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Gastrointestinal (Heartburn, Reflux, Vomiting)
* indicates generic
Proper Use of This Medicine
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 butalbital and acetaminophen combination is taken regularly (for example, every day), it may become habit-forming (causing mental or physical dependence). The caffeine in some butalbital and acetaminophen combinations can also increase the chance of dependence. Dependence is especially likely 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 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.
The dose of butalbital and acetaminophen combination 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 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 each capsule or tablet, you should not take more than six capsules or tablets a day. If your medicine contains 650 mg of acetaminophen in each capsule or tablet, you should not take more than four capsules or tablets a day.
- Children Dose must be determined by your doctor.
- For tension headaches:
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.
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.
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 butalbital and acetaminophen combinations, the following should be considered:
Allergies Tell your doctor if you have ever had any unusual or allergic reaction to butalbital or other barbiturates, or to acetaminophen, aspirin, or caffeine. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.
- For butalbital: Barbiturates such as butalbital 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.Butalbital may cause breathing problems in the newborn baby if taken just before or during delivery.
- For acetaminophen: Although studies on birth defects with acetaminophen have not been done in pregnant women, it has not been reported to cause birth defects or other problems.
- For caffeine: Studies in humans have not shown that caffeine (contained in some of these combination medicines) 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 present in 12 to 24 cups of coffee a day).
- For butalbital: Barbiturates such as butalbital pass into the breast milk and may cause drowsiness, unusually slow heartbeat, shortness of breath, or troubled breathing in nursing babies.
- For acetaminophen: Although acetaminophen has not been shown to cause problems in nursing babies, it passes into the breast milk in small amounts.
- For caffeine: Caffeine (present in some butalbital and acetaminophen combinations) passes into the breast milk in small amounts. Taking caffeine in the amounts present in these medicines has not been shown to cause problems in nursing babies. However, studies have shown that nursing babies may appear jittery and have trouble in sleeping 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.
- For butalbital: Although barbiturates such as butalbital often cause drowsiness, some children become excited after taking them.
- For acetaminophen: Acetaminophen has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.
- 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.
- For butalbital: Certain side effects, such as confusion, excitement, or mental depression, may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of the butalbital in this combination medicine.
- For acetaminophen: Acetaminophen has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.
- 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 a butalbital and acetaminophen combination, it is especially important that your 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 medicines less 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 cause drowsiness) These medicines may add to the effects of butalbital and increase the chance of drowsiness or other side effects
- Divalproex (e.g., Depakote) or
- Valproic acid (e.g., Depakene) The chance of side effects may be increased
- Alcohol abuse (or history of) or
- Drug abuse or dependence (or history of) Dependence on butalbital may develop; also, acetaminophen may cause liver damage in people who abuse alcohol
- Asthma (or history of), emphysema, or other chronic lung disease or
- Hepatitis or other liver disease or
- Hyperactivity (in children) or
- Kidney 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 can make these conditions worse
- Heart disease (severe) The caffeine in some butalbital and acetaminophen combinations can make some kinds of heart disease worse