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alprostadil IV (Rx)Brand and Other Names:Prostin VR Pediatric

 
 
 

Dosing & Uses

AdultPediatric

Not indicated

Dosage Forms & Strengths

IV solution

  • 500mcg/mL
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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

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Adverse 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

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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

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Pregnancy & 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.

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Pharmacology

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)

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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)

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Images

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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