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Ambroxol hydrochloride injection
Generic name: Ambroxol Hydrochloride Injection
Active ingrient: Ambroxol Hydrochloride
Excipient: Citric acid, disodium hydrogen phosphate, sodium chloride and water for injection
Molecular formula:C13H18Br2N2O·HCl
Molecular weight:414.57
Description
A colorless clear liquid.
Indications
This product is indicated for acute and chronic lung diseases accompanied by abnormal secretion of sputum and poor sputum function, the expectorant treatment for chronic bronchitis exacerbation, asthmatic bronchitis and bronchial asthma for example. It can also be used for prevention of pulmonary complications after surgery and treatment of infant respiratory distress syndrome (IRDS) in preterm and neonates.
Strength
2ml: 15mg; 4ml:30mg
Dosage and administration
Prevention and treatment:
Adults and children over 12 years old: 2-3 times a day, 15 mg each time, slow intravenous infusion; increase to 30 mg each time for severe cases.
Children 6-12 years: 2-3 times a day, 15mg each time.
Children aged 2-6: 3 times a day, 7.5 mg each time.
Children under 2 years: 2 times a day, 7.5mg each time.
All are slow intravenous infusion.
Treatment of infant respiratory distress syndrome (IRDS):The total daily dose is calculated based on infant weight and 30 mg/kg is administered in 4 divided doses.
Syringe pumps should be used for administration with at least 5 minutes of intravenous injection duration.
The injection can also be used intravenously with glucose, fructose, saline or Ringer's solution.
Adverse effects
This product is usually well tolerated. Mild upper gastrointestinal adverse reactions have been reported (mainly stomach burning, indigestion, occasional nausea and vomiting, etc.).Allergic reactions rarely occur, mainly rashes. Very few cases have been reported for severe acute allergic reactions, but their association with ambroxol hydrochloride has not been established and these patients are usually allergic to other substances.
Contraindication
It is known that allergy to ambroxol hydrochloride or other formulation ingredients should not be used.
Precaution
Do not mix this product with other solutions having a pH greater than 6.3, as the increase in pH will cause precipitation of free base.
Pregnant and lactating women medication
Preclinical testing and extensive clinical experience after 28 weeks of gestation show no adverse effects on pregnancy. However, drugs should be used with caution during pregnancy, especially during the first trimester of pregnancy. The drug can enter the milk, but the therapeutic dose should have no effect on the baby.
Children medication
Refer to dosage and administration.
Elderly medication
No special precautions.
Medicine interactions
Combination therapy of this product and antibiotics (amoxicillin, cefuroxime, erythromycin, doxycycline) in can increase the concentration of antibiotics in lung tissue.
Overdose
So far there have been no reports of symptoms on overdose of this medicine.
Pharmacokinetics
The distribution of this product from the blood to the tissue is fast and significant, and the lung is the main target organ. Plasma half-life is 7-12 hours and there is no cumulative effect. Ambroxol hydrochloride is mainly metabolized in the liver and approximately 90% is cleared by the kidneys.
Pharmacology and toxicology
Pharmacological effects: This product is a metabolite of bromhexine in the body and has the property of promoting the elimination of mucocele and dissolving secretions. It can promote the elimination of viscous secretions in the respiratory tract and reduce the retention of mucus, thus significantly promoting drainage and improving breathing. When the product is used, the patient's mucus secretion can be restored to normal conditions. Cough and sputum levels are usually significantly reduced, and the surface active substances in the respiratory mucosa can thus exert their normal protective functions.
Toxicological effects: Ambroxol hydrochloride has a very low toxicity index in acute toxicity tests. Ames test and micronucleus test showed that ambroxol hydrochloride had no mutagenicity. Carcinogenicity studies in mice and rats showed that ambroxol hydrochloride is not carcinogenic.
Storage
Sealed and kept under 30oC.
Packaging
Brown glass ampoules, 5 ampoules/box, 10 ampoules/box and 20 ampoules/box.
Shelf life
24 months
Specification
YBH02352010
Approval number
GUOYAOZHUNZI H20103255
GUOYAOZHUNZI H20113116

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