Description
Alprostadil (al-PROS-ta-dil)
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 the following
dosage forms:
Intraurethral
-
Suppositories (U.S.)
Parenteral
-
Injection (U.S. and Canada)
Before Using This Medicine
In deciding to use a medicine,
the risks of using the medicine must be weighed against the good it will do.
This is a decision you and your doctor will make. For alprostadil, the following
should be considered:
Allergies--Tell your doctor if you have ever had any unusual or
allergic reaction to alprostadil. Also tell your health care professional
if you are allergic to any other substances, such as foods, preservatives,
or dyes.
Older adults--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.
Other medicines--Although certain medicines should not be used
together at all, in other cases two different medicines may be used together
even if an interaction might occur. In these cases, your doctor may want to
change the dose, or other precautions may be necessary. Tell your health care
professional if you are taking any other prescription or nonprescription (over-the-counter
[OTC]) medicine.
Other medical problems--The presence of other medical
problems may affect the use of alprostadil. Make sure you tell your doctor
if you have any other medical problems, especially:
-
Abnormal penis, including curved penis and birth defects of the penis--Chance
of problems occurring may be increased
-
Bleeding problems--Chance of bleeding at the place of injection
may be increased
-
Infection of penis or
-
Red or itchy (inflamed) penis--Conditions may worsen with the
use of alprostadil suppositories. Also, local skin problems and minor bleeding
from inserting the suppository may occur
-
Conditions causing thickened blood or slower blood flow, including
leukemia; multiple myeloma (tumors of the bone marrow); polycythemia, sickle
cell disease, or thrombocythemia (blood problems) or
-
Priapism (history of)--Patients with these conditions have an
increased risk of priapism (erection lasting longer than 6 hours) while using
alprostadil
Proper Use of This Medicine
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
.
-
One product called Alprostadil for Injection (brand names
Caverject
and
Edex
) is available as a powder
in an injection bottle (vial).
Caverject
must be
mixed with a solution called Bacteriostatic Water for Injection USP.
Edex
must be mixed with a solution called Sodium Chloride
Injection USP. The solution for mixing comes with your product and may be
already loaded into a syringe or contained in another injection bottle (vial).
-
Another product is called Alprostadil Injection (brand names
Prostin VR Pediatric
and
Prostin
VR
). Although the medicine is already in solution, it is much too strong
to be injected into the penis. The solution must be mixed (diluted) with another
liquid that is sold as a separate prescription, called 0.9% Sodium Chloride
Injection USP. In most cases, a pharmacist will make this solution for you,
giving you the proper strength that you need. Check with your doctor or pharmacist
to make sure the solution has been diluted before using it.
It is important to follow several steps to prepare your alprostadil injection
correctly. Before drawing up the medicine into the syringe:
-
Wash your hands with soap and water.
-
Set the bottles on a clean surface. Wipe the top of the injection
bottles with an alcohol swab.
Do not wipe the needle
.
Throw away the alcohol swab.
-
You may need to attach the needle to the syringe. Do not take the
cap off yet.
How to mix Caverject
:
-
If the syringe already contains the Bacteriostatic Water for Injection
USP, then you need only add the plunger to the syringe. To do this:
-
Pick up the rod-like plunger and place it within the barrel of the
syringe until it touches the rubber piece. Gently screw the plunger into the
rubber piece until it seems secure. Do not use a lot of force.
-
Hold the syringe by the barrel (not the plunger) and take the cap
off the needle.
-
You are now ready to mix the water and the powder. Skip to the directions
under the title, “
To mix the water and powder
.”
-
If the syringe does not already contain the Bacteriostatic Water
for Injection USP, you must withdraw 1 milliliter (mL) of it from the bottle
provided. To do this:
-
Pick up the syringe and take the cap off the needle.
-
Pull the plunger back to the 1-mL mark on the syringe. This pulls
air into the syringe. Insert the needle into rubber top of the bottle while
it is upright and inject the 1 mL of air into the bottle.
-
Turn the bottle upside down using one hand. Be sure the tip of the
needle is covered by solution.
-
With your other hand, pull the plunger back slowly to withdraw 1
mL of solution into the syringe. Remove the needle and skip to the directions
under the title, “
To mix the water and powder
.”
-
To mix the water and powder
:
-
Insert the needle into the bottle of alprostadil and inject 1 milliliter
of Bacteriostatic Water for Injection USP from your syringe into the bottle
of alprostadil.
-
Remove the needle from the bottle, holding the barrel of the syringe.
-
Gently swirl the bottle to mix the powder into the solution, turning
it upside down to wet all the powder in the bottle.
-
Follow the directions below, “
How to draw
your dose into the syringe
.”
How to mix Edex
:
-
The syringe already contains the Sodium Chloride Injection USP. You
need only attach the needle to the syringe and add the plunger. To do this:
-
Remove the needle from its package. Do not remove the needle cap.
Gently screw the needle into place on the syringe tip.
-
Pick up the rod-like plunger and place it within the barrel of the
syringe until it touches the rubber piece. Gently screw the plunger into the
rubber piece until it seems secure. Do not use a lot of force.
-
Hold the syringe by the barrel (not the plunger) and take the cap
off the needle.
-
You are now ready to mix the Sodium Chloride Injection USP and the
powder.
-
Insert the needle into the bottle of alprostadil and inject 1.2 milliliters
of the Sodium Chloride Injection USP from your syringe into the bottle of
alprostadil.
-
Remove the needle from the bottle, holding the barrel of the syringe.
-
Gently swirl the bottle to mix the powder into the solution, turning
it upside down to wet all the powder in the bottle.
