
• For caffeine : Studies in humans have not shown that caffeine causes birth defects. However, use of large amounts of caffeine during pregnancy may cause problems with the heart rhythm and the growth of the fetus. Also, studies in animals have shown that caffeine causes birth defects when given in very large doses (amounts equal to those in 12 to 24 cups of coffee a day).

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

• For butalbital or phenobarbital : Barbiturates pass 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 breast milk. However, taking aspirin in the amount present in these combination medicines has not been reported to cause problems in nursing babies.
• For codeine : Codeine passes into the breast milk in small amounts. However, it has not been reported to cause problems in nursing babies.
• For caffeine : The caffeine in the butalbital, aspirin, and codeine combination medicine passes into the breast milk in small amounts. Taking caffeine in the amounts present in this combination medicine has not been reported to cause problems in nursing babies. However, studies have shown that nursing babies may appear jittery when their mothers drink large amounts of caffeine-containing beverages. Therefore, breast-feeding mothers who use caffeine-containing medicines should probably limit the amount of caffeine they take in from other medicines or from beverages.

Children—

• For butalbital or phenobarbital : Although barbiturates often cause drowsiness, some children become excited after taking them.
• For aspirin: Do not give a medicine containing aspirin to a child with fever or other symptoms of a virus infection, especially flu or chickenpox, without first discussing its use with your child"s doctor . This is very important because aspirin may cause a serious illness called Reye"s syndrome in children with fever caused by a virus infection, especially flu or chickenpox. Children who do not have a virus infection may also be more sensitive to the effects of aspirin, especially if they have a 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 information comparing use of caffeine in children up to 12 years of age with use in other age groups. However, caffeine is not expected to cause different side effects or problems in children than it does in adults.

Older adults—

• For butalbital or phenobarbital : Confusion, depression, or excitement may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of barbiturates.
• For aspirin : Elderly patients are more sensitive than younger adults to the effects of aspirin. This may increase the chance of side effects during treatment.
• For codeine : Breathing problems may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of codeine.
• For caffeine : Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of caffeine in the elderly with use in other age groups.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this combination medicine, it is especially important that your health care professional know if you are taking any of the following:

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

• Anticoagulants (blood thinners) or
• Heparin—Use of these medicines together with aspirin may increase the chance of bleeding; also, barbiturates, especially phenobarbital, may decrease the effects of anticoagulants

• 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 cause drowsiness)—These medicines may add to the effects of barbiturates and codeine and increase the chance of drowsiness or other side effects

• Carbamazepine or
• Contraceptives, oral (birth control pills) containing estrogens or
• Corticosteroids (cortisone-like medicines) or
• Corticotropin (ACTH)—Barbiturates, especially phenobarbital, may make these medicines less effective

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

• Naltrexone (e.g., Trexan)—Naltrexone blocks the pain-relieving effect of codeine

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

Other medical problems—The presence of other medical problems may affect the use of butalbital, aspirin, and codeine combination. 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 barbiturates and/or codeine may develop

• Asthma, especially if occurring together with other allergies and nasal polyps (history of), or
• Brain disease or head injury or
• Colitis or
• Convulsions (seizures) (history of) or
• Emphysema or other chronic lung disease or
• Enlarged prostate or problems with urination or
• Gallbladder disease or gallstones 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)—Barbiturates can make these conditions worse

• Gout—Aspirin can make this condition worse and can also lessen the effects of some medicines used to treat gout

• Heart disease (severe)—The caffeine in the butalbital, aspirin, and codeine combination can make some kinds of heart disease worse

• Hemophilia or other bleeding problems or
• Vitamin K deficiency—Aspirin increases the chance of serious bleeding

• Stomach ulcer, especially with a history of bleeding, or other stomach problems—Aspirin can make your condition worse

Proper Use of This Medicine

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

Do not take this medicine if it has a strong vinegar-like odor . This odor means the aspirin in it is breaking down. If you have any 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 take it for a longer time than your doctor ordered. If a barbiturate or codeine is taken regularly (for example, every day), it may become habit-forming (causing mental or physical dependence). Regular use of caffeine can also cause physical dependence. Dependence is especially likely to occur in people who take these medicines to relieve frequent headaches. Also, taking too much of this combination medicine may cause stomach problems or 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 of a migraine, take this medicine as soon as you are sure that the migraine is coming. This may even stop the headache pain from occurring. Lying down in a quiet, dark room for a while after taking the medicine also helps to relieve headaches .

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

Dosing—The dose of these medicines will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

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

• For Butalbital, Aspirin, and Codeine combination
• For oral dosage forms (capsules and tablets):
  • For relieving pain:
    • 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.

• For Phenobarbital, Aspirin, and Codeine combination
• For oral dosage form (capsules):
  • For relieving pain:
    • Adults—One or 2 capsules every three or four hours as needed.
    • Children—Dose must be determined by your doctor.

Missed dose—If your doctor has ordered you to take this medicine according to a regular schedule and you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose 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 dangerous in 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 break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that 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 started using it. This may mean that you are in danger of becoming dependent on the medicine. Do not try to get better pain relief by increasing the dose .
• If you are having headaches more often than you did before you started using this medicine . This is especially important if a new headache occurs within 1 day after you took your last dose of headache medicine, headaches begin to occur every day, or a headache continues for several days in a row. This may mean that you are dependent on the headache medicine. Continuing to take this medicine will cause even more headaches later on . Your doctor can give you advice on how to relieve the headaches.

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

The barbiturate and the codeine in this medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; other barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Also, stomach problems may be more likely to occur if you drink alcoholic beverages while you are taking aspirin. Therefore, do not drink alcoholic beverages, and check with your doctor before taking any of the medicines listed above, while you are using this medicine .

This medicine may cause some people to become drowsy, dizzy, or lightheaded, or to feel a false sense of well-being. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert and clearheaded .

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Lying down for a while may relieve these effects.

Nausea or vomiting may occur, especially after the first couple of doses. This effect may go away if you lie down for a while. However, if nausea or vomiting continues, check with your doctor.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine. Serious side effects can occur if your medical doctor or dentist gives you certain medicines without knowing that you have taken a barbiturate or codeine.

Do not take this medicine for 5 days before any planned surgery, including dental 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 are taking this medicine. The caffeine in the butalbital, aspirin, and codeine combination interferes with the results of certain tests that use dipyridamole (e.g., Persantine) to help show how well blood is flowing to your heart. Caffeine should not be taken for 8 to 12 hours before the test. The results of some other tests may also be affected by this medicine.

If you have been taking large amounts of this medicine, or if you have been 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 before stopping completely, to lessen the chance of withdrawal side effects.

If you think you or anyone else may have taken an overdose of this medicine, get emergency help at once . Taking an overdose of this medicine or taking alcohol or CNS depressants with this medicine may lead to unconsciousness or death. Signs of overdose of this medicine include convulsions (seizures); hearing loss; confusion; ringing or buzzing in the ears; severe excitement, nervousness, or restlessness; severe dizziness; severe drowsiness; unusually slow 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 may need medical attention.

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 the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

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

Revised: 08/26/2002

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