Anpusuo Ambroxol Hydrochloride Tablets

1. Indications and Usage
Respiratory Tract Disorders: Treatment of respiratory tract diseases with insufficient mucus secretion or impaired mucus clearance, such as acute and chronic bronchopulmonary disorders.
2. Dosage and Administration
Adults and Children ≥12 years: 30 mg per dose, three times daily. For long-term therapy, the dose may be reduced to twice daily.
Children <12 years: Dosage should be 1.2 to 1.6 mg per kg of body weight daily, divided into 2 to 3 doses.
Administration: Oral administration. The tablet should be swallowed whole with water.
3. Mechanism of Action
Mucolytic Effect: The drug increases the secretion of respiratory tract serous glands and decreases the secretion of mucus glands, thereby reducing mucus viscosity.
Surfactant Promotion: It promotes the secretion of pulmonary surfactant and increases bronchial ciliary movement, making it easier to expectorate sputum.
4. Safety and Warnings
Cough Suppressants: Should not be used simultaneously with central cough suppressants (e.g., dextromethorphan), as liquefied sputum may obstruct the airway.
Pregnancy and Lactation: Contraindicated during the first trimester of pregnancy. Use with caution during the second and third trimesters and while breastfeeding.
Severe Skin Reactions: Rare cases of severe cutaneous adverse reactions (e.g., Stevens-Johnson syndrome) have been reported. Discontinuation is required if skin or mucosal lesions appear.
Fructose Intolerance: The tablets contain lactose; they are contraindicated in patients with rare hereditary fructose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: Nausea, vomiting, dyspepsia, abdominal pain, decreased appetite, and diarrhea.
Rare Adverse Reactions: Hypersensitivity reactions (including rash, urticaria, and angioedema), headache, and taste disturbance.
Clinical Research: Clinical studies have demonstrated the efficacy of ambroxol in reducing sputum viscosity and improving cough and expectoration symptoms.
6. Drug Interactions
Antibiotics: Concomitant use with antibiotics (e.g., amoxicillin, cefuroxime, erythromycin, doxycycline) increases the concentration of these drugs in lung tissue.
Cough Suppressants: Concomitant use with central cough suppressants increases the risk of airway obstruction due to impaired sputum clearance.
7. Pharmaceutical Information
Active Ingredient: Ambroxol Hydrochloride.
Appearance: White or off-white tablets.
Storage: Store protected from light and moisture.