Remedia, pills 500mg, 10pcs

Composition

Active ingredient:

levofloxacin hemihydrate 256.0 mg,512.0 mg, or 768.0 mg, which is equivalent to levofloxacin 250 mg,500 mg, or 750 mg, respectively,

Auxiliary substances:  

microcrystalline cellulose,

povidone (K 30),

crospovidone,

colloidal silicon dioxide,

magnesium stearate,

sodium lauryl sulfate,

Shell composition:

coating material yellow (hypromellose, talc, titanium dioxide E 171, iron (III) oxide yellow E 172), propylene glycol.

Pharmacological action

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

In in vitro sensitive (MPC:  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. groups viridans (penicillin-sensitive/resistant strains); aerobic gram-negative microorganisms:  Acinetobacter baumannii, Acinetobacter spp., Actinobacillus actinomycetemcomitans, Citrobacter freundii, Eikenella corrodens, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter spp. 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 that produce and do not produce beta-lactamase), Morganella morganii, Neisseria gonorrhoeae (strains that produce and do not produce penicillinase), Neisseria meningitidis, Pasteurella spp. (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.

Levofloxacin is moderately active (BMD> 4 mg / L ) against aerobic gram-positive microorganisms:  Corynebacterium urealyticum, Corynebacterium xerosis, Enterococcus faecium, Staphylococcus epidermidis (methicillin-resistant strains), Staphylococcus haemolyticus (methicillin-resistant strains); aerobic gram-negative microorganisms:  Burkholderia cepacia, Campylobacter jejuni, Campylobacter coli; anaerobic microorganisms:  Bacteroides thetaiotaomicron, Bacteroides vulgatus, Bacteroides ovatus, Prevotella spp., Porphyromonas spp.

Aerobic gram-positive microorganisms are resistant to levofloxacin (BMD> 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

Protein binding is 30-40%. Accumulation at a dose of 500 mg 1 time / day is insignificant. When administered at a dose of 500 mg 2 times/day, accumulation may occur to a small extent. Css is reached 3 days after the application starts.

It penetrates well into organs and tissues: lungs, bronchial mucosa, sputum, urinary system organs, genitals, bone tissue, prostate gland, polymorphonuclear leukocytes, alveolar macrophages. Levofloxacin does not penetrate well into the cerebrospinal fluid.

Mean urinary concentrations 8-12 hours after a single use of 150,300, or 500 mg of levofloxacin were 44,91, and 200 g/l, respectively.

Metabolism

In the liver, a small portion of levofloxacin is metabolized to form desmethylvofloxacin and levofloxacin-N-oxide, which constitute

Deduction

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

Indications

• Infectious and inflammatory diseases caused by microorganisms sensitive to levofloxacin;
• lower respiratory tract infections (exacerbations of chronic bronchitis, community-acquired pneumonia);
• acute maxillary sinusitis;
• uncomplicated urinary tract infections;
• complicated urinary tract infections (including acute pyelonephritis):
• skin and soft tissue infections (suppurated atheromas, abscesses, boils);
• septicemia/bacteremia;
• chronic bacterial prostatitis;
• intra-abdominal infection;
• complex therapy of drug-resistant forms of tuberculosis.

Use during pregnancy and lactation

The drug is contraindicated during pregnancy and lactation.

Contraindications

• epilepsy;
• tendon damage during previous treatment with quinolones;
• pregnancy;
• lactation;
• children and adolescents (up to 18 years);
• hypersensitivity to levofloxacin, any other component of the drug or other drugs from the group of fluoroquinolones.

With caution:  older age (high probability of having a concomitant decrease in renal function), deficiency of glucose-6-phosphate dehydrogenase in patients with brain lesions in history (stroke, or severe trauma), in patients receiving both drugs that reduce the threshold of convulsive readiness of the brain (perhaps the development of seizures) in patients with psevdoparaliticheskimi myasthenia (myasthenia grais), with known risk factors for QT interval prolongation.

Side effects

From the digestive system:  nausea, vomiting, diarrhea (including blood), digestive disorders, decreased appetite, abdominal pain, pseudomembranous colitis, increased activity of hepatic transaminases, hyperbilirubinemia, hepatitis, dysbiosis.

From the cardiovascular system:  reduced 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.

Nervous system disorders:  headache, dizziness, weakness, drowsiness, insomnia, restlessness, paresthesia in the hands, fear, hallucinations, confusion, depression, motor disorders, seizures, peripheral sensory neuropathy, peripheral sensory-motor neuropathy, mental disorders with behavioral disorders with self-harm, including suicidal thoughts and suicide attempts.

From the side of the senses:  disorders of vision, hearing, smell, taste and tactile sensitivity.

Musculoskeletal disorders:  arthralgia, muscle weakness, myalgia, tendon rupture, tendinitis, rhabdomyolysis.

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

From the side of hematopoietic organs:  eosinophilia, hemolytic anemia, leukopenia, neutropenia, agranulocytosis. thrombocytopenia, pancytopenia, hemorrhage.

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

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

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

Interaction

Levofloxation increases the T1 / 2 of cyclosporine.

NSAIDs, theophylline increase the risk of developing seizures.

Taking corticosteroids increases the risk of tendon rupture (especially in the elderly).

Cimetidine and drugs that block tubular secretion slow down the elimination of levofloxacin.

The 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).

Do not mix with heparin and solutions that have an alkaline reaction (for example, with a solution of sodium bicarbonate).

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

Levofloxacin enhances the anticoagulant activity of warfarin

Alcohol can increase the side effects of the central nervous system (dizziness, numbness, drowsiness).

How to take, course of use and dosage

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

Dosage depends on the type and severity of infection, the sensitivity of the suspected 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 are possible.

In accordance with the general principles of antibiotic therapy, taking Remedia tablets should be continued for at least 48-72 hours after normalization of 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 should be divided along the fault line. Tablets can be taken during meals or between meals. Remedia tablets should be taken 2 hours before taking iron salts, antacids and sucralfate due to a possible decrease in absorption.

Overdose

Symptoms: They are mainly manifested from the central nervous system (confusion, dizziness, impaired consciousness and seizures like epileptic seizures).

In addition, gastrointestinal disorders (for example, nausea) and erosive lesions of the gastrointestinal mucosa, prolongation of the QT interval may occur.

Treatment: symptomatic. Dialysis is ineffective. The specific antidote is not known.

Special instructions

When the body temperature normalizes, it is recommended to continue treatment for at least 48-72 hours.

During treatment, it is necessary to avoid sun and artificial ultraviolet radiation in order to avoid damage to the skin (photosensitization). If signs of tendinitis, pseudomembranous colitis, or allergic reactions occur, levofloxacin is immediately discontinued.

It should be borne in mind that patients with a history of brain damage (stroke or severe injury) may develop seizures, with glucose-6-phosphate dehydrogenase deficiency, the risk of developing hemolysis of red blood cells.

Alcohol consumption should be avoided during treatment.

Influence on the ability to drive motor vehicles and manage mechanisms

During the treatment period, care should be taken when driving a car and potentially dangerous mechanisms due to the possible appearance of dizziness, drowsiness, stiffness and visual disturbances, which can lead to a slowdown in the speed of psychomotor reactions and a decrease in the ability to concentrate.

Form of production

Tablets

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Levofloxacin

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

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