![]() ![]() Individuals who have already experienced NAION are at increased risk of NAION recurrence. Physicians should consider whether their patients with underlying NAION risk factors could be adversely affected by use of PDE5 inhibitors. Neither the rare post-marketing reports, nor the association of PDE5 inhibitor use and NAION in the observational studies, substantiate a causal relationship between PDE5 inhibitor use and NAION. Other risk factors for NAION, such as the presence of "crowded" optic disc, may have contributed to the occurrence of NAION in these studies. A similar study reported a consistent result, with a risk estimate of 2.27 (95% CI 0.99, 5.20). The results suggest an approximate 2-fold increase in the risk of NAION, with a risk estimate of 2.15 (95% CI 1.06, 4.34). An observational case-crossover study evaluated the risk of NAION when PDE5 inhibitor use, as a class, occurred immediately before NAION onset (within 5 half-lives), compared to PDE5 inhibitor use in a prior time period. Based on published literature, the annual incidence of NAION is 2.5–11.8 cases per 100,000 in males aged ≥ 50. ![]() Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a rare condition and 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. Physicians should advise patients to stop use of all phosphodiesterase type 5 (PDE5) inhibitors, including VIAGRA, and seek medical attention in the event of a sudden loss of vision in one or both eyes. Patients with cardiac failure or coronary artery disease causing unstable angina.Patients with resting hypotension (BP 170/110 mmHg).Patients who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months.There are no controlled clinical data on the safety or efficacy of VIAGRA in the following groups if prescribed, this should be done with caution. Use with caution in patients with the following underlying conditions which can be particularly sensitive to the actions of vasodilators including VIAGRA – those with left ventricular outflow obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis) and those with severely impaired autonomic control of blood pressure. While this normally would be expected to be of little consequence in most patients, prior to prescribing VIAGRA, 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. VIAGRA has systemic vasodilatory properties that resulted in transient decreases in supine blood pressure in healthy volunteers (mean maximum decrease of 8.4/5.5 mmHg). The evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following a complete medical assessment. Therefore, treatments for erectile dysfunction, including VIAGRA, should not be generally used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status. There is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease. Decrease in VIAGRA dosage is recommended ( 2.4, 5.6) In patients taking strong CYP inhibitors, such as ritonavir, sildenafil exposure is increased. Decreased blood pressure, syncope, and prolonged erection may occur at higher sildenafil exposures.Concomitant use may lead to hypotension ( 5.5) Caution is advised when VIAGRA is co-administered with alpha-blockers or anti-hypertensives.Patients should stop VIAGRA and seek prompt medical attention in the event of sudden decrease or loss of hearing ( 5.4).Patients with a "crowded" optic disc may also be at an increased risk of NAION. VIAGRA should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients should stop VIAGRA and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non arteritic anterior ischemic optic neuropathy (NAION). ![]() Use VIAGRA with caution in patients predisposed to priapism ( 5.2)
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