Duloxetine

Dosage in Patients with Hepatic Impairment or Severe Renal impairment Avoid use in patients with chronic liver disease or cirrhosis [see Warnings and Precautions and Use in Specific Populations] . Avoid use in patients with severe renal impairment, GFR <30 mL/minute [see Warnings and Precautions and Use in Specific Populations] .

Hepatic Impairment Patients with clinically evident hepatic impairment have decreased duloxetine metabolism and elimination. After a single 20 mg dose of duloxetine delayed-release capsules, 6 cirrhotic patients with moderate liver impairment (Child-Pugh Class B) had a mean plasma duloxetine clearance about 15% that of age- and gender-matched healthy subjects, with a 5-fold increase in mean exposure (AUC).

Although C max was similar to normals in the cirrhotic patients, the half-life was about 3 times longer [see Dosage and Administration and Warnings and Precautions].

Important Administration Instructions Administer duloxetine delayed-release capsule orally (with or without meals) and swallow whole. Do not chew or crush, and do not open the delayed-release capsule and sprinkle its contents on food or mix with liquids because these actions might affect the enteric coating. If a dose of duloxetine delayed-release capsule is missed, take the missed dose as soon as it is remembered.

If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time. Do not take two doses of duloxetine delayed-release capsule at the same time.