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Overview
Alprostadil (injection) is an erectile dysfunction agent that is FDA approved for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology.. Common adverse reactions include {{{adverseReactions}}}.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
Edex® is indicated for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology.
Dosage
Edex® in the Treatment of Erectile Dysfunction
The dosage range of edex® for the treatment of erectile dysfunction is 1 to 40 mcg. The intracavernous injection should be given over a 5 to 10 second interval. In a study with a dose range of 1 to 20 mcg of edex®, the mean dose was 10.7 mcg at the end of the dose titration period. In two studies with a dose range of 1 to 40 mcg of edex®, the mean dose was 21.9 mcg at the end of the dose titration period. Doses greater than 40 mcg have not been studied. A ½ inch, 27 to 30 gauge needle is generally recommended for the intracavernous injection. The patient is advised not to exceed the optimum edex® dose which was determined in the doctor's office. The lowest possible effective dose should always be used.
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 to a dose of 5 micrograms and then in increments of 5 to 10 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. It 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.
Erectile Dysfunction of Pure Neurogenic Etiology (Spinal Cord Injury)
Dosage titration should be 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.
At-Home (Maintenance Therapy) Dosing Instructions
The first injections of edex® 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 instruct the patient to discard any needles which become bent during the self-injection procedure as these needles may break. The physician should make a careful assessment of the patient's skills and competence with the self-injection procedure. The intracavernous injection must be done under sterile conditions. The site of injection is usually along the 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 injection must be alternated. The injection site must be cleansed with an alcohol swab before injection.
The dose of edex® 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 erection is longer than 1 hour, the dose of edex® should be reduced. The lowest effective dose should be used at home. Self-injection therapy for use at home should be initiated at the dose that was determined in the physician's office. Dose adjustment may be required and should be made only after consultation with the physician.
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 edex® may be needed. The recommended frequency of injection is no more than 3 times weekly, with at least 24 hours between each dose. The reconstituted edex® cartridge and needle are intended for single use only and should be discarded after use. The user should be instructed in the proper disposal of the needles and cartridges.
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 edex® should be adjusted, if needed.
The patient is instructed to follow the enclosed patient information pamphlet.
Preparation of Solution
The edex® injection device is used to reconstitute the single-dose, dual-chamber cartridge. The plunger is used to force the sterile 0.9% sodium chloride (1.075 mL) in one chamber into the chamber containing alprostadil. After reconstitution, the edex® injection device is used to administer the intracavernous injection of alprostadil. The reusable edex® injection device is for use only with the cartridges and needles included in the edex® Cartridge Packs.
Prepare the edex® solution immediately before use. Do not administer unless solution is clear. Do not add any drugs or solutions to the edex® solution. Discard any unused solution remaining in the cartridge. The reconstituted solution should not be stored.
The edex® cartridge contains a solid layer or lyophilized cake of dry white powder approximately 3/8" in thickness. A normal cake may appear cracked or crumbled. If the cartridge is damaged, the cake may shrink in size. Do not use the cartridge if it appears damaged or the cake is substantially reduced in size.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. The reconstituted solution may initially appear cloudy due to small air bubbles. Do not use the solution if it remains cloudy, contains precipitates, or is discolored.
CAUTION: Do not reuse any solution remaining in the cartridge due to the possibility of bacterial contamination.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Alprostadil (injection) in adult patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Alprostadil (injection) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding FDA-Labeled Use of Alprostadil (injection) in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Alprostadil (injection) in pediatric patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Alprostadil (injection) in pediatric patients.
Contraindications
Condition1
Warnings
Description
Precautions
Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Alprostadil (injection) in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Alprostadil (injection) in the drug label.
Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Alprostadil (injection) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Alprostadil (injection) during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Alprostadil (injection) with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Alprostadil (injection) with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Alprostadil (injection) with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Alprostadil (injection) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Alprostadil (injection) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Alprostadil (injection) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Alprostadil (injection) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Alprostadil (injection) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Alprostadil (injection) in patients who are immunocompromised.
Administration and Monitoring
Administration
Edex® is given as an intracavernous injection over a 5 to 10 second interval. See patient information for edex®.
Stability
The single-dose, dual-chamber cartridge should be reconstituted only when it is certain that the patient is ready to administer the drug. The reconstituted drug solution should be used immediately after reconstitution. Any solution remaining in the cartridge should be discarded.
Monitoring
There is limited information regarding Monitoring of Alprostadil (injection) in the drug label.
IV Compatibility
There is limited information regarding IV Compatibility of Alprostadil (injection) in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
Description
Management
Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Alprostadil (injection) in the drug label.
Pharmacology
There is limited information regarding Alprostadil (injection) Pharmacology in the drug label.
There is limited information regarding Pharmacodynamics of Alprostadil (injection) in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Alprostadil (injection) in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Alprostadil (injection) in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Alprostadil (injection) in the drug label.
How Supplied
Edex® (alprostadil for injection) is available in single-dose, dual-chamber cartridges intended for use with the reusable edex® injection device. One chamber of the cartridge contains 10.75, 21.5 or 43.0 mcg of alprostadil as a white, sterile, lyophilized powder. The other chamber contains 1.075 mL of sterile 0.9% sodium chloride. When the cartridge is placed into the edex® injection device and reconstituted, the deliverable amount of alprostadil in each milliliter is 10, 20 or 40 micrograms, respectively. edex® Cartridge 2 Pack contains one reusable edex® injection device, two single-dose, dual-chamber cartridges, two ½ inch, 29 gauge (0.33 mm × 12.7 mm) needles, and four alcohol swabs. edex® Cartridge 6 Pack contains one reusable edex® injection device, six single-dose, dual-chamber cartridges, six ½ inch, 29 gauge (0.33 mm × 12.7 mm) needles, and twelve alcohol swabs.
The edex® cartridges are supplied in the following packages:
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Storage
Store at 25°C (77°F); excursions permitted between 15° - 30°C (59° - 86°F).
Images
Drug Images
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