BNF for Children 2011-2012

390 6.6.2 Bisphosphonates BNFC 2011–2012hypernatraemia; osteonecrosis of the jaw (seeMHRA/CHM advice, p. 389); isolated cases of seizures,hallucinations, thrombocytopenia, haematuria,acute renal failure, deterioration of renal disease,conjunctivitis and other ocular symptoms; atrialfibrillation, and reactivation of herpes simplex andzoster also reported; also local reactions at injectionsiteLicensed use not licensed for use in childrenIndication and doseSee notes above, specialist use onlyRisedronate Sodium (Non-proprietary) ATablets, risedronate sodium 5 mg, net price 28-tabpack = £17.99; 30 mg, 28-tab pack = £143.95; 35 mg,4-tab pack = £19.12. Counselling, administration,food, and calcium (see above)Actonel c (Warner Chilcott) ATablets, f/c, risedronate sodium 5 mg (yellow), netprice 28-tab pack = £17.99; 30 mg (white), 28-tab pack= £143.95. Counselling, administration, food, andcalcium (see above)6 Endocrine systemDisodium pamidronate (Non-proprietary) AConcentrate for intravenous infusion, disodiumpamidronate 3 mg/mL, net price 5-mL vial = £27.50,10-mL vial = £55.00; 6 mg/mL, 10-mL vial = £95.00;9 mg/mL, 10-mL vial = £165.00; 15 mg/mL, 1-mLvial = £29.83, 2-mL vial = £59.66, 4-mL vial = £119.32,6-mL vial £170.46Aredia Dry Powder c (Novartis) AInjection, powder for reconstitution, disodium pamidronate,for use as an infusion. Net price 15-mg vial =£29.83; 30-mg vial = £59.66; 90-mg vial = £170.45 (allwith diluent)RISEDRONATE SODIUMCautions oesophageal abnormalities and other factorswhich delay transit or emptying (e.g. stricture orachalasia—see also under Side-effects); correcthypocalcaemia before starting, correct other disturbancesof bone and mineral metabolism (e.g. Vitamin-D deficiency) at onset of treatment; consider dentalcheck-up before initiating bisphosphonate (risk ofosteonecrosis of the jaw, see MHRA/CHM advice,p. 389); interactions: Appendix 1 (bisphosphonates)Contra-indications hypocalcaemia (see Cautionsabove)Renal impairment avoid if estimated glomerular filtrationrate is less than 30 mL/minute/1.73 m 2Pregnancy avoidBreast-feeding avoidSide-effects abdominal pain, dyspepsia, nausea,diarrhoea, constipation, headache, musculoskeletalpain; less commonly oesophagitis, oesophageal ulcer,dysphagia, gastritis, duodenitis, uveitis; rarely glossitis,oesophageal stricture; also reported gastroduodenalulceration, hepatic disorders, Stevens-Johnsonsyndrome, toxic epidermal necrolysis, hair loss,cutaneous vasculitis, osteonecrosis of the jaw (seeMHRA/CHM advice, p. 389)Oesophageal reactions Children and their carers should beadvised to stop taking the tablets and seek medical attentionif they develop symptoms of oesophageal irritation such asdysphagia, pain on swallowing, retrosternal pain, or heartburnLicensed use not licensed for use in childrenIndication and doseSee notes above, specialist use onlyCounselling Swallow tablets whole with full glass of water;on rising, take on an empty stomach at least 30 minutesbefore first food or drink of the day or, if taking at any othertime of the day, avoid food and drink for at least 2 hoursbefore or after risedronate (particularly avoid calcium containingproducts e.g. milk; also avoid iron and mineralsupplements and antacids); stand or sit upright for at least 30minutes; do not take tablets at bedtime or before risingActonel Once a Week c (Warner Chilcott) ATablets, f/c, orange, risedronate sodium 35 mg, netprice 4-tab pack = £19.12. Counselling, administration,food and calcium (see above)SODIUM CLODRONATECautions monitor renal and hepatic function andwhite cell count; also monitor serum calcium andphosphate periodically; renal dysfunction reported inpatients receiving concomitant NSAIDs; maintainadequate fluid intake during treatment; considerdental check-up before initiating bisphosphonate (riskof osteonecrosis of the jaw, see MHRA/CHM advice,p. 389); interactions: Appendix 1 (bisphosphonates)Contra-indications acute gastro-intestinal inflammatoryconditionsRenal impairment use half normal dose if estimatedglomerular filtration rate 10–30 mL/minute/1.73 m 2 ;avoid if estimated glomerular filtration rate less than10 mL/minute/1.73 m 2Pregnancy avoidBreast-feeding no information availableSide-effects nausea, diarrhoea; skin reactions; bronchospasm;very rarely osteonecrosis of the jaw (seeMHRA/CHM advice, p. 389)Licensed use not licensed for use in childrenIndication and doseSee notes above, specialist use onlyCounselling Avoid food for 1 hour before and after oraltreatment, particularly calcium-containing products e.g.milk; also avoid iron and mineral supplements and antacids;maintain adequate fluid intakeBonefos c (Bayer Schering) ACapsules, yellow, sodium clodronate 400 mg. Netprice 120-cap pack = £139.83. Counselling, food andcalciumTablets, f/c, scored, sodium clodronate 800 mg. Netprice 60-tab pack = £146.43. Counselling, food andcalciumClasteon c (Beacon) ACapsules, blue/white, sodium clodronate 400 mg, netprice 30-cap pack = £34.96, 120-cap pack = £139.83.Counselling, food and calciumLoron c (Roche) ALoron 520 c tablets, f/c, scored, sodium clodronate520 mg, net price 60-tab pack = £152.59. Label: 10,patient information leaflet, counselling, food andcalcium