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

Antibacterial drug of the 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 disruption in the synthesis of DNA from the microbial cell.

In vitro, the drug is active against a wide range of gram-negative and gram-positive bacteria, anaerobic, acid-fast and atypical bacteria. Effective against bacteria resistant to beta-lactam and macrolide antibiotics.

To moxifloxacin are sensitive Gram-positive bacteria: Enterococcus faecalis, Staphylococcus aureus (including strains sensitive to msticillin), Streptococcus anginosus, Streptococcus constellatus, Streptococcus pneumoniae (including strains resistant to penicillin and macrolides), Streptococcus pyogenes (group A);

Gram-negative bacteria: Enterobacter .cloacae, Escherichia coli, Haemophilus influenzae (including strains producing and not producing beta-lactamase), Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella.catarrhalis (including strains producing beta-lactamase), Proteus mirabilis;

anaerobic bacteria: Bacteroides fragilis, Bacteroides thetaiotaomicronron, Clostridium perfringens, Peptostreptococcus species;

also Chlamydia pneumoniae, Mycoplasma pneumoniae.

According to in vitro studies on moxifloxacin are also sensitive:

aerobic gram-positive bacteria: Staphylococcus epidermidis, Streptococcus agalactiae, Streptococcus group of viridans;

aerobic gram-negative bacteria: Citrobacter freundii, Klebsiella oxytoca, Legionella pneumophila;

anaerobic bacteria: Fusobacterium species, Prevotella species.

There is no cross-resistance with penicillins, cephalosporins, aminoglycosides, macrolides and tetracyclines. The overall incidence of resistance is low. In vitro studies have shown that resistance to moxifloxacin develops slowly as a result of a number of consecutive mutations. Between drugs from the group of fluoroquinolones cross-resistance develops. However, some Gram-positive and anaerobic microorganisms resistant to other fluoroquinolones are susceptible to moxifloxacin.

Pharmacokinetics:

After oral administration moxifloxacin almost completely absorbed. Bioavailability is about 90%. After a single dose of moxifloxacin 400 mg, the maximum concentration in the blood is reached within 0.5-4 h and is 3.1 mg / l. Eating does not affect the absorption of moxifloxacin.

The binding of moxifloxacin to plasma proteins (mainly albumins) is 40%. Moxifloxacin quickly distributed in tissues and organs. High concentrations of moxifloxacin are created in lung tissue, bronchial mucosa, nasal sinuses, alveolar macrophages, in female genital organs. In the interstitial fluid and in the saliva, the drug is determined at concentrations higher than in the plasma.

Moxifloxacin biotransformation and excreted by the kidneys and the gastrointestinal tract, both unchanged and as inactive sulpho compounds and atsetilglyukuronida. The half-life is approximately 12 hours. Moxifloxacin It is not metabolized by microsomal hepatic enzymes of the cytochrome P450 system.

Pharmacokinetics in special clinical cases:

There are no differences in pharmacokinetic parameters of moxifloxacin depending on age and sex.Studies of the pharmacokinetics of moxifloxacin in children have not been conducted.

No significant changes in the pharmacokinetics of moxifloxacin with impaired renal function (creatinine clearance at below 30 ml / min / 1.73 m²) and liver.

Indications:

Infectious-inflammatory diseases caused by microorganisms sensitive to the preparation:

- Acute sinusitis;

- exacerbation of chronic bronchitis;

- community-acquired pneumonia;

- skin and soft tissue infections;

- complicated intra-abdominal infections;

uncomplicated inflammatory diseases of the pelvic organs.

Contraindications:

- Pregnancy;

- lactation period;

- Children and adolescence (up to 18 years);

- hypersensitivity to moxifloxacin and preparations of the quinolone series;

- epilepsy;

severe diarrhea;

- lactose intolerance, lactase deficiency, glkozo-galactose malabsorption.

Carefully:Writhing syndrome (history), hepatic failure (class C Child-Pugh), lengthening QT interval; bradycardia, myocardial ischemia, simultaneous drug prolonging the interval QT (incl, antiarrhythmic drugs of class Ia, II, III,tricyclic antidepressants, neuroleptics), myasthenia gravis, hypokalemia; in patients on hemodialysis (insufficient experience of application); pseudomembranous colitis; simultaneous reception of glucocorticosteroids, deficiency of glucose-6-phosphate dehydrogenase.

Dosing and Administration:

The drug is prescribed for adults to 400 mg (1 tab) 1 time per day. Tablets should be taken without chewing, squeezed with enough water, regardless of food intake. Duration of use depends on the type of infection: exacerbation of chronic bronchitis - 5 days, community-acquired pneumonia - 10 days, acute sinusitis - 7 days, uncomplicated skin and soft tissue infections - 7 days, complicated skin and soft tissue infections -7-21 days, complicated intra-abdominal infection - 5-14 days, uncomplicated inflammatory diseases of the pelvic organs - 14 days.

It is not necessary to change the dosage regimen in elderly patients.

