INDICATIONS AND USAGE Alprostadil injection, USP 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.

Alprostadil injection, USP should be administered only by trained personnel in facilities that provide pediatric intensive care.

WARNINGS See WARNING box.

NOTE : Alprostadil injection must be diluted before it is administered.

See dilution instructions in DOSAGE AND ADMINISTRATION section.

The administration of alprostadil injection 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 alprostadil injection at recommended doses for more than 120 hours should be closely monitored for evidence of antral hyperplasia and gastric outlet obstruction.

Alprostadil injection 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 alprostadil injection should be weighed against the possible benefits that critically ill infants may derive from its administration.

ADVERSE REACTIONS Central Nervous System Apnea has been reported in about 12% of the neonates treated (see WARNING box).

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%.

The following reactions have been reported in less than 1% of the patients: congestive heart failure, hyperemia, second degree heart block, shock, spasm of the right ventricle infundibulum, supraventricular tachycardia, and ventricular fibrillation.

Respiratory System The following reactions have been reported in less than 1% of the patients: bradypnea, bronchial wheezing, hypercapnia, respiratory depression, respiratory distress, and tachypnea.

Gastrointestinal System See WARNINGS .

The most common adverse reaction reported has been diarrhea in about 2% of the patients.

The following reactions have been reported in less than 1% of the patients: gastric regurgitation, and hyperbilirubinemia.

Hematologic System The most common hematologic event reported has been disseminated intravascular coagulation in about 1% of the patients.

The following events have been reported in less than 1% of the patients: anemia, bleeding, and thrombocytopenia.

Excretory System Anuria and hematuria have been reported in less than 1% of the patients.

Skeletal System Cortical proliferation of the long bones has been reported (see PRECAUTIONS ).

Miscellaneous Sepsis has been reported in about 2% of the patients.

Peritonitis has been reported in less than 1% of the patients.

Hypokalemia has been reported in about 1%, and hypoglycemia and hyperkalemia have been reported in less than 1% of the patients.

To report SUSPECTED ADVERSE REACTIONS, contact Meitheal Pharmaceuticals, Inc.

at 1-844-824-8426 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .