Muse Urethral

In the U.S.

• Muse

In Canada

• Muse Micro

Available Dosage Forms:

• Suppository

Therapeutic Class: Erectile Dysfunction Agent

Pharmacologic Class: Prostaglandin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Alprostadil urethral suppository is not indicated for use in children.

Geriatric

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

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Heparin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal penis, including curved penis and birth defects of the penis or
• Heart or blood vessel disease or
• Hyperviscosity syndrome or
• Leukemia (blood related cancer) or
• Multiple myeloma (blood related cancer) or
• Polycythemia or
• Priapism (prolonged erection) or
• Sickle cell anemia (blood disorder) or
• Sickle cell trait or
• Thrombocythemia or
• Trouble urinating—Chance of problems occurring may be increased and this medicine should be used with caution in these patients.

• Bleeding problems—Chance of bleeding in the urethra may be increased.

• Hypotension (low blood pressure) or
• Syncope (fainting)—Use with caution. May make these conditions worse.

Penis/testicle/groin pain, minor bleeding or spotting from the penis, dizziness, swelling (especially of leg veins), and rapid heartbeat may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: fainting.

In the very unlikely event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and seek immediate medical attention, or permanent problems could occur.

In female partners, vaginal burning/itching may occur. It is not clear if this side effect is caused by the medication or sexual intercourse itself. The use of a water-based lubricant may help prevent vaginal irritation.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: "blood thinners" (e.g., warfarin, heparin), high blood pressure medicines.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: fainting, painful/prolonged erection.

Notes

Do not share this medication with others.

Missed Dose

Not applicable.

Storage

Store unopened foil pouches in the refrigerator at 36-46 degrees F (2-8 degrees C). If necessary, this product may also be stored at room temperature below 86 degrees F (30 degrees C) for up to 14 days. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.