Source: FDA, National Drug Code (US) Revision Year: 2018
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.
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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 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 mcg, 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:
For more information, call Endo Pharmaceuticals Inc. at 1-800-462-3636. Distributed by: Endo Pharmaceuticals Inc., Malvern, PA 19355 |
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| Drug | Countries | |
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| EDEX | France, Tunisia, United States |
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