Alprostadil

PROSTIN VR PEDIATRIC Sterile Solution is indicated for palliative, not definitive, therapy to temporarily maintain the patency of the ductus arteriosus until corrective or palliative surgery can be performed in neonates who have congenital heart defects and who depend upon the patent ductus for survival. Such congenital heart defects include pulmonary atresia, pulmonary stenosis, tricuspid atresia, tetralogy of Fallot, interruption of the aortic arch, coarctation of the aorta, or transposition of the great vessels with or without other defects. In infants with restricted pulmonary blood flow, the increase in blood oxygenation is inversely proportional to pretreatment pO 2 values, that is, patients with low pO 2 values respond best, and patients with pO 2 values of 40 torr or more usually have little response.

The preferred route of administration for PROSTIN VR PEDIATRIC Sterile Solution is continuous intravenous infusion into a large vein. Alternatively, PROSTIN VR PEDIATRIC may be administered through an umbilical artery catheter placed at the ductal opening. Increases in blood pO 2 (torr) have been the same in neonates who received the drug by either route of administration. Begin infusion with 0.05 to 0.1 micrograms alprostadil per kilogram of body weight per minute. A starting dose of 0.1 micrograms per kilogram of body weight per minute is the recommended starting dose based on clinical studies, however, adequate clinical response has been reported using a starting dose of 0.05 micrograms per kilogram of body weight per minute.

None.

WARNING Apnea is experienced by about 10 to 12% of neonates with congenital heart defects treated with PROSTIN VR PEDIATRIC Sterile Solution. Apnea is most often seen in neonates weighing less than 2 kg at birth and usually appears during the first hour of drug infusion. Therefore, respiratory status should be monitored throughout treatment, and PROSTIN VR PEDIATRIC should be used where ventilatory assistance is immediately available. See WARNING box. NOTE: PROSTIN VR PEDIATRIC Sterile Solution must be diluted before it is administered. See dilution instructions in DOSAGE AND ADMINISTRATION section. The administration of PROSTIN VR PEDIATRIC 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.

Central Nervous System Apnea has been reported in about 12% of the neonates treated. Other common adverse reactions reported have been fever in about 14% of the patients treated and seizures in about 4%. The following reactions have been reported in less than 1% of the patients: cerebral bleeding, hyperextension of the neck, hyperirritability, hypothermia, jitteriness, lethargy, and stiffness. Cardiovascular System The most common adverse reactions reported have been flushing in about 10% of patients (more common after intraarterial dosing), bradycardia in about 7%, hypotension in about 4%, tachycardia in about 3%, cardiac arrest in about 1%, and edema in about 1%.

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.

Store PROSTIN VR PEDIATRIC Sterile Solution in a refrigerator at 2° to 8°C (36° to 46°F).