Individual generic drug information

montelukast

Reference monograph

Part of registered formulation

MONTELUKAST

Reference record: Montelukast
Source: BNF 80 (2020–2021)
Printed source pages: 306, 307
Age groups indexed: 2

Individual active ingredientSource records are displayed separately

Some source sections could not be separated reliably in the extraction. Review the printed source pages when a field is missing or incomplete.

Overview

Extracted information for Montelukast only.

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

Source page 306

Prescribing And Dispensing Information

Flavours of chewable tablet formulations may include cherry.

Source page 306

Safety

Extracted information for Montelukast only.

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.

Source page 306

Interactions

→Appendix 1: montelukast

Source page 306

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.

Source page 306

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.

Source page 306

Breast Feeding

Manufacturer advises avoid unless essential.

Source page 306

Dose and formulations

Extracted information for Montelukast only.

Directions For Administration

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

Source page 306

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

Source pages 306, 307

Clinical care

Extracted information for Montelukast only.

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

Source page 306

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Children

First line only; read the complete Indications and dose section above.

4 mg once daily, dose to be

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 306

Children

First line only; read the complete Indications and dose section above.

5 mg once daily, dose to be taken in

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 306

Children

First line only; read the complete Indications and dose section above.

10 mg once daily, dose to be taken in

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 306

Children

First line only; read the complete Indications and dose section above.

10 mg once daily, dose to be taken in

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 306

Age labels are extracted from the printed dose headings and require clinical review. Confirm current local guidance, dose, route, formulation, contraindications and interactions before prescribing.

Individual generic drug information

montelukast

Reference monograph

Part of registered formulation

MONTELUKAST

Reference record: Montelukast
Source: BNF 80 (2020–2021)
Printed source pages: 306, 307
Age groups indexed: 2

Individual active ingredientSource records are displayed separately

Some source sections could not be separated reliably in the extraction. Review the printed source pages when a field is missing or incomplete.

Overview

Extracted information for Montelukast only.

Indications And Dose

Source page 306

Prescribing And Dispensing Information

Flavours of chewable tablet formulations may include cherry.

Source page 306

Safety

Extracted information for Montelukast only.

Important Safety Information

Source page 306

Interactions

→Appendix 1: montelukast

Source page 306

Side Effects

Source page 306

Pregnancy

Source page 306

Breast Feeding

Manufacturer advises avoid unless essential.

Source page 306

Dose and formulations

Extracted information for Montelukast only.

Directions For Administration

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

Source page 306

Medicinal Forms

Source pages 306, 307

Clinical care

Extracted information for Montelukast only.

Patient And Carer Advice

Source page 306

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Children

First line only; read the complete Indications and dose section above.

4 mg once daily, dose to be

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 306

Children

First line only; read the complete Indications and dose section above.

5 mg once daily, dose to be taken in

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 306

Children

First line only; read the complete Indications and dose section above.

10 mg once daily, dose to be taken in

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 306

Children

First line only; read the complete Indications and dose section above.

10 mg once daily, dose to be taken in

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 306

Age labels are extracted from the printed dose headings and require clinical review. Confirm current local guidance, dose, route, formulation, contraindications and interactions before prescribing.