Montelukast and Levocetirizine: Uses, Side Effects, Dose and Brands in India (2026)

• Updated 9 October 2026
• Reviewed by Sudhanshu Singhal
• 22 min read
• 55 sources

Products listed on PharmEasy at a glance

All the MRPs above are the listed prices on the PharmEasy e-pharmacy, read on 9 October 2026. They change from time to time, so please check the current price at the chemist or on the e-pharmacy before you buy. The list is by availability on that e-pharmacy, not by sales.

What is montelukast + levocetirizine (and each alone)?

Montelukast + levocetirizine is a fixed-dose combination of two anti-allergy medicines of different classes, sold in India mainly as tablets and syrups. Each acts on a different chemical messenger in the allergy chain, which is why doctors sometimes prescribe them together.

Levocetirizine

Levocetirizine is the active (R) enantiomer of cetirizine and belongs to the antihistamine group; its main effect comes from selective blocking of H1 receptors. It reaches its peak blood level about 0.9 hour after a tablet, less than 14% of it is metabolised, and it is mainly excreted unchanged through the kidneys, which is why kidney function matters for dosing. In allergic-rhinitis exposure studies, a 5 mg tablet showed an onset of action one hour after intake.

Montelukast

Montelukast is a leukotriene receptor antagonist: it binds with high affinity to the CysLT1 receptor and blocks the action of leukotriene D4 there. Cysteinyl leukotrienes are released from mast cells and eosinophils and, in allergic rhinitis, from the nasal lining after allergen exposure; they cause swelling, mucus and airway narrowing. Montelukast contains no steroid and it controls the symptoms of asthma and allergic rhinitis but does not cure them.

In plain words, levocetirizine blocks histamine, which drives sneezing, itching and a runny nose, while montelukast blocks leukotrienes, which drive swelling, mucus and tightening of the airways. In the combination, levocetirizine adds the antihistamine part of symptom relief and montelukast adds the leukotriene part.

Forms and strengths sold in India

• Adult tablet: levocetirizine 5 mg + montelukast 10 mg, in strips of 10 or 15.
• Children's forms: montelukast 4 mg + levocetirizine 2.5 mg dispersible tablet and syrup (Cipla's Montair-LC Kid), and Torrent's Lezyncet-M suspension with levocetirizine dihydrochloride 2.5 mg + montelukast 4 mg per 5 mL.
• Levocetirizine alone: the 5 mg tablet is the common strength in India; PharmEasy also lists Dr Reddy's Xyzal 10 mg tablets and a Xyzal 2.5 mg/5 mL syrup of 60 mL (listing titles only).
• Abroad, the US labels describe montelukast 10 mg film-coated tablets, 5 mg and 4 mg chewable tablets and 4 mg oral granules, and levocetirizine 5 mg scored tablets (can be halved to 2.5 mg) and 2.5 mg/5 mL oral solution.
• No single-pill montelukast + levocetirizine label was found in the US DailyMed database; it is mainly an India-market product.

What is it used for?

In India, montelukast + levocetirizine is indicated for the relief of symptoms of allergic rhinitis (seasonal and perennial), as stated in the manufacturer product information. Cipla's page for Montair-LC tablets and the Kid dispersible tablet and syrup gives this indication for all the forms. Torrent's Uvnil Mont prescribing information states "for the treatment of allergic rhinitis in adults only", and its Lezyncet-M suspension is stated "for the treatment of Allergic Rhinitis in Children aged 2 years and above" (tablets are preferred from 15 years).

None of the three Indian product-information documents we read lists asthma or hives as an indication of the combination; allergic rhinitis is the only indication stated. E-pharmacy pages that also mention asthma or urticaria are marketing text, not regulator text. Published clinical trials report that the combination improved daytime nasal symptom scores more than single-drug treatment in allergic rhinitis, with similar adverse-event rates, but the decision to prescribe it rests with the treating doctor.

Levocetirizine alone

The US prescription label lists perennial allergic rhinitis symptoms in children 6 months to 2 years and the uncomplicated skin manifestations of chronic idiopathic urticaria (hives) in adults and children 6 months and older. The US over-the-counter Drug Facts label states temporary relief of runny nose, sneezing, itchy watery eyes and itching of the nose or throat due to hay fever or other respiratory allergies. The UK product information lists symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) and urticaria in adults and children 6 years and above.

