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Getriebe Porsche 944
Datum: Montag, 11. August 2008
Autor: Gast
Bewertung:
were as follows Placebo-subtracted mean maximum decrease in systolic blood pressure mm Hg Viagra 50 mg 95 CI Supine 5 68 Standing 7 90 Figure 6 Mean Standing Systolic Blood Pressure Change from Baseline Blood pressure was measured after administration of Viagra at the same times as those specified for the first doxazosin study There were two subjects who had a standing SBP of 85 mmHg In these two subjects hypotension was reported as a moderately severe adverse event beginning at approximately 1 hour after administration of Viagra 50 mg and resolving after approximately hours There was one subject with a decrease from baseline in standing systolic BP 30mmHg following Viagra 50 mg and one subject with a decrease from baseline in standing systolic BP 30 mmHg following both Viagra 50 mg and placebo There were no severe adverse events potentially related to blood pressure and no episodes of syncope reported in this study In the third study a single oral dose of Viagra 100 mg or matching placebo was administered in a 3-period crossover design to 20 generally healthy males with BPH In dose period 1 subjects were administered open-label doxazosin and a single dose of Viagra 50 mg simultaneously after at least 14 consecutive days of doxazosin If a subject did not successfully complete this first dosing period he was discontinued from the study Subjects who had successfully completed the previous doxazosin interaction study using Viagra 50 mg including no significant hemodynamic adverse events were allowed to skip dose period 1 Treatment with doxazosin continued for at least 7 days after dose period 1 Thereafter Viagra 100mg or matching placebo was administered simultaneously with doxazosin 4 mg 14 subjects or doxazosin 8 mg 6 subjects in standard crossover fashion The mean subject age in this study was years Twenty-five subjects were screened Two were discontinued after study period 1 one failed to meet pre-dose screening qualifications and the other experienced symptomatic hypotension as a moderately severe adverse event 30 minutes after dosing with open-label Viagra 50 mg Of the twenty subjects who were ultimately assigned to treatment a total of 13 subjects successfully completed dose period 1 and seven had successfully completed the previous doxazosin study using Viagra 50 mg For the 20 subjects who received Viagra 100 mg and matching placebo the placebo-subtracted mean maximum decreases from baseline 95 CI in systolic blood pressure were as follows Placebo-subtracted mean maximum decrease in systolic blood pressure mm Hg Viagra 100 mg Supine 4 1 Standing -1 3 Figure 7 Mean Standing Systolic Blood Pressure Change from Baseline Blood pressure was measured after administration of Viagra at the same times as those specified for the previous doxazosin studies There were three subjects who had a standing SBP of 85 mmHg All three were taking Viagra 100 mg and all three reported mild adverse events at the time of reductions in standing SBP including vasodilation and lightheadedness There were four subjects with a decrease from baseline in standing systolic BP 30mmHg following Viagra 100 mg one subject with a decrease from baseline in standing systolic BP 30 mmHg following placebo and one subject with a decrease from baseline in standing systolic BP 30 mmHg following both Viagra and placebo While there were no severe adverse events potentially related to blood pressure reported in this study one subject reported moderate vasodilatation after both Viagra 50 mg and 100 mg There were no episodes of syncope reported in this study When Viagra 100 mg oral was coadministered with amlodipine 5 mg or 10 mg oral to hypertensive patients the mean additional reduction on supine blood pressure was 8 mmHg systolic and 7 mmHg diastolic No significant interactions were shown with tolbutamide 250 mg or warfarin 40 mg both of which are metabolized by CYP2C9 Viagra 50 mg did not potentiate the increase in bleeding time caused by aspirin 150 mg Viagra 50 mg did not potentiate the hypotensive effect of alcohol in healthy volunteers with mean maximum blood alcohol levels of In a study of healthy male volunteers sildenafil 100 mg did not affect the steady state pharmacokinetics of the HIV protease inhibitors saquinavir and ritonavir both of which are CYP3A4 substrates Sildenafil at steady state 80 mg t i d resulted in a 50 increase in AUC and a 42 increase in Cmax of bosentan 125 mg b i d Carcinogenesis Mutagenesis Impairment of Fertility Sildenafil was not carcinogenic when administered to rats for 24 months at a dose resulting in total systemic drug exposure AUCs for unbound sildenafil and its major metabolite of 29- and 42-times for male and female rats respectively the exposures observed in human males given the Maximum Recommended Human Dose MRHD of 100 mg Sildenafil was not carcinogenic when administered to mice for months at dosages up to the Maximum Tolerated Dose MTD of 10 mg kg day approximately times the MRHD on a mg m2 basis Sildenafil was negative in in vitro bacterial and Chinese hamster ovary cell assays to detect mutagenicity and in vitro human lymphocytes and in vivo mouse micronucleus assays to detect clastogenicity There was no impairment of fertility in rats given sildenafil up to 60 mg kg day for 36 days to females and 102 days to males a dose producing an AUC value of more than 25 times the human male AUC There was no effect on sperm motility or morphology after single 100 mg oral doses of Viagra in healthy volunteers Pregnancy Nursing Mothers and Pediatric Use Viagra is not indicated for use in newborns children or women Pregnancy Category B No evidence of teratogenicity embryotoxicity or fetotoxicity was observed in rats and rabbits which received up to 200 mg kg day during organogenesis
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