Moflaxia pills 400mg, 7pcs

Composition

1 film-coated tablet contains:

Core:

Active ingredient:

moxifloxacin hydrochloride 454.75 mg, equivalent to moxifloxacin 400.00 mg;

auxiliary substances:

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, the causative agents of which are strains of microorganisms with multiple resistance to antibiotics*;

– complicated infections of the skin and subcutaneous structures (including infected diabetic foot);

– complicated intraabdominal infections, including polymicrobial infections, including intraperitoneal abscesses;

– uncomplicated inflammatory diseases of the pelvic organs (including salpingitis and endometritis).

*Streptococcus pneumoniae with multiple antibiotic resistance include strains resistant to penicillin and strains resistant to two or more antibiotics from groups such as penicillins (at MIC ≥ 2 mcg/ml), cephalosporins of the second generation, macrolides, tetracyclines and trimethoprim/sulfamethoxazole. It is necessary to take into account the current official guidelines on the rules for the use of antibacterial agents.

Use during pregnancy and lactation

Pregnancy The safety of using moxifloxacin during pregnancy has not been established, therefore its use is contraindicated. Cases of reversible joint injuries in children receiving some quinolones are described, however, the manifestation of this effect in the fetus has not been reported (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. The period of breastfeeding In preclinical studies has been established, 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, other quinolones or any other component of the drug;

– age up to 18 years;

– pregnancy and breastfeeding;

– a history of tendon pathology developed as a result of treatment with quinolone antibiotics;

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

– moxifloxacin cannot be used with other drugs that prolong the interval of QT;

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

With caution:

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

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

– use in patients with potentially proarrhythmic conditions (especially in women and elderly patients), such as acute myocardial ischemia and cardiac arrest;

– use in patients with cirrhosis of the liver;

– myasthenia gravis;

-simultaneous use with drugs that reduce potassium content;

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

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) were obtained from clinical studies and post-marketing reports;(in italics). The adverse reactions listed in the “frequently” group occurred with a frequency below 3%, except for nausea and diarrhea.

The frequency was classified as follows: often (from ≥ 1/100 to 1/10), infrequently (from ≥ 1/1000 to 1/100), rarely (from ≥ 1/10000 to 1/1000), very rarely (; 1/10000).

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

The possible additive effect of prolonging the QT interval of moxifloxacin and other drugs that affect the prolongation of the QT interval should be taken into account. Concomitant use of moxifloxacin and drugs that affect the prolongation of the QT interval increases the risk of ventricular arrhythmia, including polymorphic ventricular tachycardia.

Contraindicated concomitant use of moxifloxacin with the following drugs affecting QT interval prolongation:

– antiarrhythmic drugs of class IA (quinidine, gedragingen, disopyramide, etc. );

– anti-arrhythmic drugs class III (amiodarone, sotalol, dofetilide, ibutilide, etc. );

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

– tricyclic antidepressants;

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

– antihistamines (terfenadine, astemizole, mizolastine);

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

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, prothrombin time and other blood clotting parameters do not change.

Changing the INR value

In 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.

Digoxin

Moxifloxacin 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 Carbon

With the simultaneous use of activated carbon and moxifloxacin at a dose of 400 mg orally, the systemic bioavailability of moxifloxacin decreases by more than 80% as a result of a decrease in its 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 it, 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 duratAs 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 mechanisms:Fluoroquinolones, including moxifloxacin, can interfere with 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.

Shelf

life is 2 years. Do not use the product after the expiration date.

Active ingredient

Moxifloxacin

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

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