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A medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes, before pharmacological treatment is considered.
Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Sildenafil has a vasodilator property, resulting in mild and transient decreases in blood pressure. Prior to prescribing Sildenafil, physicians should carefully consider whether their patients with certain underlying conditions could be adversely affected by such vasodilatory 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.
Elonza potentiates the hypotensive effect of nitrates.
Serious cardiovascular events, including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension and hypotension have been reported post-marketing in temporal association with the use of Elonza. Most, but not all, of these patients had pre-existing cardiovascular risk factors. Many events were reported to occur shortly after the use of Elonza without sexual activity. It is not possible to determine whether these events are related directly to these factors or to other factors.
Agents for the treatment of erectile dysfunction, including Sildenafil, should be used with caution in patients with anatomical deformation of the penis (such as angulations, 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 combination of Sildenafil with other treatments for erectile dysfunction have not been studied. Therefore the use of such combinations is not recommended.
Visual defects and cases of non-arteritic anterior ischemic optic neuropathy have been reported in connection with the intake of Sildenafil and other PDE5 inhibitors. The patient should be advised that in case of sudden visual defect, he should stop taking Elonza and consult a physician immediately.
Co-administration of Sildenafil with Ritonavir is not advised.
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. 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 a dose of 25 mg should be considered. In addition, physicians should advise patients what to do in the event of postural hypotensive symptoms.
Studies with human platelets indicate that Sildenafil potentiates the angioaggregatory effect of sodium nitroprusside in vitro. There is no safety information on the administration of Sildenafil to patients with bleeding disorder or active peptic ulceration. Therefore, Sildenafil should be administered to the patients only after careful benefit-risk assessment.
Elonza is not indicated for use by women.
