Butalbital, Acetaminophen, Caffeine, and Codeine (Systemic)

Brand Names : Fioricet with Codeine

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, acetaminophen, caffeine, and codeine combination, 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, caffeine, or codeine. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy -

• 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 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 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.

Breast-feeding -

• 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 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 codeine : Codeine passes into the breast milk in small amounts. However, it has not been reported to cause problems in nursing babies.

Children -

• 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.

Older 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.
• 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.

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 butalbital, acetaminophen, caffeine, and codeine 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 or codeine 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
• Naltrexone (e.g., Trexan) - Naltrexone blocks the pain-relieving effect of codeine

Other medical problems - The presence of other medical problems may affect the use of butalbital, acetaminophen, caffeine, 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 butalbital and codeine may develop; also, acetaminophen may cause liver damage in people who abuse alcohol

• Asthma (or history of), emphysema, or other chronic lung disease 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
• 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 can make some kinds of heart disease worse