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VIAGRA (SILDENAFIL CITRATE): INFORMATION FOR PATIENTS

Doctors should discuss with patients the contraindication of Viagra tablets with regular and/or intermittent use of organic nitrates.

Physicians should advise patients of the potential for Viagra (Sildenafil) to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications. Concomitant administration of Viagra (Sildenafil) tablets and an alpha-blocker may lead to symptomatic hypotension in some patients. Therefore, when Viagra (Sildenafil Citrate) is co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating Viagra (Sildenafil Citrate) tablets treatment and this medicine should be initiated at the lowest dose.

Doctor, pharmacist, or other healthcare professional should discuss with patients the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors. Patients who experience symptoms (e.g., dizziness, angina pectoris, nausea) upon initiation of sexual activity should be advised to refrain from further activity and should discuss the episode with their physician.

Physicians should advise patients to stop use of all PDE5 inhibitors, including Sildenafil (Viagra), and seek medical attention in the event of a 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 are 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.

Healthcare provider should advise patients to stop taking PDE5 inhibitors, including Sildenafil (Viagra) 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 Sildenafil Citrate (Viagra). It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors.

Doctor or pharmacist should warn patients that prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of Sildenafil Citrate (Viagra) tablets. In the event of an erection that 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.

Physicians should inform patients not to take Viagra with other PDE5 inhibitors including Revatio. Sildenafil is also marketed as Revatio for the treatment of pulmonary arterial hypertension. The safety and efficacy of Viagra (Sildenafil) with other PDE5 inhibitors, including Revatio, have not been studied.

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

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