Generic Name: Clotrimazole (kloe-TRIM-uh-zole)
Brand Name: Mycelex

Mycelex Troches are used for:

Treating or preventing fungal infections of the mouth and throat.

Mycelex Troches are an antifungal agent. It kills sensitive fungi by binding to the fungal cell membrane and weakening it. This allows the cell contents to leak out and results in the death of the fungus.

Do NOT use Mycelex Troches if:

• you are allergic to any ingredient in Mycelex Troches
• you are taking pimozide or an ergot alkaloid (eg, ergotamine)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Mycelex Troches:

Some medical conditions may interact with Mycelex Troches. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have liver disease

Some MEDICINES MAY INTERACT with Mycelex Troches. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Ergot alkaloids (eg, ergotamine), imatinib, macrolide immunosuppressants (eg, tacrolimus), or pimozide because the actions and the risk of their side effects may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Mycelex Troches may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Mycelex Troches:

Use Mycelex Troches as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Allow Mycelex Troches to dissolve slowly in your mouth. Do not chew or swallow whole.
• To clear up your infection completely, use Mycelex Troches for the full course of treatment. Keep using it even if you feel better in a few days.
• If you miss a dose of Mycelex Troches, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Mycelex Troches.

Important safety information:

• Be sure to use Mycelex Troches for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The fungus could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
• Lab tests, including liver function tests, may be performed while you use Mycelex Troches. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Mycelex Troches should not be used in CHILDREN younger than 3 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Mycelex Troches while you are pregnant. It is not known if Mycelex Troches are found in breast milk. If you are or will be breast-feeding while you use Mycelex Troches, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Mycelex Troches:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Itching; nausea; unpleasant mouth sensations; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Proper storage of Mycelex Troches:

Store Mycelex Troches at room temperature, below 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Mycelex Troches out of the reach of children and away from pets.

General information:

• If you have any questions about Mycelex Troches, please talk with your doctor, pharmacist, or other health care provider.
• Mycelex Troches are to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Mycelex Troches. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: micafungin (MYE ka FUN jen)
Brand Names: Mycamine

What is micafungin?

Micafungin is an antifungal antibiotic.

Micafungin is used to treat infections caused by the Candida fungus. Micafungin is also used to prevent Candida fungal infections in stem cell transplant patients.

Micafungin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about micafungin?

You should not use this medication if you are allergic to micafungin.

Before using micafungin, tell your doctor if you are allergic to any drugs, or if you have liver or kidney disease.

Before receiving micafungin, tell your doctor if you are also using sirolimus (Rapamune), itraconazole (Sporanox), or nifedipine (Adalat, Procardia).

Micafungin is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine.

You may need to receive this medication for several weeks.

What should I discuss with my healthcare provider before receiving micafungin?

You should not use this medication if you are allergic to micafungin.

Before using micafungin, tell your doctor if you are allergic to any drugs, or if you have:

• liver disease; or
• kidney disease.

If you have any of these conditions, you may need a dose adjustment or special tests to safely receive this medication.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether micafungin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is micafungin given?

Micafungin is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine.

You will need to mix micafungin with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication.

Micafungin must be given slowly through an IV infusion, and each injection can take at least 1 hour to complete. Do not mix micafungin with any other medicines, or give other medicines through the same IV line.

Micafungin is usually given once daily. You may need to receive this medication for several weeks.

Do not shake the medicine bottle (vial). Vigorous shaking can ruin the medicine. Do not mix your micafungin dose into an IV bag until you are ready to give yourself an injection. Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription. After mixing this medicine, do not expose it to light. Cover the IV bag during your infusion to protect the medicine from light. Use the medicine within 24 hours after mixing.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

If you store micafungin at home, keep it at room temperature away from moisture, heat, and light. Mixed medicine can be stored at room temperature but must be used within 24 hours after mixing.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of a micafungin overdose are not known.

What should I avoid while using micafungin?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are using micafungin.

Micafungin side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• pale or yellowed skin, dark colored urine, confusion or weakness;

• stomach pain, itching, clay-colored stools, jaundice (yellowing of the skin or eyes);

• fever, chills, body aches, flu symptoms;

• easy bruising or bleeding;

• urinating less than usual or not at all;

• drowsiness, mood changes, increased thirst, loss of appetite, nausea and vomiting;

• uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling; or

• swelling of your hands or feet.

Less serious side effects may include:

• warmth, redness, or tingly feeling under your skin;

• mild nausea, vomiting, or stomach pain;

• diarrhea, constipation, indigestion;

• headache;

• sleep problems (insomnia);

• mild itching or skin rash; or

• pain, swelling, or tenderness where the medicine was injected.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect micafungin?

The following drugs can interact with micafungin. Tell your doctor if you are using any of these:

• sirolimus (Rapamune);

• itraconazole (Sporanox); or

• nifedipine (Adalat, Procardia).

This list is not complete and there may be other drugs that can interact with micafungin. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about micafungin.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.04. Revision Date: 4/12/2009 4:45:45 PM.

Generic Name: ethambutol (eth AM bue tol)
Brand Names: Myambutol

What is Myambutol (ethambutol)?

Ethambutol is an antibiotic. It prevents growth of the tuberculous bacteria in the body.

Ethambutol is used to treat tuberculosis (TB).

Ethambutol may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Myambutol (ethambutol)?

Take all of the ethambutol that has been prescribed for you even if you begin to feel better. Your symptoms may begin to improve before the infection is completely treated.

Call your doctor immediately if you experience changes in vision (e.g., blurring, red-green color blindness) or a rash.

What should I discuss with my healthcare provider before taking Myambutol (ethambutol)?

