Adults: The recommended dose is 20 mg 3 times/day, taken approximately 6-8 hours apart with or without food. Do not exceed the recommended dose.
Special populations: Elderly ≥65 years: Dose adjustments are not required in elderly patients. However, decreased hepatic, renal and cardiac function in elderly as well as concomitant disease or drug used should be taken into consideration in dosage selection.
Renal impairment: Dose adjustments are not required in patients with renal impairment.
Hepatic impairment: In volunteers with mild to moderate hepatic cirrhosis (Child-Pugh class A and B), sildenafil clearance was reduced, resulting in increases in AUC (84%) and Cmax (47%), compared with age-matched volunteers with no hepatic impairment.
Dose adjustments are not required in patients with mild to moderate hepatic impairment (Child-Pugh class A and B). Sildenafil has not been studied in patients with severe hepatic impairment (Child-Pugh class C).
Pediatric patients: It is not recommended for use in children (below 18 years) due to insufficient data on safety and efficacy.
Patients using other medicinal products: Co-administration of most potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir) with sildenafil is not recommended.
A downward dose adjustment to 20 mg twice a day should be considered when sildenafil is co-administered to patients already receiving CYP3A4 inhibitors like erythromycin or saquinavir. A downward dose adjustment to 20 mg once daily is recommended in case of co-administration with more potent CYP3A4 inhibitors like clarithromycin, telithromycin and nefazodone.
Dose adjustments for sildenafil may be required when co-administered with CYP3A4 inducers.