💊 Montelukast (Montelukast)
Montelukast is an oral leukotriene receptor antagonist used for prophylaxis and chronic treatment of asthma, prevention of exercise-induced bronchoconstriction, and relief of allergic rhinitis symptoms in patients 15 years of age and older. It carries a boxed warning for serious neuropsychiatric events.
In Arabic: مونتيلوكاست
🏷️ Brand names & manufacturers
Packages shown are US-market (DailyMed). Brands available in Palestine are in the price section below.
Montelukast Sodium🏭 Ajanta Pharma USA Inc.
Montelukast🏭 BluePoint Laboratories
Montelukast🏭 Quallent Pharmaceuticals Health LLC
Montelukast🏭 Sandoz Inc✅ What it is used for
- Prophylaxis and chronic treatment of asthma in patients 15 years and older
- Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years and older
- Relief of symptoms of seasonal and perennial allergic rhinitis in patients 15 years and older; use is reserved for patients with an inadequate response or intolerance to alternative therapies
- Not indicated for the treatment of an acute asthma attack
🧪 Active ingredient
The active ingredient is montelukast sodium, a selective, orally active antagonist of the cysteinyl leukotriene CysLT1 receptor that blocks leukotriene effects involved in asthma and allergic rhinitis.
🌿 Benefits
- Prevention and chronic treatment of asthma
- Prevention of exercise-induced bronchoconstriction
- Relief of seasonal and perennial allergic rhinitis symptoms
📝 How to use
- The dose and duration are determined by your doctor or pharmacist; do not change the dose on your own
- Asthma: one tablet taken by mouth once daily in the evening, with or without food
- EIB prevention: a single dose taken at least 2 hours before exercise; do not take an additional dose within 24 hours of a previous dose
- Allergic rhinitis: once daily, without regard to food; timing can be individualized to patient needs
- Patients with both asthma and allergic rhinitis take only one dose daily in the evening
- All patients should have a short-acting β-agonist available for rescue
💊 Dosage forms
- Film-coated tablets 10 mg (beige, rounded square-shaped, biconvex, debossed 'CL 26')
⚠️ Common side effects
- Upper respiratory infection
- Fever
- Headache
- Pharyngitis
- Cough
- Abdominal pain
- Diarrhea
- Otitis media
- Influenza
- Rhinorrhea
- Sinusitis
- Dyspepsia
- Asthenia/fatigue
- Dizziness
- Rash
- Increased ALT and AST
🚨 Serious — seek medical help
- Serious neuropsychiatric events: agitation, aggressive behavior or hostility, anxiousness, depression, disorientation, hallucinations, insomnia, irritability, memory impairment, obsessive-compulsive symptoms, restlessness, somnambulism, suicidal thoughts and behavior (including suicide), tic, tremor, stuttering
- Systemic eosinophilia, sometimes with clinical features of vasculitis consistent with Churg-Strauss syndrome, sometimes associated with reduction of oral corticosteroid therapy
- If behavior changes or new neuropsychiatric symptoms or suicidal thoughts occur, stop the medicine and contact a healthcare provider immediately
⛔ Do not use if
- Hypersensitivity to montelukast or any component of the product
❗ Warnings & precautions
- Boxed warning: serious neuropsychiatric events have been reported in adult, adolescent, and pediatric patients, with or without a prior psychiatric history, during treatment and after discontinuation
- Benefits may not outweigh risks in some patients, particularly when disease symptoms are mild and adequately treated with alternative therapies
- Discuss benefits and risks with patients and caregivers, and watch for behavior changes or new neuropsychiatric symptoms
- Do not use to treat an acute asthma attack; keep appropriate rescue medication available
- Do not abruptly substitute montelukast for inhaled or oral corticosteroids; inhaled corticosteroid may be reduced gradually
- Patients with known aspirin sensitivity should continue to avoid aspirin or NSAIDs while taking montelukast
- Daily use for chronic asthma has not been established to prevent acute episodes of EIB
🔄 Drug interactions
- No dose adjustment is needed when co-administered with theophylline, prednisone, prednisolone, oral contraceptives, fexofenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative hypnotics, NSAIDs, benzodiazepines, decongestants, and CYP enzyme inducers
🤰 Pregnancy
Published prospective and retrospective cohort data over decades have not established a drug-associated risk of major birth defects. In animal studies, no adverse developmental effects were seen at doses approximately 100 and 110 times the maximum recommended human daily oral dose (rats and rabbits). Poorly or moderately controlled asthma in pregnancy increases maternal and fetal risks. Consult your doctor before use.
