Montelukast Uses, Dosage, Side Effects & Warnings | DrugsAtlas
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Therapeutic Class
Anti-asthmatic / Anti-allergic
Subclass
Leukotriene Receptor Antagonist (LTRA)
Speciality
Allergy & Immunology
Schedule (India)
Schedule H
Routes
Oral
Formulations
| Form | Strengths Available |
|---|---|
| Film-coated tablets | 10 mg |
| Chewable tablets | 4 mg, 5 mg |
| Oral granules (sachets) | 4 mg |
Adult indications
INDICATIONS + DOSING ā FOR CLINICIAN USE ONLY
Primary Indications (Approved / Standard in India)
1. Chronic Persistent Asthma (Mild to Moderate) ā As Add-on Therapy
| Parameter | Recommendation |
|---|---|
| Starting dose | 10 mg once daily in the evening |
| Titration | Not applicable |
| Usual maintenance dose | 10 mg once daily |
| Maximum dose | 10 mg/day |
| Clinical notes | Add-on to inhaled corticosteroids (ICS); NOT a substitute for ICS; NOT for acute bronchospasm relief; continue other asthma controller medications; particularly useful in aspirin-exacerbated respiratory disease (AERD) |
2. Allergic Rhinitis (Seasonal and Perennial)
| Parameter | Recommendation |
|---|---|
| Starting dose | 10 mg once daily |
| Titration | Not applicable |
| Usual maintenance dose | 10 mg once daily |
| Maximum dose | 10 mg/day |
| Duration | Seasonal: during allergen season; Perennial: continuous as needed |
| Clinical notes | Evening administration preferred; can be used alone or with antihistamines; for seasonal rhinitis, start 1ā2 days before expected allergen exposure if predictable |
3. Exercise-Induced Bronchoconstriction (EIB) ā Prophylaxis
| Parameter | Recommendation |
|---|---|
| Starting dose | 10 mg as single dose |
| Titration | Not applicable |
| Usual maintenance dose | 10 mg at least 2 hours before exercise |
| Maximum dose | 10 mg in 24 hours |
| Clinical notes | NOT for treatment of acute bronchospasm; do not repeat dose within 24 hours; if already on daily montelukast for another indication, no additional dose required before exercise |
4. Asthma with Concomitant Allergic Rhinitis
| Parameter | Recommendation |
|---|---|
| Starting dose | 10 mg once daily in the evening |
| Titration | Not applicable |
| Usual maintenance dose | 10 mg once daily |
| Maximum dose | 10 mg/day |
| Clinical notes | Single agent addresses both conditions; particularly beneficial when both conditions coexist; continue ICS for asthma control |
Secondary Indications ā Adults (Off-label)
| Indication | Dose | Duration | Evidence | Notes |
|---|---|---|---|---|
|
Chronic spontaneous urticaria (antihistamine-refractory)
|
10 mg once daily | 4ā12 weeks trial; continue if responding | RCTs; Indian dermatology/allergy practice | OFF-LABEL; Specialist only; add-on to second-generation antihistamines |
|
Aspirin-exacerbated cutaneous disease (AECD)
|
10 mg once daily | Long-term | Case series; specialist practice | OFF-LABEL; Specialist only; may reduce aspirin sensitivity |
|
Nasal polyposis (adjunctive)
|
10 mg once daily | Months; long-term | Small RCTs; Indian ENT practice | OFF-LABEL; Specialist only; used with intranasal steroids; modest benefit |
|
Atopic dermatitis (adjunctive)
|
10 mg once daily | 8ā12 weeks trial | Limited RCT data | OFF-LABEL; Specialist only; inconsistent benefit; consider if prominent pruritus |
|
Post-infectious cough
|
10 mg once daily | 2ā4 weeks | Limited evidence; Indian pulmonology practice | OFF-LABEL; May reduce cough hypersensitivity |
Paediatric indications
PAEDIATRIC DOSING (Specialist Only)
ā ļø Age and Safety Statement
- Minimum age for asthma: 6 months
- Minimum age for allergic rhinitis: 2 years