Before taking this medication, tell your doctor if you have

• ever had an allergic reaction to ethambutol;

• cataracts, diabetic retinopathy, or optic neuritis; or

• kidney disease.

You may not be able to take ethambutol, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

It is not known whether ethambutol will be harmful to an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is also not known whether ethambutol will be harmful to a nursing baby. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

How should I take Myambutol (ethambutol)?

Take ethambutol exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass (8 ounces) of water.

Ethambutol can be taken with or without food. Taking ethambutol with food may decrease stomach upset.

Take all of the ethambutol that has been prescribed for you even if you begin to feel better. Your symptoms may begin to improve before the infection is completely treated.

Ethambutol is usually combined with one or more other tuberculosis medicines.

Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for the next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention if an overdose is suspected.

Symptoms of an ethambutol overdose are unknown.

What should I avoid while taking Myambutol (ethambutol)?

There are no restrictions on foods, beverages, or activities during treatment with ethambutol unless otherwise directed by your doctor.

Myambutol (ethambutol) side effects

If you experience any of the following serious side effects, stop taking ethambutol and seek emergency medical attention or contact your doctor immediately:

• an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

• vision changes (e.g., blurring, red-green color blindness);

• a rash;

• numbness or tingling in your fingers, toes, hands, or feet;

• confusion, disorientation, or hallucinations; or

• fever.

Other, less serious side effects may be more likely to occur. Continue to take ethambutol and talk to your doctor if you experience

• stomach upset, nausea, vomiting, abdominal pain, or decreased appetite;

• headache;

• mild dizziness;

• worsening gout; or

• joint pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Myambutol (ethambutol)?

Do not take antacids that contain aluminum within several hours of taking a dose of ethambutol. Aluminum will decrease the amount of ethambutol that is absorbed by the body. If you need an antacid, ask your doctor or pharmacist to recommend one that is aluminum free.

Drugs other than those listed here may also interact with ethambutol. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

Where can I get more information?

• Your pharmacist can provide more information about ethambutol.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 2.05. Revision Date: 4/12/2009 4:22:38 PM.

Generic Name: mitomycin (MYE toe MYE sin)
Brand Names: Mutamycin

What is Mutamycin (mitomycin)?

Mitomycin is an antineoplastic medication. Mitomycin interferes with the growth of cancer cells and slows their growth and spread in the body.

Mitomycin is used to treat cancer of the stomach and pancreas.

Mitomycin may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Mutamycin (mitomycin)?

Mitomycin should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Serious side effects have been reported with the use of mitomycin including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; or fever, chills, or signs of infection); kidney damage (little or no urine production, blood in the urine, lower back or side pain, difficulty urinating, or swelling of the ankles or feet); lung and heart problems; and others. Talk to your doctor about the possible side effects from treatment with mitomycin.

Tell your doctor or nurse right away if you notice redness, pain or swelling at the place of injection or anywhere else on your skin.

What should I discuss with my healthcare provider before using Mutamycin (mitomycin)?

Do not use mitomycin without first talking to your doctor if you have

• kidney disease;

• poorly functioning bone marrow; or

• a bleeding or blood clotting disorder

The use of mitomycin may be dangerous if you have any of the conditions listed above.

Mitomycin may be harmful to an unborn baby. Do not use mitomycin without first talking to your doctor if you are pregnant. Discuss with your doctor the appropriate use of birth control during treatment with mitomycin if necessary. It is not know whether mitomycin passes into breast milk. Breast-feeding should be avoided during treatment with mitomycin.

How should I use Mutamycin (mitomycin)?

Mitomycin should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Your doctor will determine the correct amount and frequency of treatment with mitomycin depending upon the type of cancer being treated and other factors. Talk to your doctor if you have any questions or concerns regarding the treatment schedule.

Tell your doctor or nurse right away if you notice redness, pain or swelling at the place of injection or anywhere else on your skin.

Your doctor will probably want you to have regularly scheduled blood tests and other medical evaluations during treatment with mitomycin to monitor progress and side effects.

Your healthcare provider will store mitomycin as directed by the manufacturer. If you are storing mitomycin at home, follow the directions provided by your healthcare provider.

What happens if I miss a dose?

Contact your doctor if you miss a dose of mitomycin.

What happens if I overdose?

If, for any reason an overdose of mitomycin is suspected, seek emergency medical attention or contact your healthcare provider immediately.

Symptoms of a mitomycin overdose tend to be similar to side effects caused by the medication, although often more severe.

What should I avoid while using Mutamycin (mitomycin)?

Mitomycin can lower the activity of the immune system making you more susceptible to infection. Avoid contact with people who have colds, the flu, or other contagious illnesses. In addition, do not receive vaccines that contain a live strain of the virus (e.g., live oral polio vaccine) and avoid contact with individuals who have recently been vaccinated with a live virus.

Mutamycin (mitomycin) side effects

If you experience any of the following serious side effects from mitomycin, contact your doctor immediately:

• an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

• kidney damage (little or no urine production, blood in the urine, lower back or side pain, difficulty urinating, or swelling of the ankles or feet);

• decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; or fever, chills, or signs of infection);

• redness, pain or swelling at the place of injection or elsewhere on the skin;

• severe nausea, vomiting, diarrhea, or loss of appetite; or

• shortness of breath or difficulty breathing.

Other, less serious side effects may be more likely to occur. Continue taking mitomycin and talk to your doctor if you experience:

• mild to moderate nausea, vomiting, or loss of appetite;

• headache;

• blurred vision;

• drowsiness or dizziness;

• weakness; or

• confusion.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Mutamycin (mitomycin)?

Do not receive “live” vaccines during treatment with mitomycin. Administration of a live vaccine may be dangerous during treatment with mitomycin.

