Beilai Ambroxol Hydrochloride Tablets

Brand Name:贝莱®( Beilai®)
Generic Name: Ambroxol Hydrochloride
Strength: 30 mg per tablet
Manufacturer: Jiangsu Hengrui Medicine Co., Ltd.
Marketing Authorization Holder: Jiangsu Hengrui Medicine Co., Ltd.
Approval Date in China: 1998
Registration Number: 国药准字H19980016
Storage: Store tightly sealed in a cool, dry place away from light; keep out of reach of children, follow the full storage instructions in the package insert

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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: For adults, take 1 to 2 tablets each time, 3 times a day, after meals.
Children: For children under 12 years, the 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: It should be avoided to be used simultaneously with central cough suppressants (such as dextromethorphan, etc.) to prevent the diluted sputum from blocking the airway.
Pregnancy and Lactation:

This product is contraindicated for women during the first three months of pregnancy.

Severe Skin Reactions: Rare cases of severe cutaneous adverse reactions (e.g., Stevens-Johnson syndrome) have been reported.
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:

Occasionally, rashes, nausea, stomach discomfort, loss of appetite, abdominal pain and diarrhea may occur.

Rare Adverse Reactions: Hypersensitivity reactions, 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: When this product is taken concurrently with antibiotics (amoxicillin, cefuroxime, erythromycin, doxycycline), it may lead to an increase in the concentration of antibiotics 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:

This product is a white or off-white tablet.

Storage:

Store in a light-proof and sealed container.

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