Stendra relaxes muscles found in the walls of blood vessels and increases blood flow to particular areas of the body.

Stendra is used to treat erectile dysfunction (impotence).

Stendra should not be taken by a woman or a child.

Taking Stendra with certain other medicines can cause a sudden and serious decrease in blood pressure. Do not take avanafil if you also take riociguat (Adempas) or a nitrate drug such as nitroglycerin, isosorbide dinitrate, or isosorbide mononitrate.

If you become dizzy or nauseated during sexual activity, or if you 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.

Stop using Stendra and get emergency medical help if you have sudden vision loss. Avanafil can decrease blood flow to the optic nerve of the eye, causing sudden vision loss. This has occurred in a small number of people taking a similar medication called sildenafil (Viagra). Most of these people also had heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and in those who smoke or are over 50 years old.

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

Before taking this medicine

You should not take Stendra if you are allergic to avanafil, or:

• If you take nitrates

• if you take medicine to treat pulmonary arterial hypertension, such as riociguat (Adempas).

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

To make sure Stendra is safe for you, tell your doctor if you have ever had:

• heart failure;

• angina (chest pain);

• a heart rhythm disorder;

• a heart attack or stroke;

• heart surgery;

• severe or uncontrolled high blood pressure;

• low blood pressure;

• retinitis pigmentosa (an inherited condition of the eye);

• hearing or vision problems, or vision loss;

• bleeding problems;

• a blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia;

• a stomach ulcer;

• liver disease, kidney disease (or if you are on dialysis);

• priapism (an erection that is painful or lasts longer than 4 hours);

• a physical deformity of the penis (such as Peyronie's disease); or

• if you have been told you should not have sexual intercourse for health reasons.

Stendra can decrease blood flow to the optic nerve of the eye, causing sudden vision loss. This has occurred in a small number of people taking sildenafil (Viagra) or other drugs similar to avanafil. Most of these people 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 avanafil is the actual cause of vision loss.

Stendra is for use only in men. It is not known whether this medicine would be harmful if used by a woman during pregnancy or while breast-feeding.

Take Stendra exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Stendra can be taken with or without food.

Stendra is usually taken only when needed, about 15 to 30 minutes before sexual activity. Follow your doctor's instructions.

Stendra can help achieve an erection when sexual stimulation occurs. An erection will not occur just by taking a pill.

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

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.

Store at room temperature away from moisture, heat, and light.

Usual Adult Dose for Erectile Dysfunction:

Initial dose: 100 mg orally as needed approximately 15-30 minutes before sexual activity.
Maintenance dose: 50 to 200 mg orally as needed 15-30 minutes before sexual activity.
Maximum dose: 200 mg orally once a day

Comments:
-The lowest dose that provides benefit should be taken.
-Sexual stimulation is needed for a response to treatment.

Use: Treatment of erectile dysfunction

You should not take Stendra if you are allergic to avanafil, or:

• If you take nitrates

• if you take medicine to treat pulmonary arterial hypertension, such as riociguat (Adempas).

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

To make sure Stendra is safe for you, tell your doctor if you have ever had:

• heart failure;

• angina (chest pain);

• a heart rhythm disorder;

• a heart attack or stroke;

• heart surgery;

• severe or uncontrolled high blood pressure;

• low blood pressure;

• retinitis pigmentosa (an inherited condition of the eye);

• hearing or vision problems, or vision loss;

• bleeding problems;

• a blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia;

• a stomach ulcer;

• liver disease, kidney disease (or if you are on dialysis);

• priapism (an erection that is painful or lasts longer than 4 hours);

• a physical deformity of the penis (such as Peyronie's disease); or

• if you have been told you should not have sexual intercourse for health reasons.

Stendra can decrease blood flow to the optic nerve of the eye, causing sudden vision loss. This has occurred in a small number of people taking sildenafil (Viagra) or other drugs similar to avanafil. Most of these people 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 avanafil is the actual cause of vision loss.

Stendra is for use only in men. It is not known whether this medicine would be harmful if used by a woman during pregnancy or while breast-feeding.

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

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

Drinking alcohol can increase certain side effects of avanafil. Avoid drinking more than 3 alcoholic beverages while you are taking Stendra.

Grapefruit may interact with avanafil and lead to unwanted side effects. Avoid the use of grapefruit products.

This medication will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

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

Stop using Stendra 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 of Stendra.

Stop using this medicine and call your doctor at once if you have:

• vision changes, sudden vision loss;

• ringing in your ears, or sudden hearing loss;

• pain, swelling, warmth, or redness in one or both legs;

• shortness of breath, swelling in your hands or feet;

• a light-headed feeling, like you might pass out; or

• penis erection that is painful or lasts 4 hours or longer.

Common Stendra side effects may include:

• headache;

• flushing (warmth, redness, or tingly feeling);

• cold symptoms such as runny or stuffy nose, sore throat; 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 take avanafil with similar medicines such as sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra, Staxyn). These medicines also have other brand names (Adcirca, Revatio) that are used to treat a condition called pulmonary arterial hypertension.

Tell your doctor about all your other medicines, especially:

• all other medications you use for erectile dysfunction;

• an antibiotic - clarithromycin, erythromycin, telithromycin, and others;

• antifungal medicine - itraconazole, ketoconazole, and others;

• drugs to treat high blood pressure or a prostate disorder - alfuzosin, doxazosin, prazosin, silodosin, terazosin, tamsulosin, and others;

• nitrates

• hepatitis C medication - boceprevir or telaprevir; or

• HIV/AIDS medicine - atazanavir, indinavir, ritonavir, saquinavir, and others.

This list is not complete. Other drugs may interact with avanafil, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.