PRECAUTIONS: Before taking vardenafil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. Before using this medication, tell your doctor or pharmacist your medical history, especially of: penis conditions (e.g., angulation, fibrosis/scarring, Peyronie's disease), history of painful/prolonged erection (priapism), sickle cell anemia, blood system cancers (e.g., leukemia or myeloma), eye problems (e.g., retina diseases like retinitis pigmentosa), kidney disease, liver disease, bleeding disorders, active stomach ulcers, heart problems (e.g., recent heart attack or serious arrhythmia within past 6 months, heart failure, coronary artery disease with unstable angina, aortic stenosis, idiopathic hypertrophic subaortic stenosis, congenital QT prolongation), recent stroke within past 6 months, very high or low blood pressure. This drug may make you dizzy or cause vision changes; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages. To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position. Caution is advised when using this drug in the elderly because they may be more sensitive to the side effects of the drug. This drug is not indicated for use in women or children.

DRUG INTERACTIONS: See also How To Use section for drug-food interactions. This drug should not be used with the following medications because very serious (possibly fatal) interactions may occur: nitrates (e.g., nitroglycerin, isosorbide), nitroprusside (or any "nitric oxide donor" drugs), recreational drugs called "poppers" containing amyl or butyl nitrite, alpha-blocker medication (e.g., doxazosin, prazosin, terazosin). If you are currently using any of these medications, tell your doctor or pharmacist before starting vardenafil. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other medications for impotence, drugs that affect certain liver enzymes (CYP 3A4 substrates, inhibitors and inducers, e.g., cimetidine, rifamycins, St. John's wort, certain anti-seizure drugs), high blood pressure medicines. If you are taking ritonavir, do not take more than a 2.5mg dose of vardenafil in a 72 hour period. If you are taking indinavir or high doses (400mg daily) of either ketoconazole or itraconazole, do not take more than a 2.5mg dose of vardenafil per day. If you are taking erythromycin or low doses (200mg daily) of either ketoconazole or itraconazole, do not take more than 5mg dose of vardenafil per day. For more details contact your doctor or pharmacist. Other drugs besides vardenafil which may affect the heart rhythm (QTc prolongation in the EKG) include dofetilide, pimozide, amiodarone, quinidine, sotalol, procainamide, and sparfloxacin among others. QTc prolongation can infrequently result in serious, rarely fatal, irregular heartbeats. Consult your doctor or pharmacist for details before taking vardenafil. Ask for instructions about whether you need to stop any other QTc-prolonging drugs you may be using in order to minimize the risk of this effect. Do not start or stop any medicine without doctor or pharmacist approval.

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