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VIAGRA (SILDENAFIL CITRATE): WARNINGS

There is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease. Therefore, treatments for erectile dysfunction, including Viagra (Sildenafil), should not be generally used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status.

Viagra (Sildenafil) tablets have systemic vasodilatory properties that resulted in transient decreases in supine blood pressure in healthy volunteers (mean maximum decrease of 8.4/5.5 mmHg). While this normally would be expected to be of little consequence in most patients, prior to prescribing Viagra (Sildenafil Citrate), physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects, especially in combination with sexual activity. Patients with the following underlying conditions can be particularly sensitive to the actions of vasodilators including Viagra (Sildenafil Citrate) tablets - those with left ventricular outflow obstruction (e.g. aortic stenosis, idiopathic hypertrophic subaortic stenosis) and those with severely impaired autonomic control of blood pressure.

There is no controlled clinical data on the safety or efficacy of Sildenafil (Viagra) in the following groups; if prescribed, this should be done with caution.

  • Patients who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months;
  • Patients with resting hypotension (BP < 90/50) or hypertension (BP > 170/110);
  • Patients with cardiac failure or coronary artery disease causing unstable angina;
  • Patients with retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases);
  • Patients with sickle cell or related anemias.

    Prolonged erection greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of Sildenafil (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 could result.

    The concomitant administration of the protease inhibitor ritonavir substantially increases serum concentrations of sildenafil (11-fold increase in AUC). If Sildenafil Citrate (Viagra) is prescribed to patients taking ritonavir, caution should be used. Data from subjects exposed to high systemic levels of sildenafil are limited. Visual disturbances occurred more commonly at higher levels of sildenafil exposure. Decreased blood pressure, syncope, and prolonged erection were reported in some healthy volunteers exposed to high doses of sildenafil (200-800 mg). To decrease the chance of adverse events in patients taking ritonavir, a decrease in sildenafil dosage is recommended.

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