Edex

Alprostadil is used to produce erections in some men who need treatment for erectile dysfunction (sexual impotence). This medicine causes an erection because it increases the blood flow to the penis.

Alprostadil injection should not be used as a sexual aid by men who do not have erectile dysfunction . If the medicine is not used properly, permanent damage to the penis and loss of the ability to have erections could result.

Alprostadil is used alone or with medical tests to help diagnose erectile dysfunction that may be caused by nerve or blood vessel problems in the penis.

Alprostadil is available only with your doctor`s prescription.

This product is available in the following dosage forms:

• Powder for Solution


• Kit


• Suppository


• Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Heparin

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal penis, including curved penis and birth defects of the penisa€”Chance of problems occurring may be increased

• Bleeding problemsa€”Chance of bleeding at the place of injection may be increased

• Infection of penis or


• Red or itchy (inflamed) penisa€”Conditions may worsen with the use of alprostadil suppositories. Also, local skin problems and minor bleeding from inserting the suppository may occur

• Conditions causing thickened blood or slower blood flow, including leukemia; multiple myeloma (tumors of the bone marrow); polycythemia, sickle cell disease, or thrombocythemia (blood problems) or

• Priapism (history of)a€”Patients with these conditions have an increased risk of priapism (erection lasting longer than 6 hours) while using alprostadil

Proper Use

Special patient directions come with the suppositories and some of the injection medicines. Read the directions carefully before using the medicine.

For the injectionsa€”There are several alprostadil products that can be injected. Although the injection method is the same, the mixing procedures are different. Be sure you know which of these products you will be using and the proper way to mix the injection .

• One product called Alprostadil for Injection (brand names Caverject and Edex) is available as a powder in an injection bottle (vial). Caverject must be mixed with a solution called Bacteriostatic Water for Injection USP. Edex must be mixed with a solution called Sodium Chloride Injection USP. The solution for mixing comes with your product and may be already loaded into a syringe or contained in another injection bottle (vial).


• Another product is called Alprostadil Injection (brand names Prostin VR Pediatric and Prostin VR). Although the medicine is already in solution, it is much too strong to be injected into the penis. The solution must be mixed (diluted) with another liquid that is sold as a separate prescription, called 0.9% Sodium Chloride Injection USP. In most cases, a pharmacist will make this solution for you, giving you the proper strength that you need . Check with your doctor or pharmacist to make sure the solution has been diluted before using it.

It is important to follow several steps to prepare your alprostadil injection correctly. Before drawing up the medicine into the syringe:

• Wash your hands with soap and water .


• Set the bottles on a clean surface . Wipe the top of the injection bottles with an alcohol swab. Do not wipe the needle. Throw away the alcohol swab.


• You may need to attach the needle to the syringe. Do not take the cap off yet.

How to mix Caverject:

• If the syringe already contains the Bacteriostatic Water for Injection USP, then you need only add the plunger to the syringe. To do this:
  
  
  
  • Pick up the rod-like plunger and place it within the barrel of the syringe until it touches the rubber piece. Gently screw the plunger into the rubber piece until it seems secure. Do not use a lot of force .
  
  
  • Hold the syringe by the barrel (not the plunger) and take the cap off the needle.
  
  
  • You are now ready to mix the water and the powder. Skip to the directions under the title, a€śTo mix the water and powder."
  
  
  
  


• If the syringe does not already contain the Bacteriostatic Water for Injection USP, you must withdraw 1 milliliter (mL) of it from the bottle provided. To do this:
  
  
  
  • Pick up the syringe and take the cap off the needle. Pull the plunger back to the 1-mL mark on the syringe. This pulls air into the syringe. Insert the needle into rubber top of the bottle while it is upright and inject the 1 mL of air into the bottle .
  
  
  • Turn the bottle upside down using one hand . Be sure the tip of the needle is covered by solution.
  
  
  • With your other hand, pull the plunger back slowly to withdraw 1 mL of solution into the syringe. Remove the needle and skip to the directions under the title, "To mix the water and powder."
  
  
  
  


• To mix the water and powder:
  
  
  
  • Insert the needle into the bottle of alprostadil and inject 1 milliliter of Bacteriostatic Water for Injection USP from your syringe into the bottle of alprostadil.
  
  
  • Remove the needle from the bottle, holding the barrel of the syringe.
  
  
  • Gently swirl the bottle to mix the powder into the solution, turning it upside down to wet all the powder in the bottle .
  
  
  • Follow the directions below, a€śHow to draw your dose into the syringe."
  
