Adult: As conventional tab: 10 mg once daily. Child: 6-23 months As granules: 1 sachet (4 mg) once daily in the evening; 2-5 years As 4 mg chewable tab or granules: 1 tab or sachet once daily in the evening; 6-14 years As 5 mg chewable tab: 1 tab once daily in the evening; ≥15 years As conventional tab: Same as adult dose. Dosage recommendations may vary among countries or individual products. Refer to specific product guidelines.
Oral Seasonal allergic rhinitis
Adult: As conventional tab: 10 mg once daily. Child: 2-5 years As 4 mg chewable tab or granules: 1 tab or sachet once daily in the evening; 6-14 years As 5 mg chewable tab: 1 tab once daily in the evening; ≥15 years As conventional tab: Same as adult dose. Dosage recommendations may vary among countries or individual products. Refer to specific product guidelines.
Oral Chronic asthma
Adult: As conventional tab: 10 mg once daily in the evening. Child: 6-23 months As granules: 1 sachet (4 mg) once daily in the evening; 2-5 years As 4 mg chewable tab or granules: 1 tab or sachet once daily in the evening; 6-14 years As 5 mg chewable tab: 1 tab once daily in the evening; ≥15 years As conventional tab: Same as adult dose. Dosage recommendations may vary among countries or individual products. Refer to specific product guidelines.
Oral Prophylaxis of exercise-induced asthma
Adult: As conventional tab: 10 mg given at least 2 hours before exercise; limit to 1 dose every 24 hours. Child: 2-5 years As 4 mg chewable tab or granules: 1 tab or sachet once daily in the evening; 6-14 years As 5 mg chewable tab: 1 tab once daily in the evening; ≥15 years As conventional tab: Same as adult dose.
What are the brands available for Montelukast in Malaysia?
Montelukast sodium May be taken with or without food.
Special Precautions
Patient with known aspirin sensitivity (continue avoidance of aspirin or NSAIDs during treatment with montelukast). Not indicated for the treatment of acute asthma attacks, including status asthmaticus. Not recommended as monotherapy in patients with moderate persistent asthma. Avoid abrupt substitution to inhaled or oral corticosteroids. Children. Pregnancy and lactation.
Adverse Reactions
Significant: Neuropsychiatric events (e.g. agitation, depression, hallucinations, suicidal thoughts and behaviour, dream abnormalities, aggressive behaviour or hostility, anxiety, disorientation, disturbance in attention, dysphemia, insomnia, irritability, memory impairment, obsessive-compulsive symptoms, restlessness, somnambulism, tic, tremor). Rarely, systemic eosinophilia (sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome). Blood and lymphatic system disorders: Rarely, increased bleeding tendency, thrombocytopenia. Cardiac disorders: Rarely, palpitations. Ear and labyrinth disorders: Otitis media. Gastrointestinal disorders: Abdominal pain, diarrhoea, nausea, vomiting, thirst, dry mouth, dyspepsia. General disorders and administration site conditions: Pyrexia, asthenia, malaise, oedema. Immune system disorders: Hypersensitivity reactions including anaphylaxis. Investigations: Elevated ALT/AST levels. Musculoskeletal and connective tissue disorders: Myalgia, arthralgia, muscle cramps. Nervous system disorders: Headache, dizziness, drowsiness, paraesthesia, hypoaesthesia, seizure. Respiratory, thoracic and mediastinal disorders: Upper respiratory tract infection, pharyngitis, cough, influenza, rhinorrhea, sinusitis, epistaxis. Skin and subcutaneous tissue disorders: Rash, pruritus, urticaria, bruising.
Monitor for neuropsychiatric symptoms, including changes in behaviour and suicidal thoughts.
Drug Interactions
Decreased plasma concentration with CYP inducers (e.g. phenobarbital, phenytoin, rifampicin). Increased systemic exposure with gemfibrozil.
Action
Description: Mechanism of Action: Montelukast is a selective leukotriene receptor antagonist. It inhibits cysteinyl leukotriene type-1 (CysLT1) receptor found in the human airway and on other pro-inflammatory cells. The binding of CysLTs in leukotriene receptors is involved in the pathophysiology of asthma, including bronchoconstriction, mucous secretion, vascular permeability, and eosinophil recruitment. Additionally, CysLTs are released from the nasal mucosa after allergen exposure which is associated with symptoms of allergic rhinitis. Duration: >24 hours. Pharmacokinetics: Absorption: Rapidly absorbed. Bioavailability: 64% (conventional tab); 73% (5 mg chewable tab). Time to peak plasma concentration: 3-4 hours (conventional tab); 2 hours (chewable tab). Distribution: Volume of distribution: 8-11 L. Plasma protein binding: >99%. Metabolism: Extensively metabolised in the liver, mainly by CYP2C8, and to a lesser extent by CYP3A4 and CYP2C9 enzymes. Excretion: Mainly via faeces (86%); urine (<0.2%). Elimination half-life: 2.7-5.5 hours.
Chemical Structure
Montelukast Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 5281040, Montelukast. https://pubchem.ncbi.nlm.nih.gov/compound/Montelukast. Accessed June 28, 2022.
Storage
Store between 15-30°C. Protect from light and moisture.
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