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PubMed1989

Ambroxol for prevention and treatment of hyaline membrane disease.

To estimate the efficacy of ambroxol for clinical use in prenatal prevention and postnatal therapy of hyaline membrane disease (HMD) all available experimental and clinical data were reviewed. The administration of ambroxol in animals has a certain promoting influence on lung maturation, a high specificity to lung tissue and a favourable relationship between intended action and negative adverse effects. In clinical studies concerning the prevention of HMD, ambroxol increases the values of amniotic fluid parameters used for estimation of lung maturity and reduces the incidence of HMD at least as effectively as corticosteroids. The number of infants at less than 33 gestational weeks in these reports is small, and further studies will have to confirm the results. Ambroxol applied postnatally has beneficial effects on the course of severe HMD by increasing survival rate, by decreasing duration of oxygen need and artificial ventilation and by improving compliance. Pharmacological studies in preterm HMD-infants showed no influence of ambroxol on blood pressure and heart rate. In 3 of 8 newborns a transient increase of transcutaneous oxygen tension was seen during infusion of ambroxol. Ambroxol is quickly bound to tissue receptors which release it continuously indicating that repeated applications are as effective as continuous infusion.

Adrenal Cortex Hormones↗
PubMed1999

Depressant effects of ambroxol on lipopolysaccharide- or fMLP-stimulated free radical production and granule enzyme release by alveolar macrophages.

In order to explore the depressant action of ambroxol, a bronchial expectorant, on the activated alveolar macrophage responses, its effect on lipopolysaccharide (LPS)- or N-formyl-methionyl-leucyl-phenylalanine (fMLP)- stimulated free radical production and granule enzyme release by rat lung alveolar macrophages was investigated. Ambroxol attenuated the 100 ng/ml LPS- or 1 microM fMLP-stimulated superoxide, H(2)O(2)and nitric oxide production and releases of acid phosphatase and lysozyme by alveolar macrophages. Ambroxol attenuated phorbol myristate acetate-stimulated superoxide and nitric oxide production that was inhibited by 100 nM staurosporine. N,N-dimethylsphingosine (DMS, 4.5 and 9 microM) alone stimulated superoxide production by macrophages, while 45 microM of the compound did not show a stimulatory effect. However, DMS decreased nitric oxide production in a dose-dependent manner. Ambroxol did not alter the DMS effect on free radical production that was affected by 10 microM genistein. A preincubation of macrophages with ambroxol (10 and 100 microM), staurosporine and genistein attenuated the elevation of [Ca(2+)](i)caused by LPS. The results suggest that ambroxol exerts a depressant effect on LPS- or fMLP-stimulated free radical production and granule enzyme release by rat alveolar macrophages, which may be attributed to its inhibitory action on the activation process, protein kinase C, but its action on protein tyrosine kinase is not suggested.

Acid Phosphatase↗
PubMed1992

Randomized double blind trial of Ambroxol for the treatment of respiratory distress syndrome.

In order to test the ability of Ambroxol to improve the clinical course of respiratory distress syndrome and to reduce the incidence of complications a multicentre, randomized, placebo-controlled double-blind trial was conducted. Entry was limited to infants with a birth weight below 1500 g. A total of 179 neonates were enrolled, but 31 were later excluded because they had other diseases. Of the remaining 148 babies, 74 received Ambroxol (birth weight 1190 +/- 216 g; gestational age 29.1 +/- 1.9 weeks) and 74 placebo (birth weight 1168 +/- 216 g; gestational age 28.9 +/- 1.9 weeks). In the Ambroxol group 23 (31%) and in the placebo group 27 (37%) infants died during the first 5 months of life. In 28 day-survivors Ambroxol was able to significantly improve the PaO2/FiO2 ratio, mean airway pressure, phospholipid profile of tracheal effluent and pulmonary mechanics of spontaneously breathing infants. In addition, the incidences of bronchopulmonary dysplasia (29% vs 54%), intraventricular haemorrhage (25% vs 44%) and postnatally acquired pneumonia (15% vs 36%) were significantly reduced in the Ambroxol group as compared to the control group. No adverse events attributed to the Ambroxol treatment were reported.

Ambroxol↗
PubMed1991

Prevention by ambroxol of bronchopulmonary complications after upper abdominal surgery: double-blind Italian multicenter clinical study versus placebo.

