Muse 500mcg Suppositories
It is used to treat erectile dysfunction (ED).Some products may be used to help test for ED.
Drug Class
Agent for erectile dysfunction
Pharmacologic Class
Prostaglandin E1 analog
Pregnancy Category
Not applicable (for male use)
FDA Approved
Nov 1996
DEA Schedule
Not Controlled
Overview
What is this medicine?
Muse is a small pellet containing a medicine called alprostadil. You insert it into the opening of your penis (urethra) to help you get an erection. It works by increasing blood flow to the penis.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. This medication is designed for insertion into the urethra, the tube through which urine passes. Your doctor will provide personalized guidance on how to use it. Make sure you understand the proper technique before proceeding.
Before using this medication, empty your bladder by urinating. Wash your hands thoroughly before and after handling the medication to maintain cleanliness.
Storage and Disposal
Store unopened foil pouches in the refrigerator to preserve the medication's effectiveness.
Missed Dose
Since this medication is used as needed, there is no fixed dosing schedule. However, do not use it more frequently than recommended by your doctor. If you have any questions or concerns about using this medication, consult your doctor or pharmacist for clarification.
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. This medication is designed for insertion into the urethra, the tube through which urine passes. Your doctor will provide personalized guidance on how to use it. Make sure you understand the proper technique before proceeding.
Before using this medication, empty your bladder by urinating. Wash your hands thoroughly before and after handling the medication to maintain cleanliness.
Storage and Disposal
Store unopened foil pouches in the refrigerator to preserve the medication's effectiveness.
Missed Dose
Since this medication is used as needed, there is no fixed dosing schedule. However, do not use it more frequently than recommended by your doctor. If you have any questions or concerns about using this medication, consult your doctor or pharmacist for clarification.
Lifestyle & Tips
- Do not use more than two doses in 24 hours or more than seven doses in a week.
- Avoid using with other treatments for erectile dysfunction unless advised by your doctor.
- Use barrier contraception (e.g., condom) if your partner is pregnant or may become pregnant, as alprostadil can affect the fetus.
- Avoid alcohol or other substances that may impair your ability to get or maintain an erection or increase the risk of side effects like dizziness.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose of 125 mcg or 250 mcg, administered as a single urethral suppository. Subsequent doses may be titrated up to 1000 mcg based on response and tolerability.
Dose Range:
125 - 1000 mg
Condition-Specific Dosing:
erectileDysfunction:
Administer as needed, not more than twice in a 24-hour period and not more than 7 times per week. Allow at least 24 hours between doses.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed due to minimal systemic absorption.
Moderate:
No specific adjustment needed due to minimal systemic absorption.
Severe:
No specific adjustment needed due to minimal systemic absorption.
Dialysis:
No specific adjustment needed due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No specific adjustment needed due to minimal systemic absorption.
Moderate:
No specific adjustment needed due to minimal systemic absorption.
Severe:
No specific adjustment needed due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Alprostadil is a synthetic prostaglandin E1 (PGE1) analog. It acts by directly relaxing the smooth muscle of the corpus cavernosum and dilating the cavernosal arteries, leading to increased arterial inflow and veno-occlusion, which results in penile erection. This effect is mediated by activation of adenylate cyclase, increasing intracellular cyclic AMP (cAMP) levels.
Pharmacokinetics
Absorption:
Bioavailability:
Low systemic bioavailability (rapid local metabolism), high local concentration in corpus cavernosum.
Tmax:
Systemic Tmax is variable and low (minutes), local effect onset within 5-20 minutes.
FoodEffect:
Not applicable (urethral administration).
Distribution:
Vd:
Not well-defined due to rapid local metabolism and limited systemic distribution.
ProteinBinding:
Approximately 81% bound to plasma proteins.
CnssPenetration:
Limited
Elimination:
HalfLife:
Systemic half-life is very short, approximately 5-10 minutes.
Clearance:
Rapid systemic clearance, primarily via pulmonary first-pass metabolism.
ExcretionRoute:
Metabolites are primarily excreted renally (approximately 90%) and fecally (approximately 10%).
Unchanged:
Less than 1% of the administered dose is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
5-20 minutes after administration.
PeakEffect:
30-60 minutes after administration.
DurationOfAction:
30-60 minutes (duration of erection sufficient for intercourse).
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
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 immediate medical attention:
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 help immediately. This can occur even when you are not having sex, and if left untreated, may lead to long-term sexual dysfunction.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Penile pain
Warm or burning sensation in the urethra
Aching in the penis, testicles, legs, or 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.
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 immediate medical attention:
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 help immediately. This can occur even when you are not having sex, and if left untreated, may lead to long-term sexual dysfunction.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Penile pain
Warm or burning sensation in the urethra
Aching in the penis, testicles, legs, or 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) â seek immediate medical attention.
- Severe penile pain or discomfort.
- Significant urethral bleeding.
- Dizziness or lightheadedness.
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 allergic reaction 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 about your condition, consult your doctor.
