Olanzapine

ELDERLY CONTEXT. Elderly (SPC section 4.2, Special populations): a lower starting dose (5 mg/day) is not routinely indicated but should be considered for those 65 and over when clinical factors warrant. When more than one factor is present which might result in slower metabolism (female gender, geriatric age, non-smoking status), consideration should be given to decreasing the starting dose, and dose escalation should be conservative. Renal and/or hepatic impairment: a lower starting dose (5 mg) should be considered; in moderate hepatic insufficiency (cirrhosis, Child-Pugh Class A or B) the starting dose should be 5 mg and only increased with caution. SPC section 4.4 warning — dementia-related psychosis and/or behavioural disturbances: olanzapine is NOT recommended in this population because of an increase in mortality and the risk of cerebrovascular accident; in placebo-controlled trials in elderly patients (mean age 78 years) there was a 2-fold increase in the incidence of death (3.5% vs 1.5%) and a 3-fold increase in cerebrovascular adverse events (1.3% vs 0.4%). Risk factors include age > 65 years, dysphagia, sedation, malnutrition and dehydration, pulmonary conditions, or concomitant use of benzodiazepines; age > 75 years and vascular/mixed type dementia were identified as risk factors for cerebrovascular events. Efficacy was not established in these trials. Parkinson's disease: use for dopamine agonist associated psychosis is not recommended. Other adult regimens from the same SPC: manic episode — starting dose 15 mg as a single daily dose in monotherapy or 10 mg daily in combination therapy. Increases above the recommended starting dose only after appropriate clinical reassessment and generally at intervals of not less than 24 hours. Smokers: the starting dose and dose range need not be routinely altered, but metabolism may be induced by smoking — clinical monitoring is recommended and a dose increase may be considered. Olanzapine can be given without regard to meals; gradual tapering of the dose should be considered when discontinuing. Orodispersible tablet: place in the mouth to disperse rapidly in saliva, or disperse in a full glass of water immediately before administration; it is fragile and should be taken immediately on opening the blister. Paediatric population: not recommended in children and adolescents below 18 years of age due to a lack of data on safety and efficacy. eMC section 4.5 was not captured in this bundle — the eMC interactions listed below are drawn from sections 4.2/4.4 and the remainder from the US label section 7; verify against UK SPC section 4.5.