  
  
  

How to mix Edex:

• The syringe already contains the Sodium Chloride Injection USP. You need only attach the needle to the syringe and add the plunger. To do this:
  
  
  
  • Remove the needle from its package . Do not remove the needle cap. Gently screw the needle into place on the syringe tip.
  
  
  • Pick up the rod-like plunger and place it within the barrel of the syringe until it touches the rubber piece. Gently screw the plunger into the rubber piece until it seems secure. Do not use a lot of force .
  
  
  • Hold the syringe by the barrel (not the plunger) and take the cap off the needle.
  
  
  • You are now ready to mix the Sodium Chloride Injection USP and the powder.
  
  
  • Insert the needle into the bottle of alprostadil and inject 1.2 milliliters of the Sodium Chloride Injection USP from your syringe into the bottle of alprostadil.
  
  
  • Remove the needle from the bottle, holding the barrel of the syringe.
  
  
  • Gently swirl the bottle to mix the powder into the solution, turning it upside down to wet all the powder in the bottle .
  
  
  • Follow the directions below, a€śHow to draw your dose into the syringe."
  
  
  
  

How to mix Prostin VR or Prostin VR Pediatric:

• You will need to get exact mixing instructions from your doctor or pharmacist if you are given two solutions to be mixed . Follow them carefully, asking the pharmacist or doctor any questions that you might have before injecting the medicine.


• After you or the pharmacist has mixed these solutions, follow the directions below, a€śHow to draw your dose into the syringe."

How to draw your dose into the syringe (for all injection products):

• Check the solution to make sure it is clear. Do not use the mixture if you can see anything solid in the solution or if the solution is cloudy or colored.


• After the alprostadil solution is mixed and the needle is inserted into the alprostadil bottle, turn the bottle with the syringe as a unit upside down in one hand . Be sure the tip of the needle is covered by the solution. With your other hand, pull the plunger back slowly to draw the correct dose of the medicine into the syringe.


• Hold the syringe with the measuring scale at eye level to see that the proper dose is withdrawn and to check for air bubbles. To remove air bubbles, tap gently on the measuring scale of the syringe to move any bubbles to the top of the syringe near the needle.


• If your dose measures too low in the syringe, withdraw more solution from the bottle . If there is too much medicine in the syringe, put some back into the bottle . Then check your dose again.


• Remove the needle from the bottle, holding the barrel of the syringe, not the plunger.


• Place the cover back on the needle. You are now ready to inject your dose . Follow the directions below, a€śHow to give the alprostadil injection ."

How to give the alprostadil injection:

• Choose a spot on your penis as directed by your doctor where you will give the injection .


• Clean the injection site with alcohol . Sitting upright or slightly reclined, hold your penis against the side of your thigh so that it cannot move.


• Remove the cover from the needle and hold the needle at a 90-degree angle to the place of injection .


• Insert the needle until almost all of the metal part of the needle is inserted into the penis.


• Do not inject the medicine just under the surface of the skin, at the top or head of the penis, or at the base of the penis near the scrotum or testes. Avoid injecting the medicine into blood vessels that you can see.


• Press the plunger down slowly, taking 5 to 10 seconds to release the dose into the penis.


• The injection is usually not painful . If the injection is very painful or if you notice bruising or swelling at the place of injection, that means you are injecting the medicine under the skin . Stop, withdraw the needle, and reposition it properly before continuing with the injection .


• Remove the needle and recap it.


• After you have completed the injection, put pressure on the place of injection for about 5 minutes or until any bleeding stops. This will prevent bruising. Then massage your penis as instructed by your doctor . This helps the medicine spread to all parts of the penis, so that the medicine will work better.

Choose a different place of injection each time you use the medicine to prevent skin problems . This includes switching the place of injection from the right side of the penis for one injection to the left side for the next injection .

After a single-use injection is mixed, the medicine must be used immediately. Throw away any unused mixture in the syringe. It cannot be stored for a later injection .

Do not reuse your needles.

How to throw away the syringes and bottles safely:

Dispose of your materials properly. Caverject comes in a plastic case that can be permanently locked with the red locking device that is included with the packaging. When the case label is removed, you can see a hole in the center of the case. The red locking device can be inserted and, by firmly pressing it down with your thumb, you will permanently lock the case. The locked case is safe to be thrown away.

If you do not have the plastic case or are using Prostin VR or Prostin VR Pediatric injection, unscrew the needle from the barrel of the syringe. Then bend, break, or cut the needle into two pieces with wire cutters. The pieces can be placed in a heavy plastic container, such as a bleach container, and thrown away. Or you may give them to a health care professional to throw away. If you have any questions about disposing of the syringe and needles, ask your health care professional .

