Pharmacological properties of the drug Moxifloxacin
Antibacterial drug of the fluoroquinolone group. Has a bactericidal effect. The mechanism of action is due to the inhibition of bacterial topoisomerases II and IV, which leads to disruption of the DNA synthesis of the microbial cell. In vitro, it is active against a wide range of gram-negative and gram-positive bacteria, anaerobes, acid-fast bacteria and atypical forms, including Mycoplasma, Chlamydia, Legionella. Effective against bacteria resistant to β-lactam and macrolide antibiotics. Gram-positive bacteria are sensitive to moxifloxacin - Staphylococcus aureus (including strains sensitive to methicillin), Streptococcus pneumoniae (including strains resistant to penicillin and macrolides), Streptococcus pyogenes (group A), Streptococcus milleri, Streptococcus mitior , Streptococcus agalactiae, Streptococcus dysgalactiae, Staphylococcus cohni, Staphylococcus epidermidis (including strains sensitive to methicillin), Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus saprophyticus, Staphylococcus simulans, Corynebacterium diphtheriae ; gram-negative bacteria - Haemophilus influenzae (including strains producing β-lactamases), Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis (including strains producing β-lactamases), Escherichia coli, Enterobacter cloacae; Bordetella pertussis, Klebsiella oxytoca, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter intermedius, Enterobacter sakazakii, Proteus mirabilis, Proteus vulgaris, Morganella morganii, Providencia rettgeri, Providencia stuartii; anaerobic bacteria - Bacteroides distasonis, Bacteroides eggerthii, Bacteroides fragilis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides unoformis, Fusobacterium spp., Porphyromonas spp. (including Porphyromonas anaerobus, Porphyromonas asaccharolytica, Porphyromonas magnus), Prevotella spp., Propionibacterium spp., Clostridium perfringens, Clostridium ramnosum . Moxifloxacin is also active against Chlamydia pneumoniae, Mycoplasma pneumoniae, Legionella pneumophila, Caxiella burnettii . It has a clinically significant post-antibiotic effect against gram-positive and gram-negative microorganisms (on average 2 hours). When taken orally, it is quickly and almost completely absorbed from the gastrointestinal tract (food intake does not affect the absorption of moxifloxacin). Absolute bioavailability is 86–92%. The maximum concentration in the blood serum is reached after 1–2.5 hours and after oral administration of 400 mg of moxifloxacin is 2.5–4.98 mg/l. Plasma protein binding is 39.4–48%. It is well distributed in tissues and body fluids, the volume of distribution is 3–3.5 l/kg. Creates high concentrations in bronchial secretions, alveolar macrophages, the mucous membrane of the maxillary sinus and bronchial secretions, which exceed the level of moxifloxacin in the blood. Metabolized in the liver without the participation of the cytochrome P450 system with the formation of two inactive metabolites - acetyl glucuronide and N-sulfate, the first of which binds to proteins by 89.5%, and the second practically does not bind to albumin (4.8%). The half-life is 12–14 hours. Total clearance is 254 ml/min, renal clearance is 50 ml/min. 42% is excreted in the urine (22% unchanged, 20% in the form of metabolites), as well as in bile (12% unchanged, 27% in the form of metabolites).
Use of the drug Moxifloxacin
Take 400 mg orally, regardless of food intake, once a day for 5–10 days. The IV drug is prescribed at a dose of 400 mg once a day. The duration of treatment depends on the indications for use and is: for chronic bronchitis in the acute phase - 5 days, for community-acquired pneumonia - 10 days, for acute sinusitis - 7 days, for infections of the skin and soft tissues - 7 days. Moxifloxacin can be used intravenously throughout the entire course of treatment. It is possible to use it in the form of a solution for infusion at the initial stages of treatment, followed by a transition to taking moxifloxacin orally. The solution for infusion should be administered intravenously slowly over 60 minutes.
Moxifloxacin during pregnancy and breastfeeding
Due to the possibility of a destructive effect on the cartilage tissue of the fetus, taking pills while carrying a child is strictly contraindicated. If the mother's health is in danger, infusion administration is possible. In this case, the attending physician must carefully weigh the risks of such treatment.
Due to insufficient research on the danger of active components passing into breast milk during breastfeeding, antibiotics are not taken. In case of urgent need, feeding is interrupted.