Other drugs may also interact with mitomycin. Talk to your doctor and pharmacist before taking any other prescription or over-the-counter medicines, including vitamins, minerals, and herbal products, during treatment with mitomycin.

Where can I get more information?

• Your healthcare provider may have additional information about mitomycin that you may read.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 2.04. Revision Date: 4/12/2009 4:36:56 PM.

Generic Name: alprostadil (Intraurethral route, Intravenous route, Intracavernosal route)

al-PROS-ta-dil

Commonly used brand name(s):

In the U.S.

• Caverject
• Edex
• Muse
• Prostin VR Pediatric

In Canada

• Muse Micro

Available Dosage Forms:

• Powder for Solution
• Kit
• Suppository
• Solution

Therapeutic Class: Erectile Dysfunction Agent

Pharmacologic Class: Prostaglandin

Uses For Muse Micro

Alprostadil belongs to a group of medicines called vasodilators that can increase blood flow by expanding blood vessels. Alprostadil is used to produce erections in some men who need treatment for erectile dysfunction (sexual impotence). This medicine causes an erection because it increases the blood flow to the penis.

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

Alprostadil is used alone or with medical tests to help diagnose erectile dysfunction that may be caused by nerve or blood vessel problems in the penis.

Alprostadil is available only with your doctor’s prescription.

Before Using Muse Micro

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.

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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

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—Chance of problems occurring may be increased

• Bleeding problems—Chance of bleeding at the place of injection may be increased

• Infection of penis or
• Red or itchy (inflamed) penis—Conditions may worsen with the use of alprostadil suppositories. Also, local skin problems and minor bleeding from inserting the suppository may occur

• Conditions causing thickened blood or slower blood flow, including leukemia; multiple myeloma (tumors of the bone marrow); polycythemia, sickle cell disease, or thrombocythemia (blood problems) or

• Priapism (history of)—Patients with these conditions have an increased risk of priapism (erection lasting longer than 6 hours) while using alprostadil

Proper Use of alprostadil

This section provides information on the proper use of a number of products that contain alprostadil. It may not be specific to Muse Micro. Please read with care.

Special patient directions come with the suppositories and some of the injection medicines. Read the directions carefully before using the medicine.

For the injections—There are several alprostadil products that can be injected. Although the injection method is the same, the mixing procedures are different. Be sure you know which of these products you will be using and the proper way to mix the injection.

• One product called Alprostadil for Injection (brand names Caverject and Edex) is available as a powder in an injection bottle (vial). Caverject must be mixed with a solution called Bacteriostatic Water for Injection USP. Edex must be mixed with a solution called Sodium Chloride Injection USP. The solution for mixing comes with your product and may be already loaded into a syringe or contained in another injection bottle (vial).
• Another product is called Alprostadil Injection (brand names Prostin VR Pediatric and Prostin VR). Although the medicine is already in solution, it is much too strong to be injected into the penis. The solution must be mixed (diluted) with another liquid that is sold as a separate prescription, called 0.9% Sodium Chloride Injection USP. In most cases, a pharmacist will make this solution for you, giving you the proper strength that you need. Check with your doctor or pharmacist to make sure the solution has been diluted before using it.

It is important to follow several steps to prepare your alprostadil injection correctly. Before drawing up the medicine into the syringe:

• Wash your hands with soap and water.
• Set the bottles on a clean surface. Wipe the top of the injection bottles with an alcohol swab. Do not wipe the needle. Throw away the alcohol swab.
• You may need to attach the needle to the syringe. Do not take the cap off yet.

How to mix Caverject:

• If the syringe already contains the Bacteriostatic Water for Injection USP, then you need only add the plunger to the syringe. To do this:
  • Pick up the rod-like plunger and place it within the barrel of the syringe until it touches the rubber piece. Gently screw the plunger into the rubber piece until it seems secure. Do not use a lot of force.
  • Hold the syringe by the barrel (not the plunger) and take the cap off the needle.
  • You are now ready to mix the water and the powder. Skip to the directions under the title, “To mix the water and powder.”
• If the syringe does not already contain the Bacteriostatic Water for Injection USP, you must withdraw 1 milliliter (mL) of it from the bottle provided. To do this:
  • Pick up the syringe and take the cap off the needle. Pull the plunger back to the 1-mL mark on the syringe. This pulls air into the syringe. Insert the needle into rubber top of the bottle while it is upright and inject the 1 mL of air into the bottle.
  • Turn the bottle upside down using one hand. Be sure the tip of the needle is covered by solution.
  • With your other hand, pull the plunger back slowly to withdraw 1 mL of solution into the syringe. Remove the needle and skip to the directions under the title, “To mix the water and powder.”
• To mix the water and powder:
  • Insert the needle into the bottle of alprostadil and inject 1 milliliter of Bacteriostatic Water for Injection USP from your syringe into the bottle of alprostadil.
  • Remove the needle from the bottle, holding the barrel of the syringe.
  • Gently swirl the bottle to mix the powder into the solution, turning it upside down to wet all the powder in the bottle.
  • Follow the directions below, “How to draw your dose into the syringe.”

How to mix Edex:

• The syringe already contains the Sodium Chloride Injection USP. You need only attach the needle to the syringe and add the plunger. To do this:
  • Remove the needle from its package. Do not remove the needle cap. Gently screw the needle into place on the syringe tip.
  • Pick up the rod-like plunger and place it within the barrel of the syringe until it touches the rubber piece. Gently screw the plunger into the rubber piece until it seems secure. Do not use a lot of force.
  • Hold the syringe by the barrel (not the plunger) and take the cap off the needle.
  • You are now ready to mix the Sodium Chloride Injection USP and the powder.
  • Insert the needle into the bottle of alprostadil and inject 1.2 milliliters of the Sodium Chloride Injection USP from your syringe into the bottle of alprostadil.
  • Remove the needle from the bottle, holding the barrel of the syringe.
  • Gently swirl the bottle to mix the powder into the solution, turning it upside down to wet all the powder in the bottle.
  • Follow the directions below, “How to draw your dose into the syringe.”

