home > drugs a-z list > prostin vr pediatric (alprostadil) drug center > prostin vr pediatric (alprostadil) drug - warnings and precautions

Prostin VR Pediatric Sterile Solution: See BOXED WARNING.

NOTE: Prostin VR Pediatric (alprostadil) Sterile Solution must be diluted before it is administered. See DOSAGE AND ADMINISTRATION, Dilution Instructions.

The administration of Prostin VR Pediatric (alprostadil) to neonates may result in gastric outlet obstruction secondary to antral hyperplasia. This effect appears to be related to duration of therapy and cumulative dose of the drug. Neonates receiving Prostin VR Pediatric (alprostadil) ar recommended doses for more than 120 hours should be closely monitored for evidence of antral hyperplasia and gastric outlet obstruction.

Prostin VR Pediatric (alprostadil) should be infused for the shortest time and at the lowest dose that will produce the desired effects. The risks of long-term infusion of Prostin VR Pediatric (alprostadil) should be weighed against the possible benefits that critically ill infants may derive from its administration.

Prostin VR Pediatric (alprostadil) Sterile Solution

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 (alprostadil) 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 (alprostadil) . The incidence of such structural alterations has not been defined.

Because alprostadil inhibits platelet aggregation, use Prostin VR Pediatric (alprostadil) cautiously in neonates with bleeding tendencies.

Prostin VR Pediatric (alprostadil) 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 (alprostadil) 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.

Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term carcinogenicity studies and fertility studies have not been done. The Ames and Alkaline Elution assays reveal no potential for mutagenesis.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.