A double-blind multicenter study was carried out to evaluate the effectiveness of ambroxol, a drug able to promote surfactant synthesis, in the prevention of postoperative bronchopulmonary complications. A total of 252 patients with chronic obstructive lung disease (COLD) undergoing upper abdominal surgery were randomly allocated to receive either 1 g/day of ambroxol intravenously for 6 consecutive days in the perioperative period or placebo. Pulmonary complications were evaluated by clinical studies, radiographic, and blood gas analysis. There was a significant difference in atelectasis between the 2 groups (10.6% ambroxol vs 23.9% placebo). In addition, analysis of variance showed that the PaO2 values of the ambroxol-treated group after surgery decreased less than those of the placebo-treated group (p less than 0.05) from the preoperative values. The treatment was well tolerated, although nausea was significantly more frequent in the ambroxol-treated group. We think that ambroxol should be considered as an alternative and new pharmacologic approach for the prevention of postoperative pulmonary complications.

Adult↗
PubMed1994

Antioxidant properties of Ambroxol.

We tested whether Ambroxol, a drug which stimulates the release of surfactant by pneumocytes type II, may also possess antioxidant properties. To assess the reactivity of Ambroxol with reactive oxygen species, we analysed its ability to decompose hydrogen peroxide (H2O2) and to inhibit the superoxide (O2.-)-dependent autooxidation of pyrogallol, hydroxyl radical (.OH)-mediated deoxyribose oxidation, and hypochlorous acid (HClO-induced chlorination of monochlorodimedon. Ambroxol was found to be a sufficient scavenger of HClO and .OH and also revealed the capacity to decompose H2O2. At concentrations of 25 and 70 microM, it inhibited HClO-induced chlorination of monochlorodimedon by 22 +/- 13 and 59 +/- 14%, respectively. Similarly, at concentrations of 1, 2, and 10 mM, Ambroxol decreased .OH-mediated deoxyribose oxidation by 47 +/- 11, 75 +/- 9, and 89 +/- 4%. In addition, at concentrations of 1 to 5 mM, it completely protected linoleic acid from .OH-induced peroxidative damage. Ambroxol had a weak effect on O2.(-)-dependent autooxidation of pyrogallol. Our results indicate that Ambroxol has antioxidant activity, which may have clinical significance in protecting lung tissue from oxidant-induced injury.

Ambroxol↗
PubMed2003

Inhibition of bleomycin-induced cell death in rat alveolar macrophages and human lung epithelial cells by ambroxol.

The mitochondrial permeability transition is recognized to be involved in toxic and oxidative forms of cell injury. In the present study, we investigated the effect of ambroxol against the cytotoxicity of bleomycin (BLM) by looking at the effect on the mitochondrial membrane permeability in alveolar macrophages and lung epithelial cells. Alveolar macrophages or lung epithelial cells exposed to BLM revealed the loss of cell viability and increase in caspase-3 activity. Ambroxol (10-100 microM) reduced the 75 mU/mL BLM-induced cell death and activation of caspase-3 in macrophages or epithelial cells. It reduced the condensation and fragmentation of nuclei caused by BLM in macrophages. Ambroxol alone did not significantly cause cell death. Treatment of alveolar macrophages with BLM resulted in the decrease in transmembrane potential in mitochondria, cytosolic accumulation of cytochrome c, increase in formation of reactive oxygen species (ROS) and depletion of GSH. Ambroxol (10-100 microM) inhibited the increase in mitochondrial membrane permeability, ROS formation and decrease in GSH contents due to BLM in macrophages. Ambroxol exerted a scavenging effect on hydroxyl radicals and nitric oxide and reduced the iron-mediated formation of malondialdehyde and carbonyls in liver mitochondria. It prevented cell death due to SIN-1 in lung epithelial cells. The results demonstrate that ambroxol attenuates the BLM-induced viability loss in alveolar macrophages or lung epithelial cells. This effect may be due to inhibition of mitochondrial damage and due to the scavenging action on free radicals.

Ambroxol↗
PubMed2000

Ambroxol as an inhibitor of nitric oxide-dependent activation of soluble guanylate cyclase.

