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warnings
WARNINGS Drug Dependency: Prolonged use of barbiturates can produce drug dependence, characterized by psychic dependence, and less frequently, physical dependence and tolerance. The abuse liability of butalbital, aspirin, and caffeine is similar to that of other barbiturate-containing drug combinations. Caution should be exercised when prescribing medication for patients with a known propensity for taking excessive quantities of drugs, which is not uncommon in patients with chronic tension headache. Use in Ambulatory Patients: Butalbital, aspirin, and caffeine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a car or operating machinery. The patient should be cautioned accordingly. Central Nervous System depressant effects of butalbital may be additive with those of other CNS depressants. Concurrent use with other sedative-hypnotics or alcohol should be avoided. When such combined therapy is necessary, the dose of one or more agents may need to be reduced. Use in Pregnancy: Adequate studies have not been performed in animals to determine whether this drug affects fertility in males or females, has teratogenic potential, or has other adverse effects on the fetus. While there are no well-controlled studies in pregnant women, over twenty years of marketing and clinical experience does not include any positive evidence of adverse effects on the fetus. Although there is no clearly defined risk, such experience cannot exclude the possibility of infrequent or subtle damage to the human fetus. Butalbital, aspirin, and caffeine should be used in pregnant women only when clearly needed. Nursing Mothers : The effects of butalbital, aspirin, and caffeine on infants of nursing mothers are not known. Salicylates and barbiturates are excreted in the breast milk of nursing mothers. The serum levels in infants are believed to be insignificant with therapeutic doses.
ADVERSE REACTIONS The most frequent adverse reactions are drowsiness and dizziness. Less frequent adverse reactions are lightheadedness and gastrointestinal disturbances including nausea, vomiting, and flatulence. A single incidence of bone marrow suppression has been reported with the use of butalbital, aspirin, and caffeine. Several cases of dermatological reactions including toxic epidermal necrolysis and erythema multiforme have been reported.