Paliperidone

INDICATION: schizophrenia - the indication this page leads on and the one both fetched labels dose; the US label additionally doses schizoaffective disorder in adults at the identical 6 mg once daily starting dose and 3 to 12 mg once daily range. || SWITCHING TO THE MONTHLY INJECTION (UK SPC §4.2): equivalence table for patients already stabilised on oral prolonged-release paliperidone - 3 mg daily = 25-50 mg monthly; 6 mg daily = 75 mg monthly; 9 mg daily = 100 mg monthly; 12 mg daily = 150 mg monthly. From risperidone long-acting injection, the day 1 / day 8 initiation regimen 'is not required' and the injection is started 'in place of the next scheduled injection': 25 mg every 2 weeks = 50 mg monthly; 37.5 mg every 2 weeks = 75 mg monthly; 50 mg every 2 weeks = 100 mg monthly. 'Some patients switching from higher paliperidone oral doses (e.g., 9-12 mg daily) to gluteal injections... may have lower plasma exposure during the first 6 months after the switch. Therefore, alternatively, it could be considered to give deltoid injections for the first 6 months.' || MISSED DOSES (UK SPC §4.2): the second initiation dose may be given 4 days either side of day 8, and monthly injections up to 7 days either side of the monthly point. If the day-8 dose is missed and under 4 weeks have elapsed, give 100 mg deltoid as soon as possible and a 75 mg third injection 5 weeks after the first. If 4-7 weeks have elapsed, give two 100 mg deltoid injections a week apart, then resume monthly 25-150 mg. If more than 7 weeks have elapsed, restart the full initiation regimen. For a missed maintenance dose under 6 weeks late, give the previously stabilised dose as soon as possible; if 6 weeks to 6 months late and the patient was stabilised on 25-100 mg, give a deltoid injection at that dose as soon as possible, repeat the same dose deltoid one week later, then resume monthly. || TABLET SHELL (US label §2.3): 'Paliperidone extended-release tablets must be swallowed whole with the aid of liquids. Tablets should not be chewed, divided, or crushed. The medication is contained within a nonabsorbable shell designed to release the drug at a controlled rate. The tablet shell, along with insoluble core components, is eliminated from the body; patients should not be concerned if they occasionally notice in their stool something that looks like a tablet.' || 'Paliperidone should not be used to manage acutely agitated or severely psychotic states when immediate symptom control is warranted' (UK §4.4). || On stopping the injection, 'its prolonged release characteristics must be considered', and 'the full effect of maintenance doses may not be evident for several months' (UK §4.2). || Concomitant use with risperidone 'has not been studied'; paliperidone is the major active metabolite of risperidone, so additive exposure must be considered (US §2.4).

WEIGHT-BANDED, NOT PER-KG - dosePerKg is deliberately null; there is no per-kg figure anywhere in this bundle. US label §2.1, schizophrenia in adolescents 12 to 17 years, verbatim: 'The recommended starting dose of paliperidone extended-release tablets for the treatment of schizophrenia in adolescents 12 to 17 years of age is 3 mg administered once daily. Initial dose titration is not required. Dose increases, if considered necessary, should be made only after clinical reassessment and should occur at increments of 3 mg/day at intervals of more than 5 days.' The label's dosing table gives: weight under 51 kg - initial 3 mg/day, recommended 3 to 6 mg/day, maximum 6 mg/day; weight 51 kg or more - initial 3 mg/day, recommended 3 to 12 mg/day, maximum 12 mg/day. The label cautions that 'in the adolescent schizophrenia study, there was no clear enhancement to efficacy at the higher doses... while adverse events were dose-related'. 'Safety and effectiveness of paliperidone for the treatment of schizophrenia in patients < 12 years of age have not been established' and schizoaffective disorder 'in patients < 18 years of age' has not been studied (§8.4). ROUTE LIMIT: this adolescent regimen is for the ORAL extended-release tablets only - the fetched UK SPC is the monthly injection and its retrieved posology contains no paediatric dosing, so do not transfer this to the depot.