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The complete body clearance of sildenafil is 41 l/h with a resultant terminal section half lifetime of 3-5 h. The N-desmethyl metabolite is additional metabolised, with a terminal half life of approximately four h. There was no effect on sperm motility or morphology after single 100mg oral doses of sildenafil in wholesome volunteers (see section four.6).. The postulated mechanism for this change in colour discrimination is said to inhibition of PDE6, which is concerned in the phototransduction cascade of the retina. Single oral doses of sildenafil up to 100mg in healthy volunteers produced no clinically related effects on ECG. In a separate RigiScan study, sildenafil was still capable of produce an erection in response to sexual stimulation 4-5 hours post-dose.
- Sildenafil (100 mg) did not have an result on the regular state pharmacokinetics of the HIV protease inhibitors, saquinavir and ritonavir, each of that are CYP3A4 substrates.
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Co-administration of the HIV protease inhibitor saquinavir, a CYP3A4 inhibitor, at regular state (1200mg thrice a day) with sildenafil (100mg single dose) resulted in a 140% improve in sildenafil Cmax and a 210% improve in sildenafil AUC. Based Mostly on these pharmacokinetic outcomes co-administration of sildenafil with ritonavir isn’t suggested (see Section four.4) and in any occasion the utmost dose of sildenafil should by no means exceed 25mg inside 48 hours. Co-administration of the HIV protease inhibitor ritonavir, which is a highly potent P450 inhibitor, at regular state (500mg twice daily) with sildenafil (100mg single dose) resulted in a 300% (4-fold) increase in sildenafil Cmax and a 1,000% (11-fold) enhance in sildenafil plasma AUC.
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