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Generic Name
Alprostadil
Brand Names
Prostin, Caverject, Edex
FDA approval date: October 16, 1981
Classification: Prostaglandin Analog
Form: Injection
What is Prostin (Alprostadil)?
CAVERJECT is a prostaglandin E1 agonist indicated For the treatment of erectile dysfunction.
Approved To Treat
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Brand Information
PROSTIN (alprostadil)
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.
1DESCRIPTION
PROSTIN VR PEDIATRIC Sterile Solution for intravascular infusion contains 500 micrograms alprostadil, more commonly known as prostaglandin E
The chemical name for alprostadil is (11α,13E,15S)-11,15 dihydroxy-9-oxo-prost-13-en-1-oic acid, and the molecular weight is 354.49.
Alprostadil is a white to off-white crystalline powder with a melting point between 110° and 116°C. Its solubility at 35°C is 8000 micrograms per 100 mL double distilled water.
Structural Formula
2CLINICAL PHARMACOLOGY
Alprostadil (prostaglandin E
Smooth muscle of the ductus arteriosus is especially sensitive to alprostadil, and strips of lamb ductus markedly relax in the presence of the drug. In addition, administration of alprostadil reopened the closing ductus of new-born rats, rabbits, and lambs. These observations led to the investigation of alprostadil in infants who had congenital defects which restricted the pulmonary or systemic blood flow and who depended on a patent ductus arteriosus for adequate blood oxygenation and lower body perfusion.
In infants with restricted pulmonary blood flow, about 50% responded to alprostadil infusion with at least a 10 torr increase in blood pO
In infants with restricted systemic blood flow, alprostadil often increased pH in those having acidosis, increased systemic blood pressure, and decreased the ratio of pulmonary artery pressure to aortic pressure.
Alprostadil must be infused continuously because it is very rapidly metabolized. As much as 80% of the circulating alprostadil may be metabolized in one pass through the lungs, primarily by β- and ω- oxidation. The metabolites are excreted primarily by the kidney, and excretion is essentially complete within 24 hours after administration. No unchanged alprostadil has been found in the urine, and there is no evidence of tissue retention of alprostadil or its metabolites.
3INDICATIONS 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 pO
PROSTIN VR PEDIATRIC should be administered only by trained personnel in facilities that provide pediatric intensive care.
4CONTRAINDICATIONS
None.
5WARNINGS
See
NOTE: PROSTIN VR PEDIATRIC Sterile Solution must be diluted before it is administered. See dilution instructions in DOSAGE AND ADMINISTRATION section.
The administration of PROSTIN VR PEDIATRIC 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 PROSTIN VR PEDIATRIC at recommended doses for more than 120 hours should be closely monitored for evidence of antral hyperplasia and gastric outlet obstruction.
PROSTIN VR PEDIATRIC 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 PROSTIN VR PEDIATRIC should be weighed against the possible benefits that critically ill infants may derive from its administration.
6OVERDOSAGE
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.
7DOSAGE 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 pO
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
7.1Dilution 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.
8HOW SUPPLIED
PROSTIN VR PEDIATRIC Sterile Solution is available in a package of 5 ×1 mL ampoules (NDC 0009-0215-05). Each mL contains 500 micrograms alprostadil in dehydrated alcohol.
9PRINCIPAL DISPLAY PANEL - 1 mL Ampoule Label
NDC 0009-0215-01
Prostin VR Pediatric
For Intravenous Use Only.
1 mL
500 mcg/mL
Refrigerate at 2° to 8°C (36° to 46°F).
Distributed by Pharmacia & Upjohn Co
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PAA190991
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10PRINCIPAL DISPLAY PANEL - 1 mL Ampoule Package
NDC 0009-0215-05
Prostin VR Pediatric
500 mcg/mL
5—1 mL Ampoules
For Intravenous Use Only.
Rx ONLY
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