Stendra

Stendra is a prescription medication used to treat erectile dysfunction in men. Stendra belongs to a group of drugs called phosphodiesterase (PDE) inhibitors. These work by increasing blood flow to the penis during sexual stimulation. This increased blood flow can cause an erection.

This medication comes in tablet form and is taken typically once a day, on an as needed basis, approximately 30 minutes before sexual activity. Stendra can be taken with or without food.

Common side effects of Stendra include headache, flushing, and back pain.

Stendra is a prescription medication used to treat erectile dysfunction in men.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Auxilium Pharmaceuticals, Inc.

Serious side effects have been reported with Stendra. See the “Stendra Precautions” section.

Common side effects of Stendra include the following:

• headache
• flushing
• stuffy or runny nose
• sore throat
• back pain

This is not a complete list of Stendra side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medicines called nitrates such as isosorbide dinitrate (Isordil), isosorbide mononitrate (Imdur, ISMO), and nitroglycerin (Nitro-BID, Nitro-Dur, Nitroquick, Nitrostat)
• medicines called HIV protease inhibitors, such as ritonavir (Norvir), indinavir (Crixivan), saquinavir (Fortavase or Invirase), fosamprenavir (Lexiva), atazanir (Reyataz), or nelfinavir (Viracept)
• some types of oral antifungal medicines, such as ketoconazole (Nizoral), fluconazole (Diflucan), and itraconozale (Sporonox)
• some types of antibiotics, such as clarithromycin (Biaxin), telithromycin (Ketek), or erythromycin
• medicines called alpha blockers. These include Hytrin (terazosin), Flomax (tamsulosin), Cardura (doxazosin), Minipress (prazosin), Uroxatral (alfuzosin), Jalyn (dutasteride and tamsulosin), or Rapaflo (silodosin). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients, the use of Stendra with alpha-blockers can lead to a drop in blood pressure or to fainting.
• amlodipine (Norvasc), diltiazem (Cardizem, Dilacor, Tiazac), and verapamil (Calan, Covera, Isoptin, Verelan)
• nefazodone
• aprepitant (Emend)
• other medicines that treat high blood pressure
• other medicines or treatments for erectile dysfunction

This is not a complete list of Stendra drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Stendra including the following:

• An erection that will not go away (priapism). If you have an erection that lasts more than 4 hours, get medical help
  right away.
• Sudden vision loss in one or both eyes. Some patients experienced a sudden loss of some or all of their vision after they took medications that are similar to Stendra. The vision loss was permanent in some cases. It is not known if the vision loss was caused by the medication. Stop taking Stendra and seek immediate medical care if sudden loss of vision occurs in one or both eyes. This can be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION). Patients with a “crowded” optic disc may also be at an increased risk of NAION.

• Sudden hearing decrease or hearing loss. Use of medications, similar to Stendra, have been associated with sudden decrease or loss of hearing. Contact your doctor immediately if you notice a sudden decrease or if a loss of hearing occurs. Some people may also have ringing in their ears (tinnitus) or dizziness.

Talk to your doctor about the safe use of alcoholic beverages during your treatment with Stendra. If you drink a large amount of alcohol (more than three glasses of wine or three shots of whiskey) while you are taking Stendra you are more likely to experience certain side effects of Stendra such as dizziness, headache, fast heartbeat, and low blood pressure.

Do not take Stendra if you:

• are allergic to Stendra or to any of its ingredients
• take medications called nitrates which includes nitroglycerin found in tablets, sprays, ointments, pastes, or patches. Nitrates can also be found in other medicines such as isosorbide dinitrate or isosorbide mononitrate.
• use street drugs called "poppers" also contain nitrates, such as amyl nitrate and butyl nitrate

Grapefruit and grapefruit juice may interact with Stendra and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before taking Stendra, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Stendra or to any of its ingredients
• have or have had heart problems such as a heart attack, irregular heartbeat, angina, or heart failure
• have had heart surgery within the last 6 months
• have had a stroke
• have low blood pressure, or high blood pressure that is not controlled
• have a deformed penis shape
• have had an erection that lasted for more than 4 hours
• have problems with your blood cells such as sickle cell anemia, multiple myeloma, or leukemia
• have bleeding problems
• have or have had stomach ulcers
• have liver problems
• have kidney problems or are having kidney dialysis
• drink alcohol
• have retinitis pigmentosa, a rare genetic eye disease
• have ever had severe vision loss, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION)
• are pregnant or planning to become pregnant
• are breastfeeding or planning to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Stendra falls into category C. Stendra is not indicated for use in women. There are no adequate and well-controlled studies of Stendra in pregnant women.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Stendra crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Stendra.

Take Stendra exactly as prescribed. Your healthcare provider will tell you how much Stendra to take and when to take it.

Stendra comes in tablet form and is taken typically once a day, on an as needed basis. Stendra can be taken with or without food.

Take Stendra about 30 minutes before sexual activity. Some men may achieve an erection in approximately 15 minutes, and therefore, may be taken 15 minutes before sexual activity.

Do not take more Stendra than 1 time a day.

Do not drink too much alcohol when taking Stendra (for example, 3 glasses of wine, or 3 shots of whiskey). Drinking too much alcohol when taking Stendra can increase your chances of getting a headache or getting dizzy, increasing your heart rate, or lowering your blood pressure.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The dose range of Stendra (avanafil) is 50 mg-200 mg. For most patients, the starting dose is 100 mg taken approximately 30 minutes before sexual activity, on an as needed basis.

You should take the lowest dose of Stendra that works for you. You and your healthcare provider should decide
on the lowest dose of Stendra that works for you.

Your healthcare provider may change your dose if needed and may be based on efficacy and tolerability.

If you take too much Stendra, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Stendra at 68°F to 77°F (20°C to 25°C).
• Store Stendra out of the light.
• Keep this and all medicines out of the reach of children.