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PubMed2006

Ambroxol for the prevention of acute upper respiratory disease.

Although acute upper respiratory diseases (AURDs) such as common cold and influenza are common, few interventions have been proven to be effective in their prevention and treatment. The aim of this study was to assess the efficacy of ambroxol for preventing AURD. Fifty-four patients were randomly divided into 3 groups: a rebamipide (non-mucoactive drug) group (300 mg/day), carbocisteine group (1500 mg/day) and ambroxol group (45 mg/day). The study was divided into 2 terms, the first half-year (summer season) and the second half-year (winter season). In the preceding winter, only 19.5% of the patients had been vaccinated against influenza viruses (flu). The primary goal of this study was to evaluate the effectiveness of mucoactive drugs in decreasing the frequency of AURD. Treatment with ambroxol, but not carbocisteine, significantly reduced the median number of AURD episodes (P=0.0049 vs. rebamipide). Thirty-three patients without vaccination against flu were assessed especially during the second half-year. Treatment with ambroxol also significantly reduced the median number of AURD episodes in this assessment (P=0.0028 vs. rebamipide in the second half-year). In conclusion, ambroxol may be useful for preventing AURD.

Aged↗
PubMed1999

The inhibitory effect of ambroxol on hypochlorous acid-induced tissue damage and respiratory burst of phagocytic cells.

Ambroxol (100 microM and 1 mM) and the thiols (all 1 mM), glutathione, tiopronin and cysteine, significantly attenuated the myeloperoxidase, H(2)O(2) and Cl(-) system-caused destruction of alpha(1)-antiproteinase and the HOCl-induced destruction of collagen, whereas they did not affect the elastase-induced destruction of collagen. Glutathione, tiopronin and cysteine almost completely decomposed both HOCl and H(2)O(2), while ambroxol up to 1 mM did not show a scavenging action on H(2)O(2). Ambroxol (1 to 100 microM) and 1 mM thiol compounds markedly inhibited the HOCl-induced alteration of elastase activity. Thiol compounds significantly attenuated the HOCl production caused by degraded immunoglobulin G-activated neutrophils. Ambroxol depressed superoxide and H(2)O(2) production induced by degraded immunoglobulin G-activated neutrophils and by lipopolysaccharide-activated alveolar macrophages in a dose-dependent manner. The results show that ambroxol may interfere with oxidative tissue damage and decrease proteolytic tissue destruction by attenuation of oxidative stress-induced inactivation of alpha(1)-antiproteinase through both decomposition of HOCl and inhibition of the respiratory burst in phagocytic cells.

Ambroxol↗
PubMed2003

Sonolytic debromination of ambroxol process wastewater.

In this study ultrasound was examined in terms of its effectiveness in treating wastewater containing ambroxol and process water from ambroxol synthesis. The organic bromine contents of the water samples investigated were in the 20-1200 mg l(-1) range. Ultrasound is capable to debrominate the ambroxol molecule rendering it biologically degradable. The debromination rate increases with the ultrasound intensity and the 0.4 order of the organic bromine concentration. Temperature and pH have only a small influence. Bromide ions reduce the debromination efficiency of the ultrasound. No removal of the organic carbon could be observed during ultrasonic treatment. The process water from ambroxol syntheses shows higher sonolytical debromination rates than the ambroxol model water. After extracting the process water with butyl acetate, the debromination reaction of the remaining organic bromine is considerably smaller. Argon increases the debromination under certain circumstances. The specific electric energy requirements for sonolysis vary between 7 and 920 kWh g(-1) of removed organic bromine.

Ambroxol↗
PubMed2001

Attenuation by ambroxol of monochloramine-enhanced gastric carcinogenesis: a possible prevention against Helicobacter pylori-associated gastric carcinogenesis.

