Active substanceOfloxacinOfloxacin
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  • Dosage form: & nbsp

    film-coated tablets

    Composition:

    Active substance: Ofloxacin 200 mg.

    Excipients: microcrystalline cellulose, lactose, sodium lauryl sulfate, povidone, sodium carboxymethyl starch, crospovidone, colloidal silicon dioxide, talc purified, magnesium stearate;

    Shell composition: hypromellose, talc purified, titanium dioxide, magnesium stearate, dye quinoline yellow, macrogol 6000, diethyl phthalate.

    Description:

    Yellow, oval, biconvex tablets, covered with a film membrane.

    Pharmacotherapeutic group:Antimicrobial agent - fluoroquinolone
    ATX: & nbsp

    S.01.A.E.01   Ofloxacin

    J.01.M.A.01   Ofloxacin

    Pharmacodynamics:

    Antimicrobial drug from the group of fluoroquinolones of broad spectrum of action. It is bactericidal. The mechanism of the action of ofloxacin is associated with the blockade of the DNA-gyrase enzyme in bacterial cells.

    Highly active against most gram-negative and some gram-positive microorganisms: Aeromonas hydrophila, Branhamella catarrhalis, Brucella spp., Clostridium perfringens, Esherichia coli, Salmonella spp., Enterobacter spp., Serratia spp., Citrobacter spp., Yersinia spp., Providencia spp., Haemophilus influenzae, Haemophilus parainfluenzae, Haemophilus ducreyi, Plesiomonas , Legionella, Shigella spp., Proteus spp., including Proteus mirabilis, Proteus vulgaris (indole positive and indole negative), Moraxellamorganii, Klebsiella spp., including Klebsiella pneumoniae, Helicobacter pylori, Mycoplasma spp., Vibrio spp., Gardnerella vaginalis, Neisseria gononrhoeae, Neisseria meningitidis, Chlamydia trachomatis, Staphylococcus aureus methi-S, Staphylococcus coagulase negative.

    Moderately sensitive to ofloxacin Acinetobacter spp., Ureaplasma urealyticum, Bacteroides fragilis, Mycobacterium tuberculosis, Mycobacterium leprae, Chlamidia psittaci, Anaerobic Gram positive cocci, Enterococcus faecal is, Streptococcus pneumoniae, Pseudomonas spp., Streptococcus spp (special βhemolytic).

    To ofloxacin insensitive: Acinetobacter braumanmii, Clostridium difficile, Enterococci, Listeria monocytogenes, Staphylococci methi-R, Nocardia spp., Ofloxacin is inactive with respect to Treponema pallidum.

    Pharmacokinetics:

    After oral administration ofloxacin quickly and almost completely (95%) is absorbed from the gastrointestinal tract. Bioavailability is almost 100%. The maximum concentration of ofloxacin in the blood plasma after taking a single dose of 200 mg is 2.5-3 mg / ml and is achieved after 1 hour, food can slow absorption.Binding to plasma proteins is 25 %. Metabolized in the liver (about 5%) with formation Noxide ofloxacin and dimethyl ofloxacin. The half-life is 6-7 hours. To 9.0% ofloxacin is excreted by the kidneys unchanged. In patients with impaired function kidneys (creatinine clearance 50 ml / min or less) the half-life of ofloxacin increases.

    Indications:

    Infectious-inflammatory diseases caused by microorganisms sensitive to ofloxacin:

    - infections of the lower respiratory tract (with the exception of cases of pneumococcal infection);

    - infection of the ENT organs (except in cases of acute tonsillitis);

    - infection of the abdominal cavity and biliary tract;

    - kidney infection (pyelonephritis) and urinary tract (cystitis, urethritis (including gonococcal nature));

    - infections of the pelvic organs and genital organs (including gonococcal and chlamydial nature);

    - infection of bones and joints;

    - infections of the skin and soft tissues;

    Prevention of infections in patients with immunodeficiency of various etiologies (including neutropenia).

    Contraindications:

    - Hypersensitivity to ofloxacin and other quinolone preparations;

    - epilepsy (including in the anamnesis);

    - lesions of the central nervous system with a decrease in convulsive threshold (after craniocerebral trauma, stroke, inflammatory processes of the central nervous system);

    - age to 18 years;

    - deficiency of glucose-6-phosphate dehydrogenase;

    - creatinine clearance less than 20 ml / min;

    - pregnancy;

    - lactation period.

    Carefully:

    Atherosclerosis of cerebral vessels, cerebral circulatory disorders (in history), chronic renal failure, organic lesions of the central nervous system, in patients with an elongated interval QT.

    Pregnancy and lactation:Contraindicated.
    Dosing and Administration:

    The dose of ofloxacin and the duration of treatment depend on the severity and type of infection, the general condition of the patient and the function of the kidneys. Tablets are taken internally as a whole, with water, before or during meals.

    The average daily intake for adults is from 200 mg to 600 mg. A dose of up to 400 mg / day can be given in one session, preferably in the morning. Doses over 400 mg / day should be divided into two doses at equal intervals.

    The duration of treatment is 7-10 days. Treatment should continue for at least 3 more days after the disappearance of the symptoms of the disease and complete normalization of body temperature.In the treatment of salmonellosis, the course of treatment is 7-8 days.

    In severe infections or in the treatment of patients with overweight, the daily dose can be increased to 800 mg.

    In uncomplicated infections of the lower urinary tract, the drug is prescribed at a dose of 200 mg / day for 3-5 days. With gonorrhea prescribed 400 mg once.

    Have patients from impaired renal function The dose of ofloxacin is determined depending on the creatinine clearance:

    - in patients with creatinine clearance (CK) above 50 ml / min, dose adjustment is not required.

