MUSE Urethral Stick Ref.[8671] Active ingredients: Alprostadil

Use in Adults

Treatment of erectile dysfunction

Initiation of therapy: a medical professional should instruct each patient on the correct use of MUSE. 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 MUSE easier and is essential to dissolve the drug. To administer MUSE, remove the protective cover from the MUSE 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 MUSE, 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.

Adjunct to other tests in the diagnosis and management of erectile dysfunction

MUSE 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 MUSE 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.

Use in the elderly

No adjustment for age is required.

Overdosage has not been reported with MUSE.

Symptomatic hypotension, persistent penile pain and in rare instances, priapism may occur with alprostadil overdosage. Patients should be kept under medical supervision until systemic or local symptoms have resolved.

Should a prolonged erection lasting 4 or more hours occur, the patient should be advised to seek medical help. The following actions can be taken:

• The patient should be supine or lying on his side. Apply an ice pack alternately for two minutes to each upper inner thigh (this may cause a reflex opening of the venous valves). If there is no response after 10 minutes, discontinue treatment.
• If this treatment is ineffective and a rigid erection has lasted for more than 6 hours, penile aspiration should be performed. Using aseptic technique, insert a 19-21 gauge butterfly needle into the corpus cavernosum and aspirate 20-50 ml of blood. This may detumesce the penis. If necessary, the procedure may be repeated on the opposite side of the penis.
• If still unsuccessful, intracavernous injection of α-adrenergic medication is recommended. Although the usual contraindication to intrapenile administration of a vasoconstrictor does not apply in the treatment of priapism, caution is advised when this option is exercised. Blood pressure and pulse should be continuously monitored during the procedure. Extreme caution is required in patients with coronary heart disease, uncontrolled hypertension, cerebral ischaemia, and in subjects taking monoamine oxidase inhibitors. In the latter case, facilities should be available to manage a hypertensive crisis.
• A 200 microgram/ml solution of phenylephrine should be prepared, and 0.5 to 1.0 ml of the solution injected every 5-10 minutes. Alternatively, a 20 microgram/ml solution of adrenaline should be used. If necessary, this may be followed by further aspiration of blood through the same butterfly needle. The maximum dose of phenylephrine should be 1 mg, or adrenaline 100 micrograms (5ml of the solution).
• As an alternative metaraminol may be used, but it should be noted that fatal hypertensive crises have been reported. If this still fails to resolve the priapism, the patient should immediately be referred for surgical management.

Shelf life: 2 years.

From a microbiological point of view, the product should be used immediately after opening the foil pouch.

Store at 2°-8°C (in a refrigerator). Store in the original package.

Unopened pouches may be kept out of the refrigerator by the patient, at a temperature below 30°C, for up to 14 days prior to use.

MUSE is supplied as cartons of 1, 2, 3, 6 or 10 foil pouches, with each pouch containing one delivery system. Not all pack sizes may be marketed.

The pouches are composed of aluminium foil/laminate. The applicators are made from radiation-resistant medical-grade polypropylene.

No special requirements.