Composition and release form
Tablets - 1 tablet:
- Active ingredients: levofloxacin hemihydrate - 512.46 mg (corresponding to the content of levofloxacin - 500 mg);
- Excipients: microcrystalline cellulose - 44.69 mg, crospovidone - 7.85 mg, sodium stearyl fumarate - 1.41 mg, croscarmellose sodium - 6.15 mg, colloidal silicon dioxide - 15.38 mg, maltodextrin - 24.6 mg, magnesium stearate - 2.46 mg;
- Shell composition: Opadry orange 20A230018 - 15 mg (hydroxypropyl methylcellulose 2910 [hypromellose 6cP] (E464) - 6.6 mg, titanium dioxide (E171) - 1.375 mg, talc - 3.150 mg, hyprolose [hydroxypropylcellulose, klucel EF] ( E463) - 3.851 mg, sunset yellow dye (E110) - 0.024 mg).
3/5/7/10 pcs. — contour packaging, cardboard packs.
Avelox
Use during pregnancy and breastfeeding
The safety of moxifloxacin during pregnancy has not been established and its use is contraindicated.
Cases of reversible joint damage have been described in children receiving some quinolones, but this effect has not been reported in the fetus (when used by the mother during pregnancy). Reproductive toxicity has been shown in animal studies. The potential risk to humans is unknown.
Like other quinolones, moxifloxacin causes cartilage damage in large joints in premature animals. Preclinical studies have shown that small amounts of moxifloxacin are excreted in breast milk. There are no data on its use in women during lactation. Therefore, the use of moxifloxacin during breastfeeding is contraindicated.
Use for liver dysfunction
Patients with impaired liver function do not require a change in dosage regimen.
The drug should be used with caution in patients with liver cirrhosis.
Use for renal impairment
Patients with impaired renal function (including those with CC <30 ml/min/1.73 m2), as well as patients on continuous hemodialysis and long-term ambulatory peritoneal dialysis, do not require changes in the dosage regimen.
Use in children
Contraindicated: children and adolescents under 18 years of age.
Use in elderly patients
Elderly patients do not require changes in the dosage regimen.
special instructions
In some cases, after the first use of the drug, hypersensitivity and allergic reactions may develop, which should be reported to your doctor immediately. Very rarely, even after the first use of the drug, anaphylactic reactions can progress to life-threatening anaphylactic shock. In these cases, treatment with Avelox® should be stopped and the necessary therapeutic measures (including anti-shock) should be started immediately.
When using Avelox®, some patients may experience prolongation of the QT interval.
Avelox® should be used with caution in women and elderly patients. Because women have a longer QT interval than men, they may be more sensitive to drugs that prolong the QT interval. Elderly patients are also more susceptible to drugs that affect the QT interval.
The degree of QT interval prolongation may increase with increasing drug concentrations, so the recommended dose should not be exceeded. Prolongation of the QT interval is associated with an increased risk of ventricular arrhythmias, including polymorphic ventricular tachycardia. However, in patients with pneumonia, a correlation between moxifloxacin plasma concentrations and QT interval prolongation was noted. None of the 9,000 patients receiving Avelox® experienced cardiovascular complications or deaths associated with QT prolongation.
When using Avelox®, the risk of developing ventricular arrhythmias may increase in patients with conditions predisposing to arrhythmias. In this regard, Avelox® is contraindicated in:
- changes in electrophysiological parameters of the heart, expressed in prolongation of the QT interval (congenital or acquired documented prolongation of the QT interval, electrolyte disturbances, especially uncorrected hypokalemia, clinically significant bradycardia, clinically significant heart failure with reduced left ventricular ejection fraction, a history of indications of rhythm disturbances, accompanied by clinical symptoms);
- use with other drugs that prolong the QT interval.
Avelox® should be used with caution:
- in patients with potentially proarrhythmic conditions, such as acute myocardial ischemia;
- in patients with liver cirrhosis (since in this category of patients the risk of developing a prolongation of the QT interval cannot be excluded).
Cases of fulminant hepatitis, potentially leading to liver failure (including fatal cases), have been reported while taking Avelox®. The patient should be informed that if symptoms of liver failure occur, it is necessary to consult a doctor before continuing treatment with Avelox®.
Cases of bullous skin lesions (such as Stevens-Johnson syndrome or toxic epidermal necrolysis) have been reported while taking Avelox®. The patient should be informed that if symptoms of skin or mucous membrane lesions appear, it is necessary to consult a doctor before continuing treatment with Avelox®.
The use of quinolone drugs is associated with a possible risk of developing seizures. Avelox® should be used with caution in patients with diseases of the central nervous system and disorders of the central nervous system that predispose to seizures or reduce the threshold for seizure activity.
The use of broad-spectrum antibacterial drugs, including Avelox®, is associated with a risk of developing pseudomembranous colitis. This diagnosis should be kept in mind in patients who develop severe diarrhea during treatment with Avelox®. In this case, appropriate therapy should be prescribed immediately. Drugs that inhibit intestinal motility are contraindicated in the development of severe diarrhea.
Avelox® should be used with caution in patients with myasthenia gravis due to a possible exacerbation of the disease.
During therapy with quinolones, incl. moxifloxacin, tendonitis and tendon rupture may develop, especially in the elderly and patients receiving corticosteroids. Cases have been described that occurred within several months after completion of treatment. At the first symptoms of pain or inflammation at the site of injury, the drug should be stopped and the affected limb should be unloaded.
When using quinolones, photosensitivity reactions are observed. However, during preclinical and clinical studies, as well as when using the drug Avelox® in practice, no photosensitivity reactions were observed. However, patients receiving Avelox® should avoid exposure to direct sunlight and ultraviolet radiation.
The use of the drug in the form of tablets for oral administration is not recommended in patients with complicated inflammatory diseases of the pelvic organs (for example, associated with tubo-ovarian or pelvic abscesses).
Moxifloxacin is not recommended for the treatment of infections caused by methicillin-resistant Staphylococcus aureus (MRSA). Suspected or confirmed MRSA infections should be treated with appropriate antibacterial drugs.
The ability of Avelox® to inhibit the growth of mycobacteria may cause in vitro interaction of moxifloxacin with the test for Mycobacterium spp., leading to false negative results when analyzing samples from patients who are being treated with Avelox® during this period.
In patients treated with quinolones, including Avelox®, cases of sensory or sensorimotor polyneuropathy leading to paresthesia, hypoesthesia, dysesthesia or weakness have been described. Patients being treated with Avelox should be advised to seek immediate medical attention before continuing treatment if symptoms of neuropathy, including pain, burning, tingling, numbness or weakness, occur.
Psychiatric reactions can occur even after the first prescription of fluoroquinolones, including moxifloxacin. In very rare cases, depression or psychotic reactions progress to suicidal thoughts and behavior with a tendency to self-harm, including suicide attempts. If patients develop such reactions, the drug Avelox® should be discontinued and the necessary measures taken. Caution should be exercised when prescribing Avelox® to patients with a history of psychosis and/or psychiatric illness.
