Ofloxacin, 400 mg 10 pcs

A broad-spectrum antimicrobial agent of the group of fluoroquinolones. It acts on the bacterial enzyme DNA-hyraza, which provides superspiralization and thus stability of bacterial DNA (destabilization of DNA chains leads to their death). It has a bactericidal effect.

The drug is active against β-lactamase-producing microorganisms and fast-growing atypical mycobacteria.

The following are sensitive to the drug: Staphylococcus aureus, Staphylococcus epidermidis, Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Citrobacter spp, Klebsiella spp. (including Klebsiella pneumoniae), Enterobacter spp., Hafnia spp., Proteus spp. (including Proteus mirabilis, Proteus vulgaris – indole positive and indole negative strains), Salmonella spp, Shigella spp. (including Shigella sonnei), Yersinia enterocolitica, Campylobacter jejuni, Aeromonas hydrophila, Plesiomonas aeruginosa, Vibrio cholerae, Vibrio parahaemolyticus, Haemophilus influenzae, Chlamydia spp, Legionella spp., Serratia spp., Providencia spp., Haemophilus ducreyi, Bordetella parapertussis, Bordetella pertussis, Moraxella catarrhalis, Propionibacterium acnes, Brucella spp.

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

The drug is resistant to Nocardia asteroides, anaerobic bacteria (Bacteroides spp., Peptococcus spp., Peptostreptococcus spp., Eubacterium spp., Fusobacterium spp., Clostridium difficile).

The drug is inactive against Treponema pallidum.

Indications

Active ingredient

Composition

Active substance:

ofloxacin – 400 mg;

Associates:

Corn or potato starch;

MCC;

Talc;

Low molecular weight polyvinylpyrrolidone;

Magnesium or calcium stearate;

Arosil

Shell composition:

Oxypropyl methylcellulose; talc; titanium dioxide; propylene glycol; polyethylene oxide 4000 or opadray II

How to take, the dosage

Orally, before or during meals, whole, with water. Doses are selected individually depending on the localization and severity of the infection as well as the sensitivity of microorganisms, the general condition of the patient and liver and kidney function.

Adults: 200-800 mg per day, the course of treatment – 7-10 days, 2 times a day. Dose up to 400 mg in 1 dose, preferably in the morning. In gonorrhea it is 400 mg once.

In patients with impaired renal function (in creatinine Cl 50-20 ml/min), a single dose should be taken once daily or 50% of the average dose twice daily. In creatinine Cl less than 20 ml/min a single dose of 200 mg, then 100 mg per day every other day.

In hemodialysis and peritoneal dialysis, 100 mg every 24 hours. Maximum daily dose in hepatic failure is 400 mg.

The duration of treatment course is determined by the sensitivity of the causative agent and clinical picture; the treatment should be continued for at least 3 days after relief of symptoms and complete normalization of temperature. For treatment of salmonellosis the course of treatment shall be 7-8 days, in case of uncomplicated lower urinary tract infections – 3-5 days.

In children – only for vital indications, if it is impossible to substitute other drugs. The average daily dose is 7.5 mg/kg and the maximum dose is 15 mg/kg.

Interaction

Compatible with the following infusion solutions: isotonic sodium chloride solution, Ringer’s solution, 5% fructose solution, 5% dextrose (glucose) solution.

Do not mix with heparin (risk of precipitation).

Foods, antacids containing Al3+, Ca2+, Mg2+ or iron salts, reduce the absorption of Ofloxacin by forming insoluble complexes (the interval between doses of these drugs should be at least 2 hours).

Decreases clearance of theophylline by 25% (theophylline dose should be reduced with concomitant use).

Cimetidine, furosemide, methotrexate and drugs that block tubular secretion increase plasma concentration of ofloxacin.

Increases the plasma concentration of glibenclamide.

Concomitant administration with vitamin K antagonists requires monitoring of the clotting system.

The risk of neurotoxic effects increases when prescribed with NSAIDs, nitroimidazole derivatives and methylxanthine.

The risk of tendon rupture increases when concomitantly prescribed with glucocorticoids, especially in the elderly.

The risk of crystalluria and nephrotic effects increases when prescribed with drugs that alkalize the urine (carboanhydrase inhibitors, sodium bicarbonate).

Special Instructions

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

At the time of treatment it is necessary to refrain from driving vehicles and engaging in potentially dangerous activities that require increased concentration and quick psychomotor reactions. Alcohol must not be consumed.

Tampax tampons should not be used during treatment with the drug, because of the increased risk of thrush.

Treatment may cause worsening of myasthenia gravis, and increased incidence of porphyria in susceptible patients.

Possible false-negative results in bacteriological diagnosis of tuberculosis (prevents isolation of Mycobacterium tuberculosis).

Contraindications

With caution, the drug should be used in case of atherosclerosis of cerebral vessels, cerebral blood circulation disorders (in anamnesis), chronic renal insufficiency and organic CNS lesions.

Side effects

Gastrointestinal system disorders: gastralgia, anorexia, nausea, vomiting, diarrhea, flatulence, abdominal pain, increased liver transaminase activity, hyperbilirubinemia, cholestatic jaundice, pseudomembranous enterocolitis.

Nervous system and sensory organs: Headache, dizziness, uncertainty of movements, tremor, convulsions, numbness and paresthesias of the extremities, intense dreams, “nightmares” dreams, psychotic reactions, anxiety, state of agitation, phobias, depression, confusion, hallucinations, increased intracranial pressure; color perception disorders, diplopia, disorders of taste, smell, hearing and balance. When using the ointment – a burning sensation and discomfort in the eyes, hyperemia, itching and dryness of the conjunctiva, photophobia, lacrimation.

Musculoskeletal system: tendinitis, myalgia, arthralgia, tenosynovitis, tendon rupture.

Cardiovascular and blood (hematopoiesis, hemostasis): tachycardia, BP decrease (when infused; if BP drops rapidly, the infusion is stopped), vasculitis, collapse; leukopenia, agranulocytosis, anemia, thrombocytopenia, pancytopenia, hemolytic and aplastic anemia.

Allergic reactions: skin rash, itching, urticaria, allergic pneumonitis, allergic nephritis, eosinophilia, fever, Quincke’s edema, bronchospasm, Stevens-Johnson and Lyell syndrome, photosensitization, erythema multiforme, rarely – anaphylactic shock.

Skin disorders: petechial hemorrhages (petechiae), bullous hemorrhagic dermatitis, papular rash with crust, indicating vascular lesions (vasculitis).

Urinary system disorders: acute interstitial nephritis, impaired renal function, hypercreatininemia, increased urea.

Others: dysbacteriosis, superinfection, hypoglycemia (in diabetic patients), vaginitis.

Overdose

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

Treatment: gastric lavage, symptomatic therapy.

Similarities