Simoflox - instructions for use, dose, side effects, contraindications

Composition:Each film-coated tablet contains:
Active substance:
Moxifloxacin hydrochloride (equivalent to 400,000 mg of moxifloxacin) - 437.00 mg.
Excipients:
Lactose monohydrate is 130,000 mg, microcrystalline cellulose is 25,000 mg, povidone (PVP K 30) is 10,000 mg, croscarmellose sodium is 16,000 mg. silicon dioxide colloid - 5,000 mg, talc - 3,000 mg, magnesium stearate - 4,000 mg.
Sheath: Opaprai pink II 85G540021 (polyvinyl alcohol 8,800 mg, lecithin 0.700 mg, macrogol 4000 2.470 mg, titanium dioxide 3,790 mg, talc 4,000 mg, ferric oxide red oxide 0,240 mg) - 20,000 mg.

Description:Oblong biconvex tablets covered with a film membrane, red-brown color, with a transverse separation risk on one side. On the cross-section - the core is light yellow.

Pharmacotherapeutic group:Antimicrobial agent - fluoroquinolone.

ATX: & nbsp

J.01.M.A.14 Moxifloxacin

Pharmacodynamics:Antimicrobial drug group of fluoroquinolones. Has a bactericidal effect.
The mechanism of action is due to the inhibition of bacterial topoisomerase II (DNA gyrase) and topoisomerase IV, which leads to a violation of the synthesis of microbial cell DNA and, as a consequence, to the death of microbial cells.
The minimum bactericidal concentrations of moxifloxacin are generally comparable to its minimum inhibitory concentrations.
Mechanisms that lead to the development of resistance to penicillins, cephalosporins, aminoglycosides, macrolides and tetracyclines do not interfere with the antibacterial activity of moxefloxacin. Cross-resistance between these groups of antibacterial drugs and moxifloxacin is not noted. Plasmid resistance cases have also been observed so far. 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 the minimum inhibitory concentration (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 retain sensitivity to moxifloxacin.
Moxifloxacin in vitro is active against a wide range of gram-negative and gram-positive microorganisms, anaerobes, acid-fast bacteria and atypical bacteria such as Mycoplasma spp.Chlamydia spp., Legionella spp., As well as bacteria resistant to β-lactam and macrolide antibiotics.
To moxifloxacin are sensitive aerobic gram-positive bacteria: Gardnerella vaginalis, Streptococcus pneumoniae (including strains resistant to penicillin and strains with multiple antibiotic resistance), and strains resistant to two or more antibiotics, such as penicillin (minimum inhibitory concentration (MIC) ≥ 2 μg / ml), cephalosporins of the second generation (for example, cefuroxime), macrolides, tetracyclines, trimethoprim / sulfamethoxazole) *, Streptococcus pyogenes (group A) *, Streptococcus milled (Streptococcus angiosus *, Streptococcus constellatus *, Streptococcus intermedins *), Streptococcus viridans (Streptococcus viridans, Streptococcus mutans, Streptococcus mitis, Streptococcus sanguinis , Streptococcus salivarius, Streptococcus thermophilus, Streptococcus constellatus), Streptococcus agalactiae, Streptococcus dysgalactiae, Staphylococcus aureus (sensitive to methicillin strains) *, coagulase-negative staphylococci (Staphylococcus cohnii, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus saprophyticus, Staphylococcus simulans) sensitive methicillin strains.
aerobic gram-negative bacteria: Haemophilus influenzae (including strains producing and non-producing beta-lactamases) *, Haemophilus parainfluenzac *, Moraxclla catarrhalis (including strains producing and non-producing beta-lactamases) *, Bordetella pertussis, Acinetobacter baumanii, Proteus vulgaris.
anaerobic bacteria: Fusobacterium spp., Porphyromonas spp., Prevotella spp., Propionibacterium spp.
Atypical: Chlamydia pneumoniae *, Chlamydia trachomatis *, Mycoplasma pneumoniae *, Legionella pneumophila *, Mycoplasma hominis, Mycoplasma gcnitalium, Coxiella burnettii.
Moderately sensitive:
Aerobic Gram-positive bacteria: Enterococcus faecalis (only strains sensitive to vancomycin and gentamicin) *, Enterococcus avium *, Enterococcus faecium *
Aerobic Gram-negative bacteria: Escherichia coli *^# , Klebsiella pneumoniae *, Klebsiella oxytoca, Citrobacler freundii *, Enterobactcr spp. (Enterobacter aerogenes, Enterobacter intermedius, Enterobactcr sakazakii), Enterobacter cloacae *, Pantoea agglomerans, Pseudomonas fluorescens, Burkholderia cepacia, Stenotrophomonas maltophilia, Proteus mirabilis *, Morganella morganii, Neisseria gonorrhoeae *, Providencia spp. (Providencia rettgeri, Providencia stuartii).
Anaerobic bacteria: Bactcroidcs spp. (Bacteroides lragilis *, Bactcroides distasonis *, Bacteroides thetaiotaomicron *, Bacteroides vulgaris *, Bacteroides ovatus *, Bacteroides uniformis *), Peptostreptococcus spp. *, Clostridium spp. *
* - Sensitivity to moxifloxacin is confirmed by clinical data.
The following microorganisms are resistant to moxifloxacin:
Staphylococcus aureus (methicillin / ofloxacin resistant strains)^#, coagulase-negative Staphylococcus spp. (Methicillin resistant strains of Staphylococcus cohnii, Staphylococcus epidermidis, Staphylococcus hacmolyticus, Staphylococcus hominis, Staphylococcus saprophyticus, Staphylococcus simulans), Pseudomonas aeruginosa.^# - The use of the drug is not recommended for the treatment of infections caused by Staphylococcus aureus strains resistant to methicillin (MRSA). In the case of suspected or confirmed infections caused by MRSA, treatment should be prescribed with appropriate antibacterial drugs.
For certain strains, the spread of acquired resistance may vary depending on the geographical region and over time. In this regard, when testing the sensitivity of the strain, it is desirable to have local information. about resistance, especially when treating severe infections.

