Avanafil

Source: UK SPC (eMC) section 4.2 for Spedra 100 mg tablets (https://www.medicines.org.uk/emc/product/7421/smpc). VERBATIM: 'The recommended dose is 100 mg taken as needed approximately 15 to 30 minutes before sexual activity... Based on individual efficacy and tolerability, the dose may be increased to a maximum dose of 200 mg or decreased to 50 mg. The maximum recommended dosing frequency is once per day.' Adult men (erectile dysfunction): recommended dose 100 mg taken as needed approximately 15-30 minutes before sexual activity. Based on individual efficacy and tolerability the dose may be increased to a maximum of 200 mg or decreased to 50 mg. Sexual stimulation is required for a response to treatment. Elderly (>=65 years): no dose adjustment required; limited data in patients aged 70 years or above. No dose adjustment required in diabetic patients. Hepatic impairment: mild to moderate (Child-Pugh A or B) should initiate treatment with the minimum efficacious dose and adjust posology based on tolerance; contraindicated in severe hepatic impairment (Child-Pugh C). Concomitant moderate CYP3A4 inhibitors (including erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, verapamil): maximum recommended dose should not exceed 100 mg with an interval of at least 48 hours between doses. Potent CYP3A4 inhibitors are contraindicated. If taken with food, onset of activity may be delayed compared with the fasted state. Paediatric: the SPC states there is no relevant use of this product in the paediatric population in the indication of erectile dysfunction. US labelling differs on two points (verify before use): moderate CYP3A4 inhibitor cap is 50 mg per 24 hours, and a 50 mg starting dose is recommended in patients on stable alpha-blocker therapy. Note: the UK section 4.5 was not retrieved in this bundle - the interactions below come from the section 4.2 and 4.3 text.