Lilac Garden Forum member @yi***6 Posting for help:
63-year-old male patient, severe After craniocerebral injury, she lived in the ICU ward with pulmonary infection and sputum. Ambroxol 60 mg IV tid was applied in the ICU for 1 week in the early stage, and the patient was transferred to the general ward after the condition stabilized in the later stage. The patient was discontinued 2 weeks after ambroxol Severe exfoliative dermatitis allergic reaction occurred, transferred to a higher-level hospital for treatment ineffective and died.
The allergic reaction of exfoliative dermatitis should have nothing to do with ambroxol, but the patient’s family members seized on the off-label dose application of ambroxol to talk about it. Take us to court.
The old instructions did say that adults and children over 12 years old: 2 to 3 times a day, 15 mg each time, severe cases may increase. to 30 mg each time. But I heard that the dosage of 1 g of the new specification can be 30 mg/kg, and the total amount can be used 1 g per day.
Ambroxol infusion 60 mg tid, is it an off-label dose?
What is the recommended dose in the instructions?
Ambroxol, as the most widely used expectorant in clinical practice, is mainly used for acute, Chronic lung disease, prevention of postoperative pulmonary complications and infant respiratory distress syndrome in premature infants and neonates. Taking Ambroxol Hydrochloride Injection (Mucosolvan) as an example, its instructions are recommended as follows:: Assistant App (screenshot source) As recommended by the instructions, the maximum daily dose of Ambroxol Hydrochloride Injection is: Adults and children over 12 years old are 90 mg/d (maximum dose 30 mg tid), infants with respiratory distress Syndrome 30 mg/kg. In other words, the ambroxol in the opening case was indeed used in an off-label dose.
Ambroxol, why is overdose used clinically?
Ambroxol overdose is commonly used in clinical practice. These off-label applications are mainly used for the treatment of chronic obstructive pulmonary disease, severe pneumonia, acute respiratory distress syndrome, neonatal respiratory distress syndrome, prevention of respiratory complications during perioperative period, etc. It has been reported that [1], the use of high-dose ambroxol (15 mg/kg/d or > 1000 mg/d) can significantly protect lung function, but there is a dose-dependent This effect may be related to the following pharmacological mechanisms:
1. Promote the production of alveolar surfactant, reduce alveolar surface tension, and prevent alveolar collapse;
< p>2. Reduce the generation of superoxide anion and hydrogen peroxide, etc., and reduce oxidative lung oxidative damage;
3. Reduce a variety of inflammatory cells and inflammatory mediators The release of alveoli can reduce the lung damage caused by excessive inflammatory response, thereby inhibiting the damage of alveolar epithelial cells, maintaining the integrity of epithelial cells, and reducing the degree of fluid exudation and edema.
For perioperative patients [2], overdose use of ambroxol can effectively improve postoperative respiratory symptoms and reduce pulmonary complications such as atelectasis Preoperative application can also reduce the decline of pulmonary surfactant caused by mechanical damage during surgery, and play a good role in lung protection. “Expert Consensus on Prevention and Treatment of Perioperative Pulmonary Complications in Thoracic Surgery(2009 Edition)“[3] clear Point out:In general, the preoperative dose of Mucosolvan is 90 mg/d, and there are high risk factors for preoperative prophylactic application of Mucosolvan, and the recommended dose is 1 g/d. After surgery, high-dose Mucosolvan 1 g/d is recommended. “List of Drugs Off the Instructions (2016 Edition)”[4] Recommendation: Ambroxol hydrochloride can be used in high-risk patients undergoing thoracic surgery1 g/d. German Ambroxol Hydrochloride Injection Instructions: It has been approved for prophylactic treatment of postoperative pulmonary complications at a dose of 1 g/d. New Pharmacology (17th Edition)[5] states:High-dose Ambroxol ( 250-500 mg/d, twice a day) can reduce plasma uric acid concentration, promote uric acid excretion, and can be used to treat gout. However, some studies [6] pointed out: Although the efficacy and safety of perioperative application of ambroxol are better than Good, the incidence of postoperative pulmonary complications was significantly lower, and it also shortened postoperative antibiotic use time and patient hospitalization time, but the incidence of pulmonary complications in the high-dose group of ambroxol (> 900 mg/d) was similar to There was no statistical difference between the middle and low dose groups. Whether it is necessary to use high-dose ambroxol in the perioperative period needs more verification.
Clinical VS Instructions, how to choose?
At present, the application of high-dose ambroxol in common diseases of the respiratory system lacks sufficient and high-level evidence-based medical evidence, and the application is risky. The 2012 CFDA Adverse Drug Reaction Information Circular (No. 49) pointed out that among children with serious adverse reactions, the overdose of ambroxol accounted for 64.56% of the total serious cases. %. From a legal perspectiveIn other words, although the contents of the instructions may lag behind clinical practice, the former has legal effect, so in clinical application, the drug should be used safely and rationally on the basis of compliance with laws and regulations. Ambroxol Overdose Recommendations:
Ambroxol The safety and efficacy of overdose use still lack the support of large-scale multi-center clinical research data, and there is a risk of serious adverse reactions;
The domestic instructions still recommend the maximum daily dose: 90 mg/d for adults and children over 12 years old, and 30 mg/kg for infant respiratory distress syndrome;
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If overdose ambroxol is clinically necessary, the patient should be informed in advance and informed consent should be obtained(this is very important).
First Release: Lilac Garden Breathing TimeSubmission: [email protected]Title: Station Cool Hero
References:
[1] Li Hui, Xu Xiaofeng, Qiu Shaoxiao. A systematic review of the efficacy of high-dose ambroxol on acute lung injury/acute respiratory distress syndrome [J]. Chinese Journal of Respiratory and Critical Care, 2012, 11( 5):459-464.
[2] Zhang Jin, Shi Zixia, Zhang Bingbing, Ma Zheng. Effects of different doses of ambroxol hydrochloride on pulmonary function and pulmonary function in postoperative patients with lung cancer. Influence of complications[J]. China Pharmaceutical.2015(10).
[3] Chinese Medical Doctor Association Thoracic Surgeons Branch. Perioperative pulmonary complications in thoracic surgery [J]. Chinese Journal of Thoracic and Cardiovascular Surgery, 2009, 25(4):217-218.
[4] Anonymous. (2016 edition)[J]. Pharmacy Today, 2016(6):369-383.
[5] Chen Xinqian, Jin Youyu, Tang Guang. New Pharmacology .17 edition [M]. People’s Health Publishing House, 2011.
[6] Wan Sihui, Zhang Wenjing, Chen Lizhi, et al. Direct and indirect comparison of efficacy and safety of ambroxol in the prevention and treatment of postoperative pulmonary complications [J]. World Clinical Medicine, 2015, 36(3).
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