BNF for Children 2011-2012

BNFC 2011–2012 5.3.3 Viral hepatitis 325hypotension, anaphylactic reactions, psychosis, tremor,male infertility, haematuria, disturbances inhearing and vision, and alopeciaLicensed use not licensed for use in childrenIndication and doseLife-threatening or sight-threatening cytomegalovirusinfections in immunocompromisedpatients only; prevention of cytomegalovirusdisease duringimmunosuppressive therapy following organtransplantation. By intravenous infusionChild 1 month–18 years initially (induction)5 mg/kg every 12 hours for 14–21 days for treatmentor for 7–14 days for prevention; maintenance(for patients at risk of relapse of retinitis), 6 mg/kgdaily on 5 days per week or 5 mg/kg daily untiladequate recovery of immunity; if retinitis progressesinitial induction treatment may berepeatedCongenital cytomegalovirus infection of theCNS. By intravenous infusionNeonate 6 mg/kg every 12 hours for 6 weeksLocal treatment of CMV retinitis section 11.3.3Administration for intravenous infusion, reconstitutewith Water for Injections (500 mg/10 mL) then diluteto a concentration of not more than 10 mg/mL withGlucose 5% or Sodium Chloride 0.9% and give over 1hourCymevene c (Roche) AIntravenous infusion, powder for reconstitution,ganciclovir (as sodium salt). Net price 500-mg vial =£29.77Electrolytes Na + 2 mmol/500-mg vialCaution in handling Ganciclovir is toxic and personnelshould be adequately protected during handling andadministration; if solution comes into contact with skin ormucosa, wash off immediately with soap and waterFOSCARNET SODIUMCautions monitor electrolytes, particularly calciumand magnesium; monitor serum creatinine everysecond day during induction and every week duringmaintenance; ensure adequate hydration; avoid rapidinfusion; interactions: Appendix 1 (foscarnet)Renal impairment reduce dose; consult product literaturePregnancy avoidBreast-feeding avoid—present in milk in animalstudiesSide-effects nausea, vomiting, diarrhoea (occasionallyconstipation and dyspepsia), abdominal pain,anorexia; changes in blood pressure and ECG; headache,fatigue, mood disturbances (including psychosis),asthenia, paraesthesia, convulsions, tremor, dizziness,and other neurological disorders; rash;impairment of renal function including acute renalfailure; hypocalcaemia (sometimes symptomatic) andother electrolyte disturbances; abnormal liver functiontests; decreased haemoglobin concentration,leucopenia, granulocytopenia, thrombocytopenia;thrombophlebitis if given undiluted by peripheral vein;genital irritation and ulceration (due to high concentrationsexcreted in urine); isolated reports of pancreatitisLicensed use not licensed for use in childrenIndication and doseCMV disease. By intravenous infusionChild 1 month–18 years induction 60 mg/kgevery 8 hours for 2–3 weeks then maintenance60 mg/kg daily, increased to 90–120 mg/kg if tolerated;if disease progresses on maintenance dose,repeat induction regimenMucocutaneous herpes simplex infection. By intravenous infusionChild 1 month–18 years 40 mg/kg every 8 hoursfor 2–3 weeks or until lesions healAdministration for intravenous infusion, give undilutedsolution via a central venous catheter; alternativelydilute to a concentration of 12 mg/mL withGlucose 5% or Sodium Chloride 0.9% for administrationvia a peripheral vein; give over at least 1 hour(give doses greater than 60 mg/kg over 2 hours)Foscavir c (Clinigen) AIntravenous infusion, foscarnet sodium hexahydrate24 mg/mL, net price 250-mL bottle = £34.495.3.3 Viral hepatitisTreatment for viral hepatitis should be initiated by aspecialist in hepatology or infectious diseases. Themanagement of uncomplicated acute viral hepatitis islargely symptomatic. Hepatitis B and hepatitis C virusesare major causes of chronic hepatitis. For details onimmunisation against hepatitis A and B infections, seesection 14.4 (active immunisation) and section 14.5(passive immunisation).Chronic hepatitis B Interferon alfa (section 8.2.4),peginterferon alfa-2a, lamivudine (section 5.3.1), adefovirdipivoxil, entecavir, and tenofovir disoproxilhave a role in the treatment of chronic hepatitis B inadults, but their role in children has not been wellestablished. Specialist supervision is required for themanagement of chronic hepatitis B.Tenofovir, or a combination of tenofovir with eitheremtricitabine or lamivudine, may be used with otherantiretrovirals, as part of ‘highly active antiretroviraltherapy’ (section 5.3.1) in children who require treatmentfor both HIV and chronic hepatitis B. If childreninfected with both HIV and chronic hepatitis B onlyrequire treatment for chronic hepatitis B, they shouldreceive antivirals that are not active against HIV. Managementof these children should be co-ordinatedbetween HIV and hepatology specialists.Chronic hepatitis C Treatment should be consideredfor children with moderate or severe liver disease.Specialist supervision is required and the regimen ischosen according to the genotype of the infecting virus5 Infections