BRONCACE-M

Scientific Product Overview

BRONCACE-M addresses chronic inflammatory airway disorders via two complementary pharmacodynamic pathways. Acebrophylline acts as an airway phosphodiesterase inhibitor and secretolytic mucoregulator, while Montelukast selectively antagonizes the CysLT1 receptor, blocking cysteinyl leukotriene-mediated bronchoconstriction, vascular exudation, and eosinophilic inflammatory cascades.

The bi-layered tablet engineering provides immediate release of Montelukast for rapid anti-inflammatory receptor occupancy combined with prolonged release of Acebrophylline from a polymeric matrix for sustained 24-hour bronchodilation and nocturnal asthma protection.

Pharmacological Role of Each Ingredient

Acebrophylline (SR 200mg): Mediates selective airway phosphodiesterase inhibition leading to smooth muscle relaxation, while stimulating type II alveolar cells to synthesize endogenous surfactant, reducing mucus adhesiveness and improving airway patency throughout the dosing interval.

Montelukast Sodium (10mg): A potent, selective cysteinyl leukotriene receptor antagonist. By competitively binding the CysLT1 receptor, it blocks the actions of LTD4, LTC4, and LTE4, preventing leukotriene-induced airway smooth muscle spasm, reducing microvascular permeability and mucosal edema, and attenuating eosinophilic cellular infiltration.

Formulation-Specific Features & Specifications

• Active Composition: Acebrophylline 200mg (Sustained Release) + Montelukast Sodium IP equivalent to Montelukast 10mg (Immediate Release).
• Bi-Layered Tablet Engineering: Optimizes distinct drug release kinetics for immediate anti-inflammatory coverage and prolonged bronchodilation.
• Dual Pathway Control: Concurrently inhibits leukotriene-driven inflammation and promotes surfactant-assisted mucociliary clearance.
• Patient Compliance: Vanilla flavour coated finish with 3 x 10 Alu-Alu cold-form packaging providing complete moisture and light barrier protection.
• Prescription Schedule: Schedule H Prescription Drug.

Approved Indications & Clinical Applications

• Maintenance therapy of bronchial asthma accompanied by concomitant allergic rhinitis.
• Maintenance management of chronic asthma in patients requiring dual bronchodilator and anti-leukotriene therapy.
• Chronic Obstructive Pulmonary Disease (COPD) with allergic airway components and hyperviscous sputum.
• Clinical Limitation: Not indicated for the reversal of acute severe bronchospasm or status asthmaticus.

Mandatory Prescribing Advisory: Neuropsychiatric Events

Serious neuropsychiatric events have been reported in patients taking montelukast, including agitation, aggressive behavior, hostility, depression, abnormal dreams, hallucinations, insomnia, irritability, restlessness, somnambulism, suicidal thoughts and actions (including completed suicide), and tremor. Healthcare professionals must advise patients and caregivers to monitor for behavioral or mood alterations and evaluate discontinuation of treatment immediately if symptoms manifest.

Contraindications, Precautions & Safety Warnings

• Contraindications: Known hypersensitivity to acebrophylline, montelukast, or xanthines; acute myocardial infarction; active gastrointestinal bleeding or peptic ulcer disease; severe hepatic impairment.
• Precautions: Do not abruptly substitute for inhaled or oral corticosteroids. Observe for systemic eosinophilia occasionally presenting with clinical vasculitis consistent with Churg-Strauss syndrome.
• Adverse Reactions: Headache, dyspepsia, abdominal pain, cough, nausea, pharyngitis, insomnia, mild transaminase elevations.