Vardenafil (By mouth)

Introduction

Vardenafil (var-DEN-a-fil)

Treats erectile dysfunction (trouble having an erection). Helps a man have an erection or have a better erection of his penis during sex.

Brand Name(s)

Levitra, Staxyn

There may be other brand names for this medicine.

When This Medicine Should Not Be Used

You should not use this medicine if you have had an allergic reaction to vardenafil. Do not use this medicine if you are also using a nitrate medicine, often used to treat angina (chest pain). Nitrate medicines include nitroglycerin, isosorbide, Imdur®, Nitro-Bid®, Nitrostat®, Nitro-Dur®, Transderm Nitro®, Nitrol® Ointment, and Nitrolingual® Spray. Some illegal ("street") drugs called "poppers" (such as amyl nitrate, butyl nitrate, or nitrite) contain nitrates.

How to Use This Medicine

Tablet, Dissolving Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• The usual schedule for erectile dysfunction is to take this medicine about 60 minutes (1 hour) before having sex.
• Do not use this medicine more than one time a day. Always allow at least 24 hours between doses. In some cases, your doctor might tell you not to use this medicine more than once every three days (72 hours).
• You may take this medicine with or without food.
• It is best to not eat a high-fat meal before using this medicine, because it may take longer for the medicine to work.
• If you are using the disintegrating tablet, make sure your hands are dry before you handle the tablet. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Place the tablet on your tongue. It should melt quickly. The tablet should be taken without liquids. Do not break, crush, or chew it.
• Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

If you notice other side effects that you think are caused by this medicine, tell your doctor

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

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not take clarithromycin (Biaxin®), erythromycin (EES®, Erytab®), itraconazole (Sporanox®), ketoconazole (Nizoral®), or medicine to treat HIV or AIDS (such as atazanavir, indinavir, ritonavir, saquinavir, Crixivan®, Fortovase®, Invirase®, Kaletra®, Norvir®, or Reyataz®) while you are being treated with this medicine, unless your doctor says it is okay.
• Make sure your doctor knows if you are also using medicine to treat prostate problems or high blood pressure (such as alfuzosin, amlodipine, doxazosin, prazosin, silodosin, tamsulosin, terazosin, Cardura®, Flomax®, Hytrin®, Minipress®, Norvasc®, Rapaflo®, or Uroxatral®). Your doctor should also know if you use medicine for heart rhythm problems (such as amiodarone, procainamide, quinidine, sotalol, Betapace®, Cardioquin®, Cordarone®, Procanbid®, or Quinaglute®).
• Tell your doctor about all other treatments you are using for erectile dysfunction.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine

• Make sure your doctor knows if you have kidney disease, liver disease, diabetes, high cholesterol, stomach ulcer, bleeding problems, seizures, or problems with the retina in your eyes (retinitis pigmentosa). Tell your doctor if you or anyone in your family has a heart condition called "long QT syndrome." Make sure your doctor knows if your penis has an abnormal shape.
• Tell your doctor if you have phenylketonuria (PKU) and a condition called fructose intolerance. The orally disintegrating tablet contains phenylalanine and sorbitol, which can make these conditions worse.
• Your doctor needs to know if you have heart disease, a bleeding disorder, or problems related to your blood cells. This includes valve problems, uneven heartbeats, high or low blood pressure, angina (chest pain), heart failure, sickle cell anemia, or cancer of the blood (leukemia or multiple myeloma).
• Tell your doctor if you have ever had chest pain during sex. Make sure your doctor knows if you have had a stroke or heart attack within the past 3 to 6 months. Your doctor should also know if you smoke or if you are over 50 years old.
• Your doctor needs to know if you are using any other medicine that might cause low blood pressure, because vardenafil might also lower your blood pressure. If your blood pressure gets too low, you might faint or have other health problems.
• This medicine should not be used by women or children.
• Vardenafil is for men who have trouble getting and keeping an erection. It will not make a normal erection last longer or occur more often. This medicine is not for men who have normal sexual function.
• This medicine will not cure erectile dysfunction or increase your sexual desire.
• If you do not have an erection or if you are unhappy with your erection after taking this medicine, tell your doctor. This medicine will not cause an erection unless you are sexually stimulated.
• This medicine will not protect you from sexually transmitted diseases (including HIV or AIDS). This medicine will not prevent pregnancy and should not be used as a form of birth control. If this is a concern for you or your partner, talk with your doctor.
• This medicine may cause the penis to become erect at unwanted times, or to stay erect for longer than needed. If you have an erection that lasts longer than 4 hours, call your doctor right away or go to an emergency room.
• Stop using this medicine and check with your doctor right away if you have sudden loss of vision in one or both eyes, or if you have sudden decrease in hearing or loss of hearing accompanied by dizziness and ringing in the ears. You may already be having a serious side effect from this medicine.
• Levitra® also contains vardenafil. If you take too much vardenafil or take it together with these medicines, the chance for side effects will be higher.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, especially if it spreads to your jaw or arm.
• Erection that is painful or lasts longer than 4 hours.
• Fast, pounding, or uneven heartbeat.
• Fever, chills, cough, sore throat, and body aches.
• Lightheadedness or fainting.
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet.
• Shortness of breath, numbness or weakness, sudden or severe headache, or problems with speech or walking.
• Sudden changes in your vision or changes in how you see colors (especially blue or green).
• Sudden decrease in hearing or hearing loss, ringing in the ears, or dizziness.

If you notice these less serious side effects, talk with your doctor:

• Back pain.
• Dry mouth.
• Flushing (warmth or redness in your face, neck, arms, or upper chest).
• Headache.
• Joint or muscle pain.
• Stuffy or runny nose.
• Trouble sleeping.
• Upset stomach, nausea, or diarrhea.