How to mix Prostin VR or Prostin VR Pediatric:

• You will need to get exact mixing instructions from your doctor or pharmacist if you are given two solutions to be mixed. Follow them carefully, asking the pharmacist or doctor any questions that you might have before injecting the medicine.
• After you or the pharmacist has mixed these solutions, follow the directions below, “How to draw your dose into the syringe.”

How to draw your dose into the syringe (for all injection products):

• Check the solution to make sure it is clear. Do not use the mixture if you can see anything solid in the solution or if the solution is cloudy or colored.
• After the alprostadil solution is mixed and the needle is inserted into the alprostadil bottle, turn the bottle with the syringe as a unit upside down in one hand. Be sure the tip of the needle is covered by the solution. With your other hand, pull the plunger back slowly to draw the correct dose of the medicine into the syringe.
• Hold the syringe with the measuring scale at eye level to see that the proper dose is withdrawn and to check for air bubbles. To remove air bubbles, tap gently on the measuring scale of the syringe to move any bubbles to the top of the syringe near the needle.
• If your dose measures too low in the syringe, withdraw more solution from the bottle. If there is too much medicine in the syringe, put some back into the bottle. Then check your dose again.
• Remove the needle from the bottle, holding the barrel of the syringe, not the plunger.
• Place the cover back on the needle. You are now ready to inject your dose. Follow the directions below, “How to give the alprostadil injection.”

How to give the alprostadil injection:

• Choose a spot on your penis as directed by your doctor where you will give the injection.
• Clean the injection site with alcohol. Sitting upright or slightly reclined, hold your penis against the side of your thigh so that it cannot move.
• Remove the cover from the needle and hold the needle at a 90-degree angle to the place of injection.
• Insert the needle until almost all of the metal part of the needle is inserted into the penis.
• Do not inject the medicine just under the surface of the skin, at the top or head of the penis, or at the base of the penis near the scrotum or testes. Avoid injecting the medicine into blood vessels that you can see.
• Press the plunger down slowly, taking 5 to 10 seconds to release the dose into the penis.
• The injection is usually not painful. If the injection is very painful or if you notice bruising or swelling at the place of injection, that means you are injecting the medicine under the skin. Stop, withdraw the needle, and reposition it properly before continuing with the injection.
• Remove the needle and recap it.
• After you have completed the injection, put pressure on the place of injection for about 5 minutes or until any bleeding stops. This will prevent bruising. Then massage your penis as instructed by your doctor. This helps the medicine spread to all parts of the penis, so that the medicine will work better.

Choose a different place of injection each time you use the medicine to prevent skin problems. This includes switching the place of injection from the right side of the penis for one injection to the left side for the next injection.

After a single-use injection is mixed, the medicine must be used immediately. Throw away any unused mixture in the syringe. It cannot be stored for a later injection.

Do not reuse your needles.

How to throw away the syringes and bottles safely:

Dispose of your materials properly. Caverject comes in a plastic case that can be permanently locked with the red locking device that is included with the packaging. When the case label is removed, you can see a hole in the center of the case. The red locking device can be inserted and, by firmly pressing it down with your thumb, you will permanently lock the case. The locked case is safe to be thrown away.

If you do not have the plastic case or are using Prostin VR or Prostin VR Pediatric injection, unscrew the needle from the barrel of the syringe. Then bend, break, or cut the needle into two pieces with wire cutters. The pieces can be placed in a heavy plastic container, such as a bleach container, and thrown away. Or you may give them to a health care professional to throw away. If you have any questions about disposing of the syringe and needles, ask your health care professional.

For suppositories—Before inserting the suppository, you should urinate. The small amount of urine normally left in your urethra will help dissolve the suppository after it is inserted.

How to insert suppositories:

• 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.

How to throw away the suppository delivery device safely:

• Replace the cap on the delivery device. After storing it in the foil, fold and throw away.

For injections or suppositories—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.

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 the treatment of erectile dysfunction:
  • For injection dosage form:
    • Adults—1.25 to 60 micrograms (mcg) as a single dose once a day. Your exact dose will be determined by your doctor. Inject this medicine very slowly into your penis as shown to you by your doctor ten to thirty minutes before intercourse. Allow five to ten seconds to completely inject the dose. Do not inject more than one dose within twenty-four hours. Also, do not use this medicine for more than two days in a row or more than three times a week.
  • For suppository dosage form:
    • Adults—125, 250, 500, or 1000 mcg as a single dose once a day. Your exact dose will be determined by your doctor. Insert this medicine into the urethra of your penis as shown to you by your doctor ten to thirty minutes before intercourse. Do not insert more than two doses within twenty-four hours.

Storage

Store in the refrigerator. Do not freeze.

You may store the suppositories in the refrigerator, but do not freeze them.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Alprostadil for Injection while in the powder form can be stored at room temperature (between 15 and 25 °C or 59 and 77 °F) for 3 months. After it is mixed, the solution must be used immediately. Suppositories may be stored at room temperature

Precautions While Using Muse Micro

Do not use alprostadil if you have a penile implant unless advised by doctor.

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

Use alprostadil exactly as directed by your doctor . Do not use more of it and do not use it more often than your doctor ordered. If too much is used, 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 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.

