pharmacopeia
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/api/v1/drug/alprostadil

Boxed warning

Apnea is experienced by about 10 to 12% of neonates with congenital heart defects treated with alprostadil injection. Apnea is most often seen in neonates weighing less than 2 kg at birth and usually appears during the first hour of drug infusion. Therefore, respiratory status should be monitored throughout treatment, and alprostadil injection should be used where ventilatory assistance is immediately available.

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Prostaglandin Receptor Agonists.

Prostaglandin Receptor

Indications

Sourced from openFDA
  • 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.

Contraindications

Sourced from openFDA
  • None.contraindicated

Dosage & administration

Sourced from openFDA

The preferred route of administration for alprostadil injection is continuous intravenous infusion into a large vein. Alternatively, alprostadil injection may be administered through an umbilical artery catheter placed at the ductal opening. Increases in blood pO 2 (torr) have been the same in neonates who received the drug by either route of administration. Begin infusion with 0.05 to 0.1 micrograms alprostadil per kilogram of body weight per minute. A starting dose of 0.1 micrograms per kilogram of body weight per minute is the recommended starting dose based on clinical studies; however, adequate clinical response has been reported using a starting dose of 0.05 micrograms per kilogram of body weight per minute. After a therapeutic response is achieved (increased pO 2 in infants with restricted pulmonary blood flow or increased systemic blood pressure and blood pH in infants with restricted systemic blood flow), reduce the infusion rate to provide the lowest possible dosage that maintains the response. This may be accomplished by reducing the dosage from 0.1 to 0.05 to 0.025 to 0.01 micrograms per kilogram of body weight per minute. If response to 0.05 micrograms per kilogram of body weight per minute is inadequate, dosage can be increased up to 0.4 micrograms per kilogram of body weight per minute although, in general, higher infusion rates do not produce greater effects. Dilution Instructions To prepare infusion solutions, dilute 1 mL of alprostadil injection with sodium chloride injection, USP or dextrose injection, USP.

Warnings & precautions

Sourced from openFDA

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

Sourced from openFDA

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.

Overdosage

Sourced from openFDA

Apnea, bradycardia, pyrexia, hypotension, and flushing may be signs of drug overdosage. If apnea or bradycardia occurs, discontinue the infusion, and provide appropriate medical treatment. Caution should be used in restarting the infusion. If pyrexia or hypotension occurs, reduce the infusion rate until these symptoms subside. Flushing is usually a result of incorrect intraarterial catheter placement, and the catheter should be repositioned.

Approval history

Sourced from openFDA
  • Oct 16, 1981NDANDA018484Pfizer
  • Jul 6, 1995NDANDA020379Pfizer
  • Jun 12, 1997NDANDA020649Endo Operations
  • Apr 30, 1999ANDAANDA075196Meitheal
  • Jun 11, 2002NDANDA021212Pfizer

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
3,565 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective88025%
  2. 2Off Label Use1524.3%
  3. 3Erection Increased1363.8%
  4. 4Erectile Dysfunction932.6%
  5. 5Injection Site Pain922.6%
  6. 6Product Quality Issue922.6%
  7. 7Penile Pain872.4%
  8. 8Pyrexia852.4%
  9. 9Haemoglobin Decreased832.3%
  10. 10Pain812.3%
  11. 11Priapism812.3%
  12. 12Lymphocyte Count Decreased792.2%
  13. 13Diarrhoea772.2%
  14. 14Cardiac Failure732.0%
  15. 15Drug Effect Decreased732.0%

Literature

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Recent PubMed references pinned to Alprostadil as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 211 ClinicalTrials.gov registrations naming Alprostadil as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Alprostadil work?
Mechanism-of-action class: Prostaglandin Receptor Agonists.
What is Alprostadil used for?
According to FDA labeling, Alprostadil carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Alprostadil?
Alprostadil is classified as Drugs used in erectile dysfunction, Prostaglandins, Prostaglandin Analog, Prostaglandin E1 Agonist, Prostaglandin Receptor Agonists, Decreased Blood Pressure, Decreased Platelet Aggregation, Genitourinary Arterial Vasodilation, Venous Vasodilation.
What are the brand names for Alprostadil?
Alprostadil is marketed under brand names including Caverject, Edex, Muse, Prostin VR.
What are the contraindications for Alprostadil?
Alprostadil labeling lists contraindications including: None.. Always consult the full prescribing information and a clinician.
Note. Data for alprostadil is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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