Adult Dosing

• Not indicated in adults

Pediatric Dosing

Patency of ductus arteriosus

• Initial dose: 0.05-0.1 mcg/kg/min IV
• After a therapeutic response is achieved, use lowest effective dose by reducing the dosage from 0.1 to 0.05 to 0.025 to 0.01 mcg/kg/min
• Max: 0.4 mcg/kg/min

[Outline]

• Adult Dosing
• Pediatric Dosing

• Palliative therapy to maintain the patency of ductus arteriosus temporarily, until surgery can be performed, in neonates who have congenital heart defects (eg, pulmonary stenosis, tricuspid atresia, tetralogy of Fallot) and who depend upon the patent ductus arteriosus for survival

• Hypersensitivity to any of the ingredients of the product
• Respiratory distress syndrome

• 10-12% of neonates with congenital heart defects experience apnea with the use of alprostadil injection. Most commonly seen in neonates weighing <2 kg at birth and usually appears during the first hour of drug infusion; monitor respiratory status throughout treatment, and use alprostadil injections where ventilatory assistance is immediately available

Renal Dose Adjustment

• Renal impairment: No dose adjustments

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• Apnea may occur in neonates with the use of alprostadil injections, mostly seen in neonates <2 kg at birth and during the first hour of drug infusion; monitor respiratory status throughout the treatment [US Black Box Warning]
• Gastric outlet obstruction secondary to antral hyperplasia may occur, mostly related to cumulative dose and with duration of therapy; closely monitor for such events in neonates when receiving doses for more than 120 hrs
• Alprostadil should be infused for the shortest time and at the lowest dose that will produce the desired effects
• Use cautiously in neonates with bleeding tendencies because alprostadil inhibits platelet aggregation
• Contraindicated in neonates with respiratory distress syndrome
• Monitor arterial pressure at periodic intervals using umbilical artery catheter, auscultation, or with a Doppler transducer
• In infants with restricted pulmonary blood flow, measure efficacy of drug by monitoring improvement in blood oxygenation and in patients with restricted systemic blood flow, measure efficacy by monitoring improvement of systemic blood pressure and blood pH
• Cortical proliferation of the long bones may occur in infants during long-term infusions of alprostadil; this usually regresses after withdrawal of the drug
• Alprostadil injections should be administered only by trained personnel in facilities that provide pediatric intensive care; the sterile solution must be diluted before administration

Pregnancy Category: Not Applicable

Breastfeeding: Safety unknown.

• CNS: Apnea, seizures
• CV: Flushing, bradycardia, hypotension, tachycardia, ventricular fibrillation, cardiac arrest, heart block, shock
• RESP: Respiratory distress
• GI: Diarrhea, gastric outlet obstruction
• HEMA: Disseminated intravascular coagulation, bleeding, thrombocytopenia, anemia
• GU: Anuria, hematuria
• MUSC: Cortical proliferation of the long bones
• METABOLIC: Hypokalemia
• MISC: Fever, sepsis

• Ductus arteriosus patency adjuncts (prostaglandins); directly relaxes smooth muscle of the ductus arteriosus producing vasodilation
• Metabolized in lungs (80%)
• Excretion in urine
• Half-life: 5-10 min

US Trade Name(s)

• Prostin VR Pediatric

US Availability

alprostadil (generic)

• INJ: 0.5 mg/mL (1 mL vial)

Prostin VR Pediatric

• INJ: 0.5 mg/mL (1 mL amp)

Canadian Trade Name(s)

• Prostin VR

Canadian Availability

alprostadil (generic)

• INJ: 0.5 mg/mL

Prostin VR

• INJ: 0.5 mg/mL (1 mL amp)

UK Trade Name(s)

• Prostin VR

UK Availability

Prostin VR

• INJ: 0.5 mg/mL (1 mL amp)

Australian Trade Name(s)

• Prostin VR

Australian Availability

Prostin VR

• INJ: 0.5 mg/mL (1 mL amp)

[Outline]

Cardiovascular

Prostaglandin

Vasodilator