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3. safdgs July 28th, 2008 4:21 pm

   reproductive performance or reproductive organ morphology in male or female rats given oral doses of tadalafil up to 400 mg kg day a dose producing AUCs for unbound tadalafil of 14 fold for males or 26 fold for females the exposures observed in human males given the MRHD of 20 mg In beagle dogs given tadalafil daily for 3 to 12 months there was treatment related non reversible degeneration and atrophy of the seminiferous tubular epithelium in the testes in of the dogs that resulted in a decrease in spermatogenesis in of the dogs at doses of 10 mg kg day Systemic exposure based on AUC at no observed adverse-effect level NOAEL 10 mg kg day for unbound tadalafil was similar to that expected in humans at the MRHD of 20 mg There were no treatment related testicular findings in rats or mice treated with doses up to 400 mg kg day for 2 years Animal Toxicology Animal studies showed vascular inflammation in tadalafil treated mice rats and dogs In mice and rats lymphoid necrosis and hemorrhage were seen in the spleen thymus and mesenteric lymph nodes at unbound tadalafil exposure of 2 to 33 fold above the human exposure AUCs at the MRHD of 20 mg In dogs an increased incidence of disseminated arteritis was observed in 1 and 6 month studies at unbound tadalafil exposure of 1 to 54 fold above the human exposure AUC at the MRHD of 20 mg In a 12 month dog study no disseminated arteritis was observed but 2 dogs exhibited marked decreases in white blood cells neutrophils and moderate decreases in platelets with inflammatory signs at unbound tadalafil exposures of approximately 14 to 18 fold the human exposure at the MRHD of 20 mg The abnormal blood cell findings were reversible within 2 weeks upon removal of the drug Pregnancy Nursing Mothers and Pediatric Use Cialis is not indicated for use in newborns children or women Tadalafil and or its metabolites cross the placenta resulting in fetal exposure in rats Tadalafil and or its metabolites were secreted into the milk in lactating rats at concentrations approximately fold greater than found in the plasma Following a single oral dose of 10 mg kg approximately of the total radioactive dose was excreted into the milk within 3 hours It is not known if tadalafil and or its metabolites is excreted in human breast milk Use of tadalafil in nursing mothers is not recommended Pregnancy Category B There was no evidence of teratogenicity embryotoxicity or fetotoxicity in rat or mouse fetuses that received up to 1000 mg kg day during the major organ development Plasma exposure at this dose is approximately 11 fold greater than the AUC values for unbound tadalafil in humans given the MRHD of 20 mg In a rat prenatal and postnatal development study at doses of and 1000 mg kg there was a reduction in postnatal survival of pups The no observed effect level NOEL for maternal toxicity was 200 mg kg day and for developmental toxicity was 30 mg kg day which gives approximately 16 and 10 fold exposure multiples respectively of the human AUC for the MRHD dose of 20 mg There are no adequate and well controlled studies of tadalafil in pregnant women Geriatric Use Approximately 25 of patients in the primary efficacy and safety studies of tadalafil were greater than 65 years of age No overall differences in efficacy and safety were observed between older and younger patients No dose adjustment is warranted based on age alone However greater sensitivity to medications in some older individuals should be considered see Special Populations under CLINICAL PHARMACOLOGY Adverse Reactions Tadalafil was administered to over 5700 men mean age 59 range 19 to 87 years during clinical trials worldwide Over 1000 patients were treated for 1 year or longer and over 1300 patients were treated for 6 months or more In placebo controlled Phase 3 clinical trials the discontinuation rate due to adverse events in patients treated with tadalafil 10 or 20 mg was compared to in placebo treated patients When tadalafil was taken as recommended in the placebo controlled clinical trials the following adverse events were

4. fhsd August 11th, 2008 5:16 pm

   follows Placebo-subtracted mean maximum decrease in systolic blood pressure mm Hg Viagra 25 mg Supine -0 7 Standing -0 8 Figure 5 Mean Standing Systolic Blood Pressure Change from Baseline Blood pressure was measured immediately pre-dose and at 45 minutes and 5 5 6 and 8 hours after Viagra or matching placebo Outliers were defined as subjects with a standing systolic blood pressure of 85 mmHg or a decrease from baseline in standing systolic blood pressure of 30 mmHg at one or more timepoints There were no subjects treated with Viagra 25 mg who had a standing SBP 85mmHg There were three subjects with a decrease from baseline in standing systolic BP 30mmHg following Viagra 25 mg one subject with a decrease from baseline in standing systolic BP 30 mmHg following placebo and two subjects with a decrease from baseline in standing systolic BP 30 mmHg following both Viagra and placebo No severe adverse events potentially related to blood pressure effects were reported in this group Of the four subjects who received Viagra 100 mg in the first part of this study a severe adverse event related to blood pressure effect was reported in one patient postural hypotension that began 35 minutes after dosing with Viagra with symptoms lasting for 8 hours and mild adverse events potentially related to blood pressure effects were reported in two others dizziness headache and fatigue at 1 hour after dosing and dizziness lightheadedness and nausea at 4 hours after dosing There were no reports of syncope among these patients For these four subjects the placebo-subtracted mean maximum decreases from baseline in supine and standing systolic blood pressures were mmHg and mmHg respectively Two of these subjects had a standing SBP 85mmHg Both of these subjects were protocol violators one due to a low baseline standing SBP and the other due to baseline orthostatic hypotension In the second study a single oral dose of Viagra 50 mg or matching placebo was administered in a 2-period crossover design to 20 generally healthy males with BPH Following at least 14 consecutive days of doxazosin Viagra 50mg or matching placebo was administered simultaneously with doxazosin 4 mg 17 subjects or with doxazosin 8 mg 3 subjects The mean subject age in this study was years Twenty subjects received Viagra 50 mg but only 19 subjects received matching placebo One patient discontinued the study prematurely due to an adverse event of hypotension following dosing with Viagra 50 mg This patient had been taking minoxidil a potent vasodilator during the study For the 19 subjects who received both Viagra and matching placebo the placebo-subtracted mean maximum decreases from baseline 95 CI in systolic blood pressure

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