Alprostadil

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 medicine in erectile disorders.

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

This medicine is identical to a naturally occurring substance found in the body that helps keep the blood vessels open, letting blood flow more easily. Alprostadil helps treat erectile dysfunction (ED) by increasing the blood flow to the penis, causing an erection.

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

Alprostadil is also available as an intraurethral suppository. However, due to efficacy, cost, and side effects, it is not used often.

Description

Alprostadil is produced endogenously and causes vasodilation by means of a direct effect on vascular and ductus arteriosus (DA) smooth muscle, preventing or reversing the functional closure of the DA that occurs shortly after birth. This results in increased pulmonary or systemic blood flow in infants. In infants, it is used for palliative, not definitive, therapy to temporarily maintain the patency of the ductus arteriosus until corrective or palliative surgery can be performed in neonates who have congenital heart defects and who depend upon the patent ductus for survival. In adults, it is used for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology.

Dosage

Your first dose of this medicine will be given in your doctor’s office. You will then be shown how to properly give the medication to yourself. Wait at least 1 day after your first dose before using the medicine again.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

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.

The injectable form of alprostadil is injected into the side of the penis.

The transurethral pellet is a very small suppository that is inserted into the opening of the penis (the urethra).

Do not use more than 2 alprostadil pellets in one day (24 hours). Do not use more than 3 alprostadil injections per week. Allow at least 24 hours to pass between injections.

Alprostadil injectable is a powder medicine that comes with a sterile liquid for mixing it. Your medicine may be supplied in a needle and syringe that contains both the powder medicine and the sterile liquid. The dose is automatically mixed when you turn a dial on the end of the syringe. This syringe is designed for only one use. Carefully follow the instructions provided with this product.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof “sharps” disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Prepare your alprostadil dose only when you are ready to use the medicine. Do not shake the mixed medicine. After mixing, the medicine should be clear. Do not use the medicine if it looks cloudy or has particles in it. Call your pharmacist for new medicine.

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

The Caverject Impulse device uses a very thin needle, which could bend or break easily. Do not use a needle that looks bent. If the needle breaks during injection and you can see and grasp the broken end, remove it and contact your doctor. If you cannot remove the broken end, call your doctor right away.

An alprostadil injection can cause bleeding where the needle is placed. This can make it easier for your sexual partner to be exposed to your blood. A virus such as hepatitis or HIV can be passed to another person who comes into contact with your blood.

To be sure alprostadil is not causing harmful effects, your penis may need to be examined every 3 months. Visit your doctor regularly.

Important Safety Information

Do not use:

• If you are allergic to alprostadil
• If you have an abnormally formed penis or inflammation / infection of the urethra or glans of the penis
• If you have been advised not to undertake sexual activity
• If you have conditions that might result in long-lasting erections, such as sickle cell anemia or trait, leukemia, low blood platelet count, high red blood cell count, or tumors of the bone marrow (multiple myeloma)
• If your partner is pregnant unless you use a condom barrier
• More than twice in a 24-hour period

If your erection is rigid for more than 4 hours, call your doctor promptly.

Do not drive or do other hazardous activities after taking, because dizziness or fainting could occur. In patients experiencing these symptoms, the symptoms have usually occurred during the beginning of treatment and within one hour of using.

Before using, tell your doctor if you have a history of fainting. The first time you use, you should be in your doctor’s office so that your doctor can find the right dose for you and monitor you for symptoms indicating that your blood pressure may be too low, like lightheadedness.

If you do feel dizzy or faint after using, this may be due to the lowering of your blood pressure. Lie down immediately and raise your legs. If these symptoms persist, call your doctor promptly.

does not protect against sexually transmitted diseases or pregnancy. Partners should use adequate protective and contraceptive measures.

The most common side effects that have been seen using are aching in the penis, testicles, legs, and in the perineum (area between the penis and rectum), warmth or burning sensation in the urethra, redness of the penis due to increased blood flow and minor urethral bleeding or spotting due to improper administration.

Storing

• Keep each urethral pellet in its original foil pouch until you are ready to use it. Store the foil pouches in the refrigerator. You may store the pouches at room temperature for up to 14 days.
• Store alprostadil injectable at room temperature. The 40 microgram strength of unmixed alprostadil can be stored at room temperature for up to 3 months, or until the expiration date on the label, whichever happens first.
• After mixing powder with a diluent, store at room temperature and use within 24 hours.
• Do not expose alprostadil products to freezing or very hot temperatures. Do not store your medication in a closed automobile, or pack it into luggage that will be placed into a cargo area during travel.

Overdose symptoms may include feeling light-headed, fainting, or having a painful or prolonged erection lasting 4 hours or longer.

Since alprostadil is used as needed, you will not be on a dosing schedule.

Why is this medication 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).

Brand Names

• Bioglandin Injection

Alprostadil Interactions

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Taking this medicine will not prevent you from passing a disease such as hepatitis or HIV to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Tell your doctor about all your current medicines and any you start or stop using, especially:

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

This list is not complete. Other drugs may interact with alprostadil, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Side Effects

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
• headache
• back pain
• skin problems
• vision problems

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

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

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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: genito-urinary tract disorder (e.g., urethral stricture/obstruction, urethritis, inflammation/infection of the head of the penis), indwelling urethral catheter.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: penis conditions (e.g., angulation, cavernosal fibrosis, Peyronie’s disease), bleeding disorders, blood system cancers (e.g., leukemia, multiple myeloma), heart disease, low blood pressure, sickle cell anemia.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

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.

This medication is not for use in women. If this drug is used by a male for sexual intercourse with a pregnant woman, an effective barrier method such as a latex or polyurethane condom should be used. Consult your doctor or pharmacist for more details.

How to use Alprostadil

Read the Patient Information Leaflet provided by your pharmacist before you start using alprostadil and each time you get a refill. Learn all usage instructions in the product package. If any of the information is unclear, consult your doctor or pharmacist.

This medication is used by inserting the suppository into the penis as directed by your doctor. Dosage is based on your medical condition and response to therapy. This medication should usually work within 5-10 minutes to produce an erection that lasts for about 30-60 minutes. The manufacturer recommends that you use no more than 2 doses in a 24-hour period.

Inform your doctor if your condition persists or worsens (e.g., the drug does not produce an erection or it becomes more difficult to get an erection).

How should alprostadil be used?

Several alprostadil products can be injected. The injection method for these products is the same. However, the ways of preparing the mixtures are different. Be sure you know which product you are using and that you fully understand the correct way to mix the injection.

Do not use alprostadil more often than your doctor has ordered, or in larger amounts. This could result in permanent damage to the penis.

Before drawing the medicine into the syringe, make sure you wash your hands with soap and water and set the bottles on a clean surface. You must also wipe the tops of the injection bottles with an alcohol swab. Do not wipe the needle with the alcohol swab.

Uses

This medication is used to treat male sexual function problems (erectile dysfunction). It works by helping the blood flow into the penis to achieve and maintain an erection.

This medication is not for use in women or children.