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Montelukast Uses, Dosage, Side Effects & Warnings | DrugsAtlas

Authoritative Clinical Reference

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 — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Chronic Persistent Asthma (Mild to Moderate) — 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 1–2 days before expected allergen exposure if predictable

3. Exercise-Induced Bronchoconstriction (EIB) — 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 — Adults (Off-label)

Indication	Dose	Duration	Evidence	Notes
Chronic spontaneous urticaria (antihistamine-refractory)	10 mg once daily	4–12 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	8–12 weeks trial	Limited RCT data	OFF-LABEL; Specialist only; inconsistent benefit; consider if prominent pruritus
Post-infectious cough	10 mg once daily	2–4 weeks	Limited evidence; Indian pulmonology practice	OFF-LABEL; May reduce cough hypersensitivity

Paediatric indications

PAEDIATRIC DOSING (Specialist Only)

⚠️ 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 – 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 – 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) — 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 – 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 – 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 – 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 (4–5 mg once daily)	3–6 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 (4–5 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 – 5 years	4 mg once daily	During viral illness + 1–2 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 — monitor closely; discontinue if symptoms emerge
Systemic eosinophilic conditions: May unmask Churg-Strauss syndrome (eosinophilic granulomatosis with polyangiitis) particularly during corticosteroid dose reduction — 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 (4–5 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 (2–4 weeks)	Assess clinical response (symptom control); screen for neuropsychiatric symptoms (especially in children and adolescents)
Ongoing (every 3–6 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) — 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	₹4–12 per tablet	Wide brand variation
Chewable tablet 4 mg	₹4–10 per tablet
Chewable tablet 5 mg	₹4–10 per tablet
Oral granules 4 mg (sachet)	₹6–15 per sachet
FDC with Levocetirizine (strip of 10)	₹60–150

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 — 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 3–4 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" — 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 — 27 Jan 2025

Reference

- CDSCO approved prescribing information for Montelukast
- Indian Pharmacopoeia 2022
- NLEM India 2022
- API Textbook of Medicine (11th Edition) — Bronchial Asthma, Allergic Rhinitis chapters
- IAP Guidelines on Childhood Asthma (2021)
- Indian Chest Society / NCCP Guidelines on Asthma Management
- AIIMS Treatment Protocols — Allergy and Pulmonology
- GINA 2023 (supportive reference, adapted to Indian context)
- US FDA Drug Safety Communication — 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)

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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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