VARDENAFIL - ORAL
Common Brand Name(s): Levitra
Phonetic Pronunciation: (var-DEN-ah-fil)
Information last revised May 2010
What does VARDENAFIL - ORAL look like?
Levitra 20 mg Tab
Levitra 10 mg Tab
Levitra 5 mg Tab
Levitra 2.5 mg Tab
Uses:
Vardenafil is used to treat male sexual function problems (impotence or erectile dysfunction) by blocking a certain enzyme (phosphodiesterase-PDE5). In combination with sexual stimulation, vardenafil works by helping the blood flow into the penis to achieve and maintain an erection. Use of this drug does not protect against sexually transmitted diseases (e.g., HIV, hepatitis B, gonorrhea, syphilis). Practice "safe sex" such as using latex condoms. Consult your doctor or pharmacist for more details.
How To Use
This drug is taken by mouth as needed, 1 hour before sexual activity with or without food; or use as directed by your doctor. Do not take more often than once daily as needed. A high fat meal may decrease the amount of drug that is absorbed. Avoid eating grapefruit or drinking grapefruit juice while you are being treated with this medication unless your doctor instructs you otherwise. The dosage is based on your medical condition, response to therapy, and other medications you may be taking (see also Drug Interactions section). Consult your doctor or pharmacist for more details. Read the patient information leaflet provided by your pharmacist and ask questions if any of the information is unclear.
Drug Interactions
Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first. See also How To Use section for drug-food interactions. This drug should not be used with the following medications because very serious (possibly fatal) interactions may occur: nitrates (e.g., nitroglycerin, isosorbide), nitroprusside (or any "nitric oxide donor" drugs), recreational drugs called "poppers" containing amyl or butyl nitrite. If you are currently using any of these medications, tell your doctor or pharmacist before starting vardenafil. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: alpha-blocker medication (e.g., doxazosin, prazosin, terazosin, or doses greater than 0.4 milligrams daily of tamsulosin), other medications for impotence, drugs that affect certain liver enzymes (CYP 3A4 substrates, inhibitors and inducers, e.g., cimetidine, rifamycins, St. John's wort, certain anti-seizure drugs), high blood pressure medicines. If you are taking ritonavir or nelfinavir, do not take more than a 2.5 milligrams dose of vardenafil in a 72 hour period. If you are taking indinavir or high doses (400 milligrams daily) of either ketoconazole or itraconazole, do not take more than a 2.5 milligrams dose of vardenafil per day. If you are taking erythromycin or low doses (200 milligrams daily) of either ketoconazole or itraconazole, do not take more than 5 milligrams dose of vardenafil per day. For more details contact your doctor or pharmacist. Many drugs besides vardenafil may affect the heart rhythm (QT prolongation), including dofetilide, pimozide, amiodarone, quinidine, sotalol, procainamide, macrolide antibiotics (such as erythromycin), sparfloxacin, among others. Therefore, before using vardenafil, report all medications you are currently using to your doctor or pharmacist. Do not take this medication with any other product that contains vardenafil or other similar medications used to treat erectile dysfunction/pulmonary hypertension (e.g., sildenafil, tadalafil). This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
Notes
Do not share this medication with others, since they may have a problem that is not effectively treated by this drug, or they may have a condition that is complicated by this drug.
Overdose
If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include back pain, muscle pain, abnormal vision.
Precautions
Before taking vardenafil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: penis conditions (e.g., angulation, fibrosis/scarring, Peyronie's disease), history of painful/prolonged erection (priapism), sickle cell anemia, blood system cancers (e.g., leukemia or myeloma), eye problems (e.g., retina diseases like retinitis pigmentosa), kidney disease, liver disease, bleeding disorders, active stomach ulcers, heart problems (e.g., recent heart attack or serious arrhythmia within past 6 months, coronary artery disease with unstable angina, aortic stenosis, idiopathic hypertrophic subaortic stenosis), recent stroke within past 6 months, very high or low blood pressure. Vardenafil may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using vardenafil, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death). Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using vardenafil safely. This drug may make you dizzy or cause vision changes. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages. To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position. Caution is advised when using this drug in the elderly because they may be more sensitive to the side effects of the drug. This medication is not usually used in women. Therefore, it is unlikely to be used during pregnancy or breast-feeding. Consult your doctor if you have any questions about this medication.
Storage
Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Side Effects
Headache, flushing, nasal stuffiness, stomach upset, heartburn, runny nose, dizziness, or nausea may occur. Vision changes such as increased sensitivity to light, blurred vision, or impaired blue/green color discrimination may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Rarely, a sudden loss of eyesight in one or both eyes (NAION) may occur. This may or may not be due to vardenafil. If this serious problem occurs, seek immediate medical attention. You have a slightly greater chance of developing this serious eye problem if you have heart disease, diabetes, high cholesterol, certain eye problems ("crowded disk"), high blood pressure, are over 50 years of age, or if you smoke. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: fast/slow/irregular heartbeat, seizures, short-term memory loss. Sexual activity may put extra strain on your heart, especially if you have heart problems. If you have heart problems and experience any of these serious side effects while having sex, stop and seek immediate medical attention: severe dizziness, fainting, chest pain. For males, in the very unlikely event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and seek immediate medical attention, or permanent problems could occur. Rarely, vardenafil may cause sudden hearing problems, or ringing in the ears. Stop taking this medication and tell your doctor immediately if these effects occur. A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.