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:

– infections of the ENT organs (including acute sinusitis);

– lower respiratory tract infections (including chronic bronchitis in the acute stage of pneumonia);

– urinary tract and kidney infections (including acute pyelonephritis);

– chronic bacterial prostatitis;

– infections of the skin and soft tissues (including suppurating atheromas, abscess, furunculosis);

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

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

Pharmacological effect

Pharmacotherapeutic group

Antimicrobial agent – fluoroquinolone

ATX code: J01MA

Pharmacodynamics:

Remedia is a broad-spectrum antimicrobial bactericidal agent from the group of fluoroquinolones. The active substance contains levofloxacin, a levorotatory isomer of ofloxacin. Blocks DNA gyrase (topoisomerase I) and topoisomerase IV; disrupts supercoiling and cross-linking of DNA breaks; suppresses DNA synthesis; causes morphological changes in the cytoplasm, cell wall and membranes of bacteria.

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

– gram-positive microorganisms: CorynebacteriumdiphtheriaeEnterococcusspp. (including Enterococcus faecalis) Listeria monocytogenes. Staphylococcus spp. coagulase-negative and methicillin-sensitive (including moderately sensitive). Staphylococcusaureus (methicillin-sensitive) Staphylococcusepidermidis (methicillin-sensitive). Streptococcus spp. (groups C and G). Streptococcus agalactiae. Streptococcus pneumoniae (penicillin-sensitive. moderately sensitive resistant) Streptococcus pyogenes (penicillin-sensitive moderately sensitive resistant) Streptococcus viridans group;

– gram-negative microorganisms: Acinetobacter spp. (including Acinetobacter baumannii) Actinobacillus actinomycetemcomitans. 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) Neisseriameningitidis Pasteurellaspp. (including 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. Clostridium perfringens Fusobacterium spp. Peptostreptococcus spp. Propionibacterium spp. Veilonella spp.;

– other microorganisms: Bartonella spp.. 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 concentration (Cmax) in blood plasma when taking 250 mg and 500 mg is achieved after 1-2 hours and is 28 mcg/ml and 5.2 mcg/ml, respectively. Communication with plasma proteins – 30-40%.

Penetrates well into organs and tissues: lungs, bronchial mucosa, sputum, organs of the genitourinary system, bone tissue. cerebrospinal fluid polymorphonuclear leukocytes alveolar macrophages. The average volume of distribution ranges from 89 to 112 liters after single and multiple doses of 500 mg of the drug.

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

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

Renal clearance accounts for 70% of the total clearance.

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

Special instructions

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

During treatment, it is necessary to avoid solar and artificial ultraviolet irradiation to avoid damage to the skin (photosensitization). If signs of tendinitis, pseudomembranous colitis, or allergic reactions appear, levofloxacin is immediately discontinued.

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

During treatment you should avoid drinking alcohol.

Impact on the ability to drive vehicles and operate machinery

During the treatment period, care must be taken when driving a car and potentially dangerous mechanisms due to the possible occurrence 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.

Active ingredient

Levofloxacin

Composition

Composition per tablet

Active substance:

levofloxacin hemihydrate 512 mg, equivalent to levofloxacin 500 mg.

Excipients: microcrystalline cellulose 81.0 mg; povidone K-30 9.0 mg; crospovidone 27.0 mgg; colloidal silicon dioxide 6.0 mgg; magnesium stearate 5.0 mg; sodium lauryl sulfate 10.0 mg.

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

Pregnancy

The drug is contraindicated during pregnancy and lactation.

Contraindications

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

– epilepsy;

– tendon damage due to previous treatment with quinolones;

– childhood and adolescence (up to 18 years);

– pregnancy;

– lactation period.

With caution:

Old age (high probability of concomitant decline in kidney function) deficiency of glucose-6-phosphate dehydrogenase.

Side Effects

From the digestive system: nausea, vomiting, diarrhea (including blood), indigestion, loss of appetite, abdominal pain, pseudomembranous colitis, increased activity of liver transaminases, hyperbilirubinemia, hepatitis, dysbacteriosis.

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

Metabolism: hypoglycemia (increased appetite, increased sweating, trembling, nervousness), hyperglycemia.

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

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

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

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

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

Allergic reactions: itching and redness of the skin, swelling 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: asthenia, exacerbation of porphyria, photosensitivity, persistent fever, leukocytoclastic vasculitis, development of superinfection.

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

Interaction

Increases the half-life of cyclosporine.

Medicines that inhibit intestinal motility, sucralfate, aluminum- and magnesium-containing antacid medications, as well as preparations containing iron and zinc salts reduce the effect of levofloxacin. The drug should be taken 2 hours before or 2 hours after taking these drugs.

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

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

Glucocorticosteroids increase the risk of tendon rupture.

Hypoglycemic drugs increase the likelihood of hyper- and hypoglycemia, so strict control of blood glucose levels is necessary.

When used simultaneously with vitamin K antagonists, monitoring of blood clotting parameters is necessary.

Overdose

Symptoms: manifest primarily from the central nervous system (confusion, dizziness, disturbances of consciousness and convulsions similar to epileptic seizures).

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

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

Storage conditions

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

Shelf life

3 years

Manufacturer

Simpex Pharma Pvt. Ltd, India