What is the most important information I should know about Levitra (Vardenafil) ?

Do not take Levitra if you are taking any of the following medicines:

• a nitrate such as nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, Minitran, Deponit, Transderm-Nitro, others), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), isosorbide mononitrate (Imdur, ISMO, Monoket), and others;
• a recreational drug such as amyl nitrate or nitrite ("poppers"); or
• an alpha blocker such as doxazosin (Cardura), guanadrel (Hylorel), prazosin (Minipress), terazosin (Hytrin), alfuzosin (Uroxatral), tamsulosin (Flomax), and others.

Taking Levitra with any of these medications may cause very low blood pressure, possibly resulting in dizziness, fainting, stroke, or heart attack

Contact your doctor or seek emergency medical attention for any erection that lasts longer than 4 hours. A sustained erection can damage the penis.

Refrain from further sexual activity and notify your doctor it you develop dizziness, nausea, or angina (pain, tightness, discomfort, numbness, or tingling in the chest, arms, neck, or jaw) during sexual activity.

Do not take Levitra more than once a day. In some cases, use of Levitra may be restricted to once every 72 hours (3 days). Follow your doctor's instructions.

What is Levitra?

Generic Levitra relaxes muscles within the penis. This allows increased blood flow into the penis which is necessary to achieve and maintain an erection.

Generic Levitra is used to treat erectile dysfunction (impotence).

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

What should I discuss with my healthcare provider before taking Levitra?

Do not take Levitra if you are taking any of the following medicines:

• a nitrate such as nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, Minitran, Deponit, Transderm-Nitro, others), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), isosorbide mononitrate (Imdur, ISMO, Monoket), and others;
• a recreational drug such as amyl nitrate or nitrite ("poppers"); or
• an alpha blocker such as doxazosin (Cardura), guanadrel (Hylorel), prazosin (Minipress), terazosin (Hytrin), alfuzosin (Uroxatral), tamsulosin (Flomax), and others.

Taking Levitra with any of these medications may cause very low blood pressure, possibly resulting in dizziness, fainting, stroke, or heart attack

Before taking Levitra, tell your doctor if you

• currently have or have ever had a heart attack, stroke, irregular heartbeats, angina (chest pain), or congestive heart failure;
• have high or low blood pressure;
• have a personal or family history of a rare heart condition known as prolongation of the QT interval (long QT syndrome);
• have liver problems;
• have kidney problems;
• have ever had blood problems, including sickle cell anemia, multiple myeloma, or leukemia;
• have a bleeding or blood clotting disorder;
• have a stomach ulcer;
• a family history of degenerative eye disease (e.g., retinitis pigmentosa); or
• have a physical deformity of the penis such as Peyronie's disease.

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

Although Levitra is not indicated for use by women, it is in the FDA pregnancy category B. This means that Levitra is not expected to be harmful to an unborn baby. Generic Levitra should not be taken by women.

It is not known whether Levitra passes into breast milk. Generic Levitra should not be taken by women.

If you are over 65 years of age, you may be more likely to experience side effects from Levitra. Your doctor may prescribe a lower dose of the medication.

How should I take Levitra?

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

Take each dose with a full glass of water.

Generic Levitra can be taken with or without food.

Generic Levitra is usually taken when needed. Generally, it is taken about 1 hour before sexual activity. The medication can help achieve an erection when sexual stimulation occurs. An erection will not occur just by taking a pill. Follow your doctor's instructions.

Generic Levitra should not be taken with grapefruit or grapefruit juice. Generic Levitra can interact with grapefruit and grapefruit juice, and the interaction may have dangerous effects. You should discuss the use of grapefruit and grapefruit juice with your doctor.

Do not take Levitra more than once a day. In some cases, use of Levitra may be restricted to once every 72 hours (3 days). Follow your doctor's instructions.

If you develop dizziness, nausea, or angina (pain, tightness, discomfort, numbness, or tingling in the chest, arms, neck, or jaw) during sexual activity, refrain from further sexual activity and notify your doctor.

Contact your doctor or seek emergency medical attention for any erection that lasts longer than 4 hours. A sustained erection can damage the penis.

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

What happens if I miss a dose?

Generic Levitra is used as needed, so you are not likely to miss a dose.

What happens if I overdose?

Seek emergency medical attention if an overdose is suspected.

Symptoms of a Levitra overdose are not known, but are likely to include chest pain, back pain, dizziness, an irregular heartbeat, abnormal vision, and swelling of the ankles or legs.

What should I avoid while taking Levitra?

Do not take any other drug used to treat impotence, such as alprostadil (Caverject, Muse, Edex) or yohimbine (Yocon, Yodoxin, others), without first talking to your doctor.

Generic Levitra should not be taken with grapefruit or grapefruit juice. Generic Levitra can interact with grapefruit and grapefruit juice, and the interaction may have dangerous effects. You should discuss the use of grapefruit and grapefruit juice with your doctor.

What are the possible side effects of Levitra?

If you experience any of the following serious side effects, stop taking Levitra 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);
• chest pain or an irregular heartbeats;
• swelling of the ankles or legs;
• shortness of breath;
• prolonged or severe dizziness;
• fainting;
• a prolonged (lasting longer than 4 hours) or painful erection;
• dizziness, nausea, or angina (pain, tightness, discomfort, numbness, or tingling in the chest, arms, neck, or jaw); or
• back pain.

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

• flushing;
• mild dizziness;
• headache;
• nasal congestion;
• stomach upset;
• sensitivity of the eyes to light; or
• temporary blue tint in vision or other vision abnormalities.

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.

What other drugs will affect Levitra?

Do not take Levitra if you are taking any of the following medicines:

• a nitrate such as nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, Minitran, Deponit, Transderm-Nitro, others), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), isosorbide mononitrate (Imdur, ISMO, Monoket), and others;
• a recreational drug such as amyl nitrate or nitrite ("poppers"); or
• an alpha blocker such as doxazosin (Cardura), guanadrel (Hylorel), prazosin (Minipress), terazosin (Hytrin), alfuzosin (Uroxatral), tamsulosin (Flomax), and others.

Taking Levitra with any of these medications may cause very low blood pressure, possibly resulting in dizziness, fainting, stroke, or heart attack

Before taking Levitra, tell your doctor if you are taking any of the following medications:

• any other drug used to treat impotence, such as alprostadil (Caverject, Muse, Edex) or yohimbine (Yocon, Yodoxin, others);
• the antibiotic drug erythromycin (E-Mycin, Eryc, Ery-Tab, others);
• an antifungal medication such as itraconazole (Sporanox) or ketoconazole (Nizoral);
• a medication used to treat irregular heartbeats such as quinidine (Quinaglute, Quinidex, Quin-Release), procainamide (Procan SR, Procanbid, Pronestyl), amiodarone (Cordarone, Pacerone), or sotalol (Betapace, Sorine); or
• the HIV medications indinavir (Crixivan) or ritonavir (Norvir).

You may not be able to take Levitra, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

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

Where can I get more information?

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

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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 1996-2003 Cerner Multum, Inc. Version: 2.01. Revision date: 9/28/04.