Lisdexamfetamine mesilate

PAGE IDENTITY MATCH: this page is the oral lisdexamfetamine page whose single named brand is Elvanse, category 'Amphetamine prodrug stimulant', route PO, filed under psychiatry (and paediatrics). The source recovered in this bundle is the UK SPC for 'Elvanse 20mg Hard Capsules' (eMC product 14091) — the page's own brand, the oral route, and §4.2 names the indication being treated ('Pharmacological treatment of ADHD may be needed for extended periods'). The previous hold reason ('no UK source exists') is therefore out of date and superseded. || VERBATIM §4.2 Posology, in full: 'Dosage should be individualised according to the therapeutic needs and response of the patient. Careful dose titration is necessary at the start of treatment with Elvanse. The starting dose is 30 mg taken once daily in the morning. When in the judgment of the clinician a lower initial dose is appropriate, patients may begin treatment with 20 mg once daily in the morning. The dose may be increased by 10 or 20 mg increments, at approximately weekly intervals. Elvanse should be administered orally at the lowest effective dosage. The maximum recommended dose is 70 mg/day; higher doses have not been studied. Treatment must be stopped if the 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.' || SPECIALIST INITIATION, verbatim: 'Treatment must be initiated under the supervision of an appropriate specialist in behavioural disorders.' || BEFORE PRESCRIBING, verbatim §4.2: 'Prior to prescribing, it is necessary to conduct a baseline evaluation of a patient's cardiovascular status including blood pressure and heart rate. A comprehensive history should document concomitant medications, past and present co-morbid medical and psychiatric disorders or symptoms, family history of sudden cardiac/unexplained death, and accurate recording of pre-treatment weight. For paediatric patients, height and weight should be recorded on a growth chart. Consistent with other stimulants, the potential for abuse, misuse or diversion of Elvanse should be considered prior to prescribing.' || LONG-TERM USE, verbatim: 'The physician who elects to use Elvanse for extended periods (over 12 months) should re-evaluate the usefulness of Elvanse at least yearly, and consider trial periods off medication to assess the patient's functioning without pharmacotherapy, preferably during times off from school or work.' || ELDERLY, verbatim: 'Data is limited in elderly patients; therefore, a thorough pre-treatment evaluation and ongoing monitoring of blood pressure and cardiovascular status is required. Dexamfetamine clearance is reduced in the elderly, therefore dose adjustment may be required.' || SCOPE CAVEAT: §4.1 (therapeutic indications) was not fetched in this bundle, so the licensed indication wording and the licensed age range of this particular presentation cannot be quoted here. The titration figures above are stated in §4.2 without an age qualifier, and §4.2's only age restriction is the under-6 bar recorded in paedDose. Confirm the licensed indication and age range against the product's own full SPC before prescribing. || CONTROLLED DRUG: prescribe, store and dispose of accordingly — §4.4 warns 'Stimulants including lisdexamfetamine dimesylate have a potential for abuse, misuse, dependence, or diversion for non-therapeutic uses' and 'The risk of misuse may be greater in adults (especially young adults) than in paediatric use.'

⚠️ dosePerKg IS DELIBERATELY NULL AND unit IS NULL — lisdexamfetamine is NOT weight-dosed in this SPC. §4.2 gives one fixed-milligram titration scheme and no mg/kg figure at any age, so there is no per-kilogram number to feed a weight calculator and none may be derived. || THE LABEL'S OWN PAEDIATRIC DOSING is the same scheme as for adults, quoted unaltered and not scaled: starting dose 30 mg once daily in the morning, or 20 mg once daily in the morning where the clinician judges a lower initial dose appropriate; increased by 10 or 20 mg increments at approximately weekly intervals; maximum recommended dose 70 mg/day. §4.2 states these figures without banding them by age. || AGE BAR, verbatim §4.2: 'Children under 6 years: Elvanse should not be used in children under the age of 6 years. Safety and efficacy in this age group has not been established. Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.' || PAEDIATRIC-SPECIFIC MONITORING, verbatim §4.2: 'Growth (paediatric patients), psychiatric, and cardiovascular status should be continually monitored'; 'Blood pressure and pulse should be recorded at each adjustment of dose and at least every six months. For paediatric patients this should be recorded on a centile chart'; 'For paediatric patients: height, weight, and appetite should be recorded at least six-monthly with maintenance of a growth chart'; and before prescribing, 'For paediatric patients, height and weight should be recorded on a growth chart.' || §4.4 CARDIAC WARNING FOR CHILDREN AND ADOLESCENTS, verbatim: 'Sudden death has been reported in children and adolescents taking CNS stimulants, including those with structural cardiac abnormalities or other serious heart problems. Although some serious heart problems alone carry an increased risk of sudden death, stimulant products generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.' || concentration is NULL because the source product is a hard CAPSULE, not a liquid; no volume can be calculated and the capsule must not be divided. || Verify against a children's formulary and current prescribing references before prescribing.