Hinemox pills 400 mg, 5 pcs.

Composition

Each film-coated tablet contains:

Active ingredient: moxifloxacin hydrochloride 436.30 mg (corresponds to moxifloxacin-400 mg)

auxiliary substances: corn starch – 52 mg; sodium lauryl sulfate – 7.5 mg; talc purified – 15 mg; magnesium stearate – 6.5 mg; carboximetilkrahmal sodium 20 mg; silicon dioxide colloidal anhydrous – 3.5 mg; croscarmellose sodium – 6.5 mg; cellulose microcrystalline – of 130.7 mg.

shell: Opadry white (85G58977) Make-Colorcon (polyvinyl alcohol, titanium dioxide, talc, macrogol – 3000, lecithin (soy)) – 17,32 mg; iron oxide red – 0,68 mg.

Pharmacological properties

Pharmacotherapeutic group: an antimicrobial agent is a fluoroquinolone.

ATX Code: J01MA14

Pharmacological properties

Pharmacodynamics

Mechanism of action

Moxifloxacin is a broad-spectrum bactericidal antibacterial drug,8-methoxyfluoroquinolone. The bactericidal effect of moxifloxacin is due to the inhibition of bacterial topoisomerases II and IV, which leads to disruption of the processes of replication, repair and transcription of microbial cell DNA biosynthesis and, as a result, to the death of microbial cells.

The minimum bactericidal concentrations of moxifloxacin are generally comparable to its minimum inhibitory concentrations.

Mechanisms of resistance

Mechanisms leading to the development of resistance to penicillins, cephalosporins, aminoglycosides, macrolides and tetracyclines do not affect the antibacterial activity of moxifloxacin. There is no cross-resistance between these groups of antibacterial drugs and moxifloxacin. So far, no cases of plasmid resistance have been observed. The overall frequency of resistance development is very low (10-7-10-10). Resistance to moxifloxacin develops slowly through multiple mutations. Repeated exposure of moxifloxacin to microorganisms at concentrations below the minimum inhibitory concentration (MIC) is accompanied by only a slight increase in MIC. There are cases of cross-resistance to quinolones. However, some gram-positive and anaerobic microorganisms resistant to other quinolones remain sensitive to moxifloxacin.

It was found that the addition of a methoxy group at position C8 to the moxifloxacin molecule structure increases the activity of moxifloxacin and reduces the formation of resistant mutant strains of gram-positive bacteria. The addition of the bacycloamine group at position C7 prevents the development of active efflux, a mechanism of resistance to fluoroquinolones.

Moxifloxacin is active in vitro against a wide range of Gram-negative and gram-positive microorganisms, anaerobes, acid-resistant bacteria and atypical bacteria such as Mycoplasma spp., Chlamydia spp., Legionella spp., as well as bacteria resistant to beta-lactam and macrolide antibiotics.

Effect on human intestinal microflora

In two studies conducted on volunteers, the following changes in the intestinal microflora were noted after oral administration of moxifloxacin.

There was a decrease in the concentrations of Echerichia coli, Bacillus spp., Bacteroides vulgatus, Enterococcus spp., Klebsiella spp., as well as anaerobes Bifidobacterium spp., Eubacterium spp., and Peptostreptococcus spp. These changes were reversible within two weeks. No Clostridium difficile toxin was detected.

Pharmacokinetics

Suction

After oral administration, moxifloxacin is absorbed rapidly and almost completely. Absolute bioavailability is about 91%.

The pharmacokinetics of moxifloxacin when taken at a dose of 50 to 1200 mg once, as well as 600 mg/day for 10 days is linear. The equilibrium state is reached within 3 days.

After a single dose of 400 mg of moxifloxacin, the blood max is reached within 0.5-4 hours and is 3.1 mg/l. After oral administration of 400 mg moxifloxacin once a day, the_ssmax and_ssmin values are 3.2 mg / l and 0.6 mg/L, respectively.

When taking moxifloxacin with food, there is a slight increase in the time to reach_cmax (by 2 hours) and a slight decrease_{in cmax} (by approximately 16%), while the duration of absorption does not change. However, these data are not clinically relevant, and the drug can be used regardless of food intake.

Distribution

Moxifloxacin is rapidly distributed in tissues and organs and binds to blood proteins (mainly albumins) by about 45%. The volume of distribution is approximately 2 l / kg.