The effects of combined administration of a reactive oxidant, monochloramine, and a mucoregulatory agent, ambroxol, on the development of gastric cancers induced by N-methyl-N'-nitro-N-nitrosoguanidine (MNNG) were investigated in inbred Wistar rats. After receiving oral MNNG and regular chow pellets for 25 weeks, rats received regular chow pellets or chow pellets containing 20% ammonium acetate, and normal tap water or water containing 30 mM sodium hypochlorite, with or without subcutaneous injection of ambroxol at high or low doses, until the end of the experiment at week 52. Treatment with both ammonium acetate and sodium hypochlorite, which produce monochloramine, significantly increased the incidence of gastric cancers at week 52, whereas concomitant administration of ambroxol with ammonium acetate and sodium hypochlorite significantly attenuated this enhanced gastric carcinogenesis. Results also revealed that ambroxol scavenged monochloramine. Because monochloramine is closely related to Helicobacter pylori-associated gastric carcinogenesis, these findings suggest that ambroxol may prevent H. pylori-associated gastric carcinogenesis.

Ambroxol↗
PubMed2003

Determination of ambroxol in human plasma using LC-MS/MS.

A sensitive and selective liquid chromatographic method coupled with tandem mass spectrometry (LC-MS/MS) was developed for the quantification of ambroxol in human plasma. Domperidone was used as internal standard, with plasma samples extracted using diethyl ether under basic condition. A centrifuged upper layer was then evaporated and reconstituted with 200 microl methanol. The reconstituted samples were injected into a C(18) XTerra MS column (2.1 x 30 mm) with 3.5 microm particle size. The analytical column lasted for at least 600 injections. The mobile phase was composed of 20 mM ammonium acetate in 90% acetonitrile (pH 8.8), with flow rate at 250 microl/min. The mass spectrometer was operated in positive ion mode using turbo electrospray ionization. Nitrogen was used as the nebulizer, curtain, collision, and auxiliary gases. Using MS/MS with multiple reaction monitoring (MRM) mode, ambroxol was detected without severe interferences from plasma matrix. Ambroxol produced a protonated precursor ion ([M+H](+)) at m/z 379 and a corresponding product ion at m/z 264. And internal standard (domperidone) produced a protonated precursor ion ([M+H](+)) at m/z 426 and a corresponding product ion at m/z 174. Detection of ambroxol in human plasma was accurate and precise, with quantification limit at 0.2 ng/ml. This method has been successfully applied to a study of ambroxol in human specimens.

Adult↗
PubMed1998

Characterization of N-acetylcysteine and ambroxol in anti-oxidant therapy.

Reactive free oxygen radicals are known to play an important role in the pathogenesis of various lung diseases such as idiopathic pulmonary fibrosis (IPF), adult respiratory distress syndrome (ARDS) or cystic fibrosis (CF). They can originate from endogenous processes or can be part of exogenous exposures (e.g. ozone, cigarette smoke, asbestos fibres). Consequently, therapeutic enhancement of anti-oxidant defence mechanisms in these lung disorders seems a rational approach. In this regard, N-acetyl-L-cysteine (NAC) and ambroxol have both been frequently investigated. Because of its SH group, NAC scavenges H2O2 (hydrogen peroxide), .OH (hydroxol radical), and HOCl (hypochlorous acid). Furthermore, NAC can easily be deacetylated to cysteine, an important precursor of cellular glutathione synthesis, and thus stimulate the cellular glutathione system. This is most evident in pulmonary diseases characterized by low glutathione levels and high oxidant production by inflammatory cells (e.g. in IPF and ARDS). NAC is an effective drug in the treatment of paracetamol intoxication and may even be protective against side-effects of mutagenic agents. In addition NAC reduces cellular production of pro-inflammatory mediators (e.g. TNF-alpha, IL-1). Also, ambroxol [trans-4-(2-amino-3,5-dibromobenzylamino)-cyclohexane hydrochloride] scavenges oxidants (e.g. .OH, HOCl). Moreover, ambroxol reduces bronchial hyperreactivity, and it is known to stimulate cellular surfactant production. In addition, ambroxol has anti-inflammatory properties owing to its inhibitory effect on the production of cellular cytokines and arachidonic acid metabolites. For both substances effective anti-oxidant and anti-inflammatory function has been validated when used in micromolar concentrations. These levels are attainable in vivo in humans. This paper gives an up-to-date overview about the current knowledge of the hypothesis that oxidant-induced cellular damage underlies the pathogenesis of many human pulmonary diseases, and it discusses the feasibility of anti-oxidant augmentation therapy to the lung by using NAC or ambroxol.

