PROSTIN VR PEDIATRIC

Clinical safety rating: caution

Comprehensive clinical and safety monograph for PROSTIN VR PEDIATRIC (PROSTIN VR PEDIATRIC).

How it works

Prostaglandin E1 (alprostadil) causes direct vasodilation of vascular smooth muscle and inhibits platelet aggregation. It also stimulates adenylate cyclase, increasing cAMP levels, leading to relaxation of vascular smooth muscle, particularly in the ductus arteriosus.

What the body does with it

Metabolism	Rapidly metabolized in the lungs via 15-hydroxy dehydrogenase; approximately 80% cleared in one pass through the pulmonary circulation. Metabolites are excreted primarily in urine.
Excretion	Primarily renal (≥80%) as metabolites after rapid enzymatic degradation; less than 1% excreted unchanged; biliary/fecal elimination is minor (<10%).
Half-life	Terminal elimination half-life is approximately 5–10 minutes for the parent compound (alprostadil); rapid inactivation by 15-hydroxyprostaglandin dehydrogenase in the lung; clinical effects persist for 1–2 hours due to active metabolites.
Protein binding	Approximately 80–90% bound to plasma albumin.
Volume of Distribution	Vd approximately 0.1–0.2 L/kg; suggests limited distribution, largely confined to vascular space.
Bioavailability	Not applicable by oral route (extensive first-pass metabolism); only available as continuous intravenous infusion; absorption from other routes is not clinically relevant.
Onset of Action	Intravenous infusion: vasodilation and ductus arteriosus patency achieved within 10–20 minutes of initiating continuous infusion.
Duration of Action	Duration of pharmacological effect is 1–2 hours after cessation of infusion, corresponding to washout of metabolites; continuous infusion is required to maintain ductus patency.

Classification & Brands

Dosing & administration

Prostin VR Pediatric (alprostadil) is not indicated for adult use. In neonates, the typical dose is 0.05-0.1 mcg/kg/min continuous IV infusion.

Dosage form	INJECTABLE
Renal impairment	No specific GFR-based dose adjustments are established; dose may need reduction in renal impairment due to potential hypotension, but no formal guidelines exist.
Liver impairment	No Child-Pugh based adjustments are established; use with caution in hepatic impairment due to limited metabolism data.
Pediatric use	Neonates: Initial 0.05-0.1 mcg/kg/min continuous IV infusion; titrate to lowest effective dose (range 0.01-0.4 mcg/kg/min).
Geriatric use	Not indicated for geriatric use; no specific dosing recommendations available.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for PROSTIN VR PEDIATRIC (PROSTIN VR PEDIATRIC).

Breastfeeding	No human data available. Prostaglandin E1 is rapidly metabolized; M/P ratio unknown. Caution is advised; consider risk-benefit.
Teratogenic Risk	Pregnancy Category C. First trimester: Increased risk of spontaneous abortion. Second/third trimesters: Prostaglandin E1 can stimulate uterine contractions, leading to premature labor, fetal distress, or abortion. Avoid use during pregnancy unless clearly needed.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

Apnea occurs in 10-12% of neonates, especially those weighing <2 kg, usually during the first hour of infusion. Respiratory status must be monitored, and ventilatory support should be readily available.

Side Effect Profile

Serious Effects

Absolute Contraindications

Respiratory distress syndrome; hyaline membrane disease; persistent fetal circulation (contraindicated if ductus arteriosus is not required for survival).

Clinical Precautions

Precautions

Monitor for apnea, hypotension, flushing, bradycardia, fever, seizures, cortical hyperostosis, and gastric outlet obstruction with long-term use. Use with caution in neonates with bleeding tendencies because of platelet inhibition.

Clinical Tips & Counseling

Drug interactions

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PROSTIN VR PEDIATRIC

Clinical safety rating: caution

Comprehensive clinical and safety monograph for PROSTIN VR PEDIATRIC (PROSTIN VR PEDIATRIC).

How it works

What the body does with it

Metabolism	Rapidly metabolized in the lungs via 15-hydroxy dehydrogenase; approximately 80% cleared in one pass through the pulmonary circulation. Metabolites are excreted primarily in urine.
Excretion	Primarily renal (≥80%) as metabolites after rapid enzymatic degradation; less than 1% excreted unchanged; biliary/fecal elimination is minor (<10%).
Half-life	Terminal elimination half-life is approximately 5–10 minutes for the parent compound (alprostadil); rapid inactivation by 15-hydroxyprostaglandin dehydrogenase in the lung; clinical effects persist for 1–2 hours due to active metabolites.
Protein binding	Approximately 80–90% bound to plasma albumin.
Volume of Distribution	Vd approximately 0.1–0.2 L/kg; suggests limited distribution, largely confined to vascular space.
Bioavailability	Not applicable by oral route (extensive first-pass metabolism); only available as continuous intravenous infusion; absorption from other routes is not clinically relevant.
Onset of Action	Intravenous infusion: vasodilation and ductus arteriosus patency achieved within 10–20 minutes of initiating continuous infusion.
Duration of Action	Duration of pharmacological effect is 1–2 hours after cessation of infusion, corresponding to washout of metabolites; continuous infusion is required to maintain ductus patency.

Classification & Brands

Dosing & administration

Prostin VR Pediatric (alprostadil) is not indicated for adult use. In neonates, the typical dose is 0.05-0.1 mcg/kg/min continuous IV infusion.

Dosage form	INJECTABLE
Renal impairment	No specific GFR-based dose adjustments are established; dose may need reduction in renal impairment due to potential hypotension, but no formal guidelines exist.
Liver impairment	No Child-Pugh based adjustments are established; use with caution in hepatic impairment due to limited metabolism data.
Pediatric use	Neonates: Initial 0.05-0.1 mcg/kg/min continuous IV infusion; titrate to lowest effective dose (range 0.01-0.4 mcg/kg/min).
Geriatric use	Not indicated for geriatric use; no specific dosing recommendations available.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for PROSTIN VR PEDIATRIC (PROSTIN VR PEDIATRIC).

Breastfeeding	No human data available. Prostaglandin E1 is rapidly metabolized; M/P ratio unknown. Caution is advised; consider risk-benefit.
Teratogenic Risk	Pregnancy Category C. First trimester: Increased risk of spontaneous abortion. Second/third trimesters: Prostaglandin E1 can stimulate uterine contractions, leading to premature labor, fetal distress, or abortion. Avoid use during pregnancy unless clearly needed.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

Side Effect Profile

Serious Effects

Absolute Contraindications

Respiratory distress syndrome; hyaline membrane disease; persistent fetal circulation (contraindicated if ductus arteriosus is not required for survival).