• administered concomitantly to hypertensive patients mean additional blood pressure reduction of 8 mmHg systolic and 7 mmHg diastolic were noted.
• The safety of Aggra is unknown in patients with bleeding disorders and patients with active peptic ulceration.
• Aggra 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 Aggra with other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.

There is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease. Therefore, treatments for erectile dysfunction, including Aggra, should not be generally used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status. Aggra 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). While this normally would be expected to be of little consequence in most patients, prior to prescribing Aggra, 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 Aggra - 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 Aggra 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 Aggra. 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. If Aggra is prescribed to patients taking ritonavir, caution should be used. Data from subjects exposed to high systemic levels of Aggra are limited. Visual disturbances occurred more commonly at higher levels of Aggra exposure. Decreased blood pressure, syncope, and prolonged erection were reported in some healthy volunteers exposed to high doses of Aggra (200-800 mg). To decrease the chance of adverse events in patients taking ritonavir, a decrease in Aggra dosage is recommended.

In studies with healthy volunteers of single doses up to 800 mg, adverse events were similar to those seen at lower doses but incidence rates and severities were increased. 24 In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance as Aggra is highly bound to plasma proteins and it is not eliminated in the urine.

Drugs for Erectile Dysfunction

Keep in a dry place, away from light and heat. Keep out of the reach of children.