Monitor liver function. Perform LFTs before starting treatment & then around 3 wk, 6 wk (end of acute phase), 12 wk & 24 wk (end of maintenance phase) & thereafter when clinically indicated. Repeat LFT w/in 48 hr in patient who develops increased serum transaminases. Cases of liver injury including liver enzyme elevations >10 x ULN, hepatic failure, hepatitis & jaundice have been reported. Patient w/ hepatic injury risk factors eg, overwt, obesity, non-alcoholic fatty liver disease, diabetes or use w/ medicines associated w/ risk of hepatic injury, alcohol use disorder &/or substantial alcohol intake; pre-treatment elevated transaminases. Immediately discontinue if serum transaminases increases >3 x ULN; signs or symptoms of potential liver injury eg, dark urine, light coloured stools, yellow skin/eyes, upper right abdomen pain, sustained new-onset & unexplained fatigue. Discontinue if manic symptoms develop in patient w/ history of bipolar disorder, mania or hypomania. Caution in patient w/ history of suicide-related events or exhibiting suicidality prior to commencement of treatment; depression. Concomitant use w/ moderate CYP1A2 inhibitors (eg, propranolol). Avoid alcohol consumption. Contains lactose monohydrate; not to be taken by patient w/ rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Contraindicated in patient w/ hepatic impairment. Caution in patient w/ moderate or severe renal impairment. Avoid use during pregnancy. Consider the relative benefits of breastfeeding for the child & of therapy for the woman. Not recommended in childn & adolescents <18 yr; to treat GAD in elderly >65 yr. Not to be used in elderly ≥75 yr w/ MDD; for treatment of MDD or GAD in elderly w/ dementia.
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