Avelox - instructions for use, analogs, reviews and release forms (400 mg tablets, injections in ampoules for injection in solution) antibiotic medications for the treatment of chlamydia and prostatitis in adults, children and pregnancy. Composition and alcohol
In this article, you can read the instructions for using the drug Avelox. Presented are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of Avelox in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Avelox with available structural analogues.The use for the treatment of chlamydia, mycoplasmosis, chronic bronchitis and prostatitis in adults, children, and during pregnancy and breastfeeding. Composition and interaction of the drug with alcohol.
Avelox - Antibacterial drug of the group of fluoroquinolones. Has a bactericidal effect. The mechanism of action is due to inhibition of bacterial topoisomerase 2 and 4, which disrupts DNA synthesis in the bacterial cell and, consequently, to the microbial cell death. The minimum bactericidal concentration of the drug as a whole is comparable to its MIC.
The drug is active against a broad spectrum of gram-negative and gram-positive bacteria, anaerobes, and atypical acid-fast bacterial forms such as Mycoplasma spp. (mycoplasma), Chlamydia spp. (chlamydia), Legionella spp. (Legionella), as well as bacteria resistant to beta-lactam and macrolide antibiotics.
For Avelox susceptible gram-positive and gram-negative aerobic bacteria, anaerobic bacteria, atypical bacteria: Chlamydia pneumoniae, Mycoplasma pneumoniae, Legionella pneumophila, Coxiella burnettii, Chlamydia trachomatis, Mycoplasma hominis, Mycoplasma genitalium.
Moxifloxacin (active ingredient Aveloks drug) less active against Staphylococcus aureus (strains resistant to methicillin / ofloxacin), Staphylococcus epidermidis (strains resistant to methicillin / ofloxacin), Pseudomonas aeruginosa, Pseudomonas fluorescens, Burkholderia cepacia, Stenotrophomonas maltophilia, Neisseria gonorrhoea.
Mechanisms that lead to the development of resistance to penicillins, cephalosporins, aminoglycosides, macrolides and tetracyclines, do not interfere with the antibacterial activity of moxifloxacin. Cross-resistance between these groups of antibacterial drugs and moxifloxacin is not noted. So far, no cases of plasmid resistance have been observed. The overall frequency of development of resistance is very low (10-7-10-10). Resistance to moxifloxacin develops slowly by multiple mutations. Multiple effects of moxifloxacin on microorganisms at concentrations below MIC are accompanied by only a slight increase in MIC.
There are cases of cross-resistance to quinolones. Nevertheless, some gram-positive and anaerobic microorganisms resistant to other quinolones are sensitive to moxifloxacin.
Composition
Moxifloxacin hydrochloride + excipients.
Pharmacokinetics
After oral administration, Avelox absorbs quickly and almost completely. When taking moxifloxacin together with food, the duration of absorption does not change. The drug can be used regardless of food intake. Absolute bioavailability is about 91%.Binding to blood proteins (mainly with albumins) is about 45%. Moxifloxacin is rapidly distributed in organs and tissues. High concentrations of the drug, exceeding those in plasma, are created in the lung tissue (including in alveolar macrophages), in the bronchial mucosa, in the nasal sinuses, in soft tissues, skin and subcutaneous structures, inflammation foci. In the interstitial fluid and in saliva, the drug is determined in a free, non-protein-binding form at a concentration higher than in the plasma. In addition, high concentrations of the drug are determined in the organs of the abdominal cavity and peritoneal fluid, as well as in the tissues of the female genital organs.
Biotransformed to inactive sulfo compounds and glucuronides. After passing the 2nd phase of biotransformation, moxifloxacin is excreted from the body by the kidneys and through the intestine both in unmodified form and in the form of inactive sulfo compounds and glucuronides. It is excreted in the urine, as well as with feces, both in unmodified form and in the form of inactive metabolites.
There are no differences in pharmacokinetic parameters of moxifloxacin depending on age, gender and race.
Studies of the pharmacokinetics of moxifloxacin in children have not been conducted.
