Oflox, 200 mg 10 pcs
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ATC:
S.01.A.E.01 Ofloxacin
J.01.M.A.01 Ofloxacin
A broad spectrum antimicrobial from the group of fluoroquinolones. It has bactericidal action. It inhibits DNA-gyrease (topoisomerase II and IV), breaks process of superspiralization and cross-linking of DNA breaks, inhibits cell division, causes structural changes of cytoplasm and death of microorganisms. It has a wide spectrum of action. Primarily affects gram-negative and some gram-positive microorganisms. Effective against beta-lactamase-producing microorganisms and fast-growing atypical mycobacteria. Cross-resistance of bacteria to ofloxacin and other fluoroquinolones is possible. 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. including Pseudomonas aeruginosa, Aeromonas hydrophila, Bordetella parapertussis, Bordetella pertussis, Klebsiella spp, including 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.
Different sensitivity to the drug has: 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 Nocardia asteroides, anaerobic bacteria (e.g. Bacteroides spp., Peptococcus spp., Peptostreptococcus spp., Eubacterium spp., Fusobacterium spp., Clostridium difficile) are not sensitive. It has no effect on Treponema pallidum.
Fully absorbed in the gastrointestinal tract (about 95%), bioavailability is 96%. The maximum concentration is reached in 1-2 hours, depends on the dose: after oral administration of 100, 300 or 600 mg it is 1, 3.4 and 6.9 mg/l. About 25% is bound to plasma proteins. The apparent volume of distribution is 100 l. Distribution: cells (leukocytes, alveolar macrophages), skin, soft tissues, bones, abdominal and pelvic organs, respiratory system, urine, saliva, bile, prostate secretion, penetrates well through the blood-brain barrier, placental barrier, secreted with breast milk. It penetrates into the cerebrospinal fluid in inflamed and uninflamed cerebral membranes (14-60%).
It is metabolized in the liver (about 5%) with the formation of N-oxide ofloxacin and demethylofloxacin. It is mainly excreted unchanged by the kidneys (80-90%); a small part is excreted with the bile (about 4%), with the breast milk (extra-renal clearance is less than 20%). The half-life (regardless of the dose) is 4.5-7 hours. After a single oral administration, 200 mg is detectable in the urine within 20-24 hours. In liver and/or kidney disease, excretion may be delayed. Repeated administration does not lead to cumulation.
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Indications
Active ingredient
Composition
Active ingredient:
Ofloxacin – 200 mg.
Excipients:
Core: potato starch – 23mg, magnesium stearate – 3mg, microcrystalline cellulose – 54mg, povidone – 10mg
Film coating: ready-made water-soluble film coating – 15mg. (Shell composition: hydroxypropyl methylcellulose (hypromellose) – 3.75 mg, copovidone (copolyvidone) -3.375, polyethylene glycol 6000 (Macrogol 6000) – 1.425 mg, glyceryl caprylocaprate – 0.45 mg, polydextrose -2.25 mg, titanium dioxide – 3.75 mg.
How to take, the dosage
Ingestion. 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 the function of the liver and kidneys.
Adults – 200-800 mg per day, frequency of use – 2 times a day. A dose of up to 400 mg per day may be administered in 1 dose, preferably in the morning. In gonorrhea it is 400 mg once daily.
In patients with impaired renal function (with a creatinine clearance of 50-20 ml/min), the single dose should be 50% of the average dose with 2 times daily administration, or the full single dose administered once daily. If creatinine clearance is less than 20 ml/min, the single dose is 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/day.
The tablets are taken whole with water before or with a meal. Duration of treatment course is determined by pathogen sensitivity and clinical picture; treatment should be continued for at least 3 days after symptoms disappear and temperature normalizes completely. During treatment of salmonellosis the course of treatment is 7-8 days, in case of uncomplicated infections of the lower urinary tract the course of treatment is 3-5 days.
Interaction
Inhibits theophylline clearance by 25% (when using simultaneously theophylline dose should be reduced).
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 nonsteroidal anti-inflammatory drugs, nitroimidazole derivatives and methylxanthines.
The risk of tendon rupture increases when concomitantly prescribed with glucocorticosteroids, especially in the elderly.
The risk of crystalluria and nephrotoxic effects increases when prescribed with drugs that alkalize the urine (carboanhydrase inhibitors, citrates, sodium bicarbonate).
Special Instructions
It is not the drug of choice for pneumonia caused by pneumococci. It is not indicated in the treatment of acute tonsillitis.
It is not recommended to use for more than 2 months, exposure to sunlight, exposure to ultraviolet rays (mercury quartz lamps, solarium).
In case of side effects of the central nervous system, allergic reactions, pseudomembranous colitis, the drug should be stopped. In pseudomembranous colitis confirmed by colonoscopy and/or histology, oral administration of vancomycin and metronidazole is indicated.
Rarely occurring tendinitis may lead to tendon rupture (predominantly Achilles tendon), especially in elderly patients. If signs of tendinitis occur, treatment should be stopped immediately, the Achilles tendon should be immobilized, and an orthopedic surgeon should be consulted.
Women should not use tampons when using the drug, due to the increased risk of thrush.
The course of myasthenia gravis may worsen with treatment and increased incidence of porphyria in predisposed patients.
May lead to false-negative results in bacteriological diagnosis of tuberculosis (prevents isolation of Mycobacterium tuberculosis).
In patients with impaired hepatic or renal function it is necessary to monitor plasma concentration of Ofloxacin. In patients with severe renal or hepatic insufficiency the risk of toxic effects increases (dose adjustment is required).
Contraindications
Side effects
Gastrointestinal tract: gastralgia, anorexia, nausea, vomiting, diarrhea, flatulence, abdominal pain, increased activity of liver transaminases, hyperbilirubinemia, cholestatic jaundice, pseudomembranous enterocolitis.
Nervous system disorders: headache, dizziness, uncertainty of movements, tremor, convulsions, numbness and paresthesias of extremities, intense dreams, “nightmares” dreams, psychotic reactions, anxiety, state of agitation, phobias, depression, confusion, hallucinations, increased intracranial pressure.
Musculoskeletal system: tendinitis, myalgia, arthralgia, tenosynovitis, tendon rupture.
Sensory organs: color perception disorders, diplopia, disorders of taste, smell, hearing and balance.
Cardiovascular system: tachycardia, decreased blood pressure.
Allergic reactions: skin rash, itching, urticaria, allergic pneumonitis, allergic nephritis, eosinophilia, fever, Quincke’s edema, bronchospasm, Stevens-Johnson and Lyell syndrome, photosensitization, erythema multiforme exudative, anaphylactic shock.
Skin disorders: petechial hemorrhages (petechiae), bullous hemorrhagic dermatitis, papular rash with crust, indicating vascular lesions (vasculitis).
Hematopoietic organs: leukopenia, agranulocytosis, anemia, thrombocytopenia, pancytopenia, hemolytic and aplastic anemia.
Urinary system disorders: acute interstitial nephritis, renal dysfunction, hypercreatininemia, increased urea.
Others: dysbacteriosis, superinfection, hypoglycemia (in diabetic patients), vaginitis.
Overdose
Similarities
Weight | 0.012 kg |
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Shelf life | 4 years. Do not use after the expiration date. |
Conditions of storage | In a dry, light-protected place at a temperature not exceeding 25°C. Store out of the reach of children. |
Manufacturer | Pharmasintez JSC, Russia |
Medication form | pills |
Brand | Pharmasintez JSC |
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