Vardenafil orally disintegrating tablets

Pronunciation

Generic Name: vardenafil (var-DEN-a-fil)
Brand Name: Staxyn

Vardenafil orally disintegrating tablets is used for:

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

Vardenafil orally disintegrating tablets 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 orally disintegrating tablets if:

  • you are allergic to any ingredient in vardenafil orally disintegrating tablets
  • you have been advised by your doctor to avoid sexual activity because of heart problems
  • you have certain heart problems (eg, severe heart failure, unstable angina), low blood pressure, uncontrolled high blood pressure, moderate to severe liver problems, or severe kidney problems that require dialysis
  • you have certain hereditary degenerative eye problems (eg, retinitis pigmentosa) or hereditary problems of fructose intolerance
  • 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 are taking certain azole antifungals (eg, ketoconazole, itraconazole), HIV protease inhibitors (eg, indinavir, ritonavir), or certain macrolide antibiotics (eg, clarithromycin, erythromycin)
  • you take another PDE5 inhibitor (eg, sildenafil, tadalafil), another medicine that contains vardenafil, or any other medicine for ED (eg, alprostadil)

Contact your doctor or health care provider right away if any of these apply to you.

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Before using vardenafil orally disintegrating tablets:

Some medical conditions may interact with vardenafil orally disintegrating tablets. 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, nonarteritic anterior ischemic optic neuropathy [NAION], 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 a heart attack, a stroke, a certain type of irregular heartbeat (long QT syndrome), or a family history of long QT syndrome

Some MEDICINES MAY INTERACT with vardenafil orally disintegrating tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Certain antiarrhythmics (eg, amiodarone, procainamide, quinidine, sotalol) because the risk of irregular heartbeat may be increased
  • 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
  • Azole antifungals (eg, itraconazole, ketoconazole ), HIV protease inhibitors (eg, indinavir, ritonavir), macrolide antibiotics (eg, clarithromycin, erythromycin), or telithromycin because they may increase the risk of vardenafil orally disintegrating tablets's side effects

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

Use vardenafil orally disintegrating tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with vardenafil orally disintegrating tablets. Talk to your pharmacist if you have questions about this information.
  • Take vardenafil orally disintegrating tablets by mouth with or without food.
  • Take vardenafil orally disintegrating tablets about 1 hour before sexual activity.
  • Do not take vardenafil orally disintegrating tablets more often than once daily or as directed by your doctor.
  • Be sure your hands are completely dry before you remove vardenafil orally disintegrating tablets from the blister.
  • Take vardenafil orally disintegrating tablets immediately after you remove it from the blister. Do not store the removed tablet for future use.
  • Do not crush or split vardenafil orally disintegrating tablets. Place vardenafil orally disintegrating tablets on the tongue. Allow it to completely dissolve.
  • Take vardenafil orally disintegrating tablets without liquid.
  • Do not eat grapefruit or drink grapefruit juice while you use vardenafil orally disintegrating tablets.
  • If you miss a dose of vardenafil orally disintegrating tablets 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 orally disintegrating tablets.

Important safety information:

  • Vardenafil orally disintegrating tablets may cause drowsiness, dizziness, fainting, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use vardenafil orally disintegrating tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Vardenafil orally disintegrating tablets 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 orally disintegrating tablets may be at increased risk of heart-related side effects, including a 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.
  • Do not switch between vardenafil orally disintegrating tablets and vardenafil tablets without checking with your doctor. The tablets may not provide the same amount of medicine to your body as the same dose of vardenafil orally disintegrating tablets. Discuss any questions or concerns with your doctor.
  • Vardenafil orally disintegrating tablets contains phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.
  • Vardenafil orally disintegrating tablets 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 orally disintegrating tablets 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 orally disintegrating tablets 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 orally disintegrating tablets 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 NAION has been reported in patients who took vardenafil orally disintegrating tablets. 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 orally disintegrating tablets. 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 orally disintegrating tablets without first checking with your doctor.
  • Tell your doctor or dentist that you take vardenafil orally disintegrating tablets before you receive any medical or dental care, emergency care, or surgery (including care for a heart problem).
  • Use vardenafil orally disintegrating tablets with caution in the ELDERLY; they may be more sensitive to its effects, including NAION.
  • Vardenafil orally disintegrating tablets is not recommended for use in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Vardenafil orally disintegrating tablets 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 orally disintegrating tablets while you are pregnant. It is not known if vardenafil orally disintegrating tablets is found in breast milk. If you are or will be breast-feeding while you use vardenafil orally disintegrating tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of vardenafil orally disintegrating tablets:

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; mild back pain; stuffy 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, jaw, or left arm 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 orally disintegrating tablets:

Store vardenafil orally disintegrating tablets 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 in the original packaging away from heat, moisture, and light. Do not store in the bathroom. Do not use if the blister is open, torn, or broken. Keep vardenafil orally disintegrating tablets out of the reach of children and away from pets.

General information:

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

Issue Date: November 5, 2014
Database Edition 14.4.1.002
Copyright © 2014 Wolters Kluwer Health, Inc.

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.

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