Ofloxacin, 200 mg 10 pcs

Ofloxacin

Indications

Infectious and inflammatory diseases of the ENT organs, upper and lower respiratory tract, skin and soft tissues, bones and joints, abdominal cavity and biliary tract, kidneys and urinary tract, prostate gland, gynecological; gonorrhea.

Pharmacological effect

Pharmacological action
Pharmacological action – antibacterial, bactericidal.

Blocks DNA gyrase and disrupts DNA replication in microbial cells.

Pharmacodynamics

Active against microorganisms producing beta-lactamases and fast-growing atypical mycobacteria. Sensitive: Staphylococcus aureus, Staphylococcus epidermidis, Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Citrobacter, Klebsiella spp., (including Klebsiella pneumoniae), Enterobacter spp. (including Enterobacter cloacae), Hafnia, Proteus spp. (including Proteus mirabilis, Proteus vulgaris – indole-positive and indole-negative), Salmonella spp., Shigella spp. (including Shigella sonnei), Yersinia enterocolitica, Campylobacter jejuni, Aeromonas hydrophila, Plesiomonas aeruginosa, Vibrio cholerae, Vibrio parahaemolyticus, Haemophilus influenzae, Chlamydia spp. (including Chlamydia trachomatis), Legionella spp., Serratia spp., Providencia spp., Haemophilus ducreyi, Bordetella parapertussis, Bordetella pertussis, Moraxella catarrhalis, Propionibacterium acnes, Staphylococcus spp., Brucella spp.

The following have varying sensitivity to the drug: Enterococcus faecalis, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans, Serratia marcescens, Pseudomonas aeruginosa, Acinetobacter, Mycoplasma hominis, Mycoplasma pneumoniae, Mycobacterium tuberculosis, Mycobacterium fortuitum, Ureaplasma urealyticum, Clostridium perfringens, Corynebacterium spp., Helicobacter pylori, Listeria monocytogenes, Gardnerella vaginalis.

Generally insensitive: Nocardia asteroides, anaerobic bacteria (eg Bacteroides spp., Peptococcus spp., Peptostreptococcus spp., Eubacterium spp., Fusobacterium spp., Clostridium difficile). Does not affect Treponema pallidum.

Pharmacokinetics

After oral administration, it is quickly and completely absorbed. Bioavailability – over 96%, binding to plasma proteins – 25%. Tmax is 1–2 hours, Cmax after administration at a dose of 100, 300, 600 mg is 1, 3.4 and 6.9 mg/l. After a single dose of 200 or 400 mg, it is 2.5 mcg/ml and 5 mcg/ml, respectively.

The apparent volume of distribution is 100 l. Penetrates into tissues, organs and environments of the body: into cells (leukocytes, alveolar macrophages), skin, soft tissues, bones, abdominal and pelvic organs, respiratory system, urine, saliva, bile, prostate secretions, passes well through the BBB, placental barrier, and is excreted in breast milk. Penetrates into the cerebrospinal fluid in inflamed and non-inflamed meninges (14–60%).

Metabolized in the liver (about 5%) to form N-oxide ofloxacin and dimethylofloxacin. T1/2 does not depend on the dose and is 4.5–7 hours. 75–90% is excreted by the kidneys (unchanged), about 4% with bile. Extrarenal clearance is less than 20%.

After a single dose of 200 mg, it is detected in the urine within 20–24 hours. In case of renal/liver failure, excretion may slow down. Does not cumulate.

Special instructions

It is not a drug of choice for the treatment of pneumonia caused by pneumococci, and is not indicated for the treatment of acute tonsillitis.

During the treatment period, it is necessary to refrain from driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions. You can’t drink alcohol.

During treatment with the drug, you should not use hygienic tampons like Tampax, due to the increased risk of developing thrush.

During treatment, the course of myasthenia gravis may worsen and attacks of porphyria may increase in predisposed patients.

False-negative results are possible in the bacteriological diagnosis of tuberculosis (prevents the isolation of Mycobacterium tuberculosis).

Active ingredient

Ofloxacin

Composition

Active ingredient: ofloxacin 200 mg;

Excipients:

corn or potato starch;

MCC;

talc;

low molecular weight polyvinylpyrrolidone;

magnesium or calcium stearate;

Aerosil;

Shell composition: hydroxypropyl methylcellulose; talc; titanium dioxide; propylene glycol; polyethylene oxide 4000 or opadry IIOfloxacin – 400 mg.

Pregnancy

Contraindicated during pregnancy. Breastfeeding should be stopped during treatment.

Contraindications

Hypersensitivity, diseases of the central nervous system accompanied by convulsive syndrome, epilepsy, pregnancy, breastfeeding, childhood and adolescence until the end of skeletal formation.

Side Effects

From the nervous system and sensory organs: headache, dizziness, sleep disturbance, drowsiness, anxiety, extrapyramidal disorders, hallucinations (including visual and auditory), visual impairment, smell and taste.

From the cardiovascular system and blood (hematopoiesis, hemostasis): leuko-, neutro-, thrombocytopenia, agranulocytosis, eosinophilia, hemolytic anemia, pancytopenia.

From the gastrointestinal tract: anorexia, nausea, vomiting, diarrhea, abdominal pain, pseudomembranous colitis.

From the genitourinary system: impaired renal function, increased creatinine levels, interstitial nephritis.

From the senses: rarely – disturbances of vision, taste, smell.

From the skin: skin rash, redness, vascular purpura.

Allergic reactions: angioedema, bronchospasm, weakness, anaphylactic shock, Stevens-Johnson syndrome, toxic epidermal necrolysis, photosensitivity.

Other: arthralgia, myalgia, tendon inflammation, hypoglycemia (due to diabetes), hyperthermia, sweating.

Interaction

Probenecid, cimetidine, furosemide, methotrexate increase plasma concentrations. Increases the concentration of glibenclamide in plasma. Antacids and iron-containing drugs reduce effectiveness (should be taken 2 hours before or after taking the drug). When used concomitantly with vitamin K antagonists, coagulation must be monitored.

Overdose

Symptoms: dizziness, confusion, lethargy, disorientation, drowsiness, vomiting.

Treatment: gastric lavage, symptomatic therapy.

Storage conditions

In a place protected from light, at a temperature of 15–25 °C. Freezing is unacceptable.

Shelf life

2 years

Manufacturer

Sintez, Russia