Due to the widespread and increasing incidence of infections caused by fluoroquinolone-resistant Neisseria gonorrhoeae, moxifloxacin monotherapy should not be used in the treatment of patients with pelvic inflammatory disease, unless the presence of fluoroquinolone-resistant N. gonorrhoeae is excluded. If the presence of fluoroquinolone-resistant N. gonorrhoeae cannot be excluded, consideration should be given to supplementing empiric moxifloxacin therapy with an appropriate antibiotic that is active against N. gonorrhoeae (eg, a cephalosporin).
As with other fluoroquinolones, changes in blood glucose concentrations, including hypo- and hyperglycemia, were observed when using Avelox®. During therapy with Avelox®, dysglycemia occurred predominantly in elderly patients with diabetes mellitus receiving concomitant therapy with oral hypoglycemic drugs (for example, sulfonylureas) or insulin. When treating patients with diabetes mellitus, careful monitoring of blood glucose concentrations is recommended.
Impact on the ability to drive vehicles and operate machinery
Fluoroquinolones, including moxifloxacin, may impair the ability of patients to drive a car and engage in other potentially hazardous activities that require increased attention and speed of psychomotor reactions due to their effects on the central nervous system and visual impairment.
Description of the dosage form
Film-coated tablets, pinkish-orange, oval, biconvex; When cut, it is white to light yellow in color.
pharmachologic effect
Levofloxacin is a synthetic broad-spectrum antibacterial drug from the group of fluoroquinolones, containing levofloxacin, a levorotatory isomer of ofloxacin, as an active substance. Levofloxacin blocks DNA gyrase, disrupts supercoiling and cross-linking of DNA breaks, inhibits DNA synthesis, and causes profound morphological changes in the cytoplasm, cell wall and membranes.
Levofloxacin is active against most strains of microorganisms both in vitro and in vivo.
Aerobic gram-positive microorganisms: Corynebacterium diphtheriae, Enterococcus faecalis, Enterococcus spp, Listeria monocytogenes, Staphylococcus coagulase-negative methi-S(I), Staphylococcus aureus methi-S, Staphylococcus epidermidis methi-S, Staphylococcus spp(CNS), Streptococci group C and G, Streptococcus agalactiae, Streptococcus pneumoniae peni I/S/R, Streptococcus pyogenes, Viridans streptococci peni-S/R.
Aerobic gram-negative microorganisms: Acinetobacter baumannil, Acinetobacter spp, Actinobacillus actinomycetemcomitans, Citrobacter freundii, Eikenella corrodens, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter cloacae, Enterobacter spp, Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae ampi-S/R, Haemophilus parainfluenzae, Helicobacter pylori, Klebsiella oxytoca, Klebsiella pneumoniae, Klebsiella spp, Moraxela catarrhalis (3+/p-, Morganella morganii, Neisseria gonorrhoeae non PPNG/PPNG, Neisseria meningitidis, Pasteurella conis, Pasteurella dagmatis, Pasteurella multocida, Pasteurella spp, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Providencia spp, Pseudomonas aeruginosa, Pseudomonas spp, Salmonella spp, Serratia marcescens, Serratia spp.
Anaerobic microorganisms: Bacteroides fragilis, Bifidobacterium spp, Clostridium perfringens, Fusobacterium spp, Peptostreptococcus, Propionibacterum spp, Veilonella spp.
Other microorganisms: Bartonella spp, Chlamydia pneumoniae, Chlamydia psittaci, Chlamydia trachomatis, Legionella pneumophila, Legionella spp, Mycobacterium spp, Mycobacterium leprae, Micobacterium tuberculosis, Mycoplasma hominis, Mycoplasma pneumoniae, Ricketsia spp, Ureaplasma urealyticum.
Pharmacokinetics
Levofloxacin is rapidly and almost completely absorbed after oral administration. Food intake has little effect on the speed and completeness of absorption. The bioavailability of 500 mg levofloxacin after oral administration is almost 100%. After taking a single dose of 500 mg of levofloxacin, Cmax is 5.2-6.9 mcg/ml, the time to reach Cmax is 1.3 hours, T1/2 is 6-8 hours.
Bonding with plasma proteins is 30-40%. Penetrates well into organs and tissues: lungs, bronchial mucosa, sputum, genitourinary organs, bone tissue, cerebrospinal fluid, prostate gland, polymorphonuclear leukocytes, alveolar macrophages.
In the liver, a small portion is oxidized and/or deacetylated. It is excreted from the body primarily by the kidneys by glomerular filtration and tubular secretion. After oral administration, approximately 87% of the dose taken is excreted unchanged in the urine within 48 hours, less than 4% in the feces within 72 hours.
The effectiveness of the drug against coronavirus
To understand whether Moxifloxacin helps against COVID-19, it is worth studying the effect of the drug, it:
- actively resists microbes and bacteria;
- reduces the activity of viral pathogens;
- acts instantly after entering the body;
- prevents the development of pneumonia.
On a note!
This drug is almost completely absorbed when taken orally. When the solution is injected into a vein, its concentration will be slightly higher.
The action and effectiveness are not affected by food intake and its content. The drug is compatible with other medications. The method of application is also determined by the doctor. Oral administration has the advantage of convenience and cost. Injections are given to patients in a hospital.
Indications for use of Levofloxacin
Infectious and inflammatory diseases caused by sensitive microorganisms:
- acute sinusitis;
- exacerbation of chronic bronchitis;
- community-acquired pneumonia;
- complicated urinary tract infections (including pyelonephritis);
- uncomplicated urinary tract infections;
- prostatitis;
- infections of the skin and soft tissues;
- septicemia/bacteremia associated with the above indications;
- intra-abdominal infection.
Until relatively recently, the latest generation of fluoroquinolones—moxifloxacin and levofloxacin—were not seriously considered as treatments for severe infections (with the exception of severe pneumonia). Arguments against their use were the lack of a pronounced effect against some current pathogens (Pseudomonas aeruginosa, anaerobes - levofloxacin), the presence of effective antibiotics among drugs of other classes, and most importantly, the need to accumulate reliable material on the effectiveness of these drugs for “non-respiratory” diseases. However, it is now becoming clear that with increased attention to antimicrobial rotation as a factor in preventing pathogen resistance, these fluoroquinolones may be potentially useful in empirical antibiotic regimens and severe infections.
Fluoroquinolones in general and ciprofloxacin, which has the greatest activity against Pseudomonas aeruginosa in particular, have been successfully used for a long time to treat serious hospital infections [1, 2]. In terms of its antimicrobial spectrum, ciprofloxacin is generally comparable to aminoglycosides, but does not have the inherent nephro- and ototoxicity of the latter. At the same time, it is characterized by low activity against streptococci and no effect against actual anaerobes. Moxifloxacin belongs to the group of extended-spectrum fluoroquinolones. It exhibits increased activity against pneumococci, streptococci and staphylococci, is comparable to ciprofloxacin in its effect on Enterobacteriaceae (although it is inferior to it in its effect on Pseudomonas aeruginosa), but unlike ciprofloxacin it has a high bactericidal index against anaerobes, comparable to the “standard” antianaerobic agent - metronidazole [3]. Its activity against anaerobes does not differ from amoxicillin/clavulanate [4] and even carbapenems. This spectrum of action allows us to consider moxifloxacin as a promising antimicrobial agent for the treatment of mixed (including nosocomial) infections.
