Composition
Active ingredient:
Ofloxacin – 200 mg.
Auxiliary substances:
Core: potato starch-23 mg, magnesium stearate-3 mg, microcrystalline cellulose-54 mg, povidone-10 mg
Film coating: ready-made water-soluble film coating – 15 mg. (Shell composition: hydroxypropylmethylcellulose (hypromellose) – 3.75 mg, copovidone (copolividone)-3.375, polyethylene glycol 6000 (Macrogol 6000) – 1.425 mg, glyceryl caprylocaprate-0.45 mg, polydextrose -2.25 mg, titanium dioxide-3.75 mg
Pharmacological action
Pharmacotherapy group: Antimicrobial agent-Fluoroquinolonate: Â
S. 01. A. E. 01 Ofloxacin
J. 01. M. A. 01 Ofloxacin
Pharmacodynamics :
Broad-spectrum antimicrobial drug from the group of fluoroquinolones. It acts bactericidal. It inhibits DNA gyrase (topoisomerase II and IV), disrupts the process of supercoiling and crosslinking of DNA breaks, inhibits cell division, causes structural changes in the cytoplasm and the death of microorganisms. It has a wide range of actions. It affects mainly gram-negative and some gram-positive microorganisms. It is effective against microorganisms producing beta-lactamases and fast-growing atypical mycobacteria. Cross-resistance of bacteria to ofloxacin and other fluoroquinolones is possible. The spectrum of action includes:  Escherichia coli, Salmonella spp., Enterobacter spp., Serratia spp., Citrobacter spp., Yersinia spp., Haemophilis influenzae, Haemophilis ducreyi, Proteus mirabilis, Proteus vulgaris, Pseudomonas spp., include Pseudomonas aeruginosa, Aeromonas hydrophila, Bordetella parapertussis, Bordetella pertussis, Klebsiella spp., include Klebsiella pneumoniae, Moraxella (Branhamella) catarrhalis, Morganella morganii, Providencia spp., Neisseria meningitidis, Shigella sonnei, Helicobacter pyroli, Mycoplasma spp., Ureaplasma urealyticum, Vibrio spp., Gardnerella vaginalis, Chlamydia spp., Legionella pneumophila, Staphylococcus spp., Propionibacterium acnes.
They have different sensitivity to the drug:  Enterococcus faecalis, Streptococcus pyogenes, Streptococcus pneumoniae, Streptococcus viridans, Serratio marcescens, Pseudomonas aeruginosa, Acinetobacter spp., Mycoplasma hominis, Mycobacterium pneumoniae, Mycobacterium tuberculosis, as well as Mycobacterium fortuim, Ureaplasma urealyticum, Clostridium perfringens, Corynebacterium spp., Helicobacter pylori, Listeria monocytogenes, Gardnerella vaginalis.
In most cases, they are insensitive: Â Nocardia asteroides, anaerobic bacteria (for example, Bacteroides spp., Peptococcus spp., Peptostreptococcus spp., Eubacterium spp., Fusobacterium spp., Clostridium difficile). He acts on Treponema pallidum.
Pharmacokinetics:
Completely absorbed in the gastrointestinal tract (about 95%), bioavailability-96%. The maximum concentration is reached in 1-2 hours, depending on the dose: after oral use of 100,300 or 600 mg, it is 1,3.4 and 6.9 mg/l. About 25% binds to plasma proteins. The apparent volume of distribution is 100 liters. Distribution: cells (leukocytes, alveolar macrophages), skin, soft tissues, bones, abdominal and pelvic organs, respiratory system, urine, saliva, bile, prostate secretions, penetrates well through the blood-brain barrier, placental barrier, is secreted with mother’s milk. Penetrates the cerebrospinal fluid in inflamed and non-inflamed meninges (14-60%).
It is metabolized in the liver (about 5%) to form N-oxide ofloxacin and demetilofloxacin. It is mainly excreted by the kidneys in unchanged form (80-90%); a small part is excreted in bile (about 4%), breast milk (extrarenal clearance is less than 20%). The half-life (regardless of the dose) is 4.5-7 hours. After a single oral use of 200 mg in the urine is detected within 20-24 hours. In cases of liver and/or kidney diseases, excretion may slow down. Re-assignment does not result in cumulation.
Indications
Infectious and inflammatory diseases caused by microorganisms sensitive to ofloxacin: infections of the respiratory tract (bronchitis, pneumonia), ENT organs (sinusitis, pharyngitis, otitis media, laryngitis); skin, soft tissues; bones, joints; infectious and inflammatory diseases of the abdominal cavity and biliary tract (except for bacterial enteritis); kidneys (pyelonephritis), urinary tract (cystitis, urethritis); pelvic organs (endometritis, salpingitis, oophoritis, cervicitis, parametritis, prostatitis); genitals (colpitis, orchitis, epididymitis), gonorrhea, chlamydia; prevention of infections in patients with impaired immune status (including neutropenia).
Contraindications
Hypersensitivity, glucose-6-phosphate dehydrogenase deficiency, epilepsy (including in the anamnesis), reduced seizure threshold (including after a traumatic brain injury, stroke, or inflammatory processes in the central nervous system); age up to 18 years (until skeletal growth is completed), pregnancy, lactation. With caution: Arteriosclerosis of the cerebral vessels, cerebral circulatory disorders (in the anamnesis), chronic renal failure, organic lesions of the central nervous system.
