Dosage in Hepatic Impairment

In patients with moderate hepatic impairment (Child-Pugh class B), decrease initial dosage to 5 mg; maximum dosage is 10 mg once daily. Not studied in patients with severe hepatic impairment (Child-Pugh class C).

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

• erection that lasts longer than 4 hours
• sudden severe loss of vision
• 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 doctor if you have any unusual problems while taking this medication.

What special precautions should I follow?

Before taking vardenafil:

• tell your doctor what herbal products you are taking, especially St. John's wort.
• tell your doctor if you smoke and if you have ever had an erection that lasted more than 4 hours. Also tell your doctor 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); and liver, kidney, or heart disease. Also tell your doctor 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 doctor 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 breast-feeding. If a pregnant woman takes vardenafil, she should call her doctor.
• if you are having surgery, including dental surgery or any dental procedure, tell the doctor 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 doctor immediately and avoid sexual activity until your doctor 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.

Vardenafil Drug Interactions

Other nitrate medicines include sodium nitroprusside, isosorbide mononitrate and isosorbide dinitrate. Isosorbide mononitrate tablets can be sold under tradenames:

• Corangin
• Duride
• Imdur Durules
• Imtrate SR
• ISMO 20
• Isomonit
• Monodur

Isosorbide dinitrate tablets can be sold under tradenames:

• Coronex
• Isordil
• Sorbidin

Dosage

Take Vardenafil only before sexual activity. The manufacturer recommends a maximum of one dose per day. However, your doctor may need to lower the dose if you're taking certain drugs that affect the liver, including erythromycin, indinavir, itraconazole, ketoconazole, and ritonavir.

If you have moderate liver impairment, the recommended starting dose is 5 milligrams, not to exceed a daily dose of 10 milligrams. If your liver problems are mild, no dosage adjustment is required.

NOTES:

Do not share this medication with others, since they may have a problem that is not effectively treated by this drug, or they may have a condition that is complicated by this drug.