Pharmacokinetics:After oral administration, moxifloxation is absorbed quickly and almost completely. Absolute bio-availability is about 91%.
After a single dose of 400 mg of moxifloxacin, the maximum concentration (C_max) is achieved within 0.5-4 hours and is about 3 μg / ml.
Moxifloxation is rapidly distributed in tissues and organs and binds to blood proteins (mainly albumins) by about 45%. The distribution volume is approximately 2 l / kg. High concentrations of moxifloxacin, exceeding those in plasma, are created in lung tissue, in alveolar macrophages, bronchial mucosa, in the mucous membrane of the nasal sinuses, in foci of inflammation (in the contents of blisters in skin lesions). In the interstitial fluid and in saliva, the moxifloxation is determined in a free, non-protein-bound form at a concentration higher than in the plasma. In addition, high concentrations of the drug are determined in the tissues of the abdominal cavity, peritoneal fluid and female genital organs.
After passing the 2nd phase of biotransformation, moxifloxation is excreted from the body by the kidneys, as well as by the intestines both in unchanged form and in the form of inactive sulfo compounds and glucuronides. Moxifloxation is not biotransformed with the cytochrome P450 microsomal system.
The half-life of moxifloxacin is approximately 12 hours. The average total clearance after administration in a dose of 400 mg is from 179 to 246 ml / min. About 22% of a single dose (400 mg) is excreted unchanged by the kidneys, about 26% by the intestine.
Pharmacokinetics in special clinical cases:
Age, Pop and Ethnicity
In studies of the pharmacokinetics of moxifloxacin in men and women, differences in 33% in terms of the area under the pharmacokinetic curve of concentration-time (AUC) and C_max. Absorption of moxifloxacin did not depend on sex. Differences in AUC and C_max were caused more by a difference in body weight than by ion and are not clinically significant.
There were no clinically significant differences in the pharmacokinetics of moxifloxacin in patients of different ethnic groups and ages.
Children
The pharmacokinetics of moxifloxacin in children have not been studied.
Renal insufficiency
There were no significant changes in the pharmacokinetics of moxifloxacid in patients with impaired renal function (including patients with creatinine clearance <30 mL / min / 1.73 m² ) and in patients on continuous hemodialysis and long-term outpatient peritoneal dialysis.
Impaired liver function
The concentration of moxifloxacin in patients with impaired liver function (classes A, B on the Child-Pugh scale) did not differ significantly from that in healthy volunteers or in patients with normal liver function.