The effectiveness of moxifloxacin against P. aeruginosa is less than that of ceftazidime and other antibiotics with targeted “antipseudomonas” activity [5]. In principle, it is also less than that of ciprofloxacin. However, recently, evidence has been accumulating that the minimum inhibitory concentration (MIC) of ciprofloxacin for this pathogen is increasing, which indicates the formation of resistance and predetermines attempts to replace this drug with other antimicrobial agents.
Moxifloxacin inhibits enzymes of the topoisomerase class – DNA gyrase (topoisomerase II) and topoisomerase IV, which are the targets of fluoroquinolones in the bacterial cell and are responsible for changes in the spatial configuration of bacterial DNA IV [6]. DNA gyrase supercoils bacterial DNA, and topoisomerase IV separates daughter chromosomes during replication. The key point in the action of moxifloxacin is the formation of a three-component complex, bacterial DNA - enzyme - quinolone, which prevents the replication of bacterial DNA.
The level of bacterial activity of fluoroquinolones is determined by the degree of their affinity for topoisomerases. To suppress the vital activity of a microbial cell, it is sufficient to inhibit the activity of only one enzyme. This feature explains the fact that for all fluoroquinolone drugs it is possible to distinguish a primary and secondary target of action. The primary target is the enzyme for which a given fluoroquinolone exhibits the greatest affinity. In gram-negative bacteria, fluoroquinolones exhibit the greatest affinity for DNA gyrase, making this enzyme the primary target. In Gram-positive bacteria, the primary target of most drugs in this class is topoisomerase IV [7].
Only moxifloxacin has the same affinity for the two enzymes, which most contributes to the bactericidal effect and prevents the selection of resistant strains [8]. The main mechanism of resistance to fluoroquinolones is a change in the structure of topoisomerase as a result of mutations in the corresponding genes and amino acid substitutions in enzyme molecules. In the vast majority of cases, stability is formed in stages. After the occurrence and selection of mutations in the genes that control the enzyme that is the primary target, the MIC of fluoroquinolones increases 4–8 times. If you continue to administer the drugs, the second enzyme (secondary target) is suppressed, and the MIC increases another 4–8 times.
It is believed that it is the affinity for both topoisomerases that allows moxifloxacin to avoid the formation of stepwise mutations in bacteria and provide an almost constant effect on sensitive strains. This advantage of the drug is relevant for intensive care units, since it is the rapid selection of resistant strains of bacteria that poses the main threat to effective treatment of infection. The reliable effect of the drug is also confirmed by in vitro data. Its activity decreases only slightly with shifts in the pH of the environment in the range of 5.6–8.4 and remains virtually unchanged at inoculum values of 104–106 CFU/ml [9]. This circumstance is extremely important, since during infectious inflammation the pH values of the environment undergo fluctuations over a wide range, and the inoculum tends to rapidly increase.
It is believed that the maximum therapeutic effect of fluoroquinolones and a reduction in the risk of developing microbial resistance to them are achieved when the ratio of peak concentration to MIC is > 8–10, and the ratio of the area under the concentration-time curve (AUC) to MIC should be £ 125 for gram-negative microorganisms and Ћ 30 for gram-positive pathogens [10].
Even more accurate is to take into account the ratio of the AUC of the free fraction of the drug to the MIC. As is known, it is the free fraction of fluoroquinolones, not bound to proteins, that has pharmacological activity. With this approach, the optimal ratio for eliminating microorganisms and preventing microbial resistance is considered to be Ћ 25. For moxifloxacin, this figure is more than 50 (for ciprofloxacin, only 7); when it is reached, the elimination of sensitive microorganisms occurs within 12 hours [11].
Moxifloxacin is registered in Russia under the commercial name Avelox in dosage forms for enteral and intravenous administration. The bioavailability of moxifloxacin when taken orally is close to 100%, i.e. its concentrations after oral and intravenous administration are identical, which determines the same severity of the bactericidal effect in tissues [12]. In addition, it has a clinically significant post-antibiotic effect, which prolongs the effect of the drug up to 24 hours. The convenient mode of administration – once a day and the availability of enteral and parenteral dosage forms makes moxifloxacin one of the drugs of choice for “stepped” treatment tactics – first parenterally, then orally [13].
The results of the clinical use of moxifloxacin indicate its high effectiveness and good tolerability in pneumonia, exacerbation of chronic bronchitis, urogenital infections, and infections of the pelvic organs in women [14]. There are individual reports of the successful use of this drug in surgery, in particular for complicated infectious processes in ENT practice [15]. Particular attention is paid to the issues of “stepwise” use of moxifloxacin, which reduces the cost of treatment. It has been shown that the effectiveness of this method of use in severe pneumonia is comparable to the results of a parenteral course of beta-lactam antibiotics or their combination with antianaerobic agents.
The following features of the pharmacodynamics and pharmacokinetics of moxifloxacin allow us to count on its effectiveness for the prevention and treatment of surgical infections:
- wide spectrum of antibacterial action against gram-positive and gram-negative aerobic and anaerobic bacteria;
- simple and convenient dosing regimen – 400 mg once a day;
- the ability to choose between intravenous or oral administration at the same dose and (if necessary and/or possible) conducting “stepped” therapy;
- favorable safety and tolerability profile.
Let us note that if in outpatient practice the use of all fluoroquinolones in children is still contraindicated, then in the treatment of severe infections in a hospital, this restriction, in our opinion, should not be approached so strictly.
Moxifloxacin was officially included in the recommendations for the management of septic patients with community-acquired surgical infections of the abdominal cavity, as well as with a primary bacterial focus in the kidneys [16]. At the same time, we should not forget about the leading role of this drug in the treatment of severe respiratory tract infections. It is significant that in case of aspiration pneumonia with the formation of a cavity in the lung, moxifloxacin has advantages over many antibiotics and their combinations. Its effect extends to the anaerobic flora that occurs during this process; the drug penetrates well into this cavity [17]. The effectiveness of “stepped” therapy with moxifloxacin (intravenously for 3–4 days, then orally for 4–10 days) and those carried out using a combination therapy method that included amoxicillin/clavulanate and clarithromycin was almost equal (88 and 83%, respectively) [18]. Of course, monotherapy treatment should be considered preferable from a compliance point of view. In addition, it is better tolerated by patients.
Moxifloxacin demonstrates good activity against hospital strains of methicillin-sensitive staphylococci (in some cases against methicillin-resistant strains) and satisfactory activity against enterococci and even Pseudomonas aeruginosa with low MIC90 values [19]. It is the increased activity against gram-positive microorganisms that is considered one of the important advantages of moxifloxacin over previous generations of fluoroquinolones.
In cases of polymicrobial etiology of lung diseases (after artificial ventilation) with higher MIC90 values for moxifloxacin, it is recommended to combine this fluoroquinolone with amikacin [20]. Treatment with moxifloxacin after mechanical ventilation is also justified because after intravenous administration of the drug at a dose of 400 mg during the day, high bactericidal concentrations are established in the lung tissue, which cannot be achieved by administering some beta-lactam antibiotics and vancomycin [21].