🍼 Breastfeeding
A published study reports the presence of montelukast in human milk. Consult your doctor before using during breastfeeding.
🧒 Children
This leaflet covers patients 15 years and older. Safety and effectiveness have not been established in patients below 12 months with asthma, below 6 months with perennial allergic rhinitis, and below 6 years with EIB. Consult a doctor regarding use in children.
👴 Older adults
No overall differences in safety or effectiveness were observed between elderly and younger subjects, and no dose adjustment is required, although greater sensitivity of some older individuals cannot be ruled out. Plasma half-life is slightly longer in the elderly.
🌡️ Storage
Store at 20° to 25°C (excursions permitted to 15° to 30°C). Protect from moisture and light. Store in the original package.
⏰ Missed dose
If a dose is missed, take the next dose at the regular time and do not take 2 doses at the same time.
🆘 Overdose
No specific information is available on treating overdosage. Usual supportive measures are reasonable: remove unabsorbed material from the gastrointestinal tract, clinical monitoring, and supportive therapy if required. It is not known whether montelukast is removed by peritoneal dialysis or hemodialysis. Seek medical help immediately.
💰 Price & brands in your area
🏛️ Official price in Palestine — Ministry of Health price list:
| Product | Company | Pack | Price |
|---|---|---|---|
| LEUKOMONT4MG CHEWABEL TABLETS MONTELUKAST (AS SODIUM) | Beit Jala | 30 TAB | 67 ₪ |
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Mechanism of action
Montelukast is a selective, orally active CysLT1 receptor antagonist that binds with high affinity and selectivity and inhibits the physiologic actions of LTD4 without agonist activity, reducing airway edema, smooth muscle contraction, and inflammatory cell activity associated with asthma and allergic rhinitis symptoms.
Labeled dosing
Adults and adolescents 15 years and older: one 10-mg tablet. Asthma: once daily in the evening. EIB: single dose at least 2 hours before exercise, with no additional dose within 24 hours. Allergic rhinitis: once daily. Dose and duration are set by the prescriber or pharmacist.
- Boxed warning for serious neuropsychiatric events; weigh benefits and risks in asthma and EIB, and reserve use in allergic rhinitis for patients with inadequate response or intolerance to alternative therapies
- Counsel patients and caregivers to monitor for behavior changes and new neuropsychiatric symptoms and to discontinue if they occur
- Not for acute asthma attacks; ensure rescue medication is available
- Do not abruptly substitute for corticosteroids
- Systemic eosinophilia with vasculitic features consistent with Churg-Strauss syndrome has been reported
- No dose adjustment needed with the drugs listed in the interactions section
🎓 Key points for students
- Class: CysLT1 receptor antagonist
- Boxed warning: serious neuropsychiatric events
- Indications: chronic asthma prophylaxis/treatment, EIB prevention, allergic rhinitis
- Not for acute asthma attacks
- Evening dosing for asthma; at least 2 hours before exercise for EIB
- Contraindication: hypersensitivity to any component
- Do not abruptly replace corticosteroids
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Does montelukast treat an acute asthma attack?
No. It is not indicated for acute asthma attacks, and you should keep appropriate rescue medication available.
When should I stop the medicine and contact my doctor?
If you notice behavior changes, new neuropsychiatric symptoms, or suicidal thoughts, stop the medicine and contact a healthcare provider immediately.
When do I take it?
For asthma, once daily in the evening; for EIB prevention, at least 2 hours before exercise; for allergic rhinitis, once daily. Your doctor or pharmacist sets your dose.
What if I miss a dose?
Take the next dose at your regular time and do not take 2 doses at the same time.
Can I take an extra dose before exercise if I already take it daily?
No. Patients already taking it daily for any indication should not take an additional dose for EIB, and no additional dose should be taken within 24 hours of a previous dose.
Is it for children?
This leaflet covers patients 15 years and older. Ask a doctor about use in children.
⚕️ For education only — not a substitute for advice from your doctor or pharmacist. Do not start or stop any medicine without advice. Source: official FDA drug label via openFDA (2022-03), simplified. Updated: 2026-11-10.