Not to be initiated in patients w/ baseline values of ALT &/or AST >3 times ULN. Patients w/ pretreatment elevated transaminases (>ULN ranges & ≤3 times ULN range); hepatic injury risk factors eg, obesity/overwt/non-alcoholic fatty liver disease, diabetes, alcohol use disorder, substantial alcohol intake or concomitant use w/ drugs associated w/ risk of hepatic injury. History of bipolar disorder, mania or hypomania; history of suicide-related events; suicidal ideation. Perform LFTs prior to treatment & periodically thereafter. Concomitant use w/ moderate CYP1A2 inhibitors (eg, propranolol, enoxacin). Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption. May affect ability to drive & use machines. Severe or moderate renal impairment. Avoid use during pregnancy. Lactation. Not recommended in childn <18 yr. Not to be used in elderly w/ dementia & elderly ≥75 yr.