The influence of ambroxol on the activity of human platelet soluble guanylate cyclase and rat lung soluble guanylate cyclase was investigated. Ambroxol in the concentration range from 0.1 to 10 microM had no effect on the basal activity of both enzymes and slightly enhanced it at 50 and 100 microM. Ambroxol inhibited in a concentration-dependent manner the sodium nitroprusside-induced activation of both enzymes. The IC(50) values for inhibition by ambroxol of sodium nitroprusside-stimulated human platelet soluble guanylate cyclase and rat lung soluble guanylate cyclase were 3.9 and 2.1 microM, respectively. Ambroxol did not influence the stimulation of soluble guanylate cyclase by protoporphyrin 1X. Thus, it is possible that the molecular mechanism of the therapeutic action of ambroxol involves the inhibition of nitric oxide (NO)-dependent activation of soluble guanylate cyclase.

Ambroxol↗
PubMed2003

Pharmacokinetic properties of single-dose loratadine and ambroxol alone and combined in tablet formulations in healthy men.

BACKGROUND: Due to Mexico's complicated socioeconomic environment, causing a high occurrence of >1 person sharing a single room, respiratory conditions are spread easily. Respiratory conditions are the main reason for consultation with a physician. The most frequent symptoms are throat soreness and cough; therefore, a new formulation combining loratadine and ambroxol hydrochloride was designed to treat these 2 major symptoms. The combination is expected to provide relief when coprescribed with more specific therapies, such as antibiotics. OBJECTIVE: This study determined the pharmacokinetic profile of single-dose loratadine-ambroxol hydrochloride combination therapy versus each component given separately. The analyses included descarboethoxyloratadine (DCL), the primary active metabolite of loratadine. METHODS: This was a 4-week, single-center, randomized, open-label, 3-period crossover study in adult male volunteers aged 18 to 50 years and in good general health. Subjects were randomized to receive single doses of treatment A (2 loratadine 5-mg tablets + ambroxol 30-mg tablets), B (2 ambroxol 30-mg tablets), or C (1 loratadine 10-mg tablet) in 1 of 3 sequences (ABC, BCA, or CAB) per period. A 14-day washout period separated each treatment period. Plasma concentration-time data curves for each subject and treatment were analyzed by noncompart-mental methods to obtain values for area under the curve (AUC), maximum plasma concentration (C(max)), and time to reach C(max) (T(max)). RESULTS: Thirty subjects (mean [SD] age, 22.5 [2.6] years) were enrolled. All treatments were well tolerated. Formulations A and C produced similar loratadine and DCL AUC from time 0 to 24 hours (AUC(0-24)) values, but showed slightly high C(max). values for loratadine and slightly low C(max) values for DCL, indicating failure to demonstrate bioinequivalence. Formulations A and B produced similar ambroxol C(max), T(max), and AUC(0-24) values. CONCLUSIONS: In this population of healthy mate volunteers, results showed the bioavailability of loratadine and ambroxol from the new formulation and did not show impairment of absorption when the drugs were formulated in a combination tablet.

Administration, Oral↗
PubMed1987

[Induction of fetal lung maturation using ambroxol and betamethasone. Results of an open multicenter study].

In a randomized open multicenter study the results of antenatal prophylaxis against neonatal RDS by administration of betamethasone were compared with those obtained with the bromhexine VIII metabolite Ambroxol. Ambroxol was administered for a maximum of 5 days - 1000 mg in an infusion solution; betamethasone was injected intramuscularly in 2 daily doses of 8 mg. One of these two substances was given to 123 pregnant women for pulmonary maturation in the fetus, in accordance with a randomization plan. The patients were either being treated for premature labor or pregnancy was terminated on the basis of indication between the 28th and 36th week. Therapy had to be discontinued in 4 cases in each group, because of continued labor and birth, and in one case because of an amniotic infection syndrome. A full analysis of the treatment records of 57 pregnancies in the Ambroxol group was carried out; the corresponding figure for the betamethasone group was 58. In 39 patients the duration of pregnancy was 37 weeks or more, so that no assessment on the basis of neonatal pulmonary maturity was possible. In the remaining pregnancies, RDS morbidity was estimated on the basis of clinical and radiological findings and blood gas analysis. Related to a maximum duration of pregnancy of 34 weeks, RDS morbidity after Ambroxol therapy was 18.2% (2 out of 11), as opposed to 35.7% (5 out of 14) after betamethasone treatment. The results confirm that antenatal administration of Ambroxol can bring about a reduction in neonatal RDS corresponding to that achieved with betamethasone therapy. However, with Ambroxol the occurrence of side-effects is potentially lower; it therefore has advantages over betamethasone while being equally efficacious.

