Levitra®
Brand Name: Levitra®
Active Ingredient:   vardenafil
Strength(s): 2.5, 5, 10, 20 mg
Dosage Form(s):   Tablet
Company Name:    Bayer Pharmaceuticals
Availability:         Prescription only
*Date Approved by the FDA:   August 19, 2003
*Approval by FDA does not mean that the drug is available for consumers at this time.

What is Levitra used for?  

Levitra is a medicine taken by mouth for the treatment of erectile dysfunction (ED) in men. ED is a condition where the penis does not harden and expand when a man is sexually excited, or when he cannot keep an erection. Levitra may help a man with ED get and keep an erection when he is sexually excited. Levitra must be used only under a doctor's care.

Special Warnings with Levitra:

Levitra can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines such as nitrates and alpha-blockers, and recreational drugs that contain nitrates called "poppers". A sudden drop in your blood pressure could cause you to become dizzy, faint, or have a heart attack or stroke.

Who should not take Levitra?

Do not take Levitra if you: 

  • take any medicines called “nitrates.” Medicines called nitrates include nitroglycerin and are commonly used to treat angina. Nitrates can also be found in other medicines such as isosorbide dinitrate or isosorbide mononitrate. Some recreational drugs called "poppers" also contain nitrates, such as amyl nitrate and butyl nitrate. 
  • take any medicines called “alpha blockers.” Alpha blockers are sometimes prescribed for prostate problems or high blood pressure. 
  • have been told by your health care provider not to have sexual activity because you have 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. 
  • are allergic to Levitra or any of its ingredients.  

What should I tell my health care provider?

Tell your health care provider if you: 

  • have or had heart problems 
  • have low blood pressure or have high blood pressure that is not controlled 
  • have had a stroke 
  • 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 eye disease 
  • have stomach ulcers 
  • have a bleeding problem 
  • have a deformed penis shape or Pyroine’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 
  • about all the medicines you take, such as prescription and non-prescription medicines, vitamins, and herbal supplements. Levitra and other medicines may affect each other. Always check with your doctor before starting or stopping any medicines. Especially tell your health care provider if you take: 
    • medicines called “nitrates” medicines called “alpha blockers. Examples of alpha blockers include Terazosin (Hytrin®), tamsulosin (Flomax®), doxazosin (Cardura®), prazosin (Minipress®), or alfuzosin (Uroxatral®) 
    • medicines that treat abnormal heartbeat (quinidine, procainamide, amiodarone, sotolol) 
    • ritonavir (Norvir®) or indinavir (Crixivan®) 
    • ketoconazole or itraconazole (such as Nizoral® or Sporanox®) 
    • erythromycin 
    • other medicines or treatments for ED

What are some possible side effects of Levitra? (This is NOT a complete list of side effects reported with Levitra. Your health care provider or pharmacist can discuss with you a more complete list of side effects.)  

Some common side effects with Levitra include: 
  • headache 
  • flushing 
  • stuffy or runny nose 
  • indigestion 
  • upset stomach 
  • dizziness 

Levitra may uncommonly cause: 

  • an erection that won’t go away (priapism). Priapism must be treated as soon as possible or lasting damage can happen to your penis including the inability to have erections. 
  • vision changes, such as seeing a blue tinge to objects or having difficulty telling the difference between the colors blue and green

For more detailed information about Levitra, ask your health care provider or pharmacist.

Link to Levitra's approved label  ../../graphics/Pdf.gif (146 bytes)

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Posted: 12/04/03