Dantrolene sodium

SCOPE - the acute malignant hyperthermia crisis is the only indication the UK intravenous SPC doses, and it is this Anaesthesia & ICU page's primary indication, so that alone is published. OUT OF SCOPE, DELIBERATELY NOT REPRODUCED: the US cross-check label in this bundle is a different product (oral dantrolene) for different indications - chronic spasticity, plus oral pre-operative and post-crisis malignant-hyperthermia cover. Its oral regimens are NOT quoted anywhere in this draft, because on a crisis page an oral milligram-per-kilogram-per-DAY figure sitting beside the 2.5 mg/kg per-BOLUS intravenous dose is a per-dose confusion hazard in a time-critical resuscitation. If the site wants the oral spasticity regimen, it belongs on a separate oral dantrolene entry sourced from an oral product label. VERBATIM §4.2: 'Treatment with Agilus should be started as soon as a malignant hyperthermia crisis is suspected.' 'Agilus should be administered rapidly by intravenous injection at an initial dose of 2.5 mg/kg body weight for adult and paediatric patients.' 'If a cumulative dose of 10 mg/kg or above is considered, the diagnosis of malignant hyperthermia should be re-examined.' - that cumulative figure is a prompt to re-examine the diagnosis, NOT a permitted ceiling, and is deliberately kept out of maxDose. RECRUDESCENCE, verbatim: 'It should be noted that the hypermetabolic features of malignant hyperthermia recur within the first 24 hours after initial resolution. If a recrudescence occurs, Agilus should be re-administered at a dose of 2.5 mg/kg every 10 minutes until the signs of malignant hyperthermia regress once more.' SPC TABLE 1, worked examples of the 2.5 mg/kg loading dose for both adults and children ('Total volume of one reconstituted vial is 22.6 mL'): 3 kg = 7.5 mg = 1.4 mL; 6 kg = 15 mg = 2.8 mL; 12 kg = 30 mg = 5.6 mL; 24 kg = 60 mg = 11.3 mL; 48 kg = 120 mg = 22.6 mL; 72 kg = 180 mg = 33.9 mL; 96 kg = 240 mg = 45.2 mL; 120 kg = 300 mg = 56.5 mL; 144 kg = 300 mg = 56.5 mL. Vials to prepare: 1 vial up to 48 kg, 2 vials from 49 kg to 96 kg, 3 vials from 97 kg. §4.4: 'The use of Agilus in the management of malignant hyperthermic crisis is not a substitute for other supportive measures. These must be individually continued in their various forms.' CORRECTIONS TO THE EXISTING PAGE - its 5-minute repeat interval is not in the source (the SPC says every 10 minutes), and its cumulative ceiling of 30 mg per kilogram appears nowhere in the fetched text; the only cumulative figure in the SPC is the 10 mg/kg diagnosis-re-examination trigger above.

Identical to the adult dose: §4.2 'an initial dose of 2.5 mg/kg body weight for adult and paediatric patients', and 'Paediatric population: No dose adjustment required.' 2.5 mg/kg is a genuine per-DOSE per-kilogram figure valid across the whole paediatric range, which is why dosePerKg is populated; the 300 mg ceiling sits in maxDose, not here. The SPC's own worked examples for the 2.5 mg/kg dose start at 3 kg: 3 kg = 7.5 mg = 1.4 mL; 6 kg = 15 mg = 2.8 mL; 12 kg = 30 mg = 5.6 mL; 24 kg = 60 mg = 11.3 mL; 48 kg = 120 mg = 22.6 mL. CONCENTRATION LEFT null DELIBERATELY: the bundle gives the vial strength (Agilus 120 mg) and the reconstituted volume ('Total volume of one reconstituted vial is 22.6 mL') but never states a milligrams-per-mL concentration for dantrolene itself, so none is asserted - use the SPC volume table above. WARNING: the only milligrams-per-mL figure anywhere in this bundle is '156.2 mg/mL in the reconstituted solution', which is the hydroxypropylbetadex EXCIPIENT, not dantrolene - it must never be used as a dantrolene concentration. §4.8: 'Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.' Verify the paediatric dose against a children's formulary before administration.