Vardenafil (AKA Levitra®) for Men

How should this medicine be used?

Vardenafil comes as an oral medication that is rapidly disintegrating (dissolves in the mouth and is swallowed without water). It is usually taken as needed, without food 30 minutes before sexual activity. Vardenafil usually should not be taken more often than once every 24 hours. If you have certain health conditions or are taking certain medications, your provider may tell you to take vardenafil less often. Follow the directions on your prescription label carefully, and ask your provider to explain any part you do not understand. Take vardenafil exactly as directed. Do not take more or less of it or take it more often than prescribed by your provider.

After you remove the tablet from its container, immediately place it on your tongue and close your mouth. The tablet will quickly dissolve. Do not take the rapidly disintegrating tablet with water or other liquids.
Your provider will probably start you on an average dose of vardenafil tablets and increase or decrease your dose depending on your response to the medication. Tell your provider if vardenafil is not working well or if you are experiencing side effects.

What special precautions should I follow before taking vardenafil?

• tell your provider if you are allergic to vardenafil, any other medications, or any of the ingredients in vardenafil tablets. Ask your pharmacist for a list of the ingredients if you are allergic to some medications.
• do not take vardenafil if you are taking or have recently taken riociguat (Adempas) or nitrates such as isosorbide dinitrate (Dilatrate-SR, Isordil, in BiDil), isosorbide mononitrate (Monoket), and nitroglycerin (Minitran, Nitro-Dur, Nitromist, Nitrostat, others). Nitrates come as tablets, sublingual (under the tongue) tablets, sprays, patches, pastes, and ointments. Ask your provider if you are not sure if any of your medications contain nitrates.
• do not take street drugs containing nitrates such as amyl nitrate and butyl nitrate (‘poppers’) while taking vardenafil.
• tell your provider and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), tamsulosin (Flomax, in Jalyn), and terazosin; amiodarone (Cordarone, Pacerone); antifungals such as fluconazole (Diflucan), itraconazole (Onmel, Sporanox), and ketoconazole (Nizoral); clarithromycin (Biaxin, in Prevpac); disopyramide (Norpace); erythromycin (E.E.S., E-Mycin, Erythrocin); haloperidol (Haldol); HIV protease inhibitors including atazanavir (Reyataz, in Evotaz), indinavir (Crixivan), ritonavir (Norvir, in Kaletra), and saquinavir (Invirase); medications for high blood pressure or irregular heartbeat; other medications or treatments for erectile dysfunction; methadone (Dolophine, Methadose); moxifloxacin (Avelox); pimozide (Orap); procainamide; quinidine (in Nuedexta); sotalol (Betapace, Sorine, Sotylize); thioridazine; and verapamil (Calan, Covera, Verelan, others). Your provider may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may interact with vardenafil, so be sure to tell your provider about all the medications you are taking, even those that do not appear on this list.
• tell your provider what herbal products you are taking, especially St. John’s wort.
• tell your provider if you smoke and if you have ever had an erection that lasted more than 4 hours. Also tell your provider if you have or have ever had a condition that affects the shape of the penis, such as angulation, cavernosal fibrosis, or Peyronie’s disease; diabetes; high cholesterol; high or low blood pressure; irregular heartbeat; a heart attack; angina (chest pain); a stroke; ulcers in the stomach or intestine; a bleeding disorder; blood cell problems such as sickle cell anemia (a disease of the red blood cells), multiple myeloma (cancer of the plasma cells), or leukemia (cancer of the white blood cells); seizures; and liver, kidney, or heart disease. Also tell your provider if you or any of your family members have or have ever had long QT syndrome (a heart condition) or retinitis pigmentosus (an eye disease) or if you have ever had severe vision loss, especially if you were told that the vision loss was caused by a blockage of blood flow to the nerves that help you see. Tell your provider if you have ever been advised by a health care professional to avoid sexual activity for medical reasons.
• you should know that vardenafil is only for use in males. Women should not take vardenafil, especially if they are or could become pregnant or are breastfeeding. If a pregnant woman takes vardenafil, she should call her provider.
• if you are having surgery, including dental surgery or any dental procedure, tell the provider or dentist that you are taking vardenafil.
• you should know that sexual activity may be a strain on your heart, especially if you have heart disease. If you have chest pain during sexual activity, call your provider immediately and avoid sexual activity until your provider tells you otherwise.
• tell all your health care providers that you are taking vardenafil. If you ever need emergency medical treatment for a heart problem, the health care providers who treat you will need to know when you last took vardenafil.
• if you have phenylketonuria (PKU, an inherited condition in which a special diet must be followed to prevent mental retardation), you should know that the rapidly disintegrating tablets are sweetened with aspartame, a source of phenylalanine.
• if you have fructose intolerance (an inherited condition in which the body lacks the protein needed to break down fructose,[a fruit sugar found in certain sweeteners such as sorbitol]), you should know that the the rapidly disintegrating tablets are sweetened with sorbitol. Tell your provider if you have fructose intolerance.

What special dietary instructions should I follow?

Talk to your provider about eating grapefruit or drinking grapefruit juice while taking this medicine.

What side effects can this medication cause?

Vardenafil may cause side effects. Tell your provider if any of these symptoms are severe or do not go away:

• headache
• upset stomach
• heartburn
• flushing
• stuffy or runny nose
• flu-like symptoms

Some side effects can be serious. If you experience any of the following symptoms, call your provider immediately:

• erection that lasts longer than 4 hours
• sudden severe loss of vision (see below for more information)
• blurred vision
• changes in color vision (seeing blue tinge on objects, difficulty telling the difference between blue and green, or difficulty seeing at night)
• dizziness
• sudden decrease or loss of hearing
• ringing in ears
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness
• difficulty breathing or swallowing
• fainting
• hives
• rash

Vardenafil may cause other side effects. Call your provider if you have any unusual problems while taking this medication.

If you experience a sudden loss of vision or hearing (sometimes with ringing in the ears or dizziness), while you are taking vardenafil, call your provider immediately. Do not take any more doses of vardenafil or similar medications such as sildenafil (Viagra) or tadalafil (Cialis) until you talk to your provider.

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community.

What other information should I know?

• Keep all appointments with your provider.
• Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
• It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a provider or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

It is important that you continue to see your regular medical doctor for your usual health care, tests, and routine health maintenance. We are not replacing your primary medical doctor.