Muse 250mcg Transurethral System
Overview
What is this medicine?
How to Use This Medicine
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.
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.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
Side Effects
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.
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.
Before Using This Medicine
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.
Precautions & Cautions
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.
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
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
Baseline Monitoring
Rationale: To determine appropriate dosing and assess baseline severity of ED.
Timing: Prior to initiation of therapy
Rationale: To identify patients at risk for adverse cardiovascular events (e.g., hypotension, syncope).
Timing: Prior to initiation of therapy
Routine Monitoring
Frequency: With each use
Target: Sufficient for intercourse
Action Threshold: If insufficient, consider dose adjustment or alternative therapy
Frequency: With each use
Target: <4 hours
Action Threshold: If >4 hours, seek immediate medical attention (priapism)
Frequency: With each use
Target: Minimal to none
Action Threshold: If severe or persistent, consider dose reduction or discontinuation
Frequency: With each use
Target: None
Action Threshold: If present, advise patient to lie down; if severe or persistent, seek medical attention
Symptom Monitoring
- Penile pain
- Urethral pain or burning
- Urethral bleeding or spotting
- Dizziness
- Lightheadedness
- Fainting (syncope)
- Priapism (erection lasting >4 hours)
Special Patient Groups
Pregnancy
Not applicable for male patients. There is no indication for use in women.
Trimester-Specific Risks:
Lactation
Not applicable for male patients. There is no indication for use in women.
Pediatric Use
Contraindicated. Safety and efficacy have not been established in pediatric patients.
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
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.
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)