Ambroxol Hydrochloride Injection

1. Pharmacological action This product is a metabolite of bromhexine in the body, which has the characteristics of promoting the elimination of sticky sputum and dissolving secretions. It can promote the elimination of sticky secretions in the respiratory tract and reduce the retention of mucus, thus significantly promoting expectoration and improving respiratory conditions. When this product is used for treatment, the patient's mucus secretion can be restored to normal, and the amount of cough and sputum is usually significantly reduced. The surfactant on the respiratory mucosa can thus play its normal protective function. 2. Toxicological action The toxicity index of ambroxol hydrochloride in acute toxicity tests is very low. The Ames test and micronucleus test show that ambroxol hydrochloride is not mutagenic. Carcinogenicity studies in mice and rats show that ambroxol hydrochloride is not carcinogenic.

trans-4-[(2-amino-3,5-dibromobenzyl)amino]cyclohexanol hydrochloride.

This product is a colorless or almost colorless clear liquid.

1. Applicable to acute and chronic respiratory diseases accompanied by abnormal sputum secretion and poor sputum removal function, such as acute exacerbation of chronic bronchitis, asthmatic bronchitis, bronchiectasis and bronchial asthma. 2. Preventive treatment of postoperative pulmonary complications. 3. Treatment of premature infants and neonatal respiratory distress syndrome (IRDS).

1. Adults and children over 12 years old: 2-3 times a day, 15 mg each time, slow intravenous injection, severe cases can be increased to 30 mg each time. 2. Children aged 6-12 years old: 2-3 times a day, 15 mg each time. 3. Children aged 2-6 years old: 3 times a day, 7.5 mg each time. 4. Children under 2 years old: 2 times a day, 7.5 mg each time. All are slow intravenous injections. Or add the drug to glucose injection (or saline) and use it intravenously. 5. Treatment of infant respiratory distress syndrome (IRDS): The total daily medication is calculated based on the infant's weight of 30 mg/kg, divided into 4 doses. Use a syringe pump to administer the drug, and the infusion time is at least 5 minutes.

This product is well tolerated, with occasional reports of mild upper gastrointestinal adverse reactions, mainly heartburn, indigestion, and occasional nausea and vomiting. Allergic reactions rarely occur, mainly rashes, and severe acute allergic reactions have been reported in very few cases, but their relevance to ambroxol hydrochloride is not certain, and such patients are usually allergic to other substances.

Patients with known hypersensitivity to ambroxol hydrochloride or other ingredients of the formula are contraindicated.

Precautions for children: During medication, pay attention to observation. Precautions for pregnancy and lactation: Preclinical trials and a large amount of clinical experience after 28 weeks show that there is no adverse effect on pregnancy, but the drug should be used with caution during pregnancy, especially in the first three months of pregnancy. The drug can enter breast milk, but the therapeutic dose should have no effect on the baby. Precautions for the elderly: The safety and efficacy of the drug were evaluated for elderly and adult patients, and no difference was found.

The simultaneous use of antibiotics such as amoxicillin, cefuroxime, erythromycin, and doxycycline may lead to increased concentrations of antibiotics in lung tissue. No clinically relevant adverse effects caused by the combined use of other drugs have been reported.

Store in a dark and airtight container at room temperature.

4ml:30mg

Tentatively 24 months.

Tipr Pharmaceutical Co., Ltd.

• Founded in:

  1994-08-18

• Address:

  No. 29, Huixin Road, Binhai Science and Technology Park, Binhai Hi-tech Zone, Tianjin

• Tax NO.:

  91120116238991799D

• Registered Funds:

  50 million yuan

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