Recently, Stenotrophomonus maltophilia has become one of the current causative agents of nosocomial infections. It is found in critically ill patients who have undergone massive antibiotic therapy with broad-spectrum drugs. The resistance of this pathogen is largely determined by the formation of antibiotic efflux. Moxifloxacin has good MIC90 values against S. maltophilia - 0.0625–0.5 μg/ml, surpassing ciprofloxacin in this regard (0.5–2 μg/ml). Suppression of the growth of this bacterium by moxifloxacin after a single dose is 1.5–2 times longer than by ciprofloxacin, and the number of mutated strains formed is several times less [22]. In addition, this problematic pathogen is able to protect itself from beta-lactam antibiotics using the biofilm it forms, which makes it impossible for these drugs to penetrate the microbial cell, which makes it impossible to ensure effective eradication. As recently shown, moxifloxacin, even at low concentrations (equal to half the MIC90), inhibits biofilm growth and provides a reliable bactericidal effect [23].
Moxifloxacin is considered as one of the effective agents for severe infections of the skin and soft tissues [24]. It is of particular relevance in patients with concomitant diabetes mellitus, with lesions of the skin and underlying structures, when there are polymicrobial associations of gram-positive aerobic and anaerobic flora.
It should be noted that there are no generic drugs of moxifloxacin on the domestic pharmaceutical market (contrast with “ciprofloxacins”), which guarantees all the above-described characteristics of action when using the original drug Avelox.
In conclusion, I would like to emphasize the authors’ understanding of the importance of the position according to which practical recommendations, in particular for the use of moxifloxacin for sepsis and other severe infections, should be based on the results of large international studies assessing the effectiveness and tolerability of the drug. However, given the great importance of the problem of treating these infections, the article makes an attempt, even before obtaining data from this type of research, to draw the attention of clinicians to the potential opportunities inherent in moxifloxacin, a modern antibacterial drug with a wide spectrum of action. Discovering these possibilities seems to be an urgent task for the specialists themselves, who in their daily work are faced with the problem of treating severe infections.
Contraindications to the use of Levofloxacin
- hypersensitivity to levofloxacin or other quinolones;
- renal failure (with creatinine clearance less than 20 ml/min. - due to the impossibility of dosing this dosage form);
- epilepsy;
- tendon lesions due to previous treatment with quinolones;
- childhood and adolescence (up to 18 years);
- pregnancy and lactation period.
It should be used with caution in the elderly due to the high likelihood of a concomitant decrease in renal function, as well as in cases of glucose-6-phosphate dehydrogenase deficiency.
Analogs
There are a large number of analogues with similar effects on the body:
- Kimox;
- Avelox;
- Moxie;
- Plevilox;
- Moflaxia;
- Simoflox;
- Rotomox;
- Ultramox.
These analogues are mainly produced in tablets. The country of origin in most cases is Russia, and some are made in India. Their operating principle is described in the instructions. You need to check with a specialist to replace one with the other.
On a note!
You cannot choose a remedy on your own, as this may worsen the condition and not provide treatment results.
Use of Levofloxacin during pregnancy and children
The incidence of levofloxacin-related adverse reactions in Phase 3 clinical trials conducted in North America was 6.3%. Therapy was discontinued due to drug-related side effects in 3.9% of patients.
In clinical studies, the following side effects were considered likely to be related to levofloxacin: nausea (1.3%), diarrhea (1%), vaginitis (0.7%), insomnia (0.5%), abdominal pain (0. 4%), flatulence (0.4%), itching (0.4%), dizziness (0.3%), dyspepsia (0.3%), rash (0.3%), genital candidiasis (0. 2%), taste disturbance (0.2%), vomiting (0.2%), constipation (0.1%), fungal infection (0.1%), itching in the genital area (0.1%), headache pain (0.1%), thrush (0.1%), nervousness (0.1%), erythematous rash (0.1%), urticaria (0.1%).
In clinical studies, the following side effects were observed without taking into account the relationship with the drug.
From the nervous system and sensory organs: headache (6.4%), insomnia (4.6%), dizziness (2.7%), fatigue (1.2%), impaired taste sensitivity (1%); <1%: asthenia, incoordination, coma, convulsions, speech impairment, stupor, tremor, vertigo, confusion, aggression, agitation, anxiety, anorexia, delirium, depression, emotional lability, hallucinations, difficulty concentrating, mania, nervousness, paranoia, impaired thinking, unusual dreams, sleep disturbance, somnolence, diplopia, cerebrovascular disorders, tinnitus, hearing and vision impairment, conjunctivitis, parosmia.
From the cardiovascular system and blood <1%: hypertension, hypotension (including orthostatic), heart failure, circulatory failure, arrhythmia, bradycardia, tachycardia, blockade, cardiac arrest, supraventricular tachycardia, ventricular and atrial fibrillation, palpitation , angina pectoris, coronary thrombosis, myocardial infarction, thromboembolism, phlebitis, platelet pathology, epistaxis, purpura, thrombocytopenia, leukocytosis, leukopenia, lymphopenia, granulocytopenia, lymphadenopathy.
From the respiratory system: sinusitis (1.3%), rhinitis (1%); <1%: asthma, acute respiratory distress syndrome, cough, hemoptysis, dyspnea, hypoxia, pleural effusion, respiratory failure.
From the gastrointestinal tract: nausea (7.2%), diarrhea (5.6%), constipation (3.2%), abdominal pain (2.5%), dyspepsia (2.4%), vomiting (2 .3%), flatulence (1.5%); <1%: dry mouth, dysphagia, swelling of the tongue, gastroenteritis, gastrointestinal bleeding, pseudomembranous colitis, hepatic coma, increased LDH, jaundice, impaired liver function, cholelithiasis.
From the genitourinary system: vaginitis (1.8%); <1%: itching in the genital area, impaired ejaculation, impotence, increased serum creatinine, decreased renal function, acute renal failure, hematuria.
From the musculoskeletal system <1%: arthralgia, arthritis, arthrosis, muscle weakness, myalgia, osteomyelitis, synovitis, tendonitis, rhabdomyolysis, hyperkinesis, involuntary muscle contractions, increased muscle tone, paresthesia, paralysis.
From the skin: itching (1.3%), rash (1.2%); <1%: erythema nodosum, skin peeling, skin ulceration, urticaria, increased sweating.
Other: local reaction (3.5%), pain (1.7%) and inflammation (1.1%) at the injection site; pain (1.4%), chest pain (1.2%) and back pain (1.1%); <1%: hyperkalemia, hypokalemia, dehydration, hypoglycemia, hyperglycemia, worsening diabetes mellitus, weight loss, carcinoma, fever, facial edema, withdrawal syndrome.
The following adverse effects have been reported in post-marketing studies: hypersensitivity pneumonitis, anaphylactic shock, anaphylactoid reaction, dysphonia, abnormal EEG, encephalopathy, eosinophilia, erythema multiforme, hemolytic anemia, multiple organ failure, increased international normalized ratio (INR), Stevens-Johnson syndrome, rupture tendons, ventricular fibrillation, vasodilation.
Below are data from 29 pooled Phase 3 clinical trials (n=7537). The average age of patients is 50 years (approximately 74% of patients are younger than 65 years), 50% are male, 71% are Caucasian, and 19% are black. Patients received levofloxacin for the treatment of various infections at a dose of 750 mg once daily, 250 mg once daily, or 500 mg twice daily. The duration of therapy was usually 3–14 days (average 10 days).