    - in patients with KK 50-20 ml / min single dose is 200 mg with an interval between doses of 24 hours.

    In patients from hepatic impairment it is not recommended to exceed the maximum daily dose of 400 mg.

    Side effects:
    Allergic reactions: skin rash, itching, urticaria, angioedema, allergic nephritis, allergic pneumonitis, eosinophilia, bronchospasm, anaphylactic shock, erythema multiforme exudative (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), purpura, fever.

    From the skin: point hemorrhages (petechiae), dermatitis bullous hemorrhagic, papular rash with cortex, vasculitis.

    From the digestive system: gastralgia, abdominal pain, anorexia, nausea, vomiting, diarrhea, flatulence; rarely - hyperbilirubinemia and increased activity of liver transaminases in blood plasma; in isolated cases of hepatitis, cholestatic jaundice. There is a risk of developing pseudomembranous colitis.

    From the central nervous system: decreased reaction rate, headache, dizziness, sleep disturbance, general weakness; in some cases, extrapyramidal disorders or other disorders of muscle coordination, tremor, muscle cramps, numbness and paresthesia in the limbs, intense dreams, nightmarish dreams, psychotic reactions in the form of anxiety, arousal, feelings of fear, depressions, confusion, visual and auditory hallucinations, increased intracranial pressure.

    From the sense organs: diplopia, violations of color perception, violation of taste, smell, hearing and balance.

    On the part of the hematopoiesis system: leukopenia, agranulocytosis, thrombocytopenia, eosinophilia; in isolated cases - hemolytic anemia, pancytopenia, aplastic anemia.

    From the urinary system: in some cases - acute interstitial nephritis, hypercreatinemia, increased urea concentration, impaired renal function. From the cardiovascular system: tachycardia, lowering blood pressure.

    From the side of the musculoskeletal system: arthralgia, myalgia, tendinitis, tendosynovitis, tendon rupture.

    Other: hypoglycemia (in patients with diabetes mellitus), weakness, photosensitivity,

    dysbacteriosis, superinfection, vaginitis.

    Overdose:

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

    Treatment: gastric lavage; if necessary, symptomatic therapy. There is no specific antidote. When hemodialysis is removed 10-30% ofloxacin.

    Interaction:

    When taking concomitantly with antacids containing aluminum, calcium and magnesium or iron-containing preparations, the effectiveness of ofloxacin decreases (the time interval between administration of these drugs should be at least 2 h).

    With simultaneous use ofloxacin, a slight increase in the concentration of glibenclamide in the blood plasma is possible.

    With simultaneous use ofloxacin with probenicide, cimetidine, furosemide or methotrexate, it is possible to increase the concentration of ofloxacin in the blood plasma.

    Reduces the clearance of theophylline by 25% (with simultaneous use should reduce the dose of theophylline).

    When administered with non-steroidal anti-inflammatory drugs, derivatives of nitroimidazole and methyl xanthines, the risk of neurotoxic effects increases.

    At simultaneous appointment with glucocorticosteroids, the risk of rupture of tendons increases, especially in the elderly.

    When administered with drugs that alkalinize urine (inhibitors of carbonic anhydrase, citrates, sodium hydrogen carbonate), the risk of crystalluria and nephrotoxic effects increases.

    With the simultaneous use of ofloxacin with vitamin K antagonists, control over the blood coagulation system is necessary.

    In patients with impaired hepatic or renal function, it is necessary to monitor the concentration of ofloxacin in plasma, with severe hepatic or renal insufficiency, the risk of toxic effects increases.

    When co-administered with drugs, the lengthening interval QT (IA and III class antiarrhythmic drugs, tricyclic antidepressants, macrolides) increases the risk of lengthening the interval QT.
    Special instructions:

    When using ofloxacin should not be exposed to natural and artificial ultraviolet radiation. It is not recommended to use more than 2 months.

    In case of side effects, especially from the nervous system or allergic reactions, which may appear after the first application, the drug must be immediately canceled.

    In case of signs of tendonitis (especially in elderly patients) it is recommended to immediately stop treatment, immobilize the Achilles tendon and provide orthopedic consultation.

    In the first weeks of treatment, severe, prolonged diarrhea caused by Clostridium difficile (pseudomembranous colitis), in this case immediately stop taking ofloxacin and prescribe adequate therapy, including oral administration of vancomycin or metronidazole.

    When using the drug, women are not recommended to use hygiene tampons due to the increased risk of thrush development.

    Ofloxacin can lead to a worsening of myasthenia flow.

    Perhaps more frequent attacks of porphyria in predisposed patients.

    Ofloxacin prevents the release of Mycobacterium tuberculosis, leading to false-negative results in the bacteriological diagnosis of tuberculosis.

    During the period of treatment can not be consumed ethanol.

    Effect on the ability to drive transp. cf. and fur:The drug may interfere with the patient's ability to engage in potentially hazardous activities requiring increased attention and rapid psychomotor reactions.
    Form release / dosage:

    Tablets, film-coated, 200 mg.

    Packaging:

    6 tablets in a blister (PVC / aluminum). 10 blisters with instructions for use are placed in a pack of cardboard.

    10 tablets in a blister (PVC / aluminum). 1 or 10 blisters with instructions for use are placed in a cardboard pack.

    Storage conditions:Store in a dry, dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:П N013336 / 01
    Date of registration:18.03.2009
    Expiration Date:Unlimited
    The owner of the registration certificate:McLeodz Pharmaceuticals Co., Ltd. McLeodz Pharmaceuticals Co., Ltd. India
    Manufacturer: & nbsp
    Information update date: & nbsp18.06.2017
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