Side effects of the drug Moxifloxacin
From the digestive system: often - abdominal pain, nausea, diarrhea, vomiting, dyspepsia, taste disturbances, changes in the results of liver function tests; rarely - dry mouth, flatulence, constipation, candidiasis of the oral mucosa, anorexia, stomatitis, glossitis, gastrointestinal dysfunction; in some cases - gastritis, discoloration of the tongue, dysphagia, transient jaundice. From the central nervous system and peripheral nervous system: often - headache, dizziness; rarely - insomnia, nervousness, drowsiness, anxiety, tremor, paresthesia; in isolated cases - hallucinations, depersonalization, increased muscle tone, coordination disorders, agitation, amnesia, aphasia, emotional lability, sleep disorders (including parasomnias), speech disorders, cognitive impairment, hypoesthesia, convulsions, confusion, depression. From the cardiovascular system: often - prolongation of the QT in patients with concomitant hypokalemia; rarely - tachycardia, hypertension (arterial hypertension), palpitations, prolongation of the QT with normal potassium levels in the blood serum; in some cases - arterial hypotension, vasodilation, peripheral edema. From the blood system: rarely - leukopenia, increased prothrombin time, eosinophilia, thrombocytosis; in isolated cases - decreased thromboplastin levels, decreased prothrombin time, thrombocytopenia, anemia. Metabolism: rarely - increased amylase activity; in isolated cases - hyperglycemia, hyperuricemia, increased LDH activity. From the musculoskeletal system: rarely - arthralgia, myalgia; in isolated cases - arthritis, tendinopathy. From the respiratory system: rarely - shortness of breath; in isolated cases - BA. From the reproductive system: rarely - vaginal candidiasis, vaginitis. From the urinary system: in isolated cases - impaired renal function. From the senses: in isolated cases - visual impairment, amblyopia, loss of taste sensitivity, parosmia. On the skin: rarely - rash, itching, increased sweating. Allergic reactions: in isolated cases - urticaria. Local reactions: often - swelling, allergic reactions, inflammation, pain in the area of drug administration, rarely - phlebitis at the infusion site. Other: rarely - asthenia, candidiasis, general discomfort, chest pain; in some cases - pain in the pelvis, swelling of the face, back pain, abnormal laboratory tests, pain in the legs.
Special instructions for the use of the drug Moxifloxacin
The use of quinolone drugs is associated with a possible risk of developing seizures. Moxifloxacin should be used with caution in patients with central nervous system diseases that predispose to seizures. Moxifloxacin should not be prescribed to patients with epilepsy. When using moxifloxacin, a slight prolongation of the QT on the ECG is possible. Do not exceed a dose of 400 mg and an infusion time of 60 minutes. Prolongation of the QT is associated with an increased risk of ventricular arrhythmias, including torsade de pointes. Caution should be exercised when prescribing moxifloxacin to patients with diseases accompanied by an increased risk of developing ventricular arrhythmias, with congenital or acquired diseases accompanied by prolongation of the QT , or receiving drugs that potentially slow intracardiac conduction. Due to the risk of arrhythmia in patients with clinically significant bradycardia and signs of acute myocardial ischemia, moxifloxacin should be used with caution. Considering that during fluoroquinolone therapy in elderly patients and patients receiving corticosteroids, there is a risk of tendon rupture or tenosynovitis, if pain or signs of inflammation of the tendon appear, it is recommended to stop using moxifloxacin. There is a risk of developing hypersensitivity reactions, including anaphylaxis, during the initial use of the drug. In such cases, the administration of moxifloxacin should be stopped immediately and appropriate emergency measures should be taken. Patients with impaired renal function (creatinine clearance ≤30 ml/min) do not require dosage adjustment. For moderately severe liver dysfunction (Child-Pugh functional class A, B), no dosage adjustment is required. In severe liver dysfunction, moxifloxacin should be used with extreme caution. If moxifloxacin is necessary, breastfeeding should be discontinued.
Moxifloxacin: focus on safety profile
A.I. SINOPALNIKOV
, Doctor of Medical Sciences, Professor,
Russian Medical Academy of Postgraduate Education, Moscow Today new, or so-called.
respiratory, fluoroquinolones are among the most frequently prescribed antimicrobial drugs (AMPs), in particular, for such an important indication in everyday clinical practice as community-acquired lower respiratory tract infections (cLRTIs). The popularity of this group of funds is explained by the following circumstances:
• firstly, respiratory fluoroquinolones have a wide spectrum of activity against almost all potential pathogens of vURTI, including pneumococci (regardless of their sensitivity to penicillin and/or macrolides), atypical and gram-negative microorganisms [1, 2]; • secondly, respiratory fluoroquinolones have attractive pharmacokinetic characteristics (high bioavailability when taken orally, achieving significant intra- and extracellular concentrations in the bronchial mucosa, the fluid lining the epithelium of the respiratory tract, alveolar macrophages, polymorphonuclear leukocytes). The possibility of administering a number of them in parenteral and oral dosage forms (in particular, moxifloxacin) opens up the prospect of stepwise therapy in a hospital setting, and oral administration opens up the prospect of widespread use in outpatient settings. It should also be mentioned here that the drugs are administered once a day [3, 4]; • thirdly, it is a proven clinical superiority or comparable effectiveness compared to standard empirical antibacterial therapy (penicillins, macrolides, cephalosporins), in particular, for such a common disease as community-acquired pneumonia (CAP) [5].