The overall incidence, type, and distribution of adverse reactions were similar in patients receiving levofloxacin 750 mg once daily compared with patients receiving 250 mg once daily or 500 mg twice daily. Therapy was discontinued due to drug-related adverse events in 4.3% of patients overall, 3.8% of patients taking the 250 and 500 mg doses, and 5.4% of patients taking the 750 mg dose. The most common side effects leading to discontinuation of the drug at doses of 250 and 500 mg were gastrointestinal complaints (1.4%), nausea (0.6%), vomiting (0.4%), dizziness (0.3%) , headache (0.2%). The most common side effects leading to discontinuation of the drug at a dose of 750 mg were gastrointestinal disturbances (1.2%), nausea (0.6%), vomiting (0.5%), dizziness (0.3%), headache pain (0.3%).
The following are side effects noted in clinical trials and observed with an incidence of more than 0.1%.
From the nervous system and sensory organs: headache (6%), dizziness (3%), insomnia (4%); 0.1–1%: anxiety, agitation, confusion, depression, hallucinations, nightmares, sleep disturbances, anorexia, unusual dreams, tremors, convulsions, paresthesia, vertigo, hypertension, hyperkinesis, incoordination, drowsiness, fainting.
From the cardiovascular system and blood: 0.1–1%: anemia, arrhythmia, palpitations, cardiac arrest, supraventricular tachycardia, phlebitis, epistaxis, thrombocytopenia, granulocytopenia.
From the respiratory system: shortness of breath (1%).
From the gastrointestinal tract: nausea (7%), diarrhea (5%), constipation (3%), abdominal pain (2%), dyspepsia (2%), vomiting (2%); 0.1–1%: gastritis, stomatitis, pancreatitis, esophagitis, gastroenteritis, glossitis, pseudomembranous colitis, liver dysfunction, increased levels of liver enzymes, increased alkaline phosphatase.
From the genitourinary system: vaginitis (1%); 0.1–1%: impaired renal function, acute renal failure, genital candidiasis.
From the musculoskeletal system: 0.1–1%: arthralgia, tendinitis, myalgia, skeletal muscle pain.
From the skin: rash (2%), itching (1%); 0.1–1%: allergic reactions, edema (1%), urticaria.
Other: candidiasis (1%), reaction at the IV injection site (1%), chest pain (1%); 0.1–1%: hypoglycemia/hyperglycemia, hyperkalemia.
The following side effects have been reported in post-marketing studies.
From the nervous system and sensory organs: isolated reports of encephalopathy, EEG abnormalities, peripheral neuropathy, psychosis, paranoia, isolated reports of suicide attempts and suicidal thoughts, visual impairment (including diplopia, decreased visual acuity, blurred vision, scotoma ), hearing loss, tinnitus, parosmia, anosmia, loss of taste, taste perversion, dysphonia.
From the cardiovascular system and blood: isolated reports of torsade de pointes, prolongation of the QT interval, tachycardia, vasodilation, increased INR, prolongation of prothrombin time, pancytopenia, aplastic anemia, leukopenia, hemolytic anemia, eosinophilia.
From the gastrointestinal tract: liver failure (including fatal cases), hepatitis, jaundice.
From the musculoskeletal system: tendon rupture, muscle damage, including rupture, rhabdomyolysis.
From the skin: bullous rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, photosensitivity/phototoxicity reactions.
Allergic reactions: hypersensitivity reactions (sometimes fatal), incl. anaphylactic/anaphylactoid reactions, anaphylactic shock, angioedema, serum sickness; isolated reports of hypersensitivity pneumonitis.
Other: vasculitis, increased activity of muscle enzymes, hyperthermia, multiorgan failure, interstitial nephritis.
When using levofloxacin in the form of 0.5% eye drops, the most frequently observed effects were: 1-3% - transient decreased vision, transient burning, pain or discomfort in the eye, sensation of a foreign body in the eye, fever, headache, pharyngitis, photophobia; <1% - allergic reactions, swelling of the eyelids, dry eyes, itching in the eye.
Moxifloxacin
In some cases, after the first use of the drug, anaphylactic reactions can progress to life-threatening anaphylactic shock. In these cases, treatment with moxifloxacin should be stopped and the necessary therapeutic measures (including anti-shock) should be started immediately.
QT interval prolongation may occur in some patients when using moxifloxacin. Because women have a longer QT interval than men, they may be more sensitive to drugs that prolong the QT interval. Elderly patients are also more susceptible to drugs that affect the QT interval. Prolongation of the QT interval is associated with an increased risk of ventricular arrhythmias, including polymorphic ventricular tachycardia.
The degree of QT interval prolongation may increase with increasing drug concentrations, so the recommended dose and infusion rate (400 mg over 60 minutes) should not be exceeded. However, in patients with pneumonia, there was no correlation between moxifloxacin plasma concentrations and QT interval prolongation. Prolongation of the QT interval is associated with an increased risk of ventricular arrhythmias, including polymorphic ventricular tachycardia. None of the 9,000 patients treated with moxifloxacin experienced cardiovascular complications or deaths associated with QT prolongation.
When using moxifloxacin, the risk of developing ventricular arrhythmias may increase in patients with conditions predisposing to arrhythmias. In this regard, moxifloxacin is contraindicated in:
· changes in electrophysiological parameters of the heart, expressed in prolongation of the QT interval: congenital or acquired documented prolongation of the QT interval; electrolyte disturbances, especially uncorrelated hypokalemia; clinically significant bradycardia; clinically significant heart failure with reduced left ventricular ejection fraction; a history of rhythm disturbances accompanied by clinical symptoms;
· use with other drugs that prolong the QT interval (see section “Interaction with other drugs”).
The drug should be used with caution
· in patients with potentially proarrhythmic conditions such as acute myocardial ischemia and cardiac arrest;
· in patients with liver cirrhosis (since in this category of patients the risk of prolongation of the QT interval cannot be excluded).
Cases of fulminant hepatitis, potentially leading to liver failure (including fatal cases), have been reported with the use of moxifloxacin (see section "Side effects"). The patient should be informed that if symptoms of liver failure occur, it is necessary to consult a doctor before continuing treatment with moxifloxacin.
Cases of bullous skin lesions such as Stevens-Johnson syndrome or toxic epidermal necrolysis have been reported with the use of moxifloxacin (see section "Side effects"). The patient should be informed that if symptoms of skin or mucous membrane lesions occur, they should consult a doctor before continuing treatment with 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 and central nervous system disorders that predispose to seizures or lower the threshold for seizure activity.
The use of broad-spectrum antibacterial drugs, including moxifloxacin, is associated with a risk of developing pseudomembranous colitis. This diagnosis should be considered in patients who experience severe diarrhea during treatment with moxifloxacin. In this case, appropriate therapy should be prescribed immediately. Drugs that inhibit intestinal motility are contraindicated in the development of severe diarrhea.
