Avanafil is used to treat erectile dysfunction (impotence).

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

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

Taking avanafil 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.

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

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.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Avanafil can be taken with or without food.

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

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

Do not take avanafil 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 30 minutes before sexual activity.
Maintenance dose: 50 to 200 mg orally as needed 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 avanafil if you are allergic to it, or:

• 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.

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.

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 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.

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

Since avanafil 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.

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 and drinking grapefruit juice while taking this medication.

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

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: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using avanafil 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 avanafil.

Avanafil may cause serious side effects. Stop using avanafil 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 side effects of avanafil 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;

• hepatitis C medication--boceprevir or telaprevir; or

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

This list is not complete. Other drugs may affect avanafil, including 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.