Indications
Infectious-inflammatory diseases in adults caused by microorganisms sensitive to the preparation:
- acute sinusitis;
- Community-acquired pneumonia (including caused by strains of microorganisms with multiple antibiotic resistance);
- exacerbation of chronic bronchitis;
- uncomplicated skin and soft tissue infections;
- complicated infections of the skin and subcutaneous structures (including an infected diabetic foot);
- complicated intra-abdominal infections, including polymicrobial infections, incl. intraperitoneal abscesses;
- uncomplicated inflammatory diseases of the pelvic organs (including salpingitis and endometritis).
Forms of release
The tablets covered with a cover of 400 mg.
Solution for infusions (injections in ampoules for injections).
Instructions for use and dosing regimen
The drug is administered intravenously and intravenously 400 mg once a day.
The duration of treatment with Avelox at ingestion and / or induction is determined by the severity of the infection and the clinical effect and is: with exacerbation of chronic bronchitis - 5 days; with community-acquired pneumonia, the total duration of the stepwise therapy (intravenous administration followed by oral administration) is 7-14 days, first iv, then inside,or 10 days inside; with acute sinusitis and uncomplicated skin and soft tissue infections - 7 days; with complicated infections of the skin and subcutaneous tissues - the total duration of stepwise therapy (intravenous administration followed by oral administration) is 7-21 days; with complicated intra-abdominal infections - the total duration of the stepwise therapy (iv administration of the drug with subsequent ingestion) is 5-14 days; with uncomplicated inflammatory diseases of the pelvic organs -14 days.
Duration of treatment Avelox intravenously can reach 14 days, inside - 21 days.
Elderly patients, patients with minor violations of liver function (class A or B on the Child-Pugh scale), patients with impaired renal function (including with QC <30 mL / min / 1.73 m2), and patients who are on continuous hemodialysis and long-term outpatient peritoneal dialysis, changes in the dosing regimen are not required.
Tablets should be taken without chewing, washed down with a small amount of water, regardless of food intake.
Solution for infusion should be administered intravenously slowly for 60 minutes.The drug can be administered both in diluted and undiluted form. Avelox solution is compatible with the following solutions: water for injection, 0.9% sodium chloride solution, 1M sodium chloride solution, 5% Dextrose solution, 10% dextrose solution, 40% dextrose solution, 20% xylitol solution, Ringer's solution, Ringer's lactate solution, aminofusin solution 10%, solution of yonostearil. Use only a clear solution.
Side effect
- prolongation of the QT interval (often in patients with concomitant hypokalemia, sometimes in other patients);
- tachycardia and vasodilation (tides of blood to the face);
- arterial hypotension;
- arterial hypertension;
- fainting;
- ventricular tachyarrhythmias;
- nonspecific arrhythmias (including extrasystole);
- polymorphic ventricular tachycardia (ventricular arrhythmia of the "pirouette" type) or cardiac arrest predominantly in persons with predisposing conditions to arrhythmias, such as clinically significant bradycardia, acute myocardial ischemia;
- shortness of breath, including asthma;
- nausea, vomiting;
- stomach ache;
- diarrhea;
- anorexia;
- constipation;
- dyspepsia;
- flatulence;
- gastroenteritis (except erosive gastroenteritis);
- stomatitis;
- pseudomembranous colitis (in very rare cases associated with life-threatening complications);
- jaundice;
- hepatitis (mostly cholestatic);
- dizziness;
- headache;
- confusion of consciousness;
- disorientation;
- drowsiness;
- tremor;
- sleep disorders;
- sense of anxiety;
- increased psychomotor activity;
- impaired coordination (including gait disturbance due to dizziness, in very rare cases leading to trauma from falling, especially in elderly patients);
- convulsive seizures with various clinical manifestations (including seizures of grand mal);
- violation of attention;
- speech disorders;
- amnesia;
- depression (in very rare cases, behavior with a tendency to self-harm is possible);
- hallucinations;
- psychotic reactions (potentially manifested in behavior with a tendency to self-harm);
- taste disorders;
- visual impairment (blurred vision, decreased visual acuity, diplopia, especially in combination with dizziness and confusion);
- noise in ears;
- violation of the sense of smell, including anosmia;
- loss of taste sensitivity;
- anemia, leukopenia (including neutropenia), thrombocytopenia, thrombocytosis,prolongation of prothrombin time and decrease of INR;
- arthralgia;
- myalgia;
- tendonitis;
- increased muscle tone and cramps;
- ruptures of tendons;
- Candidiasis superinfection;
- vaginitis;
- dehydration (caused by diarrhea or decreased fluid intake);
- impaired renal function;
- renal failure due to dehydration, which can lead to kidney damage (especially in elderly patients with concomitant renal dysfunction);
- bullous skin reactions, for example, Stevens-Johnson syndrome or toxic epidermal necrolysis (potentially life-threatening);
- hives;
- itching;
- rash;
- eosinophilia;
- anaphylactic / anaphylactoid reactions;
- angioedema, including laryngeal edema (potentially life-threatening);
- anaphylactic shock (including life-threatening);
- general malaise (including symptoms of poor health, nonspecific pain and sweating);
- edema.
