Remedia tablets 500 mg, 10 pcs. (Levofloxacin)

packaging 10 pcs

Pharmacological action

Remedia is an antimicrobial drug from the group of fluoroquinolones, the levorotatory ofloxacin isomer. It has a wide range of antimicrobial effects. Levofloxacin blocks DNA gyrase (topoisomerase II) and topoisomerase IV, disrupts supercoiling and cross-linking of DNA breaks, inhibits DNA synthesis, and causes deep morphological changes in the cytoplasm, cell wall and bacterial membranes. Levofloxacin is active against most strains of microorganisms both in vitro and in vivo.

In vitro sensitive (MIC <2 mg / L) aerobic gram-positive microorganisms: Corynebacterium diphtheriae, Enterococcus spp. (including Enterococcus faecalis), Listeria monocytogenes, Staphylococcus spp. (coagulase-negative methicillin-sensitive / methicillin-moderately sensitive strains), Staphylococcus aureus (methicillin-sensitive strains), Staphylococcus epidermidis (methicillin-sensitive strains), Staphylococcus spp. (leukotoxin-containing and coagulase-negative methicillin-sensitive / moderately sensitive strains), Streptococcus spp. groups C and G (including Streptococcus agalactiae, Streptococcus pneumoniae (penicillin-sensitive / moderately sensitive / resistant strains), Streptococcus pyogenes, Streptococcus spp. viridans groups (penicillin-sensitive / resistant strains) aerobic gram-negative microorganisms: Acinetobacter spp., Actinobacillus actinomycetemcomitans, Citrobacter freundii, Eikenella corrodens, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter spp. (including Enterobacter cloacae), Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae (ampicillin-sensitive / resistant strains), Haemophilus parainfluenzae, Helicobacter pylori, Klebsiella spp. (including Klebsiella oxytoca, Klebsiella pneumoniae), Moraxella catarrhalis (strains producing and non-producing beta-lactamase), Morganella morganii, Neisseria gonorrhoeae (strains producing and non-producing penicillinase), Neisseria meninge. (including Pasteurella canis, Pasteurella dagmatis, Pasteurella multocida), Proteus mirabilis, Proteus vulgaris, Providencia spp. (including Providencia rettgeri, Providencia stuiartii), Pseudomonas spp. (including Pseudomonas aeruginosa), Salmonella spp., Serratia spp. (Serratia marcescens) anaerobic microorganisms: Bacteroides fragilis, Bifidobacterium spp., Clostridium perfringens, Fusobacterium spp., Peptostreptococcus spp., Propionibacterum spp., Veillonella spp. other microorganisms: Bartonella spp., Chlamydia pneumoniae, Chlamydia psittaci, Chlamydia trachomatis, Legionella pneumophila, Legionella spp., Mycobacterium spp. (including Mycobacterium leprae, Mycobacterium tuberculosis), Mycoplasma hominis, Mycoplasma pneumoniae, Rickettsia spp., Ureaplasma urealyticum.

Levofloxacia is moderately active (MIC> 4 mg / l) against aerobic gram-positive microorganisms: Corynebacterium urealyticum, Corynebacterium xerosis, Enterococcus faecium, Staphylococcus epidermidis (methicillin-resistant strains), Staphylococcus haemolyticus (methicillin-resistant strains) of aerobic gram-negative microorganisms: Burkholderia cepacia, Campylobacter jejuni, Campylobacter coli anaerobic microorganisms: Bacteroides thetaiotaomiсron, Bacteroides vulgatusppactus, Bacteroides vulphatusppactus, bact.

Aerobic gram-positive microorganisms resistant to levofloxacin (MIC> 8 mg / h): Corynebacterium jeikeium, Staphylococcus aureus (methicillin-resistant strains), Staphylococcus spp. (coagulase-negative methicillin-resistant strains) aerobic gram-negative microorganisms: Alcaligenes xylosoxidans other microorganisms: Mycobacterium avium.

Pharmacokinetics

Distribution of

Protein Binding - 30-40%. Cumulation in the appointment of a dose of 500 mg 1 time / day is negligible. When prescribed at a dose of 500 mg 2 times / day, cumulation to a small extent may be observed. Css are reached 3 days after the start of use.

It penetrates well into organs and tissues: lungs, mucous membrane of the bronchi, sputum, organs of the urinary system, genitals, bone tissue, prostate gland, polymorphonuclear leukocytes, alveolar macrophages. Levofloxacin penetrates poorly into the cerebrospinal fluid.

Average concentrations in urine 8-12 hours after a single injection of 150, 300 or 500 mg of levofloxacin were 44, 91 and 200 g / l, respectively.

Metabolism

In the liver, a small part of levofloxacin is metabolized to form desmethyl levofloxacin and levofloxacin-N-oxide, which make up <5% of levofloxacin excreted by the kidneys.

Excretion of

After administration in a single dose of 500 mg, T1 / 2 is 6-8 hours. It is excreted mainly by the kidneys by glomerular filtration and tubular secretion. Less than 5% of levofloxacin is excreted as metabolites. In unchanged form, 70% is excreted and in 48 hours - 87%.

