Remedia, 500 mg 10 pcs

Pharmacotherapeutic group

Antimicrobial agent – fluoroquinolone

ATX code: J01MA

Pharmacodynamics:

Remedia is a broad-spectrum antimicrobial bactericidal agent from the group of fluoroquinolones. As an active substance it contains levofloxacin – the left-handed isomer ofloxacin. It blocks DNA-gyrease (topoisomerase I) and topoisomerase IV disrupts superspiralization and cross-linking of DNA breaks inhibits DNA synthesis and causes morphological changes in cytoplasm of cell wall and bacterial membranes.

Active against a wide range of the following clinically relevant microorganisms:

– Gram-positive microorganisms: CorynebacteriumdiphtheriaeEnterococcusspp. (including Enterococcusfaecalis) Listeriamonocytogenes. Staphylococcusspp. coagulazonegative and methicillin-sensitive (including moderately sensitive). Staphylococcusaureus (methicillin-sensitive) Staphylococcusepidermidis (methicillin-sensitive). Streptococcusspp. (groups C and G). Streptococcusagalactiae. Streptococcuspneumoniae (penicillin-sensitive. moderately sensitive resistant) Streptococcuspyogenes (penicillin-sensitive moderately sensitive resistant) Streptococcus viridans group;

– Gram-negative microorganisms: Acinetobacterspp. (including Acinetobacterbaumannii) Actinobacillusactinomycetemcomitans. Citrobacter freundii Eikenella corrodens Enterobacter spp. (in t. 4. Enterobacter aerogenes. Enterobacter agglomerates Enterobacter cloacae) EscherichiacoliGardnerellavaginalisHaemophilusducreyiHaemophilusinfluenzae(ampicillin sensitive and resistant) HaemophilusparainfluenzaeHelicobacterpyloriKlebsiellaspp. (including KlebsiellapneumoniaeKlebsiellaoxytoca) Moraxellacatarrhalis (beta-lactamase producing and non-producing) Morganellamorganii. Neisseriagonorrhoeae (penicillin-sensitive moderately sensitive resistant) NeisseriameningitidisPasteurellaspp. Pasteur el la can is Pasteurella dagmatis Pasteurella multocida) Proteus mirabilis Proteus vulgaris Providencia spp. (Providencia rettgeri Providencia stuartii) Pseudomonas spp. (including Pseudomonas aeruginosa) Salmonella spp. Serratia spp. (including Serratia marcescens);

– anaerobic microorganisms: BacteroidesfragilisBifidobacteriumspp. ClostridiumperfringensFusobacteriumspp. Peptostreptococcusspp. Propionibacteriumspp. Veilonellaspp.;

– other microorganisms: Bartonellaspp. Chlamydiapneumoniae. Chlamydia psittaci Chlamydia trachomatis Legionella spp. (including Legionella pneumonia) Mycobacterium spp. (including Mycobacterium leprae Mycobacterium tuberculosis) Mycoplasma hominis Mycoplasma pneumoniae Rickettsia spp. Ureaplasma urealyticum.

Pharmacokinetics:

After oral administration it is quickly and almost completely absorbed from the gastrointestinal tract. Bioavailability is 99%. Food intake has little effect on the speed and completeness of absorption.

The maximum plasma concentration (Cmax) with 250 mg and 500 mg is reached after 1-2 hours and is 28 mcg/ml and 5.2 mcg/ml, respectively. The binding to plasma proteins is 30-40%.

It penetrates well into organs and tissues: lungs bronchial mucosa sputum urogenital organs bone tissue. cerebrospinal fluid polymorphonuclear leukocytes alveolar macrophages. Average volume of distribution is from 89 to 112 liters after a single and repeated administration of 500 mg of the drug.

In the liver, a small portion is oxidized and/or deacetylated.

The elimination half-life (T1/2) is 6-8 hours. About 70% of levofloxacin is excreted by the kidneys during 24 hours unchanged (about 87% during 48 hours) and less than 5% as metabolites during 48 hours. The intestine excretes less than 4% of the dose taken in 72 hours.

Renal clearance is 70% of total clearance.

It is not excreted by hemodialysis or chronic ambulatory peritoneal dialysis.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

– ENT organ infections (including acute sinusitis);

– lower respiratory tract infections (including acute chronic bronchitis with acute pneumonia);

– urinary tract and kidney infections (including.

– infections of the urinary tract and the kidneys (including acute pyelonephritis);

– chronic bacterial prostatitis.

