lBREAST FEEDINGManufacturer advises avoid unless
essential.
lDIRECTIONS FOR ADMINISTRATIONGranules may be
swallowed or mixed with cold, soft food (not liquid) and
taken immediately.
lPRESCRIBING AND DISPENSING INFORMATIONFlavours of
chewable tablet formulations may include cherry.
lPATIENT AND CARER ADVICEPatients or carers should be
given advice on how to administer montelukast granules.
Medicines for Children leaflet: Montelukast for
asthmawww.medicinesforchildren.org.uk/montelukast-for-
asthma
lNATIONAL FUNDING/ACCESS DECISIONS
SINGULAIR®GRANULES
Scottish Medicines Consortium (SMC) Decisions
TheScottish Medicines Consortiumhas advised (June 2007 )
thatSingulair®granules are restricted for use as an
alternative to low-dose inhaled corticosteroids for children
2 – 14 years with mild persistent asthma who have not
recently had serious asthma attacks that required oral
corticosteroid use and who are not capable of using
inhaled corticosteroids;Singulair®granules should be
initiated by a specialist in paediatric asthma.
SINGULAIR®CHEWABLE TABLETS
Scottish Medicines Consortium (SMC) Decisions
TheScottish Medicines Consortiumhas advised (June 2007 )
thatSingulair®chewable tablets are restricted for use as an
alternative to low-dose inhaled corticosteroids for children
2 – 14 years with mild persistent asthma who have not
recently had serious asthma attacks that required oral
corticosteroid use and who are not capable of using
inhaled corticosteroids;Singulair®chewable tablets
should be initiated by a specialist in paediatric asthma.lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Granules
▶Montelukast (Non-proprietary)
Montelukast (as Montelukast sodium) 4 mgMontelukast 4 mg
granules sachets sugar free sugar-free| 28 sachetP£ 4. 85 –
£ 19. 99 DT = £ 4. 85
▶Singulair(Merck Sharp & Dohme Ltd)
Montelukast (as Montelukast sodium) 4 mgSingulair Paediatric
4 mg granules sachets sugar-free| 28 sachetP£ 25. 69 DT = £ 4. 85
Tablet
▶Montelukast (Non-proprietary)
Montelukast (as Montelukast sodium) 10 mgMontelukast 10 mg
tablets| 28 tabletP£ 26. 97 DT = £ 1. 10
▶Singulair(Merck Sharp & Dohme Ltd)
Montelukast (as Montelukast sodium) 10 mgSingulair 10 mg
tablets| 28 tabletP£ 26. 97 DT = £ 1. 10
Chewable tablet
CAUTIONARY AND ADVISORY LABELS23, 24
EXCIPIENTS:May contain Aspartame
▶Montelukast (Non-proprietary)
Montelukast (as Montelukast sodium) 4 mgMontelukast 4 mg
chewable tablets sugar free sugar-free| 28 tabletP£ 25. 69 DT =
£ 0. 89
Montelukast (as Montelukast sodium) 5 mgMontelukast 5 mg
chewable tablets sugar free sugar-free| 28 tabletP£ 25. 69 DT =
£ 1. 06
▶Singulair(Merck Sharp & Dohme Ltd)
Montelukast (as Montelukast sodium) 4 mgSingulair Paediatric
4 mg chewable tablets sugar-free| 28 tabletP£ 25. 69 DT = £ 0. 89
Montelukast (as Montelukast sodium) 5 mgSingulair Paediatric
5 mg chewable tablets sugar-free| 28 tabletP£ 25. 69 DT = £ 1. 06Zafirlukast
lINDICATIONS AND DOSE
Prophylaxis of asthma
▶BY MOUTH
▶Child 12–17 years: 20 mg twice dailylSIDE-EFFECTS
▶Common or very commonAbdominal pain.headache.
infection.myalgia.nausea.skin reactions.vomiting
▶UncommonAngioedema.arthralgia.hyperbilirubinaemia
.malaise.oedema.sleep disorders
▶Rare or very rareHaemorrhagic disorder.hepatic
disorders.menorrhagia.thrombocytopenia
▶Frequency not knownAgranulocytosis.dizziness.
sensation abnormal
SIDE-EFFECTS, FURTHER INFORMATION
Eosinophilic granulomatosis with polyangiitis (Churg-
Strauss syndrome)Churg-Strauss syndrome has
occurred rarely in association with the use of zafirlukast;
in many of the reported cases the reaction followed the
reduction or withdrawal of oral corticosteroid therapy.
Prescribers should be alert to the development of
eosinophilia, vasculitic rash, worsening pulmonary
symptoms, cardiac complications, or neuropathy.
Hepatic disorderSymptoms such as as persistent nausea,
vomiting, malaise, or jaundice may develop, and indicate
the development of a liver disorder.
lPREGNANCYManufacturer advises use only if potential
benefit outweighs risk. There is limited evidence for the
safe use of zafirlukast during pregnancy; however, it can
be taken as normal in women who have shown a
significant improvement in asthma not achievable with
other drugs before becoming pregnant.
lBREAST FEEDINGPresent in milk—manufacturer advises
avoid.
lHEPATIC IMPAIRMENTManufacturer advises avoid.
lRENAL IMPAIRMENTManufacturer advises caution.
lPATIENT AND CARER ADVICE
Medicines for Children leaflet: Zafirlukast for asthma prevention
(prophylaxis)www.medicinesforchildren.org.uk/zafirlukast-for-
asthma-preventionlMEDICINAL FORMS
No licensed medicines listed.MAST-CELL STABILISERS
Cromoglicate and related therapy
Overview
The mode of action of sodium cromoglicate p. 167 and
nedocromil sodium p. 167 is not completely understood;
they may be of value asprophylaxisin asthma with an allergic
basis, but the evidence for benefit of sodium cromoglicate in
children is contentious. Prophylaxis with sodium
cromoglicate or nedocromil sodium is less effective than
with inhaled corticosteroids.
Nedocromil sodium may be of some benefitinthe
prophylaxis of exercise-induced asthma.
Sodium cromoglicate and nedocromil sodium may also
have a role in allergic conjunctivitis; sodium cromoglicate is
used also in allergic rhinitis and allergy-related diarrhoea.166 Airways disease, obstructive BNFC 2018 – 2019
Respiratory system3