Moxifloxacin should be used with caution in patients with myasthenia gravis due to possible exacerbation of the disease. During therapy with quinolones, including moxifloxacin, tendonitis and tendon rupture may develop, especially in the elderly and patients receiving glucocorticosteroids. Cases have been described that occurred within several months after completion of treatment. At the first symptoms of pain or inflammation at the site of injury, the use of the drug should be stopped and the affected limb should be unloaded.
When using quinolones, photosensitivity reactions are observed. However, during preclinical and clinical studies, as well as with the use of moxifloxacin in practice, no photosensitivity reactions were observed. However, patients using moxifloxacin should avoid exposure to direct sunlight and ultraviolet light.
The use of moxifloxacin is not recommended to treat infections caused by methicillin-resistant Staphylococcus aureus (MRSA). In cases of suspected or confirmed infections caused by MRSA, treatment with appropriate antibacterial drugs should be prescribed (see section "Pharmacodynamics").
The ability of moxifloxacin to inhibit the growth of mycobacteria may cause in vitro interaction between moxifloxacin and the test for Mycobacterium spp., leading to false-negative results when analyzing samples from patients who are being treated with moxifloxacin during this period.
In patients treated with quinolones, including moxifloxacin, cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons and leading to paresthesia, hypoesthesia, dysesthesia and weakness have been described.) Symptoms may appear immediately shortly after the start of use and may be irreversible.
Patients being treated with moxifloxacin should be warned to seek immediate medical attention if symptoms of neuropathy occur, including pain, burning, tingling, numbness and/or weakness or other sensory disturbances, including touch, pain, temperature, vibration and feeling. position (see section "Side effects"). Moxifloxacin should be discontinued immediately.
Psychiatric reactions may occur even after the first use of fluoroquinolones, including moxifloxacin. In very rare cases, depression or psychotic reactions progress to the occurrence of suicidal thoughts and behavior with a tendency to self-harm, including suicide attempts (see section "Side effects"). If patients develop such reactions, moxifloxacin should be discontinued and the necessary measures taken. Caution should be exercised when using moxifloxacin in patients with psychosis and/or a history of psychiatric illness.
Due to the widespread and increasing incidence of infections caused by fluoroquinolone-resistant Neisseria gonorrhoeae, patients with pelvic inflammatory disease should not be treated with moxifloxacin monotherapy unless the presence of fluoroquinolone-resistant Neisseria gonorrhoeae has been excluded. If the presence of fluoroquinolone-resistant Neisseria gonorrhoeae cannot be excluded, consideration should be given to supplementing empirical therapy with moxifloxacin, an appropriate antibacterial drug that is active against Neisseria gonorrhoeae.
As with other fluoroquinolones, changes in blood glucose concentrations, including hypo- and hyperglycemia, were observed with the use of moxifloxacin. During the use of moxifloxacin, dysglycemia occurred predominantly in elderly patients with diabetes mellitus receiving concomitant therapy with oral hypoglycemic drugs (for example, sulfonylureas) or insulin. When treating patients with diabetes mellitus, careful monitoring of blood glucose concentrations is recommended.
Patients on a low-salt diet (with heart failure, renal failure, nephrotic syndrome) should take into account that the solution for infusion contains sodium chloride. The daily dose of sodium chloride in moxifloxacin is 34 mol.
Impact on the ability to drive vehicles and machinery
Fluoroquinolones, including moxifloxacin, may impair the ability of patients to drive vehicles and engage in other potentially hazardous activities that require increased attention and speed of psychomotor reactions due to their effects on the central nervous system and visual impairment.
Side effects of Levofloxacin
Allergic reactions: sometimes – itching and redness of the skin; rarely - general hypersensitivity reactions (anaphylactic and anaphylactoid reactions) with symptoms such as urticaria, constriction of the bronchi and possibly severe suffocation; very rarely - swelling of the skin and mucous membranes (for example, in the face and throat), sudden drop in blood pressure and shock, increased sensitivity to solar and ultraviolet radiation, allergic pneumonitis, vasculitis; in some cases - severe skin rashes with blistering, for example, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome) and exudative erythema multiforme. General hypersensitivity reactions may sometimes be preceded by milder skin reactions. The above reactions can develop after the first dose, a few minutes or hours after administration of the drug.
From the digestive system: often - nausea, diarrhea, increased activity of liver enzymes (for example, alanine aminotransferase and aspartate aminotransferase); sometimes - loss of appetite, vomiting, abdominal pain, digestive disorders; rarely - diarrhea mixed with blood, which in very rare cases can be a sign of intestinal inflammation and even pseudomembranous colitis.
On the metabolic side: very rarely - a decrease in the concentration of glucose in the blood, which is of particular importance for patients with diabetes (possible signs of hypoglycemia: increased appetite, nervousness, perspiration, trembling). Experience with the use of other quinolones suggests that they can cause exacerbation of porphyria in patients already suffering from this disease. A similar effect cannot be excluded when using the drug levofloxacin.
From the nervous system: sometimes - headache, dizziness and/or stupor, drowsiness, sleep disturbances; rarely - anxiety, paresthesia in the hands, trembling, psychotic reactions such as hallucinations and depression, agitation, convulsions and confusion; very rarely - impaired vision and hearing, impaired taste and smell, decreased tactile sensitivity.
From the cardiovascular system: rarely - increased heartbeat, decreased blood pressure; very rarely - vascular (shock-like) collapse; in some cases - prolongation of the QT interval.
From the musculoskeletal system: rarely - tendon damage (including tendinitis), joint and muscle pain; very rarely - tendon rupture (for example, Achilles tendon); this side effect can be observed within 48 hours after the start of treatment and can be bilateral in nature, muscle weakness, which is of particular importance for patients with bulbar syndrome; in some cases - muscle damage (rhabdomyolysis).
From the urinary system: rarely - increased levels of bilirubin and creatinine in the blood serum; very rarely - deterioration of kidney function up to acute renal failure, interstitial nephritis.
From the hematopoietic organs: sometimes - an increase in the number of eosinophils, a decrease in the number of leukocytes; rarely - neutropenia, thrombocytopenia, which may be accompanied by increased bleeding; very rarely - agranulocytosis and the development of severe infections (persistent or recurrent increase in body temperature, deterioration in health); in some cases - hemolytic anemia; pancytopenia.
Other: sometimes - general weakness; very rarely - fever.
Any antibiotic therapy can cause changes in the microflora that is normally present in humans. For this reason, increased proliferation of bacteria and fungi resistant to the antibiotic used may occur, which in rare cases may require additional treatment.