High concentrations of moxifloxacin, exceeding those in plasma, are created in the lung tissue (including in the epithelial fluid, alveolar macrophages), in the nasal sinuses (maxillary and ethmoid sinuses), in nasal polyps, in inflammatory foci (in the contents of blisters with skin damage). In interstitial fluid and saliva, moxifloxacin is detected in a free, non-protein-bound form, at a concentration higher than in blood plasma.

In addition, high concentrations of moxifloxacin are detected in the tissues of the abdominal cavity, peritoneal fluid and female genitalia.

Metabolism

Moxifloxacin undergoes phase 2 biotransformation and is excreted from the body by the kidneys, as well as through the intestines, both in unchanged form and in the form of inactive sulfo compounds (M1) and glucuronides (M2). Moxifloxacin is not biotransformed by the cytochrome P 450 microsomal system. Metabolites M1 and m2 are present in blood plasma at concentrations lower than the parent compound. Based on the results of preclinical studies, it was proved that these metobolites do not have a negative effect on the body from the point of view of safety and tolerability.

Deduction

The elimination half-life of moxifloxacin is approximately 12 hours. The average total clearance after administration at a dose of 400 mg is 179-246 ml / min. Renal clearance is 24-53 ml/min. This indicates partial tubular reabsorption of the drug. The mass balance of the parent compound and phase 2 metabolites is approximately 96-98%, which indicates the absence of oxidative metabolism. About 22% of a single dose (400 mg) is excreted unchanged by the kidneys, about 26% – through the intestines.

Pharmacokinetics in different groups of patients

Age, gender, and ethnicity. When studying the pharmacokinetics of moxifloxacin in men and women, differences in AUC and Cmax were found in 33%. Moxifloxacin absorption was independent of gender. Differences in AUC and Cmax were due to differences in weight rather than gender and are not considered clinically significant. There were no clinically significant differences in the pharmacokinetics of moxifloxacin in patients of different ethnic groups and different ages.

Children. The pharmacokinetics of moxifloxacin in children have not been studied.

Kidney failure. There were no significant changes in the pharmacokinetics of moxifloxacin in patients with impaired renal function (including patients with creatinine clearance

Impaired liver function. There were no significant differences in the concentration of moxifloxacin in patients with impaired liver function (Child-Pugh class A, B, C) compared with healthy volunteers with normal liver function.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to moxifloxacin:

• uncomplicated infections of skin and subcutaneous structures;
• community-acquired pneumonia, including community-acquired pneumonia caused by strains of microorganisms with multiple resistance to antibiotics*;
• complicated infections of skin and subcutaneous structures (including infected diabetic foot);
• complicated intra-abdominal infections including polymicrobial infections, including intra-abdominal abscesses;
• uncomplicated inflammatory diseases of the pelvic organs (including salpingitis and endometritis).

For the treatment of the following infectious and inflammatory diseases, moxifloxacin can only be used as an alternative to other antimicrobial drugs:

• acute sinusitis;
• exacerbation of chronic bronchitis.

* 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

The safety of using moxifloxacin during pregnancy has not been established and 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 shown 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. Preclinical studies have shown that a large 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 other components of the drug;
• children up to age 18;
• allergic reactions to peanuts or soy;
• the defeat of the tendons at the earlier treatment quinolones;
• concomitant use of drugs that lengthen the QT interval (including antiarrhythmic drugs of class IA and III), see section “Interaction with other drugs”;
• the use of moxifloxacin causes lengthening 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 heart failure with reduced ejection fraction of the left ventricle; a history of arrhythmias, accompanied by clinical symptoms;
• patients with impaired liver function (class C classification for child-Pugh) and elevation of transaminases more than three times the upper limit of normal;
• pregnancy and breastfeeding.

With caution

• in diseases of the Central nervous system (including suspicious of the involvement of the Central nervous system), predisposing to the occurrence of seizures and lowering the threshold of convulsive activity;
• in patients with psychosis and psychiatric diseases in the anamnesis;
• in patients with potentially prioritiesin conditions such as acute myocardial ischemia, especially in women and elderly patients;
• myasthenia gravis;
• liver cirrhosis;
• the simultaneous administration of drugs that reduce potassium content.