If you notice bleeding at the place where you injected the medicine, put pressure on the spot until the bleeding stops. If it doesn’t stop within 10 minutes, check with your doctor.

Muse Micro Side Effects

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:

Rare

• Curving of penis with pain during erection
• erection continuing for 4 to 6 hours
• erection continuing longer than 6 hours with severe and continuing pain of the penis
• swelling in or pain of the testes

Symptoms of too much medicine being absorbed into the body

• Dizziness
• faintness
• pelvic pain
• flu-like symptoms

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:

More common

• Bleeding at place of injection, short-term
• mild bleeding or spotting from urethra (suppository only)
• pain at place of injection
• painful erection
• stinging of urethra (suppository only)

Rare

Female partners may experience itching or stinging of vagina when you first begin using the alprostadil suppository. These side effects may not be caused from the medicine but may result if female partner has not had frequent or recent sexual intercourse.

• Bruising or clotted blood in penis at place of injection, usually caused by an incorrect injection

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.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided “AS IS” and “as available” for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

Generic Name: mechlorethamine (mech klor EH tha meen)
Brand Names: Mustargen

What is Mustargen (mechlorethamine)?

Mechlorethamine is a cancer (antineoplastic) medication. Mechlorethamine interferes with the growth of cancer cells and slows their growth and spread in the body.

Mechlorethamine is used to treat several types of cancer, such as Hodgkin’s Disease, lymphosarcoma, chronic myelocytic or chronic lymphocytic leukemia, lung cancer and mycosis fungoides. Mechlorethamine is also used to treat certain other blood disorders (polycythemia vera) and is sometimes injected into body spaces, such as the chest, abdomen or the sack containing the heart, to stop the accumulation of fluids caused by cancer.

Mechlorethamine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Mustargen (mechlorethamine)?

Mechlorethamine should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Serious side effects have been reported with the use of mechlorethamine including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; fever or chills; or signs of infection such as fever; chills, or sore throat); severe nausea, vomiting, diarrhea, and loss of appetite; and others. Talk to your doctor about the possible side effects from treatment with mechlorethamine.

Mechlorethamine is highly toxic and both the powder and solution must be handled with care. Inhalation of dust or vapors and contact with skin or mucous membranes (eyes, nose and mouth) must be avoided.

Who should not take Mustargen (mechlorethamine)?

Before taking mechlorethamine, tell your doctor if you

• have had recent vaccinations;

• have any type of infection;

• have bone marrow problems;

• have had radiation or x-ray therapy; or

• have been treated with other cancer (chemotherapy) medicines.

You may not be able to take mechlorethamine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Mechlorethamine is in the FDA pregnancy category D. This means that mechlorethamine is known to cause birth defects in an unborn baby. Do not take mechlorethamine without first talking to your doctor if you are pregnant or could become pregnant during treatment. Contraceptive measures are recommended during treatment with mechlorethamine. It is not known whether mechlorethamine passes into breast milk. Do not take mechlorethamine without first talking to your doctor if you are breast feeding a baby.

How should I take Mustargen (mechlorethamine)?

Mechlorethamine should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Your doctor will determine the correct amount and frequency of treatment with mechlorethamine depending upon the type of cancer being treated and other factors. Talk to your doctor if you have any questions or concerns regarding the treatment schedule.

Your doctor will probably want you to have regularly scheduled blood tests and other medical evaluations during treatment with mechlorethamine to monitor progress and side effects.

Mechlorethamine is highly toxic and both the powder and solution must be handled with care. Inhalation of dust or vapors and contact with skin or mucous membranes (eyes, nose and mouth) must be avoided. Should accidental contact occur, rinse the area with water and seek emergency medical attention.

Your healthcare provider will store mechlorethamine as directed by the manufacturer.

What happens if I miss a dose?

Contact your doctor if you miss a dose of mechlorethamine injection.

What happens if I overdose?

If for any reason an overdose of mechlorethamine is suspected, seek emergency medical attention or contact your healthcare provider immediately.

Symptoms of a mechlorethamine overdose tend to be similar to side effects caused by the medication, although often more severe.

What should I avoid while taking Mustargen (mechlorethamine)?

Mechlorethamine can lower the activity of your immune system making you susceptible to infections. Avoid contact with people who have colds, the flu, or other contagious illnesses and do not receive vaccines that contain live strains of a virus (e.g., live oral polio vaccine) during treatment with mechlorethamine. In addition, avoid contact with individuals who have recently been vaccinated with a live vaccine. There is a chance that the virus can be passed on to you.

Mechlorethamine is highly toxic and both the powder and solution must be handled with care. Inhalation of dust or vapors and contact with skin or mucous membranes (eyes, nose and mouth) must be avoided.

Mustargen (mechlorethamine) side effects

If you experience any of the following serious side effects, seek emergency medical attention or contact your doctor immediately:

• an allergic reaction (shortness of breath; closing of your throat; difficulty breathing; swelling of your lips, face, or tongue; or hives);

• blood in the urine;

• black or tarry stools;

• signs of infection such as fever; chills, or sore throat;

• joint pain and stiffness similar to gout (high levels of uric acid in the blood);

• jaundice (yellowing of the skin or eyes);or

• unusual bleeding or bruising.

Other less serious side effects may be more likely to occur. Talk to your doctor if you experience:

• nausea, vomiting, or decreased appetite;

• mouth sores;

• a sensation of spinning or dizziness (vertigo);

• diarrhea;

• temporary hair loss;

• rash;

• a ringing in the ears or decreased ability to hear; or

• weakness.

In some cases, second malignancies have been reported to occur during and following treatment with mechlorethamine. Talk to your doctor about the risks and benefits of this medication.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Mustargen (mechlorethamine)?

