Tadalafil
Dosing in kidney impairment
Use in Specific Populations Renal Impairment Tadalafil tablets for Use as Needed Creatinine clearance 30 to 50 mL/min: A starting dose of 5 mg not more than once per day is recommended, and the maximum dose is 10 mg not more than once in every 48 hours. Creatinine clearance less than 30 mL/min or on hemodialysis: The maximum dose is 5 mg not more than once in every 72 hours [see Warnings and Precautions and Use in Specific Populations] .
Tadalafil tablets for Once Daily Use Erectile Dysfunction Creatinine clearance less than 30 mL/min or on hemodialysis: Tadalafil tablets for once daily use is not recommended [see Warnings and Precautions and Use in Specific Populations] . Benign Prostatic Hyperplasia and Erectile Dysfunction/Benign Prostatic Hyperplasia Creatinine clearance 30 to 50 mL/min: A starting dose of 2.5 mg is recommended.
An increase to 5 mg may be considered based on individual response. Creatinine clearance less than 30 mL/min or on hemodialysis: Tadalafil tablets for once daily use is not recommended [see Warnings and Precautions and Use in Specific Populations] . Hepatic Impairment Tadalafil tablets for Use as Needed Mild or moderate (Child Pugh Class A or B): The dose should not exceed 10 mg once per day.
The use of tadalafil tablets once per day has not been extensively evaluated in patients with hepatic impairment and therefore, caution is advised. Severe (Child Pugh Class C): The use of tadalafil tablets are not recommended [see Warnings and Precautions and Use in Specific Populations] . Tadalafil tablets for Once Daily Use Mild or moderate (Child Pugh Class A or B): Tadalafil tablets for once daily use has not been extensively evaluated in patients with hepatic impairment.
Therefore, caution is advised if tadalafil tablets for once daily use is prescribed to these patients. Severe (Child Pugh Class C): The use of tadalafil tablets are not recommended [see Warnings and Precautions and Use in Specific Populations] .
Dosing in liver impairment
Hepatic Impairment In clinical pharmacology studies, tadalafil exposure (AUC) in subjects with mild or moderate hepatic impairment (Child-Pugh Class A or B) was comparable to exposure in healthy subjects when a dose of 10 mg was administered. There are no available data for doses higher than 10 mg of tadalafil in patients with hepatic impairment.
Insufficient data are available for subjects with severe hepatic impairment (Child-Pugh Class C). [see Dosage and Administration and Warnings and Precautions] .