Contraindications
- pregnancy;
- lactation (breastfeeding);
- children and adolescents under 18;
- hypersensitivity to moxifloxacin and other components of the drug.
Application in pregnancy and lactation
Safety of application of Avelox during pregnancy is not established, therefore its use is contraindicated.
A small amount of moxifloxacin is excreted in breast milk. Data on the use of moxifloxacin in women during lactation are absent. Therefore, the use of Avelox during breastfeeding is also contraindicated.
In experimental studies, when studying the effect of moxifloxacin on reproductive function in rats, rabbits and monkeys, it has been proven that moxifloxacin penetrates the placental barrier. Studies carried out on rats (with the administration of moxifloxacin inside and / in) and monkeys (when moxifloxacin was administered orally) did not reveal teratogenic effects of moxifloxacin and its effect on fertility. With iv administration of moxifloxacin to rabbits at a dose of 20 mg / kg, malformations of the skeleton were observed. An increase in the number of miscarriages in monkeys and rabbits with the use of moxifloxacin in a therapeutic dose has been revealed. In rats, a decrease in fetal weight, increased frequency of miscarriages, a slight increase in the duration of pregnancy, and an increase in the spontaneous activity of the offspring of both sexes with moxifloxacin,the dose of which was 63 times higher than the recommended dose.
Application in elderly patients
Elderly patients are not required to change the dosage regimen.
Use in children
The drug is contraindicated in children and adolescents under 18 years.
special instructions
It should be borne in mind that when the drug Avelox increases the risk of seizures, therefore, with caution appoint the drug to patients with CNS diseases, accompanied by convulsions or predisposing to their development or reduce the threshold of convulsive readiness, as well as suspected of such diseases and conditions.
It is not recommended to use the drug in patients with severe impairment of liver function (class C on the Child-Pugh scale) due to the lack of sufficient clinical data.
It is not recommended to use the drug in patients with complicated inflammatory diseases of the pelvic organs (for example, associated with tubo-ovarian or pelvic abscesses).
When using Avelox in some patients, the QT interval may be prolonged. In this regard, the appointment of the drug to patients with prolonged QT interval, hypokalemia,and also against treatment with antiarrhythmic drugs of class 1 A (quinidine, procainamide) or class 3 (amiodarone, sotalol), since the experience of using moxifloxacin in these patients is limited. Caution should be used to administer Avelox along with drugs that extend the QT interval (cisapride, erythromycin, antipsychotics, tricyclic antidepressants), and patients with predisposing conditions such as bradycardia, acute myocardial ischemia. The degree of elongation of the QT interval may increase with increasing drug concentration, therefore, do not exceed the recommended dose. The prolongation of the QT interval is associated with an increased risk of ventricular arrhythmias, including polymorphic ventricular tachycardia. In patients with pneumonia, there was no correlation between the concentration of moxifloxacin in the blood plasma and the prolongation of the QT interval. None of the 9,000 patients receiving moxifloxacin had any cardiovascular complications associated with prolonged QT and lethal cases. However, in patients with predisposing arrhythmias, the risk of developing ventricular arrhythmias may increase with moxifloxacin.
