Rotomox, 400 mg 5 pcs

An antimicrobial agent of the group of fluoroquinolones, acts bactericidally. It is active against a wide range of Gram-positive and Gram-negative microorganisms, anaerobic, acid-resistant and atypical bacteria: Mycoplasma spp., Chlamydia spp., Legionella spp.

Effective against bacterial strains resistant to beta-lactams and macrolides.

Active against most strains of microorganisms: Gram-positive – Staphylococcus aureus (including strains insensitive to methicillin), Streptococcus pneumoniae (including strains resistant to penicillin and macrolides), Streptococcus pyogenes (group A); gram-negative – Haemophilus influenzae (including both beta-lactamase producing and non-producing strains), Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis (including both beta-lactamase producing and non-producing strains), Escherichia coli, Enterobacter cloacae; atypical – Chlamydia pneumoniae, Mycoplasma pneumoniae.

Indications

Infections of the upper and lower respiratory tracts: acute sinusitis, exacerbation of chronic bronchitis, community-acquired pneumonia; skin and soft tissue infections.

Active ingredient

Composition

One tablet contains:

Active ingredient:

Moxifloxacin hydrochloride 436.80 equivalent to moxifloxacin 400.00 mg.

Auxiliary substances:

Corn starch 188.46 mg,

sodium methyl parahydroxybenzoate 0.015 mg,

microcrystalline cellulose 55.00 mg,

/p>

talc 7.00 mg,

silicon dioxide colloid 4.00 mg,

/p>

magnesium stearate 14.00 mg,

sodium carboxymethyl starch 24.00 mg.

Composition of the shell:

Opaglass (60.0% shellac, 25.0% carnauba wax, 10.0% ethanol, 5.0% beeswax) – 0.035 mg; Opadray pink (polyvinyl alcohol 58.0%, talc 3.0%, titanium dioxide 30.0%, macrogol 6.3%, lecithin 1.7%, iron oxide red dye 1.0%) -0.70 mg.

How to take, the dosage

Intravenously, 400 mg of Rotomox once a day.

The course of treatment with Rotomox in exacerbation of chronic bronchitis is 5 days, outpatient pneumonia – 10 days, acute sinusitis, skin and soft tissue infections – 7 days.

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Interaction

The simultaneous use of moxifloxacin and glucocorticosteroids increases the risk of tenosynovitis and tendon rupture.

No dosing regimen correction is required when concomitant use with atenololol, ranitidine, calcium supplements, theophylline, oral contraceptives, glibenclamide, itraconazole, digoxin, morphine, probenecid.

Antacids, multivitamins and minerals
Moxifloxacin concomitantly with antacids, multivitamins and minerals can lead to malabsorption of moxifloxacin due to the formation of chelate complexes. In this regard, antacids, preparations containing vitamins, magnesium, aluminum, iron or zinc salts, sucralfate should be taken at least 4 hours before or 4 hours after oral administration of moxifloxacin.

Warfarin

When combined with warfarin, prothrombin time and other parameters, blood clotting are not changed. However, in patients receiving concomitant treatment with these drugs, INR (international normalized ratio) should be monitored and the dose of oral anticoagulants should be adjusted if necessary.

Digoxin

Moxifloxacin and digoxin have no significant effect on the pharmacokinetic parameters of each other. When repeated doses of moxifloxacin were administered, the maximum concentration of digoxin was increased. by approximately 30%, and the minimum concentration of digoxin was unchanged.

Activated charcoal

When activated charcoal and moxifloxacin are administered orally simultaneously, the systemic bioavailability of moxifloxacin is reduced by more than 80% due to inhibition of its absorption.

Dairy products and food intake

Absorption of moxifloxacin is not altered by simultaneous intake of food (including dairy products).

Drugs prolonging the Q-T interval

Potential interactions of moxifloxacin, leading to prolongation of the Q-T interval due to the risk of additive action: with drugs that prolong the Q-T interval (including antiarrhythmic drugs).including antiarrhythmic drugs of class IA, III tricyclic and tetracyclic antidepressants, neuroleptics, macrolides, antifungal agents, imidazole derivatives, cisapride).

Special Instructions

In some cases, after the first use of the drug allergic reactions of varying severity may develop. In these cases, the use of moxifloxacin should be cancelled and the necessary medical measures should be taken.

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

When using moxifloxacin some patients may show prolongation of the Q-T interval. Since women, compared to men, have a longer interval, they may be more sensitive to the drugs prolonging the Q-T interval. Older patients are also more susceptible to the effects of drugs prolonging the Q-T interval.

There is a direct correlation between the increased concentration of moxifloxacin and the increase in the QT interval (the risk of ventricular arrhythmias, including torsade de pointes). Consequently, the recommended dose (400 mg/day) should not be exceeded.

