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zydus lifesciences limited - vardenafil hydrochloride trihydrate (unii: 5m8s2cu0ts) (vardenafil - unii:uce6f4125h) - vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction. administration of vardenafil 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 vardenafil, may potentiate the hypotensive effects of nitrates. a suitable time interval following dosing of vardenafil for the safe administration of nitrates or nitric oxide donors has not been determined. do not use vardenafil in patients who are using a gc stimulator, such as riociguat. pde5 inhibitors, including vardenafil may potentiate the hypotensive effects of gc stimulators. pregnancy category b vardenafil is not indicated for use in women. there are no studies of vardenafil use in pregnant women. no evidence of specific potential for teratogenicity, embryotoxicity or fetotoxicity was observed in rats and rabbits that
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amneal pharmaceuticals ny llc - vardenafil hydrochloride (unii: 5m8s2cu0ts) (vardenafil - unii:uce6f4125h) - vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction. administration of vardenafil hydrochloride 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 vardenafil hydrochloride may potentiate the hypotensive effects of nitrates. a suitable time interval following dosing of vardenafil hydrochloride for the safe administration of nitrates or nitric oxide donors has not been determined. do not use vardenafil hydrochloride in patients who are using a gc stimulator, such as riociguat. pde5 inhibitors, including vardenafil hydrochloride may potentiate the hypotensive effects of gc stimulators. risk summary vardenafil hydrochloride is not indicated for use in females. there are no data with the use of vardenafil hydrochloride in pregnant women to inform any drug-associat
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