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Prostin VR Pediatric

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Prostin VR Pediatric

Prostin VR Pediatric

INDICATIONS

Prostin VR Pediatric (alprostadil) Sterile Solution

Prostin VR Pediatric (alprostadil) 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 pO2values; 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 (alprostadil) should be administered only by trained personnel in facilities that provide pediatric intensive care.

DOSAGE AND ADMINISTRATION

Prostin VR Pediatric (alprostadil) Sterile Solution

The preferred route of administration for Prostin VR Pediatric (alprostadil) Sterile Solution is continuous intravenous infusion into a large vein. Alternatively, Prostin VR Pediatric (alprostadil) may be administered through an umbilical artery catheter placed at the ductal opening. Increases in blood pO2have 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 (alprostadil) Sterile Solution with Sodium Chloride Injection USP or Dextrose Injection USP. Undiluted Prostin VR Pediatric (alprostadil) 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, 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 ( TABLE 3).

TABLE 3 - 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)
250 ml 2 0.05
100 ml 5 0.02
50 ml 10 0.01
25 ml 20 0.005

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 (alprostadil) in 100 ml of saline or dextrose:

INFUSION RATE = 0.02 ml/min per kg X 2.8 kg = 0.056 ml/min or 3.36 ml/hr.

HOW SUPPLIED

Prostin VR Pediatric (alprostadil) Sterile Solution

Prostin VR Pediatric (alprostadil) Sterile Solution is available in packages of 5-1 ml ampoules . Each ml contains 500 micrograms alprostadil in dehydrated alcohol.

Store Prostin VR Pediatric (alprostadil) Sterile Solution in a refrigerator at 2-8°C (36-46°F).

Pharmacia & Upjohn Company, A subsidiary of Pharmacia Corporation
Kalamazoo, MI 49001, USA
Revised August 2002

Caverject:
Manufactured for:
Pharmacia & Upjohn Company
Kalamazoo, MI 49001, USA
By:
Pharmacia & Upjohn (Perth) Pty Limited
Bentley, WA 6102, Australia
817 587 102
Revised March 1999

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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