BRONCACE-DM

Scientific Product Overview

BRONCACE-DM is a tablet formulation (Bi-layered tablet) containing Acebrophylline (SR) 200mg + Desloratadine 5mg + Montelukast 10mg, marketed by Aerochem Neutron as part of its respiratory range. It is a prescription medicine intended for use under the supervision of a registered medical practitioner.

Acebrophylline is a xanthine derivative with bronchodilator, anti-inflammatory and mucoregulatory properties. Desloratadine is a non-sedating second-generation H1-antihistamine. Montelukast is a leukotriene receptor antagonist that blocks cysteinyl leukotrienes involved in airway inflammation and bronchoconstriction.

Use should follow an individual assessment of benefits and risks by the treating physician. Refer to the approved prescribing information for contraindications, precautions and interactions before use.

Pharmacological Role of Ingredients

Acebrophylline (SR 200mg): Provides extended-release bronchodilation via cyclic nucleotide phosphodiesterase inhibition while promoting alveolar surfactant secretion for continuous mucociliary clearance.

Desloratadine (5mg): A potent, long-acting, non-sedating peripheral histamine H1-receptor antagonist. Possesses approximately 3 to 4 times higher affinity for the H1-receptor than loratadine, with an elimination half-life of 27 hours, suppressing histamine-mediated vascular leakage and pruritus without central sedation.

Montelukast Sodium (10mg): A selective cysteinyl leukotriene receptor (CysLT1) antagonist, inhibiting bronchoconstrictor and microvascular inflammatory responses to endogenous leukotrienes.

Formulation Specifications

• Active Composition: Acebrophylline 200mg (SR) + Desloratadine 5mg + Montelukast Sodium 10mg.
• Mechanism Profile: Triple action combining bronchodilation, non-sedating antihistaminic coverage, and leukotriene receptor blockade.
• Delivery Architecture: Staged bi-layered tablet separating the immediate-release desloratadine/montelukast phase from the extended-release acebrophylline matrix.
• Dosage Form: Tablets (Bi-layered tablet).
• Prescription Schedule: Schedule H Prescription Drug.

Approved Indications & Clinical Applications

• Bronchial asthma with allergic rhinitis.
• Allergic bronchitis and chronic asthma with allergic airway hyperreactivity.
• Chronic Obstructive Pulmonary Disease (COPD) with allergic component.
• Clinical Limitation: Not indicated for emergency treatment 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, suicidal thoughts and actions. Healthcare professionals must advise patients and caregivers to monitor for behavioral changes.