Side effects

Data on adverse reactions reported with the use of moxifloxacin 400 mg (orally, with step therapy[intravenous administration of the drug with subsequent oral administration] and only intravenously) are obtained from clinical studies and post-marketing reports (italicized). Adverse reactions listed in the “often” group were found with a frequency below 3%, with the exception of nausea and diarrhea. In each frequency group, adverse drug reactions are listed in descending order of significance. The frequency is determined as follows:common (≥1/100 to <1/10), infrequent (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000), very rare (

Infectious and parasitic diseasesfungal superinfections

From the hematopoietic systemanemia-Leukopenia-Neutropenia-Thrombocytopenia-Thrombocytemia-Prothrombin time extension/increase in the international normalized ratio (INR)Change in thromboplastin concentrationincrease in prothrombin concentration/decrease in INR

On the part of the immune systemallergic reactionssudes of urticaria eosinophilia anaphylactic /anaphylactoid reactionsangioedema, including laryngeal edema (potentially life-threatening)Anaphylactic / anaphylactoid shock (including potentially life-threatening ones)

From the side of metabolism hyperlipidemiyagyperglycemiyagyperuricemiyagypoglycemia

Mental disorders Anxiety Psychomotor hyperactivity / agitation Emotional lability Depression (in very rare cases, behavior with a tendency to self-harm, such as suicidal thoughts or suicide attempts, is possible)HALLUCINATIONSPERSONALIZATIONSPSYCHOTIC reactions (potentially manifested in behaviors with a tendency to self-harm, such as suicidal thoughts or suicide attempts)

Nervous system disorders: Headache, vertigo, paresthesia/dysesthesia, impaired taste sensitivity (including, in very rare cases, ageusia)Confusion and disorientationnormorvertigo-sleep disorders Hypesthesia Olfactory disorders (including anosmia)Atypical dreams Coordination disorders (including gait disorders due to dizziness or vertigo, in very rare cases leading to injuries as a result of a fall, especially in elderly patients) Convulsions with various clinical manifestations (including “grand mal” seizures)Attention disorders Speech disorders History Peripheral neuropathy and polyneuropathyperesthesia

From the side of the organ of vision Visual disturbances (especially with reactions from the central nervous system)Transient vision loss (especially with CNS reactions)

Hearing disorders and labyrinth disorders tinnitus Hearing loss, including deafness (usually reversible)

From the cardiovascular system QT interval prolongation in patients with concomitant hypokalemia QT interval prolongation Palpitation sensation tachycardia Vasodilation Ventricular tachyarrhythmias Syncope Increased blood pressure Decreased blood pressurespecific arrhythmias polymorphic ventricular tachycardia (torsades des pointes), cardiac arrest (mainly in individuals with predisposing factors arrhythmias with conditions such as clinically significant bradycardia, acute myocardial ischemia)

Respiratory, thoracic and mediastinal disorders Dyspnea (including asthmatic conditions)

From the gastrointestinal tract Nausea tarvotabol in the abdomen diarexplaced appetite and reduced food consumptionspordispepsiymetheorismgastroenteritis (except erosive gastroenteritis)Increased amylase activitydisphagiaastomatitpseudomembranous colitis (in very rare cases associated with life-threatening complications)

From the liver and biliary tract, increased activity of “hepatic” transaminases, impaired liver function (including increased activity of lactate dehydrogenase)Increased bilirubin concentration Increased gamma-glutamyltransferase activityincreased blood alkaline phosphotase activityeltuhepatitis (mainly cholestatic)Fulminant hepatitis, potentially leading to life-threatening liver failure (including fatal cases)

Skin and subcutaneous tissue disorders Bullous skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis (potentially life – threatening)

Musculoskeletal and connective tissue disorders Arthralgia and myalgia tendinitis Increased muscle tone and convulsions Muscle weakness Tendon ruptures Arthritis Gait disorders due to damage to the musculoskeletal system Increased symptoms of myasthenia gravis.

Kidney and urinary tract disorders Dehydration (caused by diarrhea or decreased fluid intake)

Renal Dysfunctionrenal insufficiency (as a result of dehydration, which can lead to kidney damage, especially in elderly patients with pre-existing renal dysfunction)

General disorders and disorders at the injection site Injection site reactions / infusions General malaise Specific pain Sweating phlebitis / thrombophlebitis at the infusion site Edema The

incidence of the following adverse reactions was higher in the group receiving step therapy:Often: Increased gamma-glutamyltransferase activity is common: ventricular tachycardia, 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

There is no clinically significant interaction of moxifloxacin with atenolol, ranitidine, calcium-containing supplements, theophylline, oral contraceptives, glibenclamide, itraconazole, digoxin, morphine, probenecid. Correction of the dosage regimen when used together with these drugs is not required.

