A pharmaceutical collocation comprising a PDE5 inhibitor, a package and a label

摘要

A pharmaceutical article for use in patients suffering from sexual dysfunction. The article comprises: (a) an oral dosage form comprising about 1 to about 20 mg of a selective PDE5 inhibitor having at least a 100 fold differential in IC50 values for the inhibition of PDE5 versus PDE6, at least 1000 fold differential in IC50 values for the inhibition of PDE5 versus PDE1c, an IC50 less than 10nm, and a sufficient bioavailability to be effective in about 1 to about 20 mg unit oral dosages; (b) a package insert providing that the PDE5 inhibitor is useful to treat sexual dysfunction in a patient in need thereof and that is free of any contraindications regarding administration of the PDE5 inhibitor to a patient suffering from a retinal disease; and combinations thereof; and (c) a container.