Country: United States
Language: English
Source: NLM (National Library of Medicine)
ALPROSTADIL (UNII: F5TD010360) (ALPROSTADIL - UNII:F5TD010360)
Endo Pharmaceuticals Inc.
ALPROSTADIL
ALPROSTADIL 10 ug in 1 mL
INTRACAVERNOUS
PRESCRIPTION DRUG
edex® is indicated for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology. edex® should not be used: - 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® (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: Store at 25°C (77°F); excursions permitted between 15°C - 30°C (59°F - 86°F).
New Drug Application
EDEX- ALPROSTADIL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION ENDO PHARMACEUTICALS INC. ---------- EDEX (ALPROSTADIL FOR INJECTION) FOR INTRACAVERNOUS USE ONLY STERILE POWDER AND DILUENT (STERILE 0.9% SODIUM CHLORIDE) IN CARTRIDGES RX ONLY DESCRIPTION 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 E (PGE ). 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 C H O 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 C H O and the molecular weight is 972.85. The chemical structure is: ® ® 1 1 ® ® ® ® ® ® 20 34 5 36 60 30 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 ingredien Read the complete document