Montek-LC Tablet combines Montelukast 10 mg (a leukotriene receptor antagonist) and Levocetirizine 5 mg (a second-generation antihistamine). It is prescribed for allergic rhinitis, chronic urticaria, and asthma maintenance in adults and children over 12. One tablet is taken orally once daily, preferably in the evening.
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Formulation Composition Table
| Component | Type | Strength | Function |
|---|---|---|---|
| Montelukast Sodium | Active pharmaceutical ingredient | Equivalent to Montelukast 10 mg | Leukotriene receptor antagonist; reduces airway inflammation |
| Levocetirizine Dihydrochloride | Active pharmaceutical ingredient | Equivalent to Levocetirizine 5 mg | H1-antihistamine; blocks histamine-mediated allergic response |
| Microcrystalline Cellulose | Binder / diluent | q.s. | Provides tablet cohesion and compressibility |
| Hydroxypropyl Methylcellulose (HPMC) | Film-coating polymer | q.s. | Controls moisture barrier and disintegration rate |
| Croscarmellose Sodium | Superdisintegrant | q.s. | Rapid disintegration; target NLT 15 min per IP/USP |
| Magnesium Stearate | Lubricant | q.s. | Reduces die-wall friction during compression |
| Colloidal Silicon Dioxide | Glidant | q.s. | Improves powder flow before compression |
Montelukast Sodium is chemically designated as [R-(E)]-1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetic acid, monosodium salt.[1] Levocetirizine Dihydrochloride is the R-enantiomer of cetirizine, with superior H1-receptor binding affinity compared to the racemate.[2]
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What Is Montek-LC Tablet?
Montek-LC Tablet is a fixed-dose combination (FDC) prescription medicine widely used in India for allergy management and adjunct asthma therapy.[3] It delivers dual pharmacological action: Montelukast targets the leukotriene pathway and Levocetirizine blocks histamine H1-receptors — together covering two distinct inflammatory cascades that drive allergic disease.[2,4]
The Montek-LC tablet is most commonly manufactured by Sun Pharmaceutical Industries Ltd., a company holding USFDA and WHO-GMP approvals.[5] Several other Indian manufacturers — including Cipla, Mankind Pharma, Alkem Laboratories, Lupin, and Intas Pharmaceuticals — produce bioequivalent formulations under their own trademarks (e.g., Montair-LC by Cipla).[3]
Manufacturers and Regulatory Approvals
| Brand Name | Manufacturer | Regulatory Status |
|---|---|---|
| Montek-LC | Sun Pharmaceutical Industries Ltd. | USFDA, WHO-GMP |
| Montair-LC | Cipla Ltd. | USFDA, WHO-GMP |
| Zinte-M | Laafon Galaxy Pharmaceuticals | Schedule M (India) |
| Levocet-M | Hetero Labs Ltd. | WHO-GMP |
| Montemac-L | Macleods Pharmaceuticals | WHO-GMP |
| Generic versions | Alkem, Lupin, Intas, others | Schedule M, WHO-GMP |
All tablets marketed in India for prescription sale must comply with Schedule H of the Drugs and Cosmetics Act, 1940 and meet the quality standards specified in the Indian Pharmacopoeia (IP).[6] Manufacturers supplying export markets must additionally satisfy the standards of the destination country’s regulatory authority (e.g., USFDA 21 CFR, EMA/EU GMP Annex 1 for sterile lines, WHO Technical Report Series for prequalification).[7]
Also Read: Pharma top 10 companies in India
Mechanism of Action: How Montek-LC Tablet Works
Step 1 — Montelukast Blocks the Leukotriene Pathway
Leukotrienes (LTC4, LTD4, LTE4) are inflammatory mediators released from mast cells and eosinophils during allergic reactions. They bind to cysteinyl leukotriene receptors (CysLT1) in the airways, causing bronchoconstriction, mucus hypersecretion, and mucosal edema.[4] Montelukast selectively and competitively blocks the CysLT1 receptor, interrupting this cascade at its receptor level.[1,4]
Step 2 — Levocetirizine Blocks the Histamine Pathway
Histamine, released from mast cells during allergen exposure, binds to H1-receptors on sensory nerve endings and vascular endothelium, producing sneezing, rhinorrhoea, pruritus, and urticaria.[2] Levocetirizine competitively and selectively antagonises peripheral H1-receptors with minimal CNS penetration compared to first-generation antihistamines, reducing sedation risk.[2,8]
Synergistic Effect in Practice
Because allergy involves both the leukotriene and histamine pathways simultaneously, monotherapy with either agent alone may leave residual symptoms. The FDC of Montelukast + Levocetirizine offers broader symptom control with a single daily dose.[3,4]
