Muse

Muse is used to treating men who have erectile dysfunction (sexual impotence). It belongs to a group of medications called vasodilators that increase blood flow by expanding blood vessels. This medication 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 medication is not used properly, permanent damage to the penis and loss of ability to have erections may result.

This medication is available only with your doctor’s prescription.

This product is available in the following dosage forms:

• Suppository

If you are about to start using Muse, speak with your doctor about what you need to know, the risks must be compared to how much a medication will help you. This is a decision that you and your doctor will make together.

For this medication, there are many things that need to be considered:

Allergies

Inform your doctor if you have ever had an allergic reaction to any other medications. It is also important to inform your doctor of any non-medicine allergies such as foods, dyes, preservatives or animals.

Pediatric

This medication is not for use in children.

Geriatric

No appropriate studies have been performed on the relationship of age to the effects of this medication in the geriatric population. Safety and efficacy have not been established.

Pregnancy

This medication is listed as Pregnancy Category C. This means that animal studies have shown an adverse effect and no studies have been performed on pregnant women OR there are no adequate studies on pregnant animals and pregnant women.

Breastfeeding

There are no up-to-date studies in women for determining infant risk when using this medication while breastfeeding. Weigh the potential risks with the benefits before taking this medication while breastfeeding.

Drug Interactions

Certain medications should not be used together. However, in certain cases, two medications may be used together, even if an interaction might occur. In these cases, your doctor may want to change your dose
or take other precautions. When taking this medication, it is important that you inform your doctor if you are taking any of the medications listed below. The following interactions were selected on the basis of
potential significance and are not all-inclusive.

Using this medication with any of the following is not recommended. Your doctor may decide not to treat you with this medication, or change some of the other medications you take:

• Heparin

Other Interactions

Certain medications should not be used while eating, or while eating certain foods in case of negative interactions. Using alcohol or tobacco with certain medications may also cause negative interactions. Talk with your doctor about the use of your medication with food, alcohol or tobacco.

Other Medical Problems

• Abnormal penis, including curved penis and birth defects of the penis
• Heart or blood vessel disease
• Hyperviscosity syndrome
• Leukemia (blood-related cancer)
• Multiple myelomas (blood-related cancer)
• Polycythemia
• Priapism (prolonged erection)
• Sickle-cell anemia (blood disorder)
• Sickle cell trait
• Thrombocythemia
• 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.

To use Muse properly, you must follow all instructions given by your doctor. Do not take more, less or for a longer or shorter period of time than your doctor tells you.

This medication comes with a patient information brochure. It is very important that your read this information. Ask your doctor if you have any questions.

This medication normally begins working within 5-10 minutes. You should attempt intercourse 10-30 minutes after using the medication. Your 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 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 it’s collar into your urethra. If you have pain or a fulling 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 in your penis still for 5 seconds, carefully rock the penis and device from side to side. This helps remove the suppository from the device.

• Remove the device while your penis is upright. Look at the device to make sure 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 dissolve the suppository. If you feel any stinging, continue the motion to help stop it.

• Sitting, standing or walking for 10 minutes while an erection is developing helps to increase the blood flow to your penis to gain a proper erection.

• Replace the cap on the device and store it in the foil. Fold and throw away.

Dosing

Different patients will be given a different dose of this medication based on the strength of the medication. The number of doses you take each day, the time between doses and the length of time you take this medication depends on the reason you are taking this medication. The following information only includes the average dose of this medication. If your dose is different, do not change it without first speaking to your doctor.

• Adults - One suppository inserted into the urethra once a day, 10-30 minutes before sexual intercourse. Do not use more than 2 suppositories per day.

Storage

Store unopened foil pouches in the refrigerator. Keep the medication away from heat. It may not work if exposed to temperatures above 30C/86F. You may also store the suppositories at room temperature for up to 14 days before each use.

Keep our of the reach of children

Do not keep expired medication or medication you no longer need. Ask your doctor how to dispose of any medication you do not use.

Before using Muse, there are some precautions you must take. Do not use this medication if you have a penile implant unless advised by a doctor.

Use a condom when having sexual intercourse with a pregnant female while using this medication. Although harm to the fetus is unlikely, using a condom will protect the fetus from exposure to this medication. If a woman can become pregnant, use of contraceptive methods is recommended because the effects of this medication on early pregnancy are unknown.

This medication may cause some people to become drowsy or lightheaded. Make sure you know how you react to this medication before driving, using machinery or doing anything else that could be dangerous if you are not alert.

If you use too much of this medication, the erection lasts too long and does not reverse when it should. This condition is called priapism. If the erection is not reversed, the blood supply to the penis may be cut off and cause permanent damage.

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 immediately.

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

Do not take other prescription or over-the-counter medications without asking your doctor.

Muse may produce unwanted side effects along with the intended 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 you experience any of the following side-effects:

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 fatigue or weakness

Rare:

• Fainting (syncope)

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

• Painful or prolonged erection

Some side effects that may occur do not normally need medical attention. These may leave as your body becomes accustomed to treatment. Ask your doctor about ways to prevent or reduce some of these side effects.

Talk to your doctor if any of the following side effects continue or are bothersome, or if you have questions:

Less common:

• Back pain
• Chills
• Cough
• Diarrhea
• Fever
• General feeling of discomfort or illness (malaise)
• 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 (insomnia)
• Vomiting

Some patients may experience other side effects that are not listed. Check with your doctor if you notice any other side effects.

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