Lisdexamfetamine

Source: UK SPC (eMC) for Elvanse 20mg Hard Capsules, §4.2 (https://www.medicines.org.uk/emc/product/14091/smpc). SCOPE NOTE: the §4.2 posology of this SPC gives a single titration schedule and does not state separate adult and paediatric doses; the only age statement is that Elvanse should not be used in children under 6 years (safety and efficacy not established, and no recommendation on a posology can be made for that age group). §4.1 (therapeutic indications) was not retrieved in this bundle — confirm the licensed population of the specific Elvanse product before applying this regimen to adults. INITIATION: treatment must be initiated under the supervision of an appropriate specialist in behavioural disorders. Dosage should be individualised according to therapeutic needs and response; careful dose titration is necessary at the start of treatment. Treatment must be stopped if symptoms do not improve after appropriate dosage adjustment over a 1-month period; if paradoxical aggravation of symptoms or other intolerable adverse events occur, the dosage should be reduced or discontinued. PRE-TREATMENT EVALUATION: baseline evaluation of cardiovascular status including blood pressure and heart rate; comprehensive history documenting concomitant medications, past and present co-morbid medical and psychiatric disorders or symptoms, family history of sudden cardiac/unexplained death, and accurate pre-treatment weight; for paediatric patients record height and weight on a growth chart. Consider the potential for abuse, misuse or diversion before prescribing. ONGOING MONITORING: blood pressure and pulse at each dose adjustment and at least every six months (on a centile chart for paediatric patients); paediatric height, weight and appetite at least six-monthly with a growth chart; weight recorded regularly in adults; monitor for de novo or worsening psychiatric disorders at every dose adjustment, then at least every six months and at every visit; monitor for diversion, misuse and abuse. METHOD OF ADMINISTRATION: with or without food; swallowed whole, or the capsule opened and the entire contents emptied and mixed with a soft food such as yogurt, or in a glass of water or orange juice, stirred until completely dispersed and consumed immediately (not stored). The patient should not take less than one capsule per day and a single capsule should not be divided. If a dose is missed, dosing can resume the next day. LONG-TERM USE: a physician electing to use Elvanse for over 12 months should re-evaluate its usefulness at least yearly and consider trial periods off medication, preferably during times off from school or work. ELDERLY: data are limited; thorough pre-treatment evaluation and ongoing monitoring of blood pressure and cardiovascular status required; dexamfetamine clearance is reduced in the elderly, so dose adjustment may be required. HEPATIC IMPAIRMENT: no studies have been conducted. §4.4 and §4.8 were truncated at the source-fetch limit and §4.5 was not retrieved — verify the complete interactions section (the interactions listed below are from §4.3 of the UK SPC and the US label's drug-interaction summary, as marked).