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Levitra

Levitra is used for:

Treating erectile dysfunction (ED). It may also be used for other conditions as determined by your doctor.

Levitra 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 Levitra if:

  • you are allergic to any ingredient in Levitra
  • 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 Levitra:

Some medical conditions may interact with Levitra. 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 Levitra. 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 Levitra's side effects
  • Rifampin because it may decrease Levitra's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Levitra 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 Levitra:

Use Levitra as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Levitra. Talk to your pharmacist if you have questions about this information.
  • Take Levitra by mouth with or without food.
  • Take Levitra about 1 hour before sexual activity.
  • Do not take Levitra 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 Levitra.
  • If you miss a dose of Levitra 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 Levitra.

Important safety information:

  • Levitra may cause dizziness, drowsiness, fainting, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Levitra with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Levitra 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 Levitra 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.
  • Levitra 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.
  • Levitra 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.
  • Levitra 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.
  • Levitra 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 Levitra. 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 Levitra. 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 Levitra without first checking with your doctor.
  • Use Levitra with caution in the ELDERLY; they may be more sensitive to its effects.
  • Levitra is not recommended for use in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Levitra 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 Levitra while you are pregnant. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you use Levitra, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Levitra:

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:

Dizziness; flushing; headache; heartburn; nausea; stuffy or runny nose; upset stomach.

Seek medical attention right away if any of these SEVERE side effects occur:

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 Levitra:

Store Levitra 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 Levitra out of the reach of children and away from pets.

General information:

  • If you have any questions about Levitra, please talk with your doctor, pharmacist, or other health care provider.
  • Levitra 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 Levitra 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 Levitra. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Levitra. 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 Levitra.

Review Date: August 8, 2016

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.

More about Levitra (vardenafil)

Erectile dysfunction is the inability to get or keep an erection. ED usually has a physical cause.

LEVITRA helps improve erectile function by increasing blood flow to the penis. LEVITRA has helped many men and it may help you, too.

LEVITRA can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. With a sudden drop in blood pressure, you could get dizzy, faint, or have a heart attack or stroke.

If, like millions of other men, you have noticed changes in your erections, you can do something about it. Talking to your doctor is the first step.

Did you know
ED usually has
a physical cause?

Erectle Dysfunction Treatment - LEVITRA
See your doctor.

Indication
LEVITRA is a prescription medicine used for the treatment of erectile dysfunction (ED) in men.

Important Safety Information

  • LEVITRA can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. With a sudden drop in blood pressure, you could get dizzy, faint, or have a heart attack or stroke.
  • Do not take LEVITRA if you:
    • Take any medications called "nitrates" (often used to control chest pain, also known as angina), or if you use recreational drugs called "poppers" like amyl nitrate and butyl nitrate. Nitrates may cause abnormally low blood pressure and LEVITRA may increase that risk
    • Take riociguat (Adempas ® ), a guanylate cyclase stimulator. a medicine that treats pulmonary arterial hypertension and chronic-thromboembolic pulmonary hypertension
    • Have been told by your healthcare provider not to have sexual activity because of health problems. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease
  • Tell all your healthcare providers that you take LEVITRA. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took LEVITRA.
  • LEVITRA does not protect a man or his partner from sexually transmitted diseases, including HIV.
  • Before taking LEVITRA, tell your doctor about all your medical problems, including if you:
    • have heart problems such as angina, heart failure, irregular heartbeats, or have had a heart attack—ask your doctor if it is safe for you to have sexual activity
    • have low blood pressure or have high blood pressure that is not controlled
    • have pulmonary hypertension
    • have had a stroke
    • have had a seizure
    • or any family members have a rare heart condition known as prolongation of the QT interval (long QT syndrome)
    • have liver problems
    • have kidney problems and require dialysis
    • have retinitis pigmentosa, a rare genetic (runs in families) eye disease
    • have ever had severe vision loss, or if you have an eye condition called non-arteritic anterior ischemic optic neuropathy (NAION)
    • have stomach ulcers
    • have a bleeding problem
    • have a deformed penis shape or Peyronie's disease
    • have had an erection that lasted more than 4 hours
    • have blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia
    • have hearing problems
  • Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. LEVITRA and other medicines may affect each other. Especially tell your doctor if you take any of the following:
    • Ritonavir (Norvir ® ) or indinavir sulfate (Crixivan ® ), saquinavir (Fortavase ® or Invirase ® ) or atazanavir (Reyataz ® ), or other HIV protease inhibitors
    • Ketoconazole or itraconazole (such as Nizoral ® or Sporanox ® )
    • Erythromycin or clarithromycin
  • Tell your doctor if you take alpha-blockers. These include Hytrin ® (terazosin HCl), Flomax ® (tamsulosin HCl), Cardura ® (doxazosin mesylate), Minipress ® (prazosin HCl), Uroxatral ® (alfuzosin HCl), or Rapaflo ® (silodosin). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients, the use of PDE5 inhibitor drugs, including LEVITRA, with alpha-blockers can lower blood pressure significantly, leading to fainting.
    • Contact the prescribing physician if alpha-blockers or other drugs that lower blood pressure are prescribed by another healthcare provider
  • Tell your doctor if you take medicines that treat abnormal heartbeat. These include quinidine, procainamide, amiodarone, and sotalol. Patients taking these drugs should not use LEVITRA.
  • Do not use LEVITRA with other medicines or treatments for ED.
  • Take LEVITRA exactly as your doctor prescribes. LEVITRA comes in different doses (2.5 mg, 5 mg, 10 mg, and 20 mg). For most men, the recommended starting dose is 10 mg. Do not take more than one tablet of LEVITRA per day. Doses should be taken at least 24 hours apart. Some men can take only a low dose of LEVITRA because of medical conditions or medicines they take. Your doctor will prescribe the dose that is right for you.
    • If you are older than 65 or have liver problems, your doctor may start you on a lower dose of LEVITRA
    • If you have prostate problems or high blood pressure for which you take medicines called alpha-blockers, your doctor may start you on a lower dose of LEVITRA
    • If you are taking certain other medicines, your doctor may prescribe a lower starting dose and limit you to one dose of LEVITRA in a 72-hour (3-day) period.
  • The most common side effects with LEVITRA are headache, flushing, stuffy or runny nose, indigestion, upset stomach, dizziness, and back pain.
  • LEVITRA may uncommonly cause:
    • An erection that lasts more than 4 hours. Get medical help right away to avoid lasting damage to your penis
    • Color vision changes. such as seeing a blue tinge to objects or having difficulty telling the difference between the colors blue and green
  • In rare instances, men taking PDE5 inhibitors (oral erectile dysfunction medicines, including LEVITRA) reported a sudden decrease or loss of vision in one or both eyes or a sudden decrease or loss in hearing, sometimes with ringing in the ears and dizziness. It is not possible to determine whether these events are related directly to the PDE5 inhibitors, to other diseases or medications, to other factors, or to a combination of factors. If you experience sudden decrease or loss of vision or hearing, stop taking LEVITRA and contact a doctor right away.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please read the Patient Information and discuss it with your doctor.

