Muse (Urethral)

Alprostadil urethral suppository is used to treat men who have erectile dysfunction (also called sexual impotence). It is part of a group of medicines called vasodilators that can increase blood flow by expanding blood vessels. This medicine causes an erection because it increases the blood flow to the penis.

Alprostadil should not be used as a sexual aid by men who do not have erectile dysfunction. If the medicine is not used properly, it could cause permanent damage to the penis and loss of the ability to have erections.

This medicine is available only with your doctor's prescription.

Do not use alprostadil suppositories if you have a penile implant unless your doctor advises you to do so.

Use a condom during sexual intercourse with a pregnant woman while using this medicine. Although it is unlikely to harm the fetus, using a condom will protect the fetus from exposure to this medicine. If a woman can become pregnant, it is recommended to use contraceptive methods because the effects of this medicine on early pregnancy are not known.

This medicine may cause dizziness or lightheadedness. Do not drive or do anything that could be dangerous until you know how this medicine affects you.

If too much is used, the erection may last too long and not go away when it should. This condition is called priapism. If the erection does not go away, the blood supply to the penis may be cut off and permanent damage may occur.

Contact your doctor immediately if the erection lasts longer than 4 hours or if it becomes painful. This may be a sign of priapism and must be treated right away to prevent permanent damage.

This medicine will not prevent pregnancy or protect you or your partner from diseases such as syphilis, herpes, or HIV. Use a latex condom during sex for protection.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine versus the benefits it may provide. For this medicine, the following points should be taken into account:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other 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 meant for use in children.

Geriatric

There is no information available on how age affects the effects of alprostadil urethral suppository in older adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if there is a chance of an interaction. In these cases, your doctor might want to adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below while using this medicine. The following interactions have been highlighted for their potential significance and may not include all possible interactions.

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

• Heparin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around mealtime or with certain types of food, as interactions may happen. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how you can use this medicine. Make sure to tell your doctor if you have any other medical conditions, 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—The risk of problems may be higher, and this medicine should be used cautiously in these patients.

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

• Hypotension (low blood pressure) or
• Syncope (fainting)—Use with caution. It may worsen these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Burning sensation in the urethra
• Pain in the penis or urethra

Less common

• Bleeding and pain in the testes
• Blurred vision
• Confusion
• Dizziness
• Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• Pain in the testes
• Sweating
• Unusual tiredness or weakness

Rare

• Fainting

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Painful or prolonged erection of the penis

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Back pain
• Chills
• Cough
• Diarrhea
• Fever
• General feeling of discomfort or illness
• Headache
• Joint pain
• Loss of appetite
• Muscle aches and pains
• Nausea
• Runny nose
• Shivering
• Sneezing
• Sore throat
• Stuffy nose
• Sweating
• Swelling of the legs
• Trouble sleeping
• Vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Muse

In Canada

• Muse Micro

Available Dosage Forms:

• Suppository

Therapeutic Class: Erectile Dysfunction Agent

Pharmacologic Class: Prostaglandin

Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often or longer than your doctor ordered.

This medicine comes with patient directions. Read and follow the instructions carefully. Ask your doctor if you have any questions.

This medicine usually begins to work in about 5 to 10 minutes. You should attempt intercourse within 10 to 30 minutes after using the medicine. An erection may continue after ejaculation.

To use:

• Before inserting a suppository, you should urinate. The small amount of urine normally left in your urethra will help dissolve the suppository after it is inserted.
• Remove the delivery device containing the suppository from the foil. Remove the cap from the applicator stem.
• Stretch your penis upward to extend its length, pressing your penis top and bottom. Gently insert the delivery stem up to its collar into your urethra (located at the top of the penis). If you have pain or a pulling feeling in the penis, withdraw the device and start again.
• Press the button down slowly as far as it will go. This releases the suppository into the urethra. After holding the delivery device within your penis still for 5 seconds, carefully rock the penis and delivery device as a unit from side to side. This helps remove the suppository from the device.
• Remove the delivery device while your penis is upright. Look at the device to make sure that the suppository was completely released.
• Repeat the process if a part of the suppository remains in the device.
• After the suppository is completely released, roll your penis between your hands for 10 seconds. This helps to dissolve the suppository. If you feel any stinging, continue this motion to help stop it.
• Sitting, standing, or walking for 10 minutes while an erection is developing helps increase the blood flow to your penis to gain a proper erection.
• Replace the cap on the delivery device. After storing it in the foil, fold and throw away.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For urethral dosage form (suppositories):For erectile dysfunction: Adults—One suppository inserted into the urethra once a day, 10 to 30 minutes before sexual intercourse. Do not use more than 2 suppositories each day. Children—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store unopened foil pouches in the refrigerator. Keep the medicine away from heat. It may not work if exposed to temperatures above 30 degrees C. You may also store the suppositories at room temperature for up to 14 days before each use.