Side effects
From the gastrointestinal tract: gastralgia, anorexia, nausea, vomiting, diarrhea, flatulence, abdominal pain, increased activity of “hepatic” transaminases, hyperbilirubinemia, cholestatic jaundice, pseudomembranous enterocolitis.
Nervous system disorders: headache, dizziness, movement uncertainty, tremor, convulsions, numbness and paresthesia of the extremities, intense dreams, “nightmarish” dreams, psychotic reactions, anxiety, agitation, phobias, depression, confusion, hallucinations, increased intracranial pressure.
Musculoskeletal disorders: tendinitis, myalgia, arthralgia, tendosynovitis, tendon rupture.
Sensory disorders: color perception disorders, diplopia, taste, smell, hearing and balance disorders.
From the cardiovascular system: tachycardia, low blood pressure.
Allergic reactions: skin rash, pruritus, urticaria, allergic pneumonitis, allergic nephritis, eosinophilia, fever, angioedema, bronchospasm, Stevens-Johnson and Lyell syndromes, photosensitization, erythema multiforme, anaphylactic shock.
From the skin: spot hemorrhages (petechiae), bullous hemorrhagic dermatitis, papular rash with a crust, indicating vascular damage (vasculitis).
Hematopoietic disorders: leukopenia, agranulocytosis, anemia, thrombocytopenia, pancytopenia, hemolytic and aplastic anemia.
From the urinary system: acute interstitial nephritis, impaired renal function, hypercreatininemia, increased urea content.
Other: dysbiosis, superinfection, hypoglycemia (in patients with diabetes mellitus), vaginitis.
Interaction
Food products, antacids containing aluminum, calcium, magnesium or iron salts reduce the absorption of ofloxacin, forming insoluble complexes (the time interval between the appointment of these drugs should be at least 2 hours).
Reduces the clearance of theophylline by 25% (with simultaneous use, the dose of theophylline should be reduced).
Cimetidine, furosemide, methotrexate and drugs that block tubular secretion-increase the concentration of ofloxacin in plasma.
Increases the concentration of glibenclamide in plasma.
When taking vitamin K antagonists at the same time, it is necessary to monitor the blood coagulation system.
When prescribed with nonsteroidal anti-inflammatory drugs, nitroimidazole and methylxanthine derivatives, the risk of neurotoxic effects increases.
Concomitant use with glucocorticosteroids increases the risk of tendon rupture, especially in the elderly.
When prescribed with drugs that alkalize the urine (carbonic anhydrase inhibitors, citrates, sodium bicarbonate), the risk of crystalluria and nephrotoxic effects increases.
How to take, course of use and dosage
Inside. Doses are selected individually depending on the location 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 frequency of use-2 times a day. A dose of up to 400 mg per day can be administered in 1 dose, preferably in the morning. For gonorrhea – 400 mg once.
In patients with impaired renal function (with a creatinine clearance of 50-20 ml / min), a single dose should be 50% of the average dose with a multiplicity of 2 times a day, or a full single dose should be administered 1 time a day. If creatinine clearance is less than 20 ml / min – a single dose of 200 mg, then-100 mg per day every other day.
For hemodialysis and peritoneal dialysis-100 mg every 24 hours. The maximum daily dose for hepatic insufficiency is 400 mg/day.
Tablets are taken whole, washed down with water before or during meals. The duration of the course of treatment is determined by the sensitivity of the pathogen and the clinical picture; treatment should be continued for at least 3 more days after the disappearance of symptoms of the disease and full normalization of temperature. In the treatment of salmonellosis, the course of treatment is 7-8 days, in uncomplicated lower urinary tract infections, the course of treatment is 3-5 days.
Overdose
Symptoms: dizziness, confusion, lethargy, disorientation, drowsiness, vomiting. Treatment: gastric lavage, symptomatic therapy. During hemodialysis,10-30% of the drug is removed.
Special instructions
It is not the drug of choice for pneumococcal pneumonia.It is not indicated in the treatment of acute tonsillitis.
It is not recommended to use it for more than 2 months, to be exposed to sunlight, to ultraviolet radiation (mercury-quartz lamps, tanning beds).
In case of side effects from the central nervous system, allergic reactions, pseudomembranous colitis, discontinuation of the drug is necessary. If pseudomembranous colitis is confirmed colonoscopically and/or histologically, oral use of vancomycin and metronidazole is indicated.
Rarely occurring tendinitis can lead to tendon rupture (mainly the Achilles tendon), especially in elderly patients. In case of signs of tendinitis, it is necessary to immediately stop treatment, immobilize the Achilles tendon and consult an orthopedic specialist.
When using the drug, women are not recommended to use tampons, due to the increased risk of developing thrush.
Against the background of treatment, the course of myasthenia gravis may worsen, and porphyria attacks may become more frequent in predisposed patients.
It can lead to false negative results in the bacteriological diagnosis of tuberculosis (prevents the release of Mycobacterium tuberculosis).
In patients with impaired liver or kidney function, it is necessary to monitor the concentration of ofloxacin in plasma. With severe renal and hepatic insufficiency, the risk of toxic effects increases (dose adjustment is required).
Influence on the ability to drive vehicles and mechanisms:During the treatment period, it is necessary to refrain from driving vehicles and engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions, you can not use ethanol.
Storage conditions
Store in a dry place protected from light at a temperature not exceeding 25°C.
Keep out of reach of children.
Shelf
life is 4 years. Do not use after the expiration date.
Active ingredient
Ofloxacin
Conditions of release from pharmacies
By prescription
Dosage form
Tablets
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