Muse 250mcg Transurethral System

Manufacturer MEDA Active Ingredient Alprostadil Urethral Suppository(al PROS ta dill) Pronunciation al PROS ta dill
It is used to treat erectile dysfunction (ED).Some products may be used to help test for ED.
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Drug Class
Erectile Dysfunction Agent
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Pharmacologic Class
Prostaglandin E1 (PGE1) analog; Vasodilator
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Pregnancy Category
Not applicable (for male use)
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FDA Approved
Nov 1996
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Muse is a small pellet containing the medicine alprostadil that is inserted into the opening of the penis (urethra). It works by increasing blood flow to the penis, which helps to achieve and maintain an erection for sexual activity.
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How to Use This Medicine

Proper Use of This Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is designed for insertion into the urethra, the tube through which urine passes. Your doctor will provide guidance on how to properly administer the medication. It's essential to understand the correct usage, so be sure to read the instructions for use that come with the medication. If you have any questions or concerns, or if instructions are not provided, consult with your doctor or pharmacist.

For optimal effectiveness, urinate before using the medication. To maintain hygiene, wash your hands both before and after use.

Storage and Disposal

Store unopened foil pouches in the refrigerator.

Missed Dose

This medication is used as needed. Do not use it more frequently than directed by your doctor.
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Lifestyle & Tips

  • Follow the administration instructions carefully to ensure proper use and minimize side effects.
  • Avoid alcohol consumption, as it can worsen erectile dysfunction and increase the risk of dizziness or fainting.
  • Do not use Muse more often than prescribed (maximum twice in 24 hours and 7 times per week).
  • Muse does not protect against sexually transmitted infections (STIs) or pregnancy. Use condoms for STI prevention.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial dose of 125 mcg or 250 mcg. Subsequent doses may be increased to 500 mcg or 1000 mcg based on response. Maximum of 2 doses in 24 hours and no more than 7 doses per week.
Dose Range: 125 - 1000 mg

Condition-Specific Dosing:

erectile_dysfunction: Initial dose 125 mcg or 250 mcg. Titrate to effective dose (125 mcg, 250 mcg, 500 mcg, or 1000 mcg). Administer no more than twice in 24 hours and no more than 7 times per week.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment required
Moderate: No dosage adjustment required
Severe: No dosage adjustment required
Dialysis: No specific recommendations; rapid local metabolism limits systemic exposure.

Hepatic Impairment:

Mild: No dosage adjustment required
Moderate: No dosage adjustment required
Severe: No dosage adjustment required

Pharmacology

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Mechanism of Action

Alprostadil is a synthetic prostaglandin E1 (PGE1) analog. It acts by binding to PGE1 receptors in the smooth muscle cells of the corpus cavernosum. This binding activates adenylate cyclase, leading to an increase in intracellular cyclic AMP (cAMP). Elevated cAMP levels cause relaxation of the smooth muscle, resulting in vasodilation of the cavernosal arteries and arterioles, increased blood flow into the lacunar spaces, and subsequent penile erection.
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Pharmacokinetics

Absorption:

Bioavailability: Local (minimal systemic)
Tmax: 10-20 minutes (for peak plasma concentrations of alprostadil and its metabolites)
FoodEffect: Not applicable

Distribution:

Vd: Not well-defined for urethral administration due to local action
ProteinBinding: Approximately 81%
CnssPenetration: Limited

Elimination:

HalfLife: 0.5-10 minutes (systemic)
Clearance: Rapid
ExcretionRoute: Primarily renal (metabolites), some fecal
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: 5-20 minutes
PeakEffect: 30-60 minutes
DurationOfAction: 30-60 minutes (or until ejaculation), but can vary

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Attention Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Redness, lumps, swelling, tenderness, or curving of the erection (hard penis)
Irritation at the injection site
Chest pain or pressure, or a rapid heartbeat
Dizziness or fainting
Severe headache
Shortness of breath
Unexplained bruising or bleeding
Swelling of the leg veins

If you experience a painful erection or an erection that lasts longer than 4 hours, seek medical attention immediately. This can occur even when you are not engaging in sexual activity. If left untreated, it may lead to permanent sexual dysfunction.

Other Possible Side Effects

Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical help:

Penile pain
Warm or burning sensation in the urethra
Aching in the penis, testicles, legs, or perineum (the area between the penis and rectum)

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Erection lasting longer than 4 hours (priapism): Seek immediate medical attention.
  • Severe penile pain or discomfort.
  • Dizziness, lightheadedness, or fainting: Lie down immediately if these occur.
  • Significant urethral bleeding or persistent irritation.
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the symptoms you experienced.
If you have been advised against engaging in sexual activity due to health concerns.
If you have a deformed penis, penile implant, or other penile problems.
If you have been diagnosed with polycythemia or thrombocythemia.
If you have any of the following health conditions: leukemia, multiple myeloma, sickle cell anemia, or other conditions that may increase the risk of painful erections (priapism) or prolonged erections lasting more than 4 hours. If you are unsure, consult your doctor.
If you are female, as this medication is not approved for use in women.

