Avelox (moxifloxacin) coated tablets 400 mg. N5

$67.10

Manufacturer: Germany

Avelox is a drug that treats bacterial infections. It can be used to treat respiratory tract infections, skin and soft tissue infections, and pelvic inflammatory diseases. It is effective against infections caused by bacteria that are resistant to multiple antibiotics, including Streptococcus pneumoniae.

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Description

Ingredients

Active ingredient : moxifloxcin.

Excipients : microcrystalline cellulose – 136 mg, croscarmellose sodium – 32 mg, lactose monohydrate – 68 mg, magnesium stearate – 6 mg.

Dosage form

Film-coated tablets.

Basic physical and chemical properties:  pink, opaque, oblong, biconvex, chamfered tablets, engraved with “BAYER” on one side and “M400” on the other side.

Pharmacotherapeutic group

Antibacterial drug of the fluoroquinolone group. The antimicrobial agent is a fluoroquinolone. 

ATX code: J01MA14.

Pharmacodynamics

An antimicrobial agent from the group of fluoroquinolones, acts bactericidal. Shows activity 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 β-lactamase and non-β-lactamase producing strains), Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis (including both β-lactamase producing and non-β-lactamase producing strains), Escherichia coli, Enterobacter cloacae; atypical – Chlamydia pneumoniae, Mycoplasma pneumoniae . According to in vitro studies, although the following microorganisms are susceptible to moxifloxacin, its safety and efficacy in the treatment of infections have not been established. Gram-positive microorganisms: Streptococcus milleri, Streptococcus mitior, Streptococcus agalactiae, Streptococcus dysgalactiae, Staphylococcus cohnii, Staphylococcus epidermidis (including strains sensitive to methicillin), Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus saprophyticus, Staphylococcus simulans, Corynebacterium diphtheriae. Gram-negative microorganisms: Bordetella pertussis, Klebsiella oxytoca, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter intermedius, Enterobacter sakazaki, Proteus mirabilis, Proteus vulgaris, Morganella morganii, Providencia rettgeri, Providencia stuartii. Anaerobic microorganisms: Bacteroides distasonis, Bacteroides eggerthii, Bacteroides fragilis, Bacteroides ovatus, Bacteroides thetaiotaornicron, Bacteroides uniformis, Fusobacterium spp., Porphyromonas spp., Porphyromonas anaerobius, Porphyromonas asaccharolyticus, Porphyromonas magnus, Prevotella spp., Propionibacterium spp., Clostridium perfringens, Clostridium ramosum. Atypical microorganisms: Legionella pneumophila, Caxiella burnettii.

Blocks with topoisomerases II and IV, enzymes that control the topological properties of DNA and are involved in DNA replication, repair and transcription. The action of moxifloxacin depends on its concentration in the blood and tissues. The minimum bactericidal concentrations are almost the same as the minimum inhibitory concentrations.

Resistance mechanisms that inactivate penicillins, cephalosporins, aminoglycosides, macrolides, and tetracyclines do not affect the antibacterial activity of moxifloxacin. There is no cross-resistance between moxifloxacin and these drugs. A plasmid-mediated mechanism for the development of resistance was not observed. The overall incidence of resistance is low. In vitro studies have shown that resistance to moxifloxacin develops slowly as a result of a series of successive mutations. With repeated exposure of microorganisms to moxifloxacin in subminimal inhibitory concentrations, MIC indicators only slightly increase. Between drugs from the group of fluoroquinolones, cross-resistance is observed. However, some Gram-positive and anaerobic organisms resistant to other fluoroquinolones.

Indications

  • Treatment of bacterial infections caused by susceptible microorganisms.
  • Infectious diseases of the respiratory tract: chronic bronchitis during an exacerbation; community-acquired pneumonia, the causative agents of which are strains of microorganisms with multiple resistance to antibiotics; acute sinusitis;
  • Uncomplicated skin and soft tissue infections.
  • Uncomplicated inflammatory diseases of the pelvic organs (including infectious diseases of the upper genital area in women, including salpingitis and endometritis).
  • Complicated infectious diseases of the skin and subcutaneous structures (including an infected diabetic foot).
  • Complicated intra-abdominal infections, including polymicrobial infections (such as abscess formation).
  • Streptococcus pneumoniae with multiple antibiotic resistance, including strains resistant to penicillin and strains resistant to two or more antibiotics of such groups as penicillins (with a minimum inhibitory activity ≥2 μg / ml), second-generation cephalosporins (cefuroxime), macrolides, tetracyclines and trimethoprim/sulfamethoxazole.

