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Avanafil

Generic Name: avanafil (a-VAN-a-fil)
Brand Name: Stendra

Avanafil is used for:

Treating erectile dysfunction (ED). It may also be used for other conditions as determined by your doctor.

Avanafil is a phosphodiesterase type 5 (PDE5) inhibitor. It works by helping to increase blood flow into the penis during sexual stimulation. This helps you to achieve and maintain an erection.

Do NOT use avanafil if:

  • you are allergic to any ingredient in avanafil
  • you have been advised by your doctor to avoid sexual activity
  • you have severe liver or kidney problems, or you are on dialysis
  • you have certain eye problems (eg, a hereditary degenerative retinal disorder, including retinitis pigmentosa)
  • you have certain heart problems (eg, unstable angina, angina during sexual intercourse, severe heart failure), low blood pressure, or uncontrolled high blood pressure
  • you have had a heart attack, stroke, life-threatening irregular heartbeat, or a certain type of heart surgery within the past 6 months
  • you are taking nitrates (eg, isosorbide, nitroglycerin) in any form (eg, tablet, capsule, patch, ointment), or nitroprusside
  • you use certain recreational drugs called "poppers" (eg, amyl nitrate or nitrite, butyl nitrate or nitrite)
  • you take another PDE5 inhibitor (eg, tadalafil, sildenafil) or another medicine for ED
  • you are taking atazanavir, boceprevir, clarithromycin, indinavir, itraconazole, ketoconazole, mifepristone, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, telithromycin, or voriconazole

Contact your doctor or health care provider right away if any of these apply to you.

Before using avanafil:

Some medical conditions may interact with avanafil. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a deformed penis (eg, cavernosal fibrosis, Peyronie disease), blood cell problems (eg, leukemia, multiple myeloma, sickle cell anemia), or any other condition that may increase the risk of a prolonged erection (priapism)
  • if you have a history of a prolonged (more than 4 hours) or painful erection (priapism)
  • if you have a history of certain eye problems (eg, macular degeneration, optic neuropathy, sudden vision loss in one or both eyes, nonarteritic anterior ischemic optic neuropathy/NAION) or hearing problems (eg, ringing in the ears, decreased hearing, hearing loss)
  • if you are dehydrated or have low blood volume, or you have a history of liver or kidney problems, high or low blood pressure, ulcers, bleeding problems, heart problems (eg, angina, aortic stenosis, heart failure, irregular heartbeat), or blood vessel problems
  • if you have a history of heart attack, stroke, irregular heartbeat, or heart surgery
  • if you drink alcohol

Some MEDICINES MAY INTERACT with avanafil. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Alpha-blockers (eg, doxazosin, alfuzosin), medicines for high blood pressure, nitrates (eg, isosorbide, nitroglycerin), or nitroprusside because severe low blood pressure with dizziness, light-headedness, and fainting may occur
  • Aprepitant, azole antifungals (eg, fluconazole, itraconazole, ketoconazole, voriconazole), diltiazem, fosaprepitant, macrolide antibiotics (eg, clarithromycin, erythromycin), mifepristone, nefazodone, protease inhibitors (eg, boceprevir, ritonavir, saquinavir), telithromycin, or verapamil because they may increase the risk of avanafil's side effects
  • Carbamazepine, hydantoins (eg, phenytoin), phenobarbital, primidone, rifamycins (eg, rifampin), or St. John's wort because they may decrease avanafil's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if avanafil may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use avanafil:

Use avanafil as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with avanafil. Talk to your pharmacist if you have questions about this information.
  • Take avanafil by mouth with or without food.
  • Take avanafil before sexual activity as you were told by your doctor. If you are not sure when to take avanafil, talk with your doctor.
  • Do NOT take more than the recommended dose without checking with your doctor. Do NOT take avanafil more often than 1 time daily.
  • Eating grapefruit or drinking grapefruit juice may increase the amount of avanafil in your blood, which may increase your risk of side effects. Talk with your doctor before including grapefruit or grapefruit juice in your diet.
  • If you miss a dose of avanafil and you still intend to engage in sexual activity, take it as soon as you remember. Continue to take it as directed by your doctor.

Ask your health care provider any questions you may have about how to use avanafil.

Important safety information:

  • Avanafil may cause dizziness, drowsiness, fainting, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use avanafil with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Avanafil may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. The risk may be greater if you drink large amounts of alcohol (eg, more than 3 drinks). To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
  • Patients with heart problems who take avanafil may be at increased risk for heart-related side effects, including heart attack or stroke. Symptoms of a heart attack may include chest, shoulder, neck, or jaw pain; numbness of an arm or leg; severe dizziness, headache, nausea, stomach pain, or vomiting; fainting; or vision changes. Symptoms of a stroke may include confusion, vision or speech changes, one-sided weakness, or fainting. Contact your doctor or seek medical attention right away if you experience these symptoms.
  • Avanafil may rarely cause a prolonged (eg, more than 4 hours) or painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if you have an erection that lasts more than 4 hours.
  • Avanafil does not stop the spread of HIV to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors.
  • Avanafil will not prevent pregnancy. If your partner may become pregnant and you wish to avoid pregnancy, be sure to use an effective form of birth control.
  • Rarely, an eye problem called nonarteritic anterior ischemic optic neuropathy (NAION) has been reported in patients who took avanafil. This may lead to decreased vision or permanent loss of vision in some cases. The risk may be increased if you have experienced NAION in the past. If you notice a sudden decrease in vision or loss of vision in one or both eyes, contact your doctor right away.
  • Sudden decreases in hearing and loss of hearing have been reported in some patients who have taken avanafil. Sometimes they also noticed ringing in the ears or dizziness. If you notice a sudden decrease or loss of hearing, contact your doctor right away.
  • Do not use other medicines or treatments for ED while you are taking avanafil without first checking with your doctor.
  • Avanafil is not recommended for use in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Avanafil is not approved for use in women. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using avanafil while you are pregnant. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you use avanafil, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of avanafil:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; dizziness; flushing; headache; mild sore throat; stuffy or runny nose.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, eyelids, lips, or tongue); chest pain; fainting; fast or irregular heartbeat; painful or prolonged erection; ringing in the ears; severe or persistent dizziness; severe or persistent vision changes; sudden decrease or loss of hearing; sudden decrease or loss of vision in one or both eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of avanafil:

Store avanafil at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between up to 86 degrees F (30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep avanafil out of the reach of children and away from pets.

General information:

  • If you have any questions about avanafil, please talk with your doctor, pharmacist, or other health care provider.
  • Avanafil is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take avanafil or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about avanafil. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to avanafil. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using avanafil.

Review Date: August 8, 2016

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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