BNF for Children 2011-2012

128 2.12 Lipid-regulating drugs BNFC 2011–20122 Cardiovascular systemSIMVASTATINCautions see notes aboveHepatic impairment see notes aboveRenal impairment doses above 10 mg daily should beused with caution if estimated glomerular filtrationrate less than 30 mL/minute/1.73 m 2Pregnancy see notes aboveBreast-feeding see notes aboveSide-effects see notes above; also rarely anaemiaLicensed use not licensed for use in children under10 yearsIndication and doseHyperlipidaemia including familial hypercholesterolaemia. By mouthChild 5–10 years initially 10 mg at nightincreased, if necessary, at intervals of at least 4weeks to max. 20 mg at nightChild 10–18 years initially 10 mg at nightincreased, if necessary, at intervals of at least 4weeks to max. 40 mg at nightNote Reduced dose required with concomitant ciclosporin,danazol, fibrates (except fenofibrate), amiodarone,diltiazem, or verapamil—seek specialist adviceSimvastatin (Non-proprietary) TATablets, simvastatin 10 mg, net price 28-tab pack =90p; 20 mg, 28-tab pack = £1.01; 40 mg, 28-tab pack =£1.32; 80 mg, 28-tab pack = £2.29. Counselling,muscle effects, see notes aboveBrands include Simvador cOral suspension, simvastatin 20 mg/5 mL, net price150-mL = £99.50, 40 mg/5 mL, 150-mL = £152.00.Counselling, muscle effects, see notes aboveExcipients may include propylene glycolZocor c (MSD) TATablets, all f/c, simvastatin 10 mg (peach), net price28-tab pack = £18.03; 20 mg (tan), 28-tab pack =£29.69; 40 mg (red), 28-tab pack = £29.69; 80 mg (red),28-tab pack = £29.69. Counselling, muscle effects, seenotes aboveBile acid sequestrantsColestyramine (cholestyramine) and colestipol are bileacid sequestrants used in the management of hypercholesterolaemia.They act by binding bile acids, preventingtheir reabsorption; this promotes hepatic conversionof cholesterol into bile acids; the resultantincreased LDL-receptor activity of liver cells increasesthe clearance of LDL-cholesterol from the plasma. Thusboth compounds effectively reduce LDL-cholesterol butcan aggravate hypertriglyceridaemia. Bile acid sequestrantsare not well tolerated and compliance with treatmentis poor, therefore they are rarely used in children.Cautions Bile acid sequestrants interfere with theabsorption of fat-soluble vitamins; supplements of vitaminsA, D, K, and folic acid may be required whentreatment is prolonged and the child’s growth anddevelopment should be monitored. Interactions:Appendix 1 (bile acid sequestrants).Pregnancy and breast-feeding Bile acid sequestrantsshould be used with caution as although the drugsare not absorbed, they may cause fat-soluble vitamindeficiency on prolonged use.Side-effects As bile acid sequestrants are notabsorbed, gastro-intestinal side-effects predominate.Constipation is common, but diarrhoea has occurred,as have nausea, vomiting, and gastro-intestinal discomfort.Hypertriglyceridaemia may be aggravated. Anincreased bleeding tendency has been reported due tohypoprothrombinaemia associated with vitamin K deficiency.Counselling Other drugs should be taken at least 1hour before or 4–6 hours after bile acid sequestrants toreduce possible interference with absorption.COLESTYRAMINE(Cholestyramine)Cautions see notes aboveContra-indications complete biliary obstruction (notlikely to be effective)Pregnancy see notes aboveBreast-feeding see notes aboveSide-effects see notes above; intestinal obstructionreported rarely and hyperchloraemic acidosisreported on prolonged useLicensed use licensed in children over 6 years toreduce cholesterol; see also section 1.9.2Indication and doseFamilial hypercholesterolaemia. By mouthChild 6–12 years initially 4 g once daily increasedto 4 g up to 3 times daily according to responseChild 12–18 years initially 4 g once dailyincreased by 4 g at weekly intervals to 12–24 gdaily in 1–4 divided doses, then adjusted accordingto response; max. 36 g dailyCholestatic pruritus section 1.9.2Diarrhoea section 1.9.2Administration The contents of each sachet should bemixed with at least 150 mL of water or other suitableliquid such as fruit juice, skimmed milk, thin soups,and pulpy fruits with a high moisture content; totaldaily dose may be given as a single dose if toleratedColestyramine (Non-proprietary) APowder, sugar-free, colestyramine (anhydrous) 4 g/sachet, net price 50-sachet pack = £18.34. Label: 13,counselling, avoid other drugs at same time (see notesabove)Excipients may include aspartame (section 9.4.1)Questran c (Bristol-Myers Squibb) APowder, colestyramine (anhydrous) 4 g/sachet, netprice 50-sachet pack = £10.76. Label: 13, counselling,avoid other drugs at same time (see notes above)Excipients include sucrose 3.79 g/sachetQuestran Light c (Bristol-Myers Squibb) APowder, sugar-free, colestyramine (anhydrous) 4 g/sachet, net price 50-sachet pack = £16.15. Label: 13,counselling, avoid other drugs at same time (see notesabove)Excipients include aspartame (section 9.4.1)