Midazolam (Paediatric)

PAEDIATRIC DOSING IS RECORDED IN THE paedDose FIELD AND MUST BE VERIFIED AGAINST A CHILDREN'S FORMULARY. Midazolam is a potent sedative agent that requires slow administration and titration; it should be administered only by experienced physicians in a setting fully equipped for the monitoring and support of respiratory and cardiovascular function, or by persons specifically trained in the recognition and management of adverse reactions including respiratory and cardiac resuscitation. Severe cardiorespiratory adverse reactions have been reported including respiratory depression, apnoea, respiratory arrest and/or cardiac arrest, and are more likely when the injection is given too rapidly or a high dosage is administered. OTHER ADULT INDICATIONS (section 4.2): anaesthesia premedication, adults under 60 years - 1 to 2 mg IV repeated as necessary, or 0.07 to 0.1 mg/kg IM; adults 60 years and over, debilitated or chronically ill - initial 0.5 mg IV slowly increased as needed, or 0.025 to 0.05 mg/kg IM; with concomitant narcotics the midazolam dosage should be reduced and the usual dosage is 2 to 3 mg. Anaesthesia induction, premedicated adults under 60 years - 0.15 to 0.2 mg/kg IV; non-premedicated adults under 60 years - 0.3 to 0.35 mg/kg IV, with additional doses of approximately 25 percent of the initial dose if full induction is sought, and in refractory cases a total dosage of up to 0.6 mg/kg may be used but may prolong recovery; premedicated adults over 60 years, debilitated or chronically ill - 0.05 to 0.15 mg/kg IV over 20 to 30 seconds; non-premedicated adults over 60 years - initial 0.15 to 0.3 mg/kg; non-premedicated debilitated patients or patients with severe systemic disease - initial 0.15 to 0.25 mg/kg generally sufficient. Each induction increment of not more than 5 mg should be injected over 20 to 30 seconds with 2-minute intervals between doses. Sedative component in combined anaesthesia, adults - intermittent IV doses of 0.03 to 0.1 mg/kg or continuous infusion of 0.03 to 0.1 mg/kg/h, typically with analgesics. Sedation in the intensive care unit, adults - IV loading dose 0.03 to 0.3 mg/kg administered slowly in increments, each 1 to 2.5 mg dose over 20 to 30 seconds with 2-minute intervals; IV maintenance dose 0.03 to 0.2 mg/kg/h; reduce or omit the loading dose and reduce the maintenance dose in hypovolaemia, vasoconstriction or hypothermia; if strong analgesics are co-administered they should be given first. HEPATIC IMPAIRMENT: hepatic impairment reduces clearance with increased terminal half-life, which may lead to a stronger and prolonged clinical effect - the required dose may be reduced and vital signs should be properly monitored. SOURCE COMPLETENESS: eMC section 4.5 (interactions) was NOT captured in this bundle, and sections 4.4 and 4.8 were truncated at the source-fetch limit.

dosePerKg is left null because the SPC gives DIFFERENT per-kg figures for different indications, routes and age bands - a single number would be unsafe. VERBATIM SPC section 4.2 PAEDIATRIC REGIMENS. Conscious sedation, intravenous: 'Children under 6 months of age: children under 6 months of age are especially predisposed to develop airway obstruction and hypoventilation. Therefore, conscious sedation is not recommended in children under 6 months of age.' 'Patients 6 months to 5 years of age: the initial dose is 0.05 to 0.1 mg/kg. To reach the desired effect, it may be necessary to administer a dose up to 0.6 mg/kg. However, the total dosage should not exceed 6 mg.' 'Children 6 to 12 years of age: the initial dose is 0.025 to 0.05 mg/kg. It may be necessary to administer a total dosage of 0.4 mg/kg (10 mg as the maximum dosage).' 'Children 12 to 16 years of age: use the recommended dosages for adults.' For infants and children under 5 years of age, significantly higher doses may be required (mg/kg) compared with older children and adolescents. Conscious sedation, RECTAL: 'the total dosage of midazolam is usually 0.3 to 0.5 mg/kg', administered at once by plastic applicator; if the volume is too small, water may be added to a total volume of 10 ml; avoid repeated rectal administration; not recommended in children under 6 months due to limited data. Conscious sedation, INTRAMUSCULAR: 'doses range from 0.05 to 0.15 mg/kg'; the IM route should only be used in exceptional cases as it is painful, and rectal administration should be preferred. ANAESTHESIA PREMEDICATION, children over 6 months: rectal 0.3 to 0.5 mg/kg administered 15 to 30 minutes before induction of anaesthesia; intramuscular 'the proven and safe dosage range for intramuscular administration is 0.08 to 0.2 mg/kg'; children 1 to 15 years of age require proportionally higher dosages per body weight than adults; not recommended in neonates and children up to 6 months of age due to limited data. SEDATION IN THE INTENSIVE CARE UNIT: 'Neonates and children up to 6 months of age: Midazolam is administered as an intravenous continuous infusion. The initial dose for neonates born before 32 weeks of gestation is 0.03 mg/kg/h (0.5 micrograms/kg/min), and in neonates born after 32 weeks of gestation as well as children up to 6 months of age 0.06 mg/kg/h (1 microgram/kg/min). Intravenous loading doses are not recommended in preterm infants, neonates and children up to 6 months of age; rather the infusion rate should be higher during the first hours to reach therapeutic concentrations.' 'Children over 6 months of age: Intubated and ventilated children should be administered a loading dose of 0.05 to 0.2 mg/kg IV, slowly over 2 to 3 minutes... Following the loading dose, midazolam is administered as continuous infusion at a rate of 0.06 to 0.12 mg/kg/h (1 to 2 micrograms/kg/min). As necessary, the infusion rate can be increased or reduced (generally, 25% of the initial or following infusion rate).' Midazolam should not be administered as a rapid intravenous injection. In haemodynamically unstable patients the usual loading dose should be titrated with low doses and the patient monitored for hypotension; these patients are more sensitive to midazolam's depressive effect on respiration and careful monitoring of respiratory rate and oxygen saturation is required. The infusion rate should be frequently and carefully re-evaluated to select the lowest possible effective dose and to prevent accumulation, especially over the first 24 hours. Paediatric patients, especially those with cardiovascular instability, are listed in section 4.4 as high-risk patients requiring lower doses and continuous monitoring. Paradoxical reactions have been reported among children in particular, and convulsions have been reported in premature infants and neonates. This SPC gives NO regimen for status epilepticus or seizure termination and no buccal/oromucosal regimen - source those separately. Verify against a children's formulary before use.