Quetiapine (Elderly — Dementia Caution)

Source: UK SPC (eMC) for Biquelle XL 150mg prolonged-release tablets, §4.2 (https://www.medicines.org.uk/emc/product/3613/smpc). ELDERLY (the focus of this page): 'As with other antipsychotics and antidepressants, Biquelle XL should be used with caution in the elderly, especially during the initial dosing period. The rate of dose titration may need to be slower, and the daily therapeutic dose lower, than that used in younger patients. The mean plasma clearance of quetiapine was reduced by 30% to 50% in elderly patients when compared to younger patients. Elderly patients should be started on 50 mg/day.' In elderly patients with major depressive episodes in MDD, dosing should begin with 50 mg/day on Days 1–3, increasing to 100 mg/day on Day 4 and 150 mg/day on Day 8; the lowest effective dose starting from 50 mg/day should be used, and based on individual patient evaluation a dose increase to 300 mg/day, if required, should not be prior to Day 22 of treatment. Efficacy and safety have not been evaluated in patients over 65 years with depressive episodes in bipolar disorder. DEMENTIA CAUTION: the fetched §4.2 and the retrieved part of §4.4 do NOT contain a dementia-related-psychosis statement (the SPC has no such licensed indication and §4.4 was truncated at the fetch limit before any such paragraph). The US label §5.3 does state: 'Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack) has been seen in elderly patients with dementia-related psychoses treated with atypical antipsychotic drugs', and §6 lists 'Increased mortality in elderly patients with dementia-related psychosis'. Source the full UK §4.4 dementia/cerebrovascular wording before publishing the caution. STANDARD ADULT REGIMENS (for reference — different dosing schedules exist for each indication and patients must be given clear information on the dose for their condition): Schizophrenia and moderate to severe manic episodes in bipolar disorder — administer at least one hour before a meal; 300 mg on Day 1 and 600 mg on Day 2; recommended daily dose 600 mg, which may be increased to 800 mg daily if clinically justified, adjusted within the effective range of 400–800 mg/day; no dose adjustment needed for maintenance therapy in schizophrenia. Major depressive episodes in bipolar disorder — at bedtime; 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3), 300 mg (Day 4); recommended daily dose 300 mg; dose reduction to a minimum of 200 mg may be considered for tolerance concerns; doses above 300 mg should be initiated by physicians experienced in treating bipolar disorder. Preventing recurrence in bipolar disorder — continue at the same dose at bedtime, adjustable within 300–800 mg/day, using the lowest effective dose. Add-on treatment of major depressive episodes in MDD — before bedtime; 50 mg on Days 1 and 2, 150 mg on Days 3 and 4; antidepressant effect was seen at 150 and 300 mg/day as add-on and at 50 mg/day in monotherapy trials; there is an increased risk of adverse events at higher doses so the lowest effective dose starting at 50 mg/day should be used. SWITCHING: patients on divided doses of immediate-release quetiapine may be switched to the prolonged-release tablets at the equivalent total daily dose taken once daily, with individual adjustment as necessary. HEPATIC IMPAIRMENT: use with caution; start at 50 mg/day and increase in increments of 50 mg/day to an effective dose. PAEDIATRIC: not recommended below 18 years of age due to lack of data — hence paedDose is null; verify any under-18 use against a children's formulary. NOTE ON SOURCES: §4.5 was not retrieved in this bundle — the interactions below come from UK §4.3 plus §7 of the US label (Bryant Ranch Prepack quetiapine tablets, https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=01261008-5f42-4844-8a65-d4545a67a309). §4.4 and §4.8 were truncated at the fetch limit.