Contraindications

epilepsy

tendon damage with previous treatment with quinolones

pregnancy lactation

childhood and adolescence (up to 18 years)

hypersensitivity to the drug levofloxacin or any other drug.

Precautions: old age (high likelihood of a concomitant decrease in renal function), glucose-6-phosphate dehydrogenase deficiency, in patients with a history of brain damage (stroke or severe trauma), in patients simultaneously receiving drugs that lower the threshold for convulsive readiness of the head brain (seizures may develop), in patients with pseudoparalytic myasthenia (myasthenia grais), with known risk factors for lengthening the QT interval.

Use during pregnancy and lactation

The drug is contraindicated in pregnancy and lactation.

Composition of

1 tablet contains:

Active ingredient: levofloxacinamigihydrate 256.0 mg, 512.0 mg, or 768.0 mg, which is equivalent to levofloxacin 250 mg, 500 mg, or 750 mg, respectively,

Excipients: silicon crystal, 30 g, crystal colloidal dioxide, magnesium stearate, sodium lauryl sulfate,

Shell composition: yellow coating material (hypromellose, talc, titanium dioxide E171, iron (III) oxide yellow E172), propylene glycol.

Dosage and administration of

Remedia tablets are prescribed for adults 1-2 times a day.

Dosage depends on the type and severity of the infection, the sensitivity of the alleged or isolated microorganism that is the causative agent of the disease.

The duration of treatment varies depending on the disease with a maximum duration of treatment of 14 days, with bacterial prostatitis, up to 28 days is possible.

In accordance with the general principles of antibiotic therapy, taking Remedia tablets should be continued for at least 48-72 hours after normalizing body temperature or receiving a negative bacteriological analysis.

Remedia tablets are taken orally without chewing with a sufficient amount of liquid. For the recommended dosage, tablets can be divided along the fault line. Tablets can be taken during meals or between meals. Remedia tablets should be taken within 2 hours of supplementation with iron salts, antacids and sucralfate due to a possible decrease in absorption.

Side effects of the digestive system: nausea, vomiting, diarrhea (including blood), indigestion, decreased appetite, abdominal pain, pseudomembranous colitis, increased activity of hepatic transaminases, hyperbilirubinemia, hepatitis, dysfunction.

From the cardiovascular system: decreased blood pressure, vascular collapse, tachycardia, increased QT interval on the cardiogram, atrial fibrillation.

From the side of metabolism: hypoglycemia (increased appetite, increased sweating, trembling, nervousness), hyperglycemia.

From the nervous system: headache, dizziness, weakness, drowsiness, insomnia, anxiety, paresthesia in the hands of hands, fear, hallucinations, confusion, depression, motor disorders, cramps, peripheral sensory neuropathy, peripheral sensory-motor neuropathy, mental disorders with behavioral disorders causing self-harm, including suicidal thoughts and suicidal attempts.

On the part of the sensory organs: impaired vision, hearing, smell, taste and tactile sensitivity.

From the musculoskeletal system: arthralgia, muscle weakness, myalgia, tendon rupture, tendonitis, rhabdomyolysis.

From the urinary system: hypercreatininemia, interstitial nephritis, acute renal failure.

From the hemopoietic organs: eosinophilia, hemolytic anemia, leukopenia, neutropenia, agranulocytosis. thrombocytopenia, pancytopenia, hemorrhage.

Allergic reactions: itching and hyperemia of the skin, swelling of the skin and mucous membranes, urticaria, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome), bronchospasm, anaphylactic shock, allergic pneumonitis, vasculitis.

Other: asthenia, exacerbation of porphyria, photosensitivity, persistent fever, leukocytoclastic vasculitis, development of superinfection.

Local reactions: pain, redness at the injection site, phlebitis.

Drug interaction

Levofloxation increases T1 / 2 cyclosporine.

NSAIDs, theophylline increase the risk of cramps.

The use of ACS increases the risk of tendon rupture (especially in old age).

Cimetidine and drugs, blocking tubular secretion, slow the excretion of levofloxacin.

Infusion solution is compatible with 0.9% sodium chloride solution, 5% dextrose solution, 2.5% Ringer's solution with dextrose, combined solutions for parenteral nutrition (amino acids, carbohydrates, electrolytes).

Cannot be mixed with heparin and solutions having an alkaline reaction (for example, sodium bicarbonate solution).

In patients with diabetes receiving oral hypoglycemic agents or insulin, hypo- and hyperglycemic conditions are possible against the background of administration of levofloxacin, so blood glucose monitoring is recommended.

Levofloxacin enhances the anticoagulant activity of warfarin

Alcohol can increase the side effects of the CNS (dizziness, drowsiness, drowsiness).

Overdose

Symptoms: manifested mainly by the CNS (confusion, dizziness, impaired consciousness and convulsions by type of epileptic seizures).

In addition, gastrointestinal disorders (such as nausea) and erosive lesions of the gastrointestinal mucosa may be noted, QT lengthening.

Treatment: symptomatic. Dialysis is ineffective. The specific antidote is unknown.

Storage conditions

The drug should be stored out of the reach of children, protected from light at a temperature of 10 ° to 25 ° C.

Expiration

2 years.

Deystvuyuschee substances

Levofloxacin

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