If you are:
Only When Necessary: CASE REPORT OF NEONATAL WITHDRAWAL SEIZURES WITH BUTALBITAL COMBO PRODUCT
FDB Contraindicated or Not Recommended: NO FDA CATEGORY; NOT RECOMMENDED ESPECIALLY IN 3RD TRIMESTER OR NEAR TERM
Only When Necessary: REPORTS OF MISCARRIAGE,POOR FETAL GROWTH POSSIBLY ASSOC W/HIGH DOSES OF CAFFEINE
Precaution: HIGH DOSES MAY CAUSE HYPERACTIVITY AND WAKEFULNESS IN INFANT.
Precaution: POSSIBILITY OF CENTRAL NERVOUS SYSTEM DEPRESSION IN NURSING INFANT.
Absolute Contraindication: ONE REPORT OF METABOLIC ACIDOSIS; RISK OF REYE'S SYND IN VIRAL ILLNESS.
An adult over 60:
management or monitoring precaution: Neuro/Psych-Avoid in elderly with insomnia due to CNS stimulation effects.
management or monitoring precaution: General-Not recommended in the elderly due to sedation which may predispose to falls. May exacerbate depression. Renal-Renal excretion may increase adverse events with renal impairment. Monitor renal function.
Giving Butalbital Compound tablet to a child under 12:
management or monitoring precaution: Adverse CNS effects of insomnia, restlessness, nervousness, and mild delirium, more severe in children.
Severe Precaution: Reye syndrome risk with viral illness, fever, and/or flu symptoms.
Severe Precaution: Safety and effectiveness not established age < 12 years.
management or monitoring precaution: Caution in: seizure disorder, cardiovascular disease, or in premature neonates with renal or hepatic impairment.