Staxyn belogs to a class of medications called phosphodiesterase (PDE) inhibitors. Vardenafil relaxes muscles found in the walls of blood vessels and increases blood flow to particular areas of the body.

Staxyn orally disintegrating tablets work by increasing blood flow to the penis during sexual stimulation. This increased blood flow can cause an erection.

Staxyn orally disintegrating tablets are used to treat erectile dysfunction (impotence; inability to get or keep an erection) in men.

Staxyn does not cure erectile dysfunction or increase sexual desire. This medicine does not prevent pregnancy or the spread of sexually transmitted diseases such as human immunodeficiency virus (HIV).

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

Do not take Staxyn 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 Staxyn and get emergency medical help if you have sudden vision loss.

During sexual activity, if you become dizzy or nauseated, or have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away. You could be having a serious side effect.

Staxyn orally 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.

Take Staxyn exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Staxyn can be taken with or without food.

Remove a Staxyn orally disintegrating 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 the tablet with liquid.

Staxyn 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 Staxyn.

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 Staxyn if you are allergic to vardenafil, 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.

To make sure Staxyn is safe for you, 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 orally disintegrating tablets may contain phenylalanine. Talk to your doctor before using this form of vardenafil if you have phenylketonuria (PKU).

Staxyn is not approved for use in women, and the effects of this medicine during pregnancy or in breastfeeding women are unknown.

Since Staxyn is used as needed, you are not likely to be on a dosing schedule.

Do not take Staxyn 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.

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

Stop using Staxyn 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 Staxyn 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 Staxyn side effects 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 Staxyn 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 interact with vardenafil. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.