Antacids, minerals, and multivitamins

Concomitant administration of moxifloxacin and antacids, minerals, and multivitamins may impair the absorption of moxifloxacin, due to the formation of chelate complexes with polyvalent cations contained in these drugs, and, consequently, reduce the concentration of moxifloxacin in blood plasma. In this regard, antacids, antiretroviral drugs (for example, didanosine) and other drugs containing magnesium, aluminum, sucralfate, iron, zinc should be taken at least 4 hours before or 4 hours after oral administration of moxifloxacin.

Drugs that prolong the QT interval

Since moxifloxacin affects the prolongation of the QT interval, co-administration of moxifloxacin with the following drugs is contraindicated:

– antiarrhythmic IA (quinidine, gedragingen, disopyramide, etc. ) and III (amiodarone, sotalol, dovetail, ibutilide, etc. ) classes;

– tricyclic antidepressants;

– antipsychotics (fenotiazin, pimozide, sertindole, haloperidol, and sultopride, etc. );

– antimicrobial drugs (sparfloxacin, erythromycin IV, pentamidine, antimalarials particularly halofantrine);

– antihistamines (astemizole, terfenadine, mizolastine);

– other (cisapride, vincamine has IV, bepridil have diphemanil).

Warfarin

When combined with warfarin, prothrombin time and other blood clotting parameters do not change.However, patients treated with anticoagulants in combination with antibiotics, including moxifloxacin, have experienced 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 concomitant treatment with these drugs should monitor the INR value and, if necessary, adjust the dose of indirect anticoagulants.

Digoxin

Moxifloxacin and digoxin do not significantly affect each other’s pharmacokinetic parameters. With repeated doses of moxifloxacin, the maximum digoxin concentration increased by approximately 30%, while the area under the concentration-time curve (AUC) and the minimum digoxin concentration did not change.

Activated Carbon

When activated carbon and moxifloxacin are co-administered orally at a dose of 400 mg, the systemic bioavailability of moxifloxacin decreases by more than 80%, as a result of inhibition of its absorption. In case of overdose, the use of activated carbon at an early stage of absorption prevents further increase in systemic exposure.

Glucocorticosteroids

Concomitant use of moxifloxacin and glucocorticosteroids increases the risk of tendinitis and tendon rupture.

How to take, course of administration and dosage

Inside. The tablet should be swallowed whole, without chewing, with a sufficient amount of water, regardless of the meal (preferably after a meal). Do not exceed the recommended dose.

Infection

Dose every 24 hours (1 time per day)

Duration of treatment, days

Community-acquired pneumonia

400 mg

7-14 (intravenous administration followed by oral administration)

In case of exacerbation of chronic bronchitis

400 mg

5-10

Acute bacterial sinusitis

400 mg

7

Uncomplicated skin and soft tissue infections

400 mg

7 Complicated skin and subcutaneous tissue

infections 400 mg

7-21 (intravenous administration followed by oral administration)

Complicated intra-abdominal infections

400 mg

5-14 (intravenous administration followed by oral administration)

Uncomplicated pelvic inflammatory

diseases 400 mg

14

Do not exceed the recommended duration of treatment. No dosage changes required:- in elderly patients; – in patients with impaired liver function (class A, B on the Child-Pugh scale);- in patients with impaired renal function (including those with severe renal insufficiency with creatinine clearance < 30 ml / min/1.73 m2, as well as those on continuous hemodialysis and long-term outpatient peritoneal dialysis);- in patients of different ethnic groups; – the efficacy and safety of moxifloxacin in children and adolescents has not been established.

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.

Description

Pinkish-red color, oval, biconvex, film-coated tablets with a risk. In the fracture, a homogeneous mass from white to light yellow with a greenish tinge of color.

Special instructions

In some cases, hypersensitivity and allergic reactions may develop after the first use of moxifloxacin, which should be immediately reported to the doctor. Very rarely, even after the first administration of moxifloxacin, anaphylactic reactions may 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 initiated immediately.

When using moxifloxacin, some patients may experience prolongation of the QT interval. 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. Older 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 increasing moxifloxacin concentration, 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 experienced any cardiovascular events or deaths associated with prolongation of the QT interval. When using moxifloxacin, the risk of ventricular arrhythmias may increase in patients with conditions predisposing to arrhythmias.