Indications:Infectious-inflammatory diseases caused by micro-organisms sensitive to moxifloxacin:
- Acute sinusitis;
- exacerbation of chronic bronchitis;
- Community acquired pneumonia, including CAP pathogens which microorganisms are strains of multidrug resistance to antibiotics *;
- uncomplicated infections of the skin and subcutaneous structures;
- complicated infections of the skin and subcutaneous structures (including an infected diabetic foot);
- complicated intra-abdominal infections, including infections caused by several pathogens, including intraperitoneal abscesses;
- uncomplicated inflammatory diseases of the pelvic organs (including salpingitis and endometritis).
* Streptococcus pneumoniae with multiple resistance to antibacterial drugs include strains resistant to penicillin and strains,resistant to two or more antibiotics from such groups as peicillins (minimum inhibitory concentration ≥ 2 μg / ml), cephalosporins of the second generation (cefuroxime), macrolides, tetracyclines, trimethoprim / sulfamethoxazole.
It is necessary to take into account the current official guidelines on the rules for the use of antibacterial drugs.

Contraindications:- hypersensitivity to moxifloxacin, other quinolones and components of the drug;
- Pregnancy;
- lactation period;
- age up to 18 years;
- damage to the tendons during the previous treatment with quinolones;
- syndrome of congenital or acquired lengthening of the QT interval;
- clinically significant bradycardia, clinically significant heart failure with a lower left ventricular ejection fraction, a history of rhythm disorders accompanied by clinical symptoms;
- simultaneous reception of drugs that extend the QT interval;
- pronounced electrolyte imbalance (uncorrectable hypokalemia);
- severe hepatic insufficiency (Child-Pugh class C) and an increase in the content of transaminases more than five times higher than the upper limit of the norm, due to the limited amount of clinical data.
- Congenital lactose intolerance, lactase deficiency, glucose-galactose malabsorption (since the formulation includes lactose).

Carefully:Convulsive syndrome (in the anamnesis), diseases of the central nervous system predisposing to occurrence of seizures and lowering the threshold of convulsive activity; in patients with psychoses and psychiatric illnesses in the anamnesis; in patients with potentially proarrhythmic conditions (especially in women and elderly patients), such as acute myocardial ischemia and cardiac arrest; with cirrhosis of the liver; myasthenia gravis; with the simultaneous administration of drugs that reduce the concentration of potassium; deficiency of glucose-6-phosphate dehydrogenase.

Dosing and Administration:The recommended dosage regimen of Simoflox is 400 mg (1 tablet) once a day. Hc should be exceeded the recommended dose. The tablet should be swallowed whole, not liquid, squeezed with enough water, regardless of food intake.
Duration of therapy.
The duration of treatment is determined by the localization and severity of the infection, as well as 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 stepwise therapy with moxifloxacin (intravenous administration followed by oral administration) is 7-14 days.
Complicated infections of the skin and subcutaneous structures: the total duration of stepwise therapy with moxifloxacin (intravenous administration followed by oral administration) is 7-21 days.
Complicated intra-abdominal infections: the total duration of stepwise therapy with moxifloxacin (intravenous administration followed by oral administration) is 5-14 days.
Uncomplicated infections of the pelvic organs: 14 days.
Do not exceed the recommended duration of treatment.
Elderly patients
Changes in the dosing regimen in elderly patients are not required.
Impaired liver function
Patients with impaired liver function (class A, B but Child-Pugh) do not need to change the dosing regimen.
Renal insufficiency
In patients with impaired renal function (including with creatinine clearance <30 ml / min), as well as in patients on continuous hemodialysis and long-term outpatient peritoneal dialysis, changes in the dosing regimen are not required.

