BNF for Children 2011-2012

288 5.1.7 Some other antibacterials BNFC 2011–20125 InfectionsLicensed use not licensed for use in childrenIndication and dosePneumonia, complicated skin and soft-tissueinfections caused by Gram-positive bacteria(initiated under expert supervision). By mouth or by intravenous infusion over 30–120 minutesNeonate under 7 days 10 mg/kg every 12 hours,increase to every 8 hours if poor responseNeonate over 7 days 10 mg/kg every 8 hoursChild 1 month–12 years 10 mg/kg (max. 600 mg)every 8 hoursChild 12–18 years 600 mg every 12 hoursZyvox c (Pharmacia) TATablets, f/c, linezolid 600 mg, net price 10-tab pack =£445.00. Label: 9, 10, patient information leafletSuspension, yellow, linezolid 100 mg/5 mL whenreconstituted with water, net price 150 mL (orangeflavoured)= £222.50. Label: 9, 10 patient informationleafletExcipients include aspartame 20 mg/5 mL (section 9.4.1)Intravenous infusion, linezolid 2 mg/mL, net price300-mL Excel c bag = £44.50Excipients include Na + 5 mmol/300-mL bag, glucose 13.71 g/300-mLbagPolymyxinsThe polymyxin antibiotic, colistimethate sodium (colistinsulphomethate sodium), is active against Gramnegativeorganisms including Pseudomonas aeruginosa,Acinetobacter baumanii, and Klebsiella pneumoniae.It is not absorbed by mouth and is given byinjection for a systemic effect. Intravenous administrationof colistimethate sodium should be reserved forGram-negative infections resistant to other antibacterials;its major adverse effects are dose-related neurotoxicityand nephrotoxicity.Colistimethate sodium is also given by inhalation of anebulised solution as an adjunct to standard antibacterialtherapy in patients with cystic fibrosis.Both colistimethate sodium and polymyxin B areincluded in some preparations for topical application.COLISTIMETHATE SODIUM(Colistin sulphomethate sodium)Cautions acute porphyria (section 9.8.2); risk of bronchospasmon inhalation—may be prevented or treatedwith a selective beta 2 agonist; interactions:Appendix 1 (polymyxins)Contra-indications myasthenia gravisRenal impairment monitor plasma-colistimethatesodium concentration; reduce dose during parenteraltreatment–consult product literaturePregnancy avoid—possible risk of fetal toxicity especiallyin second and third trimestersBreast-feeding present in milk but poorly absorbedfrom gut; manufacturers advise avoid (or use only ifpotential benefit outweighs risk)Side-effectsSpecific side-effects for parenteral treatment neurotoxicityreported especially with excessive doses (includingapnoea, perioral and peripheral paraesthesia, vertigo, headache,muscle weakness; rarely vasomotor instability, slurredspeech, confusion, psychosis, visual disturbances), nephrotoxicity;rashSpecific side-effects for inhaled treatment sore throat,sore mouth, cough, bronchospasmPharmacokinetics see notes above; plasma concentrationmonitoring required in renal impairment;recommended ‘peak’ plasma-colistimethate sodiumconcentration (approx. 30 minutes after intravenousinjection or infusion) 10–15 mg/litre (125–200 units/mL)Indication and dosePseudomonas aeruginosa infection in cysticfibrosis. By slow intravenous injection into a totallyimplantable venous access device, or by intravenousinfusion (but see notes above)Child 1 month–18 yearsBody-weight under 60 kg 25 000 units/kg every8 hoursBody-weight over 60 kg 2 million units every 8hours. By inhalation of nebulised solutionChild 1 month–2 years 0.5–1 million units twicedaily; increased to 1 million units 3 times daily forsubsequent respiratory isolates of Ps. aeruginosaChild 2–18 years 1–2 million units twice daily;increased to 2 million units 3 times daily for subsequentrespiratory isolates of Ps. aeruginosaAdministration For intravenous infusion, dilute to aconcentration of 40 000 units/mL with SodiumChloride 0.9%; give over 30 minutesFor slow intravenous injection into a totally implantablevenous access device, dilute to a concentrationof 90 000 units/mL with Sodium Chloride 0.9% forchild under 12 years (200 000 units/mL for child over12 years)For nebulisation administer required dose in 2–4 mLof sodium chloride 0.9% (or water for injections).Colistimethate sodium must not be mixed withtobramycin as they are chemically unstable together;it may be mixed with gentamicin if used immediatelyColistimethate sodium (Non-proprietary) AInjection, powder for reconstitution, colistimethatesodium, net price 1 million-unit vial = £1.68Colomycin c (Forest) AInjection, powder for reconstitution, colistimethatesodium, net price 1 million-unit vial = £1.68; 2 millionunitvial = £3.09Electrolytes (before reconstitution) Na + < 0.5 mmol/1 million-unit and 2million-unit vialNote Colomycin c Injection (dissolved in physiologicalsaline) may be used for nebulisationPromixin c (Profile) APowder for nebuliser solution, colistimethate sodium,net price 1 million-unit vial = £4.60.Injection, powder for reconstitution, colistimethatesodium, net price 1 million unit-vial = £2.30Electrolytes (before reconstitution) Na + < 0.5 mmol/1 million-unit vial