montelukast sodium: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
montelukast sodium: clinical details
Prescribing considerations
- Do not use for an acute asthma attack; ensure access to rescue treatment.
- Use as add-on therapy where licensed. Do not abruptly substitute it for inhaled corticosteroids.
- Explain neuropsychiatric risks and advise prompt reporting of symptoms.
- Reassess benefit if asthma control remains inadequate or deteriorates.
- Continued avoidance of triggering aspirin or NSAIDs is necessary in aspirin-sensitive asthma.
Contraindications and cautions
- Hypersensitivity to montelukast or any formulation excipient.
- Check formulation-specific excipients: chewable tablets may contain aspartame and require consideration in phenylketonuria; some film-coated products contain lactose.
- No clinical data are available for severe hepatic impairment.
Monitoring
- Review asthma control, reliever use and exacerbations.
- Ask about new or worsening neuropsychiatric symptoms; discontinue montelukast if these occur and reassess treatment.
- Assess promptly for systemic eosinophilia or vasculitic features when compatible symptoms occur.
- Investigate possible hepatic injury when clinically indicated.
Clinical pharmacology
Montelukast is a selective, orally active CysLT1-receptor antagonist. It is highly protein-bound, undergoes hepatic metabolism mainly involving CYP2C8 with contributions from CYP2C9 and CYP3A4, and is eliminated predominantly through bile.
Formulation and product differences
- Film-coated tablets are swallowed whole and may be taken with or without food.
- Chewable tablets must be chewed before swallowing, have food-separation requirements and may contain aspartame as a phenylalanine source.
- Granules can be given directly or with cold, soft food; use the opened sachet or prepared mixture promptly.
- Licensed age ranges and indications vary between formulations and products; consult the relevant product information.
montelukast sodium preparations and strengths
Chewable tablet
Route: Oral
Strengths: 4 mg, 5 mg
Granules
Route: Oral
Strengths: 4 mg
Sachet
Route: Oral
Strengths: 4 mg
montelukast sodium interactions
Tell the prescriber or pharmacist about all medicines and supplements.
Phenytoin, phenobarbital and rifampicin
These can reduce montelukast exposure and potentially reduce its effect; particular caution is advised in children.
Gemfibrozil
It can substantially increase montelukast exposure, potentially increasing adverse reactions.
Aspirin and other NSAIDs in aspirin-sensitive asthma
Montelukast does not remove this sensitivity. Continue avoiding medicines known to worsen asthma.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.