Acetylcysteine↗
PubMed2003

Depressant effects of ambroxol and erdosteine on cytokine synthesis, granule enzyme release, and free radical production in rat alveolar macrophages activated by lipopolysaccharide.

The present study examined the effects of ambroxol and erdosteine, bronchial expectorants, on the cytokine synthesis, granule enzyme release, and free radical production in rat alveolar macrophages activated by lipopolysaccharide. Ambroxol and erdosteine significantly decreased the production of tumour necrosis factors-alpha, interleukin-1beta, and interleukin-6 in alveolar macrophages activated by lipopolysaccharide. These drugs significantly reduced the production of superoxide anion, hydrogen peroxide, and nitric oxide and the release of acid phosphatase and lysozyme in lipopolysaccharide-activated macrophages. Ambroxol and erdosteine showed no scavenging effect on superoxide anion and hydrogen peroxide, whereas both drugs effectively decomposed nitric oxide. The results show that ambroxol and erdosteine may inhibit the responses, including cytokine synthesis and free radical production, in rat alveolar macrophages activated by lipopolysaccharide. Unlike the production of reactive oxygen species, the inhibitory effect of ambroxol and erdosteine on the production of nitric oxide in lipopolysaccharide-activated alveolar macrophages may be accomplished by a scavenging action on the species and inhibition of the respiratory burst.

Ambroxol↗
PubMed1995

Use of ambroxol and bromhexine as mucolytics for enhanced diffusion of furaltadone into tracheobronchial secretions in broilers.

1. Ambroxol and bromhexine were evaluated as mucolytics and to enhance the passage of furaltadone into tracheobronchial secretions (TBS) in chronic complicated respiratory disease-affected broilers. 2. Viscosity of TBS was noticeably increased in the ambroxol-treated birds and only slightly increased in the bromhexine groups; however, the physical (nature) of TBS was superior in the ambroxol-treated broilers. 3. There was a clear increase in the passage of furaltadone into tracheobronchial secretions only in the ambroxol-treated birds. 4. Everyday use of ambroxol in broilers is discussed.

Ambroxol↗
PubMed2000

Antenatal use of ambroxol for the prevention of infant respiratory distress syndrome.

OBJECTIVE: Our purpose was to evaluate the efficacy and safety of ambroxol for the prenatal prophylaxis of infant respiratory distress syndrome (IRDS). STUDY DESIGN: This was a prospective study with 2 groups of pregnant patients with premature labor or with premature rupture of membranes at an estimated gestation between 27 to 34 completed weeks. Ambroxol treatment group consisted of 39 subjects in whom 1,000 mg of ambroxol diluted in 500 ml of 5% glucose solution was given intravenously for 4 hours once a day for 3 days, while the control group consisted of 41 subjects in whom ambroxol was not administered. Main measures included Apgar scores, clinical signs of one or more of the following: respiratory rate of > 60/min, intercostal retraction, alar flaring, expiratory grunting, cyanosis on room air and radiological evidence of IRDS. Chi-square test was used to determine the statistical significance of the results. RESULTS: Tolerable maternal side effects were noted. Profile of newborns delivered were similar in both groups. Incidence of IRDS was significantly less in the treatment group (p < 0.01). CONCLUSIONS: Antenatal administration of ambroxol resulted in a significant decrease in the incidence of IRDS as well as perinatal morbidity and mortality. Due to the efficacy and safety of this drug, it might be useful for the prevention of IRDS.

Adult↗
PubMed1987

Clinical efficacy of ambroxol in the treatment of bronchial stasis. Clinical trial in 120 patients at two different doses.

