Posology: Use in adult men: The recommended dose is 100 mg taken as needed approximately 15 to 30 minutes before sexual activity (see Pharmacology: Pharmacodynamics under Actions). 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. Sexual stimulation is required for a response to treatment.
Special populations: Older men (≥ 65 years old): Dose adjustments are not required in older patients. Limited data are available in older patients aged 70 years or above.
Renal impairment: Dose adjustments are not required in patients with mild to moderate renal impairment (creatinine clearance ≥ 30 mL/min). Spedra is contraindicated in patients with severe renal impairment (creatinine clearance < 30 mL/min) (see Contraindications and Pharmacology: Pharmacokinetics under Actions). Patients with mild or moderate renal impairment (creatinine clearance ≥30 mL/min but <80 mL/min) who were enrolled in phase 3 studies showed decreased efficacy compared to those with normal renal function.
Hepatic impairment: Spedra is contraindicated in patients with severe hepatic impairment (Child Pugh class C) (see Contraindications and Pharmacology: Pharmacokinetics under Actions). Patients with mild to moderate hepatic impairment (Child-Pugh class A or B) should initiate treatment with the minimum efficacious dose and adjust posology based on tolerance.
Use in men with diabetes: Dose adjustments are not required in diabetic patients.
Paediatric population: There is no relevant use of Spedra in the paediatric population in the indication of erectile dysfunction.
Use in patients using other medicinal products: Concomitant use of CYP3A4 inhibitors: Co-administration of avanafil with potent CYP3A4 inhibitors (including ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir and telithromycin) is contraindicated (see Contraindications, Precautions and Interactions).
In patients receiving concomitant treatment with moderate CYP3A4 inhibitors (including erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, and verapamil), the maximum recommended dose of avanafil should not exceed 100 mg, with an interval of at least 48 hours between doses (see Interactions).
Method of administration: For oral use. If Spedra is taken with food, the onset of activity may be delayed compared to the fasted state (see Pharmacology: Pharmacokinetics under Actions).