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The recommended dose of tadalafil is 40 mg (two 20 mg tablets) taken once daily with or without food. Dividing the dose (40 mg) over the course of the day is not recommended.
USE IN SPECIAL POPULATIONS
Renal Impairment
- Mild (creatinine clearance: 51 to 80 mL/min) or moderate (creatinine clearance: 31 to 50 mL/min): Start dosing at 20 mg once daily. Increase to 40 mg once daily based on individual tolerability.
- Severe (creatinine clearance <30 mL/min and on haemodialysis): Avoid the use of tadalafil because of increased tadalafil exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis.
Hepatic Impairment
- Mild or moderate (Child Pugh Class A or B): Because of limited clinical experience in patients with mild to moderate hepatic cirrhosis, consider a starting dose of 20 mg once per day.
- Severe (Child Pugh Class C): Patients with severe hepatic cirrhosis have not been studied. Avoid the use of tadalafil.
Geriatric Patients
- No dose adjustment is required in patients >65 years of age without renal or hepatic impairment.
Use with Ritonavir
Co-administration of Tadalafil in Patients on Ritonavir
In patients receiving ritonavir for at least 1 week, start tadalafil at 20 mg once daily. Increase to 40 mg once daily based upon individual tolerability.
Co-administration of Ritonavir in Patients on Tadalafil
Avoid the use of tadalafil during the initiation of ritonavir. Stop tadalafil at least 24 hours prior to starting ritonavir. After at least 1 week following the initiation of ritonavir, resume tadalafil at 20 mg once daily. Increase to 40 mg once daily based upon individual tolerability.
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