Yi An Ping Ambroxol Hydrochloride Solution for Inhalation

1. Indications and Usage
Respiratory Diseases:
Treatment of acute and chronic respiratory diseases associated with abnormal mucus secretion and impaired mucus transport.
Examples: Acute and chronic bronchitis, pneumonia, bronchiectasis, and COPD.
Target Symptom: Mucus accumulation, thick sputum, and difficulty in expectoration (coughing up phlegm).
2. Dosage and Administration
Route of Administration:
For Inhalation ONLY using a nebulizer. Do not use orally or by injection.
Recommended Dosage (Typical):
Adults and Children >12 Years: 2–3 mL per dose, 1–2 times daily.
Children (2–12 Years): 2 mL per dose, 1–2 times daily.
Infants (<2 Years): 1 mL per dose, 1–2 times daily.
Critical Administration Instructions:
Dilution: It is recommended to dilute the solution with 0.9% Sodium Chloride Injection (Normal Saline) at a 1:1 ratio to ensure optimal humidification and prevent airway irritation.
Hygiene: The inhaler/nebulizer must be cleaned after each use. Discard any remaining solution in the cup after the session.
3. Mechanism of Action
Mucolysis:
Ambroxol breaks down the acidic mucopolysaccharide fibers in the sputum, thereby reducing the viscosity of the mucus and making it easier to cough up.
Surfactant Stimulation:
It stimulates the production and secretion of pulmonary surfactant in type II alveolar cells, which helps stabilize the airways and improves mucociliary clearance.
Ciliary Activity:
It enhances the movement of cilia on the respiratory epithelium, accelerating the transport of mucus out of the lungs.
4. Safety and Warnings
Bronchospasm Risk:
Deep inhalation may cause bronchospasm. Patients with asthma or hyper-reactive airways should use bronchodilators prior to inhalation.
Sputum Clearance:
If a large amount of mucus is liquefied but not expelled (especially in patients with impaired ciliary function), it may cause airway obstruction. Frequent suctioning or chest physiotherapy may be required.
Skin Reactions:
Serious skin reactions (e.g., Stevens-Johnson Syndrome, TEN) have been rarely reported. Discontinue immediately if rash or mucosal lesions occur.
5.Adverse Reactions
Most Common:
Mild irritation of the throat or airways, coughing, nausea, dysgeusia (bad taste), and rarely, allergic reactions.
6.Drug Interactions
Antibiotics:
Concurrent use with antibiotics (e.g., Amoxicillin, Cephalexin, Erythromycin, Doxycycline) may increase antibiotic concentration in lung tissue/sputum, potentially enhancing efficacy.
Cough Suppressants:
Avoid concomitant use with strong antitussives (cough suppressants). Reducing the cough reflex while increasing sputum volume can lead to dangerous mucus accumulation (“plugging”).
Alkaline Solutions:
Do not mix with alkaline injectable solutions (pH > 6.3), as this causes precipitation and drug inactivation.
7.Pharmaceutical Information
Chemical Composition:
Active Ingredient: Ambroxol Hydrochloride.
Appearance: Clear, colorless to slightly yellow solution.
Packaging: Typically available in single-dose plastic vials (e.g., 2 mL/ampoule).
Storage: Store below 30°C. Keep in the original package to protect from light.