Important Safety and Dosing Information

LEVITRA 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 loss or decrease 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 for 2.5-mg, 5-mg, 10-mg, and 20-mg LEVITRA ® (vardenafil HCl).
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