Montelukast + Levocetirizine (FDC) Schedule (India)

Schedule H

Montelukast + Levocetirizine (FDC) Routes

Oral

Montelukast + Levocetirizine (FDC) Formulations

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

Montelukast + Levocetirizine (FDC) Adult indications

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

Allergic Rhinitis (Seasonal and Perennial)

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:

Evening administration preferred due to circadian rhythm of leukotriene release

Duration: Short-term (2–4 weeks for seasonal) or long-term for perennial rhinitis based on response

Reassess need periodically; not intended for indefinite use without review

Coexisting Asthma with Allergic Rhinitis (Symptom Control Adjunct)

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:

Used as add-on therapy; NOT a substitute for inhaled corticosteroids in asthma

Suitable for patients with mild persistent asthma and concurrent allergic rhinitis

Reassess asthma control every 4–6 weeks

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.

Montelukast + Levocetirizine (FDC) Paediatric indications

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

Allergic Rhinitis (Seasonal/Perennial)

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

Asthma with Allergic Rhinitis (Add-on Therapy)

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:

Not recommended below 2 years of age except under paediatric allergy/immunology specialist supervision

FDC not adequately studied in infants

Safety Monitoring in Children:

Monitor for behavioural changes, sleep disturbances, mood alterations

Assess for sedation affecting school performance

Periodic review of ongoing need

Montelukast + Levocetirizine (FDC) Renal Adjustments

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

Montelukast + Levocetirizine (FDC) Hepatic adjustment

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.

Montelukast + Levocetirizine (FDC) Contraindications

Known hypersensitivity to montelukast, levocetirizine, cetirizine, hydroxyzine, or any excipients

Severe renal impairment (eGFR <30 mL/min) — absolute for FDC due to levocetirizine

Severe hepatic impairment or active liver disease

Children <2 years (FDC not approved or adequately studied)

Concurrent use with other cetirizine-containing products

Montelukast + Levocetirizine (FDC) Cautions

Neuropsychiatric symptoms (montelukast component): Agitation, aggressive behaviour, anxiety, depression, sleep disturbances, suicidal ideation — counsel caregivers, monitor closely

Patients with history of psychiatric disorders

CNS depression risk with levocetirizine — advise caution with driving/operating machinery

Concurrent use of alcohol or other CNS depressants

Patients with epilepsy (rare seizure reports with levocetirizine)

Acute asthma exacerbation — not for acute bronchospasm relief; not a substitute for rescue inhalers or ICS

Prostatic hypertrophy or urinary retention (anticholinergic effects minimal but possible)

Elderly with reduced renal reserve.

Montelukast + Levocetirizine (FDC) Pregnancy

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

Montelukast + Levocetirizine (FDC) Lactation

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

Montelukast + Levocetirizine (FDC) Elderly

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

Montelukast + Levocetirizine (FDC) Major drug interactions

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

Montelukast + Levocetirizine (FDC) Moderate drug interactions

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

Montelukast + Levocetirizine (FDC) Common Adverse effects

Somnolence, drowsiness

Fatigue

Headache

Dry mouth

Abdominal pain, nausea

Pharyngitis, upper respiratory symptoms

Dizziness

Increased appetite (children)

Montelukast + Levocetirizine (FDC) Serious Adverse effects

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

Montelukast + Levocetirizine (FDC) Monitoring requirements

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

Montelukast + Levocetirizine (FDC) Brands in India

Montair LC (Cipla)

Montek LC (Sun Pharma)

LC Montus (Mankind)

Odimont LC (Zydus)

Levocet M (Glenmark)

Montemac LC (Macleods)

Monte-L (Alkem)

Romilast LC (Ranbaxy/Sun)

Montelukast + Levocetirizine (FDC) Price range (INR)

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) 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.

Montelukast + Levocetirizine (FDC) Tags

montelukast; levocetirizine; FDC; allergic rhinitis; asthma adjunct; antihistamine; LTRA; paediatric; neuropsychiatric risk; renal-caution; Schedule H

Montelukast + Levocetirizine (FDC) Version

RxIndia v1.0 — 05 Jan 2025

Montelukast + Levocetirizine (FDC) Reference

CDSCO approved prescribing information

Indian Pharmacopoeia / National Formulary of India

NLEM 2022 (not listed)

API Textbook of Medicine

AIIMS Drug Formulary

IAP Guidelines for Allergic Rhinitis and Asthma in Children

Indian Association of Dermatologists, Venereologists and Leprologists (IADVL) urticaria guidelines

Indian specialist practice (Pulmonology, ENT, Allergy)

Goodman & Gilman's The Pharmacological Basis of Therapeutics

RxIndia

The Drug Registry

Montelukast + Levocetirizine (FDC)