In this regard, it is not surprising that respiratory fluoroquinolones have come to be considered as drugs of choice or alternatives in all modern schemes of empirical antibiotic therapy for URTIs, especially CAP (Table 1) [6–8]. However, the popularization of the use of respiratory fluoroquinolones for such a broad indication as URTIs may be constrained by two circumstances, namely the safety profile and the risk of selection and spread of microorganisms resistant to fluoroquinolones. And here, obviously, the most important thing is an objective assessment of safety, especially since individual problems with individual representatives of this class of antibiotics (temafloxacin, trovafloxacin, grepafloxacin, clinafloxacin, etc.), which forced them to limit their use or abandon their use altogether, could create a negative image of fluoroquinolones toxic antibiotics. In this context, the history of the creation and subsequent clinical use of fluoroquinolones is an indicative illustration of how, as the spectrum expanded and the antimicrobial effect strengthened, in some cases the frequency of serious adverse events increased, which served as the reason for the withdrawal of certain drugs from the pharmaceutical market (Table 2).
The serious adverse drug reactions (ADRs) characteristic of some fluoroquinolones are their significant drawback, and this thesis is most relevant for antibiotics with a relatively short experience of clinical use. It is appropriate to recall here that many months, or even years, may pass from the appearance of an antibiotic on the pharmaceutical market to the establishment of the fact of serious ADRs. For example, 16 months passed from the start of the use of trovafloxacin to the discovery of its severe hepatotoxicity, and the cardiotoxicity of grepafloxacin (prolongation of the QT interval, the risk of developing life-threatening cardiac arrhythmias) was confirmed only 2 years after the start of its widespread clinical use [12].
Moving on to the analysis of the structure and frequency of adverse events/NDRs when taking moxifloxacin, it should be noted that the results of the first phase II/III clinical studies indicated an attractive safety profile of the antibiotic (Table 3).
However, it should be said that within the framework of individually conducted clinical studies, which are usually characterized by limited sampling power, it is possible to identify only fairly common ADRs, while for an objective assessment of the safety profile of a drug (including AMPs), much analysis is required more appointments. For example, establishing the toxicity of temafloxacin, trovafloxacin and grepafloxacin was possible only by analyzing the widespread clinical use of these antibiotics in 180 thousand, 2.5 million and 3.7 million patients, respectively [14]. In this regard, the results of post-marketing studies based on the study of spontaneous reports of ADRs to the relevant regulatory authorities are of particular interest (Table 4).
The data from the first post-marketing studies presented in the table indicated that moxifloxacin, along with levofloxacin, is the safest fluoroquinolone. The subsequent many years of experience in the widespread clinical use of moxifloxacin confirm the validity of this conclusion.
The safety profile of moxifloxacin is characterized, in particular, by the summarized results of a number of clinical studies, during which a total of 6,270 patients received moxifloxacin, and 5,961 patients received comparison antibiotics (amoxicillin, amoxicillin/clavulanate, cefuroxime axetil, cephalexin, cefixime, clarithromycin, azithromycin, trovafloxacin , ofloxacin, levofloxacin, trimethoprim/sulfamethoxazole). There were no differences in the frequency of identified ADRs, including those probably caused by taking a particular drug [15–17].
This is indicated by a recently published meta-analysis, which included double-blind (n = 22,369) and open-label (n = 7,635) phase II–IV studies performed between 1996 and 2010, during which moxifloxacin and AMPs were compared. , in addition to patients with CAP, were prescribed for such indications as acute bacterial rhinosinusitis, exacerbation of chronic bronchitis, uncomplicated inflammatory diseases of the pelvic organs, complicated and uncomplicated skin and soft tissue infections, complicated intra-abdominal infections [18]. It is important to emphasize that the meta-analysis also included studies that included patients with risk factors for therapeutic failure: elderly and senile patients (≥ 65 years), as well as those suffering from such serious concomitant diseases as diabetes mellitus, renal and liver failure, cardiovascular diseases, etc.
