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- Cimetidine (800mg), a cytochrome P450 inhibitor and non-specific CYP3A4 inhibitor, brought on a 56% increase in plasma sildenafil concentrations when co-administered with sildenafil (50mg) to wholesome volunteers.
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There was no effect on sperm motility or morphology after single one hundred mg oral doses of sildenafil in healthy volunteers (see section 5.1). Sildenafil (100mg) didn’t have an effect on the steady state pharmacokinetics of the HIV protease inhibitors, saquinavir and ritonavir, each of that are CYP3A4 substrates. These extra blood pressure reductions were of an analogous magnitude to these seen when sildenafil was administered alone to wholesome volunteers (see Section 5.1). Sildenafil (50mg) did not potentiate the hypotensive results of alcohol in wholesome volunteers with imply maximum blood alcohol levels of 80 mg/dl.
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Concomitant use of riociguat with PDE5 inhibitors, including sildenafil, is contraindicated (see section 4.3). In clinical studies, riociguat has been shown to augment the hypotensive effects of PDE5 inhibitors. Single doses of antacid (magnesium hydroxide/aluminium hydroxide) didn’t affect the bioavailability of sildenafil. Cimetidine (800mg), a cytochrome P450 inhibitor and non-specific CYP3A4 inhibitor, caused a 56% increase in plasma sildenafil concentrations when co-administered with sildenafil (50mg) to healthy volunteers. In regular healthy male volunteers, there was no evidence of an impact of azithromycin (500mg daily for three days) on the AUC, Cmax, Tmax, elimination price constant, or subsequent half-life of sildenafil or its principal circulating metabolite.