Ambroxol↗
PubMed2002

Inhibition of tetrodotoxin (TTX)-resistant and TTX-sensitive neuronal Na(+) channels by the secretolytic ambroxol.

Ambroxol has a long history for the treatment of airway diseases because of its beneficial effects on surfactant synthesis and mucus-modifying properties. Some findings, however, point to an additional effect on neuronal signal transduction: ambroxol can suppress reflexes such as the cough or the corneal reflex. The airways and the cornea are innervated by C-fibers, which express voltage-gated Na(+) channels with and without sensitivity to tetrodotoxin (TTX). In this study, we performed voltage-clamp experiments to investigate whether ambroxol affects these channel types. In rat dorsal root ganglia, TTX-resistant Na(+) currents were suppressed in a concentration-dependent manner with IC(50) values of 35.2 and 22.5 microM for tonic and phasic block, respectively. Depolarizing prepulses increased the potency of ambroxol, and steady-state inhibition curves were shifted to more negative values. The inhibition was not frequency-dependent. TTX-sensitive currents were inhibited with lower potency (approximately 50% inhibition with 100 microM). Recombinant rat brain IIA channels in Chinese hamster ovary cells were blocked with IC(50) values of 111.5 and 57.6 microM for tonic and phasic block, respectively; in contrast to TTX-resistant channels the block was frequency-dependent. Thus, ambroxol indeed blocks neuronal voltage-gated Na(+) channels, and TTX-resistant channels in sensory neurons were more sensitive than TTX-sensitive. Compared with known local anesthetics (e.g., lidocaine or benzocaine), the potency for Na(+) channel block was relatively high. A recent clinical trial has further confirmed that ambroxol relieved pain and was beneficial in patients who suffered from sore throat.

Ambroxol↗
PubMed1998

Effect of ambroxol on oxygen radical production and generation by bronchoalveolar lavage cells in young and aged guinea pigs.

We examined the effect of ambroxol and age on oxygen radical production and generation with stimulation of phorbol-myristate acetate (PMA) by bronchoalveolar lavage (BAL) cells. Lung free cells including pulmonary alveolar macrophages were harvested from young (4-month-old) and aged (28-month-old) male guinea pigs using BAL. The oxygen radicals produced by BAL cells with or without stimulation of PMA were measured by the lucigenin-dependent chemiluminescence method using a photon counter. Oxygen radical production and generation by BAL cells were not different between young and aged guinea pigs. However, the oxygen radical generation after stimulation with PMA was greater than the oxygen radical spontaneous production both in young and aged animals. Ambroxol solution given into culture media containing BAL cells inhibited oxygen radical production and generation by BAL cells harvested from both young and aged guinea pigs in a concentration-dependent manner. Approximately 16-20 microM of ambroxol inhibited 50% of the production of oxygen radicals in vitro by BAL cells in young and aged guinea pigs, whereas a slightly greater amount of ambroxol was necessary to inhibit 50% of the PMA-induced oxygen radical generation in vitro by BAL cells in guinea pigs. These results indicate that ambroxol inhibits oxygen radicals produced by BAL cells from young and aged guinea pigs, and they suggest that ambroxol may be a possible therapeutic modality for ameliorating oxidant associated pulmonary disorders in young and aged patients.

Aging↗
PubMed1987

An alternative to steroids for prevention of respiratory distress syndrome (RDS): multicenter controlled study to compare ambroxol and betamethasone.

The results are reported of a multicenter randomized study of the effectiveness of maternal administration of betamethasone versus ambroxol, a substance of the group of the benzylamines, for prevention of RDS in preterm infants. Women of 27 to 34 weeks gestation with threatened premature delivery or planned premature delivery were admitted to the trial. Between September 1981 and November 1984 a total of 288 randomized patients delivered 315 neonates. The incidence of RDS was assessed in 169 viable neonates born before the 37th week. Of these 86 were born of 76 mothers treated with beta-methasone and 83 of 76 mothers treated with ambroxol. The overall incidence of RDS was significantly (P less than 0.05) higher in the betamethasone group (31%) than the ambroxol group (13%). Ambroxol was significantly more effective than betamethasone in twin births, in infants born before the 31st week, when ROM to delivery time was more than 48 hours, when treatment to delivery time was between 2 and 7 days and in female infants. The neonatal infection rate was significantly higher (P less than 0.05) in the group of betamethasone treated infants (18% with four fatalities) than in the group of ambroxol treated infants (9% with one fatality). These results suggest that ambroxol may be a valid alternative to steroids for prevention of RDS.

