Post-marketing reports of liver injury, including hepatic failure, liver enzyme elevations >10x ULN, hepatitis & jaundice. Carefully consider benefit & risk of treatment in patients w/ hepatic injury risk factors & in patients receiving concomitant medicinal products associated w/ risk of hepatic injury. Perform LFTs before starting treatment. Do not initiate treatment if baseline ALT &/or AST >3x ULN. Caution in patients w/ pretreatment elevated transaminases (> ULN & ≤3x ULN). Periodically monitor transaminases during treatment after around 3 wk, 6 wk (end of acute phase), 12 & 24 wk (end of maintenance phase), & thereafter when clinically indicated. When increasing dose, perform LFTs at the same frequency as when initiating treatment. Immediately discontinue treatment if patient develops symptoms or signs of potential liver injury & if increase in serum transaminases exceeds 3x ULN. Caution in patients w/ history of bipolar disorder, mania or hypomania. Discontinue treatment if manic symptoms develop. Patients w/ history of suicide-related events or those exhibiting significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, & should receive careful monitoring during treatment. Caution when combining w/ moderate CYP1A2 inhibitors (eg, propranolol, enoxacin). Should not be taken by patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Minor influence on the ability to drive & use machines. Caution in patients w/ severe or moderate renal impairment. Preferable to avoid use during pregnancy. Discontinue breast-feeding or discontinue/abstain from therapy. Not recommended in patients <18 yr. Should not be used by patients ≥75 yr. Do not use in elderly patients w/ dementia.
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