Do not receive “live” vaccines during treatment with mechlorethamine. Administration of a live vaccine may be dangerous during treatment with mechlorethamine.

Other drugs may interact with mechlorethamine. Talk to your doctor and pharmacist before taking any other prescription or over-the-counter medicines, including herbal products, during treatment with mechlorethamine.

Where can I get more information?

• Your pharmacist has additional information about mechlorethamine written for health professionals that you may read.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.04. Revision Date: 4/12/2009 4:39:42 PM.

Generic Name: alprostadil (injectable and transurethral) (al PROS ta dil)
Brand Names: Caverject, Caverject Impulse, Edex, Muse, Prostin VR Pediatric

What is alprostadil?

Alprostadil is used to treat erectile dysfunction (impotence) and to help diagnose certain causes of this disorder. Alprostadil is also used to improve blood flow in newborn babies with a certain genetic heart condition. This alprostadil medication guide addresses only the adult male use of this medication in erectile disorders.

Alprostadil relaxes blood vessels and muscles in the penis. This increases blood flow into the penis, causing an erection.

Alprostadil may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about alprostadil?

Alprostadil is used to treat erectile dysfunction (impotence) and to help diagnose certain causes of this disorder. Alprostadil is also used to improve blood flow in newborn babies with a certain genetic heart condition. This alprostadil medication guide addresses only the adult male use of this medication in erectile disorders.

The injectable form of alprostadil is injected into the side of the penis. The transurethral form is a very small suppository (pellet) that is inserted into the opening of the penis (the urethra).

Use this medication exactly as it was prescribed for you. Using too much alprostadil can be very dangerous. This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Your first dose of this medicine will be given in your doctor’s office so you can be observed for how well the medication works and if it causes any side effects. You will then be shown how to properly give the medication to yourself.

Do not give yourself an alprostadil injection or pellet if you do not understand the instructions for proper use. Call your doctor, nurse, or pharmacist for help with injection instructions. Using an alprostadil transurethral pellet improperly could cause damage to your urethra.

Alprostadil is used only when needed to get an erection. An erection should occur within 5 to 20 minutes after you use the medication, and should last for 30 to 60 minutes. The length of time your erection lasts may be slightly different from these averages.

Seek emergency medical attention if you think you have used too much of this medication. Symptoms of an alprostadil overdose may include feeling light-headed, fainting, or having a painful or prolonged erection lasting 4 hours or longer.

What should I discuss with my healthcare provider before using alprostadil?

Do not use alprostadil if you have:

• sickle cell anemia or the sickle cell anemia trait;

• leukemia;

• a tumor of the bone marrow (multiple myeloma);

• chronic urination problems;

• a history of blood clots;

• a curved or deformed penis;

• penile fibrosis or Peyronie’s disease; or

• if you have been told you should not have sexual intercourse for health reasons.

Before using alprostadil, tell your doctor if you have:

• a bleeding or blood-clotting disorder;

• a disease that could be passed in blood (such as hepatitis or HIV);

• heart disease;

• high blood pressure (hypertension); or

• if you have a penile implant.

If you have any of these conditions, you may need a dose adjustment or special tests to safely use this medication.

Use a condom to prevent transfer of this medication to your sexual partner if she is pregnant or could become pregnant.

Alprostadil should not be used by women or by anyone under 18 years old.

How should I use alprostadil?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Using too much alprostadil can be very dangerous.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

The injectable form of alprostadil is injected into the side of the penis. The transurethral form is a very small suppository (pellet) that is inserted into the opening of the penis (the urethra).

Your first dose of this medicine will be given in your doctor’s office so you can be observed for how well the medication works and if it causes any side effects. You will then be shown how to properly give the medication to yourself.

Do not give yourself an alprostadil injection or pellet if you do not understand the instructions for proper use. Call your doctor, nurse, or pharmacist for help with injection instructions. Using an alprostadil transurethral pellet improperly could cause damage to your urethra.

Alprostadil is used only when needed to get an erection. An erection should occur within 5 to 20 minutes after you use the medication, and should last for 30 to 60 minutes. The length of time your erection lasts may be slightly different from these averages.

To be sure this medication is not causing harmful effects, your penis will need to be examined on a regular basis. It is important that you not miss any scheduled appointments.

Alprostadil injectable is a powder medicine that comes with a sterile liquid for mixing it. Caverject Impulse is a brand of alprostadil injectable supplied as a needle and syringe that contains both the powder medicine and the sterile liquid. The dose is automatically mixed when you turn a dial on the end of the syringe. The Caverject Impulse syringe is designed for only one use. Carefully follow the instructions provided with this product.

Do not mix alprostadil injectable or draw your dose into a syringe until you are ready to give yourself an injection. Do not shake the mixed medication. After mixing, the medication should be clear, without any particles in it.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

The Caverject Impulse device uses a very thin needle, which could break easily. If the needle breaks during injection and you can see and grasp the broken end, remove it and contact your doctor. If you cannot remove the broken end, call your doctor right away.

An alprostadil injection can cause bleeding where the needle is placed. This can make it easier for your sexual partner to be exposed to your blood. Before using this medication, tell your doctor if you have a virus such as hepatitis or HIV, which can be passed to another person who comes into contact with your blood.

Do not use more than 2 alprostadil pellets in one day (24 hours). Do not use more than 3 alprostadil injections per week. Allow at least 24 hours to pass between injections.

Storing this medicine:

• Keep each urethral pellet in its original foil pouch until you are ready to use it. Store the foil pouches in the refrigerator. You may store the pouches at room temperature for up to 14 days.
• Store alprostadil injectable at room temperature. The 40 microgram strength of unmixed alprostadil can be stored at room temperature for up to 3 months, or until the expiration date on the label, whichever happens first.
• Do not expose alprostadil products to freezing or very hot temperatures. Do not store your medication in a closed automobile, or pack it into luggage that will be placed into a cargo area during travel.

