Hileflox pills 750 mg, 5 pcs.

Composition

1 table. contains:

Active ingredient:

levofloxacin hemihydrate 780.26 mg (corresponds to 750 mg of levofloxacin);

excipients: 

corn starch-71.96 mg;

MCC-60.5 mg;

povidone K 30-7.5 mg;

methyl parahydroxybenzoate-0.9 mg;

propyl parahydroxybenzoate-0.18 mg;

purified talc-19.5 mg;

magnesium stearate-9.6 mg;

sodium carboxymethyl starch-9.6 mg;

film shell:

hypromellose; purified talc; macrogol 6000; titanium dioxide; dye “Sunny sunset” yellow

Pharmacological action

Levofloxacin is a broad-spectrum synthetic fluoroquinolone. It inhibits DNA gyrase (topoisomerase II) and topoisomerase IV, disrupts supercoiling and crosslinking of DNA breaks, suppresses DNA synthesis, and causes deep morphological changes in the cytoplasm, cell wall, and membranes of sensitive microorganisms.

Levofloxacin is effective against most strains of the following microorganisms:

aerobic gram-positive microorganisms-Corynebacterium diphtheriae, Enterococcus spp. (including Enterococcus faecalis), Listeria monocytogenes, Staphylococcus spp. (leukotoxin-containing and coagulase-negative methicillin-sensitive/moderately sensitive strains, including methicillin-sensitive strains Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus spp. (including strains Staphylococcus groups C and G, Streptococcus agalactiae, Streptococcus pyogenes, penicillinsusceptible/moderately sensitive/resistant strains of Streptococcus pneumoniae, penicillinsusceptible/resistant strains of Streptococcus viridans group);

aerobic gram — negative microorganisms Acinetobacter spp. (including Acinetobacter baumanii), Actinobacillus actinomycetemcomitans, Citrobacter freundii, Eikenella corrodens, Enterobacter spp. (including Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter cloacae), Escherichia coli, Gardnerella vaginalis, Haemophilus spp. (including Haemophilus ducreyi, Haemophilus parainfluenzae, ampicillinampicillin/resistant strains of Haemophilus influenzae), Helicobacter pylori, Klebsiella spp. (including Klebsiella oxytoca, Klebsiella pneumoniae), Moraxela catarrhalis (producing and reproducirse beta-lactamase strains), Morganella morganii, Neisseria spp. (including Neisseria meningitidis and reproducirse producing penicillinase strains Neisseria gonorroeae), Pasteurella spp. (including conis Pasteurella, Pasteurella dagmatis, Pasteurella multocida), Proteus spp. (including Proteus mirabilis, Proteus vulgaris), Providencia spp. (including Providencia rettgeri, Providencia stuartii), Pseudomonas spp. (including Pseudomonas aeruginosa), Serratia spp. (including Serratia marcescens), Salmonella spp. ;

anaerobic microorganisms Bacteroides fragilis, Bifidobacterium spp., Clostridium perfringens, Fusobacterium spp., Peptostreptococcus spp. Propionibacterum spp. Veilonella spp. ;

other micro — organisms Bartonella spp. Chlamydia spp. (including Chlamydia pneumoniae, Chlamydia psittaci, Chlamydia trachomatis), Legionella pneumophila, Mycobacterium spp. (including Mycobacterium leprae, Mycobacterium tuberculosis), Mycoplasma spp. (including Mycoplasma hominis, Mycoplasma pneumoniae), Rickettsia spp., Ureaplasma urealyticum.

Resistant microorganisms:

aerobic gram-positive microorganisms-Corynebacterium jeikeium, Staphylococcus spp. (coagulase-negative methicillin-resistant strains, including methicillin-resistant strains Staphylococcus aureus);

aerobic gram-negative microorganisms-Alcaligenes xylosoxidans;

other microorganisms-Mycobacterium avium.

Indications

• Infectious and inflammatory diseases of mild and moderate severity caused by microorganisms sensitive to the drug:
• infections of the lower respiratory tract (pneumonia, exacerbation of chronic bronchitis);
• acute bacterial sinusitis,
• urinary tract infections and kidney function (including acute pyelonephritis);
• infections of skin and soft tissues (festering of sebaceous cysts, abscesses, boils);
• chronic bacterial prostatitis;
• intra-abdominal infections (in combination with antibacterial drugs, acting on the anaerobic microflora);
• tuberculosis (in the complex therapy of drug-resistant forms).

Contraindications

• hypersensitivity to levofoxacin, other fluoroquinolones or other components of the drug in the anamnesis;
• epilepsy;
• tendon damage associated with taking quinolones in the anamnesis;
• children and adolescents under 18 years of age;
• pregnancy;
• lactation.

With caution — elderly age (high probability of concomitant decline in renal function), glucose-6-phosphate dehydrogenase deficiency.

Side effects

Nervous system disorders: headache, dizziness, weakness, drowsiness, insomnia, tremor, anxiety, paresthesia, fear, hallucinations, confusion, depression, movement disorders, seizures.

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

From the CCC side: reduced blood pressure, vascular collapse, tachycardia, prolongation of the QT interval, atrial fibrillation.

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

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

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

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

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, suffocation, anaphylactic shock, allergic pneumonitis, vasculitis.