In this regard, moxifloxacin 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 disorders, especially 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 (antiarrhythmic IA (quinidine, hydroquinidine, disopyramide, etc. ) and III (amiodarone, sotalol, dofetidil, ibutilide, etc. ) classes, tricyclic antidepressants, neuroleptics (phenothiazine, pimozide, sertindol, haloperidol, sultoprid, etc. ), antimicrobials (sparfloxacin, erythromycin IV, pentamidine, antimalarial drugs, especially halofantrine), antihistamines (astemizole, terfenadine, mizolastine) and others (cisapride, vincamine IV, bepridil, difemanil).

Moxifloxacin 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 informed that if symptoms of renal failure occur, it is necessary to consult a doctor before continuing treatment with moxifloxacin.

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 to take moxifloxacin.

The use of quinolone drugs is associated with a possible risk of seizures. Moxifloxacin 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 moxifloxacin, 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 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 quinolone therapy, including moxifloxacin, tendinitis and tendon rupture may develop in elderly patients receiving glucocorticosteroids. Cases that occurred within a few months after the end of treatment are described. At the first symptoms of pain or inflammation at the site of injury, the drug should be discontinued to relieve the affected limb.

When using quinolones, photosensitivity reactions are noted. However, during preclinical and clinical studies, as well as the use of moxifloxacin in practice, no photosensitivity reactions were observed. However, patients receiving moxifloxacin should avoid exposure to direct sunlight and ultraviolet light.

Oral administration of moxifloxacin tablets is not recommended in patients with complicated pelvic inflammatory diseases (such as those associated with tubo-ovarian or pelvic abscesses).

It is not recommended to use moxifloxacin for the treatment of infections caused by methicillin-resistant strains of Staphylococcus aureus (MRSA). In the case of suspected or confirmed infections caused by MRSA, treatment with appropriate antibacterial drugs should be prescribed (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 who were treated with moxifloxacin 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 moxifloxacin 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 administration 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 any side effects from the central nervous system develop, including mental disorders, moxifloxacin should be immediately discontinued and appropriate therapy should be initiated. In such cases, it is recommended to switch to therapy with an antibiotic other than fluoroquinolones, if possible. Caution should be exercised when using moxifloxacin in patients with a history of psychosis and/or psychiatric illnesses.

Due to the widespread and growing incidence of infections caused by fluoroquinolone-resistant Neisseria gonorrhoea, patients with pelvic inflammatory diseases should not be treated with moxifloxacin monotherapy, unless the presence of fluoroquinolone-resistant N. Gonorrhabouteae excluded. If it is not possible to exclude the presence of fluoroquinolone-resistant N. Gonorrhoea, it is necessary to decide whether to supplement empirical therapy with moxifloxacin with an appropriate antibiotic that is active against N. Gonorrhoea (for example, cephalosporin).

Dysglycemia

As with other fluoroquinolones, changes in blood glucose concentrations, including hypo – and hyperglycemia, were observed with moxifloxacin. During moxifloxacin therapy, dysglycemia was more likely to occur in elderly patients and patients with diabetes mellitus receiving concomitant therapy with oral hypoglycemic drugs (for example, sulfonylureas) or insulin. When using moxifloxacin in such patients, the risk of hypoglycemia increases, up to hypoglycemic coma. It is necessary to inform patients about the symptoms of hypoglycemia (confusion, dizziness, “wolfish” appetite, headache, nervousness, palpitation or increased pulse, pallor of the skin, perspiration, trembling, weakness). If the patient develops hypoglycemia, it is necessary to immediately stop treatment with moxifloxacin and start appropriate therapy. In these cases, it is recommended to switch to therapy with an antibiotic other than fluoroquinolones, if possible. When conducting treatment with moxifloxacin in elderly patients, in patients with diabetes mellitus, careful monitoring of blood glucose concentration is recommended.

Effects on the ability to drive vehicles, mechanisms

Fluoroquinolones, including moxifloxacin, can interfere with the ability of patients to drive a car 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 400 mg each.5,7 or 10 tablets per Al/PVC blister/PVDC or Al/Al blister.1,2 or 10 blisters with instructions for use in a cardboard pack.

For hospitals: 100,500 or 1000 tablets in a PVC bag, a package with instructions for use in a high-density polyethylene jar.

Storage conditions

Store at a temperature not exceeding 25°C. Keep out of reach of children.

Shelf

life is 5 years. Do not use after the expiration date.

Active ingredient

Moxifloxacin

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Weight

Weight: 20 g.