Clinical example: A patient with perennial allergic rhinitis and mild asthma experiences nasal congestion, watery eyes, and nocturnal wheeze. After 2–4 weeks on Montek-LC once nightly, leukotriene-driven bronchoconstriction and histamine-mediated rhinorrhoea both decrease significantly, improving sleep quality and daytime function.[4,8]
Indications and Approved Uses
Montek-LC tablet is prescribed for the following conditions, consistent with evidence-based clinical guidelines:[3,4,8]
- Seasonal allergic rhinitis (SAR): Sneezing, nasal congestion, rhinorrhoea, and itchy eyes triggered by pollen or other seasonal allergens
- Perennial allergic rhinitis (PAR): Year-round nasal symptoms driven by house dust mites, pet dander, or mould
- Chronic spontaneous urticaria (CSU): Recurrent hives lasting more than 6 weeks without identifiable external trigger
- Bronchial asthma (maintenance): As adjunct therapy alongside inhaled corticosteroids; not for acute bronchospasm relief
- Allergic skin conditions: Pruritus and rash of allergic origin
- Exercise-induced bronchoconstriction (EIB): Montelukast component has evidence for prevention when taken at least 2 hours before exercise[4]
Can Montek-LC Tablet Be Used for Dry Cough?
Montelukast has demonstrated benefit in chronic cough associated with allergy or airway hyper-reactivity, as leukotrienes contribute to cough reflex sensitisation.[9] However, the Global Initiative for Asthma (GINA) and international cough guidelines recommend Montelukast-containing products for allergy- or asthma-driven cough, not for acute viral upper respiratory tract infection-related cough.[4,9] A physician should rule out infectious, ACE-inhibitor-related, and GERD-related causes before prescribing Montek-LC for cough.
Dosage and Administration
| Patient Group | Standard Dose | Route | Timing |
|---|---|---|---|
| Adults and adolescents ≥12 years | 1 tablet (Montelukast 10 mg + Levocetirizine 5 mg) once daily | Oral | Evening (for asthma and rhinitis control overnight) |
| Children 6–11 years | Physician-directed; weight-adjusted paediatric formulations preferred | Oral | Consult prescriber |
| Children <6 years | Not recommended with this FDC tablet | — | — |
| Hepatic impairment (severe) | Use with caution; dose adjustment may be required | Oral | Consult specialist |
| Renal impairment (CrCl <10 mL/min) | Contraindicated for Levocetirizine component | — | — |
Administration notes:
- Swallow the tablet whole; do not crush, split, or chew, as the film coat controls dissolution rate.[6]
- Take at the same time each day to maintain steady-state plasma levels.
- Montelukast reaches peak plasma concentration in approximately 3–4 hours when taken in the fasting state.[1]
- Levocetirizine reaches peak plasma concentration in approximately 0.9 hours.[2]
Side Effects and Safety Profile
Common Adverse Effects (>1% incidence)
- Somnolence and fatigue (primarily Levocetirizine; reported in approximately 10% of patients in controlled trials)[8]
- Headache
- Dry mouth
- Nausea and abdominal discomfort
- Pharyngitis and upper respiratory symptoms
- Skin rash (usually mild)
Serious / Rare Adverse Effects
The FDA issued a boxed warning for Montelukast in March 2020, highlighting the risk of serious neuropsychiatric events including agitation, aggression, anxiety, depression, hallucinations, insomnia, irritability, restlessness, suicidal ideation and behaviour, and tremor.[10] This risk applies to the Montelukast component within Montek-LC.
Additional rare serious reactions include:
- Anaphylaxis and angioedema (hypersensitivity to either active ingredient)
- Elevated hepatic transaminases (Churg-Strauss syndrome has been reported in a small number of patients with severe asthma reducing oral corticosteroid doses while on Montelukast)[1]
- Eosinophilic granulomatosis with polyangiitis (formerly Churg-Strauss syndrome) — rare
Contraindications
- Known hypersensitivity to Montelukast, Levocetirizine, cetirizine, hydroxyzine, or any excipient
- Severe renal impairment (creatinine clearance <10 mL/min) due to Levocetirizine accumulation[2]
- Rare hereditary galactose intolerance (if lactose present as excipient)
Use in Special Populations
- Pregnancy: Montelukast is classified FDA Category B (animal studies show no fetal risk, but adequate human data are limited); Levocetirizine is Category B.[1,2] Use only if clearly needed; benefit-risk decision rests with the prescriber.
