Droperidol

ELDERLY (over 65 years): 0.625 mg (0.25 ml). RENAL/HEPATIC IMPAIRMENT: 0.625 mg (0.25 ml). PCA INDICATION: adults 15 to 50 micrograms droperidol per mg of morphine, up to a maximum daily dose of 5 mg droperidol; no data are available in PCA for the elderly (over 65 years) or for renal and hepatic impairment; PCA is not indicated in children (2 to 11 years) or adolescents (12 to 18 years). The dosage should be adapted to each individual case, considering age, body weight, use of other medicinal products, type of anaesthesia and surgical procedure. MONITORING: continuous pulse oximetry should be performed in patients with identified or suspected risk of ventricular arrhythmia, and should continue for 30 minutes following single intravenous administration. §4.4 adds that patients at risk for cardiac arrhythmia should have serum electrolytes and creatinine levels assessed and the presence of QT prolongation excluded prior to administration, and that caution is needed with medicinal products likely to induce electrolyte imbalance (hypokalaemia and/or hypomagnesaemia). For instructions on dilution before administration, see SPC §6.6. PROVENANCE NOTE: the interactions listed come from the UK SPC §4.4 (which cross-references §4.5) plus the US label Drug Interactions section (openFDA), because no UK SPC §4.5 was present in the fetched bundle. The US label additionally states a different adult regimen (maximum recommended initial dose 2.5 mg IM or slow IV, with additional 1.25 mg doses) — the UK SPC PONV doses above are the ones used for this draft.

UNITS ARE MICROGRAMS PER KG, NOT MILLIGRAMS PER KG. dosePerKg is left null because the SPC states a RANGE rather than a single figure — use the quoted range. VERBATIM SPC §4.2 'Pediatric population' for prevention and treatment of post-operative nausea and vomiting: 'Children (2 to 11 years) and adolescents (12 to 18 years): 10 to 50 microgram/kg (up to a maximum of 1.25 mg). Children (below the age of 2 years): not recommended.' For prevention of nausea and vomiting induced by morphine derivatives during post-operative patient-controlled analgesia (PCA), the SPC states that children (2 to 11 years) and adolescents (12 to 18 years) are 'not indicated in PCA'. Continuous pulse oximetry should be performed in patients with identified or suspected risk of ventricular arrhythmia and should continue for 30 minutes following single intravenous administration. Verify all under-18 dosing against a children's formulary before administration.