On the background of therapy with fluoroquinolones, incl. moxifloxacin, especially in the elderly and patients receiving glucocorticosteroids (SCS), tendonitis and tendon rupture are possible. When there is pain or signs of inflammation of the tendon, stop taking Avelox and relieve the affected limb.
The use of broad-spectrum antibacterial drugs is associated with a risk of developing pseudomembranous colitis. This should be borne in mind when there is severe diarrhea on the background of treatment with Avelox. In this case, the drug should be withdrawn and immediate therapy should be prescribed.
Do not use Avelox together with ethanol (alcohol).
There is a risk of developing hypersensitivity reactions and anaphylactic reactions during the initial application of the drug. Very rarely an anaphylactic reaction can progress to anaphylactic shock. In such cases, the drug should be discontinued immediately and appropriate resuscitation (including anti-shock) measures should be carried out.
When applying quinolones, photosensitization reactions are noted. However, in the pre-clinical, clinical trials, as well as in the application of Avelox in clinical practice, photosensitivity reactions were not observed.However, patients during the period of taking the drug should avoid direct sunlight and UV irradiation.
Patients of different ethnic groups do not need dose adjustment.
Impact on the ability to drive vehicles and manage mechanisms
Despite the fact that moxifloxacin rarely causes side effects from the CNS, the question of the possibility of driving or moving mechanisms is solved individually after evaluating the patient's response to taking the drug.
Drug Interactions
No dose adjustment is required when using Avelox together with atenolol, ranitidine, calcium-containing additives, with theophylline, oral contraceptives, glibenclamide, itraconazole, digoxin, morphine, probenecid together (confirmed absence of clinically significant interaction with moxifloxacin).
Joint application of Avelox and antacids, minerals and vitamin-mineral complexes inside the body can disrupt the absorption of moxifloxacin due to the formation of chelate complexes with polyvalent cations contained in these preparations, and consequently, to reduce the concentration of moxifloxacin in the blood plasma.In this regard, antacid, antiretroviral and other drugs containing calcium, magnesium, aluminum, iron, sucralfate should be taken at least 4 hours before or 2 hours after ingestion of Avelox.
With the combined use of Avelox with warfarin, prothrombin time and other coagulation parameters do not change.
In patients who received anticoagulants in combination with antibiotics, incl. with moxifloxacin, there have been cases of increased anticoagulant activity of anticoagulant drugs. Risk factors are the presence of an infectious disease (and concomitant inflammatory process), the age and general condition of the patient. Despite the fact that there is no interaction between moxifloxacin and warfarin, in patients receiving concomitant treatment with these drugs, it is necessary to monitor the INR and, if necessary, adjust the dose of oral anticoagulants.
Moxifloxacin and Digoxin do not significantly affect the pharmacokinetic parameters of each other.
With the simultaneous use of activated charcoal and moxifloxacin inside at a dose of 400 mg, the systemic bioavailability of the drug is reduced by more than 80% as a result of a slowing of its absorption.In the case of an overdose, the use of Activated carbon at an early stage of absorption inhibits further increase in systemic exposure.
Absorption of moxifloxacin does not change with simultaneous intake of food (including dairy products). Moxifloxacin can be taken regardless of food intake.
Analogues of drug Avelox
Structural analogs for the active substance:
- Vigamox;
- Mossimak;
- Moxin;
- Moxifloxacin;
- Moxifur;
- Plevilox.
Analogues for the pharmacological group (antibiotics quinolones and fluoroquinolones):
- Abaktal;
- Altsipro;
- Vigamox;
- Gatispan;
- Glevo;
- Zanotsin;
- Zofloks;
- Quipro;
- Levot P;
- Levofloxacin;
- Lomefloxacin;
- Microfleks;
- Nevigramon;
- The Negroes;
- Nolycin;
- Norbaktin;
- Norfloxacin;
- Ofloks;
- Ofloxacin;
- Oflotsid;
- Oflotsid forte;
- Palin;
- Pefloxacin;
- Recipro;
- Siflox;
- Tavanik;
- Uniflox;
- Factual;
- Floracid;
- Hayleflex;
- Ciprobay;
- Tsiprolet;
- Ciprofloxacin;
- Tsifran;
- Eleflox;
- Unikpef;
- Utibid.
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