- Lactation: Montelukast and Levocetirizine are excreted in breast milk; breastfeeding is generally not recommended during therapy.[2]
- Elderly: Levocetirizine clearance decreases with age; monitor for increased sedation and urinary retention.
Drug Interactions
| Interacting Agent | Mechanism | Clinical Management |
|---|---|---|
| Rifampicin, Phenobarbital, Phenytoin | CYP3A4/CYP2C8 inducers reduce Montelukast plasma levels | Monitor efficacy; consider alternative anti-allergic therapy |
| CNS depressants (benzodiazepines, opioids, alcohol) | Additive sedation with Levocetirizine | Advise patients to avoid alcohol; caution with sedatives |
| Theophylline | Possible increase in theophylline AUC | Monitor theophylline levels |
| MAO inhibitors | Increased risk of adverse CNS effects | Avoid combination |
Regulatory and GMP Manufacturing Guidance
Applicable Standards
Manufacturers producing Montelukast + Levocetirizine FDC tablets in India must comply with:[6,7]
- Schedule M (revised 2023) of the Drugs and Cosmetics Act — GMP requirements for pharmaceutical products
- Indian Pharmacopoeia (IP) monographs for individual actives and finished tablet tests
- WHO Technical Report Series No. 986 (Good Manufacturing Practices for pharmaceutical products: main principles) for export-grade production
- USFDA 21 CFR Part 211 for US-destined products
Critical In-Process Controls
| Control Parameter | Specification | Frequency |
|---|---|---|
| Blend uniformity (Montelukast) | RSD ≤5.0% | Per blend batch |
| Tablet hardness | 5–9 kP (indicative; per validated range) | Every 30 minutes |
| Disintegration time | NMT 15 minutes (per IP) | Each batch start and end |
| Friability | NMT 1.0% w/w | Per batch |
| Dissolution (Montelukast) | NLT 80% (Q) at 30 min, pH 6.8 phosphate buffer | Per batch |
| Weight variation | ±5% of mean tablet weight | Every 30 minutes |
| Assay (both actives) | 90.0%–110.0% of label claim | Per batch |
Stability Requirements
Tablets should be stored at controlled room temperature (≤25°C / 60% RH in India) and must demonstrate stability over the labelled shelf life under ICH Q1A(R2) long-term (30°C/65% RH) and accelerated (40°C/75% RH) conditions.[7] Montelukast is known to be photosensitive; packaging must provide adequate light protection (amber HDPE bottles or aluminium blister).
Guidance for Plant Owners (Baddi / Uttarakhand Clusters)
Pharma plants planning to manufacture or contract-manufacture this FDC should ensure:
- Dedicated or segregated production lines for combined antihistamine–antileukotriene tablets to prevent cross-contamination
- Validated cleaning procedures (equipment train from dispensing to coating)
- Complete batch manufacturing records (BMR) with traceability of API lots, including Certificates of Analysis (CoA) from qualified suppliers
- Pharmacovigilance reporting for neuropsychiatric adverse events per the CDSCO pharmacovigilance programme
- Stability programme compliant with ICH Q1A(R2) for new product introductions[7]
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Market Pricing and ROI Analysis
Retail Price Comparison (India, per 10–15 tablet strip)
| Brand | Pack Price (₹) | Manufacturer | Price per Tablet (₹) |
|---|---|---|---|
| Montek-LC | 306–340 | Sun Pharmaceutical Industries | ~20–23 |
| Montair-LC | ~310 | Cipla Ltd. | ~20–21 |
| Zinte-M | 99 | Laafon Galaxy Pharmaceuticals | ~10 |
| Levocet-M | 108.75 | Hetero Labs | ~11 |
| Montemac-L | 163 | Macleods Pharmaceuticals | ~16 |
Prices are approximate retail MRP figures; actual trade prices vary. Verify current pricing with distributors.
ROI Considerations for Manufacturers and Distributors
- India’s allergic rhinitis prevalence is estimated at 20–30% of the urban population, with asthma affecting approximately 6% of the adult population, creating a large and stable addressable market.[3]
- The Montelukast + Levocetirizine FDC segment benefits from year-round demand (perennial rhinitis) with seasonal peaks (pollen seasons).
- Competitive generic pricing at ₹99–₹165 per strip versus branded prices at ₹300+ demonstrates significant margin opportunity for compliant generic manufacturers.
- Multi-brand licensing to regional distributors (PCD pharma franchise model) maximises geographic coverage in tier-2 and tier-3 markets.
