BNF for Children 2011-2012

BNFC 2011–2012 10.1.1 Non-steroidal anti-inflammatory drugs 501Hepatic impairment NSAIDs should be used withcaution in children with hepatic impairment; there is anincreased risk of gastro-intestinal bleeding and fluidretention. NSAIDs should be avoided in severe liverdisease; see also individual drugs.Renal impairment NSAIDs should be avoided ifpossible or used with caution in children with renalimpairment; the lowest effective dose should be usedfor the shortest possible duration, and renal functionshould be monitored. Sodium and water retention mayoccur and renal function may deteriorate, possibly leadingto renal failure; deterioration in renal function hasalso been reported after topical use; see also individualdrugs.Pregnancy Most manufacturers advise avoidingNSAIDs during pregnancy or avoiding them unless thepotential benefit outweighs risk. NSAIDs should beavoided during the third trimester because use is associatedwith a risk of closure of fetal ductus arteriosus inutero and possibly persistent pulmonary hypertensionof the newborn. In addition, the onset of labour may bedelayed and the duration may be increased.Breast-feeding NSAIDs should be used with cautionduring breast-feeding; see also individual drugs.Side-effects The side-effects of NSAIDs vary inseverity and frequency. Gastro-intestinal disturbancesincluding discomfort, nausea, diarrhoea, and occasionallybleeding and ulceration may occur (see also notesbelow and Cautions above).Gastro-intestinal side-effectsAll NSAIDs are associated with gastro-intestinaltoxicity. In adults, evidence on the relative safetyof NSAIDs indicates differences in the risks of seriousupper gastro-intestinal side-effects. Ibuprofenis associated with the lowest risk; piroxicam, indometacin,naproxen, and diclofenac are associatedwith intermediate risks (possibly higher in the caseof piroxicam, see also CHMP advice, p. 505). Selectiveinhibitors of cyclo-oxygenase-2 are associatedwith a lower risk of serious upper gastro-intestinalside-effects than non-selective NSAIDs.Children appear to tolerate NSAIDs better thanadults and gastro-intestinal side-effects are less common;use of gastro-protective drugs may not benecessary (see also section 1.3).Other side-effects include hypersensitivity reactions(particularly rashes, angioedema, and bronchospasm),headache, dizziness, nervousness, depression, drowsiness,insomnia, vertigo, hearing disturbances such astinnitus, photosensitivity, and haematuria. Blood disordershave also occurred. Fluid retention may occur(rarely precipitating congestive heart failure); bloodpressure may be raised.AsthmaAll NSAIDs have the potential to worsen asthma,either acutely or as a gradual worsening of symptoms;consider both prescribed NSAIDs and thosethat are purchased over the counter.Renal failure may be provoked by NSAIDs, especially inpatients with pre-existing renal impairment (important,see Renal impairment above). Rarely, papillary necrosisor interstitial fibrosis associated with NSAIDs can leadto renal failure. Hepatic damage, alveolitis, pulmonaryeosinophilia, pancreatitis, visual disturbances, Stevens-Johnson syndrome, and toxic epidermal necrolysis areother rare side-effects. Induction of or exacerbation ofcolitis or Crohn’s disease has been reported. Asepticmeningitis has been reported rarely with NSAIDs—children with connective tissue disorders such as systemiclupus erythematosus may be especially susceptible.Overdosage: see Emergency Treatment of Poisoning,p. 26.DICLOFENAC POTASSIUMCautions see notes above; avoid in acute porphyria(section 9.8.2)Contra-indications see notes aboveHepatic impairment see notes aboveRenal impairment avoid in severe impairment; seealso notes abovePregnancy see notes aboveBreast-feeding amount in milk too small to beharmful; see also notes aboveSide-effects see notes aboveIndication and doseRheumatic disease, musculoskeletal disorders,postoperative pain. By mouthChild 14–18 years 75–100 mg daily in 2–3divided dosesDiclofenac Potassium (Non-proprietary) ATablets, diclofenac potassium 25 mg, net price 28-tabpack = 81p; 50 mg, 28-tab pack = £1.55. Label: 211Voltarol c Rapid (Novartis) ATablets, s/c, diclofenac potassium 25 mg (red), netprice 30-tab pack = £3.46; 50 mg (brown), 30-tab pack= £6.62. Label: 211. 12.5 mg tablets can be sold to the public for the treatment ofheadache, dental pain, period pain, rheumatic and muscularpain, backache and the symptoms of cold and flu (includingfever), in patients aged over 14 years subject to max. singledose of 25 mg, max. daily dose of 75 mg for max. 3 days, andmax. pack size of 18 12.5 mgDICLOFENAC SODIUMCautions see notes above; avoid in acute porphyria(section 9.8.2)Contra-indications see notes above; avoid injectionscontaining benzyl alcohol in neonates (see preparationsbelow)Intravenous use Additional contra-indications includeconcomitant NSAID or anticoagulant use (including lowdoseheparins), history of haemorrhagic diathesis, history ofconfirmed or suspected cerebrovascular bleeding, operationswith high risk of haemorrhage, history of asthma,moderate or severe renal impairment, hypovolaemia, dehydrationHepatic impairment see notes aboveRenal impairment avoid in severe impairment; seealso Intravenous Use and notes abovePregnancy see notes aboveBreast-feeding amount in milk too small to beharmful; see also notes above10 Musculoskeletal and joint diseases