- Minimum age for exercise-induced bronchoconstriction: 6 years
- Below these ages: Use only under specialist supervision for exceptional circumstances
- Neuropsychiatric monitoring mandatory in all paediatric patients
Primary Paediatric Indications
1. Chronic Persistent Asthma (Mild to Moderate)
| Age Group | Formulation | Starting Dose | Titration | Maintenance Dose | Maximum Dose |
|---|---|---|---|---|---|
| 6 months ā 5 years | Oral granules 4 mg OR Chewable tablet 4 mg | 4 mg once daily in evening | Not applicable | 4 mg once daily | 4 mg/day |
| 6 ā 14 years | Chewable tablet 5 mg | 5 mg once daily in evening | Not applicable | 5 mg once daily | 5 mg/day |
| ≥15 years | Film-coated tablet 10 mg | 10 mg once daily in evening | Not applicable | 10 mg once daily | 10 mg/day |
Administration Notes:
- Oral granules: Administer directly in mouth OR mix with one spoonful of soft food (applesauce, mashed banana, rice cereal, ice cream) ā use within 15 minutes; do not dissolve in liquid
- Chewable tablets: Must be chewed thoroughly before swallowing
- Film-coated tablets: Swallow whole; do not chew
2. Allergic Rhinitis (Seasonal and Perennial)
| Age Group | Formulation | Starting Dose | Titration | Maintenance Dose | Maximum Dose |
|---|---|---|---|---|---|
| 2 ā 5 years | Oral granules 4 mg OR Chewable tablet 4 mg | 4 mg once daily | Not applicable | 4 mg once daily | 4 mg/day |
| 6 ā 14 years | Chewable tablet 5 mg | 5 mg once daily | Not applicable | 5 mg once daily | 5 mg/day |
| ≥15 years | Film-coated tablet 10 mg | 10 mg once daily | Not applicable | 10 mg once daily | 10 mg/day |
Clinical Note: Not approved for allergic rhinitis below 2 years of age
3. Exercise-Induced Bronchoconstriction (Prophylaxis)
| Age Group | Formulation | Dose | Notes |
|---|---|---|---|
| 6 ā 14 years | Chewable tablet 5 mg | 5 mg at least 2 hours before exercise | Do not repeat within 24 hours |
| ≥15 years | Film-coated tablet 10 mg | 10 mg at least 2 hours before exercise | Do not repeat within 24 hours |
Clinical Note: Not approved for EIB prophylaxis below 6 years of age
Safety Monitoring in Paediatrics
- Neuropsychiatric symptoms: Screen at each visit for agitation, aggressive behaviour, anxiety, depression, sleep disturbances, nightmares, hallucinations, suicidal ideation
- Growth: Monitor height and weight at routine intervals
- Asthma control: Assess symptom control, rescue medication use, exacerbation frequency
- Counsel parents/caregivers: Alert to report any behavioural or mood changes immediately
Secondary Paediatric Indications (Off-label)
| Indication | Age | Dose | Duration | Notes |
|---|---|---|---|---|
|
Adenoidal hypertrophy (mild-moderate)
|
>2 years | Age-appropriate dose (4ā5 mg once daily) | 3ā6 months trial | OFF-LABEL; Specialist (ENT/Paediatric) only; Indian ENT practice; may reduce adenoid size and symptoms; evidence limited |
|
Otitis media with effusion (adjunctive)
|
>2 years | Age-appropriate dose (4ā5 mg once daily) | 3 months | OFF-LABEL; Specialist only; used with intranasal steroids; modest benefit in some studies |
|
Allergic conjunctivitis (adjunctive)
|
>6 years | Age-appropriate dose | Seasonal use | OFF-LABEL; Limited evidence; use with topical therapy |
|
Post-viral wheeze (recurrent)
|
6 months ā 5 years | 4 mg once daily | During viral illness + 1ā2 weeks after | OFF-LABEL; May reduce wheeze episodes in virus-triggered wheezers; IAP practice |
Renal Adjustments
Montelukast is primarily metabolised hepatically with negligible renal excretion of parent drug. Safe to use at standard doses in all stages of renal impairment including dialysis patients.