Additionally, it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. This information will help your doctor and pharmacist determine whether it is safe to take this medication with your other treatments. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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Precautions & Cautions

Important Warnings and Precautions

It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

To ensure your safety, avoid operating a vehicle or engaging in any activities that require alertness until you are aware of how this drug affects you.

When changing positions, rise slowly from a sitting or lying down position to minimize the risk of dizziness or fainting. Exercise caution when navigating stairs.

Before consuming alcohol, consult with your doctor to discuss any potential risks or interactions.

It is essential to note that this medication does not protect against the transmission of diseases such as HIV or hepatitis that can be spread through sexual contact. Always use a latex or polyurethane condom during sexual activity to reduce the risk of transmission. If you have any questions or concerns, discuss them with your doctor.

If your sexual partner is capable of becoming pregnant, use a reliable form of birth control to prevent pregnancy. If your partner is already pregnant, use a condom during sexual activity to minimize potential risks.

This medication is not approved for use in children. Consult with your doctor to discuss any concerns or questions you may have regarding the use of this medication.
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Overdose Information

Overdose Symptoms:

  • Priapism (prolonged erection >4 hours)
  • Symptomatic hypotension (dizziness, lightheadedness, fainting)

What to Do:

For priapism, seek immediate medical attention. Management may involve aspiration of blood from the corpus cavernosum or intracavernosal injection of an alpha-adrenergic agonist (e.g., phenylephrine). For symptomatic hypotension, supportive care (e.g., supine position, IV fluids) is indicated. Call 1-800-222-1222 (Poison Control) for further guidance.

Drug Interactions

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Moderate Interactions

  • Antihypertensives (e.g., alpha-blockers, nitrates): Potential for additive hypotensive effects.
  • Anticoagulants/Antiplatelets: Theoretical increased risk of urethral bleeding or hematoma, though not well-documented for urethral route.

Monitoring

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Baseline Monitoring

Erectile function assessment

Rationale: To determine appropriate dosing and assess baseline severity of ED.

Timing: Prior to initiation of therapy

Cardiovascular status

Rationale: To identify patients at risk for adverse cardiovascular events (e.g., hypotension, syncope).

Timing: Prior to initiation of therapy

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Routine Monitoring

Efficacy of erection

Frequency: With each use

Target: Sufficient for intercourse

Action Threshold: If insufficient, consider dose adjustment or alternative therapy

Duration of erection

Frequency: With each use

Target: <4 hours

Action Threshold: If >4 hours, seek immediate medical attention (priapism)

Local adverse effects (e.g., penile pain, urethral bleeding, burning)

Frequency: With each use

Target: Minimal to none

Action Threshold: If severe or persistent, consider dose reduction or discontinuation

Systemic adverse effects (e.g., dizziness, hypotension)

Frequency: With each use

Target: None

Action Threshold: If present, advise patient to lie down; if severe or persistent, seek medical attention

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Symptom Monitoring

  • Penile pain
  • Urethral pain or burning
  • Urethral bleeding or spotting
  • Dizziness
  • Lightheadedness
  • Fainting (syncope)
  • Priapism (erection lasting >4 hours)

Special Patient Groups

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Pregnancy

Not applicable for male patients. There is no indication for use in women.

Trimester-Specific Risks:

First Trimester: Not applicable
Second Trimester: Not applicable
Third Trimester: Not applicable
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Lactation

Not applicable for male patients. There is no indication for use in women.

Infant Risk: Not applicable
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Pediatric Use

Contraindicated. Safety and efficacy have not been established in pediatric patients.

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Geriatric Use

No specific dosage adjustment is required for elderly patients. However, caution should be exercised in elderly patients with underlying cardiovascular disease due to the potential for hypotension.

Clinical Information

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Clinical Pearls

  • Proper administration technique is critical for the efficacy and safety of Muse. Patients should be thoroughly instructed on how to use the system.
  • Patients must be educated on the signs and symptoms of priapism and instructed to seek immediate medical attention if an erection lasts longer than 4 hours.
  • Muse is not a first-line treatment for ED for many patients, especially given the availability of oral PDE5 inhibitors. It is often considered for patients who cannot use or do not respond to oral medications.
  • Patients should be advised to urinate before administering Muse to ensure the urethra is clear.
  • Muse does not offer protection against sexually transmitted diseases (STDs) or pregnancy.
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Alternative Therapies

  • Oral Phosphodiesterase-5 (PDE5) inhibitors (e.g., sildenafil, tadalafil, vardenafil, avanafil)
  • Intracavernosal alprostadil injection (e.g., Caverject, Edex)
  • Vacuum erection devices (VEDs)
  • Penile implants (prostheses)
  • Vascular surgery (rarely)
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Cost & Coverage

Average Cost: Varies significantly by pharmacy and dosage strength (e.g., $50-$150 per single-use system) per single-use system
Insurance Coverage: Often Tier 3 or 4; may require prior authorization or step therapy by insurance plans.
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.