Edex

DRUG DESCRIPTION

edex® (alprostadil for injection) is a sterile, pyrogen-free powder containing alprostadil in an alfadex (?-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 ?-cyclodextrin, 51.06 mg lactose); 20 mcg cartridge (21.5 mcg alprostadil, 695.2 mcg ?-cyclodextrin, 51.06 mg lactose); 40 mcg cartridge (43.0 mcg alprostadil, 1,390.3 mcg ?-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 ?-cyclodextrin inclusion complex improves the water solubility of alprostadil. The empirical formula of ?-cyclodextrin is C36 H60 O30 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 ?-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;
  • ...

Read All Potential Side Effects and See Pictures of Edex »

What are the precautions when taking alprostadil for injection (Edex)?

Before using alprostadil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: penis conditions (e.g., angulation, fibrosis/scarring, Peyronie's disease), blood system cancers (e.g., leukemia, multiple myeloma), sickle cell anemia.

Use of this drug does not protect against sexually transmitted diseases (e.g., HIV, hepatitis B, gonorrhea, syphilis). To decrease your risk of infection, always use an effective barrier method such as a latex or polyurethane condom during all sexual activity. Consult...

Read All Potential Precautions of Edex »


Edex Consumer (continued)

SIDE EFFECTS: Mild/moderate pain, irritation, or slight bleeding at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: redness/tenderness/swelling of the penis, lumps/unusual curving of the penis.

In the very unlikely event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and seek immediate medical attention, or permanent problems could occur.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using alprostadil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: penis conditions (e.g., angulation, fibrosis/scarring, Peyronie's disease), blood system cancers (e.g., leukemia, multiple myeloma), sickle cell anemia.

Use of this drug does not protect against sexually transmitted diseases (e.g., HIV, hepatitis B, gonorrhea, syphilis). To decrease your risk of infection, always use an effective barrier method such as a latex or polyurethane condom during all sexual activity. Consult your doctor or pharmacist for more details.


Edex Patient Information Including Side Effects

Brand Names: Caverject, Caverject Impulse, Edex, Muse, Prostin VR Pediatric

Generic Name: alprostadil (injectable and transurethral) (Pronunciation: al PROS ta dil)

  • What is alprostadil (Edex)?
  • What are the possible side effects of alprostadil (Edex)?
  • What is the most important information I should know about alprostadil (Edex)?
  • What should I discuss with my healthcare provider before using alprostadil (Edex)?
  • How should I use alprostadil (Edex)?
  • What happens if I miss a dose (Edex)?
  • What happens if I overdose (Edex)?
  • What should I avoid while using alprostadil (Edex)?
  • What other drugs will affect alprostadil (Edex)?
  • Where can I get more information?

What is alprostadil (Edex)?

Alprostadil is used to treat erectile dysfunction (impotence) and to help diagnose certain causes of this disorder. Alprostadil is also used to improve blood flow in newborn babies with a certain genetic heart condition. This alprostadil medication guide addresses only the adult male use of this medication in erectile disorders.

Alprostadil relaxes blood vessels and muscles in the penis. This increases blood flow into the penis, causing an erection.

Alprostadil may also be used for other purposes not listed in this medication guide.

What are the possible side effects of alprostadil (Edex)?

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; or
  • redness, lumps, tenderness, unusual shape or curving of the erect penis.

Less serious side effects may include:

  • pain in your penis, urethra, or testicles;
  • headache, dizziness;
  • back pain;
  • a rash on the skin of your penis;
  • warmth or numbness of your penis; or
  • cough, stuffy nose, cold symptoms.

Your sexual partner may also experience side effects such as burning, itching, or irritation of the body areas that come into contact with your penis.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about alprostadil (Edex)?

Alprostadil is used to treat erectile dysfunction (impotence) and to help diagnose certain causes of this disorder. Alprostadil is also used to improve blood flow in newborn babies with a certain genetic heart condition. This alprostadil medication guide addresses only the adult male use of this medication in erectile disorders.

The injectable form of alprostadil is injected into the side of the penis. The transurethral form is a very small suppository (pellet) that is inserted into the opening of the penis (the urethra).

Use this medication exactly as it was prescribed for you. Using too much alprostadil can be very dangerous. This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Your first dose of this medicine will be given in your doctor's office so you can be observed for how well the medication works and if it causes any side effects. You will then be shown how to properly give the medication to yourself.

Do not give yourself an alprostadil injection or pellet if you do not understand the instructions for proper use. Call your doctor, nurse, or pharmacist for help with injection instructions. Using an alprostadil transurethral pellet improperly could cause damage to your urethra.

Alprostadil is used only when needed to get an erection. An erection should occur within 5 to 20 minutes after you use the medication, and should last for 30 to 60 minutes. The length of time your erection lasts may be slightly different from these averages.

Seek emergency medical attention if you think you have used too much of this medication. Symptoms of an alprostadil overdose may include feeling light-headed, fainting, or having a painful or prolonged erection lasting 4 hours or longer.

Related Drug Centers
  • Prostin VR Pediatric
  • Caverject Impulse
  • Edex
  • Caverject
  • Caverject Powder


Related Drugs Index: