BNF for Children 2011-2012

294 5.1.9 Antituberculosis drugs BNFC 2011–20125 InfectionsContra-indications acute porphyria (section 9.8.2)Hepatic impairment monitor hepatic function—idiosyncratichepatotoxicity more common; avoid insevere hepatic impairment; see also Hepatic DisordersabovePregnancy manufacturer advises use only if potentialbenefit outweighs risk; see also notes aboveBreast-feeding amount too small to be harmful; seealso p. 291Side-effects hepatotoxicity including fever, anorexia,hepatomegaly, splenomegaly, jaundice, liver failure;nausea, vomiting, dysuria, arthralgia, sideroblasticanaemia, thrombocytopenia, rash and occasionallyphotosensitivityLicensed use not licensedIndication and doseTuberculosis in combination with other drugssee notes abovePyrazinamide (Non-proprietary) ATablets, scored, pyrazinamide 500 mg. Label: 8Available from ‘special-order’ manufacturers or specialistimporting companies, see p. 809Extemporaneous formulations available seeExtemporaneous Preparations, p. 6RIFABUTINCautions see under Rifampicin; acute porphyria (section9.8.2)Hepatic impairment reduce dose in severe impairmentRenal impairment use half normal dose if estimatedglomerular filtration rate less than 30 mL/minute/1.73 m 2Pregnancy manufacturer advises avoid—no informationavailableBreast-feeding manufacturer advises avoid—noinformation availableSide-effects nausea, vomiting; leucopenia, thrombocytopenia,anaemia, rarely haemolysis; raised liverenzymes, jaundice, rarely hepatitis; uveitis followinghigh doses or administration with drugs which raiseplasma concentration—see also interactions:Appendix 1 (rifamycins); arthralgia, myalgia, influenza-likesyndrome, dyspnoea; also hypersensitivityreactions including fever, rash, eosinophilia, bronchospasm,shock; skin, urine, saliva and other bodysecretions coloured orange-red; asymptomaticcorneal opacities reported with long-term useLicensed use not licensed for use in childrenIndication and doseProphylaxis of Mycobacterium avium complexinfections in immunosuppressed patients withlow CD4 count (see product literature) Also seenotes above. By mouthChild 1–12 years 5 mg/kg (max. 300 mg) oncedailyChild 12–18 years 300 mg once dailyTreatment of non-tuberculous mycobacterialdisease, in combination with other drugs. By mouthChild 1month–12 years 5 mg/kg once daily forup to 6 months after cultures negativeChild 12–18 years 450–600 mg once daily for upto 6 months after cultures negativeTreatment of pulmonary tuberculosis, in combinationwith other drugs. By mouthChild 12–18years 150–450 mg once daily for atleast 6 monthsMycobutin c (Pharmacia) ACapsules, red-brown, rifabutin 150 mg. Net price 30-cap pack = £90.38. Label: 8, 14, counselling, lenses,see under RifampicinExtemporaneous formulations available seeExtemporaneous Preparations, p. 6RIFAMPICINCautions see Monitoring in notes above; also liverfunction tests and blood counts in hepatic disorders,and on prolonged therapy, see also below; acuteporphyria (section 9.8.2); important: effectiveness ofhormonal contraceptives is reduced and alternativefamily planning advice should be offered (see alsosection 7.3.1); discolours soft contact lenses; see alsonotes above; interactions: Appendix 1 (rifamycins)Note If treatment interrupted re-introduce with low dosageand increase gradually; discontinue permanently if seriousside-effects developHepatic disorders Children and their carers should be toldhow to recognise signs of liver disorder, and advised todiscontinue treatment and seek immediate medical attentionif symptoms such as persistent nausea, vomiting, malaise orjaundice developContra-indications jaundiceHepatic impairment impaired elimination; monitorliver function; avoid or do not exceed 8 mg/kg daily;see also Cautions aboveRenal impairment use with caution if dose above10 mg/kg dailyPregnancy manufacturers advise very high doses teratogenicin animal studies in first trimester; risk ofneonatal bleeding may be increased in third trimester;see also notes aboveBreast-feeding amount too small to be harmful; seealso p. 291Side-effects gastro-intestinal symptoms includinganorexia, nausea, vomiting, diarrhoea (antibioticassociatedcolitis reported); headache, drowsiness;those occurring mainly on intermittent therapyinclude influenza-like symptoms (with chills, fever,dizziness, bone pain), respiratory symptoms (includingshortness of breath), collapse and shock, haemolyticanaemia, disseminated intravascular coagulationand acute renal failure, thrombocytopenic purpura;alterations of liver function, jaundice; flushing, urticaria,and rashes; other side-effects reported includeoedema, psychoses, adrenal insufficiency, muscularweakness and myopathy, exfoliative dermatitis, toxicepidermal necrolysis, Stevens-Johnson syndrome,pemphigoid reactions, leucopenia, eosinophilia,menstrual disturbances; urine, saliva, and other body