Muse 1000mcg Suppositories

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

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 engaging in sexual activity. If left untreated, it may lead to permanent sexual dysfunction and impotence.

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 unusual symptoms, contact your doctor for advice:

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

This is not an exhaustive list of possible side effects. If you have questions or concerns, 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.

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 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 first.

Important Warnings and Precautions

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

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other activities that require alertness. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and exercise caution when climbing stairs.

Interactions with Alcohol
Discuss your alcohol consumption with your doctor before drinking while taking this medication.

Sexual Health and Disease Prevention
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 disease transmission. If you have questions or concerns, consult your doctor.

Pregnancy and Birth Control
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.

Pediatric Use
This medication is not approved for use in children. Consult with your doctor to discuss any concerns or questions you may have.

• Antihypertensives (e.g., alpha-blockers): Potential for additive hypotensive effects, though systemic absorption is minimal.
• Other erectile dysfunction treatments (e.g., PDE5 inhibitors, intracavernosal injections): Concomitant use is not recommended due to increased risk of priapism and hypotension.

• Penile pain
• Urethral bleeding or spotting
• Dizziness or lightheadedness
• Fainting (syncope)
• Priapism (erection lasting longer than 4 hours)
• Testicular pain
• Headache

Not applicable for male patients. Alprostadil is a prostaglandin. While systemic absorption from urethral administration is minimal, male patients should use a condom if their partner is pregnant or may become pregnant, as a precautionary measure.

Not applicable for male patients. Minimal systemic absorption makes transfer to breast milk unlikely if used by a male patient.

Not indicated for use in pediatric patients. Safety and efficacy have not been established.

No specific dose adjustment is required based on age alone. However, older patients may have underlying cardiovascular conditions or be on multiple medications, which should be considered. The risk of dizziness or fainting may be slightly higher in this population.

• Proper administration technique is crucial for the effectiveness of MUSE. Patients should be thoroughly instructed on how to use the applicator and insert the suppository.
• Patients should urinate immediately before using MUSE to moisten the urethra, which aids in absorption and reduces discomfort.
• Advise patients to sit or lie down for about 10 minutes after administration to minimize the risk of dizziness or fainting, especially with the first few doses.
• MUSE is not a first-line treatment for ED for many patients due to its invasive nature and potential for local side effects, but it is a valuable option for those who cannot use or do not respond to oral PDE5 inhibitors.
• Emphasize the importance of seeking immediate medical attention for priapism (erection lasting >4 hours) to prevent permanent penile damage.

• Oral Phosphodiesterase-5 (PDE5) Inhibitors (e.g., sildenafil, tadalafil, vardenafil, avanafil)
• Intracavernosal Injections (e.g., alprostadil, trimix, bimix)
• Vacuum Erection Devices (VEDs)
• Penile Implants (prostheses)
• Lifestyle modifications (e.g., diet, exercise, smoking cessation, alcohol reduction)
• Psychological counseling

If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.