BNF for Children 2011-2012

130 2.14 Drugs affecting the ductus arteriosus BNFC 2011–20122 Cardiovascular systemBezafibrate (Non-proprietary) ATablets, bezafibrate 200 mg, net price 100-tab pack =£6.86. Label: 21Bezalip c (Actavis) ATablets, f/c, bezafibrate 200 mg, net price 100-tabpack = £8.63. Label: 21FENOFIBRATECautions see under Bezafibrate; liver function testsrecommended every 3 months for first year (discontinuetreatment if significantly raised)Contra-indications gall bladder disease; photosensitivityto ketoprofenHepatic impairment avoid in severe impairmentRenal impairment reduce dose if estimated glomerularfiltration rate less than 60 mL/minute/1.73 m 2 ;avoid if estimated glomerular filtration rate less than15 mL/minute/1.73 m 2Myotoxicity Special care needed in patients 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 manufacturer advises avoid—embryotoxicityin animal studiesBreast-feeding manufacturer advises avoid—noinformation availableSide-effects see under Bezafibrate; also very rarelyhepatitis, pancreatitis, and interstitial pneumopathiesLicensed use Lipantil c Micro 67 is licensed for usein children with hypercholesterolaemiaIndication and doseHyperlipidaemias including familial hypercholesterolaemia(on specialist advice only). By mouthChild 4–15 years 1 capsule/20 kg body-weightdailyChild 15–18 years initially 3 capsules daily individed doses; usual range 2–4 capsules dailyLipantil c (Abbott Healthcare) ALipantil c Micro 67 capsules, yellow, fenofibrate(micronised) 67 mg, net price 90-cap pack = £23.30.Label: 212.13 Local sclerosantsClassification not used in BNF for Children.2.14 Drugs affecting theductus arteriosusarteriosus may increase the risk of intraventricularhaemorrhage, necrotising enterocolitis, bronchopulmonarydysplasia, and possibly death.Indometacin or ibuprofen can be used to close theductus arteriosus. Indometacin has been used formany years and is effective but it reduces cerebralblood flow, and causes a transient fall in renal andgastro-intestinal blood flow. Ibuprofen may also beused; it has little effect on renal function (there maybe a small reduction in sodium excretion) when used indoses for closure of the ductus arteriosus; gastro-intestinalproblems are uncommon.If drug treatment fails to close the ductus arteriosus,surgery may be indicated.IBUPROFENCautions may mask symptoms of infection; monitorfor bleeding; monitor gastro-intestinal function; allergicdisorders; interactions: Appendix 1 (NSAIDs)Contra-indications life-threatening infection; activebleeding especially intracranial or gastro-intestinal;thrombocytopenia or coagulation defects; markedunconjugated hyperbilirubinaemia; known or suspectednecrotising enterocolitis; pulmonary hypertensionHepatic impairment increased risk of gastro-intestinalbleeding and fluid retention; avoid in severe liverdiseaseRenal impairment use lowest effective dose andmonitor renal function; sodium and water retention;deterioration in renal function possibly leading torenal failure; avoid if possible in severe impairmentSide-effects intestinal perforation; intraventricularhaemorrhage; ischaemic brain injury; bronchopulmonarydysplasia, pulmonary haemorrhage; thrombocytopenia,neutropenia, oliguria, haematuria, fluidretention, hyponatraemia; less commonly gastrointestinalhaemorrhage; hypoxaemiaLicensed use Orphan licence for the injection forclosure of ductus arteriosus in premature neonatesless than 34 weeks gestational ageIndication and doseClosure of ductus arteriosus. By slow intravenous injectionNeonate initially 10 mg/kg as a single dose followedat 24-hour intervals by 2 doses of 5 mg/kg;course may be repeated after 48 hours if necessaryMild to moderate pain, pain and inflammationof soft tissue injuries and rheumatic disease,pyrexia section 10.1.1Administration for slow intravenous injection, giveover 15 minutes, preferably undiluted. May be dilutedwith Glucose 5% or Sodium Chloride 0.9%Pedea c (Orphan Europe) AIntravenous solution, ibuprofen 5 mg/mL, net price4 2-mL vials = £288.00Closure of the ductus arteriosusPatent ductus arteriosus is a frequent problem in prematureneonates with respiratory distress syndrome.Substantial left-to-right shunting through the ductusINDOMETACINCautions see notes above; also may mask symptomsof infection; may reduce urine output by 50% or more(monitor carefully—see also under Anuria or Oliguria,below) and precipitate renal impairment especially ifextracellular volume depleted, heart failure, sepsis, or