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

Vardenafil may also be used for purposes not listed in this medication guide.

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.

Staxyn (vardenafil disintegrating tablets) should not be used in place of Levitra (vardenafil regular tablets). Avoid medication errors by using only the form and strength your doctor prescribes.

Follow all 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.

Remove an orally disintegrating (Staxyn) tablet from the package only when you are ready to use the medicine. Place the tablet in your mouth and allow it to 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 occur just by taking a pill.

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.

If you receive medical care for heart problems, tell 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.

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 day

Patients on stable alpha blocker therapy:
-Initial dose: 5 mg orally once a day

Comments:
-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 activity

Comments: Sexual stimulation is required for a response to treatment.

Use: Erectile dysfunction

You should not use vardenafil if you are allergic to it, or if you take other medicines to treat pulmonary arterial hypertension, such as 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 decrease 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 decrease blood flow to the optic nerve of the eye, causing sudden vision loss. This has occurred in a small number of people, most of whom also had heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and in 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.

Since vardenafil is used as needed, you are not likely to be on a 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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Talk to your doctor about eating grapefruit or drinking grapefruit juice while taking this medicine.

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.

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

• erection 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, like 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.

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.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.