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PHARMACEUTICAL FORM AND CONTENTS OF PACK
Caverject is supplied in a single dose vial of 5-millilitre containing 20 micrograms of sterile lyophilised powder and a prefilled syringe of 2,5 millilitres containing 1 millilitre of diluent. The following materials are also included in the pack:
A 27 gauge needle - 0.5 inch long
A 22 gauge needle - 1½ inches long
Two alcohol swabs.
ACTIVITY
Prostaglandin E1 of vasodilator action.
INDICATIONS
Caverject is indicated in the treatment of erectile dysfunction. It can also be useful as an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction.
CONTRAINDICATIONS
Caverject should not be administered by intracavernosal injection to patients who have a known hypersensitivity to the drug or in patients who have conditions that might predispose them to priapism (erection lasting over four hours), such as sickle cell anaemia, multiple myeloma, or leukaemia, or in patients with anatomical deformation of the penis, such as angulation, cavernosal fibrosis or Peyronie's disease. Patients with penile implants should not be treated with Caverject.
Caverject should not be used in men for whom sexual activity is inadvisable or contraindicated.
PRECAUTIONS
Priapism may occur during treatment. The patient should be instructed to immediately report this to his physician.
Patients on anticoagulants such as warfarin or heparin may have increased propensity for bleeding after the intracavernosal injection. Therefore patients should inform their physician if they are taking anticoagulants.
In some patients, injection of Caverject can induce a small amount of bleeding at the site of injection. In patients infected with blood born diseases, this could increase the transmission of such diseases to their partner. Use of intracavernosal Caverject offers no protection from the transmission of sexually transmitted diseases. Individuals who use alprostadil should be counselled about the protective measures that are necessary to guard against the spread of sexually transmitted diseases, including the human immunodeficiency virus (HIV).
INTERACTIONS
No known interactions. Do not use other medicines for erectile dysfunction at the same time as Caverject.
WARNINGS
Penile fibrosis may occur on rare occasions following the intracavernosal administration of Caverject. Regular follow up of patients, with careful examination of the penis, is strongly recommended to detect signs of penile fibrosis. Treatment with Caverject should be discontinued in patients who develop penile angulation, cavernosal fibrosis or Peyronie's disease.
Use in pregnancy and lactation
Caverject should not be administered to women.
Use in children
Caverject should not be administered to children.
Use in the elderly
The use of Caverject requires no special precaution in elderly patients.
Effects on ability to drive and use machines
The administration of Caverject does not affect the ability to drive or use machines.
POSOLOGY
Caverject (sterile lyophilised) comes in vials of 5 millilitres. The diluent in the syringe provided should be used to perform the reconstitution.
After reconstitution with 1 milliliter of diluent, the volume of the resulting solution contains 20 micrograms of alprostadil per millilitre (See Storage)
Caverject should be administered by direct intracavernosal injection using a 1/2-inch, 27- to 30-gauge needle. The dose of Caverject should be individualized for each patient by careful titration under supervision by the physician. Doses of greater than 60 micrograms are not recommended. You should use Caverject no more than once in a 24 hour period and not more than three times a week.
The first injections of Caverject must be done at the physician's office by medically trained personnel. Self-injection therapy by the patient can be started only after the patient is properly instructed and well trained in the self-injection technique.
The dose of Caverject that is selected for self-injection treatment should provide the patient with an erection that is satisfactory for sexual intercourse. It is recommended that the dose administered produces a duration of the erection not exceeding one hour. If the duration is longer, the dose should be reduced. Self-injection therapy for use at home should be initiated at the dose that was determined in the physician's office; however, dose adjustment, if required should be made only after consultation with the physician. The dose should be adjusted in accordance with the titration guidelines described above. While on self-injection treatment, it is recommended that the patient visit the prescribing physician's office every 3 months so careful and continuous follow-up of the patient can be exercised. The reconstituted vial, the syringe and the needles are intended for single use only and should be discarded after use.
INSTRUCTIONS FOR THE CORRECT ADMINISTRATION OF THIS MEDICATION
Self-injection procedure
Dilution instructions
1. Wash your hands thoroughly with soap and water.
2. Remove the plastic cap from the vial.
3. Wipe the rubber stopper on the vial of Caverject with one alcohol swab provided (the other one will be used later on).
4. Unwrap the largest needle (22 gauge, 1 ½ inch), keeping its plastic needle cover in place. Turn the upper part of the white-tamper-evident seal on the syringe by breaking the seal. Join the needle to the syringe by turning it onto the neck of the syringe.