Side effects:Undesirable reactions listed in the "frequently" group occurred at a frequency below 3%, with the exception of nausea and diarrhea. In each frequency group, undesirable drug reactions are listed in order of decreasing significance. The frequency is determined as follows: often (from ≥ 1/100 to <1/10), infrequently (from ≥1 / 1000 to <1/100), rarely (from ≥ 1/10 000 to <1/1000), very rarely (<1/10 000).

Systems of organs	Often	Infrequently	Rarely	Rarely
Infectious and parasitic diseases	Fungal superinfections
On the part of the hematopoiesis system		Anemia Leukopenia Hettropenia ThrombocytoPthe Thrombocytosis Prothrombol extensioninThe increase in the international standardized ratio (INR)	Change in the concentration of thromboplastin	Increase in prothrombin concentration / decrease in INR
From the immune system		Allergic reactions Itching Rash Hives EosiMr.officilia	Anaphylactic / aMr.affilactoid reactions Angioedema, including laryngeal edema (potentially life-threatening)	Anaphylactic / anaphylactoid shock (including potentially life-threatening).
From the side of metabolism		Hyperlipidemia	Hyperglycaemia Hyperuricemia	Hypoglycaemia
Mental disorders		Anxiety Psychomotor hyperreactivityMr.awn / agitationandI	Emotional lability Depression (in very rare cases, behavior with a tendency to self-extinguisherailwayesuch as suicidal ideation or suicide attempts) Hallucinations	Depersonalizedand I Psychotic reactions (potentially manifested in behavior with a tendency to self-harm, such as suicidal thoughts or suicidal attempts)
From the nervous system	Headache Dizzinesse	Paresthesia / Dysaesthesia Disturbance of taste is sensitiveart.and (including in very rare cases, agevia) Confusion and disorientation Vertigo Drowsiness Tremor Sleep Disorders	Hypesesia Abnormalities of smell (including anosmia) Atypical dreams Disturbance of coordination (including gait disturbance due to dizziness or vertigo, in very rare cases leading to trauma from falling, especially in elderly patients) Seizures with various clinical manifestations (including "grand mal" seizures) Violations of attention Violations of speech Amnesia Peripheral neuropathy and polyneuropathy	Diperesthesia
From the side of the organ of vision		Visual disturbances (especially in reactions from the central nervous system (CNS))		Transient loss of vision (especially with CNS reactions).
From the side of the hearing organ and labyrinthine disorders			Noise in ears Deterioration of hearing, including deafness (usually reversible)
From the side of the cardiovascular system	Elongation of the QT interval in patients with concomitant hypokalemiamission	QT interval extension Heart palpitations	Ventricular tachyarrhythmias Fainting Increase blood pressure Reduction of arterial pressures	Nonspecific arrhythmias Polymorphic ventricular tachycardia (Torsade de pointes) Heart failure (mainly in people with predisposing to arrhythmias, such as clinically significant bradycardia, acute myocardial ischemia)
On the part of the respiratory system, the organs of the thorax and the mediastinum		Shortness of breath (including asthmatic condition)
From the gastrointestinal tract	Nausea Vomiting Stomach ache Diarrhea	Reduced appetite and reduced food intake Constipation Dyspepsia Flatulence Gastroenteritis (other than erosive gastroenteritis) Increase activity of amylase	Dysphagia Stomatitis Pseudomembranous colitis (in very rare cases associated with life-threatening complications)
From the liver and biliary tract	Increased activity of "liver" transaminases	Dysfunction of the liver (including increased activity of lactate dehydrogenase) Increased bilirubin concentration Increase in activity of gamma glutamyl transferase Increase in blood activity of alkaline phosphatase	Jaundice Hepatitis (predominantly cholestatic)	Fulminant hepatitis, potentially leading to life-threatening hepatic insufficiency (including fatal cases)
From the skin and soft tissues				Bullous skin reactions, for example, Stevens-Johnson syndrome or toxic epidermal nerabies (potentially life-threatening).
From the side of skeletal-muscular and connective tissue		Arthralgia Myalgia	Tendonitis Increased muscle tone and cramps Muscle weakness	Tendon tendons Arthritis Violation of the gait due to damage to thePOrno-engineTheth system Increased myasthenia gravis symptoms gravis
From the side of the urinary tract		Dehydration (caused by diarrhea or decreased fluid intake)	Renal impairment Renal failure due to dehydration, which can lead to kidney damage, especially in elderly patients with pre-existing impaired renal function)
General disorders and injuries at the site of administration		General malaise NonspecificI'm a pain Sweating