Contraindications

A history of tendon pathology that has developed as a result of treatment with quinolone antibiotics; in preclinical and clinical studies, after the administration of Avelox (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 disturbances, especially uncorrected hypokalemia; clinically significant bradycardia; clinically significant heart failure with reduced ejection fraction of the left ventricle; a history of arrhythmias accompanied by clinical symptoms; moxifloxacin should not be used with other drugs that prolong the QT interval; due to the limited number of clinical data, the use of moxifloxacin is contraindicated in patients with impaired liver function (Child-Pugh class C) and patients with an increase in transaminases more than 5 times ULN; pregnancy, breastfeeding; age up to 18 years; hypersensitivity to moxifloxacin, other quinolones.

Use with caution in diseases of the central nervous system (including diseases suspected of involving the central nervous system), predisposing to the occurrence of seizures and reducing the threshold for convulsive readiness; in patients with psychosis and / or psychiatric diseases in history; in patients with potentially proarrhythmic conditions such as acute myocardial ischemia and cardiac arrest, especially in women and elderly patients; with myasthenia gravis; with cirrhosis of the liver; when taken simultaneously with drugs that reduce the content of potassium; in patients with a genetic predisposition or actual deficiency of glucose-6-phosphate dehydrogenase.

Dosage and administration

Adults: 400 mg 1 time per day for any infections.

Duration of therapy

The duration of therapy is determined by the severity of the infection and the clinical effect. At the initial stages of treatment, Avelox (moxifloxacin) solution for infusions can be used, and then, to continue therapy, if indicated, the drug can be administered orally in tablets.

Exacerbation of chronic bronchitis  – 5 days.

Community-acquired pneumonia  – 10 days.

Acute sinusitis  – 7 days.

Uncomplicated skin and soft tissue infections  – 7 days.

Uncomplicated inflammatory diseases of the pelvic organs  – 14 days.

Complicated infections of the skin and subcutaneous structures  – the total duration of stepwise therapy with moxifloxacin (in / in the introduction of the drug, followed by oral administration) is 7-21 days.

Complicated intra-abdominal infections  – the total duration of gradual therapy (in / in the introduction of the drug, followed by oral administration) is 5-14 days.

According to clinical studies, the duration of therapy with Avelox (moxifloxacin) tablets and solution for infusions was up to 21 days (in the treatment of complicated infections of the skin and subcutaneous structures).

In elderly patients and in patients with impaired liver function, the dosing regimen does not change.

In patients with impaired renal function (including those with a creatinine clearance of 30 ml / min 1.73 m 2 ) and those on continuous hemodialysis and long-term ambulatory peritoneal dialysis, dose adjustment is not necessary.

Use for the treatment of patients of different ethnic groups – there is no need to change the dosing regimen.

Tablets should be taken without chewing, drinking plenty of water, regardless of the meal.

Avelox (moxifloxacin) infusion solution is used both for antibacterial monotherapy and in combination with other compatible drugs. Moxifloxacin solution remains stable for 24 hours at room temperature and when using the following solvents: water for injection, solutions of sodium chloride 0.9%, sodium chloride 1M, glucose 5%, 10% and 40%, solution xylitol 20%, Ringer and Ringer lactate solutions, Aminofuzin 10% and Ionosteril D5 preparations. The infusion solution should be administered intravenously slowly over 60 minutes. The maximum dose is 600 mg once or 400 mg once a day for 7-21 days. In / in appoint Avelox (moxifloxacin) at a dose of 400 mg 1 time per day. Avelox (moxifloxacin) can be used intravenously during the entire course of treatment or at the initial stages of treatment, followed by a transition to taking moxifloxacin in the form of tablets.