For suppositoriesa€”Before inserting the suppository, you should urinate. The small amount of urine normally left in your urethra will help dissolve the suppository after it is inserted.

How to insert suppositories:

• Remove the delivery device containing the suppository from the foil. Remove the cap from the applicator stem.


• Stretch your penis upward to extend its length, pressing your penis top and bottom. Gently insert the delivery stem up to its collar into your urethra (located at the top of the penis). If you have pain or a pulling feeling in the penis, withdraw the device and start again.


• Press the button down slowly as far as it will go. This releases the suppository into the urethra. After holding the delivery device within your penis still for 5 seconds, carefully rock the penis and delivery device as a unit from side to side . This helps remove the suppository from the device.


• Remove the delivery device while your penis is upright. Look at the device to make sure that the suppository was completely released.


• Repeat the process if a part of the suppository remains in the device.


• After the suppository is completely released, roll your penis between your hands for 10 seconds. This helps to dissolve the suppository. If you feel any stinging, continue this motion to help stop it.


• Sitting, standing, or walking for 10 minutes while an erection is developing helps increase the blood flow to your penis to gain a proper erection.

How to throw away the suppository delivery device safely:

• Replace the cap on the delivery device. After storing it in the foil, fold and throw away.

For injections or suppositoriesa€”This medicine usually begins to work in about 5 to 10 minutes. You should attempt intercourse within 10 to 30 minutes after using the medicine. An erection may continue after ejaculation.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor`s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For the treatment of erectile dysfunction:
  
  
  
  • For injection dosage form:
    
    
    
    • Adultsa€”1.25 to 60 micrograms (mcg) as a single dose once a day. Your exact dose will be determined by your doctor . Inject this medicine very slowly into your penis as shown to you by your doctor ten to thirty minutes before intercourse. Allow five to ten seconds to completely inject the dose . Do not inject more than one dose within twenty-four hours. Also, do not use this medicine for more than two days in a row or more than three times a week.
    
    
    
    
  
  
  • For suppository dosage form:
    
    
    
    • Adultsa€”125, 250, 500, or 1000 mcg as a single dose once a day. Your exact dose will be determined by your doctor . Insert this medicine into the urethra of your penis as shown to you by your doctor ten to thirty minutes before intercourse. Do not insert more than two doses within twenty-four hours.
    
    
    
    
  
  
  
  

Storage

Store in the refrigerator. Do not freeze .

You may store the suppositories in the refrigerator, but do not freeze them.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Alprostadil for Injection while in the powder form can be stored at room temperature (between 15 and 25 A°C or 59 and 77 A°F) for 3 months. After it is mixed, the solution must be used immediately. Suppositories may be stored at room temperature

Precautions

Do not use alprostadil if you have a penile implant unless advised by doctor .

If using the alprostadil suppository, use a condom when having sexual intercourse with a pregnant female . Although harm to the fetus is unlikely, using a condom will protect the fetus from exposure to this medicine. If a woman can become pregnant, use of contraceptive methods is recommended because the effects of this medicine on early pregnancy are not known.

Use alprostadil exactly as directed by your doctor . Do not use more of it and do not use it more often than your doctor ordered. If too much is used, the erection lasts too long and does not reverse when it should. This condition is called priapism. If the erection is not reversed, the blood supply to the penis may be cut off and permanent damage may occur.

Contact your doctor immediately if the erection lasts longer than 4 hours or if it becomes painful . This may be a sign of priapism and must be treated right away to prevent permanent damage.

If you notice bleeding at the place where you injected the medicine, put pressure on the spot until the bleeding stops. If it doesn`t stop within 10 minutes, check with your doctor .

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention .

Check with your doctor immediately if any of the following side effects occur:

Rare

• Curving of penis with pain during erection


• Erection continuing for 4 to 6 hours


• Erection continuing longer than 6 hours with severe and continuing pain of the penis


• Swelling in or pain of the testes

Symptoms of too much medicine being absorbed into the body

• Dizziness


• Faintness


• Pelvic pain


• Flu-like symptoms

Some side effects may occur that usually do not need medical attention . These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Bleeding at place of injection, short-term


• Mild bleeding or spotting from urethra (suppository only)


• Pain at place of injection


• Painful erection


• Stinging of urethra (suppository only)

Rare

• Bruising or clotted blood in penis at place of injection, usually caused by an incorrect injection

Female partners may experience itching or stinging of vagina when you first begin using the alprostadil suppository. These side effects may not be caused from the medicine but may result if female partner has not had frequent or recent sexual intercourse.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional .

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