BRONCACE-SR 200

Scientific Product Overview

BRONCACE-SR 200 provides 200mg of sustained-release Acebrophylline, a therapeutic organic salt synthesized by coupling theophylline-7-acetic acid (a xanthine-derived bronchodilator) with ambroxol (a secretolytic and surfactant-stimulating mucoregulator) in equimolar proportions. This dual-action chemical entity delivers both significant airway smooth muscle relaxation and active mucociliary clearance.

The sustained-release delivery matrix ensures controlled drug release across 12 to 24 hours, stabilizing airway caliber, attenuating nocturnal bronchospasms, and facilitating mucociliary transport in hypersecretory bronchial conditions without rapid plasma peak-and-trough fluctuations.

Pharmacological Role of Active Component

Acebrophylline (Theophylline-7-acetic acid moiety): Functions as a selective phosphodiesterase (PDE) inhibitor, increasing intracellular cyclic adenosine monophosphate (cAMP) levels in bronchial smooth muscle tissue. This action inhibits smooth muscle contraction, promotes bronchodilation, and attenuates the release of inflammatory mediators (leukotrienes and TNF-alpha) from pulmonary inflammatory cells.

Acebrophylline (Ambroxol moiety): Directly stimulates type II alveolar pneumocytes to synthesize and secrete endogenous pulmonary surfactant. Increased surfactant lowers surface tension at the bronchial epithelial interface, reducing mucus adhesiveness and facilitating the mucociliary escalator clearance of hyperviscous secretions.

Formulation-Specific Features & Specifications

• Active Composition: Each sustained-release tablet contains Acebrophylline 200mg (SR).
• Dual Pharmacology: Combines mucokinetic airway clearance with sustained bronchial smooth muscle relaxation.
• Surfactant Synthesis Stimulation: Enhances alveolar surfactant levels, decreasing mucus viscosity and work of breathing.
• Dosage Form & Packaging: Sustained-release tablets in moisture-resistant Alu-Alu blister packaging (3 x 10 / 10 x 10).
• Prescription Schedule: Schedule H Prescription Drug. Sold only against a valid medical prescription.

Approved Indications & Clinical Applications

• Maintenance therapy of Chronic Obstructive Pulmonary Disease (COPD) with persistent airflow limitation.
• Chronic bronchitis accompanied by hyperviscous mucus production and retained secretions.
• Maintenance management of bronchial asthma with viscous sputum (adjunct to anti-inflammatory controller therapy).
• Clinical Limitation: Not indicated for emergency treatment of acute severe bronchospasm or status asthmaticus.

Contraindications, Precautions & Safety Warnings

• Contraindications: Known hypersensitivity to acebrophylline, theophylline, ambroxol, or xanthine derivatives; acute myocardial infarction; severe cardiac tachyarrhythmias; active peptic ulcer disease; severe hepatic or renal dysfunction.
• Precautions: Administer with caution in patients with hypertension, cardiac disease, hyperthyroidism, epilepsy, or history of gastrointestinal ulceration.
• Drug Interactions: Monitor serum theophylline concentrations when co-administered with CYP1A2 or CYP3A4 inhibitors (e.g., ciprofloxacin, erythromycin, cimetidine).
• Adverse Reactions: Nausea, epigastric discomfort, heartburn, tachycardia, headache, tremor, transient dizziness.