Edex
Generic name: Alprostadil Injection
Brand names: Caverject, Edex
Drug classes: Impotence agents, Vasodilators
Medically reviewed by A Ras MD.
What is Edex?
Edex is a prescription penile injection used in the treatment of erectile dysfunction.
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® 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.
What is the most important information I should know about Edex?
You or your partner should be fully trained on the proper injection technique before using Edex at home. Be sure to use only the dose prescribed by your doctor.
Carefully follow the instructions for administration which come with Edex. For further information or advice, ask your doctor or pharmacist.
Note: Edex offers no protection from the transmission of sexually transmitted diseases such as HIV (the virus that causes AIDS). Small amounts of bleeding at the injection site can increase the risk of transmission of blood-borne diseases between partners.
Who should not take Edex?
Men who have conditions that might result in long-lasting erections should not use Edex. Some of these conditions include sickle cell anemia or trait, leukemia, and tumor of the bone marrow (multiple myeloma). If you have any of these conditions, consult your doctor.
Men with penile implants, severe penile curvature, or those who have been advised not to engage in sexual activity should not use Edex.
Edex should not be used by women or children.
What should I tell my healthcare provider before taking Edex?
Tell your doctor if you have a condition or are taking a medicine that interferes with blood clotting.
How should I take Edex?
Edex is injected into a specific area of the penis (see injection directions that come with Edex) and should produce an erection in 5 to 20 minutes. The erection can be expected to last up to one hour. You should not use Edex more than 3 times a week. Injections should be administered at least 24 hours apart.
Ideally, the injection should be administered just prior to foreplay. If your partner experiences insufficient vaginal lubrication or painful vaginal sensations during intercourse, the use of a lubricant may be helpful.
What are the possible side effects of Edex?
Erections that last more than 6 hours can cause serious damage to the penile tissue and may result in permanent impotence. Call the prescribing physician or, if unavailable, seek professional help immediately if you still have an erection 6 hours after injection. Various treatment options for reversing a prolonged erection are available.
A common side effect of Edex is mild to moderate pain during injection. The erection may also be associated with a painful sensation. If you experience severe pain, contact the prescribing physician.
Call your doctor if you notice any redness, lumps, swelling, tenderness or curvature of the erect penis.
Call your doctor if you have dizziness, fatigue, or chest pain.
A small amount of bleeding at the injection site may occur. To prevent bruising, apply firm pressure to the injection site for 5 minutes. Tell your doctor if you have a condition or are taking a medicine that interferes with blood clotting.
There is a possibility of needle breakage with use of Edex. To best avoid breaking the needle, you should pay careful attention to your doctor’s instructions and try to handle the injection device properly. If the needle breaks during injection and you are able to see and grasp the broken end, you should remove it and contact your doctor. If you cannot see or cannot grasp the broken end, you should promptly contact your doctor.
How should I store Edex?
Store at 25°C (77°F); excursions permitted between 15°C – 30°C (59°F – 86°F).
What are the ingredients in Edex?
Active Ingredients: alprostadil
Inactive Ingredient: alfadex, unspecified form lactose, sodium chloride, water
Label
PRINCIPAL DISPLAY PANEL – 10 MCG LABEL
- PRINCIPAL DISPLAY PANEL – 10 MCG CARTON
