Generic Name: vardenafil (var DEN a fil)
Brand Names: Levitra, Staxyn

What is Staxyn?

Staxyn (vardenafil) relaxes muscles and increases blood flow to particular areas of the body.

Staxyn orally disintegrating tablets are used to treat erectile dysfunction (impotence).

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

Important information

Do not take Staxyn orally disintegrating tablets if you are also using a nitrate drug for chest pain or heart problems (such as nitroglycerin). Taking Staxyn with a nitrate medicine can cause a sudden and serious decrease in blood pressure.

Slideshow: Setting The Record Straight: Erectile Dysfunction

Stop using this medicine 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.

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.

Before taking this medicine

You should not use Staxyn if you are allergic to vardenafil.

Do not take Staxyn if you are also using a nitrate drug for chest pain or heart problems. This includes nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, and others), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), and isosorbide mononitrate (Imdur, ISMO, Monoket). Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite ("poppers"). Taking Staxyn with a nitrate medicine can cause a sudden and serious decrease in blood pressure.

To make sure Staxyn is safe for you, tell your doctor if you have:

  • heart disease, heart rhythm problems;

  • a recent history (in the past 6 months) of a heart attack, stroke, or congestive heart failure;

  • a personal or family history of "Long QT syndrome";

  • high or low blood pressure;

  • seizures;

  • 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;

  • an eye disorder such as 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.

Staxyn 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 Staxyn, most of whom 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. It is not clear whether vardenafil is the actual cause of vision loss.

FDA pregnancy category B: Although Staxyn is not for use in women, this medication is not expected to be harmful to an unborn baby.

See also: Pregnancy and breastfeeding warnings (in more detail)

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

Staxyn may contain phenylalanine. Talk to your doctor before using this form of vardenafil if you have phenylketonuria (PKU).

How should I take Staxyn?

Take Staxyn orally disintegrating tablets exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Staxyn can be taken with or without food.

Staxyn is usually taken only when needed, about 60 minutes before sexual activity. The medicine can help achieve an erection when sexual stimulation occurs. An erection will not occur just by taking a pill. Follow your doctor's instructions.

To take the Staxyn orally disintegrating tablet:

  • Keep the tablet in its blister pack until you are ready to take it. Open the package and peel back the foil from the tablet blister. Do not push a tablet through the foil or you may damage the tablet.

  • Using dry hands, remove the tablet and place it in your mouth. It will begin to dissolve right away.

  • Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

  • Swallow several times as the tablet dissolves. Do not take Staxyn with liquid.

Do not take Staxyn 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 and heat.

Staxyn dosing information

Usual Adult Dose for Erectile Dysfunction:

-Initial dose: 10 mg orally once a day, as needed, approximately 60 minutes before sexual activity. Increase to 20 mg or decrease to 5 mg based on efficacy and tolerability.
-Maximum dose: 20 mg once a day

Patients on stable alpha blocker therapy:
-Initial dose: 5 mg orally once a day

Comments:
-Sexual stimulation is required for a response to treatment.
-A time interval between dosing should be considered when administering this drug concomitantly with alpha-blockers.
-Patients taking alpha-blockers should not initiate therapy with the Staxyn orally disintegrating tablet.

Use: Erectile dysfunction

Usual Geriatric Dose for Erectile Dysfunction:

65 years or older:
-Initial dose: 5 mg orally once a day, as needed, approximately 60 minutes before sexual activity

Comments: Sexual stimulation is required for a response to treatment.

Use: Erectile dysfunction

What happens if I miss a dose?

Since Staxyn 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 Staxyn?

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

Drinking alcohol can increase certain side effects of Staxyn.

Do not use any other drug to treat impotence unless your doctor tells you to.

Staxyn side effects

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

Stop using Staxyn 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 vardenafil.

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

  • vision changes;

  • ringing in your ears, or sudden hearing loss;

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

  • irregular heartbeat;

  • swelling in your hands, ankles, or feet;

  • shortness of breath;

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

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

  • seizure (convulsions).

Common Staxyn side effects may include:

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

  • stuffy nose;

  • headache, dizziness;

  • upset stomach; 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 Staxyn?

Do not take Staxyn with similar medicines such as avanafil (Stendra), sildenafil (Viagra), or tadalafil (Cialis). 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 Staxyn, especially:

  • all other medications you use for erectile dysfunction;

  • an antibiotic - clarithromycin, erythromycin, and others;

  • antifungal medicine - itraconazole, ketoconazole, and others;

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

  • heart rhythm medicine - amiodarone, dofetilide, disopyramide, dronedarone, procainamide, quinidine, sotalol; or

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

This list is not complete. Other drugs may interact with vardenafil, 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 Staxyn.
  • 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.
  • Disclaimer: 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 1996-2014 Cerner Multum, Inc. Version: 9.01. Revision Date: 2014-07-22, 1:15:48 PM.

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