BNF for Children 2011-2012

BNFC 2011–2012 2.5.5 Drugs affecting the renin-angiotensin system 103Liquid, various strengths available from ‘specialorder’manufacturers or specialist importing companies,see p. 809Innovace c (MSD) ATablets, enalapril maleate 2.5 mg, net price 28-tabpack = £5.35; 5 mg (scored), 28-tab pack = £7.51;10 mg (red), 28-tab pack = £10.53; 20 mg (peach), 28-tab pack = £12.51LISINOPRILCautions see notes aboveContra-indications see notes aboveRenal impairment see notes abovePregnancy see notes aboveBreast-feeding avoid—no information availableSide-effects see notes above; also less commonlytachycardia, palpitation, cerebrovascular accident,Raynaud’s syndrome, confusion, mood changes,vertigo, sleep disturbances, asthenia, impotence;rarely dry mouth, gynaecomastia, alopecia, psoriasis;very rarely allergic alveolitis, pulmonary infiltrates,profuse sweating, pemphigus, Stevens-Johnsonsyndrome, and toxic epidermal necrolysisLicensed use not licensed for use in childrenIndication and doseHypertension, proteinuria in nephritis (underspecialist supervision). By mouthChild 6–12 years initially 70 micrograms/kg(max. 5 mg) once daily, increased in intervals of 1–2 weeks to max. 600 micrograms/kg (or 40 mg)once dailyChild 12–18 years initially 5 mg once daily; usualmaintenance dose 10–20 mg once daily; max.80 mg once dailyDiabetic nephropathy (under specialist supervision). By mouthChild 12–18 years initially 5 mg once daily; usualmaintenance dose 10–20 mg once daily; max.80 mg once dailyHeart failure (adjunct) (under specialist supervision). By mouthChild 12–18 years initially 2.5 mg once daily;increased in steps no greater than 10 mg at intervalsof at least 2 weeks up to max. 35 mg oncedaily if toleratedLisinopril (Non-proprietary) ATablets, lisinopril (as dihydrate) 2.5 mg, net price 28-tab pack = 87p; 5 mg, 28-tab pack = 93p; 10 mg, 28-tab pack = £1.01; 20 mg, 28-tab pack = £1.19Liquid, various strengths available from ‘specialorder’manufacturers or specialist importing companies,see p. 809Zestril c (AstraZeneca) ATablets, lisinopril (as dihydrate) 2.5 mg, net price 28-tab pack = £1.78; 5 mg (pink), 28-tab pack = £1.31;10 mg (pink), 28-tab pack = £2.05; 20 mg (pink), 28-tab pack = £2.17Extemporaneous formulations available seeExtemporaneous Preparations, p. 62.5.5.2 Angiotensin-II receptorantagonistsLosartan and valsartan are specific angiotensin-IIreceptor antagonists with many properties similar tothose of the ACE inhibitors. However, unlike ACE inhibitors,they do not inhibit the breakdown of bradykininand other kinins, and thus are less likely to cause thepersistent dry cough which can complicate ACE inhibitortherapy. They are therefore a useful alternative forchildren who have to discontinue an ACE inhibitorbecause of persistent cough.Losartan or valsartan can be used as an alternative to anACE inhibitor in the management of hypertension.Cautions Angiotensin-II receptor antagonists shouldbe used with caution in renal artery stenosis (see alsoRenal Effects under ACE Inhibitors, section 2.5.5.1).Monitoring of plasma-potassium concentration isadvised, particularly in children with renal impairment.Angiotensin-II receptor antagonists should be used withcaution in aortic or mitral valve stenosis and in hypertrophiccardiomyopathy. They should be used withcaution in those with a history of angioedema. Childrenwith primary aldosteronism, and Afro-Caribbean children(particularly those with left ventricular hypertrophy),may not benefit from an angiotensin-II receptorantagonist. Interactions: Appendix 1 (angiotensin-IIreceptor antagonists).Pregnancy Angiotensin-II receptor antagonists shouldbe avoided in pregnancy, unless essential. They mayadversely affect fetal and neonatal blood pressure andrenal function; oligohydramnios and neonatal skulldefects have also been reported.Breast-feeding Information on the use of angiotensin-IIreceptor antagonists in breast-feeding patientsis limited, so they are not recommended in thesepatients. Alternative treatment options, with moreestablished safety information during breast-feeding,are available.Side-effects Side-effects of angiotensin-II receptorantagonists include symptomatic hypotension (includingdizziness), particularly in children with hyponatraemiaor intravascular volume depletion (e.g. thosetaking high-dose diuretics). Hyperkalaemia occurs occasionally;angioedema has also been reported (sometimeswith delayed onset).LOSARTAN POTASSIUMCautions see notes above; also severe heart failureHepatic impairment avoid—no information availableRenal impairment see notes above; also avoid ifestimated glomerular filtration rate less than 30 mL/minute/1.73m 2 —no information availablePregnancy see notes aboveBreast-feeding see notes aboveSide-effects see notes above; also malaise, anaemia;less commonly abdominal pain, constipation, diarr-2 Cardiovascular system