Moflaxia pills 400mg, 5pcs

Composition

1 film-coated tablet contains:

Core:

Active ingredient:

moxifloxacin hydrochloride 454.75 mg, equivalent to moxifloxacin 400.00 mg;

excipients:

microcrystalline cellulose 186.05 mg,

croscarmellose sodium 32.00 mg,

magnesium stearate 6.00 mg;

Film shell:

hypromellose 12.60 mg, macrogol-4000 4.20 mg, titanium dioxide (E 171) 3.78 mg, iron oxide red dye (E 172) 0.42 mg

Pharmacological action

Antimicrobial agent-fluoroquinolone

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to moxifloxacin: – acute sinusitis;- exacerbation of chronic bronchitis; – uncomplicated infections of the skin and subcutaneous structures; – community-acquired pneumonia, including community-acquired pneumonia caused by strains of microorganisms with multiple antibiotic resistance*;- complicated infections of the skin and subcutaneous structures (including infected diabetic foot);- complicated intra-abdominal infections, including polymicrobial infections, including intraperitoneal abscesses; – uncomplicated pelvic inflammatory diseases (including salpingitis and endometritis). * Streptococcus pneumoniae with multiple antibiotic resistance includes strains resistant to penicillin and strains resistant to two or more antibiotics from groups such as penicillins (with MIC ≥ 2 micrograms/ml), generation II cephalosporins (cefuroxime), macrolides, tetracyclines, and trimethoprim / sulfamethoxazole. It is necessary to take into account the current official guidelines on the use of antibacterial agents.

Use during pregnancy and lactation

Pregnancy The safety of using moxifloxacin during pregnancy has not been established, so its use is contraindicated. Cases of reversible joint damage have been reported in children receiving certain quinolones, but this effect has not been reported in the fetus (when used by the mother during pregnancy). Reproductive toxicity has been identified in animal studies. The potential risk to humans is unknown. Like other quinolones, moxifloxacin causes damage to the cartilage of large joints in premature animals. Pre-clinical studies have found that a small amount of moxifloxacin is excreted in breast milk. There are no data on its use in women during lactation. Therefore, the use of moxifloxacin during breastfeeding is contraindicated.

Contraindications

– Hypersensitivity to moxifloxacin, to other hinolona or any other component of the drug;

– age under 18 years;

– pregnancy and lactation;

– a history of the pathology of tendons, which developed as a result of treatment with antibiotics hinolonovogo series;

in preclinical and clinical studies after use of moxifloxacin was observed the changes in the electrophysiological parameters of the heart, expressed in the elongation of the QT interval. In this regard, the use of moxifloxacin is contraindicated in patients following categories: congenital or documented acquired QT prolongation, electrolyte disturbances, especially hypokalemia dekorasyonunda, clinically significant bradycardia, clinically significant chronic heart failure with reduced ejection fraction of the left ventricle, a history of arrhythmias, accompanied by clinical symptoms;

– moxifloxacin cannot be applied with other products, lengthening the interval 

– due to the limited amount of clinical data, the use of moxifloxacin is contraindicated in patients with impaired liver function (Child-Pugh class C) and in patients with increased transaminase activity more than five times higher than the upper limit of normal.

With caution:

– In diseases of the Central nervous system (CNS) (including for suspected involvement of the Central nervous system), predisposing to the occurrence of seizures and lowering the threshold of convulsive activity;

– use in patients with psychosis and/or psychiatric diseases in the anamnesis;

– use in patients with potentially prioritiesin conditions (especially women and elderly patients) such as acute myocardial ischemia and heart failure;

– use in patients with cirrhosis of the liver;

– myasthenia gravis;

– simultaneous use of drugs that reduce potassium content;

– use in patients with a genetic predisposition or actual deficit of glucose-6-phosphate dehydrogenase.

Side effects

Data on adverse reactions reported with the use of moxifloxacin 400 mg (orally, with step therapy (intravenous use of moxifloxacin followed by oral use) and only intravenously) are obtained from clinical studies and post-marketing reports (highlighted in italics). Adverse reactions listed in the “often” group were less than 3% common, with the exception of nausea and diarrhea.

