The maximum dose of vardenafil for which human data are available is a single 120 mg dose of the film–coated tablets administered to eight healthy male volunteers. The majority of these subjects experienced reversible back pain/myalgia and/or “abnormal vision.”

In cases of overdose, standard supportive measures should be taken as required. Renal dialysis is not expected to accelerate clearance because vardenafil is highly bound to plasma proteins and is not significantly eliminated in the urine.

Nitrates

Administration of STAXYN (vardenafil hydrochloride orally disintegrating tablets) with nitrates (either regularly and/or intermittently) and nitric oxide donors is contraindicated [see CLINICAL PHARMACOLOGY]. Consistent with the effects of PDE5 inhibition on the nitric oxide/cyclic guanosine monophosphate pathway, PDE5 inhibitors, including STAXYN (vardenafil hydrochloride orally disintegrating tablets) , may potentiate the hypotensive effects of nitrates. A suitable time interval following STAXYN (vardenafil hydrochloride orally disintegrating tablets) dosing for the safe administration of nitrates or nitric oxide donors has not been determined.

Last reviewed on RxList: 7/14/2010
This monograph has been modified to include the generic and brand name in many instances.