Moxifloxacin tablet p/o 400 mg N5 (Vertex)
In some cases, after the first use of the drug, hypersensitivity and allergic reactions may develop, which should be reported to your doctor immediately. Very rarely, even after the first use of the drug, anaphylactic reactions can progress to life-threatening anaphylactic shock. In these cases, treatment with moxifloxacin should be discontinued and the necessary therapeutic measures (including anti-shock) should be taken. QT interval prolongation may occur in some patients when using moxifloxacin. Moxifloxacin should be used with caution in women and elderly patients. Because women have a longer QT interval than men, they may be more sensitive to drugs that prolong the QT interval. Elderly patients are also more susceptible to drugs that affect the QT interval. The degree of QT interval prolongation may increase with increasing drug concentrations, so the recommended dose should not be exceeded. However, in patients with pneumonia, no correlation was observed between moxifloxacin plasma concentrations and QT interval prolongation. Prolongation of the QT interval is associated with an increased risk of ventricular arrhythmias, including polymorphic ventricular tachycardia. None of the 9,000 patients treated with moxifloxacin experienced cardiovascular events or deaths associated with QT prolongation. However, in patients with conditions predisposing to arrhythmias, the risk of developing ventricular arrhythmias may be increased when using moxifloxacin. In this regard, moxifloxacin is contraindicated in patients with established prolongation of the QT interval, patients with uncorrected hypokalemia, and patients taking drugs that prolong the QT interval (see section “Interaction with other drugs”). Due to the risk of additive effects on the QT interval, moxifloxacin is contraindicated in patients with conditions predisposing to arrhythmias, such as clinically significant bradycardia, clinically significant heart failure, rhythm disturbances accompanied by clinical symptoms, acute myocardial ischemia; patients with liver cirrhosis (since in this category of patients the risk of developing QT prolongation cannot be excluded). Cases of fulminant hepatitis, potentially leading to liver failure (including fatal cases), have been reported while taking moxifloxacin (see section "Side effects"). The patient should be informed that if symptoms of liver failure occur, it is necessary to consult a doctor before continuing treatment with moxifloxacin. Cases of bullous skin lesions (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported when taking moxifloxacin. The patient should be informed that if symptoms of skin or mucous membrane lesions occur, they should consult a doctor before continuing treatment with moxifloxacin. The use of quinolone drugs is associated with a possible risk of developing seizures. Moxifloxacin should be used with caution in patients with diseases of the central nervous system and with conditions suspected of involving the central nervous system, predisposing to seizures or lowering the threshold for seizure activity. The use of broad-spectrum antibacterial drugs, including moxifloxacin, is associated with the risk of developing antibiotic-associated pseudomembranous colitis. This diagnosis should be kept in mind in patients who develop severe diarrhea during treatment with moxifloxacin. In this case, the drug should be discontinued and appropriate therapy should be immediately prescribed. Drugs that inhibit intestinal motility are contraindicated in the development of severe diarrhea. Moxifloxacin should be used with caution in patients with myasthenia gravis due to possible exacerbation of the disease. During therapy with quinolones, including moxifloxacin, tendonitis and tendon rupture may develop, especially in elderly people and patients receiving glucocorticosteroids. Cases have been described that occurred within several months after completion of treatment. At the first symptoms of pain or inflammation at the site of injury, you should stop taking the drug and unload the affected limb. When using quinolones, photosensitivity reactions are observed. However, during preclinical and clinical studies, as well as when using moxifloxacin in practice, no photosensitivity reactions were observed. However, patients receiving moxifloxacin should avoid direct sunlight and ultraviolet light. The use of the drug in patients with complicated inflammatory diseases of the pelvic organs (for example, associated with tubo-ovarian or pelvic abscesses) is not recommended. The use of moxifloxacin is not recommended to treat infections caused by methicillin-resistant Staphylococcus aureus (MRSA). In cases of suspected or confirmed infections caused by MRSA, treatment with appropriate antibacterial drugs should be prescribed (see section "Pharmacodynamics"). The ability of Moxifloxacin to inhibit the growth of mycobacteria may cause in vitro interaction of moxifloxacin with the test for Mycobacterium spp., leading to false negative results when analyzing samples from patients who are being treated with moxifloxacin during this period. In patients treated with quinolones, including moxifloxacin, cases of sensory or sensorimotor polyneuropathy leading to paresthesia, hypoesthesia, dysesthesia or weakness have been described. Patients treated with moxifloxacin should be warned to seek immediate medical attention before continuing treatment if symptoms of neuropathy, including pain, burning, tingling, numbness or weakness, occur (see section "Side Effects"). Psychiatric reactions can occur even after the first prescription of fluoroquinolones, including moxifloxacin. In very rare cases, depression or psychotic reactions progress to the occurrence of suicidal thoughts and behavior with a tendency to self-harm, including suicide attempts (see section "Side effects"). If patients develop such reactions, the drug should be discontinued and the necessary measures taken. Caution must be exercised when prescribing moxifloxacin to patients with psychosis and patients with a history of mental illness. Due to the widespread and increasing incidence of infections caused by fluoroquinolone-resistant Neisseria gonorrhoeae, moxifloxacin monotherapy should not be used in the treatment of patients with pelvic inflammatory diseases. Unless the presence of fluoroquinolone-resistant N. gonorrhoeae is excluded. If the presence of fluoroquinolone-resistant N. gonorrhoeae cannot be excluded, consideration should be given to supplementing empiric moxifloxacin therapy with an appropriate antibiotic that is active against N. gonorrhoeae (eg, a cephalosporin). Effect of the drug on the ability to drive vehicles and other mechanisms: Fluoroquinolones, including moxifloxacin, may impair the ability of patients to drive a car and engage in other potentially hazardous activities that require increased attention and speed of psychomotor reactions due to their effect on the central nervous system.
Drug interactions
There are reports of a pronounced decrease in the threshold of convulsive readiness with the simultaneous use of quinolones and substances that can, in turn, reduce the cerebral threshold of convulsive readiness. This also applies equally to the simultaneous use of quinolones and theophylline.
The effect of Levofloxacin is significantly weakened when used simultaneously with sucralfate. The same thing happens with the simultaneous use of magnesium or aluminum containing antacids, as well as iron salts. Levofloxacin should be taken at least 2 hours before or 2 hours after taking these medications. No interaction was detected with calcium carbonate.
When using vitamin K antagonists simultaneously, monitoring of the blood coagulation system is necessary.
The elimination (renal clearance) of levofloxacin is slightly slowed down by the action of cimetidine and probenecid. It should be noted that this interaction has virtually no clinical significance. However, with the simultaneous use of drugs such as probenecid and cimetidine, which block a certain excretion pathway (tubular secretion), treatment with levofloxacin should be carried out with caution. This applies primarily to patients with limited renal function.
Levofloxacin slightly increases the half-life of cyclosporine.
Taking glucocorticosteroids increases the risk of tendon rupture.
Is it possible to take Moxifloxacin for coronavirus?
The drug was included in the list of drugs that help treat this disease. This remedy has been recommended by doctors and scientists. It went through a series of tests and gave positive results.
Moxifloxacin was originally invented to treat other diseases. Its distribution during the pandemic increased several times, and it began to be used everywhere. Its use is recommended for:
- symptoms of COVID-19;
- complications such as pneumonia;
- risk of disease as a preventive measure.
Levofloxacin dosage
The drug is taken orally 1 or 2 times a day. Do not chew the tablets and take a sufficient amount of liquid (from 0.5 to 1 glass); you can take them before meals or between meals. Doses are determined by the nature and severity of the infection, as well as the sensitivity of the suspected pathogen.