Montelukast alone

The US label lists prophylaxis and chronic treatment of asthma in adults and children 12 months and older, and prevention of exercise-induced bronchoconstriction in patients 6 years and older. It also lists relief of symptoms of seasonal allergic rhinitis (2 years and older) and perennial allergic rhinitis (6 months and older), with use reserved for patients who do not respond to or cannot tolerate other therapies; the FDA repeated this in its safety communication of 4 March 2020. The UK product information lists it as add-on treatment of mild to moderate persistent asthma not controlled on inhaled steroids, relief of seasonal allergic rhinitis in those asthma patients, and prophylaxis where exercise-induced bronchoconstriction is the main component.

What it is not used for

Montelukast is not indicated for the treatment of an acute asthma attack; patients must keep the rescue medicine prescribed by the doctor and use it for sudden symptoms. Montelukast should not be abruptly substituted for inhaled or oral corticosteroids, and patients with aspirin-sensitive asthma must keep avoiding aspirin and NSAIDs.

Dose as stated in the labels

Every regimen below is the dose stated in the product label or product information; always take the medicine exactly as prescribed by your doctor, and never change the dose yourself.

The Indian combination

• Cipla Montair-LC: adults and adolescents over 15 years, one tablet once daily. The Kid form is for children 2 to 5 years: one dispersible tablet once daily, dispersed in a teaspoon of boiled and cooled water immediately before giving, or 5 mL of syrup once daily measured with the cup supplied.
• Torrent Lezyncet-M: adults and children aged 15 and above, one film-coated tablet daily; children 2 years and above, 5 mL of suspension (2.5 mg levocetirizine + 4 mg montelukast) daily. The suspension is shaken well and measured with the dosing cup.
• Food: Torrent's information states the combination can be taken with or without food.
• Time of day: none of the Indian product-information text states a time of day. The component labels point to the evening, and the US label says the time of day for allergic rhinitis can be individualised to suit the patient.
• Age bands differ between labels, so give exactly the dose and age band the doctor and the pack state.

Montelukast alone

The US label for asthma states once daily in the evening, with or without food: one 10 mg tablet for 15 years and above, one 5 mg chewable tablet for 6 to 14 years, one 4 mg chewable tablet or 4 mg granules for 2 to 5 years and one 4 mg granule packet for 12 to 23 months. For a missed dose, the label says to take the next dose at the regular time and not to take two doses together. For allergic rhinitis the label states once daily without regard to food, and patients with both asthma and allergic rhinitis take only one dose once daily in the evening; the UK information for the 10 mg tablet states one tablet daily in the evening for 15 years and above.

Levocetirizine alone

The US prescription label states 5 mg once daily in the evening for adults and children 12 years and above (some patients are controlled on 2.5 mg), 2.5 mg once daily in the evening for children 6 to 11 years and 1.25 mg once daily in the evening for children 6 months to 5 years. The US over-the-counter label states one 5 mg tablet in the evening for ages 12 to 64, with a maximum of one tablet in 24 hours (half a tablet may suit less severe symptoms), half a tablet for ages 6 to 11, no use under 6 years and a doctor's advice from 65 years. The UK information states one 5 mg tablet daily for adults and children 6 years and above, swallowed whole with liquid, with or without food.

Levocetirizine can be taken with or without food; a high-fat meal delays the peak level by about 1.25 hours and lowers it by about 36%, but total exposure is unchanged. Because it is mainly excreted unchanged by the kidneys, the labels give lower doses or longer intervals in kidney impairment, and the doctor decides the correct schedule.

Side effects

The commonest side effects are sleepiness, dry mouth and tiredness with levocetirizine, and headache with montelukast. Serious neuropsychiatric events have been reported with montelukast and carry a boxed warning in the US label; their frequency is not established.