What happens if I miss a dose?

Since alprostadil is used as needed, you will not be on a dosing schedule.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medication. Overdose symptoms may include feeling light-headed, fainting, or having a painful or prolonged erection lasting 4 hours or longer.

What should I avoid while using alprostadil?

Alprostadil can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Alprostadil side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using alprostadil and call your doctor at once if you have any of these serious side effects:

• feeling light-headed, fainting;

• bleeding from your urethra;

• bleeding, bruising, or swelling where you injected the medication;

• a painful erection that lasts 4 hours or longer;

• severe pain or irritation of your penis or urethra; or

• redness, lumps, tenderness, unusual shape or curving of the erect penis.

Less serious side effects may include:

• pain in your penis, urethra, or testicles;

• headache, dizziness;

• back pain;

• a rash on the skin of your penis;

• warmth or numbness of your penis; or

• cough, stuffy nose, cold symptoms.

Your sexual partner may also experience side effects such as burning, itching, or irritation of the body areas that come into contact with your penis.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect alprostadil?

Before using alprostadil, tell your doctor if you are using any of the following drugs:

• nitroglycerin;

• hydralazine (BiDil); or

• a blood thinner such as warfarin (Coumadin), heparin, dalteparin (Fragmin), danaparoid (Orgaran), or enoxaparin (Lovenox).

This list is not complete and here may be other drugs that can interact with alprostadil. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about alprostadil.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 6.02. Revision Date: 4/12/2009 4:39:51 PM.

Generic Name: Alprostadil (al-PRAHST-uh-dill)
Brand Name: Muse

Muse Suppository is used for:

Treating erectile problems in men.

Muse Suppository is a prostaglandin (PGE-1). It induces penile erection by relaxing certain muscles in the penis and widening blood vessels, which increases blood flow to the penis and helps to cause an erection. When the effect of the alprostadil wears off, blood flow returns to normal and the erection disappears.

Do NOT use Muse Suppository if:

• you are allergic to any ingredient in Muse Suppository
• you have urinary problems (eg, inflammation or narrowing of the urinary tract), blood problems (eg, sickle cell anemia, thrombocytopenia, polycythemia, multiple myeloma, thick or “sticky” blood), blood clotting problems, or a history of blood clots
• you have inflammation or infection of the penis, your penis is not straight when erect, or your penis is structurally abnormal in any way
• you have any other physical reason that you should not have sexual intercourse
• you plan to have sexual intercourse with a pregnant woman (unless you use a condom)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Muse Suppository:

Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, if you become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have Peyronie disease (scar tissue on your penis) or a prolonged and painful erection
• if you have a penile implant, leukemia, heart problems, or lung problems (eg, adult respiratory distress syndrome)

Some MEDICINES MAY INTERACT with Muse Suppository.

• Anticoagulants (eg, warfarin) because the risk of bleeding may be increased
• Medicines for high blood pressure because side effects, such as dizziness and fainting, may be increased by Muse Suppository

This may not be a complete list of all interactions that may occur. Ask your health care provider if Muse Suppository may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Muse Suppository:

Use Muse Suppository as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Muse Suppository comes with an additional patient leaflet. Read it carefully and reread it each time you get Muse Suppository refilled.
• Muse Suppository should be used as needed to achieve an erection.
• Use Muse Suppository exactly as instructed by your health care provider. Before using Muse Suppository, your health care provider should instruct you on the proper technique for self-administering Muse Suppository. Contact your health care provider if you have any questions about using Muse Suppository.
• Muse Suppository works best if you urinate just prior to insertion.
• Do not use more than 2 systems in a 24-hour period.
• Each dose is for single use and should be properly thrown away after use.
• The medicine usually takes effect 5 to 10 minutes after being used. The effect lasts about 30 to 60 minutes. However, the duration will vary from person to person.
• If you miss a dose of Muse Suppository, use it as soon as you remember. Continue to use it as directed by your doctor.

Ask your health care provider any questions you may have about how to use Muse Suppository.

Important safety information:

• Muse Suppository may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Muse Suppository. Using Muse Suppository alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
• You will need to have a complete medical history and physical exam before using Muse Suppository.
• Wear a condom if you plan to have sexual intercourse with a pregnant woman.
• Tell your doctor if you experience painful erections or erections that last for more than 4 hours. If prolonged erection is not treated immediately, damage to the penile tissue and loss of potency could result.
• Muse Suppository does not protect against the spread of sexually transmitted diseases (STDs). Take precautions to guard against the spread of STDs, including HIV.
• If you have not had sexual intercourse for a long time, consult your health care provider before resuming sexual intercourse. It may be necessary to use a water-based lubricant during sexual intercourse.
• Muse Suppository is not recommended for use in CHILDREN; safety and effectiveness have not been established.

Possible side effects of Muse Suppository:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; burning, bleeding, or spotting of the urethra; flu symptoms; groin pain; pain; penile pain; runny nose; testicular pain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fainting; fast pulse; leg pain; prolonged, painful erections; redness, lumps, swelling, tenderness, or curving of the erect penis; swelling of the leg veins.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include fainting; lasting pain in the penis, and painful erections lasting more than 6 hours; lightheadedness.

Proper storage of Muse Suppository:

Store unopened foil pouches in refrigerator between 36 and 46 degrees F (2 and 8 degrees C). Muse Suppository may be stored at room temperature below 86 degrees F (30 degrees C) for up to 14 days. Keep Muse Suppository out of the reach of children and away from pets.

