Montelukast + Levocetirizine Uses, Dosage, Side Effects | DrugsAtlas

Authoritative Clinical Reference

Therapeutic Class: Antiallergic agents
Subclass: Leukotriene receptor antagonist + Second-generation antihistamine
Speciality: Allergy & Immunology
Schedule (India): Schedule H
Route: Oral

Formulations:
- Tablet: Montelukast 10 mg + Levocetirizine 5 mg
- Paediatric Tablet:
• Montelukast 4 mg + Levocetirizine 2.5 mg
• Montelukast 5 mg + Levocetirizine 2.5 mg
- Syrup/Oral Suspension: 4 mg + 2.5 mg per 5 mL

Adult Indications:

1. Allergic Rhinitis (Seasonal and Perennial)
- Dose: 1 tablet once daily (evening)
- Duration: 2–4 weeks (seasonal) or long-term (perennial)
- Maximum Dose: 1 tablet per day

2. Asthma with Allergic Rhinitis (Adjunct)
- Used as add-on therapy
- Not a substitute for inhaled corticosteroids
- Reassess every 4–6 weeks

Paediatric Dosing:

- 2–5 years:
Syrup: 4 mg + 2.5 mg (5 mL) once daily (evening)

- 6–14 years:
Tablet/Syrup: 5 mg + 2.5 mg once daily (evening)

- ≥15 years:
Adult dose (10 mg + 5 mg once daily)

Contraindications:

- Hypersensitivity to Montelukast or Levocetirizine
- Severe renal impairment (eGFR <30 mL/min)
- Severe hepatic impairment
- Children below 2 years

Common Side Effects:

- Drowsiness
- Headache
- Dry mouth
- Nausea
- Fatigue

Serious Side Effects:

- Neuropsychiatric symptoms (anxiety, depression, suicidal thoughts)
- Angioedema
- Anaphylaxis
- Hepatotoxicity

Brands in India:

- Montair LC
- Montek LC
- LC Montus
- Odimont LC
- Levocet M

Price Range (INR):

- Tablet (10 mg + 5 mg): ₹6–14
- Paediatric Tablet (5 mg + 2.5 mg): ₹5–10
- Syrup (60 mL): ₹35–70

Note: Not included in NLEM 2022. MRP varies by brand; not NPPA price-controlled. Generic alternatives available at lower cost.

Clinical pearls

Evening dosing preferred: Leukotriene levels peak at night; evening administration optimises symptom control and manages levocetirizine-related sedation during sleep hours.
Neuropsychiatric vigilance: Montelukast carries black-box warning (US FDA) for neuropsychiatric events — counsel patients and caregivers to report mood/behaviour changes; particularly important in children and adolescents.
Not for acute asthma: This FDC is not a rescue medication; ensure patients have appropriate reliever inhalers and understand the difference.
Avoid antihistamine stacking: Do not combine with other cetirizine/levocetirizine products — no added benefit, increased sedation and adverse effect risk.
Renal function in elderly: Always check eGFR before initiating in elderly patients; levocetirizine accumulation causes excessive sedation and fall risk.
Duration of therapy: Periodically reassess need; many patients with seasonal allergic rhinitis can discontinue after allergen season passes.

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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