Bioglandin Injection (Alprostadil Injection)

Bioglandin Injection (Alprostadil)

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

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

You should not use this medicine if you are allergic to alprostadil, or if you have sickle cell anemia, leukemia, a bone marrow tumor, a curved or deformed penis, penile fibrosis or Peyronie's disease, a penile implant, or if you have been told you should not have sexual intercourse for health reasons. Using too much alprostadil can be very dangerous. Follow all directions on your prescription label. Seek emergency medical attention if you have a painful or prolonged erection lasting 4 hours or longer.

What should I discuss with my healthcare provider before using alprostadil?

You should not use alprostadil if you are allergic to it, or if you have: sickle cell anemia or the sickle cell anemia trait; leukemia; a tumor of the bone marrow (multiple myeloma); a curved or deformed penis; penile fibrosis or Peyronie's disease; if you have a penile implant; or if you have been told you should not have sexual intercourse for health reasons.

To make sure alprostadil is safe for you, tell your doctor if you have: a history of blood clots; heart disease, high blood pressure (hypertension); a bleeding or blood-clotting disorder; or a disease that could be passed in blood (such as hepatitis or HIV). Use a condom to prevent transfer of this medicine to your sexual partner if she is pregnant or could become pregnant. Caverject, Caverject Impulse, Edex, or Muse should not be used by women or by anyone under 18 years old.

How should I use Alprostadil Injection?

Your first dose of this medicine will be given in your doctor's office so you can be watched for how well the medicine works and if it causes any side effects. 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. Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions. 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. Caverject Impulse is a brand of alprostadil injectable supplied as 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. The Caverject Impulse 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.

Storing this medicine:

• 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.

• 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.

Alprostadil side effects

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

Stop using alprostadil and call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• trouble urinating, blood in your urine;

• 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.

Common side effects may include:

• mild pain in your penis, urethra, or testicles;

• unusual discharge from your penis; or

• cough, stuffy nose, cold symptoms, flu symptoms.

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

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include feeling light-headed, fainting, or having a painful or prolonged erection lasting 4 hours or longer.

What should I avoid while using alprostadil?

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.

What other drugs will affect alprostadil?
Other drugs may interact with alprostadil, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

INTRACAVERNOUS:
1 to 40 mcg intracavernous injection into the lateral penis given over 5 to 10 seconds

Maximum dose: 3 times per week, with at least 24 hours between each use

Comments:
-Erectile dysfunction of vasculogenic, psychogenic, or mixed etiology: Initiate at 2.5 mcg; if there is partial response to initial dose, may increase to 5 mcg and then by increments of 5 to 10 mcg, depending upon erectile response, until the dose that produces an erection suitable for intercourse and not exceeding duration of 1 hour is reached; if there is no response to initial dose, may increase to 7.5 mcg and then by increments of 5 to 10 mcg.
-Erectile dysfunction of pure neurogenic etiology (spinal cord injury): Initiate at 1.25 mcg; may increase to 2.5 mcg, then 5 mcg, and then in 5 mcg increments until the dose that produces an erection suitable for intercourse and not exceeding duration of 1 hour is reached.
-The patient must remain in the physician's office following the first dose until complete detumescence occurs. If there is a response, the next dose may be given after a 1-day interval. If there is no response, the next higher dose may be given within 1 hour. 

TRANSURETHRAL:
Initial dose: 125 or 250 mcg inserted into the urethra
Maximum dose: 2 systems per 24-hour period