Generic Name: vardenafil (var-DEN-a-fil)
Brand Name: Levitra
Vardenafil is used for:
Treating erectile dysfunction (ED). It may also be used for other conditions as determined by your doctor.
Vardenafil is a phosphodiesterase type 5 (PDE5) inhibitor. It works by helping to increase blood flow into the penis during sexual stimulation. This helps you to achieve and maintain an erection.
Do NOT use vardenafil if:
- you are allergic to any ingredient in vardenafil
- you have been advised by your doctor to avoid sexual activity because of heart problems
- you have certain heart problems (eg, severe heart failure, angina), low or high blood pressure, severe liver problems or severe kidney problems that require dialysis
- you have certain hereditary degenerative eye problems (eg, retinitis pigmentosa)
- you have had a heart attack, stroke, or life-threatening irregular heartbeat within the past 6 months
- you have a history of a certain type of irregular heartbeat (eg, congenital QT prolongation) or you take certain antiarrhythmic medicines (eg, quinidine, procainamide, amiodarone, sotalol)
- you are taking a nitrate (eg, isosorbide, nitroglycerin) in any form (eg, capsule, ointment, patch, tablet), or nitroprusside
- you use certain recreational drugs called "poppers" (eg, amyl nitrate or nitrite, butyl nitrate or nitrite)
- you take another PDE5 inhibitor (eg, sildenafil, tadalafil) or another medicine that contains vardenafil
Contact your doctor or health care provider right away if any of these apply to you.
Before using vardenafil:
Some medical conditions may interact with vardenafil. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a deformed penis (eg, cavernosal fibrosis, Peyronie disease), blood cell problems (eg, leukemia, multiple myeloma, sickle cell anemia), or any other condition that may increase the risk of a prolonged erection (priapism)
- if you have a history of a prolonged (more than 4 hours) or painful erection (priapism)
- if you have a history of certain eye problems (eg, macular degeneration, optic neuropathy, retinitis pigmentosa, sudden vision loss) or hearing problems (eg, ringing in the ears, decreased hearing, hearing loss)
- if you have a history of liver or kidney problems, dialysis, high or low blood pressure, ulcers, seizures, lung problems (eg, pulmonary veno-occlusive disease), bleeding problems, blood vessel problems, or heart problems (eg, angina, aortic stenosis, heart failure)
- if you have a history of heart attack, stroke, a certain type of irregular heartbeat (long QT syndrome), or a family history of long QT syndrome
Some MEDICINES MAY INTERACT with vardenafil. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Alpha-blockers (eg, doxazosin), medicines for high blood pressure, nitrates (eg, isosorbide, nitroglycerin), or nitroprusside because severe low blood pressure with dizziness, lightheadedness, and fainting may occur
- Certain antiarrhythmics (eg, amiodarone, procainamide, quinidine, sotalol) because the risk of irregular heartbeat may be increased
- Azole antifungals (eg, itraconazole), HIV protease inhibitors (eg, indinavir, ritonavir), macrolide antibiotics (eg, erythromycin), or telithromycin because they may increase the risk of vardenafil's side effects
- Rifampin because it may decrease vardenafil's effectiveness
This may not be a complete list of all interactions that may occur. Ask your health care provider if vardenafil may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use vardenafil:
Use vardenafil as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with vardenafil. Talk to your pharmacist if you have questions about this information.
- Take vardenafil by mouth with or without food.
- Take vardenafil about 1 hour before sexual activity.
- Do not take vardenafil more often than once daily, or as directed by your doctor.
- Check with your doctor before you eat grapefruit or drink grapefruit juice while you use vardenafil.
- If you miss a dose of vardenafil and you still intend to engage in sexual activity, take it as soon as you remember. Continue to take it as directed by your doctor.
Ask your health care provider any questions you may have about how to use vardenafil.
Important safety information:
- Vardenafil may cause dizziness, drowsiness, fainting, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use vardenafil with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Vardenafil may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
- Patients with heart problems who take vardenafil may be at increased risk for heart-related side effects, including heart attack or stroke. Symptoms of a heart attack may include chest, shoulder, neck, or jaw pain; numbness of an arm or leg; severe dizziness, headache, nausea, stomach pain, or vomiting; fainting; or vision changes. Symptoms of a stroke may include confusion; vision or speech changes; one-sided weakness; or fainting. Contact your doctor or seek medical attention right away if you experience these symptoms.
- Vardenafil may rarely cause a prolonged (more than 4 hours) or painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.
- Vardenafil does not stop the spread of HIV or other sexually transmitted diseases (STDs) to others through sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection or an STD.
- Vardenafil will not prevent pregnancy. If your partner may become pregnant and you wish to avoid pregnancy, be sure to use an effective form of birth control.
- Vardenafil may uncommonly cause mild, temporary vision changes (eg, blurred vision, sensitivity to light, blue/green color tint to vision). Contact your doctor if vision changes persist or are severe.
- Rarely, an eye problem called nonarteritic anterior ischemic optic neuropathy (NAION) has been reported in patients who took vardenafil. This may lead to decreased vision or permanent loss of vision in some cases. If you notice a sudden decrease in vision or loss of vision in one or both eyes, contact your doctor right away.
- Sudden decreases in hearing and loss of hearing have been reported in some patients who have taken vardenafil. Sometimes they also noticed ringing in the ears or dizziness. If you notice a sudden decrease or loss of hearing, contact your doctor right away.
- Do not use other medicines or treatments for ED while you are taking vardenafil without first checking with your doctor.
- Use vardenafil with caution in the ELDERLY; they may be more sensitive to its effects.
- Vardenafil is not recommended for use in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Vardenafil is not approved for use in women. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using vardenafil while you are pregnant. It is not known if vardenafil is found in breast milk. If you are or will be breast-feeding while you use vardenafil, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of vardenafil:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Dizziness; flushing; headache; heartburn; nausea; stuffy or runny nose; upset stomach.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fainting; fast, slow, or irregular heartbeat; memory loss; numbness of an arm or leg; prolonged, painful erection; ringing in the ears; seizures; severe back or muscle pain; severe or persistent dizziness; severe or persistent vision changes; sudden decrease or loss of hearing; sudden decrease or loss of vision in one or both eyes; sudden, severe headache or vomiting.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include chest pain; fainting; prolonged erection; severe back or muscle pain; severe dizziness; severe or persistent vision changes.Proper storage of vardenafil:
Store vardenafil at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep vardenafil out of the reach of children and away from pets.
- If you have any questions about vardenafil, please talk with your doctor, pharmacist, or other health care provider.
- Vardenafil is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take vardenafil or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about vardenafil. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to vardenafil. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using vardenafil.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.