Mucosolvan is a 'mucus-modifier' whose active compound is ambroxol. The aim of our research was to determine its clinical efficacy in the treatment of bronchial stasis by carrying out two successive double-blind studies in two parallel groups of patients and comparing ambroxol with placebo in a treatment lasting 10 days. The first trial involving 60 patients daily treated with 120 mg of ambroxol showed significant differences (p less than 0.05) in sputum volume, sputum viscosity, difficulty of expectoration, and severity of cough when compared with the placebo group. The two groups of patients were initially well matched and the drug was well tolerated. In a second trial involving 60 new patients daily treated with 30 mg of ambroxol, the drug showed no clear clinical effects. We conclude that ambroxol is an effective 'mucus modifier' and is well tolerated at a dose of 120 mg/day.

Adult↗
PubMed1989

Lung permeability in smokers after ambroxol treatment.

There is evidence suggesting the involvement of the surfactant system in the development of lung diseases in cigarette smokers. The aim of the present study was to evaluate the effect of Ambroxol on lung epithelial permeability (LEP) in healthy smokers. Ambroxol is known to stimulate surfactant production. Twenty male patients aged between 20 and 60 years participated in the study. They all smoked at least 15 cigarettes daily for 10 years. We carried out a random double-blind study versus placebo: the drug (Ambroxol 75 mg) or the placebo were given once a day after breakfast for 30 days. Lung permeability was evaluated through scanning pulmonary scintigraphy by inhalation of the polydispersed liquid aerosol diethylenetriaminepentaacetic acid (DTPA), labelled with 99Tc, and delivered by a 'Venticis' system. LEP was expressed as the half-time clearance from the lung of 99Tc-DTPA (T50). The significance of the differences between the two treatments was determined by the Student's test for unpaired data. LEP was not different from the baseline value (T50 = 18.49 min) after placebo administration (T50 = 19.57 min). The patients receiving Ambroxol showed an increased LEP mean value (T50 = 18.36 min) in comparison with the baseline mean value (T50 = 16.41 min). Our results demonstrate that the treatment with Ambroxol was able to decrease LEP in 6 subjects, though not significantly.

Adult↗
PubMed1998

Inhibitory effect of ambroxol on superoxide anion production and generation by murine lung alveolar macrophages.

We examined the effect of ambroxol on superoxide anion production before and generation after phorbol-myristate acetate (PMA) stimulation of lung alveolar macrophages. Lung free cells including lung alveolar macrophages were obtained from Fischer 344 rats and guinea pigs using bronchoalveolar lavage. The superoxide anion produced by lung alveolar macrophages with or without stimulation of PMA was measured by lucigenin-dependent chemiluminescence method using a photon counter. Ambroxol inhibited the superoxide anion production and generation by lung alveolar macrophages harvested from both F344 rats and guinea pigs in a dose-dependent fashion. Approximately 16 mumol/L of ambroxol inhibited 50% of superoxide production of lung alveolar macrophages in rats and guinea pigs, whereas a slightly greater dose of ambroxol, i.e., 18-26 mumol/L, was necessary to inhibit 50% of PMA-enhanced superoxide generation by lung alveolar macrophages. These results suggest that ambroxol acts as an antioxidant in murine lungs and may be a potential therapeutic option for reactive oxygen species-associated lung disorders including bronchial asthma.

Acridines↗
PubMed2006

Safety and usage pattern of an over-the-counter ambroxol cough syrup: a community pharmacy-based cohort study.

