Staxyn

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

What is Staxyn?

Staxyn (vardenafil) works by helping to relax muscles and increase blood flow into the penis during sexual stimulation. This helps men to achieve and maintain an erection.

Staxyn is used to treat erectile dysfunction (impotence).

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

Important information about Staxyn

Do not take Staxyn 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. 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 Staxyn. 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. Stop using Staxyn and get emergency medical help if you have sudden vision loss.

Before taking Staxyn

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 you can safely take Staxyn, tell your doctor if you have any of these other conditions:

• 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;

• a blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia;

• a bleeding disorder such as hemophilia;

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

• 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 Staxyn is the actual cause of vision loss. Stop using Staxyn and get emergency medical help if you have sudden 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. Although Staxyn is not for use in women, it is not known if vardenafil passes into breast milk or if it could harm a nursing baby. Do not use Staxyn without telling your doctor if you are breast-feeding a baby.

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

How should I take Staxyn?

Take Staxyn exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Staxyn can be taken with or without food.

Staxyn is usually taken only when needed, about 60 minutes before sexual activity. The medication 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 Staxyn 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 Staxyn 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.

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.

Overdose symptoms may include back pain, muscle pain, or vision problems.

What should I avoid while taking Staxyn?

Drinking alcohol can increase certain side effects of Staxyn.

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

Do not use any other drug to treat impotence, such as alprostadil (Caverject, Muse, Edex) or yohimbine (Yocon, Yodoxin, others), unless your doctor tells you to.

Staxyn side effects

Stop using Staxyn and get emergency medical help if you have sudden vision loss. Get emergency medical help if you have any of these signs of an allergic reaction to Staxyn: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. 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 Staxyn. Stop using Staxyn and call your doctor at once if you have any of these serious side effects:

• sudden vision loss;

• ringing in your ears, or sudden hearing loss;

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

• irregular heartbeat;

• swelling in your hands, ankles, or feet;

• shortness of breath;

• vision changes;

• feeling light-headed, fainting;

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

• seizure (convulsions).

Less serious Staxyn side effects may include:

• warmth or redness in your face, neck, or chest;

• runny or 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.

What other drugs will affect Staxyn?

Do not take Staxyn with similar medications such as sildenafil (Viagra) or tadalafil (Cialis).

Before taking Staxyn, tell your doctor about all other medications you use for erectile dysfunction, or if you are using any of the following medications:

• conivaptan (Vaprisol);

• imatinib (Gleevec);

• isoniazid (for treating tuberculosis);

• an antidepressant such as nefazodone;

• an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), or telithromycin (Ketek);

• antifungal medications such as itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Oravig), or voriconazole (Vfend);

• drugs to treat high blood pressure or a prostate disorder, such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), terazosin (Hytrin), tamsulosin (Flomax);

• heart or blood pressure medication such as diltiazem (Cardizem, Dilacor, Tiazac), nicardipine (Cardene), or verapamil (Calan, Covera, Isoptin, Verelan);

• heart rhythm medicine such as amiodarone (Cordarone, Pacerone), quinidine (Quin-G), procainamide (Procan, Pronestyl), or sotalol (Betapace); or

• HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir, Kaletra).

This list is not complete and other drugs may interact with Staxyn. Tell your doctor about all medications you use. This includes prescription, over the counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

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 Staxyn 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.