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

Interaction

Levofloxacin increases the elimination half-life of cyclosporine. The effect of levofloxacin is reduced by drugs that inhibit intestinal motility, sucralfate, aluminum-or magnesium-containing antacids and iron preparations. NSAIDs and theophylline, when used concomitantly with levofloxacin, increase the risk of seizures in predisposed patients, and CORTICOSTEROIDS increase the risk of tendon rupture. When levofloxacin is co-administered with hypoglycemic drugs, changes in blood glucose levels, including hyperglycemia and hypoglycemia, may occur. Levofloxacin enhances the effect of warfarin. Cimetidine and drugs that block tubular secretion slow down the elimination of levofloxacin.

How to take, course of administration and dosage

Inside, before meals or in between meals, without chewing, with a sufficient amount of water. Adult patients with normal renal function (creatinine clearance >50 ml/min) should be administered according to the regimens shown in the table:Hospital-acquired pneumonia 750 mg 1 time/day for 7-14 days. Community-acquired pneumonia 500 mg 1-2 times/day for 7-14 days; 750 mg 1 time/day for 5* days. Exacerbation of chronic bronchitis 500 mg 1 time/day for 7 days. Acute bacterial sinusitis 500 mg 1 time/day for 10-14 days; 750 mg 1 time/day for 5 days. Uncomplicated urinary tract infections 250 mg 1 time/day for 3 days. Complicated urinary tract infections, including acute pyelonephritis 250 mg 1 time / day for 10* * days; 750 mg 1 time/day for 5 * * * days. Uncomplicated skin and subcutaneous tissue infections 500 mg 1 time/day for 7-10 days. Complicated skin and subcutaneous tissue infections 750 mg 1 time/day for 7-14 days. Chronic bacterial prostatitis 500 mg 1 time/day for 28 days. Intraabdominal infection (in combination with antibacterial drugs acting on anaerobic microflora) 500 mg 1 time/day for 7-14 days. Tuberculosis (as part of complex therapy of drug-resistant forms) 750 mg 1 time/day for up to 3 months* This regimen is indicated for the treatment of community-acquired pneumonia caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, Chlamydia pneumoniae. ** This regimen is indicated for the treatment of urinary tract infections caused by Enterococcus faecalis, Enterococcus cloacae, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and acute pyelonephritis caused by Escherichia coli. *** This regimen is indicated for the treatment of urinary tract infections caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and acute pyelonephritis caused by Escherichia coli, including cases with concomitant bacteremia.

Overdose

Symptoms: nausea, erosive lesions of the gastrointestinal mucosa, prolongation of the QT interval, confusion, dizziness, convulsions. Treatment: gastric lavage, if necessary — symptomatic therapy. There is no specific antidote, and dialysis is ineffective.

Special instructions

After normalization of body temperature, it is recommended to continue treatment for at least 48-72 hours. Levofloxacin is taken at least 2 hours before or 2 hours after taking antacids of magnesium/aluminum or sucralfate, or other drugs containing calcium, iron or zinc. Due to possible photosensitization during treatment and for 5 days after the end of treatment with levofloxacin, it is necessary to avoid solar and artificial UV radiation. If phototoxicity develops, treatment with the drug should be discontinued. If signs of tendinitis and pseudomembranous colitis appear, levofloxacin is immediately discontinued. It should be borne in mind that patients with a history of brain damage (stroke, severe trauma) may develop seizures. If glucose-6-phosphate dehydrogenase is insufficient, there may be a risk of hemolytic reactions. In patients with diabetes mellitus, blood glucose levels should be carefully monitored during treatment with levofloxacin. When levofloxacin and warfarin are co-administered, monitoring of PV, INR, or other anticoagulation tests is indicated, as well as monitoring for signs of bleeding. While taking levofloxacin, the patient’s ability to concentrate and the speed of psychomotor reactions may be impaired. In this regard, it is necessary to use caution when driving vehicles and engaging in other potentially dangerous activities. After normalization of body temperature, it is recommended to continue treatment for at least 48-72 hours. Levofloxacin is taken at least 2 hours before or 2 hours after taking antacids of magnesium/aluminum or sucralfate, or other drugs containing calcium, iron or zinc. Due to possible photosensitization during treatment and for 5 days after the end of treatment with levofloxacin, it is necessary to avoid solar and artificial UV radiation. If phototoxicity develops, treatment with the drug should be discontinued. If signs of tendinitis and pseudomembranous colitis appear, levofloxacin is immediately discontinued. It should be borne in mind that patients with a history of brain damage (stroke, severe trauma) may develop seizures. If glucose-6-phosphate dehydrogenase is insufficient, there may be a risk of hemolytic reactions. In patients with diabetes mellitus, blood glucose levels should be carefully monitored during treatment with levofloxacin. When levofloxacin and warfarin are co-administered, monitoring of PV, INR, or other anticoagulation tests is indicated, as well as monitoring for signs of bleeding. While taking levofloxacin, the patient’s ability to concentrate and the speed of psychomotor reactions may be impaired. In this regard, it is necessary to use caution when driving vehicles and engaging in other potentially dangerous activities.

Storage conditions

Store in a dry place, protected from light, at a temperature of 8-25 °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

Pneumonia, Urinary Tract Infections, Sinusitis, Respiratory Tract Infections, Prostatitis, Skin Infections

Weight

Weight: 16 gr.