BNF for Children 2011-2012

BNFC 2011–2012 2.12 Lipid-regulating drugs 129COLESTIPOL HYDROCHLORIDECautions see notes abovePregnancy see notes aboveBreast-feeding see notes aboveSide-effects see notes aboveLicensed use not licensed for use in childrenIndication and doseFamilial hypercholesterolaemia. By mouthChild 12–18 years initially 5 g 1–2 times dailyincreased if necessary in 5-g increments at intervalsof 1 month to max. of 30 g daily in 1–2 divideddosesAdministration the contents of each sachet should bemixed with at least 100 mL of water or other suitableliquid such as fruit juice or skimmed milk; alternativelyit can be mixed with thin soups, cereals,yoghurt, or pulpy fruits ensuring at least 100 mL ofliquid is provided; total daily dose may be given as asingle dose if toleratedColestid c (Pharmacia) AGranules, yellow, colestipol hydrochloride 5 g/sachet,net price 30 sachets = £15.05. Label: 13, counselling,avoid other drugs at same time (see notes above)Colestid Orange, granules, yellow/orange, colestipolhydrochloride 5 g/sachet, with aspartame, net price30 sachets = £15.05. Label: 13, counselling, avoidother drugs at same time (see notes above)EzetimibeEzetimibe inhibits the intestinal absorption of cholesterol.It is given in combination with a statin or alone if astatin is inappropriate. If ezetimibe is used in combinationwith a statin, there is an increased risk of rhabdomyolysis(see also Muscle Effects, p. 126)EZETIMIBECautions interactions: Appendix 1 (ezetimibe)Hepatic impairment avoid in moderate and severeimpairment—may accumulatePregnancy manufacturer advises use only if potentialbenefit outweighs risk—no information availableBreast-feeding manufacturer advises avoid—presentin milk in animal studiesSide-effects gastro-intestinal disturbances; headache,fatigue; myalgia; rarely arthralgia, hypersensitivityreactions (including rash, angioedema, and anaphylaxis),hepatitis; very rarely pancreatitis, cholelithiasis,cholecystitis, thrombocytopenia, raised creatinekinase, myopathy, and rhabdomyolysisIndication and doseAdjunct to dietary measures and statin treatmentin primary hypercholesterolaemia andhomozygous familial hypercholesterolaemia(ezetimibe alone in primary hypercholesterolaemiaif statin inappropriate or not tolerated);adjunct to dietary measures in homozygoussitosterolaemia. By mouthChild 10–18 years 10 mg once dailyEzetrol c (MSD, Schering-Plough) ATablets, ezetimibe 10 mg, net price 28-tab pack =£26.31FibratesBezafibrate and fenofibrate act mainly by decreasingserum triglycerides; they have variable effects on LDLcholesterol.Fibrates may reduce the risk of coronaryheart disease in those with low HDL-cholesterol or withraised triglycerides.Fibrates can cause a myositis-like syndrome, especiallyin children with impaired renal function. Also, combinationof a fibrate with a statin increases the risk of muscleeffects (especially rhabdomyolysis) and should be usedwith caution (see Muscle Effects, p. 126).There is limited evidence to support their use in childrenand they should only be considered if treatment with astatin and a bile acid sequestrant is unsuccessful orcontra-indicated.BEZAFIBRATECautions correct hypothyroidism before initiatingtreatment (see Hypothyroidism, p. 125); see underMyotoxicity below; interactions: Appendix 1(fibrates)Contra-indications hypoalbuminaemia, primarybiliary cirrhosis, gall bladder disease, nephroticsyndromeHepatic impairment avoid in severe liver diseaseRenal impairment reduce dose if estimated glomerularfiltration rate 15–60 mL/minute/1.73 m 2 ; avoidif estimated glomerular filtration rate less than 15 mL/minute/1.73 m 2Myotoxicity Special care needed in children with renaldisease, as progressive increases in serum-creatinine concentrationor failure to follow dosage guidelines may result inmyotoxicity (rhabdomyolysis); discontinue if myotoxicitysuspected or creatine kinase concentration increases significantlyPregnancy manufacturers advise avoid—embryotoxicityin animal studiesBreast-feeding manufacturer advises avoid—noinformation availableSide-effects gastro-intestinal disturbances, anorexia;less commonly cholestasis, weight gain, dizziness,headache, fatigue, drowsiness, renal impairment,raised serum creatinine (unrelated to renal impairment),erectile dysfunction, myotoxicity (with myastheniaor myalgia)—particular risk in renal impairment(see Cautions), urticaria, pruritus,photosensitivity reactions; very rarely gallstones,hypoglycaemia, anaemia, leucopenia, thrombocytopenia,increased platelet count, alopecia, Stevens-Johnson syndrome, and toxic epidermal necrolysisLicensed use not licensed for use in childrenIndication and doseHyperlipidaemia including familial hypercholesterolaemia(on specialist advice only). By mouthChild 10–18 years 200 mg once daily adjustedaccording to response to max. 200 mg 3 timesdaily2 Cardiovascular system