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Edex

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Edex

Edex®
(alprostadil) for Injection
For Intracavernous Use Only
Sterile Powder and Diluent
(sterile 0.9% sodium chloride) in Cartridges

DRUG 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 E1 (PGE1 ). edex® (alprostadil for injection) is supplied in single-dose, dual-chamber cartridges.

edex® (alprostadil for injection) is lyophilized in single-dose, dual-chamber cartridges intended for use with the reusable edex (alprostadil for injection) ® 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® (alprostadil for injection) 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 (43.0 mcg alprostadil, 1,390.3 mcg α-cyclodextrin, 51.06 mg lactose). The edex® (alprostadil for injection) 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® (alprostadil for injection) 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 C20 H34 O5 and the molecular weight is 354.49. The chemical structure is:

Alprostadil Structural Formula Illustration

The α-cyclodextrin inclusion complex improves the water solubility of alprostadil. The empirical formula of α-cyclodextrin is C36 H60 O30 and the molecular weight is 972.85.

The chemical structure is:

Cyclodextrin Structural Formula Illustration

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 43.0 mcg of alprostadil is placed into the edex® (alprostadil for injection) injection device and reconstituted, the deliverable amount of alprostadil in each milliliter is 10, 20 or 40 micrograms, respectively.

What are the possible side effects of alprostadil (Caverject, Caverject Impulse, Edex, Muse, Prostin VR Pediatric)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using alprostadil and call your doctor at once if you have any of these serious side effects:

  • feeling light-headed, fainting;
  • bleeding from your urethra;
  • bleeding, bruising, or swelling where you injected the medication;
  • a painful erection that lasts 4 hours or longer;
  • severe pain or irritation of your penis or urethra;...

Read All Potential Side Effects and See Pictures of Edex »

Last reviewed on RxList: 12/9/2008
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.



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