BNF for Children 2011-2012

152 3.3.2 Leukotriene receptor antagonists BNFC 2011–20123 Respiratory systemIndication and doseProphylaxis of asthma (but see notes above)Counselling Regular use is necessary. By aerosol inhalationChild 5–18 years 4 mg (2 puffs) 4 times daily,when control achieved may be possible to reduceto twice dailyAllergic conjunctivitis section 11.4.2Tilade c CFC-free inhaler (Sanofi-Aventis) TAAerosol inhalation, mint-flavoured, nedocromil sodium2 mg/metered inhalation. Net price 112-dose unit= £39.94. Label: 8, counselling, administration3.3.2 Leukotriene receptorantagonistsThe leukotriene receptor antagonists, montelukast andzafirlukast, block the effects of cysteinyl leukotrienes inthe airways; they can be used in children for the managementof chronic asthma with an inhaled corticosteroidor as an alternative if an inhaled corticosteroidcannot be used (see Management of Chronic Asthmatable, p. 135).Montelukast has not been shown to be more effectivethan a standard dose of inhaled corticosteroid, but thetwo drugs appear to have an additive effect. The leukotrienereceptor antagonists may be of benefit in exercise-inducedasthma and in those with concomitantrhinitis, but they are less effective in children withsevere asthma who are also receiving high doses ofother drugs.There is some limited evidence to support the intermittentuse of montelukast in children under 12 yearswith episodic wheeze associated with viral infections[unlicensed use]. Treatment is started at the onset ofeither asthma symptoms or of coryzal symptoms andcontinued for 7 days; there is no evidence to support thisuse in moderate or severe asthma.Churg-Strauss syndrome Churg-Strauss syndromehas occurred very rarely in association with the use ofleukotriene receptor antagonists; in many of thereported cases the reaction followed the reduction orwithdrawal of oral corticosteroid therapy. Prescribersshould be alert to the development of eosinophilia,vasculitic rash, worsening pulmonary symptoms, cardiaccomplications, or peripheral neuropathy.Pregnancy There is limited evidence for the safe useof leukotriene receptor antagonists during pregnancy;however, they can be taken as normal in females whohave shown a significant improvement in asthma notachievable with other drugs before becoming pregnant,see also p. 133.MONTELUKASTCautions interactions: Appendix 1 (leukotrienereceptor antagonists)Pregnancy manufacturer advises avoid unless essential;see also notes aboveBreast-feeding manufacturer advises avoid unlessessentialSide-effects abdominal pain, thirst; hyperkinesia (inyoung children), headache; very rarely Churg-Strausssyndrome (see notes above); dry mouth, diarrhoea,dyspepsia, nausea, vomiting, hepatic disorders, palpitation,oedema, increased bleeding, epistaxis, skinreactions, respiratory infections, depression, tremor,asthenia, dizziness, hallucinations, suicidal thoughtsand behaviour, paraesthesia, hypoaesthesia, sleepdisturbances, sleep walking, abnormal dreams, agitation,anxiety, aggression, seizures, pyrexia, arthralgia,and myalgia also reportedIndication and doseProphylaxis of asthma see notes above and Managementof Chronic Asthma table, p. 135. By mouthChild 6 months–6 years 4 mg once daily in theeveningChild 6–15 years 5 mg once daily in the eveningChild 15–18 years 10 mg once daily in the eveningSymptomatic relief of seasonal allergic rhinitisin children with asthma. By mouthChild 15–18 years 10 mg once daily in the eveningSingulair c (MSD) AChewable tablets, pink, cherry-flavoured, montelukast(as sodium salt) 4 mg, net price 28-tab pack =£25.69; 5 mg, 28-tab pack = £25.69. Label: 23, 24Excipients include aspartame equivalent to phenylalanine 674 micrograms/4-mgtablet and 842 micrograms/5-mg tablet (section 9.4.1)Granules, montelukast (as sodium salt) 4 mg, netprice 28-sachet pack = £25.69. Counselling, administrationCounselling Granules may be swallowed whole or mixedwith cold food (but not fluid) and taken immediatelyTablets, beige, f/c, montelukast (as sodium salt)10 mg, net price 28-tab pack = £26.97Note The Scottish Medicines Consortium has advised (June2007) that Singulair c chewable tablets and granules arerestricted for use as an alternative to low-dose inhaledcorticosteroids for children 2–14 years with mild persistentasthma who have not recently had serious asthma attacks thatrequired oral corticosteroid use, and who are not capable ofusing inhaled corticosteroids; Singulair c chewable tablets andgranules should be initiated by a specialist in paediatric asthmaZAFIRLUKASTCautions interactions: Appendix 1 (leukotrienereceptor antagonists)Hepatic disorders Children or their carers should be toldhow to recognise development of liver disorder and advisedto seek medical attention if symptoms or signs such aspersistent nausea, vomiting, malaise or jaundice developHepatic impairment manufacturer advises avoidRenal impairment manufacturer advises cautionPregnancy manufacturer advises use only if potentialbenefit outweighs risk; see also notes aboveBreast-feeding present in milk—manufactureradvises avoidSide-effects gastro-intestinal disturbances; headache;rarely bleeding disorders, hypersensitivity reactionsincluding angioedema and skin reactions, arthralgia,myalgia, hepatitis, hyperbilirubinaemia, thrombocytopenia;very rarely Churg-Strauss syndrome (seenotes above), agranulocytosis