INTRODUCTION: Mucoactive substances such as ambroxol, available in several countries as over-the-counter (OTC) medicines, are used for the treatment of acute and chronic bronchitis. OBJECTIVE: This study was designed to evaluate the "real life" behavior of consumers with non-prescription access to an ambroxol cough syrup with special focus on tolerability and the pattern of product usage. METHODS: Customers who bought the ambroxol syrup were recruited in 300 community pharmacies in Germany. Baseline data were collected from the participants in the pharmacy. Completing a self-administered questionnaire, participants provided information on tolerability, self-perceived effectiveness and usage pattern. RESULTS: 2,707 participants were recruited in 266 pharmacies. 2,664 questionnaires were evaluable. At baseline, the respondents reported a complex pattern of symptoms. Productive cough, congested airways, dry cough, cough irritation in the throat and soreness in the throat were the most common ones. 67 patients (2.5%) reported a total of 81 adverse events (AE) which were usually mild in nature and mostly affecting the gastrointestinal tract (n = 53) followed by skin and subcutaneous tissue disorders (n = 9). No serious or unknown AE were reported. In general, 97% of the participants assessed the safety as "very good" (51%) or "good" (46%). Overall, the respondents complied with the indications for use and the recommended dosages, with only 0.7% of the participants using the maximum daily dose. 92% of the patients assessed the self-perceived effectiveness as "very good" (29%) or "good" (63%) and 89% were willing to purchase this ambroxol cough syrup again. CONCLUSIONS: This study confirms that ambroxol is used according to the advice given in the patients' leaflet and supports the already established safety and efficacy of this product in acute bronchitis. It also demonstrates that the use of an OTC cough medication can be successfully monitored in a pharmacy-based cohort study.

Adolescent↗
PubMed2001

[The effect of inhaled ambroxol treatment on clinical symptoms and chosen parameters of ventilation in patients with exacerbation of chronic obstructive pulmonary disease patients].

It was a randomised, double-blind, placebo controlled comparative study of the clinical symptoms and chosen parameters of ventilation of inhaled ambroxol in patients hospitalized with exacerbation of chronic obstructive pulmonary disease (COPD). Eligible patients--30 patients (13 men and 17 women) aged of mean value 70.5 +/- 6.9 years who fulfilled the clinical traits of exacerbation of chronic bronchitis entered the study. 15 patients were treated with inhaled ambroxol and 15 were treated with placebo. Moreover all patients were treated with concomitant medications typical for exacerbation of COPD (systemic steroids, intravenous infusions with euphillin, antibiotics, Berodual nebulizations and oxygen therapy). Spirometry and data related to clinical symptoms were taken at the beginning of the study and after 1 and 3 days and after the end of the treatment. At the end of the treatment period in both groups (inhaled ambroxol therapy vs. placebo) there wasn't found statistically significant difference in the number of cough and dyspnoe attacks. There was found the difference in FEV1 and FEF 50 in both groups, but improvement in patients treated with ambroxol was statistically significantly faster, that can influence the cost of treatment. Moreover there were not found important adverse events in ambroxol group.

Administration, Inhalation↗
PubMed2004

[Comparison of the effect of ambroxol and dexamethasone on the expression of pulmonary surfactant proteins in the fetal rat lungs].

OBJECTIVE: To investigate the effects of maternally administered dexamethasone and ambroxol on the mRNA levels of surfactant proteins (SP-A, SP-B and SP-C) expression in fetal rat lungs at gestational age day 19. METHODS: A 19-day fetal rat lung model was employed. In situ hybridization was used to detect the expression of SP-B mRNA in alveolar type II cell, and the levels of SP-A, SP-B and SP-C mRNAs were detected by semi-quantitative reverse transcriptase-polymerase chain reaction (RT-PCR). RESULTS: (1) SP-B mRNA was detected in situ in alveolar type II cells in fetal rat lung of day 19 gestational age; (2) In the late developmental period of fetal rat lungs, alveolar type II cells were also found around bronchus; (3) Comparing to beta-actin mRNA, the relative values of SP-A, SP-B and SP-C mRNAs were 0.81 +/- 0.26, 0.97 +/- 0.20 and 0.88 +/- 0.11 in fetal lung in the control group. The relative values of mRNAs of SP-A, SP-B and SP-C to beta-actin were 1.04 +/- 0.16, 1.28 +/- 0.29, 1.09 +/- 0.25 in fetal lungs of the ambroxol injected rats, and were 1.08 +/- 0.25, 1.23 +/- 0.35, 1.21 +/- 0.25 in fetal lungs of the dexamethasone injected rats, respectively. Both ambroxol and dexamethasone-treated rats had significantly higher mRNA expression of surfactant proteins compared to the control saline injected animals (P < 0.05). (4) There were no significant differences between ambroxol and dexamethasone in the effects of increasing expressions of surfactant protein mRNAs (P > 0.05). CONCLUSION: Antepartum administration of both ambroxol and dexamethasone can significantly increase fetal lung SP-A, SP-B and SP-C mRNAs expression.

