General Precautions
Cortical proliferation of the long bones, first observed in dogs, has also been observed in infants during long-term infusions of alprostadil. The cortical proliferation in infants regressed after withdrawal of the drug.
In infants treated with PROSTIN VR PEDIATRIC at the usual doses for 10 hours to 12 days and who died of causes unrelated to ductus structural weakness, tissue sections of the ductus and pulmonary arteries have shown intimal lacerations, a decrease in medial muscularity and disruption of the medial and internal elastic lamina. Localized and aneurysmal dilatations and vessel wall edema also were seen compared to a series of pathological specimens from infants not treated with PROSTIN VR PEDIATRIC. The incidence of such structural alterations has not been defined.
Because alprostadil inhibits platelet aggregation, use PROSTIN VR PEDIATRIC cautiously in neonates with bleeding tendencies.
PROSTIN VR PEDIATRIC should not be used in neonates with respiratory distress syndrome. A differential diagnosis should be made between respiratory distress syndrome (hyaline membrane disease) and cyanotic heart disease (restricted pulmonary blood flow). If full diagnostic facilities are not immediately available, cyanosis (pO2 less than 40 torr) and restricted pulmonary blood flow apparent on an X-ray are appropriate indicators of congenital heart defects.
Necessary Monitoring
In all neonates, arterial pressure should be monitored intermittently by umbilical artery catheter, auscultation, or with a Doppler transducer. Should arterial pressure fall significantly, decrease the rate of infusion immediately.
In infants with restricted pulmonary blood flow, measure efficacy of PROSTIN VR PEDIATRIC by monitoring improvement in blood oxygenation. In infants with restricted systemic blood flow, measure efficacy by monitoring improvement of systemic blood pressure and blood pH.
Drug Interactions
No drug interactions have been reported between PROSTIN VR PEDIATRIC and the therapy standard in neonates with restricted pulmonary or systemic blood flow. Standard therapy includes antibiotics, such as penicillin and gentamicin; vasopressors, such as dopamine and isoproterenol; cardiac glycosides; and diuretics, such as furosemide.