If you are female, as this medication is not approved for use in women.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other treatments. Do not initiate, stop, or modify the dosage of any medication without consulting 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 allergic reaction 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 about your condition, consult your doctor.
If you are female, as this medication is not approved for use in women.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other treatments. Do not initiate, stop, or modify the dosage of any medication without consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
When starting this medication, avoid driving and other activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position. Be cautious when climbing stairs.
Before consuming alcohol, discuss the potential risks with your doctor.
It is crucial to note that this medication does not protect against the transmission of diseases like HIV or hepatitis through sexual contact. Always use a latex or polyurethane condom during sexual activity to reduce the risk of transmission. If you have questions or concerns, consult 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 intercourse to minimize potential risks.
This medication is not approved for use in children. If you have any questions or concerns, consult with your doctor to discuss the best course of action.
When starting this medication, avoid driving and other activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position. Be cautious when climbing stairs.
Before consuming alcohol, discuss the potential risks with your doctor.
It is crucial to note that this medication does not protect against the transmission of diseases like HIV or hepatitis through sexual contact. Always use a latex or polyurethane condom during sexual activity to reduce the risk of transmission. If you have questions or concerns, consult 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 intercourse to minimize potential risks.
This medication is not approved for use in children. If you have any questions or concerns, consult with your doctor to discuss the best course of action.
Overdose Information
Overdose Symptoms:
- Prolonged erection (priapism)
- Severe penile pain
- Hypotension
- Dizziness
What to Do:
Seek immediate medical attention for priapism. For other symptoms, supportive care. Call 1-800-222-1222 (Poison Control) for advice.
Drug Interactions
Moderate Interactions
- Anticoagulants (e.g., warfarin, heparin): Theoretical increased risk of urethral bleeding, though not well-established clinically due to minimal systemic absorption.
- Other vasodilators (e.g., nitrates, alpha-blockers): Theoretical increased risk of hypotension, though unlikely with urethral alprostadil due to minimal systemic absorption.
Monitoring
Baseline Monitoring
Cardiovascular status
Rationale: To assess suitability for sexual activity and identify contraindications.
Timing: Prior to initiation of therapy.
Penile anatomy
Rationale: To rule out conditions like Peyronie's disease or anatomical deformities that may contraindicate use.
Timing: Prior to initiation of therapy.
Routine Monitoring
Efficacy of erection
Frequency: With each use
Target: Erection sufficient for intercourse
Action Threshold: Lack of adequate erection or excessive duration (priapism).
Adverse effects (e.g., penile pain, urethral pain, priapism, urethral bleeding)
Frequency: With each use and post-use
Target: Absence of severe or persistent adverse effects
Action Threshold: Persistent pain, prolonged erection (>4 hours), or significant bleeding.
Symptom Monitoring
- Penile pain
- Urethral pain
- Priapism (erection lasting >4 hours)
- Urethral bleeding or spotting
- Dizziness
- Hypotension
Special Patient Groups
Pregnancy
Not indicated for use in females. If used by a male partner, barrier contraception is recommended if the female partner is pregnant or may become pregnant, as alprostadil can affect the fetus.
Trimester-Specific Risks:
First Trimester:
Not applicable (for male use)
Second Trimester:
Not applicable (for male use)
Third Trimester:
Not applicable (for male use)
Lactation
Not indicated for use in females.
Infant Risk:
Not applicable (for male use)
Pediatric Use
Safety and efficacy have not been established in pediatric patients. Not indicated for use in this population.
Geriatric Use
No specific dose adjustment is required for elderly patients. However, older patients may be more sensitive to the hypotensive effects of vasodilators, though systemic absorption is minimal with MUSE.
Clinical Information
Clinical Pearls
- Proper administration technique is crucial for efficacy and to minimize local side effects. Patients should be thoroughly instructed on how to use the applicator and insert the suppository.
- Patients should urinate before administration to moisten the urethra, which aids absorption.
- The most common side effects are penile pain, urethral pain, and dizziness. Priapism (erection lasting >4 hours) is a rare but serious side effect requiring immediate medical attention.
- MUSE is not a contraceptive and does not protect against sexually transmitted diseases.
- Patients with certain penile conditions (e.g., severe curvature, Peyronie's disease) or conditions predisposing to priapism (e.g., sickle cell anemia, multiple myeloma, leukemia) should not use alprostadil.
Alternative Therapies
- Oral phosphodiesterase-5 (PDE5) inhibitors (e.g., sildenafil, tadalafil, vardenafil, avanafil)
- Intracavernosal injections (e.g., alprostadil, papaverine, phentolamine)
- Vacuum erection devices
- Penile implants
- Lifestyle modifications (e.g., diet, exercise, smoking cessation)
- Psychological counseling
Cost & Coverage
Average Cost:
$100 - $200 per 6 suppositories (500mcg)
Generic Available:
Yes
Insurance Coverage:
Tier 3 or Non-preferred Brand, may require prior authorization.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 medication taken, the amount, and the time it happened.