Description
Montelukast Sodium Tablets (10 mg)
Healthy Inc is a specialized global supplier and exporter of advanced leukotriene receptor antagonists (LTRAs). We provide high-stability Montelukast Sodium 10 mg Tablets, sourced from WHO–GMP certified solid dosage facilities. This essential respiratory maintenance therapy is a top export to pulmonology clinics, asthma centers, and pharmacy chains in Africa, LATAM, and Southeast Asia, serving as a primary non-steroidal option for long-term airway management.
Product Overview
This formulation contains Montelukast Sodium, a selective agent that blocks the inflammatory response triggered by environmental allergens and exercise.
The “Airway Inflammation” Specialist:
- Mechanism of Action: Montelukast inhibits the Cysteinyl Leukotriene Receptor (CysLT1). Leukotrienes are powerful inflammatory chemicals released by the body during an allergic reaction, causing swelling in the lungs and tightening of the muscles around the airways. By blocking these receptors, Montelukast prevents bronchoconstriction, reduces mucous secretion, and diminishes vascular permeability (edema).
- Steroid-Sparing Effect: Often used as an add-on therapy, it allows some patients to reduce their dose of inhaled corticosteroids while maintaining superior control over asthma symptoms.
- Allergy Management: Beyond the lungs, it effectively treats the symptoms of seasonal and perennial allergic rhinitis by blocking the same inflammatory pathway in the nasal passages.
Product Composition & Strength
We supply this product as Film Coated Tablets for adults (10mg) and Chewable Tablets (4mg/5mg) for pediatric use. The film coating ensures stability against atmospheric moisture.
| Active Ingredient | Strength (Standard) | Therapeutic Role | |
|---|---|---|---|
| Montelukast Sodium BP/USP | 10 mg | Leukotriene Receptor Antagonist | |
| Excipients | Q.S. | Lactose Monohydrate / Croscarmellose Sodium | Disintegrant & Binder |
| Coating Agent | Q.S. | Opadry® Beige/Pink | Moisture Barrier Film |
*Pack Sizes: Alu-Alu Blister packs of 10s, 14s, 28s, or 30s (Calendar Packs).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Distributors.
| HS Code | 3004.90.99 (Other Medicaments – Mixed) |
| Dosage Form | Tablet (Film Coated) |
| Packaging | Alu-Alu Blister (Mandatory to protect from light and moisture) |
| Storage | Store below 30°C. Protect from light and moisture. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Light Sensitivity Management: Montelukast Sodium is sensitive to light (photolabile). Our manufacturing process is conducted under UV-protected lighting, and the final product is housed in opaque Alu-Alu blisters to prevent the formation of the ‘cis’ isomer impurity, ensuring full potency.
- Pediatric Formulation Expertise: We maintain a dedicated line for Chewable Tablets, using high-quality flavoring agents and sweeteners (Mannitol) to ensure patient compliance in young children (2-14 years).
Therapeutic Indications (Human Use)
Indicated for the prophylaxis and chronic treatment of asthma and allergies:
- Asthma Maintenance: Prevention of daytime and nighttime asthma symptoms.
- EIB (Exercise-Induced Bronchoconstriction): Prevention of narrowing of the airways caused by exercise.
- Allergic Rhinitis: Relief of symptoms of hay fever (sneezing, stuffy, runny, itchy nose).
Dosage & Administration
Recommended Dosage (Strictly as per Physician):
- Route: Oral.
- Adults (>15 years): One 10 mg tablet daily.
- Timing (CRITICAL): For asthma, the dose should be taken in the evening. For allergic rhinitis, the time of administration may be individualized to suit patient needs.
- Consistency: Patients must continue taking Montelukast even when their asthma is under control.
Safety Warnings:
- Neuropsychiatric Events: FDA BOXED WARNING: Serious mental health side effects have been reported (agitation, aggression, depression, sleep disturbances). Monitor patients closely for behavioral changes.
- Not a Rescue Inhaler: Montelukast is for long-term prevention. It should never be used to treat an acute asthma attack.
- Eosinophilic Conditions: In rare cases, patients may present with systemic eosinophilia (Churg-Strauss syndrome).
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for OSD (Oral Solid Dosage) forms, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government procurement in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.
Commercial Inquiries
For hospital tenders, bulk export, or distributor pricing, please contact our export team.
WhatsApp/Call: +91 7710003340
Email: info@healthyinc.co.in
