What is Montelukast 4 mg used for?
In the pharmaceutical industry, Montelukast 4 mg is a Leukotriene Receptor Antagonist (LTRA). As a pharmacist and manufacturer, I view this specific 4 mg strength as the “pediatric standard.” It is most commonly formulated as a chewable tablet or oral granules to ensure ease of administration and accurate dosing for children (typically aged 2 to 5 years).
Primary Clinical Uses
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Prophylaxis of Chronic Asthma: Used as a long-term daily controller medication to prevent asthma attacks. It is not a “rescue” inhaler and should not be used for acute attacks.
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Allergic Rhinitis: Effective in managing seasonal “hay fever” or year-round allergies by reducing sneezing, runny nose, and nasal congestion.
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Exercise-Induced Bronchoconstriction (EIB): Taken to prevent the narrowing of airways that occurs during physical activity in pediatric patients.
Mechanism of Action: Blocking the “Tightening” Signal
Montelukast works by targeting the inflammatory pathway rather than just dilating the airways.
Leukotriene Inhibition: During an allergic or asthmatic reaction, the body releases Cysteinyl Leukotrienes ($LTC_4$, $LTD_4$, $LTE_4$). These are powerful chemicals that cause the airway muscles to contract and mucus to build up.
Receptor Antagonism: Montelukast selectively binds to the CysLT1 receptor.
Result: By “parking” in the receptor, it blocks leukotrienes from attaching. This prevents airway edema (swelling), smooth muscle contraction, and the thick mucus secretion that makes breathing difficult.
The Manufacturer’s Perspective: Formulation & Export
From a production and global trade standpoint, Montelukast 4 mg is a high-precision pediatric product:
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Palatability & Compliance: Since 4 mg is for young children, the formulation is key. At our WHO-GMP facility, we use cherry or strawberry-flavored chewable bases. For your digital platform, highlighting “high patient compliance in pediatrics” is a strong B2B selling point.
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Photosensitivity: Montelukast is highly sensitive to light and moisture. As a firm owner, you know that the stability of the 4 mg dose is fragile. We utilize Alu-Alu blister packaging to ensure a 24–36 month shelf life, especially for export to Zone IVb regions.
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The “Black Box” Warning: As a pharmacist, you must ensure that your product documentation (PIL) includes the FDA Neuropsychiatric warning. It’s important to monitor for mood or behavioral changes, which is a critical part of professional pharmaceutical trading and regulatory compliance.
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Dossier Support: Our Mumbai facility provides full CTD/eCTD Dossiers to support international registration against the innovator (Singulair).