Among the known ADRs observed when taking fluoroquinolones, arthro- and tendinopathy are traditionally mentioned, additional risk factors for the development of which are old age and use of systemic glucocorticosteroids. An analysis of spontaneous reports of these ADRs indicates that they occur significantly more often when taking levofloxacin and pefloxacin compared to ciprofloxacin and moxifloxacin [19]. In general, the risk of tendonitis when treated with moxifloxacin is assessed as low, and the risk of tendon rupture is assessed as very low [20].
Although moxifloxacin prolongs the QT interval by 4-7 ms, according to available data (safety analysis of more than 54 thousand patients), this does not lead to an increased risk of cardiovascular ADRs (primarily torsades de pointes) [15, 19]. Thus, in particular, during a prospective observation of 13,578 patients receiving moxifloxacin for respiratory tract infections, no cases of torsade de pointes were recorded [21]. Currently, the instructions for use of moxifloxacin in the USA report that according to studies, including in patients with hypoglycemia, the antibiotic does not increase morbidity and mortality, which could be associated with QTc prolongation [22]. The results of the largest study evaluating cardiovascular ADRs with moxifloxacin also indicate an acceptable safety profile of the antibiotic [23]. The authors analyzed 64 phase II–IV randomized active-controlled clinical trials in which moxifloxacin was taken at a standard dose (400 mg/day) orally (n = 10,613) or as part of stepwise therapy (n = 3,431). Cardiovascular ADRs occurred with a comparatively low frequency both in the group of patients taking moxifloxacin (3.2 and 1.4% when prescribing the drug orally and as part of step-down therapy, respectively) and in the group of patients taking comparator antibiotics (2.4 and 1. 5% when prescribing drugs orally and as part of step therapy, respectively). During the period of the relevant studies, 5 deaths were recorded (the total number of patients taking moxifloxacin or comparison AMPs was 28,144): one of the deceased took comparison AMPs orally, one took stepwise therapy with moxifloxacin, and in another three cases death occurred shortly after the end of stepwise therapy. AMP therapy comparison. Only one episode of non-fatal torsade de pointes was recorded in a patient taking a comparison AMP. Important was the authors' conclusion that the incidence of cardiovascular ADRs remained low even in patients predisposed to prolongation of the QTc interval (patients aged ≥ 65 years, women, patients with documented baseline prolongation of the QTc interval, patients with severe CAP in the ICU and/or those in need in mechanical ventilation). The authors conclude that, although the expected slight prolongation of the QTc interval is observed with moxifloxacin, prescribing the antibiotic, taking into account the known precautions contained in the instructions for use, is not accompanied by any serious risk of developing cardiovascular complications.
Disorders of glucose metabolism are considered an ADR common to the entire fluoroquinolone class, however, according to available data, moxifloxacin does not cause clinically significant hypo- or hyperglycemia [15].
Allergic reactions when taking moxifloxacin are rare. Thus, the frequency of development of allergic reactions within 14 days. per 10 thousand prescriptions for moxifloxacin (4.3) was lower than for levofloxacin (8.7) and cephalosporins (7.5). At the same time, the frequency of development of anaphylactic reactions for fluoroquinolones turned out to be similar – 0.3–0.5/10 thousand [24].
As with most other antibiotics, moxifloxacin may promote the growth of Clostridium difficile in patients already colonized by this highly resistant anaerobe, which in turn can lead to suppression of normal microflora and the development of C. difficile-associated diarrhea. A case-control study of outpatients receiving fluoroquinolones did not find an increased risk of C. difficile-associated diarrhea and pseudomembranous colitis with moxifloxacin compared with levofloxacin [25].
Particularly noteworthy is the discussion of the hepatotoxicity of moxifloxacin, interest in which arose quite unexpectedly and was provoked by the activity of the European Medicines Evaluation Agency (EMEA). To comprehensively assess the benefit-risk balance of moxifloxacin, EMEA commissioned the German health authorities to carry out a cumulative review of all liver injuries reported up to 30 September 2007. Of the 48 likely moxifloxacin-related fatal liver disorders (regardless of cause), 8 were considered to be fatal. could be regarded as fatal hepatotoxicity of the antibiotic. Moreover, in 3 cases, moxifloxacin was used for the treatment of non-severe respiratory tract infections in an outpatient setting (acute bacterial rhinosinusitis, pharyngitis, acute bronchitis). This gave rise to the adoption in the European Union of amendments to the information on moxifloxacin for oral administration: the antibiotic was proposed to be used only in adults with acute bacterial rhinosinusitis, exacerbation of chronic bronchitis and community-acquired pneumonia, in whom other antibiotics are either ineffective or inapplicable [26].
