Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 07 March 2017

Indication(s)

INDICATIONS AND USAGE PROSTIN VR PEDIATRIC Sterile Solution 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. In infants with restricted pulmonary blood flow, the increase in blood oxygenation is inversely proportional to pretreatment pO2 values; that is, patients with low pO2 values respond best, and patients with pO2 values of 40 torr or more usually have little response. PROSTIN VR PEDIATRIC should be administered only by trained personnel in facilities that provide pediatric intensive care.

Learning Zones

An epgonline.org Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.

Hereditary ATTR amyloidosis

Hereditary ATTR amyloidosis

Explore the pathophysiology, epidemiology and multi-system symptoms associated with hereditary ATTR amyloidosis, as well as how to achieve an early and accurate diagnosis.

EPNS 2019 Congress Highlights

EPNS 2019 Congress Highlights

The epgonline.org team is creating daily reports from the 13th European Paediatric Neurology Society (EPNS) Congress, held in Athens, Greece from 17th to 21st September 2019, to bring you coverage of cutting-edge science and advances in clinical care across all fields of paediatric neurology. 

Anticoagulation Therapy for Stroke Prevention

Anticoagulation Therapy for Stroke Prevention

Anticoagulation therapy for Stroke Prevention Learning Zone offers a deep-dive into atrial fibrillation causes, consequences, diagnosis and management to help you deliver optimal care and prevent strokes in patients living with this common arrhythmia.

Load more

Related Content

Advisory information

contraindications
CONTRAINDICATIONS None.
Special warnings and precautions
PRECAUTIONS General Precautions Cortical proliferation of the long bones, first observed in dogs, has also been observed in infants during long-term infusions of alprostadil. The cortical proliferation in infants regressed after withdrawal of the drug. In infants treated with PROSTIN VR PEDIATRIC at the usual doses for 10 hours to 12 days and who died of causes unrelated to ductus structural weakness, tissue sections of the ductus and pulmonary arteries have shown intimal lacerations, a decrease in medial muscularity and disruption of the medial and internal elastic lamina. Localized and aneurysmal dilatations and vessel wall edema also were seen compared to a series of pathological specimens from infants not treated with PROSTIN VR PEDIATRIC. The incidence of such structural alterations has not been defined. Because alprostadil inhibits platelet aggregation, use PROSTIN VR PEDIATRIC cautiously in neonates with bleeding tendencies. PROSTIN VR PEDIATRIC should not be used in neonates with respiratory distress syndrome. A differential diagnosis should be made between respiratory distress syndrome (hyaline membrane disease) and cyanotic heart disease (restricted pulmonary blood flow). If full diagnostic facilities are not immediately available, cyanosis (pO2 less than 40 torr) and restricted pulmonary blood flow apparent on an X-ray are appropriate indicators of congenital heart defects. Necessary Monitoring In all neonates, arterial pressure should be monitored intermittently by umbilical artery catheter, auscultation, or with a Doppler transducer. Should arterial pressure fall significantly, decrease the rate of infusion immediately. In infants with restricted pulmonary blood flow, measure efficacy of PROSTIN VR PEDIATRIC by monitoring improvement in blood oxygenation. In infants with restricted systemic blood flow, measure efficacy by monitoring improvement of systemic blood pressure and blood pH. Drug Interactions No drug interactions have been reported between PROSTIN VR PEDIATRIC and the therapy standard in neonates with restricted pulmonary or systemic blood flow. Standard therapy includes antibiotics, such as penicillin and gentamicin; vasopressors, such as dopamine and isoproterenol; cardiac glycosides; and diuretics, such as furosemide. Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term carcinogenicity studies and fertility studies have not been done. The Ames and Alkaline Elution assays reveal no potential for mutagenesis.
Adverse reactions
ADVERSE REACTIONS 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. The following events have been reported in less than 1% of the patients: anemia, bleeding, and thrombocytopenia. Excretory System Anuria and hematuria have been reported in less than 1% of the patients. Skeletal System Cortical proliferation of the long bones has been reported. See PRECAUTIONS. Miscellaneous Sepsis has been reported in about 2% of the patients. Peritonitis has been reported in less than 1% of the patients. Hypokalemia has been reported in about 1%, and hypoglycemia and hyperkalemia have been reported in less than 1% of the patients.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION The preferred route of administration for PROSTIN VR PEDIATRIC Sterile Solution is continuous intravenous infusion into a large vein. Alternatively, PROSTIN VR PEDIATRIC may be administered through an umbilical artery catheter placed at the ductal opening. Increases in blood pO2 (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 pO2 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 PROSTIN VR PEDIATRIC Sterile Solution with Sodium Chloride Injection USP or Dextrose Injection USP. Undiluted PROSTIN VR PEDIATRIC Sterile Solution may interact with the plastic sidewalls of volumetric infusion chambers causing a change in the appearance of the chamber and creating a hazy solution. Should this occur, the solution and the volumetric infusion chamber should be replaced. When using a volumetric infusion chamber, the appropriate amount of intravenous infusion solution should be added to the chamber first. The undiluted PROSTIN VR PEDIATRIC Sterile Solution should then be added to the intravenous infusion solution, avoiding direct contact of the undiluted solution with the walls of the volumetric infusion chamber. Dilute to volumes appropriate for the pump delivery system available. Prepare fresh infusion solutions every 24 hours. Discard any solution more than 24 hours old. Sample Dilutions and Infusion Rates to Provide a Dosage of 0.1 Micrograms per Kilogram of Body Weight per Minute Add 1 ampoule (500 micrograms) alprostadil to: Approximate Concentration of resulting solution (micrograms/mL) Infusion rate (mL/min per kg of body weight) Example: To provide 0.1 micrograms/kilogram of body weight per minute to an infant weighing 2.8 kilograms using a solution of 1 ampoule PROSTIN VR PEDIATRIC in 100 mL of saline or dextrose: INFUSION RATE = 0.02 mL/min per kg × 2.8 kg = 0.056 mL/min or 3.36 mL/hr. 250 mL 2 0.05 100 mL 5 0.02 50 mL 10 0.01 25 mL 20 0.005

Interactions

Drug Interactions No drug interactions have been reported between PROSTIN VR PEDIATRIC and the therapy standard in neonates with restricted pulmonary or systemic blood flow. Standard therapy includes antibiotics, such as penicillin and gentamicin; vasopressors, such as dopamine and isoproterenol; cardiac glycosides; and diuretics, such as furosemide.

More information

Category Value
Authorisation number NDA018484
Agency product number F5TD010360
Orphan designation No
Product NDC 0009-3169
Date Last Revised 17-08-2016
Type HUMAN PRESCRIPTION DRUG
RXCUI 237212
Storage and handling Store PROSTIN VR PEDIATRIC Sterile Solution in a refrigerator at 2° to 8°C (36° to 46°F).
Marketing authorisation holder Pharmacia and Upjohn Company LLC
Warnings WARNING Apnea is experienced by about 10 to 12% of neonates with congenital heart defects treated with PROSTIN VR PEDIATRIC Sterile Solution. 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 PROSTIN VR PEDIATRIC should be used where ventilatory assistance is immediately available.