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A thorough medical history and physical examination should be undertaken to diagnose erectile dysfunction, determine potential underlying causes, and identify appropriate treatment. There is a degree of cardiac risk associated with sexual activity, therefore, physicians may wish to consider the cardiovascular status of their patients prior to initiating any treatment for erectile dysfunction.
Agent for the treatment of erectile dysfunction should not be used in men for whom sexual activity is inadvisable. Serious cardiovascular events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage and transient ischemic attack have been reported post-marketing in temporal association with the use of sildenafil for erectile dysfunction. Most, but not all, of these patients had pre-existing cardiovascular risk factors. Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the use of sildenafil without sexual activity. Others were reported to have occurred hours to days after the use of sildenafil and sexual activity. It is not possible to determine whether these events are related directly to sildenafil, to sexual activity, to the patient's underlying cardiovascular disease, to a combination of these factors or to other factors. Prior to prescribing sildenafil, physicians should carefully consider whether their patients with certain underlying conditions could be adversely affected by such vasodilation effects, especially in combination with sexual activity. Patients with increased susceptibility to vasodilators include those with left ventricular outflow obstruction (e.g., aortic stenosis, hypertrophic obstructive cardiomyopathy) or those with the rare syndrome of multiple system atrophy manifesting as severely impaired autonomic control of blood pressure. Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision or loss of vision, has been reported rarely post-marketing with the use of all PDE5 inhibitors, including sildenafil. Most of these patients had risk factors such as low cup to disc ration ("crowded disk"), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking. No causal relationship has been made between use of PDE5 inhibitors and NAION. Physicians should discuss with patients the increased risk NAION in individuals who have already experienced NAION. The patients should be advised that in case of sudden visual loss, to stop taking sildenafil and consult a physician immediately. Caution is advised when sildenafil is administered to patients taking an alpha-blocker, as the coadministration may lead to symptomatic hypotension in a few susceptible individuals (see INTERACTIONS). In order to minimize the potential for developing postural hypotension, patients should be hemodynamically stable on alpha-blocker therapy prior to initiating sildenafil treatment. Initiation of sildenafil at lower doses should be considered (see DOSAGE & ADMINISTRATION). In addition, physicians should advise patients what to do in the event of postural hypotensive symptoms. A minority of patients with the inherited condition retinitis pigmentosa have genetic disorders of retinal phosphodiesterases.
There is no safety information on the administration of sildenafil to patients with retinitis pigmentosa, therefore sildenafil should be administered with caution to these patients.
In vitro studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside (a nitric oxide donor). There is no safety information on the administration of sildenafil to patients with bleeding disorders or active peptic ulceration, therefore sildenafil should be administered with caution to these patients.
Agents for the treatment of erectile dysfunction should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anemia, multiple myeloma or leukemia). The safety and efficacy of combinations of sildenafil with other treatments for erectile dysfunction have not been studied, and the use of such combinations is not recommended.
Sudden decrease or loss of hearing has been reported in a small number of postmarketing and clinical trials cases with the use of all PDE5 inhibitors, including sildenafil. Most of these patients had risk factors for sudden decrease or loss of hearing. No causal relationship has been made between the use of PDE5 inhibitors and sudden decrease or loss of hearing. In case of sudden decrease or loss of hearing patients should be advised to stop taking sildenafil and consult a physician promptly.
Effects on ability to drive and use machines: The effect of sildenafil on the ability to drive and use machinery has not been studied.
Use in Pregnancy and Lactation: Sildenafil is not indicated for use in women.
No teratogenic effects, impairment of fertility or adverse effects on peri/postnatal development were found in reproduction studies in rats and rabbits following oral administration of sildenafil. There are no adequate and well-controlled studies in pregnant or lactating women.
