Composition: Montelukast sodium equivalent to Montelukast 4 mg, 5 mg or 10 mg
Dosage form: 4 mg chewable; 5 mg and 10 mg film-coated (per supplied composition)
Usage: Asthma maintenance and selected allergic conditions
Category: Anti Allergic Drugs
Therapeutic category: Leukotriene receptor antagonist / Antiasthmatic
SKU: Montelukast Tablets
Categories: Pharmaceutical Exporter India, Pharmaceutical Formulations India, WHO GMP Certified Formulations
Montelukast Tablets is listed in our pharmaceutical product portfolio for business-to-business enquiries. Product-specific formulation details, available strengths, dosage form, pack configuration and supply terms should be confirmed against the current product specification before ordering.
For distributor, wholesaler, hospital procurement and export enquiries, please request the applicable product specifications, batch documentation, shelf-life information, packaging options and regulatory documents. Availability and documentation depend on the product and destination market.
Manufacturer: Healthy Life Pharma Pvt. Ltd. (WHO-GMP status requires verification)
Exporter: Healthy Inc (Star Export House status requires verification)
Montelukast is a leukotriene receptor antagonist used as a controller medicine for selected patients with asthma and for allergic rhinitis when clinically appropriate. It blocks cysteinyl leukotriene signaling involved in airway inflammation and bronchoconstriction. It is not an antihistamine, inhaled corticosteroid or rescue medicine for an acute asthma attack.
The supplied product compositions specify 4 mg chewable, 5 mg film-coated and 10 mg film-coated tablets. Healthy Life Pharma Pvt. Ltd. is identified as manufacturer and Healthy Inc as exporter; certification and market authorizations require verification.
| Product | Montelukast Sodium Tablets |
|---|---|
| 4 mg | Montelukast sodium equivalent to Montelukast 4 mg; chewable tablet |
| 5 mg | Montelukast sodium equivalent to Montelukast 5 mg; film-coated tablet (as supplied) |
| 10 mg | Montelukast sodium equivalent to Montelukast 10 mg; film-coated tablet |
| Dosage forms | Chewable and film-coated tablets |
| Therapeutic class | Leukotriene receptor antagonist / antiasthmatic |
| Category | Anti Allergic Drugs |
| SKU | Montelukast Tablets |
| Packaging / shelf life | Verify from approved product labels and stability records |
Formulation discrepancy: The supplied 5 mg composition says film-coated, whereas the narrative describes 5 mg chewable tablets. The exact dosage form must be checked against the approved 5 mg pack. The spelling “Montekulast” has been corrected to “Montelukast.”
Manufacture requires validated controls for blending, content uniformity, compression, coating (where applicable), chewable tablet characteristics, and protection from moisture and light as established by stability data. Claims of dedicated low-humidity suites, direct compression, mannitol use, cherry flavor, or exclusive Alu-Alu packaging must be supported by actual batch records and approved specifications.
Quality testing should follow the applicable registered pharmacopoeial specifications for identification, assay, dosage-unit uniformity, dissolution, related substances, microbiological limits where applicable, and stability. Do not apply a universal dissolution percentage or assay range to all three presentations without product-specific approved methods.
Montelukast antagonizes the cysteinyl leukotriene type-1 (CysLT1) receptor. Depending on local labeling, it may be prescribed for asthma prophylaxis/chronic management, exercise-induced bronchoconstriction prevention and allergic rhinitis. Inhaled corticosteroid-containing therapy remains important in asthma management; montelukast should not replace prescribed inhalers without clinician advice.
Allergic rhinitis: Because of potentially serious neuropsychiatric effects, regulators such as the US FDA advise reserving montelukast for patients who have an inadequate response or intolerance to alternative allergy medicines.
Export registration may require market-specific CTD/ACTD dossiers, manufacturing licenses, finished-product specifications, stability studies and certificates of analysis. WHO-GMP, COPP, FSC, export permissions and Star Export House status must be confirmed from current documentary evidence before advertising them as established facts.
Q: Is montelukast an antihistamine?
A: No. It blocks leukotriene receptors rather than histamine H1 receptors.
Q: Can it treat a sudden asthma attack?
A: No. Use the prescribed reliever treatment and seek urgent medical attention if symptoms are severe.
Q: Is the 5 mg product chewable?
A: The supplied composition calls it film-coated, while the descriptive copy calls it chewable. Confirm the marketed formulation before publication.
Q: What changes in mood or behavior matter?
A: New agitation, nightmares, sleep disturbance, depression or suicidal thoughts require prompt medical assessment.
Dosage and age eligibility depend on the approved indication, country and dosage form. The commonly used strengths include 4 mg for some younger children, 5 mg for some school-age children and 10 mg for older adolescents/adults, but the exact age bands and instructions must follow the local approved label. Chewable tablets are chewed as directed; film-coated tablets are swallowed according to their labeling. Do not take additional doses for exercise symptoms when already taking daily montelukast unless specifically instructed.
Boxed neuropsychiatric warning (US): Serious mood, behavior and sleep changes, including suicidal thoughts or actions, have been reported. Discuss risks and alternatives before treatment and contact a clinician promptly if symptoms appear. Other possible adverse effects include headache, abdominal discomfort and upper respiratory symptoms. Rare eosinophilic granulomatosis with polyangiitis has been reported, sometimes in association with corticosteroid reduction. Montelukast is not appropriate as sole rescue treatment for acute bronchospasm.
Store in the original packaging, protected from moisture and light, at the temperature specified on the approved product label. Do not assume a universal below-25°C condition or 24–36 month shelf life without the actual registered stability data. Keep out of reach of children.