-
Follow the directions below, “
How to draw
your dose into the syringe
.”
How to mix Prostin VR or Prostin VR Pediatric
:
-
You will need to get exact mixing instructions from your doctor or
pharmacist if you are given two solutions to be mixed. Follow them carefully,
asking the pharmacist or doctor any questions that you might have before injecting
the medicine.
-
After you or the pharmacist has mixed these solutions, follow the
directions below, “
How to draw your dose into the
syringe
.”
How to draw your dose into the syringe (for all injection
products)
:
-
Check the solution to make sure it is clear.
Do not use the mixture if you can see anything solid in the solution or if
the solution is cloudy or colored
.
-
After the alprostadil solution is mixed and the needle is inserted
into the alprostadil bottle, turn the bottle with the syringe as a unit upside
down in one hand. Be sure the tip of the needle is covered by the solution.
With your other hand, pull the plunger back slowly to draw the correct dose
of the medicine into the syringe.
-
Hold the syringe with the measuring scale at eye level to see that
the proper dose is withdrawn and to check for air bubbles. To remove air bubbles,
tap gently on the measuring scale of the syringe to move any bubbles to the
top of the syringe near the needle.
-
If your dose measures too low in the syringe, withdraw more solution
from the bottle. If there is too much medicine in the syringe, put some back
into the bottle. Then check your dose again.
-
Remove the needle from the bottle, holding the barrel of the syringe,
not the plunger.
-
Place the cover back on the needle. You are now ready to inject your
dose. Follow the directions below, “
How to give
the alprostadil injection
.”
How to give the alprostadil injection
:
-
Choose a spot on your penis as directed by your doctor where you
will give the injection.
-
Clean the injection site with alcohol. Sitting upright or slightly
reclined, hold your penis against the side of your thigh so that it cannot
move.
-
Remove the cover from the needle and hold the needle at a 90-degree
angle to the place of injection.
-
Insert the needle until almost all of the metal part of the needle
is inserted into the penis.
-
Do not inject the medicine just under the surface of the skin, at
the top or head of the penis, or at the base of the penis near the scrotum
or testes. Avoid injecting the medicine into blood vessels that you can see.
-
Press the plunger down slowly, taking 5 to 10 seconds to release
the dose into the penis.
-
The injection is usually not painful. If the injection is very painful
or if you notice bruising or swelling at the place of injection, that means
you are injecting the medicine under the skin. Stop, withdraw the needle,
and reposition it properly before continuing with the injection.
-
Remove the needle and recap it.
-
After you have completed the injection, put pressure on the place
of injection for about 5 minutes or until any bleeding stops. This will prevent
bruising. Then massage your penis as instructed by your doctor. This helps
the medicine spread to all parts of the penis, so that the medicine will work
better.
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
:
-
Remove the delivery device containing the suppository from the foil.
Remove the cap from the applicator stem.
-
Stretch your penis upward to extend its length, pressing your penis
top and bottom. Gently insert the delivery stem up to its collar into your
urethra (located at the top of the penis).
If you have
pain or a pulling feeling in the penis, withdraw the device and start again
.
-
Press the button down slowly as far as it will go. This releases
the suppository into the urethra. After holding the delivery device within
your penis still for 5 seconds, carefully rock the penis and delivery device
as a unit from side to side. This helps remove the suppository from the device.
-
Remove the delivery device while your penis is upright. Look at the
device to make sure that the suppository was completely released.
-
Repeat the process if a part of the suppository remains in the device.
-
After the suppository is completely released, roll your penis between
your hands for 10 seconds. This helps to dissolve the suppository. If you
feel any stinging, continue this motion to help stop it.
-
Sitting, standing, or walking for 10 minutes while an erection is
developing helps increase the blood flow to your penis to gain a proper erection.
How to throw away the suppository delivery device safely
:
-
Replace the cap on the delivery device. After storing it in the foil,
fold and throw away.
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.
Dosing--The dose of alprostadil 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 alprostadil.
If your dose is different,
do not change it
unless your doctor tells you to do so.
-
For the treatment of erectile dysfunction:
-
For
injection
dosage form:
-
Adults--1.25 to 60 micrograms (mcg) as a single dose once a
day. Your exact dose will be determined by your doctor. Inject this medicine
very slowly into your penis as shown to you by your doctor ten to thirty minutes
before intercourse. Allow five to ten seconds to completely inject the dose.
Do not inject more than one dose within twenty-four hours. Also, do not use
this medicine for more than two days in a row or more than three times a week.
-
For
suppository
dosage form:
-
Adults--125, 250, 500, or 1000 mcg as a single dose once a day.
Your exact dose will be determined by your doctor. Insert this medicine into
the urethra of your penis as shown to you by your doctor ten to thirty minutes
before intercourse. Do not insert more than two doses within twenty-four hours.
Storage--To store this medicine:
-
Keep out of the reach of children.
-
Refrigerate Alprostadil Injection USP. Keep the medicine from freezing.
-
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.
-
Refrigerate alprostadil suppositories. Keep from freezing. They may
be stored at room temperature for 14 days.
-
Do not keep outdated medicine or medicine no longer needed. Be sure
that any discarded medicine is out of the reach of children.
Precautions While Using This Medicine
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.
Side Effects of This Medicine
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 the following side effects occur:
Symptoms of too much medicine being absorbed into the body
Other 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. However,
check with your doctor if any of the following side effects continue or are
bothersome:
Rare
Bruising or clotted blood in penis at place of injection, usually
caused by an incorrect injection
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 above
may also occur in some patients. If you notice any other effects, check with
your doctor.
