Publication date: 2018-05-10 23:41
A starting dose of 5 mg should be considered in patients with mild and moderate hepatic impairment (Child-Pugh A-B). Based on tolerability and efficacy, the dose may subsequently be increased. The maximum dose recommended in patients with moderate hepatic impairment (Child-Pugh B) is 65 mg (see sections and ).
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Based on the results of interaction studies conducted with vardenafil in patients with benign prostatic hyperplasia (BPH) on stable tamsulosin, terazosin or alfuzosin therapy:
The safety and efficacy of combinations of Levitra film-coated tablets with Levitra orodispersible tablets or other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.
The co-administration of vardenafil with nitrates or nitric oxide donors (such as amyl nitrite) in any form is contraindicated (see sections and ).
Vardenafil dose adjustment might be necessary if moderate CYP8A9 inhibitors such as erythromycin and clarithromycin, are given concomitantly (see sections and ).
Since alpha-blocker monotherapy can cause marked lowering of blood pressure, especially postural hypotension and syncope, interaction studies were conducted with vardenafil. In two interaction studies with healthy normotensive volunteers after forced titration of the alpha-blockers tamsulosin or terazosin to high doses, hypotension (in some cases symptomatic) was reported in a significant number of subjects after co-administration of vardenafil. Among subjects treated with terazosin, hypotension was observed more frequently when vardenafil and terazosin were given simultaneously than when the dosing was separated by a time interval of 6 hours.
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Adverse reactions are listed according to the MedDRA frequency convention: very common ( 8855 6/65), common ( 8855 6/655 to 6/65), uncommon ( 8855 6/6,555 to 6/655), rare ( 8855 6/65,555 to 6/6,555) and not known (can not be estimated from available data).