However, even after careful consideration of the published data, it is difficult to understand why this problem is primarily attributed to moxifloxacin. Thus, an analysis of reports of adverse events and case-control studies indicates that, in general, hepatotoxicity most often develops when taking amoxicillin/clavulanate, which accounts for 10–13.5% of all cases of drug-induced hepatotoxicity, including requiring hospitalization of patients [27]. The incidence of drug-induced hepatitis when taking amoxicillin/clavulanate is 9 times higher than when taking amoxicillin [28]. This fact indicates that this ADR is associated mainly with the β-lactamase inhibitor clavulanic acid. Macrolides and fluoroquinolones account for 1–5% of all cases of drug-induced hepatotoxicity. Summary literature data also indicate a minimal risk of hepatotoxicity with moxifloxacin (0.3 cases/100 thousand patients) compared with amoxicillin/clavulanate (20 cases/100 thousand patients) [29]. Even an analysis of the incidence of acute liver failure and other severe manifestations of hepatotoxicity (data obtained from ADR reports submitted to the FDA) indicates a minimal risk of developing this potentially life-threatening complication with moxifloxacin (6.6 cases / 10 million prescriptions) compared with other antibiotics: levofloxacin (2.1/10 million), gatifloxacin (6.0/10 million), trovafloxacin (58/10 million), amoxicillin/clavulanate (10/10 million) [29].
EMEA experts believe that due to hepatotoxicity, the risk-benefit ratio of moxifloxacin for non-severe infections is questionable. However, with moderate exacerbations of chronic bronchitis/chronic obstructive pulmonary disease and CAP, mortality remains quite high, which may be much more important than the small number of cases of antibiotic hepatotoxicity. Conclusion
Currently, moxifloxacin is approved for clinical use in oral and parenteral dosage forms in 126 and 115 countries, respectively, for a wide range of indications, including community-acquired pneumonia, exacerbation of chronic bronchitis, acute bacterial rhinosinusitis, pelvic inflammatory disease, complicated and uncomplicated infections skin and soft tissues, complicated intra-abdominal infections. Since the beginning of its clinical use to the present time, the antibiotic has been prescribed to 176 million patients. It is obvious that the widespread popularity of moxifloxacin is due not only to its proven clinical superiority or comparable effectiveness compared to standard empirical antimicrobial therapy (penicillins, macrolides, cephalosporins) in the treatment of the above diseases, but also to its attractive safety profile.
Literature
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Drug interactions Moxifloxacin
With the simultaneous use of moxifloxacin and GCS, the risk of developing tendovaginitis or tendon rupture increases. There was no interaction of moxifloxacin with probenecid, warfarin, or oral contraceptives. No clinically significant interaction has been established between moxifloxacin and glibenclamide. Moxifloxacin slightly changes the pharmacokinetic parameters of digoxin. When used concomitantly, moxifloxacin does not affect the pharmacokinetics of theophylline. With parenteral use of morphine and moxifloxacin, there is no decrease in the bioavailability of the latter. Moxifloxacin infusion solution is incompatible with the following infusion solutions: sodium chloride 10%, sodium chloride 20%, sodium bicarbonate 4.2%, sodium bicarbonate 8.4%.
Note!
The description of the drug Moxifloxacin on this page is a simplified author’s version of the apteka911 website, created on the basis of the instructions for use.
Before purchasing or using the drug, you should consult your doctor and read the manufacturer's original instructions (attached to each package of the drug). Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.
Moxifloxacin overdose, symptoms and treatment
There were no side effects observed in healthy volunteers with single use of moxifloxacin in doses of up to 1.2 g or at a dose of 600 mg/day for 10 days. In case of overdose, symptomatic therapy is carried out in accordance with the clinical situation. In case of oral overdose of moxifloxacin, it is advisable to use activated carbon. After intravenous administration, activated charcoal slightly (approximately 20%) reduces the systemic exposure of moxifloxacin.
List of pharmacies where you can buy Moxifloxacin:
- Moscow
- Saint Petersburg
What is better than analogues?
Moxifloxacin has a number of significant advantages that distinguish it from numerous analogues. First of all, the drug is presented in several dosage forms at once, which is very convenient. The drug does not interact with food and can be taken at any time of the day.
Moxifloxacin price varies from 100 UAH for a blister with five tablets to 560 UAH for a bottle of solution for intravenous infusion. The price range makes this medicine accessible to the masses.
