Colistimethate Sodium (Inhaled)

The dosage can be adjusted depending on the severity of the condition and clinical response; relevant clinical guidance on treatment regimens, including duration of treatment, periodicity and co-administration of other antibacterial agents, should be adhered to. Paediatric dosing is stated in MIU rather than per kilogram: children aged 2 years and over receive the same dose as adults (1-2 MIU two to three times per day, maximum 6 MIU/day), and children under 2 years receive 0.5-1 MIU twice daily, maximum 2 MIU/day — verify against a children's formulary before prescribing. Older people: dose adjustment is not considered necessary. Hepatic impairment: dose adjustment is not considered necessary. Administration should be supervised by physicians with appropriate experience in its use. In the EU the dose of colistimethate sodium must be prescribed and administered only as International Units (IU) — confusion and medication errors have occurred because of different expressions of potency; the SPC's approximate conversion table gives 1,000,000 IU = approximately 34 mg colistimethate sodium = approximately 80 mg colistin base activity (12,500 IU = 0.4 mg = 1 mg CBA; 150,000 IU = 5 mg = 12 mg CBA; 4,500,000 IU = 150 mg = 360 mg CBA; 9,000,000 IU = 300 mg = 720 mg CBA), and these values must be considered nominal and approximate only. Nebulisation may induce coughing or bronchospasm: administer the first dose under medical supervision, pre-dose routinely with a bronchodilator, and evaluate FEV1 pre and post dosing. If other treatments are being taken they should be taken in the order recommended by the physician. Note: the openFDA record in this bundle is for intravenous/intramuscular colistimethate injection (Xellia) — a different route with a mg/kg colistin base activity dose — and has deliberately NOT been used for the dose fields here. Section 4.5 was not fetched; the interactions listed below come from section 4.4 of this SPC.