The physician Prescribing Information is also available.

NOTE: All trademarks are the property of their respective owners.

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Levitra

Uses

Vardenafil is used to treat male sexual function problems (impotence or erectile dysfunction -ED). In combination with sexual stimulation, vardenafil works by increasing blood flow to the penis to help a man get and keep an erection.

How to use Levitra

Read the Patient Information Leaflet provided by your pharmacist before you start taking vardenafil and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually as needed. Take vardenafil, with or without food, about 1 hour before sexual activity. Do not take more than once daily. Doses should be taken at least 24 hours apart.

The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

Tell your doctor if your condition does not improve.

Side Effects

Headache. flushing, stuffy/runny nose. or dizziness may occur. Vision changes such as increased sensitivity to light, blurred vision. or trouble telling blue and green colors apart may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

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.

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 get medical help right away: severe dizziness, fainting. chest/jaw/left arm pain, nausea .

Rarely, sudden decreased vision. including permanent blindness, in one or both eyes (NAION) may occur. If this serious problem occurs, stop taking vardenafil and get medical help right away. You have a slightly greater chance of developing NAION if you have heart disease. diabetes. high cholesterol. certain other eye problems ("crowded disk"), high blood pressure. if you are over 50, or if you smoke.

Rarely, a sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness, may occur. Stop taking vardenafil and get medical help right away if these effects occur.

In the rare event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and get medical help right away, or permanent problems could occur.

Get medical help right away if you have any very serious side effects, including: fast/irregular heartbeat. seizures. temporary memory loss .

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction. including: 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.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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: heart problems (such as heart attack or life-threatening irregular heartbeat in the past 6 months, chest pain/angina, heart failure ), stroke in the past 6 months, kidney disease (dialysis), liver disease, high or low blood pressure. a severe loss of body water (dehydration), penis conditions (such as angulation, fibrosis/scarring, Peyronie's disease ), history of painful/prolonged erection (priapism), conditions that may increase the risk of priapism (such as sickle cell anemia. leukemia, multiple myeloma ), eye problems (such as retinitis pigmentosa. sudden decreased vision, NAION), bleeding disorders, active stomach ulcers.

Vardenafil may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using vardenafil, tell your doctor or pharmacist of all the drugs you take and 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.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

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.

Interactions

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is: riociguat.

Vardenafil can cause a serious drop in your blood pressure when used with nitrates, which can lead to dizziness, fainting, and rarely heart attack or stroke. Do not use vardenafil with any of the following: certain drugs used to treat chest pain/angina (nitrates such as nitroglycerin, isosorbide), recreational drugs called "poppers" containing amyl or butyl nitrite.

If you are also taking an alpha blocker medication (such as doxazosin, tamsulosin) to treat an enlarged prostate/BPH or high blood pressure, your blood pressure may get too low which can lead to dizziness or fainting. Your doctor may start treatment with a lower dose of vardenafil to minimize your risk of low blood pressure.

Other medications can affect the removal of vardenafil from your body, which may affect how vardenafil works. Examples include azole antifungals (such as itraconazole, ketoconazole), macrolide antibiotics (such as clarithromycin, erythromycin), HIV protease inhibitors (such as indinavir, ritonavir), hepatitis C virus protease inhibitors (such as boceprevir, telaprevir), rifampin, among others.

Many drugs besides vardenafil may affect the heart rhythm (QT prolongation), including amiodarone, procainamide, quinidine, sotalol, among others.

Do not take this medication with any other product that contains vardenafil or other similar medications used to treat erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, tadalafil).

Overdose

If overdose is suspected, contact a poison control center or emergency room right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: back/muscle pain, abnormal vision.

Notes

Do not share this medication with others.

Missed Dose

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications 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.

Information last revised October 2015. Copyright(c) 2015 First Databank, Inc.

Images

Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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