Index of drugs

Acute bacterial sinusitis (properly diagnosed) and exacerbation of chronic bronchitis (properly diagnosed), if it is not appropriate to use other antimicrobial agents, recommended in this infection as first-line agents or if after their use the infection has not subsided. Community-acquired pneumonia (except in cases of severe course), if it is not appropriate to use other antimicrobials, recommended in this infection as first-line agents. Pelvic inflammatory disease of low or moderate intensity (including infection of the upper part of the genital tract, including salpingitis and endometritis), without ovarian and ovarian abscess and pelvis abscess. Community-acquired pneumonia and complicated skin and subcutaneous tissue infections as a continuation of therapy following initial treatment with intravenous moxifloxacin. Do not use this medicine to treat any type of skin and subcutaneous tissue infections or severe community-acquired pneumonia.

1 tabl powl. contains 400 mg of moxifloxacin hydrochloride. The preparation contains lactose.

A chemotherapeutic agent from the fluoroquinolone group, inhibiting the activity of type II bacterial topoisomerases (gyrase DNA and topoisomerase IV), which are necessary for the proper course of replication, transcription and repair of bacterial DNA. Bactericidal for: Gram-positive bacteria: strainsGardnerella vaginalis, Staphylococcus aureus sensitive to methicillin,Streptococcus agalactiae, groupStreptococcus milleri (S. anginosus, S. constellatus andS. intermedius) S. pneumoniae, S. pyogenes; Gram-negative bacteria:Haemophilus influenzae, H. parainfluenzae, Moraxella catarrhalis, Klebsiella pneumoniae; anaerobic bacteria:Prevotella spp., Fusobacterium spp., Peptostreptococcus spp.; other:Mycoplasma pneumoniae, M. hominis, M. genitalium, Legionella pneumophila, Chlamydia pneumoniae, Ch. trachomatis, Coxiella burnetti. Strains for which acquired resistance may be a problem: aerobic Gram-positive bacteria:Staphylococcus aureus; aerobic Gram-negative bacteria:Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Neisseria gonorrhoeae. Species with innate resistance: Gram-negative aerobic bacteria:Pseudomonas aeruginosa. Moxifloxacin is rapidly and independently absorbed from the gastrointestinal tract (bioavailability around 91%), reaching a peak blood concentration after 0.5-4 h. Plasma proteins are 40-42% bound. It penetrates into the tissues of the respiratory system, including to the sinuses, bronchial mucosa and alveolar macrophages. It is metabolized in the liver. T_0,5 is about 12 hours. It is excreted unchanged and in the form of metabolites both in the faeces and in the urine.

Hypersensitivity to moxifloxacin, other quinolones or other components of the preparation. Pregnancy, breastfeeding period. Children and youth under 18 years. Tendon diseases due to prior use of quinolones. Congenital or acquired QT prolongation, electrolyte disturbances (especially uncorrected hypokalemia), clinical bradycardia, heart failure with reduced left ventricle ejection fraction, symptomatic cardiac arrhythmias. Hepatic insufficiency and blood aminotransferase levels exceeding the upper limit of 5 times. Do not use in combination with drugs that prolong the QT interval.

The use of the preparation for monotherapy of low or moderate pelvic inflammation induced byNeisseria gonorrhoeae, you must associate moxifloxacin with another suitable antibacterial drug (eg cephalosporin); in the absence of clinical improvement, consider alternative treatment. Moxifloxacin is not recommended for the treatment of infections caused by multiresistant Staphylococcus aureus (MRSA,Staphylococcus aureus). Patients with pelvic inflammatory disease who are being considered for intravenous therapy are not recommended.Caution should be exercised in patients taking concomitant medications to reduce the level of potassium in the blood and in patients at risk of arrhythmia (especially in women and elderly patients), for example acute myocardial ischemia or prolongation of the QT interval (risk of ventricular arrhythmias and cardiac arrest). Exercise caution in patients with CNS dysfunction that may predispose to convulsions or reduce the convulsive threshold (if they occur, discontinue drug administration and appropriate treatment), in patients with myasthenia gravis and G-6-PD deficiency (also in the past), in elderly patients with impaired renal function (risk of dehydration). Moxifloxacin should be discontinued in case of life-threatening shock, pain or other symptoms of inflammation or tendon rupture (especially in elderly patients and simultaneously treated with corticosteroids, may occur up to several months after discontinuation of quinolones) and with symptoms that may be associated with the disorder cardiac rhythm (ECG) and patients with depression or psychotic reactions during treatment. The clinical efficacy of the medicine for the treatment of severe burns, fasciitis and diabetic foot infections with osteomyelitis has not been established. In the event of diarrhea associated with the use of antibiotic or pseudomembranous enteritis, moxifloxacin should be discontinued and appropriate treatment (including measures to reduce the risk of transmission of infection) should be discontinued; the use of drugs that inhibit intestinal peristalsis is contraindicated in these clinical conditions. Data on the use of the drug in patients with hepatic insufficiency are insufficient. Do not use in patients with rare hereditary galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose.

