Generic Name: alprostadil (Intraurethral route, Intravenous route, Intracavernosal route)
Apnea is experienced by about 10% to 12% of neonates with congenital heart defects treated with alprostadil injection. Apnea is most often seen in neonates weighing less than 2 kg at birth and usually appears during the first hour of drug infusion. Therefore, respiratory status should be monitored through out treatment, and alprostadil injection should be used where ventilatory assistance is immediately available .
Apnea is experienced by about 10% to 12% of neonates with congenital heart defects treated with alprostadil injection. Apnea is most often seen in neonates weighing less than 2 kg at birth and usually appears during the first hour of drug infusion. Therefore, respiratory status should be monitored throughout treatment, and alprostadil injection should be used only where ventilatory assistance is immediately available .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Erectile Dysfunction Agent
Pharmacologic Class: Prostaglandin
Alprostadil belongs to a group of medicines called vasodilators that can increase blood flow by expanding blood vessels. 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.
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:
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.
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.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
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.
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.
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.
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:
This section provides information on the proper use of a number of products that contain alprostadil. It may not be specific to Edex. Please read with care.
Special patient directions come with the suppositories and some of the injection medicines. Read the directions carefully before using the medicine.
For the injections—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.
It is important to follow several steps to prepare your alprostadil injection correctly. Before drawing up the medicine into the syringe:
How to mix Caverject:
How to mix Edex:
How to mix Prostin VR or Prostin VR Pediatric:
How to draw your dose into the syringe (for all injection products):
How to give the alprostadil injection:
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 suppositories—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:
How to throw away the suppository delivery device safely:
For injections or suppositories—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.
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.
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 °C or 59 and 77 °F) for 3 months. After it is mixed, the solution must be used immediately. Suppositories may be stored at room temperature
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.
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
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
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.
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