Prostin VR Pediatric (injectable and transurethral)

Prostin VR Pediatric is used to treat erectile dysfunction (impotence) and to help diagnose certain causes of this condition. This medicine is also used to improve blood flow in newborn babies with heart problems. This medication guide focuses only on the use of alprostadil in adult males for erectile disorders.

Prostin VR Pediatric relaxes blood vessels and muscles in the penis, which increases blood flow and causes an erection.

Prostin VR Pediatric may also be used for reasons not mentioned in this medication guide.

This medication guide is for adult males using alprostadil for erectile disorders.

Get emergency medical help if you have a painful or prolonged erection that lasts 4 hours or longer.

You should not use Prostin VR Pediatric if you are allergic to it, or if you have:

• sickle cell anemia or the sickle cell trait;
• leukemia;
• a tumor of the bone marrow (multiple myeloma);
• a curved or deformed penis;
• penile fibrosis or Peyronie's disease;
• a penile implant; or
• if you need to avoid sexual intercourse for health reasons.

Tell your doctor if you have ever had:

• heart disease;
• high or low blood pressure; or
• bleeding problems.

Caverject, Caverject Impulse, Edex, or Muse should not be used by women or anyone under 18 years old.

While using Prostin VR Pediatric pellets, use condoms during sex if your partner is pregnant or can become pregnant. The effects of alprostadil on an unborn baby at conception or during pregnancy are unknown.

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

Prostin VR Pediatric may cause serious side effects. Stop using Prostin VR Pediatric and call your doctor right away if you have:

• a light-headed feeling, like you might pass out;
• bleeding after an injection;
• a painful erection that lasts 4 hours or longer;
• new or worsening pain in your penis; or
• redness, swelling, tenderness, lumps, unusual shape or curving of the erect penis.

Common side effects of Prostin VR Pediatric may include:

• mild pain in your penis, urethra, or testicles;
• redness of the penis; or
• warmth or burning in your urethra.

Your sex partner may have side effects such as burning, itching, or irritation of body areas that come into contact with your penis.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

A healthcare provider will give your first dose and teach you how to properly use the medication by yourself.

Follow all directions on your prescription label and read all medication guides. Use the medicine exactly as directed.

Prostin VR Pediatric is used only when needed. An erection should occur within 5 to 20 minutes and last up to 60 minutes.

Prostin VR Pediatric injection is injected into the side of the penis.

Alprostatil transurethral pellet is a very small suppository to be inserted into the opening of the penis (the urethra).

Do not use more than 2 pellets in one day. Do not use more than 3 injections per week. Wait at least 24 hours between each injection.

Ask your doctor or pharmacist if you don't understand how to use the injection.

Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors, or has particles in it.

Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

Call your doctor if a needle breaks while you are injecting Prostin VR Pediatric. If you can grasp the broken end, remove the needle right away.

Your doctor should check you every 3 months to be sure Prostin VR Pediatric is not causing harmful effects on your penis.

Storing Prostin VR Pediatric:

• Keep pellets in their original foil pouch in the refrigerator. You may store a pouch at cool room temperature for up to 14 days. Protect from freezing or extreme heat. Do not store in a closed automobile or in luggage while traveling.
• Store Prostin VR Pediatric injection vials at cool room temperature. The 40-microgram strength should be used within 3 months or before the expiration date on the label.
• After mixing a Caverject injection, keep it at room temperature and use within 24 hours.

Since Prostin VR Pediatric is used as needed, it does not have a daily dosing schedule.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

Taking too much can cause fainting or a painful and long-lasting erection.

Do not drive or do anything dangerous if you feel light-headed.

Using Prostin VR Pediatric will not protect you from sexually transmitted diseases. Ask your doctor how to prevent disease transmission during sex. Sharing drug or medicine needles is never safe.

Tell your doctor about all your other medicines, especially:

• other medicines injected into the penis; or
• a blood thinner--heparin, warfarin, Coumadin, Jantoven.

This list is not complete. Other drugs may affect Prostin VR Pediatric, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.