The frequency of development of the following adverse reactions was higher in the group receiving stepwise therapy (intravenous administration of moxifloxacin followed by oral administration):
Often: increased activity of gamma glutamyl transferase
Infrequent: ventricular tachyarrhythmias, lowering of arterial pressure, edema, pseudomembranous colitis (in very rare cases associated with life-threatening complications), seizures with various clinical manifestations (including "grand mal" seizures), hallucinations, renal dysfunction, renal insufficiency (as a result of dehydration, which can lead to kidney damage, especially in elderly patients with pre-existing impaired renal function).

Overdose:There are limited data on the overdose of moxifloxacin.In case of an overdose, one should be guided by the clinical picture and carry out symptomatic maintenance therapy with ECG monitoring. The use of activated carbon immediately after taking the drug can help prevent excessive systemic effects of moxefloxaia in cases of overdose.

Interaction:

When combined with atenolol, ranigidine, calcium-containing additives, theophylline, cyclosporine, oral contraceptives, glibenclamide, itraconazole, digoxin, morphine, probenecid (no clinically significant interaction with moxifloxacin was confirmed), dose adjustment is not required.

Drugs that extend the RT interval.

It should be taken into account the possible additive effect of lengthening the interval QT moxifloxacin and other drugs that affect the lengthening of the interval QT. Due to the combined use of moxifloxacin and drugs that affect the lengthening of the interval QT, the risk of developing ventricular arrhythmia increases, including polymorphic ventricular tachycardia (Torsade de pointes).

Contraindicated the joint use of moxifloxacin with the following drugs,affecting the lengthening of the interval QT:

- Antiarrhythmic drugs class IA (quinidip, hydroquinidine, disopyramide, etc.);

Antiarrhythmic drugs of class III (amiodarone, sotalol, dofetilide, ibutilide, etc.);
Neuroleptics (phenothiazine, pimozide, sertindole, haloperidol, sultopride, etc.);
Tricyclic antidepressants;
Antimicrobials (sparfloxacin, erythromycin for intravenous administration, pentamidine, antimalarial drugs, especially halofantrine);
Antihistamines (terfenadine, astemizole, misolastine);
Others (cisapride, wincamine for intravenous administration, bepridil, difemanyl).

Antacid preparations, multivitamins and minerals

The use of moxifloxacin concomitantly with antacids, multivitamins and minerals can lead to impaired moxifloxacin absorption due to the formation of chelate complexes. As a result, the concentration of moxifloxacin in the blood plasma may be significantly lower than desired. In this regard, antacid preparations, antiviral (HIV) agent (didanosine), preparations containing vitamins, magnesium, aluminum, iron or zinc salts, sucralfate should be taken at least 4 hours before or 4 hours after ingestion of moxifloxacin.

Warfarin

When combined with warfarin prothrombin time and other parameters of blood coagulation do not change.

Change the value of INR. In patients who received anticoagulants in combination with antibacterial drugs, including moxifloxacin, there are cases of increased anticoagulant activity of anticoagulants. Risk factors are the presence of an infectious disease (and concomitant inflammatory process), the age and general condition of the patient. Although the interaction between moxifloxacin and warfarin has not been revealed, in patients receiving concomitant treatment with these drugs, it is necessary to monitor the IMO and, if necessary, adjust the dose of indirect anticoagulants.

