LEVITRA is administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).

Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula:

Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water.

LEVITRA is formulated as orange, round, film-coated tablets with “BAYER” cross debossed on one side and “2.5”, “5”, “10”, and “20” on the other side corresponding to 2.5 mg, 5 mg, 10 mg, and 20 mg of vardenafil, respectively. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, yellow ferric oxide, and red ferric oxide.

SIDE EFFECTS: Headache, flushing, nasal stuffiness, stomach upset, heartburn, runny nose, dizziness, or nausea may occur. Vision changes such as increased sensitivity to light, blurred vision, or impaired blue/green color discrimination may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Rarely, a sudden loss of eyesight in one or both eyes (NAION) may occur. This may or may not be due to vardenafil. If this serious problem occurs, seek immediate medical attention. You have a slightly greater chance of developing this serious eye problem if you have heart disease, diabetes, high cholesterol, certain eye problems ("crowded disk"), high blood pressure, are over 50 years of age, or if you smoke.

Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: fast/slow/irregular heartbeat, seizures, short-term memory loss.

Sexual activity may put extra strain on your heart, especially if you have heart problems. If you have heart problems and experience any of these serious side effects while having sex, stop and seek immediate medical attention: severe dizziness, fainting, chest pain.

For males, in the very unlikely event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and seek immediate medical attention, or permanent problems could occur.

Rarely, vardenafil may cause sudden hearing problems, or ringing in the ears. Stop taking this medication and tell your doctor immediately if these effects occur.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking vardenafil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

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, coronary artery disease with unstable angina, aortic stenosis, idiopathic hypertrophic subaortic stenosis), recent stroke within past 6 months, very high or low blood pressure.

Vardenafil may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using vardenafil, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using vardenafil safely.

This drug may make you dizzy or cause vision changes. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. 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 medication is not usually used in women. Therefore, it is unlikely to be used during pregnancy or breast-feeding. Consult your doctor if you have any questions about this medication.