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Its effect may last up to 36 hours.1,6 The dose can be increased to 20 mg if necessary. Safe dosing of tadalafil includes downward dosage adjustment to 5 mg in patients with moderate to severe renal insufficiency. In patients with mild to moderate hepatic dysfunction, the tadalafil dose should not exceed 10 mg.

However, as with any pharmaceutical product under development, there are substantial risks and uncertainties in the process of development, commercialization, and regulatory review. There is no guarantee that the product will receive additional regulatory approvals. There is also no guarantee that the product will continue to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filings with the&nbsp