Hepatic adjustment
| Severity | Recommendation |
|---|---|
| Mild impairment (Child-Pugh A) | No dose adjustment required; use standard doses |
| Moderate impairment (Child-Pugh B) | Use with caution; no specific dose adjustment established; monitor for adverse effects |
| Severe impairment (Child-Pugh C) |
Avoid use; limited safety data; montelukast is extensively hepatically metabolised (CYP3A4, 2C8, 2C9); accumulation risk
|
Contraindications
- Known hypersensitivity to montelukast or any excipient (including mannitol, aspartame in chewable tablets)
- NOT for acute asthma attacks or status asthmaticus (lacks bronchodilator activity)
- Severe hepatic impairment
- Phenylketonuria (chewable tablets contain aspartame)
Cautions
- Neuropsychiatric events: Agitation, aggressive behaviour, anxiety, depression, disorientation, attention disturbance, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, restlessness, somnambulism, suicidal thinking and behaviour, tremor ā monitor closely; discontinue if symptoms emerge
- Systemic eosinophilic conditions: May unmask Churg-Strauss syndrome (eosinophilic granulomatosis with polyangiitis) particularly during corticosteroid dose reduction ā monitor for vasculitic rash, worsening pulmonary symptoms, cardiac complications, neuropathy
- Aspirin/NSAID sensitivity: Not a substitute for avoiding aspirin in sensitive patients; does not completely block aspirin-induced reactions
- Psychiatric history: Use with heightened vigilance; consider alternative therapies if possible
- Reduction of oral corticosteroid dose: Taper corticosteroids gradually; do not substitute montelukast for corticosteroids abruptly
- Lactose intolerance: Some formulations contain lactose
Pregnancy
| Parameter | Details |
|---|---|
| Risk Category | Limited human data; animal studies show no teratogenicity; considered relatively low risk |
| Overall Safety | May be continued if already on treatment with good asthma control prior to pregnancy |
| Preferred Alternatives | Inhaled corticosteroids (budesonide preferred ICS in pregnancy); inhaled SABA for rescue |
| When May Be Used | Continue if: well-controlled asthma pre-pregnancy on montelukast; alternative options not suitable; benefit outweighs theoretical risk |
| What to Monitor | Maternal asthma control; fetal growth (poorly controlled asthma itself risks IUGR, preterm delivery) |
| Recommendations | Do not initiate new therapy in pregnancy unless essential; if currently on montelukast with good control, may continue after shared decision-making |
Lactation
| Parameter | Details |
|---|---|
| Compatibility | Likely compatible; limited human data |
| Milk Levels | Unknown in humans; expected to be low based on pharmacokinetics |
| Preferred Alternatives | Inhaled corticosteroids, inhaled SABA (minimal systemic absorption) |
| Infant Monitoring | Observe for irritability, sleep disturbances, feeding difficulties |
| Recommendations | Can be used if clinically indicated; prefer inhaled therapies when possible |
Elderly
| Parameter | Recommendation |
|---|---|
| Starting dose | 10 mg once daily (same as adults) |
| Titration | Not applicable |
| Special Considerations | No dose adjustment for age alone; assess hepatic function before initiation |
| Extra Risks | Increased susceptibility to neuropsychiatric effects (confusion, mood changes, sleep disturbances); monitor closely; polypharmacy interactions |
| Monitoring | Cognitive and mood assessment at follow-up visits |
Major drug interactions
| Rifampicin | Marked reduction in montelukast exposure (up to 40% decrease in AUC) | Strong CYP3A4 inducer | Monitor for reduced efficacy; consider alternative asthma therapy during rifampicin treatment |
|---|---|---|---|
|
Phenobarbital
|
Reduced montelukast levels | CYP3A4 induction | Monitor asthma control; may need alternative controller |
|
Phenytoin
|
Reduced montelukast levels | CYP3A4 induction | Monitor clinical response |
|
Carbamazepine
|