- USFDA/WHO-GMP certification opens export channels to regulated markets (US, EU, ASEAN, Africa), where Montelukast + antihistamine combinations command significantly higher ex-factory prices.
Substitutes: What to Consider Before Switching
Generic formulations contain the same active pharmaceutical ingredients at equivalent labelled doses but may differ in excipient composition, manufacturing process, and dissolution profile.[6] Before substituting:
- Confirm bioequivalence data is available for the generic product (BA/BE studies per Schedule Y / 21 CFR Part 320)
- Check dissolution specifications match the reference listed drug
- Advise patients not to self-switch; brand switching should be physician-directed
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FAQs
How long does Montek-LC Tablet take to work?
Levocetirizine provides symptomatic relief of nasal and skin allergy within 1–2 hours of the first dose. Montelukast requires 1–2 weeks of consistent daily dosing for full anti-inflammatory benefit in rhinitis and asthma maintenance.[1,8]
Is Montek-LC tablet safe to take every day long-term?
Yes, when prescribed by a physician. Clinical trials support Montelukast use for up to 52 weeks in asthma without loss of efficacy or safety signal escalation.[4] Long-term use should include periodic review for neuropsychiatric symptoms, per the FDA boxed warning.[10]
Can I take Montek-LC tablet if I am pregnant?
Montelukast is FDA Category B and Levocetirizine is also Category B; neither is proven safe in human pregnancy.[1,2] Use only if your doctor determines the benefit outweighs the risk. Do not self-medicate during pregnancy.
Does Montek-LC tablet cause drowsiness?
Levocetirizine causes mild drowsiness in approximately 10% of users in controlled trials, significantly less than first-generation antihistamines.[8] Taking the tablet in the evening minimises functional impairment during the day.
What is the company name for Montek-LC Tablet?
The original branded Montek-LC is manufactured by Sun Pharmaceutical Industries Ltd. Other equivalent formulations are produced by Cipla (Montair-LC), Laafon Galaxy (Zinte-M), Hetero Labs (Levocet-M), Macleods (Montemac-L), and several other WHO-GMP–approved Indian manufacturers.[3,5]
Can Montek-LC treat cough?
Only if the cough is driven by allergy or airway hyper-reactivity (e.g., cough-variant asthma or allergic bronchitis).[9] It is not effective for coughs caused by viral infections, ACE inhibitors, or GERD. Self-medication is not advised; always consult a physician.
References:-
- U.S. National Library of Medicine. Montelukast Sodium: Drug Label Information (Singulair). DailyMed, National Institutes of Health. 2020. Available from: https://dailymed.nlm.nih.gov/dailymed/
- U.S. National Library of Medicine. Levocetirizine Dihydrochloride: Drug Label Information (Xyzal). DailyMed, National Institutes of Health. 2017. Available from: https://dailymed.nlm.nih.gov/dailymed/
- Indian Pharmaceutical Alliance; CDSCO. Fixed Dose Combinations: Regulatory Framework and Clinical Guidance. New Delhi: Ministry of Health and Family Welfare, Government of India; 2019.
- Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. GINA Report 2023. Available from: https://ginasthma.org/reports/
- Sun Pharmaceutical Industries Ltd. Annual Report 2023–2024. Mumbai: Sun Pharma; 2024. Available from: https://www.sunpharma.com/investors/annual-reports
- Ministry of Health and Family Welfare, Government of India. The Drugs and Cosmetics Act, 1940 and Rules, 1945 — Schedule M (Revised 2023). New Delhi: CDSCO; 2023. Available from: https://cdsco.gov.in/
- World Health Organization. WHO Good Manufacturing Practices for Pharmaceutical Products: Main Principles. WHO Technical Report Series No. 986, Annex 2. Geneva: WHO; 2014. Available from: https://www.who.int/publications/
- Church MK, Maurer M. H1-antihistamines and inducible urticaria: why are nonsedating antihistamines preferred? Allergy. 2017;72(7):1011–1013.
- Dicpinigaitis PV, Morice AH, Birring SS, McGarvey L, Smith JA, Canning BJ, et al. Antitussive drugs — past, present, and future. Pharmacol Rev. 2014;66(2):468–512.
- U.S. Food and Drug Administration. FDA Drug Safety Communication: FDA requires labeling changes for montelukast (Singulair) due to risk of serious neuropsychiatric events. Silver Spring, MD: FDA; March 2020. Available from: https://www.fda.gov/drugs/drug-safety-and-availability/
