Edex
(Alprostadil)Dosage & Administration
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.
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Edex Prescribing Information
edex® is indicated for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology.
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.
edex
- in men who have conditions that predispose them to priapism, such as sickle cell anemia or sickle cell trait, multiple myeloma, or leukemia (see WARNINGS).
- for the treatment of erectile dysfunction in men with fibrotic conditions of the penis, such as cavernosal fibrosis or Peyronie’s disease (see PRECAUTIONS).
- in men with penile implants
edex®, administered by intracavernous injection in doses ranging from 1 to 40 mcg per injection for periods up to 24 months, has been evaluated in clinical trials for safety in over 1,065 patients with erectile dysfunction. Discontinuation of therapy due to a side effect in clinical trials was required in approximately 9% of patients treated with edex® and in <1% of patients treated with placebo.
The pharmacodynamic interaction between heparin (5,000 units) and alprostadil intravenous infusion (90 mcg over 3 hours) was investigated. The results indicate significant changes in partial thromboplastin time (140% increase) and thrombin time (120% increase). Therefore, caution should be exercised with concomitant administration of heparin and edex®.
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In clinical trials, concomitant use of agents such as antihypertensive drugs, diuretics, antidiabetic agents (including insulin), or nonsteroidal anti-inflammatory drugs had no apparent effect on the efficacy or safety of edex®.
In clinical trials, concomitant use of agents such as antihypertensive drugs, diuretics, antidiabetic agents (including insulin), or nonsteroidal anti-inflammatory drugs had no apparent effect on the efficacy or safety of edex®.
edex® (alprostadil for injection) is a sterile, pyrogen-free powder containing alprostadil in an alfadex (α-cyclodextrin) inclusion complex. Alprostadil is an endogenous substance known as prostaglandin E1 (PGE1). edex® is supplied in single-dose, dual-chamber cartridges.
edex® is lyophilized in single-dose, dual-chamber cartridges intended for use with the reusable edex® injection device. One chamber of the cartridge contains alprostadil, alfadex and lactose as a sterile, pyrogen-free powder. The other chamber contains 1.075 mL of sterile 0.9% sodium chloride. The edex® cartridges are supplied in three strengths: 10-mcg cartridge (10.75 mcg alprostadil, 347.55 mcg α-cyclodextrin, 51.06 mg lactose); 20-mcg cartridge (21.5 mcg alprostadil, 695.2 mcg α-cyclodextrin, 51.06 mg lactose); 40-mcg cartridge (43 mcg alprostadil, 1,390.3 mcg α-cyclodextrin, 51.06 mg lactose). The edex® injection device is used to reconstitute the sterile powder in one chamber with the sterile 0.9% sodium chloride in the other chamber. After reconstitution, the edex® injection device is used to administer the intracavernous injection of alprostadil.
The chemical name for alprostadil is (1R,2R,3R)-3-Hydroxy-2-[(E)-(3S)-3-hydroxy-1-octenyl]-5-oxocyclopentane heptanoic acid. The empirical formula is C20H34O5 and the molecular weight is 354.49. The chemical structure is:
The α-cyclodextrin inclusion complex improves the water solubility of alprostadil. The empirical formula of α-cyclodextrin is C36H60O30 and the molecular weight is 972.85.
The chemical structure is:
Alprostadil alfadex is a white, odorless, hygroscopic powder. It is freely soluble in water and practically insoluble in ethanol, ethyl acetate and ether. After reconstitution, the active ingredient, alprostadil, immediately dissociates from the α-cyclodextrin inclusion complex. The reconstituted solution is clear and colorless and has a pH between 4.0 and 8.0. When the single-dose, dual-chamber cartridge containing either 10.75, 21.5, or 43 mcg of alprostadil is placed into the edex® injection device and reconstituted, the deliverable amount of alprostadil in each milliliter is 10, 20 or 40 mcg, respectively.