Pulmonary Arterial Hypertension

The recommended dose of Tadalafil (PAH) 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 hemodialysis): Avoid use of Tadalafil (PAH) because of increased tadalafil exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis [see Warnings and Precautions (5.3) and Use in Specific Populations (8.6)].

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 use of Tadalafil (PAH) [see Warnings and Precautions (5.4) and Use in Specific Populations (8.7)].

Geriatric Patients

• No dose adjustment is required in patients >65 years of age without renal impairment or hepatic impairment.

Use with Ritonavir

Coadministration of Tadalafil (PAH) in Patients on Ritonavir

In patients receiving ritonavir for at least one week, start Tadalafil (PAH) at 20 mg once daily. Increase to 40 mg once daily based upon individual tolerability [see Warnings and Precautions (5.2), Drug Interactions (7.2) and Clinical Pharmacology (12.3)].

Coadministration of Ritonavir in Patients on Tadalafil (PAH)

Avoid use of Tadalafil (PAH) during the initiation of ritonavir. Stop Tadalafil (PAH) at least 24 hours prior to starting ritonavir. After at least one week following the initiation of ritonavir, resume Tadalafil (PAH) at 20 mg once daily. Increase to 40 mg once daily based upon individual tolerability [see Warnings and Precautions (5.2), Drug Interactions (7.2) and Clinical Pharmacology (12.3)].