Alprostadil Urogenital

WHY is this medicine prescribed?

Alprostadil injection and suppositories are used to treat certain types of erectile dysfunction (impotence; inability to get or keep an erection) in men. Alprostadil injection is also sometimes used in combination with other tests to diagnose erectile dysfunction. Alprostadil is in a class of medications called vasodilators. It works by relaxing the muscles and blood vessels in the penis to keep enough blood in the penis so that an erection can occur.

Alprostadil does not cure erectile dysfunction or increase sexual desire. Alprostadil does not prevent pregnancy or the spread of sexually transmitted diseases such as human immunodeficiency virus (HIV).

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Alprostadil comes as a powder to be mixed with the liquid provided in the package and injected into the penis and as a urethral suppository (pellet to be placed into the urinary opening of the penis). Alprostadil is used as needed before sexual activity. An erection may occur within 5 to 20 minutes after using the injection and within 5 to 10 minutes after using the pellet. The erection should last approximately 30 to 60 minutes. Alprostadil injection should not be used more than three times per week, with at least 24 hours between uses. Alprostadil pellets should not be used more than twice in a 24-hour period. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use alprostadil exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Your doctor will administer the first dose of alprostadil in his or her office to determine the proper dose for you. After you begin to use alprostadil at home, your doctor may gradually increase or decrease your dose. Tell your doctor if you do not experience satisfactory erections or if your erections last for too long, but do not change your dose without talking to your doctor.

You must be trained by your doctor before using alprostadil at home. Be sure that you understand exactly how to use alprostadil. Ask your doctor or pharmacist if you have any questions about how to use your medication.

Needle breakage has occurred during administration of alprostadil To minimize the risk of this occurring, make sure you use the proper needle as instructed by your doctor or nurse. Make sure to always insert the appropriate needle perpendicular to the long axis of the penis.

Do not reuse needles, syringes, cartridges, vials, pellets, or applicators. Dispose of used needles and syringes in a puncture-resistant container. Ask your doctor or pharmacist how to dispose of the container.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before using alprostadil,

• tell your doctor and pharmacist if you are allergic to alprostadil; other prostaglandin medications such as misoprostol (Cytotec, in Arthrotec), bimatoprost (Lumigan), latanoprost (Xalatan), and travoprost (Travatan); or any other medications.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have ever been advised by a healthcare professional to avoid sexual activity for medical reasons and if you have or have ever had blood cell problems such as sickle cell anemia (a disease of the red blood cells), leukemia (cancer of the white blood cells), multiple myeloma (cancer of the plasma cells), thrombocythemia (condition in which too many platelets are produced),or polycythemia (condition in which too many red blood cells are produced); conditions affecting the shape of the penis (angulation, cavernosal fibrosis, or Peyronie's disease); a penile implant (device that is surgically placed inside the penis to treat erectile dysfunction); hypotension (low blood pressure), or heart failure. Also tell your doctor if you or any of your family members has ever had a blood clot in the legs or lungs and if you have recently undergone major surgery. Your doctor may tell you not to use alprostadil.

• if you are using the alprostadil pellet, tell your doctor if you have or have ever had any narrowing, scarring, or swelling of the urinary opening of the penis or the tip of the penis. Your doctor will probably tell you not to use alprostadil pellets.

• tell your doctor if you have or have ever had a bleeding disorder; a history of fainting; or kidney, liver, or lung disease.

• tell your doctor if your partner is pregnant or plans to become pregnant. Do not use alprostadil pellets before sexual activity with a pregnant woman or a woman who may become pregnant without using a condom barrier.

• you should know that alprostadil may cause dizziness, lightheadedness, and fainting. Do not drive a car or operate machinery after using alprostadil until you know how this medication affects you.

• talk to your doctor about the use of alcohol during your treatment with alprostadil. Alcohol may decrease the effectiveness of this medication.

• you should know that a small amount of bleeding may occur in the area where the medication was given. This can increase the risk of transmitting blood-borne diseases (conditions that are spread through contaminated blood) such as HIV, hepatitis B, and hepatitis C between you and your partner. Tell your doctor if you or your partner has a blood-borne disease.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Alprostadil may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• bleeding or bruising in the place where you administered the medication
• pain or aching in the penis, testicles, legs, or perineum (area between the penis and rectum)
• warmth or burning sensation in the urinary opening of the penis
• redness of the penis
• dizziness
• rash

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or seek emergency treatment:

• erection lasting more than 4 hours
• redness, swelling, tenderness, or unusual curving of the erect penis
• breakage of the needle in the penis
• nodules or hard areas on the penis
• fast heartbeat
• fainting
• swollen veins in the legs

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store alprostadil vials and cartridges at room temperature and away from excess heat and moisture (not in the bathroom). Read the manufacturer's instructions for information about how long alprostadil solution may be stored after mixing and where it should be kept. Alprostadil pellets should be stored in the original package in the refrigerator, but may be kept at room temperature for up to 14 days before use. Do not expose the medication to high temperatures or place it in direct sunlight since this will make it ineffective.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

When traveling, do not store alprostadil in checked luggage or leave it in the car where it may be exposed to extreme temperatures. Store alprostadil pellets in a portable ice pack or cooler.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

If someone uses too much alprostadil, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• fainting
• dizziness
• blurred vision
• nausea
• pain in the penis that does not go away
• erection lasting longer than 6 hours

What OTHER INFORMATION should I know?

Keep all appointments with your doctor. It is important to have regular follow-up visits with your doctor (e.g., every 3 months).

Do not let anyone else use your medication, needles, or syringes. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.