What are considerations of dosing for children?
No adequate well controlled studies have been conducted in pediatric patients; however, safety and effectiveness of pentobarbital in pediatric patients is supported by numerous studies and case reports cited in the literature. Pediatric dosing information for NEMBUTAL is described in the DOSAGE and ADMINISTRATION section.

What are considerations of Nembutal® use for pregnant patients?
Nembutal is a Pregnancy Category D. It has teratogenic effects. Barbiturates can cause fetal damaged when administered to pregnant woman. Retrospective, case controlled studies have suggested a connection between the maternal consumption of barbiturates and a higher than expected incidence of fetal abnormalities. Following oral and parental administration, barbiturates readily cross the placental barrier and are distributed throughout fetal tissues with the highest concentrations found in the placenta, fetal liver and brain. Fetal blood levels approach maternal blood levels following parenteral administration. Withdrawal symptoms occur in infants born to mothers who receive barbiturates through the last trimester of pregnancy (see Drug Abuse and Dependence Section of Prescribing Information).

What are considerations of dosing for elderly patients?
Clinical studies of Nembutal have not included sufficient numbers of the subjects aged 65 and over to determine whether elderly subjects 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 patients 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.

Elderly patients may react to barbiturates with marked excitement, depression, and confusion. In some persons, barbiturates repeatedly produce excitement rather than depression. Dosage should be reduced in the elderly because these patients may be more sensitive to barbiturates.