Ambroxol↗
PubMed1990

[Ambroxol versus betamethasone for the promotion of antepartum lung maturity in pathological pregnancies].

Although glucocorticoids have been universally implemented to stimulate fetal lung maturity, their effectiveness and side effects are still widely contested. In search of alternative drugs a double-blind study was conducted between June 1981 and June 1984 comparing betamethasone, a conventional corticoid, and ambroxol, a bromhexine metabolite for efficacy and tolerance in prenatal prevention of the respiratory distress syndrome (RDS) in premature infants and full-term neonates. The therapeutic efficacies of betamethasone and ambroxol for this indication proved to be comparable. Since the possible risks of corticoid therapy in abnormal pregnancies are repeatedly discussed in the literature and in daily clinical practice. 137 patients with EPH gestosis, placental insufficiency, diabetes mellitus, and premature rupture of the membranes were selected from the original group of 308 patients. Only minor side effects (e.g. nausea) were present in a few of the 137 cases undergoing treatment with the 2 test substances. No side effects were observed in the neonates. The incidence of fetal RDS was comparable in both groups (2.9% with ambroxol, 2.2% with betamethasone). Transient and mild RDS cases were slightly more frequent in the ambroxol group than in the betamethasone group. To date, contraindications to ambroxol treatment in abnormal pregnancies are unknown and since generally the rate of potential side effects is considered to be lower in comparison with corticoid treatment, the use of ambroxol especially in abnormal pregnancies corresponding indication can be recommended.

Ambroxol↗
PubMed1989

Steady-state bioavailability and pharmacokinetics of ambroxol and clenbuterol administered alone and combined in a new oral formulation.

Ambroxol and clenbuterol are two drugs with potential pharmacological synergy. The objective of this study was to compare the apparent bioavailabilities at steady-state of these two compounds administered alone or in combination (CHF-023). Nine healthy male volunteers participated in the study. They received 30 mg of ambroxol alone (one Fluibron tablet), or 20 micrograms of clenbuterol alone (one Spiropent tablet), or 30 mg of ambroxol plus 20 micrograms of clenbuterol in combination (one CHF-023 tablet), every 12 hours for 7 days on three separate occasions. Ambroxol and clenbuterol concentrations were measured in plasma by appropriate GC/MS methods. Pharmacokinetic parameters were calculated by non-compartmental methods and submitted to statistical comparisons. Compartmental analysis was also performed on data provided by CHF-023 treatment. It was concluded that apparent bioavailabilities of ambroxol and clenbuterol are almost identical in Fluibron and CHF-023 tablets, and in Spiropent and CHF-023 tablets, respectively, with no statistically significant differences between pharmacokinetic parameters calculated for these two drugs during different treatments, except for peak concentration of ambroxol.

Administration, Oral↗
PubMed1986

Ambroxol decreases bronchial hyperreactivity.

Ambroxol is a new compound which increases secretion of phosphatidylcholine by type II pneumocytes. The secretion of phosphatidylcholine could affect bronchial hyperreactivity in two ways: by increasing lysophosphatidylcholine turnover and/or by modifying the layer of bronchial secretion that covers airway receptors. To see whether ambroxol affects bronchial hyperreactivity, we carried out a double-blind cross-over study, evaluating the efficacy of this drug vs placebo in modifying methacholine PD20 in 11 asthmatic patients, 4 atopics and 7 non-atopics. 90 mg of ambroxol or placebo were randomly administered orally for one of two 14-day periods. Methacholine PD20 was evaluated before and after each treatment. A highly significant difference was demonstrated in the direct comparison between ambroxol and placebo as to their ability to modify mean metacholine PD20, which with ambroxol was more than double that with placebo. It was also seen that ambroxol induced a significant increase in baseline values of PD20, i.e. a significant decrease in bronchial hyperreactivity. Placebo did not do this.

