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Authoritative Clinical Reference
Schedule H
Oral
Tablet: Montelukast 10 mg + Levocetirizine 5 mg
Tablet (paediatric): Montelukast 4 mg + Levocetirizine 2.5 mg; Montelukast 5 mg + Levocetirizine 2.5 mg
Syrup/Oral suspension: Montelukast 4 mg + Levocetirizine 2.5 mg per 5 mL
INDICATIONS + DOSING — FOR CLINICIAN USE ONLY
Primary Indications (Approved / Standard in India)
Parameter Adults & Adolescents ≥15 years
Starting dose Montelukast 10 mg + Levocetirizine 5 mg once daily in the evening
Titration Not applicable
Usual maintenance dose 1 tablet once daily in the evening
Maximum dose 1 tablet per day (do not exceed)
Clinical Notes:
Parameter Recommendation
Starting dose 1 tablet once daily in the evening
Titration Not applicable
Usual maintenance dose 1 tablet once daily
Maximum dose 1 tablet per day
Clinical Notes:
Secondary Indications — Adults Only (Off-label)
Indication Dose Duration Notes
Chronic Spontaneous Urticaria (antihistamine-refractory) — OFF-LABEL 1 tablet once daily in the evening 2–4 weeks trial initially; longer-term under specialist supervision Adjunct when standard-dose or high-dose antihistamines insufficient. Variable response to montelukast component. Based on Indian dermatology/allergy specialist practice.
PAEDIATRIC DOSING (Specialist Only)
Primary Indications
| Age Group | Dose (mcg/kg/day) | Typical Total Daily Dose | Clinical Notes |
|---|
2–5 years Syrup Montelukast 4 mg + Levocetirizine 2.5 mg (5 mL) Once daily in the evening
6–14 years Tablet/Syrup Montelukast 5 mg + Levocetirizine 2.5 mg Once daily in the evening
≥15 years Adult tablet Montelukast 10 mg + Levocetirizine 5 mg Once daily in the evening
Dosing Structure for Paediatrics:
Parameter 2–5 years 6–14 years
Starting dose 4 mg + 2.5 mg once daily 5 mg + 2.5 mg once daily
Titration Not applicable Not applicable
Usual maintenance dose Same as starting dose Same as starting dose
Maximum dose 4 mg + 2.5 mg/day 5 mg + 2.5 mg/day
| Age Group | Dose (mcg/kg/day) | Typical Total Daily Dose | Clinical Notes |
|---|
6–14 years Montelukast 5 mg + Levocetirizine 2.5 mg once daily evening As adjunct to inhaled therapy
≥15 years Adult dosing Not monotherapy for asthma
Secondary Indications — Paediatric (Off-label)
Indication Age Dose Duration Notes
Exercise-induced bronchoconstriction with allergic rhinitis — OFF-LABEL ≥6 years Age-appropriate FDC dose once daily 4–8 weeks trial Specialist only. Based on IAP recommendations for montelukast component. Limited evidence for FDC specifically.
