Muse (Alprostadil) - Indications and Dosage

INDICATIONS AND USAGE

MUSE is indicated for the treatment of erectile dysfunction. Studies that established benefit demonstrated improvements in success rates for sexual intercourse compared with similarly administered placebo.

DOSAGE AND ADMINISTRATION

MUSE is a transurethral delivery system available in 4 dosage strengths: 125 mcg, 250 mcg, 500 mcg, and 1000 mcg. MUSE should be administered as needed to achieve an erection. The onset of effect is within 5–10 minutes after administration. The duration of effect is approximately 30–60 minutes. However, the actual duration will vary from patient to patient. Each patient should be instructed by a medical professional on proper technique for administering MUSE prior to self-administration. The maximum frequency of use is no more than 2 systems per 24-hour period.

Initiation of Therapy:

Dose titration should be administered under the supervision of a physician to test a patient's responsiveness to MUSE, to demonstrate proper administration technique (see detailed instructions for MUSE administration in patient package insert), and to monitor for evidence of hypotension (see WARNINGS). Patients should be individually titrated to the lowest dose that is sufficient for sexual intercourse. The lower doses of MUSE (125 mcg or 250 mcg) are recommended for initial dosing. If necessary, the dose should be increased (or decreased) on separate occasions in a stepwise manner until the patient achieves an erection that is sufficient for sexual intercourse.

Home Treatment Regimen:

MUSE should be used as needed to achieve an erection. The maximum frequency of use is 2 administrations per 24-hour period. Each MUSE is for single use only and should be properly discarded after use.

HOW SUPPLIED

MUSE is supplied in individual foil pouches containing one (1) system per pouch. MUSE is available in unit cartons containing six (6) systems. MUSE is available in the following 4 dosage strengths:

Dosage	NDC Numbers		Identifying
Strength	Carton	Pouch	Package Color
125 mcg	0037-8110-06	0037-8110-01	Tan
250 mcg	0037-8120-06	0037-8120-01	Green
500 mcg	0037-8130-06	0037-8130-01	Blue
1000 mcg	0037-8140-06	0037-8140-01	Burgundy

Rx Only.

STORAGE AND HANDLING

Store unopened foil pouches in a refrigerator at 2°– 8°C (36°– 46°F). Do not expose MUSE to temperatures above 30°C (86°F). MUSE may be kept by the patient at room temperature (below 30°C or 86°F) for up to 14 days prior to use.

Medical information line at Meda Pharmaceuticals Inc. 1-888-345-MUSE (1-888-345-6873).

MUSE^® IS A REGISTERED TRADEMARK OF MEDA AB, USED UNDER LICENSE BY MEDA PHARMACEUTICALS INC.

MEDA PHARMACEUTICALS^®
Meda Pharmaceuticals Inc.
Somerset, New Jersey 08873-4120

http://www.muserx.net
Catalog Number: 05-10-00001D
IN-1001-02
Revised August 2012
U.S. Patent No. 5,886,039
©2012 Meda Pharmaceuticals Inc.