Frequency was classified as follows: frequent (≥ 1/100 to < 1/10), infrequent (≥ 1/1000 to < 1/100), rare (≥1/10000 to < 1/1000), very rare (

In each group, undesirable effects are listed in descending order of significance.

The incidence of the following adverse reactions was higher in the group receiving step therapy:

often: increased gamma-glutamyltransferase activity;

infrequently: ventricular tachyarrhythmias, decreased blood pressure, edema, pseudomembranous colitis (in very rare cases associated with life-threatening complications), seizures with various clinical manifestations (including “grand mal” seizures), hallucinations, impaired renal function, renal failure (as a result of dehydration, which can lead to kidney damage, especially in elderly patients with pre-existing renal dysfunction).

Interaction

When used concomitantly with atenolol, ranitidine, calcium-containing supplements, theophylline, cyclosporine, oral contraceptives, glibenclamide, itraconazole, digoxin, morphine, probenecid (no clinically significant interaction with moxifloxacin was confirmed), no dose adjustment is required. Drugs that prolong the QT interval It is necessary to take into account the possible additive effect of prolonging the QT interval of moxifloxacin and other drugs that affect the prolongation of the QT interval. Concomitant use of moxifloxacin and drugs that affect the prolongation of the QT interval increases the risk of ventricular arrhythmia, including polymorphic ventricular tachycardia. Concomitant use of moxifloxacin with the following drugs that affect the prolongation of the QT interval is contraindicated:- class IA antiarrhythmic drugs (quinidine, hydroquinidine, disopyramide, etc. ); – class III antiarrhythmic drugs (amiodarone, sotalol, dofetilide, ibutilide, etc. ); – neuroleptics (phenothiazine, pimozide, sertindol, haloperidol, sultoprid, etc. ); – tricyclic antidepressants;- antimicrobials (sparfloxacin, erythromycin (intravenous), pentamidine, antimalarials, especially halofantrine);- antihistamines (terfenadine, astemizole, mizolastine);- others (cisapride, vincamine (intravenously), bepridil, difemanil). Antacids, multivitamins, and minerals Taking moxifloxacin concomitantly with antacids, multivitamins, and minerals can lead to impaired absorption of moxifloxacin, due to the formation of chelate complexes with the multivalent cations contained in these drugs. As a result, the concentration of moxifloxacin in the blood plasma may be significantly lower than desired. In this regard, antacids, anti-retroviral drugs (for example, didanosine) and other drugs containing magnesium or aluminum, sucralfate and other drugs containing iron or zinc should be used at least 4 hours before or 4 hours after oral use of moxifloxacin. Warfarin When used concomitantly with warfarin, the prothrombin time and other blood clotting parameters do not change. Change in the value of the MRI of patients who received anticoagulants simultaneously with antibiotics, including moxifloxacin, there are cases of increased anticoagulant activity of anticoagulants. Risk factors include the presence of an infectious disease (and associated inflammatory process), age, and general condition of the patient. Although there is no interaction between moxifloxacin and warfarin, patients receiving these drugs simultaneously should monitor their INR and, if necessary, adjust the dose of indirect anticoagulants. Digoxinmoxifloxacin and digoxin do not significantly affect each other’s pharmacokinetic parameters. With repeated doses of moxifloxacin, the cmax of digoxin in blood plasma increased by approximately 30%, while the AUC value and the minimum digoxin concentration did not change. Activated charcoal When activated charcoal and moxifloxacin are co-administered at a dose of 400 mg orally, the systemic bioavailability of moxifloxacin is reduced by more than 80% as a result of reduced absorption. In case of overdose, the use of activated carbon at an early stage of absorption prevents further increase in systemic exposure.

How to take, course of use and dosage

Inside,1 tablet (400 mg) 1 time a day for infections listed above.

Do not exceed the recommended dose.

Tablets should be swallowed whole, without chewing, with a sufficient amount of water, regardless of the time of meal.

