What is the most important information I should know about vardenafil?
Taking vardenafil with certain other medicines can cause a sudden and serious decrease in blood pressure. Do not take vardenafil if you also take riociguat (Adempas) or a nitrate drug such as nitroglycerin.
Stop using vardenafil 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.
What is vardenafil?
Vardenafil relaxes muscles of the blood vessels and increases blood flow to particular areas of the body.
Vardenafil is used to treat erectile dysfunction (impotence).
Vardenafil may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking vardenafil?
You should not use vardenafil if you are allergic to it.
Taking vardenafil with certain other medicines can cause a sudden and serious decrease in blood pressure. Do not take vardenafil 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").
To make sure vardenafil 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.
Vardenafil 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 vardenafil. 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 vardenafil is the actual cause of vision loss.
Although vardenafil is not for use in women, this medication is not expected to be harmful to an unborn baby.
Although vardenafil is not for use in women, it is not known whether this medicine 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 vardenafil?
Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Vardenafil can be taken with or without food.
Vardenafil 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 orally disintegrating tablet (Staxyn):
- 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 vardenafil 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 vardenafil 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 vardenafil?
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 vardenafil.
Do not use any other drug to treat impotence unless your doctor tells you to.
What are the possible side effects of vardenafil?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using vardenafil 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 vardenafil 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 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.
What other drugs will affect vardenafil?
Do not take vardenafil 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 vardenafil, 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;
-
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 vardenafil.
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.
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