Patients with impaired renal function (including those with a QC less than 30 ml / min) or liver function (classes A and B on the Child-Pugh scale) do not need to change the dosage regimen. Patients on hemodialysis and peritoneal dialysis also do not need a change in the dosing regimen.

Side effects:

Allergic reactions: urticaria, rash, itching, anaphylactic / anaphylactoid reactions: angioedema, including facial edema, larynx (potentially life-threatening), Stevens-Johnson syndrome, anaphylactic shock.

From the digestive system: abdominal pain, nausea, vomiting, diarrhea, increased activity of "liver" transmissions, flatulence, constipation, lack of appetite, stomatitis, glossitis, transient disorder, liver function, discoloration, pseudomembranous colitis, hepatitis.

From the nervous system: headache, dizziness, insomnia or drowsiness, increased muscle tone, impaired coordination of movements, agitation, amnesia, paresthesia, emotional lability, speech disorders, attention disturbances, convulsions, confusion, depression.

From the sense organs: visual impairment (blurred vision, reduced visual acuity), loss of taste sensitivity, tinnitus, impaired sense of smell.

From the cardiovascular system: prolongation of the QT interval (often in patients with concomitant hypokalemia), ventricular tachyarrhythmias, increased and decreased blood pressure, chest pain, fainting, vasolidation (blood flushes to the face),polymorphic ventricular tachycardia, cardiac arrest (predominantly in persons with predisposing arrhythmias, such as clinically significant bradycardia, acute myocardial ischemia).

From the respiratory system: shortness of breath, asthmatic condition.

From the musculoskeletal system: arthralgia, tendonitis, back pain, leg pain, arthritis, tendon ruptures.

From the genitourinary system: vaginal candidiasis, vaginitis, abdominal pain, facial edema, peripheral edema, impaired renal function.

Laboratory indicators: leukopenia, leukocytosis, increased prothrombin time, eosinophilia, thrombocytosis, increased activity of gamma-glutamintransferase, amylase, bilirubin, decreased thromboplastin concentration, decreased prothrombin time, thrombocytopenia, anemia, hyperglycemia, hyperlipidemia, hyperuricemia, increased lactate dehydrogenase activity, alkaline phosphatase.

Other: candidiasis, general discomfort, asthenia, sweating.

Overdose:In case of acute overdose, it is necessary to rinse the stomach. Such patients are recommended to conduct ECG monitoring in connection with possible prolongation of the QT interval.Patients should be carefully examined and receive appropriate treatment: adequate hydration, intake of activated charcoal inside, symptomatic therapy.

Interaction:

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

Ranitidine reduces the absorption of moxifloxacin.

Antacids, sucralfate, minerals, multivitamins and other preparations containing salts of magnesium, aluminum, iron, zinc impair absorption and reduce the concentration of moxifloxacin in plasma. These drugs should be taken 4 hours before or 2 hours after using moxifloxacin.

Preparations containing calcium, slightly reduce the rate of absorption of moxifloxacin.

It slightly changes the pharmacokinetic parameters of digoxin and atenolol.

Does not interact with probenecid, warfarin, oral hormonal contraceptives, theophylline, glibenclamide, morphine, itraconazole. Simultaneous use with other quinolones increases the risk of prolonging the QT interval.

Special instructions:

During treatment with moxifloxacin, inflammation and tendon rupture may develop,in particular in elderly patients and in patients receiving glucocorticosteroids in parallel. At the first signs of pain or inflammation of the tendons, patients should stop the treatment and immobilize the affected limb.

There is a direct relationship between an increase in the concentration of moxifloxacin and an increase in the QT interval (risk of developing ventricular arrhythmias, including torsades des pointes). Therefore, the recommended dose (400 mg / day) should not be exceeded.

In the case of severe diarrhea against the background of moxifloxacin treatment, the drug should be discontinued.

The drug does not have a photosensitizing effect, however, during the treatment with the drug, it is recommended to avoid ultraviolet irradiation including. direct sunlight.

Effect on the ability to drive transp. cf. and fur:The drug may interfere with the patient's ability to engage in potentially hazardous activities requiring increased attention and rapid psychomotor reactions.

Form release / dosage:Film-coated tablets,. 400 mg.

Packaging:5 tablets in a strip of aluminum foil. On 1 strip together with the instruction for use is placed in a pack of cardboard.

Storage conditions:

In a dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-001385/10

Date of registration:25.02.2010

Expiration Date:Unlimited

The owner of the registration certificate:McLeodz Pharmaceuticals Co., Ltd. McLeodz Pharmaceuticals Co., Ltd. India

Manufacturer: & nbsp

MACLEODS PHARMACEUTICALS, Ltd. India

Representation: & nbspMcLeodz Pharmaceuticals Co., Ltd.McLeodz Pharmaceuticals Co., Ltd.India

Information update date: & nbsp11.06.2018

Illustrated instructions

Instructions

Mossimak (Moximac)