Prostin VR Pediatric Sterile Solution

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 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 should be administered only by trained personnel in facilities that provide pediatric intensive care.

Caverject

Caverject is indicated for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology.

Intracavernosal Caverject may be a useful adjunct to other diagnostic tests in the diagnosis of erectile dysfunction.

Prostin VR Pediatric Sterile Solution

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 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 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, 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

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 X 2.8 kg = 0.056 ml/min or 3.36 ml/hr.

Caverject

The dose of alprostadil should be individualized for each patient by careful titration under supervision by the physician. In clinical studies, patients were treated with alprostadil in doses ranging from 0.2 to 140 micrograms; however, since 99% of patients received doses of 60 micrograms or less are not recommended. In general, the lowest possible effective dose should always be employed. In clinical studies, over 80% of patients experienced an erection sufficient for sexual intercourse after intracavernosal injection of alprostadil. A 1/2 inch, 27- to 30-gauge needle is generally recommended.

Initial Titration in Physician's Office: Erectile Dysfunction of Vasculogenic, Psychogenic, or Mixed Etiology. Dosage titration should be initiated at 2.5 micrograms of alprostadil. If there is a partial response, the dose may be increased by 2.5 micrograms, depending upon erectile response, until the dose that produces an erection suitable for intercourse and not exceeding a duration of 1 hour is reached. If there is no response to the initial 2.5-microgram dose, the second dose may be increased to 7.5 micrograms, followed by increments of 5 to 10 micrograms. The patient must stay in the physician's office until complete detumescence occurs. If there is no response, then the next higher dose should be given within 1 hour. If there is a response, then there should be at least a 1-day interval before the next dose is given.

Erectile Dysfunction of Pure Neurogenic Etiology (Spinal Cord Injury): Dosage titration should initiated at 1.25 micrograms of alprostadil. The dose may be increased by 1.25 micrograms to a dose of 2.5 micrograms, followed by an increment of 2.5 micrograms to a dose of 5 micrograms, and then in 5-microgram increments until the dose that produces an erection suitable for intercourse and not exceeding a duration of 1 hour is reached. The patient must stay in the physician's office until complete detumescence occurs. If there is no response, then the next higher dose may be given within 1 hour. If there is a response, then there should be at least a 1-day interval before the next dose is given.

The majority of patients (56%) in one clinical study involving 579 patients were titrated to doses of greater than 5 micrograms but less than or equal to 20 micrograms. The mean dose at the end of the titration phase was 17.8 micrograms of alprostadil.

Maintenance Therapy: The first injections of alprostadil must be done at the physician's office by medically trained personnel. Self-injection therapy by the patient can be started only after the patient is properly instructed and well trained in the self-injection technique. The physician should make a careful assessment of the patient's skills and competence with this procedure. This intracavernosal injection must be done under sterile conditions. The site of injection is usually along the dorso-lateral aspect of the proximal third of the penis. Visible veins should be avoided. The side of the penis that is injected and the site of the injection must be alternated; the injection site must be cleansed with an alcohol swab.

The dose of alprostadil that is selected for self-injection treatment should provide the patient with an erection that is satisfactory for sexual intercourse and that is maintained for no longer than 1 hour. If the duration of the erection is longer than 1 hour, the dose of alprostadil should be reduced. Self-injection therapy for use at home should be initiated at the dose that was determined in the physician's office; however, dose adjustment, if required (up to 57% of patients in one clinical study), should be made only after consultation with the physician. The dose should be adjusted in accordance with the titration guidelines described above. The effectiveness of alprostadil for long-term use of up to 6 months has been documented in an uncontrolled, self-injection study. The mean dose of alprostadil at the end of 6 months was 20.7 micrograms in this study.

Careful and continuous follow-up of the patient while in the self-injection program must be exercised. This is especially true for the initial self-injections, since adjustments in the dose of alprostadil may be needed. This recommended frequency of injection is no more than 3 times weekly, with at least 24 hours between each dose. The reconstituted vial of alprostadil is intended for single use only and should be discarded after use. The user should be instructed in the proper disposal of the syringe, needle, and vial.

