Brand Names: Levitra

Generic Name: vardenafil (Pronunciation: var DEN a fil)

• What is vardenafil (Levitra)?
• What are the possible side effects of vardenafil (Levitra)?
• What is the most important information I should know about vardenafil (Levitra)?
• What should I discuss with my healthcare provider before taking vardenafil (Levitra)?
• How should I take vardenafil (Levitra)?
• What happens if I miss a dose (Levitra)?
• What happens if I overdose (Levitra)?
• What should I avoid while taking vardenafil (Levitra)?
• What other drugs will affect vardenafil (Levitra)?
• Where can I get more information?

What is vardenafil (Levitra)?

Vardenafil relaxes muscles and increases blood flow to particular areas of the body.

Vardenafil is used to treat erectile dysfunction (impotence).

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

Levitra 10 mg

round, orange, imprinted with BAYER, 10

Levitra 20 mg

round, orange, imprinted with BAYER BAYER, 20

Levitra 5 mg

round, orange, imprinted with BAYER BAYER, 5

What are the possible side effects of vardenafil (Levitra)?

Stop using vardenafil and get emergency medical help if you have sudden vision loss.

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.

During sexual activity, if you become dizzy or nauseated, or have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away. You could be having a serious side effect of vardenafil.

Stop using vardenafil and call your doctor at once if you have any of these serious side effects:

• sudden vision loss;
• ringing in your ears, or sudden hearing loss;
• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
• irregular heartbeat;
• swelling in your hands, ankles, or feet;
• shortness of breath;
• vision changes;
• feeling light-headed, fainting;
• penis erection that is painful or lasts 4 hours or longer; or
• seizure (convulsions).

Less serious side effects may include:

• warmth or redness in your face, neck, or chest;
• stuffy nose;
• headache;
• memory problems;
• upset stomach; or
• back 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. You may report side effects to FDA at 1-800-FDA-1088.

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

Do not take vardenafil if you are also using a nitrate drug for chest pain or heart problems. This includes nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, and others), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), and isosorbide mononitrate (Imdur, ISMO, Monoket). Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite ("poppers"). Taking vardenafil with a nitrate medicine can cause a serious decrease in blood pressure, leading to fainting, stroke, or heart attack.

During sexual activity, if you become dizzy or nauseated, or have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away. You could be having a serious side effect of vardenafil.

Do not take vardenafil more than once a day. Allow 24 hours to pass between doses.

Contact your doctor or seek emergency medical attention if your erection is painful or lasts longer than 4 hours. A prolonged erection (priapism) can damage the penis.

Vardenafil can decrease blood flow to the optic nerve of the eye, causing sudden vision loss. This has occurred in a small number of people taking vardenafil, most of whom also had heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and in those who smoke or are over 50 years old. It is not clear whether vardenafil is the actual cause of vision loss.

Stop using vardenafil and get emergency medical help if you have sudden vision loss.

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

Do not take vardenafil if you are also using a nitrate drug for chest pain or heart problems. This includes nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, and others), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), and isosorbide mononitrate (Imdur, ISMO, Monoket). Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite ("poppers"). Taking vardenafil with a nitrate medicine can cause a serious decrease in blood pressure, leading to fainting, stroke, or heart attack.

Before taking vardenafil, tell your doctor if you are allergic to any drugs, or you have:

• heart disease or heart rhythm problems;
• a recent history (in the past 6 months) of a heart attack, angina (chest pain), or congestive heart failure;
• a recent history of stroke or blood clots;
• a personal or family history of "Long QT syndrome";
• high or low blood pressure;
• liver disease;
• kidney disease (or if you are on dialysis);
• a blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia;
• a bleeding disorder such as hemophilia;
• a stomach ulcer;
• retinitis pigmentosa (an inherited condition of the eye);
• a physical deformity of the penis (such as Peyronie's disease); or
• if you have been told you should not have sexual intercourse for health reasons.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take vardenafil.

Vardenafil can decrease blood flow to the optic nerve of the eye, causing sudden vision loss. This has occurred in a small number of people taking vardenafil, most of whom also had heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and in those who smoke or are over 50 years old. It is not clear whether vardenafil is the actual cause of vision loss.Stop using vardenafil and get emergency medical help if you have sudden vision loss.

FDA pregnancy category B: Although vardenafil is not for use in women, this medication is not expected to be harmful to an unborn baby. Do not use vardenafil without telling your doctor if you are pregnant or plan to become pregnant during treatment.

Although vardenafil is not for use in women, it is not known if vardenafil 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.

You may need a lower dose of this medication if you are older than 65. Follow your doctor's instructions.

How should I take vardenafil (Levitra)?

Take vardenafil exactly as it was prescribed for you. Do not take it in larger doses or for longer than recommended by your doctor.

Take each dose with a full glass of water.

Vardenafil can be taken with or without food.

Vardenafil is usually taken only when needed, about 60 minutes 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.

Do not take vardenafil more than once a day. Allow 24 hours to pass between doses.

Contact your doctor or seek emergency medical attention if your erection is painful or lasts longer than 4 hours. A prolonged erection (priapism) can damage the penis.

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

What happens if I miss a dose (Levitra)?

Since vardenafil is used as needed, you are not likely to be on a dosing schedule.

What happens if I overdose (Levitra)?

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

Overdose symptoms may include back pain, muscle pain, or vision problems.

What should I avoid while taking vardenafil (Levitra)?

Avoid drinking alcohol, which can increase some of the side effects of vardenafil.

Grapefruit and grapefruit juice may interact with vardenafil. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

Do not use any other drug to treat impotence, such as alprostadil (Caverject, Muse, Edex) or yohimbine (Yocon, Yodoxin, others), unless your doctor tells you to.

What other drugs will affect vardenafil (Levitra)?

Do not take vardenafil if you are also using a nitrate drug for chest pain or heart problems, including nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, Minitran, Deponit, Transderm-Nitro), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), and isosorbide mononitrate (Imdur, ISMO, Monoket), or recreational drugs such as amyl nitrate or nitrite ("poppers").

Before taking vardenafil, tell your doctor about all other medications you use for erectile dysfunction, or if you are using any of the following medications:

• conivaptan (Vaprisol);
• diclofenac (Arthrotec, Cataflam, Voltaren, Flector Patch, Solareze);
• enoxacin (Penetrex);
• imatinib (Gleevec);
• isoniazid (for treating tuberculosis);
• an antidepressant such as nefazodone;
• an antibiotic such as clarithromycin (Biaxin), clotrimazole (Mycelex Troche), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), itraconazole (Sporanox), ketoconazole (Nizoral), telithromycin (Ketek), or voriconazole (Vfend);
• drugs to treat high blood pressure or a prostate disorder, such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), terazosin (Hytrin), tamsulosin (Flomax);
• heart or blood pressure medication such as diltiazem (Cardizem, Dilacor, Tiazac), nicardipine (Cardene), quinidine (Quinaglute, Quinidex, Quin-Release), or verapamil (Calan, Covera, Isoptin, Verelan);
• heart rhythm medicine such as amiodarone (Cordarone, Pacerone), quinidine(Quinidex, Quinaglute), procainamide (Procan, Pronestyl), or sotalol (Betapace); or
• HIV/AIDS medicine such as amprenavir (Agenerase), atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir).

This list is not complete and there may be other drugs that can interact with vardenafil. 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 vardenafil.

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.

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Last Updated: April 12, 2009