Fioricet should be prescribed with caution in certain special-risk patients, such as the elderly or debilitated, and those with severe impairment of renal or hepatic function, or acute abdominal conditions.
In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
No adequate studies have been conducted in animals to determine whether acetaminophen or butalbital have a potential for carcinogenesis, mutagenesis or impairment of fertility.
Pregnancy Category C
Animal reproduction studies have not been conducted with this combination product. It is also not known whether butalbital, acetaminophen and caffeine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product should be given to a pregnant woman only when clearly needed.
Withdrawal seizures were reported in a two-day-old male infant whose mother had taken a butalbitalcontaining drug during the last two months of pregnancy. Butalbital was found in the infant’s serum. The infant was given phenobarbital 5 mg/kg, which was tapered without further seizure or other withdrawal symptoms.
Caffeine, barbiturates and acetaminophen are excreted in breast milk in small amounts, but the significance of their effects on nursing infants is not known. Because of potential for serious adverse reactions in nursing infants from butalbital, acetaminophen and caffeine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Safety and effectiveness in pediatric patients below the age of 12 have not been established.
Clinical studies of butalbital, acetaminophen and caffeine capsules did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Butalbital is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
- 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.
- 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.
- 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).
- 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.
- Although acetaminophen has not been shown to cause problems in nursing babies, it passes into the breast milk in small amounts.
- 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.