Consider patient's CV status prior to initiating treatment. Patients w/ left ventricular outflow obstruction (eg, aortic stenosis & idiopathic hypertrophic subaortic stenosis) can be sensitive to the action of vasodilators including PDE5 inhibitors. Caution in patients w/ anatomical deformation of the penis (eg, angulation, cavernosal fibrosis or Peyronie's disease), or those who have conditions which may predispose them to priapism (eg, sickle cell anaemia, multiple myeloma or leukaemia). Combination of vardenafil w/ other treatments for erectile dysfunction is not recommended. Concomitant use w/ α-blockers may lead to symptomatic hypotension. Increased plasma conc w/ potent CYP3A4 inhibitors (eg, itraconazole, ketoconazole), & grapefruit or grapefruit juice. Vardenafil dose adjustment might be necessary if moderate CYP3A4 inhibitors (eg, erythromycin, clarithromycin) are given concomitantly. Avoid medicinal products that may prolong QTc interval, including vardenafil, in patients w/ relevant risk factors eg, hypokalaemia, congenital QT prolongation, & concomitant administration w/ class IA (eg, quinidine, procainamide) or class III (eg, amiodarone, sotalol) antiarrhythmics. Increased risk of acute NAION in men w/ erectile dysfunction following exposure to PDE5 inhibitors eg, vardenafil, tadalafil & sildenafil. Stop treatment in case of sudden visual defect. High vardenafil conc potentiates the antiaggregatory effect of Na nitroprusside (nitric oxide donor). Should be administered to patients w/ bleeding disorders or active peptic ulceration only after careful benefit-risk assessment. Not indicated for individuals <18 yr. Tolerability of max 20-mg dose may be lower in elderly patients ≥65 yr.
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