MUSE 125 microgram urethral stick

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Alprostadil

Verfügbar ab:

Mylan IRE Healthcare Limited

ATC-Code:

G04BE; G04BE01

INN (Internationale Bezeichnung):

Alprostadil

Dosierung:

125 microgram(s)

Darreichungsform:

Urethral stick

Verschreibungstyp:

Product subject to prescription which may not be renewed (A)

Therapiebereich:

Drugs used in erectile dysfunction; alprostadil

Berechtigungsstatus:

Not marketed

Berechtigungsdatum:

1999-02-05

Fachinformation

Health Products Regulatory Authority
24 November 2020
CRN00C1SM
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
MUSE 125 microgram urethral stick
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each urethral stick contains 125 micrograms alprostadil.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Urethral Stick.
MUSE is a sterile, single-use transurethral system for the delivery of
alprostadil to the male urethra. Alprostadil is suspended
in polyethylene glycol and is formed into a urethral stick (1.4 mm in
diameter by 3 mm in length) which is contained in the tip
of the polypropylene applicator.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of erectile dysfunction of primarily organic etiology.
Adjunct to other tests in the diagnosis and management of erectile
dysfunction.
MUSE is indicated in adults aged 18 years and above.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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