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LEVITRA (VARDENAFIL): INFORMATION FOR PATIENTS

Physicians should discuss with patients the contraindication of Levitra (Vardenafil) with regular and/or intermittent use of organic nitrates. Patients should be counseled that concomitant use of Levitra with nitrates could cause blood pressure to suddenly drop to an unsafe level, resulting in dizziness, syncope, or even heart attack or stroke.

Physicians should inform their patients that in some patients concomitant use of PDE5 inhibitors, including Levitra (Vardenafil) tablets, with alpha-blockers can lower blood pressure significantly leading to symptomatic hypotension (e.g., fainting). Patients prescribed Levitra who are taking alpha-blockers should be started on the lowest recommended starting dose of this medication. Patients should be advised of the possible occurrence of symptoms related to postural hypotension and appropriate countermeasures. Patients should be advised to contact the prescribing physician if other anti-hypertensive drugs or new medications that may interact with Vardenafil Hydrochloride (Levitra) are prescribed by another healthcare provider.

Physicians should discuss with patients the appropriate use of Levitra and its anticipated benefits. It should be explained that sexual stimulation is required for an erection to occur after taking Vardenafil Hydrochloride (Levitra) tablets. This drug should be taken approximately 60 minutes before sexual activity. Patients should be counseled regarding the dosing of Levitra. Patients should be advised to contact their healthcare provider for dose modification if they are not satisfied with the quality of their sexual performance with Levitra (Vardenafil HCl) or in the case of an unwanted effect. Patients should be advised to contact the prescribing physician if new medications that may interact with Levitra are prescribed by another healthcare provider.

Physicians should advise patients to stop use of all PDE5 inhibitors, including Levitra, and seek medical attention in the event of sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision, including permanent loss of vision, that has been reported rarely post-marketing in temporal association with the use of all PDE5 inhibitors. It is not possible to determine whether these events were related directly to the use of PDE5 inhibitors or to other factors. Physicians should also discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye, including whether such individuals could be adversely affected by use of vasodilators such as PDE5 inhibitors.

Doctors should advise patients to stop taking PDE5 inhibitors, including Levitra (Vardenafil HCl) tablets, and seek prompt medical attention in the event of sudden decrease or loss of hearing. These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including Levitra. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors.

Healthcare providers should discuss with patients the potential cardiac risk of sexual activity for patients with preexisting cardiovascular risk factors.

The use of Vardenafil (Levitra) offers no protection against sexually transmitted diseases. Counseling of patients about protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), should be considered.

Healthcare professionals should inform patients that there have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for Levitra and this class of compounds. In the event that an erection persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.

Manufactured and distributed by Bayer, GlaxoSmithKline, Schering-Plough pharmaceutical companies and their divisions.

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