Digoxin

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

Activated carbon

With the simultaneous use of activated carbon and moxifloxacin, the systemic bioavailability of moxifloxacin is reduced by more than 80% as a result of inhibition of its absorption.

Dairy products and food intake

Absorption of moxifloxacin does not change with simultaneous intake of food (including dairy products).

With the simultaneous use of the drug Simoflox and glucocorticosteroids, the risk of developing tendovaginitis and rupture of the tendon increases.

Special instructions:

In some cases, after the first use of the drug may develop hypersensitivity and allergic reactions, which should immediately inform the doctor. Very rarely even after the first use of the drug, anaphylactic reactions can progress to a life-threatening anaphylactic shock. In these cases, the treatment with moxifloxacin should be discontinued and immediately begin the necessary medical measures (including anti-shock).

With the use of moxifloxacin in some patients, lengthening of the interval QT. Because women have a longer interval than men QT, they may be more sensitive to drugs that extend the interval QT. Elderly patients are also more prone to the effects of drugs that affect the interval QT. Degree of lengthening interval QT may increase with increasing drug concentration, therefore, do not exceed the recommended dose. However, in patients with pneumonia, the correlation between the concentration of moxifloxacin in the blood plasma and the lengthening of the interval QT was not noted. Interval lengthening QT is associated with an increased risk of ventricular arrhythmias, including polymorphic ventricular tachycardia. None of the 9,000 patients who received moxifloxacin, there were no cardiovascular complications and lethal cases associated with lengthening the interval QT.

With the use of moxifloxacin, the risk of developing ventricular arrhythmias in patients with predisposing arrhythmias may increase. Concerning moxifloxacin contraindicated in:

- Changes in the electrophysiological parameters of the heart, expressed in lengthening the interval QT: Congenital or acquired documented lengthening interval QT, electrolyte disorders, especially uncorrected hypokalemia, clinically significant bradycardia; clinically significant heart failure with a reduced fraction of the left ventricular ejection; in the presence of a history of rhythm disturbances, accompanied by clinical symptoms (since the risk of developing lengthening of the interval can not be ruled out QT;

- Use with other drugs that extend the interval QT (see the section "Interaction with other medicinal products").

The drug should be used with caution in patients with potentially proarrhythmic conditions (especially in women and elderly patients), such as acute myocardial ischemia and cardiac arrest; in patients with cirrhosis of the liver (since this category of patients can not exclude the risk of developing an extension of the interval QT).

When moxifloxacin was used, cases of fulminant hepatitis, potentially leading to hepatic insufficiency (including fatal cases) were reported (see "Side effect"). The patient should be informed that if symptoms of hepatic insufficiency (anorexia, jaundice, darkening of the urine, pruritus, abdominal pain) appear, you should consult your doctor before continuing with moxifloxacin.

When moxifloxacin was used, cases of developing bullous skin lesions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, were reported. The patient should be informed that in case of symptoms of skin or mucous membrane damage, the doctor should be consulted before continuing with moxifloxacin.

The use of drugs quinolone series is associated with a possible risk of seizures. Moxfloxacin should be used with caution in patients with CNS diseases and disorders of the CMS, predisposing to the occurrence of seizures or reducing the threshold of convulsive activity.

The use of broad-spectrum antibacterial drugs, including moxfloxacin, is associated with a risk of developing pseudomembranous colitis. This diagnosis should be kept in mind in patients who have severe diarrhea with moxifloxacin. In this case, immediate therapy should be prescribed. Drugs that inhibit the peristalsis of the intestine are contraindicated in the development of severe diarrhea.

Moxifloxacin should be used with caution in patients with myasthenia gravis gravis in connection with a possible exacerbation of the disease.