The use of the preparation during pregnancy and during breast-feeding is contraindicated, the safety of use has not been established. Moxifloxacin is excreted in breast milk.

Common: superinfections caused by resistant bacteria or fungi, e.g. oral candidiasis or vaginal candidiasis; pain and dizziness; QT interval prolongation in patients with concomitant hypokalaemia; nausea, vomiting, gastrointestinal pain, abdominal pain, diarrhea; increase in aminotransferases. Uncommon: anemia, leukopenia, neutropenia, thrombocytopenia, thrombocytosis, eosinophilia, prolonged prothrombin time, increased INR; allergic reactions; hyperlipidemia; anxiety reactions, psychomotor hyperactivity, agitation; paresthesia and dyzestezje, taste disorders (including very rarely loss of taste), confusion and disorientation, sleep disorders (usually insomnia), tremors, balance disorders, drowsiness; visual disturbances (including double vision and blurred vision, especially in connection with symptoms from the o.u.n.); QT interval prolongation, palpitations, tachycardia, atrial fibrillation, angina pectoris, vasodilation; dyspnoea (including asthma attacks), lack of appetite, constipation, indigestion, bloating, gastritis, increased amylase; impaired liver function (including increased lactate dehydrogenase activity), increased bilirubin, increased γ-glutamyltransferase activity, increased alkaline phosphatase in the blood; pruritus, rash, urticaria, dry skin; joint pain, muscle pain; dehydration; bad mood (mainly due to weakness or fatigue), pain (including back pain, chest, pelvis and limbs), excessive sweating. Rare: anaphylaxis (including life-threatening shock), allergic edema, angioneurotic edema (including laryngeal edema that may be life-threatening); hyperglycemia, hyperuricemia; emotional instability, depression (very rarely leading to self-destructive behaviors), hallucinations; hypoesthesia, olfactory disorders (including loss of smell), unusual dreams, coordination disorders (including gait disturbance due to dizziness), convulsions (including epileptic seizure), concentration disorders, speech disorders, amnesia; tinnitus, including deafness; ventricular tachyarrhythmias, fainting (sudden and short-term loss of consciousness), hypertension, hypotension; dysphagia, oral mucositis, antibiotic-related colitis (including pseudomembranous colitis, very rarely associated with life-threatening complications); jaundice, hepatitis (usually with cholestasis); tendinitis, muscle cramps, muscle twitching and weakness; impaired renal function (including increased urea nitrogen and creatinine), renal failure; swelling.Very rare: increased prothrombin levels, reduced INR, agranulocytosis; depersonalization, psychotic reactions (which may lead to self-destructive behaviors), hyperesthesia; transient loss of vision; non-specific arrhythmias torsade de pointes, cardiac arrest; fulminant hepatitis that may lead to life-threatening liver failure (including fatal outcome); bullous skin reactions (like Stevens-Johnson syndrome) or toxic epidermal necrolysis (possibly life-threatening); tendon rupture, arthritis, muscle stiffness, worsening of myasthenia gravis. hypernatremia, hypercalcemia, haemolysis, rhabdomyolysis, photosensitivity reactions, peripheral neuropathy.

Orally. Adults: 400 mg once a day. Duration of treatment: exacerbation of chronic bronchitis - 5-10 days, community-acquired pneumonia - 10 days, acute bacterial sinusitis - 7 days, pelvic inflammatory disease of low or moderate intensity - 14 days. The preparation should be taken independently of meals with liquid. No dose adjustment is required in patients with renal insufficiency, low body weight or elderly.