Ambroxol↗
PubMed1986

[Ambroxol in comparison with betamethasone for the stimulation of antepartal lung maturity. A clinical double-blind study].

Stimulation of the surfactant production in fetal cells by ambroxol (metabolite VIII of bromhexine) has been investigated in human and animal experiments. There are no contraindications for the prenatal use of ambroxol, which is also well tolerated in high dose. Therefore the 1st Department of Obstetrics and Gynecology in Vienna took part in a multicentric clinical trial, where the allocation between cortisone and ambroxol was randomised in a double blind fashion. The 1st Department included 34 women between 30 and 36 weeks of pregnancy with premature labour or indicated premature induction. Amniotic fluid samples were taken by amniocentesis before therapy to prove lung immaturity by measurement of the L/S ratio and the dynamic surface tension. Following doses were used for this clinical trial group A: 1,000 mg ambroxol in 500 ml 5% glucose infusion i.v. daily from day 1 to day 5 and 2 ml placebo-injection i.m. on day 1 and day 2, group B: 8 mg Betamethasone i.m. on day 1 and day 2 and 500 ml 5% glucose infusion with a placebo daily from day 1 to day 5. The patients were treated at least 3 days; in all cases amniotic fluid samples were taken after therapy, to examine the L/S ratio and the dynamic surface tension. 29 women of the 34 fulfilled the above criteria, 15 in group A and 14 in group B (1 twin pregnancy). With the pretreatment parameters of lung maturity being similar in both groups ambroxol was found to lead to a marked but not significant improvement of the L/S ratio and the surface tension.(ABSTRACT TRUNCATED AT 250 WORDS)

Ambroxol↗
PubMed1988

Effect of ambroxol of neutrophil chemotaxis in vitro.

Ambroxol hydrochloride has been shown to protect the lung from damage by polymorphonuclear leucocyte (PMN). In view of this observation we have studied the effect of Ambroxol on PMN chemotaxis using a variety of chemoattractants. The PMN response was inhibited 50-80% by preincubating the cells with concentrations of 10(-4) M Ambroxol. There was no evidence of PMN killing by the drug at concentration of 10(-3) M. The results suggest that Ambroxol my have a role in the management of patients whose chronic lung damage is due to excess PMN recruitment.

Ambroxol↗
PubMed1995

Ambroxol inhibits doxorubicin-induced lipid peroxidation in heart of mice.

A single intravenous injection of doxorubicin (DOX, 30 mg/kg body weight) caused a significant rise in the content of lipid peroxidation products in hearts of mice. The concentration of conjugated dienes (CD) and malondialdehyde (MDA) found 24 h after injection of DOX increased about 1.8- and 2.4-fold and reached values of 11.31 +/- 2.24 A233/g and 3.72 +/- 0.40 mumol/g, respectively. The same dose of 4'-epi-doxorubicin (EPI), a less cardiotoxic epimer of DOX, increased only the heart level of MDA. Both antracyclines were not able to induce increased formation of CD in murine liver and lungs. Ambroxol, an expectorant drug which possesses the ability to scavenge hydroxyl radicals, injected intravenously (70 mg/kg) 30 min prior to DOX, completely abolished the rise in heart content of CD and MDA. The heart levels of CD and MDA in animals treated with ambroxol and DOX were 3 and 2.7 times lower than those observed in mice treated with water and DOX, respectively. Ambroxol had no effect on DOX- and EPI-induced formation of MDA in the lungs. Our results indicate that (1) DOX is a more powerful inductor lipid peroxidation in the heart than EPI; and (2) ambroxol may be useful in preventing lipid peroxidation in the heart caused by DOX.

Ambroxol↗