INDICATION

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

Warning: Do not drive or do other hazardous activities after taking MUSE because low blood pressure or fainting may occur. Fainting within 1 hour of taking MUSE has been reported.

Important Risk Information about MUSE

Because sex is a vigorous physical activity and increases heart rate and work, make certain that your doctor determines that you are healthy enough for sex before you use MUSE. If you have chest pain, nausea or other discomforts during sex, seek immediate medical help.

You can continue to read Important Risk Information at the bottom of this page
Patient Information Full Prescribing Information U.S. Consumers U.S. Healthcare Professionals
 

Full Prescribing Information

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  • Description
    Overview of MUSE, including a description of its dosage form, and information about how it is administered and how it is packaged.
  • Clinical pharmacology
    In-depth information about the mechanism of action used by MUSE, about its pharmacokinetics, and about how it is absorbed, distributed, metabolised, and excreted. Includes information about pharmacokinetics in special populations.
  • Clinical trials
    Description of several placebo-controlled evaluations of the MUSE system.
  • Indications and usage
    Information about the indication for and usage of the MUSE system.
  • Contraindications
    Conditions and factors that could make individuals inappropriate or ineligible candidates for MUSE.
  • Warnings
    Important information about MUSE titration (dosing) and usage.
  • Precautions
    General precautions about using MUSE as well as information for patients and their partners, and about potential side effects.
  • Adverse reactions
    Potential adverse reactions that can occur during in-clinic titration (dosing) and during home treatment. Includes information about adverse reactions that may be experienced by patients' female partners.
  • Overdosage
    Information about the results of potential overdose and how, if overdose is suspected, it should be treated.
  • Dosage and administration
    Information about how to initiate therapy with MUSE and about how home treatment regimens using MUSE should be followed.
  • How supplied
    Description of how MUSE is supplied, broken down by dosage strength.
  • Storage and handling
    Recommendations for storing and handling of the MUSE system.

INDICATION: MUSE (alprostadil) 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.

Warning: Do not drive or do other hazardous activities after taking MUSE because low blood pressure or fainting may occur. Fainting within 1 hour of taking MUSE has been reported.

Important Risk Information

Because sex is a vigorous physical activity and increases heart rate and work, make certain that your doctor determines that you are healthy enough for sex before you use MUSE. If you have chest pain, nausea or other discomforts during sex, seek immediate medical help.

The first time you use MUSE should be in your doctor's office so that your doctor can find the dose that is right for you and so that you can be monitored for low blood pressure, which may cause you to faint.

Make sure your doctor knows about any drugs you are using to lower blood pressure before you start using MUSE. Tell your doctor if you have any symptoms indicating that blood pressure may be too low (e.g., lightheadedness) when you use MUSE.

Carefully follow your doctor's instructions for inserting MUSE in the urethra to avoid scratching the inside of your urethra (the channel that urine and semen pass through), which could result in minor bleeding. If you are on anti-coagulant (blood thinning) medicine, or have a bleeding disorder, you may be at higher risk of bleeding.

If you have an erection lasting more than 4 hours, seek immediate medical help to avoid long-term injury.

Use a condom if your partner is pregnant, or could become pregnant.

MUSE does not protect against sexually transmitted diseases.

The most common side effects of MUSE are penis pain, burning in the urethral opening, urethral bleeding, pain in testicles, low blood pressure, and dizziness.

Do not use MUSE if:

  1. Your penis is severely curved, or you have a narrow urethra, or your penis is otherwise abnormally shaped.
  2. The head of your penis is inflamed or you have an infection of the urethra, or regularly get infections of the urethra.
  3. You have sickle cell anemia or trait, any disorder of the red blood cells or platelets, multiple myeloma, or are prone to blood clots or have an abnormal thickening of the blood, because these things can mean you have an increased risk of priapism (rigid erection lasting 6 or more hours).
  4. You are allergic to alprostadil.

MUSE has not been studied in men who have penile implants. There is no experience in homosexual men and no experience with other than vaginal intercourse.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see Patient Information.

 

This product is intended only for residents of the United States.
©2012 Meda Pharmaceuticals Inc. All rights reserved.
MUSE and Meda are registered trademarks of Meda AB.
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