Reduced montelukast levels | CYP3A4 induction | Monitor for loss of efficacy |
|
Gemfibrozil
|
Increased montelukast exposure (4ā5 fold increase in AUC) | CYP2C8 inhibition | Monitor for increased adverse effects; no dose adjustment typically needed but increased vigilance for neuropsychiatric symptoms |
Moderate drug interactions
| Interacting Drug | Effect | Recommendation |
|---|---|---|
|
Fluconazole
|
May modestly increase montelukast levels | CYP2C9 inhibition; usually clinically insignificant; monitor |
|
Itraconazole / Ketoconazole
|
May slightly increase montelukast levels | CYP3A4 inhibition; minimal clinical significance |
|
Erythromycin / Clarithromycin
|
May slightly increase montelukast levels | Mild CYP3A4 inhibition; no dose adjustment needed |
|
Prednisone / Prednisolone
|
No pharmacokinetic interaction | Can be used together; taper corticosteroids carefully if reducing |
|
Theophylline
|
No significant interaction | Can be used together; montelukast does not affect theophylline levels |
|
Inhaled corticosteroids
|
No interaction | Additive benefit; recommended combination |
|
Antihistamines (cetirizine, fexofenadine, levocetirizine)
|
No interaction | Commonly used together for allergic rhinitis; additive benefit |
|
Oral contraceptives
|
No significant interaction | No dose adjustment needed |
|
Warfarin
|
No clinically significant effect on INR | Standard monitoring; no adjustment needed |
|
Digoxin
|
No interaction | No monitoring required |
Common Adverse effects
Adults:
- Headache
- Upper respiratory tract infection
- Pharyngitis
- Cough
- Abdominal pain
- Dyspepsia
- Diarrhoea
- Fatigue
- Dizziness
- Influenza-like symptoms
- Rash (mild)
Paediatric (additional):
- Thirst
- Hyperkinesia
- Otitis media
- Fever
- Sinusitis
Serious Adverse effects
| Adverse Effect | Clinical Notes |
|---|---|
|
Neuropsychiatric events
|
Agitation, aggression, anxiety, depression, disorientation, dream abnormalities, hallucinations, insomnia, suicidal ideation and behaviour; discontinue immediately and evaluate; US FDA boxed warning
|
|
Eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome)
|
Eosinophilia, vasculitic rash, pulmonary symptoms, peripheral neuropathy, cardiac involvement; usually emerges when corticosteroids are tapered; discontinue and refer urgently
|
|
Anaphylaxis / Angioedema
|
Rare; discontinue immediately; emergency management
|
|
Hepatotoxicity
|
Rare; cholestatic hepatitis, mixed hepatocellular injury reported; monitor if unexplained symptoms; discontinue if significant LFT elevation
|
|
Erythema multiforme / Stevens-Johnson syndrome
|
Very rare; discontinue immediately; hospitalisation required
|
|
Thrombocytopenia
|
Very rare case reports |
|
Seizures
|
Rare reports; caution in epilepsy |
|
Palpitations / Peripheral oedema
|
Rare; evaluate cardiac status |
Monitoring requirements
| Timing | Parameters |
|---|---|
|
Baseline
|
Clinical assessment of asthma severity/rhinitis severity; no routine blood tests needed in healthy individuals; LFTs if hepatic disease suspected |
|
After initiation (2ā4 weeks)
|
Assess clinical response (symptom control); screen for neuropsychiatric symptoms (especially in children and adolescents)
|
|
Ongoing (every 3ā6 months)
|
Asthma control assessment (ACT/ACQ scores, symptom diary, rescue medication use, exacerbation frequency); neuropsychiatric symptom review; adherence check |
|
Long-term
|
Periodic review of continued need for therapy; step-down consideration if asthma well-controlled; growth monitoring in children |
|
If neuropsychiatric symptoms emerge
|
Immediate discontinuation; psychiatric evaluation as needed |
Brands in India
Single-Ingredient Brands
| Brand Name | Manufacturer | Formulations |
|---|---|---|
| Montair | Cipla | 4 mg chewable, 5 mg chewable, 10 mg tablet, 4 mg granules |
| Montek | Sun Pharma | 4 mg chewable, 5 mg chewable, 10 mg tablet, 4 mg granules |
| Telekast | Lupin | 4 mg chewable, 5 mg chewable, 10 mg tablet |
