Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for Vigorex to be effective, sexual stimulation is required. Vigorex is also indicated in pulmonary arterial hypertension.
Vigorex is a selective, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). When sexual stimulation causes the local release of nitric oxide; inhibition of PDE5 by Vigorex produces increased levels of cGMP in the corpus cavernosum. This results in smooth muscle relaxation and inflow of blood into the penile tissues, thereby producing an erection. Vigorex has no effect in the absence of sexual stimulation.
Vigorex metabolism is principally mediated by the cytochrome P450 (CYP) isoforms 3A4 (major route) and 2C9 (minor route). Therefore, inhibitors of these isoenzymes 15 may reduce Vigorex clearance and inducers of these isoenzymes may increase Vigorex clearance. Cimetidine (800 mg), a nonspecific CYP inhibitor, caused a 56% increase in plasma Vigorex concentrations when coadministered with Vigorex (50 mg) to healthy volunteers.
Sildenafil is contraindicated in patient with hypersensitivity to any component of this medication. Sildenafil potentiates the hypotensive effects of nitrates, so it is contraindicated in patients who are using organic nitrates, either regularly or intermittently.
Pregnancy category B. There are no adequate and well-controlled studies of Sildenafil in pregnant women. Sildenafil is not indicated for use by women. In animal study shows that Sildenafil has no evidence of teratogenicity or embryotoxicity.
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 Vigorex 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.