– intra-abdominal infections (in combination with antibacterials acting on anaerobic flora);

– tuberculosis (complex therapy of drug-resistant forms).

Active ingredient

Composition

Composition per tablet

The active ingredient:

levofloxacin hemihydrate 512 mg, equivalent to levofloxacin 500 mg.

Excipients: microcrystalline cellulose 81.0 mg; povidone K-30 9.0 mg; crosspovidone 27.0 mg; colloidal silica 6.0 mg; magnesium stearate 5.0 mg; sodium lauryl sulfate 10.0 mg.

Film coating composition: film coating substance Yellow (hypromellose, talc, titanium dioxide, iron oxide yellow dye)15.0 mg; propylene glycol 2.0 mg.

How to take, the dosage

Remedia tablets are administered to adults 1-2 times a day.

The dosage depends on the type and severity of the infection and the sensitivity of the suspected or isolated microorganism that caused the disease.

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

According to the general principles of antibiotic therapy, Remedia pills must be continued for at least 48 to 72 hours after body temperature has returned to normal or after a negative bacteriological test has been obtained.

Remedia tablets are taken orally without chewing, with plenty of fluid. The tablets can be divided along the break line for recommended dosing. The tablets can be taken with or between meals. Remedia tablets should be taken 2 hours before taking iron salts, antacids, and sucralfate due to possible decreased absorption.

Interaction

Increases the half-life of cyclosporine.

The intestinal motility depressant drugs sucralfate aluminum- and magnesium-containing antacid drugs as well as drugs containing iron and zinc salts reduce the effect and potency of levofloxacin. The drug should be taken 2 hours or 2 hours after taking these drugs.

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

Non-steroidal anti-inflammatory drugs and theophylline increase the risk of seizures.

Glucocorticosteroids increase the risk of tendon rupture.

Hypoglycemic drugs increase the chance of hyper- and hypoglycemia, so close monitoring of blood glucose levels is necessary.

When used concomitantly with vitamin K antagonists, it is necessary to monitor blood clotting parameters.

Special Instructions

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

At the time of treatment it is necessary to avoid sunlight and artificial ultraviolet radiation in order to avoid skin damage (photosensitization). In case of signs of tendinitis, pseudomembranous colitis and allergic reactions levofloxacin should be stopped immediately.

It should be noted that in patients with a history of brain damage (stroke or severe trauma) seizures may occur, with glucose-6-phosphate dehydrogenase deficiency the risk of erythrocyte hemolysis.

Alcohol should be avoided during treatment.

Impact on driving and operating machinery

At the time of treatment, caution should be exercised when driving and operating potentially dangerous machinery because of possible dizziness, drowsiness, stiffness and visual disturbances, which may lead to slower psychomotor reactions and reduced ability to concentrate.

Contraindications

– hypersensitivity to levofloxacin other fluoroquinolones or other components of the drug;

– epilepsy;

– tendon involvement with previous treatment with quinolones;

– childhood and adolescence (under 18 years of age);

– pregnancy;

– lactation.

Elderly age (high likelihood of concomitant decreased renal function) glucose-6-phosphate dehydrogenase deficiency.

Side effects

Digestive system disorders: nausea, vomiting, diarrhea (including blood), digestive disorders, decreased appetite, abdominal pain, pseudomembranous colitis, increased liver transaminases activity, hyperbilirubinemia, hepatitis, dysbacteriosis.

Cardiovascular system disorders: decreased BP, vascular collapse, tachycardia, increased QT interval in cardiogram, atrial fibrillation.

Metabolic disorders: hypoglycemia (increased appetite, increased sweating, shivering, nervousness), hyperglycemia.

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

Sensory organs: disorders of vision, hearing, smell, taste and tactile sensitivity.

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

Urinary system disorders: hypercreatininemia, interstitial nephritis, acute renal failure.

Hematopoietic disorders: 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, erythema malignant exudative (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome), bronchospasm, anaphylactic shock, allergic pneumonitis, vasculitis.

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

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

Overdose

Symptoms: manifested mainly in the CNS (confusion, dizziness, impaired consciousness and seizures similar to epileptic seizures).

In addition, gastrointestinal disorders (e.g., nausea) and erosive lesions of gastrointestinal mucous membranes and prolongation of the QT interval may be noted.

Treatment: symptomatic. Dialysis is ineffective. No specific antidote is known.

Pregnancy use

Similarities