Muse

Name: Muse

Geriatric

No information is available on the relationship of age to the effects of alprostadil urethral suppository in geriatric patients.

Uses of Muse

Muse is a prescription medication used to treat certain types of erectile dysfunction.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Manufacturer

  • Meda Pharmaceuticals, Inc.

What do I need to tell my doctor BEFORE I take Muse?

  • If you have an allergy to alprostadil or any other part of Muse (alprostadil urethral suppository).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have been told that you are not healthy enough to have sex.
  • If you have a deformed penis, penile implant, or other penile problems.
  • If you have any of these health problems: Polycythemia or thrombocythemia.
  • If you have any of these health problems: Leukemia, multiple myeloma, sickle cell anemia, or other health problems that may raise the chance of painful erection (hard penis) or an erection that lasts for longer than 4 hours. Ask your doctor if you are not sure.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Muse with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Muse?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how Muse affects you.
  • To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
  • Talk with your doctor before you drink alcohol.
  • This medicine does not stop the spread of diseases like HIV or hepatitis that are passed through blood or having sex. Do not have any kind of sex without using a latex or polyurethane condom. Do not share needles or other things like toothbrushes or razors. Talk with your doctor.
  • This medicine is not approved for use in women.
  • If your sex partner is able to get pregnant, use birth control that you can trust to prevent pregnancy.
  • Do not have sex with a pregnant woman while using this medicine unless you use a condom.
  • This medicine is not approved for use in children. Talk with the doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Redness, lumps, swelling, tenderness, or curving of the erection (hard penis).
  • Irritation where Muse is given.
  • Chest pain or pressure or a fast heartbeat.
  • Very bad dizziness or passing out.
  • Very bad headache.
  • Shortness of breath.
  • Very bad penile pain.
  • Any unexplained bruising or bleeding.
  • Call your doctor right away if you have a painful erection (hard penis) or an erection that lasts for longer than 4 hours. This may happen even when you are not having sex. If this is not treated right away, it may lead to lasting sex problems and you may not be able to have sex.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Clinical trials

The Muse system was evaluated in 7 placebo-controlled trials of various design in over 2500 patients with a history of erectile dysfunction of various etiologies. These trials assessed erectile function in the clinic and sexual intercourse in outpatient settings. In studies of sexual performance, patients were screened in the clinic, generally using doses of 125 mcg to 1000 mcg, for a satisfactory erectile response, then sent home with the selected dose or placebo for evaluation of sexual performance. Not all patients beginning titration had a successful dose and some patients could not tolerate Muse, principally because of penile pain, so that the success rates in the studies described below must be understood to represent response rates only in patients who were successfully titrated.

In 2 identical multicenter, double-blind, placebo-controlled, parallel-group studies, 1511 monogamous and heterosexual patients with a mean 4-year history of erectile dysfunction and at least a 3-month history of no erections adequate for sexual intercourse without medical assistance, were enrolled and began dose titration in the clinic with doses between 125 mcg and 1000 mcg. 996 patients (66%) completed dose titration, achieved an erection sufficient for intercourse, and were randomized equally to placebo or active treatment and followed during at-home treatment for up to 3 months. 874 patients and partners completed 3 months of follow-up. About 10%, 20%, 30%, and 40% of patients were titrated to 125 mcg, 250 mcg, 500 mcg, and 1000 mcg, respectively. Couples on active therapy were more likely to have at least 1 successful sexual intercourse (65% vs. 19%) than were couples on placebo. Among patients who reported successful intercourse at least once with active treatment, approximately 7 of 10 Muse systems resulted in successful sexual intercourse. Results were similar in patients with erectile dysfunction stemming from surgery or trauma, diabetes, vascular disease, or other etiologies, and were similar in Caucasians and non-Caucasians. In administrations resulting in sexual intercourse, the duration of erections sufficient for penetration was 6 minutes on placebo and 16 minutes on active drug. Successful therapy with Muse was associated with improvement in the quality of life measures of “emotional well-being” for patients and “relationship with partner” for both patients and their female partners.

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.

Contraindications

Muse is contraindicated in men with any of the following:

  1. Known hypersensitivity to alprostadil.
  2. Abnormal penile anatomy: Muse is contraindicated in patients with urethral stricture, balanitis (inflammation/infection of the glans of the penis), severe hypospadias and curvature, and in patients with acute or chronic urethritis.
  3. Sickle cell anemia or trait, thrombocythemia, polycythemia, multiple myeloma: Muse is contraindicated in patients who are prone to venous thrombosis or who have a hyperviscosity syndrome and are therefore at increased risk of priapism (rigid erection lasting 6 or more hours).
  4. Muse should not be used in men for whom sexual activity is inadvisable (see General Precautions).
  5. Muse should not be used for sexual intercourse with a pregnant woman unless the couple uses a condom barrier.
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