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Concomitant use of riociguat with PDE5 inhibitors, including sildenafil, is contraindicated (see part four.3). In clinical studies, riociguat has been shown to reinforce the hypotensive effects of PDE5 inhibitors. Single doses of antacid (magnesium hydroxide/aluminium hydroxide) did not affect the bioavailability of sildenafil. Cimetidine (800mg), a cytochrome P450 inhibitor and non-specific CYP3A4 inhibitor, triggered a 56% enhance in plasma sildenafil concentrations when co-administered with sildenafil (50mg) to wholesome volunteers. In regular wholesome male volunteers, there was no proof of an impact of azithromycin (500mg day by day for 3 days) on the AUC, Cmax, Tmax, elimination price constant, or subsequent half-life of sildenafil or its principal circulating metabolite.
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There was no effect on sperm motility or morphology after single 100 mg oral doses of sildenafil in healthy volunteers (see part 5.1). Sildenafil (100mg) did not affect the regular state pharmacokinetics of the HIV protease inhibitors, saquinavir and ritonavir, each of which are CYP3A4 substrates. These extra blood stress reductions were of a similar 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 healthy volunteers with mean most blood alcohol ranges of 80 mg/dl.
Cimetidine (800 mg), a cytochrome P450 inhibitor and non-specific CYP3A4 inhibitor, triggered a 56% enhance in plasma sildenafil concentrations when co-administered with sildenafil (50 mg) to healthy volunteers. In regular wholesome male volunteers, there was no evidence of an effect of azithromycin (500 mg day by day for three days) on the AUC, Cmax, tmax, elimination price fixed, or subsequent half-life of sildenafil or its principal circulating metabolite. Co-administration of the HIV protease inhibitor saquinavir, a CYP3A4 inhibitor, at steady state (1 200 mg thrice a day) with sildenafil (100 mg single dose) resulted in a 140% increase in sildenafil Cmax and a 210% increase in sildenafil AUC. Primarily Based on these pharmacokinetic results co-administration of sildenafil with ritonavir isn’t suggested (see part four.4) and in any event the maximum dose of sildenafil should under no circumstances exceed 25 mg inside 48 hours. Co-administration of the HIV protease inhibitor ritonavir, which is a highly potent P450 inhibitor, at steady state (500 mg twice daily) with sildenafil (100 mg single dose) resulted in a 300% (4-fold) increase in sildenafil Cmax and a 1 000% (11-fold) increase in plasma AUC.