Against the background of quinolone therapy, including moxifloxacin, tendonitis and tendon rupture are possible, especially in the elderly and patients receiving glucocorticosteroids. Cases which have arisen within several months after the end of treatment are described. At the first symptoms of pain or inflammation at the site of damage, the drug should be stopped and unloaded.

If there is a violation of the vision, consultation of the ophthalmologist is necessary.

When applying quinolones, photosensitivity reactions are noted. However, during pre-clinical and clinical studies, as well as with the use of moxifloxacid, no photosensitivity reactions were observed in practice. However, patients who use moxifloxacin, should avoid exposure to direct sunlight and ultraviolet light.

It is not recommended to use moxifloxacin for the treatment of infections caused by strains Staphylococcus aureus, resistant to methicillin (MRSA). In the case of suspected or confirmed infections caused by MRSA, should be prescribed treatment with appropriate antibacterial drugs.

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).

The ability of moxifloxacid to inhibit the growth of mycobacteria can cause interaction in vitro moxifloxacid with a Mycobacterium spp., leading to false-negative results in the analysis of samples of patients 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, are described and lead to paresthesia of gyrostatic, dysesthesia and weakness. Symptoms may appear immediately after application and be irreversible. Patients undergoing treatment with moxifloxacin should be warned about the need to seek immediate medical attention in the event of symptoms of neuropathy, including pain, burning, tingling,numbness and / or weakness or other sensitivity disorders, including tactile, pain, temperature, vibration sensitivity and a sense of position (see "Side effect"), Moxifloxacin must be immediately canceled.

Reactions from the psyche 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 suicidal attempts (see section "Side effect"). In case of development of such reactions in patients it is necessary to cancel moxifloxacin and take the necessary measures. Caution should be exercised in prescribing moxifloxacin to patients with psychoses and patients with psychiatric illnesses in the anamnesis.

Because of the wide spread and growing incidence of infections caused by fluoroquinolone-resistant Neisseria gonorrhoeae In the treatment of patients with inflammatory diseases of the pelvic organs, ns should be administered monotherapy with moxifloxacin. Except where the presence of a resistant to fluoroquinolones Neisseria gonorrhoeae excluded.If there is no way to exclude the presence of fluoroquinolones resistant Neisseria gonorrhoeae, it is necessary to resolve the issue of supplementing empirical therapy with moxifloxacin, an appropriate antibacterial drug that is active against Neisseria gonorrhoeae.

As in the case of other fluoroquinolones, the use of moxifloxacin showed a change in the concentration of glucose in the blood, including hypo- and hyperglycemia. Against the background of the use of moxifloxacin, the dysentery appeared mainly in elderly patients with diabetes mellitus, receiving concomitant therapy with oral hypoglycemic drugs (for example, sulfonylureas) or insulin. When performing treatment in patients with diabetes, careful monitoring of the concentration of glucose in the blood is recommended.

Effect on the ability to drive transp. cf. and fur:

Fluoroquinolones, including moxifloxacin, can disrupt the ability of patients to drive a car and engage in other potentially dangerous activities requiring increased attention and speed of psychomotor reactions, due to the effects on the central nervous system and visual impairment.

Form release / dosage:Tablets, film-coated, 400 mg.

Packaging:For 5, 7 or 10 tablets in a blister made of polyvinyl chloride film and aluminum foil.
1 blister for 5 tablets, 7 tablets or 10 tablets in a cardboard box along with instructions for use.

Storage conditions:In a dry, protected from light place at a temperature of no higher than 25 ° C.
Keep out of the reach of children.

Shelf life:2 years.
Do not use the drug but expiration date indicated on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-002936

Date of registration:01.04.2015

Expiration Date:01.04.2020

The owner of the registration certificate: Simpex Pharma Pvt Ltd. Simpex Pharma Pvt Ltd. India

Manufacturer: & nbsp

SIMPEX PHARMA, Pvt. Ltd. India

Representation: & nbspKORAL-MED, CJSCKORAL-MED, CJSC

Information update date: & nbsp2016-10-28

Illustrated instructions

Instructions

SimoFlox (Simofloks)