Product Overview
[Drug Name]
Generic Name: Ambroxol Hydrochloride Dispersible Tablets
Trade Name: Dongcheng Pharmaceutical Ambroxol Hydrochloride Dispersible Tablets 30mg*30 Tablets
Pinyin Code: DongChengYaoYe YanSuanAnZuoSuoFenSanPian 30mg*30 Tablets
[Main Ingredient]
The main ingredient of this product is ambroxol hydrochloride.
[Properties]
This product is white or off-white tablets with a sweet taste.
[Indications/Main Functions]
It is indicated for the expectorant treatment of acute and chronic respiratory diseases associated with abnormal sputum secretion and poor expectoration function, such as acute exacerbations of chronic bronchitis, asthmatic bronchitis, bronchiectasis, and bronchial asthma.
[Specifications]
30mg*30 tablets
[Dosage and Administration]
Adults: Take one tablet three times daily. Adults: Take two tablets twice daily for improved efficacy. Children: The recommended dose is 1.2-1.6 mg/kg body weight/day. This medication should be taken with liquids after meals.
[Adverse Reactions]
Generally well tolerated. Allergic reactions are rare, primarily rash. Severe acute allergic reactions have been reported in rare cases, but their relationship to ambroxol hydrochloride is uncertain; such patients often also have allergies to other substances.
[Contraindications]
This medication should not be used by patients with known hypersensitivity to ambroxol hydrochloride or other ingredients in the formulation.
[Precautions]
This medication is not available.
Please read the package insert carefully and use as directed by your doctor.
[Drug Interactions]
Concomitant use of this medication with antibiotics (amoxicillin, cefuroxime, erythromycin, doxycycline) may increase lung concentrations of the antibiotics. No clinically relevant adverse effects have been reported with this medication.
[Use in Children]
This medication is not available.
[Use in Elderly Patients]
This medication is not available. [Use During Pregnancy and Lactation]
Preclinical studies and extensive clinical experience with use after 28 weeks of gestation have shown no adverse effects on pregnancy. However, caution should be exercised during pregnancy, especially during the first trimester. The drug may enter breast milk, but therapeutic doses are unlikely to affect the infant.
[Overdose]
No symptoms of overdose have been reported to date; if they occur, symptomatic treatment should be provided.
[Pharmacology and Toxicology]
This product is a mucolytic agent that increases secretion of serous glands in the respiratory mucosa and decreases mucous gland secretion, thereby reducing sputum viscosity. It also promotes the secretion of pulmonary surfactant and increases bronchial ciliary motility, making sputum easier to expectorate.
[Pharmacokinetics]
Ambroxol hydrochloride is rapidly and almost completely absorbed after oral administration, with peak absorption occurring between 0.5 and 3 hours. Within the therapeutic range, plasma protein binding is approximately 90%, and distribution from blood to tissues is rapid and significant, with the lungs being the primary target organ. The plasma half-life is 7-12 hours, and no cumulative effect has been observed. Ambroxol hydrochloride is primarily metabolized in the liver in a conjugated form, with approximately 90% eliminated by the kidneys.
[Storage]
Room temperature.
[Expiry Period]
24 months
[Approval Number]
National Medical Product Approval No. H20100188
[Manufacturer]
Yantai Dongcheng Dayang Pharmaceutical Co., Ltd.