While on self-injection treatment, it is recommended that the patient visit the prescribing physician's office every 3 months. At that time, the efficacy and safety of the therapy should be assessed, and the dose of alprostadil should be adjusted, if needed.

Caverject as an Adjunct to the Diagnosis of Erectile Dysfunction: On the simplest diagnostic test for erectile dysfunction (pharmacologic testing), patients are monitored for the occurrence of an erection after an intracavernosal injection of alprostadil. Extensions of this testing are the use of alprostadil as an adjunct to laboratory investigations, such as duplex or Doppler imaging. ¹³³Xenon washout tests, radioisotope penogram, and penile arteriography, to allow visualization and assessment of penile vasculature. For any less of these tests, a single dose of alprostadil that induces an erection with firm rigidity should be used.

General Procedure for Solution Preparation:

CAVERJECT Injection is packaged in a one milliliter polyethylene ampoule containing 10.2 or 20.2 mcg per mL of alprostadil, depending on ampoule strength. The deliverable amount of alprostadil is 10 or 20 mcg/mL because approximately 0.2 mcg is lost due to adsorption to the syringe during administration. CAVERJECT Injection is also available in two milliliter ampoules containing 40.4 mcg/2 mL (20.2 mcg/mL) of alprostadil. The deliverable amount of alprostadil is 40 mcg/2 mL (20 mcg/mL) because approximately 0.4 mcg is lost due to adsorption to the syringe during administration. To prepare a dose for administration, remove the ampoule from the foil wrapping. Allow the ampoule contents to warm to room temperature. The ampoule should not be cool to the touch. Do not immerse in water. Do not microwave.

Shake the ampoule vigorously for at least 30 seconds. Next, hold the shorter tab closest to the neck of the ampoule and shake it downward with a quick snap to clear any solution from the neck. Holding the ampoule by the edges, twist the top of the ampoule and lift upward to remove it. Make sure the open end of the ampoule does not touch your hands or any other surface. After opening the ampoule, the solution should be immediately transferred to a syringe and used promptly. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit.

Caution: Do not re-use any remaining CAVERJECT solution due to the possibility of bacterial contamination.

Prostin VR Pediatric Sterile Solution

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

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

Caverject

CAVERJECT Injection is a sterile isotonic solution supplied in one milliliter polyethylene ampoules containing 10.2 or 20.2 mcg per mL of alprostadil, depending on ampoule strength. The deliverable amount of alprostadil is 10 or 20 mcg/mL because approximately 0.2 mcg is lost due to adsorption to the syringe during administration. CAVERJECT Injection is also available in two milliliter ampoules containing 40.4 mcg/2 mL (20.2 mcg/mL) of alprostadil. The deliverable amount of alprostadil is 40 mcg/2 mL (20 mcg/mL) because approximately 0.4 mcg is lost due to adsorption to the syringe during administration. Each ampoule is packaged in foil wrapping.

Store CAVERJECT Injection frozen at -20° to -10°C (-4° to 14°F) until dispensed. After dispensing, store in a freezer at -20° to -10°C (-4° to 14°F) for up to 3 months. During this 3-month period, CAVERJECT Injection may be moved to and kept in a refrigerator at 2° to 8°C (36° to 46°F) for up to 7 days. Once refrigerated, it must be used within 7 days or discarded; it should not be refrozen. Once removed from the foil wrapping, the solution in the ampoule should be used immediately after allowing it to warm to room temperature or it should be discarded. Open ampoules of CAVERJECT Injection should be used immediately and not stored.

CAVERJECT Injection is available in the following packages:

10 mcg/mL:      5 - 1 mL ampoules         NDC 0009-7655-02
20 mcg/mL:      5 - 1 mL ampoules         NDC 0009-7654-02
40 mcg/2 mL:     5 - 2 mL ampoules(20 mcg/mL)   NDC 0009-7650-02

A carton containing five CAVERJECT Companion Packs is also available. Each pack contains the following:

• 1- 2.0 mL Luer-lock Syringe
• 1- Standard Needle 27 gauge x 1/2"
• 1- Standard Needle 30 gauge x 1/2"
• 1- Alcohol Swab

R_x only

Bookmark this page: