A fixed-dose combination (FDC) medication used primarily for the symptomatic management of acute and chronic respiratory disorders associated with viscid mucus and bronchospasm. It combines a mucolytic (Ambroxol), a bronchodilator (Terbutaline), and a xanthine derivative (Etofylline) to provide a multi-modal approach to airway clearance and bronchial relaxation. This combination is widely prescribed in India for conditions like COPD and bronchitis.
Adult: One tablet twice daily (every 12 hours). Maximum: Two tablets per day.
Note: Administer orally after meals with a full glass of water to minimize gastric irritation. Do not crush or chew unless advised. Maintain adequate hydration to aid mucolytic action.
This combination works synergistically to relieve bronchoconstriction and improve mucus clearance. Terbutaline relaxes bronchial smooth muscle via β2-adrenoceptor stimulation, increasing cAMP. Etofylline, a theophylline derivative, provides bronchodilation through non-selective phosphodiesterase (PDE) inhibition and adenosine receptor antagonism, also increasing cAMP/cGMP. Ambroxol reduces mucus viscosity by stimulating surfactant production in type II pneumocytes and breaking down acid mucopolysaccharide fibers, facilitating expectoration.
Pregnancy: Category C (US FDA). Terbutaline: Should be avoided, especially in the 1st trimester, except if clearly needed. Used as a tocolytic but oral use for asthma is cautioned. Ambroxol & Etofylline: Insufficient safety data. Use only if potential benefit justifies potential fetal risk. Consult specialist.
Driving: May cause dizziness, nervousness, or blurred vision. Patients should not drive or operate machinery until their individual response is known.
| Other Beta-2 Agonists (Salbutamol, Formoterol) | Additive cardiovascular and hypokalemic effects; increased risk of side effects. | Major |
| Theophylline/Aminophylline | Increased risk of theophylline (Etofylline metabolite) toxicity (nausea, seizures, arrhythmias). | Major |
| Diuretics (especially loop and thiazide) | Enhanced risk of hypokalemia. Monitor potassium levels. | Major |
| Beta-blockers (e.g., Propranolol) | Mutual antagonism; beta-blockers inhibit bronchodilator effect of Terbutaline. | Major |
| CYP1A2/CYP3A4 Inhibitors (Ciprofloxacin, Erythromycin, Fluvoxamine, Cimetidine) | Increase Etofylline/Theophylline levels, risk of toxicity. | Major |
| CYP1A2 Inducers (Phenobarbital, Phenytoin, Rifampicin, Smoking) | Decrease Etofylline/Theophylline levels, reducing efficacy. | Moderate |
| Digoxin | Possible increased risk of digoxin-induced arrhythmias due to hypokalemia. | Moderate |
| MAOIs and TCAs | Potentiation of cardiovascular effects of Terbutaline. | Major |
Same composition (Ambroxol (30mg) + Etofylline (100mg) + Terbutaline (2.5mg)), different brands: