Vardenafil

Vardenafil is used by adult men to treat erectile dysfunction (impotence).

Vardenafil may also be used for reasons that are not mentioned in this medication guide.

Staxyn (vardenafil disintegrating tablets) should not be used instead of Levitra (vardenafil regular tablets). To avoid medication mistakes, use only the form and strength that your doctor prescribes.

Follow all the directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Vardenafil can be taken with or without food.

Only remove an orally disintegrating (Staxyn) tablet from the package when you are ready to use it. Place the tablet in your mouth and let it dissolve without chewing. Swallow several times as the tablet dissolves. Do not swallow Staxyn with liquid.

Vardenafil is taken only when needed, about 60 minutes before sexual activity. The medicine can help achieve an erection when sexual stimulation occurs. An erection will not happen just by taking a pill.

Call your doctor or seek emergency medical help if your erection is painful or lasts longer than 4 hours. A prolonged erection (priapism) can damage the penis.

If you receive medical care for heart problems, inform your caregivers when you last took vardenafil.

This medicine does not prevent the spread of sexually transmitted diseases such as human immunodeficiency virus (HIV).

Store at room temperature away from moisture and heat.

Some medicines can cause unwanted or dangerous effects when used with vardenafil. Tell your doctor about all your other medicines, especially riociguat (Adempas).

Do not take vardenafil if you are also using a nitrate drug for chest pain or heart problems, including nitroglycerin, isosorbide dinitrate, isosorbide mononitrate, and some recreational drugs such as "poppers". Taking vardenafil with a nitrate medicine can cause a sudden and serious decrease in blood pressure.

Call your doctor or seek emergency medical attention if your erection is painful or lasts longer than 4 hours. A prolonged erection (priapism) can damage the penis.

Stop using vardenafil and get emergency medical help if you have sudden vision loss.

You should not use vardenafil if you are allergic to it, or if you take other medicines for pulmonary arterial hypertension, like riociguat (Adempas).

Do not take vardenafil if you are also using a nitrate drug for chest pain or heart problems, including nitroglycerin, isosorbide dinitrate, and isosorbide mononitrate. Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite ("poppers"). Taking vardenafil with a nitrate medicine can cause a sudden and serious drop in blood pressure.

Tell your doctor if you have ever had:

• heart disease, heart rhythm problems;
• a heart attack, stroke, or congestive heart failure;
• long QT syndrome (in you or a family member);
• high or low blood pressure;
• seizure (convulsions);
• a blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia;
• a bleeding disorder such as hemophilia;
• a stomach ulcer;
• hearing or vision problems, vision loss;
• an eye disorder such as retinitis pigmentosa (an inherited condition of the eye);
• a physical deformity of the penis (such as Peyronie's disease);
• if you have been told you should not have sexual intercourse for health reasons; or
• liver disease, kidney disease (or if you are on dialysis).

Vardenafil can reduce blood flow to the optic nerve of the eye, which may lead to sudden vision loss. This has happened to a small number of people, most of whom had heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye issues, and to those who smoked or were over 50 years old. It is not clear whether vardenafil is the actual cause of vision loss.

Staxyn (vardenafil disintegrating tablets) may contain phenylalanine. Talk to your doctor before using this form of vardenafil if you have phenylketonuria (PKU).

Vardenafil is not approved for use in women, and the effects of vardenafil during pregnancy or in breastfeeding women are unknown.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using vardenafil and get emergency medical help if you have:

• heart attack symptoms—chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• vision changes or sudden vision loss; or
• an erection that is painful or lasts longer than 4 hours (prolonged erection can damage the penis).

Vardenafil may cause serious side effects. Stop using vardenafil and call your doctor at once if you have:

• ringing in your ears, or sudden hearing loss;
• irregular heartbeat;
• swelling in your hands, ankles, or feet;
• shortness of breath;
• a light-headed feeling, as if you might pass out; or
• seizure (convulsions).

Common side effects of vardenafil may include:

• flushing (sudden warmth, redness, or tingly feeling);
• stuffy nose, sinus pain;
• headache, dizziness;
• upset stomach; or
• back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Erectile Dysfunction:

-Initial dose: 10 mg orally once a day, as needed, approximately 60 minutes before sexual activity. Increase to 20 mg or decrease to 5 mg based on efficacy and tolerability.-Maximum dose: 20 mg once a dayPatients on stable alpha blocker therapy:-Initial dose: 5 mg orally once a dayComments:-Sexual stimulation is required for a response to treatment.-A time interval between dosing should be considered when administering this drug concomitantly with alpha-blockers.-Patients taking alpha-blockers should not initiate vardenafil therapy with the orally disintegrating tablet.Use: Erectile dysfunction

Usual Geriatric Dose for Erectile Dysfunction:

65 years or older:-Initial dose: 5 mg orally once a day, as needed, approximately 60 minutes before sexual activityComments: Sexual stimulation is required for a response to treatment.Use: Erectile dysfunction

Since vardenafil is used as needed, you probably will not have a regular dosing schedule.

Do not take vardenafil more than once a day. Allow 24 hours to pass between doses.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Grapefruit and Seville oranges may interact with vardenafil and cause side effects. Avoid consuming grapefruit products and orange marmalades.

Drinking alcohol can increase certain side effects of vardenafil.

Do not use any other medicine to treat impotence unless your doctor tells you to.

Do not use vardenafil with similar medications such as avanafil (Stendra), sildenafil (Viagra), or tadalafil (Cialis). Tell your doctor about all other medications you use for erectile dysfunction.

Tell your doctor about all your other medicines, especially:

• an antibiotic--clarithromycin, erythromycin;
• antifungal medicine--itraconazole, ketoconazole;
• drugs to treat high blood pressure or a prostate disorder--alfuzosin, doxazosin, prazosin, silodosin, terazosin, tamsulosin;
• heart rhythm medicine--amiodarone, dronedarone, procainamide, quinidine, sotalol; or
• HIV/AIDS medicine--atazanavir, indinavir, ritonavir, saquinavir, cobicistat, and others.

This list is not complete and many other drugs may affect vardenafil. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.