Active Ingredient: Alprostadil
Alprostadil is indicated for the treatment of erectile dysfunction in adult males due to neurogenic, vasculogenic, psychogenic or mixed aetiology. Alprostadil may be a useful adjunct to other diagnostic tests in the diagnosis of erectile dysfunction.
For this indication, competent medicine agencies globally authorize below treatments:
Intracavernous
2.5 - 40 ug
From 2.5 To 40 ug once every day
Alprostadil is administered by direct intracavernous injection. A half inch, 27 to 30 gauge needle is generally recommended. The dose of Caverject should be individualised for each patient by careful titration under supervision by a physician.
The intracavernosal injection must be done under sterile conditions. The site of injection is usually along the dorsolateral aspect of the proximal third of the penis. Visible veins should be avoided. Both the side of the penis that is injected and the site of injection must be alternated; prior to the injection, the injection site must be cleansed with an alcohol swab.
20 micrograms alprostadil to be injected into the corpus cavernosum and massaged through the penis. Should an ensuing erection persist for more than one hour detumescent therapy should be employed prior to the subject leaving the clinic to prevent a risk of priapism.
Over 80% of subjects may be expected to respond to a single 20 micrograms dose of alprostadil. At the time of discharge from the clinic, the erection should have subsided entirely and the penis must be in a completely flaccid state.
These patients can be expected to respond to lower doses of alprostadil. In subjects with erectile dysfunction caused by neurologic disease/trauma the dose for diagnostic testing must not exceed 10 micrograms and an initial dose of 5 micrograms is likely to be appropriate. Should an ensuing erection persist for more than one hour detumescent therapy should be employed prior to the subject leaving the clinic to prevent a risk of priapism. At the time of discharge from the clinic, the erection should have subsided entirely and the penis must be in a completely flaccid state.
The initial dose of alprostadil in patients with erectile dysfunction of neurogenic origin secondary to spinal cord injury is 1.25 micrograms, with a second dose of 2.5 micrograms, a third of 5 micrograms, and subsequent incremental increases of 5 micrograms until an optimal dose is achieved. For erectile dysfunction of vasculogenic, psychogenic, or mixed aetiology, the initial dose is 2.5 micrograms. The second dose should be 5 micrograms if there is a partial response, and 7.5 micrograms if there is no response. Subsequent incremental increases of 5-10 micrograms should be given until an optimal dose is achieved. If there is no response to the administered dose, then the next higher dose may be given within 1 hour. If there is a response, there should be at least a 1-day interval before the next dose is given. The usual maximum recommended frequency of injection is no more than once daily and no more than three times weekly.
The first injections of alprostadil must be done by medically trained personnel. After proper training and instruction, alprostadil may be injected at home. If self-administration is planned, the physician should make an assessment of the patient’s skill and competence with the procedure. It is recommended that patients are regularly monitored (e.g. every 3 months) particularly in the initial stages of self injection therapy when dose adjustments may be needed.
The dose 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. The majority of patients achieve a satisfactory response with doses in the range of 5 to 20 micrograms. Doses of greater than 60 micrograms of alprostadil are not recommended. The lowest effective dose should be used.
Urethral
125 - 1,000 ug
From 125 To 1,000 ug once every day
Initiation of therapy: a medical professional should instruct each patient on the correct use of alprostadil. The recommended starting dose is 500 micrograms.
Dosage may be increased in a stepwise manner (to 1000 micrograms), or decreased (to 250 or 125 micrograms) under medical supervision until the patient achieves a satisfactory response. After an assessment of the patient’s skill and competence with the procedure, the chosen dose may then be prescribed for home use.
It is important for the patient to urinate before administration since a moist urethra makes administration of alprostadil easier and is essential to dissolve the drug. To administer alprostadil, remove the protective cover from the alprostadil applicator, stretch the penis upward to its full length, and insert the applicator stem into the urethra. Depress the applicator button to release the medication from the applicator and remove the applicator from the urethra, (rocking the applicator gently prior to removal will ensure that the medication is separated from the applicator stem). Roll the penis between the hands for at least 10 seconds to ensure that the medication is adequately distributed along the wall of the urethra. If the patient feels a burning sensation it may help to roll the penis for an additional 30 to 60 seconds or until the burning subsides. The erection will develop within 5-10 minutes after administration and lasts approximately 30-60 minutes. After administration of alprostadil, it is important to sit, or preferably, stand or walk for about 10 minutes while the erection is developing. More detailed information is given in the patient information leaflet. During home use, periodic checks of efficacy and safety are recommended.
Not more than 2 doses are recommended to be used in any 24-hour period, and not more than 7 doses are recommended to be used in a 7-day period. The prescribed dosage should not be exceeded.
Alprostadil can be used as an adjunct in evaluating penile vascular function using Doppler duplex ultrasonography. It has been shown that a 500 microgram dose of alprostadil has a comparable effect on penile arterial dilatation and peak systolic velocity flow to 10 microgram of alprostadil given by intracavernosal injection. At the time of discharge from the clinic, the erection should have subsided.
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