Duration of treatment

The duration of treatment is determined by the location and severity of the infection, as well as the clinical effect:

– exacerbation of chronic bronchitis: 5-10 days;

– acute sinusitis: 7 days;

– uncomplicated infections of the skin and subcutaneous structures: 7 days;

– community-acquired pneumonia: the total duration of step therapy (intravenous use followed by oral use) is 7-14 days;

– complicated infections of the skin and subcutaneous structures: the total duration of stepwise moxifloxacin therapy (intravenous use followed by oral use) is 7-21 days;

– complicated intra-abdominal infections: the total duration of step therapy (intravenous use followed by oral use) is 5-14 days;

– uncomplicated pelvic inflammatory diseases: 14 days.

Do not exceed the recommended duration of treatment.

According to clinical studies, the duration of treatment with Moflaxia tablets can reach 21 days.

Elderly patients

Changes in the dosage regimen in elderly patients are not required.

Children

The efficacy and safety of moxifloxacin in children and adolescents has not been established.

Impaired liver function

Patients with impaired liver function (Child-Pugh classes A and B) do not need to change the dosage regimen (for use in patients with cirrhosis of the liver, see the section “Special instructions”).

Impaired renal function

In patients with impaired renal function (including severe renal insufficiency with creatinine clearance

Ethnicity

Changes in the dosage regimen in patients of different ethnic groups are not required.

Overdose

There are limited data on overdose of moxifloxacin. No side effects were observed when using moxifloxacin at a dose of up to 1200 mg once and 600 mg for 10 days or more.

In case of overdose, you should focus on the clinical picture and conduct symptomatic maintenance therapy with ECG monitoring. The use of activated charcoal immediately after ingestion may help prevent excessive systemic exposure to moxifloxacin in the event of an overdose.