Moxifloxacin should be avoided for patients with diagnosed prolongation of Q-T interval, patients with significant bradycardia, significant heart failure with reduced left ventricular ejection fraction, ventricular arrhythmias (with a history of quinolones), as well as patients who are using antiarrhythmic drugs of class IA, III, patients with uncorrected hypokalemia.

Due to the risk of additive effect on the Q-T interval moxifloxacin should be used with caution in conjunction with drugs that prolong the Q:T interval (including tricyclic drugs and therapeutic agents).including tricyclic and tetracyclic antidepressants, neuroleptics, macrolides, antifungal drugs, imidazole derivatives, cisapride), patients with myocardial ischemia, women and elderly patients with diseases accompanied by the risk of ventricular arrhythmias, electrolyte imbalances (e.g. hypokalemia, hypomagnesemia).

The use of broad-spectrum antimicrobial agents, including moxifloxacin involves the risk of pseudomembranous colitis. This diagnosis should be kept in mind for patients who have severe diarrhea during treatment with moxifloxacin. In this case the drug should be cancelled and appropriate therapy should be prescribed. The drugs inhibiting intestinal peristalsis are contraindicated in the development of severe diarrhea.

The cases of fulminant hepatitis development potentially leading to liver failure were reported during the use of moxifloxacin.

The use of quinolone medicines is associated with a possible risk of seizures. When concomitant use of moxifloxacin with nonsteroidal anti-inflammatory drugs the risk of seizures increases. Moxifloxacin should be used with caution in patients with myasthenia gravis due to the possible exacerbation of the disease.

The drug has no photosensitizing effect, however, during the treatment by the drug it is recommended to avoid ultraviolet irradiation, including direct sunlight.

Influence on the ability to drive vehicles and machines:

The drug may impair the patient’s ability to perform potentially hazardous activities requiring increased attention and quick psychomotor reactions.

Contraindications

Children and adolescents under 18 years of age, pregnancy, lactation (breastfeeding period), hypersensitivity to Rotomox. tablets Rotomox are prescribed with caution in epilepsy syndrome (including anamnesis), epilepsy, hepatic failure, QT interval prolongation syndrome.

Side effects

Digestive system disorders: Abdominal pain, nausea, .vomiting, diarrhea, increased activity of “liver” transaminases, flatulence, constipation, lack of appetite, stomatitis, glossitis, transient liver dysfunction, tongue color changes, jaundice, gastroenteritis, pseudomembranous colitis, hepatitis (mostly cholestatic), fulminant hepatitis.

Inner nervous system: Headache, pain, dizziness, insomnia or drowsiness, abnormal dreams; hallucinations, anxiety, increased muscle tone, impaired movement coordination, agitation; amnesia, paraesthesia, hypoesthesia, dysesthesia, tremor, disorientation, psychomotor hyperactivity, emotional lability, speech disorders, attention disorders, seizures, confusion, depression, depersonalization, psychotic reactions with behavior disorders with self-harm.

Sensory organs: disorders of vision, (blurred, decreased visual acuity), impaired sense of taste, loss of sense of taste, tinnitus, olfactory disorders, anosmia.

Cardiovascular system:. Q-T interval prolongation (often in patients with concomitant hypokalemia), palpitations, nonspecific arrhythmias, tachycardia, increased and decreased blood pressure, pain in the (chest, , fainting, vasodilation/ (“rushes” of blood “to the face), Ventricular tachyarrhythmias, polymorphic ventricular tachycardia, cardiac arrest (mainly in individuals with conditions predisposing to arrhythmias, such as clinically significant bradycardia, acute myocardial ischemia).

In respiratory system:dyspnea, asthmatic condition.

Musculoskeletal system: arthralgia, myalgia, tendinitis, back pain, leg pain, arthritis, tendon tears, increased symptoms of myasthenia gravis.

Urogenital system:vaginal candidiasis, vaginitis, lower abdominal pain, facial edema, peripheral edema, renal dysfunction, renal failure.

Laboratory findings:. Anemia, leukopenia, neutropenia, thrombocytopenia, leukocytosis, increased prothrombin time, increased/changed international normalized ratio, eosinophilia, thrombocytosis, changes in thromboplastin and prothrombin concentration, increased activity of gamma-glutamantransferase, lactate dehydrogenase, alkaline phosphatase, amylase, increased concentration of bilirubin, decreased prothrombin time, hyperglycemia, hyperlipidemia, hyperuricemia.

Allergic reactions: urticaria, rash, pruritus, anaphylactic/anaphylactoid reactions, angioedema, including edema of the face, larynx (potentially life-threatening), Stevens-Johnson syndrome, toxic epidermal, necrolysis, anaphylactic shock.

Other:candida, general discomfort, asthenia, sweating.

Overdose

There are limited data on moxifloxacin overdose. In case of overdose, the clinical picture should be guided and symptomatic supportive therapy with ECG monitoring should be carried out.

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