Discontinue treatment if patients develop symptoms or signs of potential liver injury eg, dark urine, light coloured stools, yellow skin/eyes, upper right belly pain, sustained new-onset & unexplained fatigue; manic symptoms; if transaminases exceed 3x ULN. Not to be initiated in patients w/ baseline values of ALT &/or AST >3x ULN. Increased risk of suicidal thoughts, self harm & suicide (suicide-related events). Patients w/ hepatic injury risk factors eg, obesity/overwt/non-alcoholic fatty liver disease, diabetes, alcohol use disorder &/or substantial alcohol intake & those receiving concomitant medicinal products associated w/ risk of hepatic injury; pretreatment elevated transaminases (greater than ULN ranges & ≤3x ULN); history of bipolar disorder, mania or hypomania; suicide-related events or those exhibiting suicidal ideation prior to treatment. Perform LFTs before starting treatment & periodically after 3 wk, 6 wk (end of acute phase), 12 & 24 wk (end of maintenance phase) & thereafter. Repeat LFT w/in 48 hr in patient who develops increased serum transaminases following discontinuation until serum transaminases return to normal. Monitor patients w/ greater risk of suicidal thoughts or suicide attempts; for any clinical worsening, suicidal behaviour or thoughts & unusual changes in behaviour. Concomitant use w/ moderate CYP1A2 inhibitors eg, propranolol, enoxacine. Not to be taken in patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Liver injury including hepatic failure, liver enzyme elevations >10x ULN, hepatitis & jaundice. Depressed patients w/ severe or moderate renal impairment w/ major depressive episodes. Avoid use during pregnancy. Lactation. Not recommended in patients <18 yr. Not to be used in childn from birth to 2 yr; elderly ≥75 yr suffering from generalized anxiety disorder; for treatment of major depressive episodes in elderly w/ dementia.
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