alprostadil sterile powder for injection
IMPOTENCE: CAUSES AND TREATMENTS
There are several causes of impotence, a condition known medically as erectile dysfunction. These include: medications that you may be taking for other conditions, impaired blood circulation in the penis, nerve damage, emotional problems, excessive smoking or alcohol use, use of street drugs, and hormonal imbalances. Often, impotence is due to more than one cause.
Treatments for impotence include: switching medications (if you are taking
a medication that causes impotence), administration of hormones, penile injections,
use of medical devices that produce an erection, surgical procedures to correct
blood flow in the penis, penile implants, and psychological counseling. Your
doctor has selected CAVERJECT for injection to treat your impotence. Your doctor
can also discuss other available treatments. You should not stop taking any
prescription medications, unless told to do so by your doctor.
USE OF CAVERJECT
CAVERJECT is injected into a specific area of the penis and should produce an erection in 5 to 20 minutes. The erection should last for about 1 hour. Generally, you should not use CAVERJECT more than 3 times a week, with at least 24 hours between uses.
Who Should Not Use CAVERJECT?
Men who have conditions that might result in long-lasting erections should not use CAVERJECT. Some of these conditions include: sickle cell anemia or trait, leukemia, and tumor of the bone marrow (multiple myeloma). Men with penile implants, or an abnormally formed penis, or who have been advised not to engage in sexual activity should not use CAVERJECT. CAVERJECT should not be used by women or children.
What Are The Risks Of Using CAVERJECT?
Erections that last more than 4 hours can cause serious and permanent damage.
Call your doctor or seek professional help immediately if you still have
an erection 4 hours after injection.
The most common side effect of CAVERJECT is mild to moderate pain after injection.
About onethird of patients report this effect.
Call your doctor if you notice any redness, lumps, swelling, tenderness, or curving of the erect penis.
A small amount of bleeding at the injection site may occur. Tell your doctor if you have a condition or are taking a medicine that interferes with blood clotting.
NOTE: CAVERJECT offers no protection from the transmission of sexually transmitted diseases such as HIV (the virus that causes AIDS). Small amounts of bleeding at the injection site can increase the risk of transmission of blood-borne diseases between partners.
There is no approved injectable treatment using multiple drug components or "cocktails" for erectile dysfunction. Moreover, there are no data on the efficacy and safety of these combinations.
Unused packs of 5, 10 and 20 microgram vials of CAVERJECT may be stored
at or below 25°C (77°F). Unused packs of the 40 microgram vial
may be stored at or below 25°C (77°F) for 3 months or until expiration
date, whichever occurs first. Do not freeze.
After reconstitution, the solution of CAVERJECT should be used within 24
hours when stored at or below 25°C (77°F) and not refrigerated or
During travel, care should be taken to avoid allowing the product to freeze
or be stored at temperatures above 25°C (77°F). Therefore, do not
store in checked luggage during air travel or leave in a closed automobile.
There is a technical leaflet discussion of CAVERJECT written for health-care professionals that your pharmacist can let you read.
More information about erectile dysfunction and its treatment is available
from the National Institutes of Health (Washington, DC), the American Foundation
for Urological Diseases (Baltimore, MD), or the Impotence Institute of America
PREPARING AND INJECTING CAVERJECT
You must be properly instructed and trained in the injection technique by
your doctor before using CAVERJECT.
Before using CAVERJECT, talk to your doctor about what to expect when using it, possible side effects, and what to do if side effects occur. Your dose has been selected for your individual needs. Do not change your dose without consulting your doctor. If you are not sure of the volume or dose to be used, talk to your doctor or pharmacist.
Follow these instructions exactly to prepare and inject a sterile dose of CAVERJECT.
If the needle is severely bent at any time, do not use it for injecting CAVERJECT
and do not attempt to straighten it prior to injecting CAVERJECT. A severely
bent and restraightened needle may be predisposed to breakage. Needle breakage,
with a portion of the needle remaining in the penis, has been reported and,
in some cases, required hospitalization and surgical removal. If the needle
is severely bent while preparing the injection, remove it from the syringe,
discard, and attach a new, unused sterile needle to the syringe as described
under "Prepare the Dose" below.
Use the needle, syringe, alcohol swabs, and vials only once then safely
discard the supplies and any unused solution. Discard your needle/syringe, and
alcohol swabs in a special container for disposal of sharp medical supplies.
Ask your doctor or pharmacist where you can get these special containers.
To prepare and inject CAVERJECT you will need a vial of CAVERJECT Sterile Powder,
a vial of diluent (bacteriostatic water for injection or sterile water, both
preserved with benzyl alcohol 0.945% w/v), a disposable sterile 3-milliliter
(3-cc) syringe, a 1/2-inch 27-gauge sterile needle, and two alcohol swabs (Figure
CAVERJECT comes in 5, 10, 20 or 40 microgram strengths. MAKE SURE YOU HAVE
THE RIGHT STRENGTH VIAL OF CAVERJECT.
