WHAT SHOULD YOU DISCUSS WITH YOUR DOCTOR BEFORE TAKING LEVITRA?

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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 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 a 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
 
 

LEVITRA (vardenafil HCI) is a prescription medicine that is used to treat erectile dysfunction (ED).

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Important Safety and Dosing Information

LEVITRA (vardenafil HCI) is a prescription medicine that is used to treat erectile dysfunction (ED). Men taking nitrate drugs, often used to control chest pain (also known as angina), should not take LEVITRA. Such combinations could cause blood pressure to drop to an unsafe level.

As with all ED drugs, there is a rare risk of an erection lasting longer than four hours. To avoid long-term injury, seek immediate medical attention. LEVITRA does not protect against sexually transmitted diseases. In rare instances, men taking PDE5 inhibitors (oral erectile dysfunction medicine, 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 these medicines or to other factors. If you experience any of these symptoms, stop taking PDE5 inhibitors, including LEVITRA, and call a doctor right away.

Discuss your medical conditions, including heart problems, and medications, including alpha blockers prescribed for prostate problems or high blood pressure, with your doctor to ensure LEVITRA is right for you and that you are healthy enough for sexual activity. LEVITRA is not recommended for men with uncontrolled high blood pressure.

The starting dose of LEVITRA is 10 mg taken no more than once per day. Your doctor will decide the dose that is right for you. In patients taking alpha blockers, your doctor may start you on a lower dose of LEVITRA. In patients taking certain medications such as ritonavir, indinavir, saquinavir, atazanavir, ketoconazole, itraconazole, erythromycin and clarithromycin, lower doses of LEVITRA are recommended, and time between doses of LEVITRA may need to be extended.

In clinical trials, the most commonly reported side effects were headache, flushing, and stuffy or runny nose. LEVITRA is available in 2.5-mg, 5-mg, 10-mg, and 20-mg tablets.

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 see complete Prescribing Information, which includes the patient information, for 2.5-mg, 5-mg, 10-mg, and 20-mg
LEVITRA® (vardenafil HCl).
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