Adult↗
PubMed1995

Intraluminal inflammation in the airways of patients with chronic bronchitis after treatment with Ambroxol.

Ambroxol is a mucus-modifying drug with a known ability to stimulate surfactant secretion and inhibit, in vitro, the production of proinflammatory cytokines, neutrophil chemotaxis, and Na+ absorption by the airway epithelium. In dogs inhaling ozone, bronchial hyperreactivity can be inhibited by aerosolized Ambroxol. To verify the possibility of producing anti-inflammatory effects in a clinically relevant condition, 20 patients with chronic bronchitis, randomly divided into two balanced matched groups, were submitted to a 14 day trial with Ambroxol, 150 mg.day-1, or placebo, according to a double-blind design. A bronchoalveolar lavage (BAL) was performed the day before starting treatment (T0) and at the 14th day (T14). The analysis of the cellular and soluble (total proteins, albumin, immunoglobulin G and A (IgG and IgA)) BAL components demonstrated no clear modifications. In particular, neutrophil values from the bronchial aliquot showed a large dispersion, with no significant differences (Ambroxol: T0 = 13.7 +/- 5.2%, T14 = 14.0 +/- 6.8%; placebo: T0 = 3.6 +/- 1.1%, T14 = 5.5 +/- 2.2%). We found a nonsignificant increase of phospholipids in BAL supernatants from Ambroxol-treated patients (2.5 +/- 1.9 vs 3.0 +/- 1.9 micrograms.mg-1 of protein); whilst in the placebo group data before and after treatment were superimposable (2.2 +/- 1.5 vs 2.3 +/- 1.9 micrograms.mg-1 of protein). In conclusion, we have failed to demonstrate that conventional treatment with oral Ambroxol can modify surfactant and BAL cell populations in the airways of patients with chronic bronchitis.

Ambroxol↗
PubMed1998

The effect of ambroxol on the vascular reactivity in the rabbit.

Experiments were designed to determine whether ambroxol, a drug used for the treatment of respiratory disorders, affects the basal tension and/or contractions due to adrenergic stimuli in the isolated rabbit portal vein and pulmonary artery. Ambroxol in concentrations of 10(-6)-10(-4) mol/l produced a concentration-dependent increase in basal tension, but a decrease in spontaneous mechanical activity of portal vein. The same concentrations of ambroxol failed to influence basal tension of pulmonary artery. However, when the vessel tone was increased by exogenous noradrenaline, ambroxol elicited concentration-dependent contractions also in this vessel. Moreover, ambroxol in the concentration of 10(-5) mol/l significantly enhanced vascular contractions due to both exo- and endogenous noradrenaline. The results suggest that ambroxol, in biologically relevant concentrations, may influence or even induce vascular contractions to adrenergic stimuli. Their expression, however, depend on the type of vascular smooth muscle. (Fig. 7, Ref. 25.)

Adrenergic alpha-Agonists↗
PubMed1995

Evaluation of the effects of ambroxol on the ofloxacin concentrations in bronchial tissues in COPD patients with infectious exacerbation.

Infectious excerbations of COPD are generally due to Streptococcus pneumoniae, Haemophilus species, and other Gram-negative bacteria. Ofloxacin has potent activity against Gram-negative species but is less effective against Gram-positive species including Streptococcus pneumoniae. It has also been shown that the administration of ambroxol increases the concentration of some antibiotics in pulmonary tissues. The aim of the study was to determine whether ambroxol increases the bronchial tissue concentrations of ofloxacin to a level exceeding the MIC90 of the bacterial species less susceptible to ofloxacin. 24 patients with COPD were randomized in two groups. Drug regimens of ofloxacin alone (200 mg twice daily) or ofloxacin (200 mg twice daily)+ambroxol (30 mg thrice daily) were administered over 10 d. A fibroscopy was performed on day 10 with bronchial biopsies and broncho-alveolar lavage. At steady state, concentrations of drug in plasma and bronchial samples were assayed by HPLC with fluorometric detection. There was no significant difference in the bronchial levels of ofloxacin between the two groups; however, in alveolar cells, ofloxacin concentration was three times higher in the group with ambroxol. Ambroxol does not increase ofloxacin concentrations in bronchial tissue because high concentrations are already present in the lung.

Administration, Oral↗