Important Safety and Dosing Information

LEVITRA (vardenafil HCl) is a prescription medicine that is indicated to treat erectile dysfunction (ED). Consistent with the effects of PDE5 inhibition, administration of LEVITRA with nitrates and nitric oxide donors is contraindicated.

Caution is advised when PDE5 inhibitors, including LEVITRA, are used concomitantly with stable alpha-blocker therapy, because of the potential for lowering blood pressure.

LEVITRA is not recommended for patients with uncontrolled hypertension (>170/110 mmHg).

In men for whom sexual activity is not recommended because of their underlying cardiovascular status, any treatment for erectile dysfunction, including LEVITRA, generally should not be used.

In patients taking certain CYP3A4 inhibitors (eg, 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. See prescribing information for LEVITRA for dosing guidance.

In clinical trials, the most commonly reported adverse events with LEVITRA were headache, flushing, and rhinitis. Adverse events were generally transient.

Nonarteritic Anterior Ischemic Optic Neuropathy (NAION) has been reported rarely postmarketing in temporal relationship with the use of PDE5 inhibitors, including LEVITRA. Sudden loss of hearing, sometimes with tinnitus and dizziness, also has been reported rarely in temporal association with the use of PDE5 inhibitors, including LEVITRA. It is not possible to determine if these events are related to PDE5 inhibitors or to other factors. Physicians should advise patients to stop use of PDE5 inhibitors, including LEVITRA, and seek prompt medical attention in the event of sudden loss of vision or hearing.

The recommended starting dose of LEVITRA is 10 mg. Titrate up to 20 mg or down to 5 mg based on efficacy and side effects.

The maximum recommended dosing frequency is once daily.

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.
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