BRONCACE-N

Scientific Product Overview

BRONCACE-N combines two synergistic mucoregulatory entities in a solid oral tablet. N-Acetylcysteine (600mg) directly cleaves disulfide bridges in mucoprotein complexes, rapidly decreasing the viscosity and tenacity of purulent pulmonary secretions, while serving as a glutathione precursor that neutralizes reactive oxygen species in smoking- or pollution-induced airway cellular damage.

Acebrophylline (100mg) complements this chemical mucolysis by stimulating alveolar type II pneumocytes to secrete surfactant, improving mucociliary clearance mechanics and inhibiting cyclic nucleotide phosphodiesterases for smooth muscle relaxation.

Pharmacological Role of Each Ingredient

N-Acetylcysteine (600mg): The free sulfhydryl (-SH) group of N-acetylcysteine chemically cleaves inter- and intra-molecular disulfide (-S-S-) bonds of glycoprotein polymers in mucus, dramatically reducing sputum viscosity and elasticity. Intracellularly, NAC acts as a direct scavenger of free radicals and provides L-cysteine for biosynthesis of reduced glutathione (GSH), restoring pulmonary antioxidant defense.

Acebrophylline (100mg): Promotes surfactant synthesis at the alveolar fluid interface, diminishing mucus adhesiveness to bronchial walls. In addition, its theophylline-7-acetic acid component mediates mild bronchodilation and anti-inflammatory activity by downregulating proinflammatory cytokines.

Formulation-Specific Features & Specifications

• Active Composition: Acebrophylline 100mg + N-Acetylcysteine USP 600mg.
• Direct Disulfide Mucolysis: Liquefies thick, purulent bronchial secretions for ease of expectoration.
• Antioxidant Protection: Restores pulmonary glutathione pools against cellular oxidative stress and chronic inflammation.
• Dosage Form & Packaging: Taste-masked film-coated tablets in 3 x 10 Alu-Alu cold-form packaging protecting free sulfhydryl groups against oxidation.
• Prescription Schedule: Schedule H Prescription Drug.

Approved Indications & Clinical Applications

• Chronic Obstructive Pulmonary Disease (COPD) with persistent mucus hypersecretion and mucus plugging.
• Chronic productive bronchitis characterized by tenacious, difficult-to-expectorate sputum.
• Bronchiectasis accompanied by retained purulent bronchial secretions.
• Clinical Limitation: Not an antimicrobial agent; bacterial respiratory infections require concurrent appropriate antibiotic therapy.

Contraindications, Precautions & Safety Warnings

• Contraindications: Hypersensitivity to N-acetylcysteine, acebrophylline, or xanthines; active peptic ulcer disease (NAC may disrupt gastric mucus barrier); acute severe bronchospasm.
• Precautions: Use with caution in asthmatic patients; if bronchospasm occurs, discontinue immediately and administer a short-acting bronchodilator. Ensure adequate postural drainage if excessive secretion liquefaction occurs.
• Adverse Reactions: Epigastric discomfort, nausea, vomiting, heartburn, diarrhea, stomatitis, flushing, mild headache.