Dosing and uses of Prostin VR Pediatric (alprostadil IV)
Adult dosage forms and strengths
Not indicated
Pediatric dosage forms and strengths
IV solution
- 500mcg/mL
Maintain Patency of Ductus Arteriosus
Neonates <28 days old: 0.05-0.1 mcg/kg/min IV initially; usual maintenance ranges from 0.01-0.4 mcg/kg/min
Preferably administer via large vein; alternatively, administer through umbilical artery catheter
Reduce infusion rate to provide lowest possible dosage that maintains response
Indicated for palliative therapy to temporarily maintain patency of ductus arteriosus until surgical correction in neonates with congenital heart defects (eg, pulmonary atresia, pulmonary stenosis, tricuspid atresia, tetralogy of Fallot, interruption of the aortic arch, coarctation of the aorta, transposition of the great vessels)
Beneficial for congenital defects that restrict pulmonary or systemic blood flow, and in neonates who depend on a patent ductus arteriosus for adequate oxygenation and lower body perfusion
Prostin VR Pediatric (alprostadil IV) adverse (side) effects
>10%
Fever (14%)
Apnea (12%)
1-10%
Bradycardia (7%)
Hypotension (4%)
Seizures (4%)
Tachycardia (3%)
Diarrhea (2%)
Sepsis (2%)
Cardiac arrest (1%)
Edema (1%)
Intravascular coagulation (1%)
Hypokalemia (1%)
<1%
Cerebral bleeding
Hyperextension of the neck
Hyperirritability
Hypothermia
Jitteriness
Lethargy
Stiffness
Congestive heart failure
Hyperemia
Second degree heart block
Shock
Spasm of the right ventricle infundibulum
Supraventricular tachycardia
Ventricular fibrillation
Bradypnea
Bronchial wheezing
Hypercapnia
Respiratory depression
Respiratory distress
Tachypnea
Gastric regurgitation
Hyperbilirubinemia
Anemia
Bleeding
Thrombocytopenia
Peritonitis
Hypoglycemia
Hyperkalemia
Warnings
Black box warnings
Apnea is experienced by about 10-12% of neonates with congenital heart defects treated with alprostadil injection
Apnea is most often seen in neonates weighing <2 kg at birth and usually appears during first hr of drug infusion
Monitor respiratory status throughout treatment
Used requires ventilatory assistance to be immediately available
Contraindications
None reported
Cautions
Adverse effects and toxicity include apnea, seizures, fever, hypotension, leukocytosis, and pulmonary overcirculation
Neonates usually are intubated prophylactically because of potential risk of apnea (10-12%)
Prolonged use occasionally is necessary (in hypoplastic left heart syndrome transplant candidates) and may be associated with third spacing of fluid
Monitor blood oxygenation and arterial pressure
Caution with concurrent use of antiplatelet drugs or anticoagulants
Pregnancy and lactation
Pregnancy category: X
Lactation: Not indicated for use in women
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Prostin VR Pediatric (alprostadil IV)
Half-Life: 5-10 min
Protein Bound: 81%
Metabolism: Chiefly in lungs via enzymatic oxidation (plasma levels may be higher with pulmonary disease)
Metabolites: prostanoid metabolites (inactive)
Excretion: urine (90%); small amount via lung
Mechanism of action
Relaxes arterial smooth muscle, producing vasodilation
Inhibits platelet aggregation (prostaglandin E1)
Administration
IV Preparation
IV infusion: Dilute 1 mL (ie, 500 mcg) with sodium chloride for injection or dextrose
Undiluted alprostadil solution may interact with plastic in volumetric infusion chambers resulting in a hazy solution (replace solution and volumetric infusion chamber if this occurs)
Place appropriate amount of intravenous infusion solution (ie, sodium chloride, dextrose) in chamber first, then add undiluted alprostadil solution (avoid direct contact with walls of volumetric infusion chamber)
Dilute to volumes appropriate for the pump delivery system available
Prepare fresh infusion solutions q24hr; discard any solution >24 hr old
IV Administration
Administer via large vein or through umbilical catheter
Administer IV injection via volumetric infusion pump
Storage
Store ampoules refrigerated at 2-8C (36-46F)