For patients with normal or moderately reduced renal function (creatinine clearance > 50 ml/min.), the following dosage regimen is recommended: sinusitis: 500 mg 1 time per day - 10-14 days; exacerbation of chronic bronchitis: 250 mg or 500 mg 1 time per day - 7-10 days; community-acquired pneumonia: 500 mg 1-2 times a day - 7-14 days. uncomplicated urinary tract infections: 250 mg 1 time per day for 3 days; prostatitis: 500 mg - 1 time per day - 28 days; complicated urinary tract infections, including pyelonephritis: 250 mg 1 time per day - 7-10 days; infections of the skin and soft tissues: 250 mg 1 time a day or 500 mg 1-2 times a day - 7-14 days; septicemia/bacteremia: 250 mg or 500 mg 1-2 times a day for 10-14 days; intra-abdominal infection: 250 mg or 500 mg 1 time per day - 7-14 days (in combination with antibacterial drugs acting on anaerobic flora).
Patients undergoing hemodialysis or continuous ambulatory peritoneal dialysis do not require additional doses.
Patients with impaired liver function do not require special dosing, since levofloxacin is metabolized in the liver only to an extremely small extent.
As with the use of other antibiotics, treatment with Levofloxacin is recommended to be continued for at least 48-78 hours after normalization of body temperature or after laboratory confirmed recovery.
Why Moxifloxacin for Coronavirus?
Drug therapy for acute respiratory viral infection is carried out without the use of antibiotics. If the doctor detects signs of bacterial pneumonia or other negative consequences of the disease, it is possible to prescribe Moxifloxacin or antimicrobial medications of other groups. This tactic is aimed at destroying pathogens in the lung tissue and improving the patient’s condition. Timely treatment of pneumonia due to coronavirus helps improve the prognosis and preserve pulmonary function.
The correct selection of antibiotics is not always observed, since for the accuracy of therapy it is necessary to first conduct a study on the causative agent of pneumonia and its susceptibility to antibacterial medications. The test results are obtained within a few days, and for a patient in serious condition, treatment should be prescribed as quickly as possible. In this case, the doctor selects a medicine taking into account your medical history, symptoms and other factors. Moxifloxacin is rarely prescribed without prior diagnosis. There are more suitable broad-spectrum antimicrobial agents.
Mechanism of action
The chemical compound belongs to fluoroquinolones. The therapeutic effect is associated with the direct destruction of bacterial cells against the background of suppression of the functions of important enzyme compounds responsible for the reproduction of new deoxyribonucleic acid molecules. Pathogens in lung tissue during coronavirus are destroyed. The lowest doses to produce this therapeutic effect are close to suppressive levels. The way the effect is realized is related to the possible development of stability. Resistance to other groups of antibiotics may occur.
No cases of plasmin resistance were found. Before prescribing Moxifloxacin for coronavirus, the doctor excludes risk factors for bacterial cell resistance to this drug. The characteristics of pneumonia pathogens in a certain region are taken into account. In some places, there are bacterial cells that cannot be killed by this antibiotic. It is prohibited to carry out such therapy without preliminary analysis.
After administration, the drug is well distributed in anatomical structures. A connection occurs with plasma proteins. Mainly with albumin. Forty-five percent. The volumetric distribution index is close to two litas per kilogram. Elevated levels of the drug in the bloodstream and lung tissue are typical, so Moxifloxacin can be used for the treatment of pneumonia and other complications during coronavirus.
Restrictions on use
A complete list of contraindications for the use of the medicine is in the official instructions. These are intolerance to the components of the dosage form, increased sensitivity to related medications, minor age, pregnancy, lactation period, tendon ruptures in the past due to the use of such drugs and severe diseases of the heart muscle. Should not be prescribed for the treatment of coronavirus infection if there is low potassium, electrolyte imbalance, slow heartbeat or left ventricular dysfunction.
Moxifloxacin for the treatment of pneumonia and other diseases is not prescribed with QT-increasing medications. If there is a disorder of the liver tissue, treatment is carried out with other antibiotics. A preliminary assessment of laboratory parameters is carried out to exclude such a condition. Cautious therapy for coronavirus is carried out for convulsive reactions, pathologies of the nervous system, psychotic disorders, predisposition to arrhythmia, heart disease, liver disorders and impaired glucose absorption.
When is Moxifloxacin prescribed for coronavirus?
Drug therapy is prescribed only by a doctor. It is possible to determine symptoms at home. The doctor also assesses the oxygen saturation of the blood, performs pulmonary auscultation and takes body temperature. In severe cases, the patient is sent to the hospital for treatment of pneumonia or other complications. A full diagnosis is carried out with computed tomography, blood tests and testing for coronavirus infection. It is possible to prescribe Moxifloxacin or another antibiotic if the doctor finds indications for such therapy.
Studies have confirmed the impossibility of safe use of antibiotics during pregnancy. This chemical compound negatively affects the developing organism. Possible disruption of the development of the musculoskeletal system. The entry of a chemical compound into the secretion of the mammary glands indicates the impossibility of using the drug during the lactation period.
Overdose
Symptoms of an overdose of Levofloxacin appear at the level of the central nervous system (confusion, dizziness, disturbances of consciousness and seizures of the epileptic type). In addition, gastrointestinal disorders (for example, nausea) and erosive lesions of the mucous membranes, prolongation of the QT interval may occur.
Treatment should be symptomatic. Levofloxacin is not eliminated by dialysis (hemodialysis, peritoneal dialysis and continuous peritoneal dialysis). There is no specific antidote.
Therapy instructions
The drug treatment regimen is selected by the doctor based on the results of the examination. Typically, the patient is given four hundred milligrams of Moxifloxacin per day. The dosage is determined by the severity of pneumonia due to coronavirus and other factors. The tablet form is swallowed without division and washed down with water. Not while eating. The duration of treatment is determined by a specialist, taking into account the patient’s condition and the characteristics of the infectious process.
In some cases, adjustment of the dosage regimen is necessary. This is a disruption of the kidney tissue, when it is possible to slow down the rate of removal of a chemical compound from the body. The doctor chooses a safer dose to prevent complications. In old age, conventional therapy can be used. For mild liver dysfunction, a standard treatment regimen is also allowed. The doctor preliminarily assesses the medical history and conducts an examination.
Other Features
- There is information about the possibility of developing negative consequences due to excessive use of the drug. If an overdose occurs, you should seek medical help. Specialists provide therapy taking into account the detected disorders. Adsorbents help remove excess drugs from the body.
- In some situations, it is possible that the patient’s body is hypersensitive to Moxifloxacin. This side effect may occur in the treatment of coronavirus and other diseases. Manifested by skin changes, itching, soreness, swelling and other symptoms. Life-threatening disorders, including anaphylaxis, occur very rarely. At the first signs of such disorders, you should immediately seek medical help and stop using the drug.
- The use of the drug is rarely accompanied by damage to the liver tissue. This can lead to disruption of the organ. To exclude such a complication, the doctor carefully evaluates the medical history before administering drug therapy. Laboratory signs of liver dysfunction are excluded. During the use of an antibiotic, the patient's condition is monitored through examination.
- Any signs of changes in the skin or mucous membranes during use of the drug potentially indicate life-threatening complications such as toxic epidermal necrolysis. You need to immediately contact a specialist. The drug is being discontinued. Timely assistance helps prevent the formation of dangerous negative consequences.
- The speed of the psychomotor reaction may decrease due to the use of the drug. Because of this, it is advisable to refrain from driving and other hazardous activities during treatment.
Full information is in the official instructions.