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physicians total care, inc. - vardenafil hydrochloride (unii: 5m8s2cu0ts) (vardenafil - unii:uce6f4125h) - vardenafil 10 mg - staxyn™ is indicated for the treatment of erectile dysfunction. administration of staxyn with nitrates (either regularly and/or intermittently) and nitric oxide donors is contraindicated [see clinical pharmacology (12.2)] . consistent with the effects of pde5 inhibition on the nitric oxide/cyclic guanosine monophosphate pathway, pde5 inhibitors, including staxyn, may potentiate the hypotensive effects of nitrates. a suitable time interval following staxyn dosing for the safe administration of nitrates or nitric oxide donors has not been determined. pregnancy category b: staxyn is not indicated for use in women. there are no studies of staxyn use in pregnant women. no evidence of specific potential for teratogenicity, embryotoxicity or fetotoxicity was observed in rats and rabbits that received vardenafil at up to 18 mg/kg/day during organogenesis. this dose is approximately 100 fold (rat) and 29 fold (rabbit) greater than the auc values for unbound vardenafil and its major metabolite in humans given the maxim
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