What should I discuss with my healthcare provider before taking vardenafil (Staxyn)?

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Do not take vardenafil if you are also using a nitrate drug for chest pain or heart problems. This includes nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, and others), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), and isosorbide mononitrate (Imdur, ISMO, Monoket). Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite (“poppers”). Taking vardenafil with a nitrate medicine can cause a sudden and serious decrease in blood pressure.

To make sure you can safely take vardenafil, tell your doctor if you have any of these other conditions:

  • heart disease, heart rhythm problems;
  • a recent history (in the past 6 months) of a heart attack, stroke, or congestive heart failure;
  • a personal or family history of “Long QT syndrome”;
  • high or low blood pressure;
  • seizures;
  • liver disease, kidney disease (or if you are on dialysis);
  • a blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia;
  • a bleeding disorder such as hemophilia;
  • a stomach ulcer;
  • hearing or vision problems, history of vision loss;
  • an eye disorder such as retinitis pigmentosa (an inherited condition of the eye);
  • a physical deformity of the penis (such as Peyronie’s disease); or
  • if you have been told you should not have sexual intercourse for health reasons.

Vardenafil can decrease blood flow to the optic nerve of the eye, causing sudden vision loss. This has occurred in a small number of people taking vardenafil, most of whom also had heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and in those who smoke or are over 50 years old. It is not clear whether vardenafil is the actual cause of vision loss. Stop using vardenafil and get emergency medical help if you have sudden vision loss.

FDA pregnancy category B: Although vardenafil is not for use in women, this medication is not expected to be harmful to an unborn baby.

Although vardenafil is not for use in women, it is not known if vardenafil passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Staxyn may contain phenylalanine. Talk to your doctor before using this form of vardenafil if you have phenylketonuria (PKU).

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