Special instructions

In some cases, hypersensitivity and allergic reactions may develop after the first use of the drug, which should be immediately informed to the doctor. Very rarely, even after the first use of the drug, anaphylactic reactions can progress to life-threatening anaphylactic shock. In these cases, treatment with Moflaxia should be discontinued and the necessary therapeutic measures (including anti-shock) should be initiated immediately. When using the drug Moflaxia, some patients may experience prolongation of the QT interval. Moflaxia 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. Prolongation of the QT interval is associated with an increased risk of ventricular arrhythmias, including polymorphic ventricular tachycardia. The degree of prolongation of the QT interval may increase with an increase in the concentration of moxifloxacin in blood plasma, so do not exceed the recommended dose. However, in patients with pneumonia, there was no correlation between the concentration of moxifloxacin in blood plasma and prolongation of the QT interval. None of the 9,000 patients treated with moxifloxacin had any cardiovascular events or deaths associated with prolongation of the QT interval. The use of Moflaxia may increase the risk of ventricular arrhythmias in patients with conditions predisposing to arrhythmias. In this regard, the drug Moflaxia is contraindicated in: – changes in the electrophysiological parameters of the heart, expressed in prolongation of the QT interval: congenital or acquired documented prolongation of the QT interval; electrolyte disturbances, especially in uncorrected hypokalemia; clinically significant bradycardia; clinically significant heart failure with a reduced left ventricular ejection fraction; a history of rhythm disorders accompanied by clinical symptoms;- use with other drugs that prolong the QT interval (see the section “Interaction with other drugs”). Moflaxia should be used with caution:- in patients with potentially proarrhythmic conditions, such as acute myocardial ischemia and cardiac arrest; – in patients with cirrhosis of the liver (since the risk of QT prolongation cannot be excluded in this category of patients). Cases of fulminant hepatitis, potentially leading to the development of liver failure (including fatal cases), have been reported with moxifloxacin (see section “Adverse effects”). The patient should be advised that if symptoms of hepatic insufficiency occur, it is necessary to consult a doctor before continuing treatment with Moflaxia. Bullous skin lesions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, have been reported with moxifloxacin (see section “Side effects”). The patient should be informed that if symptoms of skin or mucosal damage occur, it is necessary to consult a doctor before continuing treatment with Moflaxia. The use of quinolone drugs is associated with a possible risk of seizures. Moflaxia should be used with caution in patients with diseases of the central nervous system and with disorders of the central nervous system that predispose to seizures or reduce the threshold of convulsive activity. The use of broad-spectrum antibacterial drugs, including Moflaxia, is associated with the risk of developing pseudomembranous colitis. This diagnosis should be taken into account in patients who have developed severe diarrhea during treatment with Moflaxia. In this case, appropriate therapy should be prescribed immediately. Drugs that inhibit intestinal motility are contraindicated in the development of severe diarrhea. Moflaxia should be used with caution in patients with myasthenia gravis due to possible exacerbation of the disease. During quinolone therapy, including moxifloxacin, tendinitis and tendon rupture may develop, especially in elderly patients and patients receiving glucocorticosteroids. Cases that occurred within a few months after the end of treatment are described. At the first symptoms: pain or inflammation at the site of injury, Moflaxia should be discontinued and the affected limb should be relieved. When using quinolones, photosensitivity reactions are noted. However, no photosensitivity reactions were observed in preclinical and clinical studies, as well as in the use of moxifloxacin in clinical practice. However, patients receiving Moflaxia should avoid exposure to direct sunlight and ultraviolet light. The use of Moflaxia tablets for oral use is not recommended in patients with complicated pelvic inflammatory diseases (for example, associated with tubo-ovarian or pelvic abscesses). It is not recommended to use moxifloxacin for the treatment of infections caused by strains Staphylococcus aureus, resistant to methicillin. In the case of suspected or confirmed infections caused by MRSA, appropriate antibacterial drugs should be used for therapy (see the section “Pharmacodynamics”). The ability of moxifloxacin to inhibit the growth of mycobacteria may cause in vitro interaction of moxifloxacin with the Mycobacterium spp. test, which leads to false negative results in the analysis of samples of patients treated with Moflaxia during this period. Patients treated with quinolones, including moxifloxacin, have reported cases of sensory or sensorimotor polyneuropathy resulting in paresthesia, hypesthesia, dysesthesia, or weakness. Patients treated with Moflaxia should be advised to seek immediate medical attention before continuing treatment if symptoms of neuropathy occur, including pain, burning, tingling, numbness, or weakness (see section “Side effects”). Mental reactions may occur even after the first use of fluoroquinolones, including moxifloxacin. In very rare cases, depression or psychotic reactions progress to suicidal thoughts and behaviors with a tendency to self-harm, including suicide attempts (see the section “Side effects”). If patients develop such reactions, the drug Moflaxia should be discontinued and the necessary measures taken. Caution should be exercised when using Moflaxia in patients with a history of psychosis and psychiatric diseases. Due to the widespread and growing incidence of infections caused by fluoroquinolone-resistant drugs Neisseria gonorrhoeae, when treating patients with pelvic inflammatory diseases, moxifloxacin monotherapy should not be used, except in cases where the presence of fluoroquinolone-resistant N. adr choeaeexcluded. If it is not possible to exclude the presence of fluoroquinolone-resistant N. Therefore, it is necessary to decide whether to supplement empirical therapy with moxifloxacin with an appropriate antibiotic that is active against N. gonorrhoeae (for example, cephalosporin). Dysglycemia As with other fluoroquinolones, changes in blood glucose concentrations, including hypo – and hyperglycemia, were observed with Moflaxia. During moxifloxacin therapy, dysglycemia occurred mainly in elderly patients with diabetes mellitus receiving concomitant therapy with hypoglycemic drugs for oral use (for example, sulfonylureas) or insulin. When conducting treatment in patients with diabetes mellitus, careful monitoring of blood glucose concentration is recommended (see the section “Side effects”). Influence on the ability to drive vehicles and fur.:Fluoroquinolones, including moxifloxacin, may impair patients ‘ ability to drive and engage in other potentially dangerous activities that require increased attention and speed of psychomotor reactions, due to their effects on the central nervous system and visual impairment.

Form of production

Film-coated tablets of dark pink color, biconvex, capsule-shaped. Cross-sectional view: bright yellow rough mass with a dark pink film shell.

Storage conditions

At a temperature not exceeding 25 °C, in the original packaging.

Keep out of reach of children.

Active ingredient

Moxifloxacin

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Respiratory Tract Infections, Pneumonia, Sinusitis, Urinary Tract Infections, Infectious Diseases, Bronchitis, Skin Infections