5. Push the needle through the centre of the vial's rubber stopper and push the syringe plunger all the way down to expel all the diluent into the vial.
6. Gently swirl the vial to mix the contents until all the powder has dissolved.
Removing fluid from the vial
7. To draw the solution from the vial, turn the vial upside down. Keep the needle tip below the level of the solution, slowly pull back on the syringe plunger to the correct volume mark for the dose prescribed by your doctor and withdraw the solution.
8. If there are air bubbles, gently tap the sides of the syringe to allow them to float to the top of the solution, or inject the solution into the vial again and draw the solution slowly.
9. Hold the sides of the syringe (not the plunger) and pull the needle/syringe from the vial.
10. Attach the smaller needle in order to carry out self-injection.
Self-injection
Caverject will be injected into a corpus cavernosum (spongy tissue) of the penis. One corpus cavernosum runs the length of the right side of the penis. Another corpus cavernosum runs the length of the left side of the penis (see Figure). Carefully follow these instructions so as to make sure that the medication is injected correctly.
11. Perform the self-injection procedure whilst sitting in an upright or slightly reclining position.
12. Inject Caverject only in the areas (corpus cavernosum) as shown in the figure. Alternate the injection site each time you use Caverject; choose one side of your penis for this injection, use the other side next time and so on. Within each area, the actual point of injection should also be changed each time.
13. Hold the head of your penis with your thumb and forefinger. Fully stretch your penis lengthwise along your thigh to keep it from moving during the injection. If you are uncircumcised the foreskin must be pulled back before you inject the solution.
14. Clean the injection area with the unused alcohol swab and let it dry. Put the swab to one side.
15. Hold the syringe between your thumb and index finger. Do not place your thumb on the plunger. Using a steady, continuous motion, push the needle straight into the selected site as indicated by your doctor. Visible veins should be avoided.
16. Place your thumb on the top of the plunger and, with a steady, continuous motion, push down on the plunger so that the entire volume of Caverject is slowly injected.
17. Withdraw the needle from your penis. Apply pressure to both sides of the penis and apply pressure to the injection site for at least three minutes with the alcohol swab. If bleeding occurs, maintain this pressure on the injection site until the bleeding stops.
18. Dispose of the syringe and the needle safely.
19. If you have any doubts or questions consult your doctor.
OVERDOSE
Prolonged erection or priapism may occur following administration of Caverject. The patient should be instructed to immediately report this to his physician or, if unavailable, to seek immediate medical assistance. In the case of an overdose or accidental ingestion, contact your local poison control centre (Servicio de Información Toxicológica. Telephone: (91) 562 04 20).
ADVERSE REACTIONS
Check with your doctor or pharmacist as soon as possible if you experience any adverse effects not listed in this leaflet.
The most frequent adverse reaction after intracavernosal injection of Caverject is mild to moderate penile pain. Hematoma at the site of injection, which is related to the injection technique rather than to the effects of Caverject has occurred less frequently. Prolonged erection and priapism has also occurred less frequently after intracavernosal administration of Caverject. In the majority of cases, spontaneous detumescence occurred. Other local adverse reactions reported after intracavernosal injection of Caverject are: injection site ecchymosis (redness of skin at injection site), injection site exanthem, injection site oedema, injection site fibrosis. The following may occur less frequently: inflammation of the glans penis, injection site hemorrhage, injection site inflammation, injection site swelling, urethral bleeding, penile warmth, numbness, yeast infection, irritation, sensitivity, phimosis, pruritus, erythema, venous leak, painful erection and abnormal ejaculation.
The following systemic events, which were possibly related to the use of Caverject were rarely reported: testicular pain or swelling, scrotal erythema, pain or tightness, urinary frequency, urinary urgency, hypotension, vasodilatation, hypertension, supraventricular extrasystole, peripheral vascular disorder, dizzoness, hypesthesia, buttock weakness, localized pain (buttocks pain, leg pain, genital pain, abdominal pain), headache, pelvic pain, back pain and flu syndrome.
Certain hemodynamic changes, manifested as decreases in blood pressure and increases in pulse rate were observed, these may be dose-dependent.
Caverject had no clinically important effect on serum or urine laboratory tests.
STORAGE
Caverject must be stored at or below 25°C. In these conditions the shelf-life of the product is 24 months (see date indicated on the pack). After reconstitution, the solution of Caverject should be used within 24 hours when stored at or below 25°C. Do not use the solution if it is cloudy, coloured or contains particles.
EXPIRY
This medication must not be used after the expiry date indicated on the pack.
OTHER PRESENTATIONS
Caverject 10 micrograms
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