Stendra

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

What is Stendra?

Stendra (avanafil) 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 may also be used for purposes not listed in this medication guide.

Important information

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

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.

Do not take avanafil 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.

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 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.

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

Before taking this medicine

You should not take Stendra if you are allergic to avanafil.

Taking Stendra with certain other medicines can cause a sudden and serious decrease in blood pressure. Do not take Stendra if you also take riociguat (Adempas), or if you take a nitrate drug for chest pain or heart problems. Nitrates include 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 this medicine is safe for you, tell your doctor if you have:

• heart disease or heart rhythm disorder;

• a recent history (in the past 6 months) of heart surgery;

• a history of heart attack, stroke, or life-threatening heart rhythm problem;

• congestive heart failure;

• angina (chest pain), high or low blood pressure;

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

• 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, history of vision loss;

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

• 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 Viagra or other drugs similar to avanafil. Most of these people also had certain pre-existing eye problems or risk factors for blood vessel disorders (such as heart disease, diabetes, high blood pressure, high cholesterol, coronary artery disease, smoking, or being over 50 years old). It is not clear whether avanafil is the actual cause of vision loss.

Stendra is not for use in women. It is not known whether avanafil will harm an unborn baby.

Although Stendra is not for use in women, it is not known if this medicine passes into breast milk or if it could harm a nursing baby.

How should I take Stendra?

Take Stendra exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

This medicine can be taken with or without food.

Stendra is usually taken only when needed, about 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.

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.

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

Stendra dosing information

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

What happens if I miss a dose?

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

What happens if I overdose?

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

What should I avoid while taking Stendra?

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

Grapefruit and grapefruit juice may interact with Stendra and lead to unwanted side effects. Avoid the use of grapefruit products while taking this medicine.

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.

Stendra side effects

Get emergency medical help if you have any 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.

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

• vision changes, sudden vision loss;

• ringing in your ears, or sudden hearing loss;

• heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• 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.

See also: Side effects (in more detail)

What other drugs will affect Stendra?

Do not take Stendra 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 medicines you use, and those you start or stop using during your treatment with Stendra, 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, cobicistat (Stribild, Tybost), 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 interactions are listed in this medication guide.

Where can I get more information?

• Your pharmacist can provide more information about Stendra.

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• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2015 Cerner Multum, Inc. Version: 3.01. Revision Date: 2015-11-06, 9:29:30 A.