Common side effects

• Levocetirizine 5 mg, adults 12 years and above (1 to 6 week trials, 1,070 patients against 912 on placebo): somnolence 6% against 2%, nasopharyngitis 4% against 3%, fatigue 4% against 2%, dry mouth 2% against 1%, pharyngitis 1% against 1%; mostly mild to moderate, and somnolence rose with the dose.
• UK information for levocetirizine 5 mg (935 patients against 771 on placebo): somnolence 5.2% against 1.4%, dry mouth 2.6% against 1.6%, fatigue 2.5% against 1.2%, headache 2.6% against 3.2%.
• Children 6 to 12 years on 5 mg: somnolence in about 3% against under 1% on placebo.
• Montelukast, adults with asthma (1,955 against 1,180 on placebo): headache 18.4% against 18.1%, abdominal pain 2.9% against 2.5%, dyspepsia 2.1% against 1.1%, dizziness 1.9% against 1.4%, fatigue 1.8% against 1.2%, rash 1.6% against 1.2%.
• The UK product information lists headache, diarrhoea, nausea, vomiting, rash, fever and raised liver enzymes as common, and drowsiness, dizziness, dry mouth, tiredness, dream abnormalities including nightmares, insomnia, sleepwalking, anxiety, agitation and depression as uncommon.
• The Indian combination product information lists headache, somnolence, dry mouth, fatigue, asthenia, abdominal pain, constipation, diarrhoea, dizziness, tremor, rash and raised liver enzymes among the reactions seen with the two drugs together.

Serious side effects

Montelukast carries a boxed warning in the US label for serious neuropsychiatric events, including agitation, aggression, depression, sleep disturbances and suicidal thoughts and behaviour. The label lists further events such as anxiousness, disorientation, hallucinations, insomnia, irritability, memory impairment, obsessive-compulsive symptoms, restlessness, sleepwalking, stuttering, tic and tremor; they have been seen in adults, adolescents and children, with or without a psychiatric history, and some cases persisted after stopping. The FDA instruction is that patients and caregivers should watch for behaviour or mood changes and, if they occur, stop montelukast and contact a healthcare provider immediately. The UK regulator MHRA also highlights the risk of neuropsychiatric reactions in its drug safety update of 29 April 2024, which notes that leaflets and product information for all UK montelukast products now carry a black box.

Other serious events listed for montelukast include eosinophilia with vasculitis, liver injury, severe skin reactions, anaphylaxis, pancreatitis, seizures and increased bleeding tendency. For levocetirizine, post-marketing reports include angioedema, anaphylaxis and seizures; urinary retention has been reported after approval; and severe new itching (pruritus) can start within days of stopping after long-term use. Contact your healthcare professional about any of these effects. In the 2026 meta-analysis of seven randomised trials, adverse-event rates were similar for the combination and single-drug treatment.

Who should not take it, and interactions

Both drugs are contraindicated in people who are allergic to them, and levocetirizine is additionally contraindicated in end-stage kidney disease and in dialysis patients.

• Allergy: do not take levocetirizine if you are allergic to levocetirizine, cetirizine, hydroxyzine or related piperazine derivatives; do not take montelukast if you are allergic to any component of the product.
• Kidneys: levocetirizine is contraindicated in end-stage kidney disease and in dialysis, and the labels give lower doses in milder kidney impairment. A fixed tablet cannot be re-dosed for kidney function, so people with kidney disease should ask the doctor; Torrent's information contraindicates severe renal impairment below 10 mL/min creatinine clearance.
• Alcohol and sedatives: levocetirizine with alcohol or other central nervous system depressants should be avoided, as alertness falls further.
• Driving and machines: the US label cautions against driving or hazardous work needing full alertness after levocetirizine; the UK information notes some patients get somnolence, fatigue and asthenia.
• Other cautions: enlarged prostate or spinal cord lesion (urinary retention with levocetirizine), epilepsy, allergy skin tests (blocked for three days before), a history of mental-health problems (tell the doctor before montelukast), liver disease, aspirin-sensitive asthma, and phenylketonuria with chewable forms containing aspartame.
• Interactions: phenobarbital lowered montelukast exposure by about 40%, and caution is advised with phenytoin, phenobarbital and rifampicin; gemfibrozil raised montelukast exposure 4.4-fold. Ritonavir raised cetirizine exposure by about 40% and theophylline 400 mg lowered cetirizine clearance by about 16%.