General information:

• If you have any questions about Muse Suppository, please talk with your doctor, pharmacist, or other health care provider.
• Muse Suppository is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Muse Suppository. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: muromonab-CD3 (myoo roe MOE nab)
Brand Names: Orthoclone OKT3

What is muromonab-CD3?

Muromonab-CD3 lowers your body’s immune system. The immune system helps your body fight infections. The immune system can also fight or “reject” a transplanted organ such as a kidney. This is because the immune system treats the new organ as an invader.

Muromonab-CD3 is used with other medications to prevent organ rejection after a kidney transplant.

Muromonab-CD3 may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about muromonab-CD3?

Muromonab-CD3 is given as an injection through a needle placed into a vein. You will receive this injection just before your transplant and again 4 days afterward. The medicine must be given slowly through an IV infusion, and can take up to 30 minutes to complete.

Some people receiving a muromonab-CD3 injection have had a reaction to the infusion (within 30 to 60 minutes after the medicine is injected into the vein). Tell your caregiver right away if you feel chilled or feverish, nauseated, weak, shaky, or light-headed, or if you have a headache, or joint and muscle aches. These side effects may also occur up to several hours after your injection.

Muromonab-CD3 can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor after your transplant.

Avoid contact with people who have colds, the flu, or other contagious illnesses. Contact your doctor immediately if you develop signs of infection.

Avoid receiving a vaccine or flu shot shortly after you have been treated with muromonab-CD3, unless your doctor has told you to.

There may be other drugs that can affect muromonab-CD3. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

What should I discuss with my health care provider before receiving muromonab-CD3?

You should not be given this medication if you are allergic to muromonab or mouse proteins, or if you have:

• heart failure;

• untreated or uncontrolled high blood pressure (hypertension);

• epilepsy or other seizure disorder; or

• if you are pregnant or breast-feeding.

Before receiving muromonab-CD3, tell your doctor if you are allergic to any drugs, or if you have:

• chest pain (angina);

• congestive heart failure;

• a breathing disorder;

• a history of heart attack or stroke; or

• if you have recently taken a diuretic (“water pill”).

If you have any of these conditions, you may need a dose adjustment or special tests to safely receive muromonab-CD3.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether muromonab-CD3 passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is muromonab-CD3 given?

Muromonab-CD3 is given as an injection through a needle placed into a vein. You will receive this injection just before your transplant and again 4 days afterward. The medicine must be given slowly through an IV infusion, and can take up to 30 minutes to complete.

You may also be given a steroid medication before you receive muromonab-CD3.

Muromonab-CD3 can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor after your transplant.

What happens if I miss a dose?

Since muromonab-CD3 is given while you are in the hospital, it is unlikely that you will miss a dose.

What happens if I overdose?

An overdose of muromonab-CD3 is not expected to produce life-threatening symptoms.

What should I avoid while receiving muromonab-CD3?

Avoid contact with people who have colds, the flu, or other contagious illnesses. Contact your doctor immediately if you develop signs of infection.

Avoid receiving a vaccine or flu shot shortly after you have been treated with muromonab-CD3, unless your doctor has told you to.

Muromonab-CD3 side effects

Some people receiving a muromonab-CD3 injection have had a reaction to the infusion (within 30 to 60 minutes after the medicine is injected into the vein). Tell your caregiver right away if you feel chilled or feverish, nauseated, weak, shaky, or light-headed, or if you have a headache, or joint and muscle aches. These side effects may also occur up to several hours after your injection. Tell your caregivers right away if you have any of these serious side effects:

• wheezing, gasping, shortness of breath;

• fast or uneven heart rate, chest pain or heavy feeling, pain spreading to the arm or shoulder, sweating, general ill feeling;

• confusion, hallucinations, unusual thoughts or behavior;

• fever, headache, neck stiffness, chills, increased sensitivity to light;

• loss of vision or muscle control;

• seizure (black-out or convulsions);

• pain or burning when you urinate;

• easy bruising or bleeding, unusual weakness; or

• high fever, chills, stomach pain, vomiting, diarrhea, tremors, body aches, flu symptoms.

Less serious side effects may include:

• mild headache;

• nausea, constipation, upset stomach;

• sleep problems (insomnia); or

• swelling in your hands, ankles, or feet.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Muromonab-CD3 Dosing Information

Usual Adult Dose for Rejection Reversal:

5 mg IV once a day for 10-14 days.

Usual Adult Dose for Rejection Prophylaxis:

5 mg IV once a day.

Usual Pediatric Dose for Rejection Reversal:

< or = 30 kg: 2.5 mg IV once a day for 7-14 days.
> 30 kg: 5 mg IV once a day for 7-14 days.

What other drugs will affect muromonab-CD3?

Before receiving muromonab-CD3, tell your doctor if you are using any drugs that weaken your immune system, such as:

• cyclosporine (Neoral, Sandimmune, Gengraf);

• basiliximab (Simulect), efalizumab (Raptiva);

• azathioprine (Imuran), leflunomide (Arava), etanercept (Enbrel);

• steroids such as prednisone, fluticasone (Advair), mometasone (Asmanex, Nasonex), dexamethasone (Decadron, Hexadrol) and others;

• sirolimus (Rapamune), tacrolimus (Prograf);

• mycophenolate mofetil (CellCept);

• azathioprine (Imuran), leflunomide (Arava), etanercept (Enbrel); or

• any type of chemotherapy or radiation treatment.

This list is not complete and there may be other drugs that can interact with muromonab-CD3. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your doctor or pharmacist can provide more information about muromonab-CD3.

• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.02. Revision Date: 4/12/2009 4:40:03 PM.