At your WHO-GMP facility in Mumbai, the 10 mg film-coated tablet is your primary adult SKU, offering a non-steroidal alternative for long-term respiratory management.

Primary Clinical Indications

• Chronic Asthma: Used for the long-term prevention of asthma symptoms in adults and adolescents. It is a “preventer,” not a “rescue” medication.

• Allergic Rhinitis: Effective for both seasonal (hay fever) and perennial (year-round) allergies, especially when symptoms include significant nasal congestion.

• Exercise-Induced Bronchoconstriction (EIB): Taken at least 2 hours before exercise to prevent the narrowing of airways during physical activity.

Mechanism: Blocking the Cysteinyl Leukotrienes

Inflammatory Trigger: When exposed to allergens, the body releases leukotrienes—powerful inflammatory chemicals that are 1,000 times more potent than histamine at causing airway constriction.

Receptor Blockade: Montelukast selectively binds to the CysLT₁ receptor found in the human airway.

Result: By “parking” in these receptors, it prevents leukotrienes from causing swelling, excess mucus production, and the tightening of the muscles around the airways.

The Pharmacist’s “Technical Warning”

As you promote your pharmaceutical firm on digital and social platforms, providing these technical insights is essential for professional authority:

• The “Black Box” Warning: In 2020, the FDA issued a serious warning regarding neuropsychiatric events. Patients should be monitored for mood changes, aggression, agitation, or suicidal thoughts.

• Optimal Timing: For asthma, the 10 mg tablet should be taken in the evening to coincide with the natural peak of leukotriene production during the night. For allergic rhinitis, the timing can be flexible.

• Not for Acute Attacks: It will not stop a sudden asthma attack. Patients must always have a fast-acting “rescue” inhaler (like Salbutamol).

The Manufacturer’s Perspective: Technical & Export

From a production and B2B standpoint at your facility in Mumbai:

• The “FDC” Opportunity: On your marketplace, highlight your Montelukast + Levocetirizine combinations. This Fixed-Dose Combination is a high-growth segment in India and emerging markets, providing dual-action relief for allergic asthma.

• Stability for Export: Montelukast is sensitive to light and moisture. Utilizing Alu-Alu blister packaging is critical to ensure a 36-month shelf life in Zone IVb tropical regions.

• Dossier Support: We provide full CTD/eCTD Dossiers to support your firm’s registration in international health tenders and for private B2B pharmacy networks.