Pregnancy and breastfeeding

For levocetirizine in pregnancy, the UK information says use may be considered if necessary, on the basis of over 1,000 cetirizine pregnancy outcomes showing no malformation or foetal toxicity; the US label says published data are insufficient to identify a drug-associated risk. For montelukast, the US label says cohort studies over decades have not established a drug-associated risk of major birth defects, while the UK information says use only if clearly essential; Cipla's information for the combination says the same and is not recommended during lactation. If you are pregnant, planning a baby or breastfeeding, discuss the medicine with your doctor before taking it.

Rules in India

Levocetirizine and montelukast are listed in Schedule H of the Drugs and Cosmetics Rules, 1945, so they are sold only against a doctor's prescription, and montelukast tablets in the NLEM strengths are price-controlled by the NPPA.

• Schedule H: the Drugs and Cosmetics Rules, 1945 (CDSCO-hosted copy as amended up to 31 December 2016) list Cetirizine hydrochloride (no. 104), Levocetirizine (no. 285) and Montelukast sodium (no. 336) in Schedule H.
• NLEM 2022: montelukast is item 24.1.5 in Section 24 (medicines acting on the respiratory tract), at level S,T, in tablet 4 mg, 5 mg (including chewable) and 10 mg, and was newly added in NLEM 2022.
• NLEM 2022 lists cetirizine as the antihistamine (Section 3.2, tablet 10 mg and oral liquid 5 mg/5 mL); levocetirizine alone and the montelukast + levocetirizine combination do not appear in the NLEM 2022 text.
• DPCO 2013: single-ingredient montelukast tablets in NLEM strengths are scheduled formulations with NPPA ceiling prices. The NPPA worksheet for the montelukast 5 mg tablet gives a ceiling price of ₹12.01 per tablet (without GST) with effect from 1 April 2023 or the date of notification, whichever is later, and the worksheet was revised after a review order dated 19 February 2024.
• Levocetirizine alone is a non-scheduled formulation, so under paragraph 20 of DPCO 2013 its MRP may not be raised by more than 10% in 12 months. We found no NPPA ceiling price for levocetirizine alone or for the combination.
• Under DPCO 2013, a formulation made by an existing manufacturer by combining an NLEM drug with another drug is treated as a new drug for price-control purposes; whether a particular combination brand has an NPPA-fixed price depends on the company, so please check the current retail price.
• CDSCO's Subject Expert Committee (Pulmonary) minutes of 5 November 2024 note that the montelukast 4 mg + levocetirizine 2.5 mg syrup and the levocetirizine 2.5 mg + montelukast 5 mg dispersible tablet are already approved by CDSCO; the minutes do not state the indication.

Brand landscape in India

Many companies market the 5 mg + 10 mg combination in India, and the brands in the table above are those with a listing on the PharmEasy e-pharmacy that we read on 9 October 2026. The list is by availability on that e-pharmacy, not by sales, and no published sales ranking was found for most of these brands. One published source, IQVIA data in Motilal Oswal's Healthcare Monthly of 13 February 2025 (MAT January 2025), shows Montair-Lc of Cipla at INR 3,019 million and Montek-Lc of Sun Pharma at INR 2,458 million in their respective companies' top-10 drug tables; those are per-company tables and not a cross-company ranking of combination brands. Prices and packs change, so treat the table as a snapshot and confirm before buying or stocking.

The Vibcare range

Vibcare Pharma supplies levocetirizine 5 mg and 10 mg tablets, levocetirizine 2.5 mg syrup, the montelukast 4 mg + levocetirizine 2.5 mg children's tablets and syrups, and montelukast 10 mg + levocetirizine 5 mg tablets in 10x10 and 10x15 alu-alu packs, along with other montelukast and levocetirizine combinations across 11 divisions.

This range is available to PCD franchise partners, with one partner appointed per district and monopoly rights confirmed in writing.

Frequently asked questions

Sources

Related reading

• PCD pharma franchise with Vibcare
• Browse the Vibcare product range