Yi’anping Ambroxol Hydrochloride Solution for Inhalation

1. Indications and Usage
Respiratory Tract Infections: Treatment of acute and chronic respiratory diseases, such as acute and chronic bronchitis and pneumonia.
Mucolysis: Indicated for the reduction of viscous sputum and difficulty in expectoration.
2. Dosage and Administration
Route of Administration: Inhalation ONLY via nebulizer. Oral or intravenous administration is prohibited.
Adults and Children ≥12 years: 2-3 mL (15-22.5 mg) once or twice daily.
Children 2-12 years: 2 mL (15 mg) once or twice daily.
Children 6 months-2 years: 1 mL (7.5 mg) once or twice daily.
Critical Administration Instructions:
Dilution: Must be mixed with 0.9% Sodium Chloride Injection in a 1:1 ratio for optimal nebulization.
Incompatibility: Do not mix with Sodium Cromoglicate. Avoid mixing with drugs resulting in a solution pH >6.3 to prevent precipitation.
Usage: Do not use with cough suppressants, as reduced cough reflex may lead to dangerous sputum retention.
3. Mechanism of Action
Mucolytic Activity: Promotes the secretion of lung surfactant and decreases the viscosity of sputum, significantly facilitating sputum clearance.
Improved Ciliary Motion: Restores normal respiratory mucus secretion and improves ciliary function.
4. Safety and Warnings
Bronchial Spasm: Inhalation carries a risk of bronchial spasm. It is not recommended for patients with known airway hypersensitivity. Asthma patients should use bronchospasmolytics prior to administration.
Severe Cutaneous Reactions: Rare but serious skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported. Discontinue immediately if progressive rash occurs.
Impaired Mucociliary Function: Use with caution in patients with impaired bronchial motility and excessive secretions (e.g., rare cases of malignant ciliary syndrome) to prevent airway obstruction.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: Taste disturbance, nausea, oral paresthesia, and pharyngeal paresthesia.
Gastrointestinal Symptoms: Occasional vomiting, diarrhea, dyspepsia, abdominal pain, and dry mouth.
Hypersensitivity: Rare reports of hypersensitivity reactions.
6. Drug Interactions
Antibiotics: Concomitant use with certain antibiotics (e.g., amoxicillin, cefuroxime, erythromycin, doxycycline) may increase antibiotic concentrations in bronchopulmonary secretions.
Cough Suppressants: Concomitant use is not recommended due to the risk of sputum retention.
7. Pharmaceutical Information
Chemical Composition: Active Ingredient: Ambroxol Hydrochloride.
Appearance: Colorless or almost colorless clear liquid.
Packaging: Single-dose ampoules (e.g., 2 mL/15 mg).
Storage: Protect from light. Once opened, the single-dose ampoule must be used immediately and any remaining solution discarded.