Prepare the Dose
Wash your hands thoroughly, and dry them with a clean towel.
Assemble the needle and syringe as follows:
a. Remove the syringe from its sterile wrapping.
b. To remove the sterile needle from its wrapping, carefully
pull the wrapper tabs back enough to expose the sterile open end of the needle
assembly. Do not touch the open end of the needle (Figure B).
c. While holding the sterile needle assembly between thumb
and forefinger, pick up syringe with other hand. With same two fingers, remove
the plastic syringe cap (Figure C). Do not touch the syringe tip.
d. Without removing the plastic needle cover, firmly attach
the needle to the syringe tip (twist to tighten) (Figure D).
e. With the needle cover in place, set the syringe and
needle down on a clean, level surface.
Remove the plastic caps from the vials of CAVERJECT and diluent.
Wipe the rubber stoppers on the vials of CAVERJECT and diluent with one
alcohol swab. Discard this alcohol swab.
Grasp the syringe barrel (not the plunger) and remove the needle cover.
Do not discard the needle cover, you will need to use it again (see step 16).
Do not touch the exposed needle. Holding the syringe/needle in a straight
line with the diluent vial to avoid bending the needle, push the needle through
the center of the diluent vial's rubber stopper.
Keeping the needle in the vial, firmly hold the vial and syringe upside
down in one hand (see Figure E).
Keeping the needle tip below the level of fluid, pull back on the syringe
plunger until all the diluent is removed from vial.
Push the syringe plunger to the 1-cc (mL) mark on the syringe. This will
expel air and excess diluent back into vial.
Grasp the side of syringe barrel (not the plunger) and pull the needle/syringe
from the diluent vial in a straight line to avoid bending the needle.
Holding the syringe/needle in a straight line with the vial of CAVERJECT
to avoid bending the needle, push the needle through the center of the rubber
stopper of the vial of CAVERJECT and push the syringe plunger all the way
down to expel all the diluent into the vial. Proceed immediately to step 11.
Without removing the needle or touching the needle or stopper, gently
swirl (do not shake) the vial until all the powder is dissolved in the diluent.
Then turn the vial and needle/syringe upside down and gently swirl
the vial to dissolve any powder in the neck of the vial. DO NOT USE THE
SOLUTION IF IT IS CLOUDY, COLORED OR CONTAINS PARTICLES.
Keeping the needle in the vial, firmly hold the vial and syringe upside
down in one hand (see Figure E).
Keeping the needle tip below the level of fluid, slowly pull back on the
syringe plunger until all the fluid is removed from the vial.
If there are air bubbles, gently tap the syringe barrel until they float
to the top of the solution (see Figure F). Holding the syringe upright, push
the syringe plunger to the correct volume mark for the dose prescribed by
your doctor. This will expel any air and excess solution into the vial.
Grasp the syringe barrel (not the plunger) and pull the needle/syringe
from the vial of CAVERJECT in a straight line to avoid bending the needle.
Place the needle cover over the needle and set the syringe down on a level
Select Injection Site
CAVERJECT will be injected into a corpus cavernosum (spongy tissue) of
the penis. One corpus cav- ernosum runs the length of the right side of the
penis. Another corpus cavernosum runs the length of the left side of the penis
(see Figures G and H).
Choose an injection site on one side of the shaft of the penis as shown
in Figure G. AVOID VISIBLE BLOOD VESSELS.
WITH EACH USE OF CAVERJECT, ALTERNATE THE SIDE OF THE PENIS AND VARY THE
Inject Your Dose of CAVERJECT
You should be sitting upright or slightly reclined when injecting CAVERJECT.
If your penis is not circumcised, pull the foreskin back. Holding the head
of your penis with your thumb and forefinger, stretch it lengthwise along
your thigh so that you can clearly see the selected injection site.
Clean the injection site with a new alcohol swab. Do not discard this swab,
you will need to use it again (see step 7).
Remove the cover from the needle. Reposition the penis firmly against your
thigh as in step 2 to keep it from moving during the injection.
Hold the syringe between your thumb and index finger (Figure I). Using
a steady motion, push the needle straight into the selected site until the
metal part of the needle is almost entirely in the penis.
Holding the syringe barrel between two fingers, move your thumb or
finger to the top of the plunger and, with a steady motion, push down on the
plunger so that the entire volume of CAVERJECT is slowly injected (Figure
Grasp the syringe barrel and pull the needle out of your penis. APPLY
PRESSURE TO THE INJECTION SITE your penis. APPLY PRESSURE TO THE INJECTION
SITE WITH THE ALCOHOL SWAB FOR ABOUT 5 MINUTES OR UNTIL BLEEDING STOPS.
Disposal of Injection Materials
Disposal of Injection Mate
Discard your needle, syringe, and alcohol swabs in a special container
for disposal of sharp medical supplies. Ask your doctor or pharmacist where
you can obtain these special containers. Follow the directions on your disposal
container for proper disposal procedures.
Do not re-use or share needles or syringes. As with all prescription medicines,
do not allow anyone else to use your medicine.