Drug reference

Montelukast

BNF 80 (2020–2021)

Source: BNF 80 (2020–2021)
PDF pages: 306, 307

Review source pages for extracted sections and age labels. BNF dose snippets show only their first line.

Overview

Indications And Dose

Prophylaxis of asthma ▶BY MOUTH ▶Child 6 months–5 years: 4 mg once daily, dose to be taken in the evening ▶Child 6–14 years: 5 mg once daily, dose to be taken in the evening ▶Child 15–17 years: 10 mg once daily, dose to be taken in the evening ▶Adult: 10 mg once daily, dose to be taken in the evening Symptomatic relief of seasonal allergic rhinitis in patients with asthma ▶BY MOUTH ▶Child 15–17 years: 10 mg once daily, dose to be taken in the evening ▶Adult: 10 mg once daily, dose to be taken in the evening

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Prescribing And Dispensing Information

Flavours of chewable tablet formulations may include cherry.

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Safety

Important Safety Information

MHRA/CHM ADVICE: MONTELUKAST (SINGULAIR ®): REMINDER OF THE RISK OF NEUROPSYCHIATRIC REACTIONS (SEPTEMBER 2019) Healthcare professionals are advised to be alert for neuropsychiatric reactions, including speech impairment and obsessive-compulsive symptoms, in adults, adolescents, and children taking montelukast. The risks and beneﬁts of continuing treatment should be evaluated if these reactions occur. Patients should be advised to read the list of neuropsychiatric reactions in the information leaﬂet and seek immediate medical attention if they occur.

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Interactions

→Appendix 1: montelukast

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Side Effects

▶Common or very common Diarrhoea. fever. gastrointestinal discomfort. headache. nausea. skin reactions. upper respiratory tract infection. vomiting ▶Uncommon Akathisia. anxiety. arthralgia. asthenia. behaviour abnormal. depression. dizziness. drowsiness. dry mouth. haemorrhage. irritability. malaise. muscle complaints. oedema. seizure. sensation abnormal. sleep disorders ▶Rare or very rare Angioedema. concentration impaired. disorientation. eosinophilic granulomatosis with polyangiitis. erythema nodosum. hallucination. hepatic disorders. memory loss. palpitations. psychiatric disorders. pulmonary eosinophilia. speech disorder. suicidal tendencies. tremor SIDE-EFFECTS, FURTHER INFORMATION Eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome) has occurred very rarely in association with the use of montelukast; 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 peripheral neuropathy.

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Pregnancy

Manufacturer advises avoid unless essential. There is limited evidence for the safe use of montelukast 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.

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Breast Feeding

Manufacturer advises avoid unless essential.

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Dose and formulations

Directions For Administration

Granules may be swallowed or mixed with cold, soft food (not liquid) and taken immediately.

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Medicinal Forms

There can be variation in the licensing of different medicines containing the same drug. Granules ▶Montelukast (Non-proprietary) Montelukast (as Montelukast sodium) 4 mg Montelukast 4mg granules sachets sugar-free | 28 sachet P £19.99 DT = £5.18 ▶Singulair (Merck Sharp & Dohme Ltd) Montelukast (as Montelukast sodium) 4 mg Singulair Paediatric 4mg granules sachets sugar-free | 28 sachet P £25.69 DT = £5.18 Tablet ▶Montelukast (Non-proprietary) Montelukast (as Montelukast sodium) 10 mg Montelukast 10mg tablets | 28 tablet P £26.97 DT = £2.30 ▶Singulair (Merck Sharp & Dohme Ltd) Montelukast (as Montelukast sodium) 10 mg Singulair 10mg tablets | 28 tablet P £26.97 DT = £2.30 Chewable tablet CAUTIONARY AND ADVISORY LABELS 23, 24 EXCIPIENTS: May contain Aspartame ▶Montelukast (Non-proprietary) Montelukast (as Montelukast sodium) 4 mg Montelukast 4mg chewable tablets sugar-free | 28 tablet P £25.69 DT = £1.51 Montelukast (as Montelukast sodium) 5 mg Montelukast 5mg chewable tablets sugar-free | 28 tablet P £25.69 DT = £1.91 ▶Singulair (Merck Sharp & Dohme Ltd) Montelukast (as Montelukast sodium) 4 mg Singulair Paediatric 4mg chewable tablets sugar-free | 28 tablet P £25.69 DT = £1.51 Montelukast (as Montelukast sodium) 5 mg Singulair Paediatric 5mg chewable tablets sugar-free | 28 tablet P £25.69 DT = £1.91 MAST-CELL STABILISERS

PDF pages 306, 307

Clinical care

Patient And Carer Advice

Administration Patients or carers should be given advice on how to administer montelukast granules. Risk of neuropsychiatric reactions The MHRA advises patients and carers to seek medical attention if changes in speech or behaviour occur—see also Important safety information. Medicines for Children leaflet: Montelukast for asthma www.medicinesforchildren.org.uk/montelukast-asthma

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Dose text by age group

Adult

10 mg once daily, dose to be taken in the

First-line fragment. Read the complete Indications and Dose section above.

PDF page 306

Adult

10 mg once daily, dose to be taken in the

First-line fragment. Read the complete Indications and Dose section above.

PDF page 306

Age labels are extracted for navigation. Check the complete source section and current local guidance before clinical use.

Drug reference

Montelukast

BNF 80 (2020–2021)

Source: BNF 80 (2020–2021)
PDF pages: 306, 307

Review source pages for extracted sections and age labels. BNF dose snippets show only their first line.

Overview

Indications And Dose

PDF page 306

Prescribing And Dispensing Information

Flavours of chewable tablet formulations may include cherry.

PDF page 306

Safety

Important Safety Information

PDF page 306

Interactions

→Appendix 1: montelukast

PDF page 306

Side Effects

PDF page 306

Pregnancy

PDF page 306

Breast Feeding

Manufacturer advises avoid unless essential.

PDF page 306

Dose and formulations

Directions For Administration

Granules may be swallowed or mixed with cold, soft food (not liquid) and taken immediately.

PDF page 306

Medicinal Forms

PDF pages 306, 307

Clinical care

Patient And Carer Advice

PDF page 306

Dose text by age group

Adult

10 mg once daily, dose to be taken in the

First-line fragment. Read the complete Indications and Dose section above.

PDF page 306

Adult

10 mg once daily, dose to be taken in the

First-line fragment. Read the complete Indications and Dose section above.

PDF page 306

Age labels are extracted for navigation. Check the complete source section and current local guidance before clinical use.