Vardenafil

SOURCE: eMC UK SPC 'Vardenafil Mylan 10 mg film-coated tablets' §4.2, quoted verbatim, for use in adult men. ELDERLY (≥65 years): 'Dose adjustments are not required in elderly patients. However, an increase to a maximum 20 mg dose should be carefully considered depending on the individual tolerability' — tolerability of the 20 mg dose may be lower in this group. HEPATIC IMPAIRMENT: consider a starting dose of 5 mg in mild and moderate impairment (Child-Pugh A-B), increasing subsequently based on tolerability and efficacy; the maximum dose recommended in moderate impairment (Child-Pugh B) is 10 mg; severe impairment (Child-Pugh C) is contraindicated. CYP3A4 INHIBITORS: 'When used in combination with the CYP3A4 inhibitors such as erythromycin or clarithromycin, the dose of vardenafil should not exceed 5 mg.' ALPHA-BLOCKERS (§4.4): initiate vardenafil only in patients stabilised on alpha-blocker therapy, at the lowest recommended starting dose of 5 mg; vardenafil may be given at any time with tamsulosin or alfuzosin, while with other alpha-blockers a time separation of dosing should be considered. PAEDIATRIC: 'Vardenafil is not indicated for individuals below 18 years of age. There is no relevant indication for use of vardenafil in children.' US CROSS-CHECK (differs — do not merge): starting dose 10 mg approximately 60 minutes before sexual activity; a 5 mg starting dose should be considered in patients ≥65 years; CYP3A4 caps are ritonavir or cobicistat no more than 2.5 mg in a 72-hour period; indinavir, saquinavir, atazanavir, ketoconazole 400 mg daily, itraconazole 400 mg daily or clarithromycin no more than 2.5 mg in a 24-hour period; ketoconazole 200 mg daily, itraconazole 200 mg daily or erythromycin no more than 5 mg in a 24-hour period; 5 mg starting dose on stable alpha-blocker therapy (2.5 mg with certain CYP3A4 inhibitors); do not use in patients on renal dialysis. §4.4 of the SPC was truncated at the source-fetch limit.