Age Restrictions:
Safety Monitoring in Children:
| eGFR (ml/min/1.73m²) | Recommendation |
|---|
50 No dose adjustment required
30–50 Consider alternate-day dosing; monitor for sedation
| eGFR (ml/min/1.73m²) | Recommendation |
|---|---|
| <10 | or Haemodialysis Avoid — levocetirizine not effectively removed by dialysis |
| eGFR (ml/min/1.73m²) | Recommendation |
| Severity | Recommendation |
|---|---|
| Mild impairment | No dose adjustment required. Standard monitoring. |
| Moderate impairment | Use with caution. Monitor for excessive sedation and hepatic function. Consider reduced frequency. |
| Severe impairment | Avoid use. Montelukast metabolism significantly affected. If essential, use levocetirizine alone with dose adjustment. |
Parameter Information
Overall safety Limited human data; animal studies do not indicate teratogenicity for either component
Risk assessment Use only if potential benefit justifies potential risk to fetus
Preferred alternatives Intranasal corticosteroids (budesonide) for allergic rhinitis; loratadine or cetirizine if oral antihistamine needed
When may be used If symptom burden is significant and topical therapies inadequate; seek specialist input
Monitoring Standard antenatal surveillance; no specific fetal monitoring required
Parameter Information
Compatibility Levocetirizine present in breast milk in low concentrations; montelukast data limited but likely low transfer
Overall recommendation May be used with caution if clinically necessary
Preferred alternatives Loratadine or cetirizine monotherapy (more safety data in lactation)
Milk levels Low (both components)
Infant monitoring Observe for sedation, irritability, poor feeding, weight gain
Parameter Recommendation
Starting dose Montelukast 10 mg + Levocetirizine 5 mg once daily (if renal function adequate)
Dose modification Consider alternate-day dosing if eGFR 30–50 mL/min; avoid if eGFR <30
Titration Not applicable (fixed dose combination)
Special risks Increased sedation, confusion, anticholinergic effects, falls, urinary retention
Monitoring Assess renal function before prescribing and periodically; monitor cognitive status
Drug/Class Interaction Mechanism Management
Alcohol Enhanced CNS depression and sedation Additive effect Advise abstinence or minimise alcohol intake
Benzodiazepines/CNS depressants Increased sedation, respiratory depression risk Additive CNS effects Avoid combination or use lowest effective doses; monitor closely
Rifampicin Significant reduction in montelukast efficacy CYP3A4 and CYP2C8 induction accelerates montelukast metabolism Consider alternative antiallergic therapy during rifampicin use
Phenytoin/Phenobarbital Reduced montelukast levels CYP enzyme induction Monitor therapeutic response; may need alternative therapy
Other cetirizine/antihistamines Additive sedation and anticholinergic toxicity Duplication Avoid concurrent use with other antihistamines
Drug/Class Interaction Management
Theophylline Montelukast may slightly reduce theophylline clearance Usually not clinically significant; monitor theophylline levels if symptoms suggest toxicity
Macrolides (erythromycin, clarithromycin) May affect montelukast metabolism Monitor for efficacy; usually no dose change needed
Fluconazole/Ketoconazole May increase montelukast exposure Generally well tolerated; monitor for adverse effects
TCAs/SSRIs Additive CNS and anticholinergic effects Monitor for sedation; caution in elderly
Warfarin Rare reports of altered INR Monitor INR more frequently when initiating or stopping FDC
Antiepileptics (except enzyme inducers) Monitor for additive sedation Clinical monitoring sufficient
Effect Notes
Neuropsychiatric events (montelukast) Agitation, aggression, anxiety, depression, abnormal dreams, hallucinations, insomnia, suicidal thinking/behaviour — discontinue immediately if observed
Angioedema Rare; discontinue and do not rechallenge
Anaphylaxis Rare but reported; emergency management required
Hepatotoxicity Rare with montelukast; discontinue if significant transaminase elevation
Seizures Rare, primarily levocetirizine-related; caution in epilepsy
Churg-Strauss syndrome/Eosinophilic granulomatosis Rare; reported with montelukast during corticosteroid tapering in asthma
Stevens-Johnson Syndrome/TEN Very rare; discontinue immediately
| Timing | Parameters |
|---|---|
| Baseline | Renal function (especially in elderly); hepatic function if prolonged therapy planned; psychiatric history assessment |
After initiation (1–2 weeks) Assess for sedation, behavioural changes (especially in children/adolescents), sleep disturbance
Long-term use Periodic renal and hepatic function (every 6–12 months); ongoing neuropsychiatric monitoring; reassess continued need
In children Monitor behaviour, attention, school performance, sleep pattern at each follow-up
| Formulation | Approximate Price (per tablet) |
|---|---|
| Tablet (10 mg + 5 mg) | ₹6–14 per tablet |
| Paediatric tablet (5 mg + 2.5 mg) | ₹5–10 per tablet |
| Syrup (60 mL) | ₹35–70 per bottle |
Note: Not included in NLEM 2022. MRP varies by brand; not NPPA price-controlled. Generic alternatives available at lower cost.
montelukast; levocetirizine; FDC; allergic rhinitis; asthma adjunct; antihistamine; LTRA; paediatric; neuropsychiatric risk; renal-caution; Schedule H
RxIndia v1.0 — 05 Jan 2025
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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