| Romilast | Ranbaxy/Sun | 10 mg tablet, 4 mg chewable, 5 mg chewable |
| Montemac | Macleods | 10 mg tablet, 5 mg chewable |
| Montelo | Intas | 10 mg tablet |
| Singulair | MSD (originator) | 4 mg chewable, 5 mg chewable, 10 mg tablet, 4 mg granules |
| Odimont | Zydus | 10 mg tablet, 5 mg chewable |
Fixed-Dose Combinations (FDCs) ā Common
| Brand Name | Combination | Notes |
|---|---|---|
| Montair-LC / Montek-LC | Montelukast 10 mg + Levocetirizine 5 mg | Allergic rhinitis with urticaria |
| Montair-FX / Montek-FX | Montelukast 10 mg + Fexofenadine 120 mg | Non-sedating option for rhinitis |
| Telekast-L | Montelukast 10 mg + Levocetirizine 5 mg | |
| L-Montus | Montelukast + Levocetirizine | Paediatric and adult formulations |
| Montemac-L | Montelukast + Levocetirizine |
Note: FDCs with antihistamines widely prescribed in India for allergic rhinitis; may increase sedation with levocetirizine combinations
Price range (INR)
| Formulation | Approximate Price (per unit) | Notes |
|---|---|---|
| Tablet 10 mg | ā¹4ā12 per tablet | Wide brand variation |
| Chewable tablet 4 mg | ā¹4ā10 per tablet | |
| Chewable tablet 5 mg | ā¹4ā10 per tablet | |
| Oral granules 4 mg (sachet) | ā¹6ā15 per sachet | |
| FDC with Levocetirizine (strip of 10) | ā¹60ā150 |
- NLEM Status: Montelukast is included in NLEM India 2022
- DPCO: Price ceiling applicable
- Government supply: Available in some public health facilities
Clinical pearls
- NOT a rescue medication: Reinforce to patients and caregivers that montelukast does NOT relieve acute asthma symptoms ā SABA (salbutamol) remains the rescue drug; montelukast takes days to weeks for full effect
- Evening dosing preferred: Circadian variation in leukotriene synthesis peaks at night; evening administration optimises efficacy for asthma and nocturnal symptoms
- Steroid-sparing role: Valuable add-on to ICS in Step 3ā4 asthma (GINA/Indian guidelines); particularly useful in aspirin-sensitive asthma, exercise-induced symptoms, and patients reluctant/unable to increase ICS
- Neuropsychiatric vigilance essential: US FDA boxed warning (2020); screen for mood changes, behavioural disturbances, sleep abnormalities at EVERY visit; particularly important in children and adolescents; counsel parents/caregivers to report immediately
- Churg-Strauss caution: Do not attribute new-onset vasculitis, worsening eosinophilia, or neuropathy to "asthma worsening" ā consider EGPA especially when tapering corticosteroids; requires urgent referral
- Oral granules administration: Mix with one spoonful of soft food only (not liquids); use within 15 minutes of mixing; do not store prepared mixture
- FDC caution: Montelukast + levocetirizine FDCs are popular but may cause sedation; avoid evening dosing of FDC in patients reporting next-morning drowsiness; consider separate dosing timings
Version
RxIndia v1.0 ā 27 Jan 2025
Reference
-
- CDSCO approved prescribing information for Montelukast
- Indian Pharmacopoeia 2022
- NLEM India 2022
- API Textbook of Medicine (11th Edition) ā Bronchial Asthma, Allergic Rhinitis chapters
- IAP Guidelines on Childhood Asthma (2021)
- Indian Chest Society / NCCP Guidelines on Asthma Management
- AIIMS Treatment Protocols ā Allergy and Pulmonology
- GINA 2023 (supportive reference, adapted to Indian context)
- US FDA Drug Safety Communication ā Montelukast Neuropsychiatric Events (March 2020)
- Indian ENT specialist practice guidelines (for adenoidal hypertrophy off-label use)
- Goodman & Gilman's The Pharmacological Basis of Therapeutics (14th Edition)
- Harrison's Principles of Internal Medicine (21st Edition)
āļø
Clinical Responsibility
This platform is designed strictly for healthcare professionals. Data provided is synthesized from authoritative pharmacological sources and clinical registries. Do not use for consumer medical decisions. Always verify critical dosing and contraindications with official institutional protocols and peer-reviewed journals.
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