Active substanceOfloxacinOfloxacin
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  • Dosage form: & nbspSolution for infusions
    Composition:

    Each 100 ml of the preparation contains:

    Active substance: ofloxacin - 200 mg.

    Excipients: sodium chloride (for injection), hydrochloric acid, disodium edetate, sodium hydroxide (for injection), water for injection.

    Description:

    a clear solution of light yellow color.

    Pharmacotherapeutic group:antimicrobial agent-fluoroquinolone
    ATX: & nbsp

    S.01.A.E.01   Ofloxacin

    J.01.M.A.01   Ofloxacin

    Pharmacodynamics:

    The broad-spectrum antimicrobial agent from the group of fluoroquinolones acts on the bacterial enzyme DNA-hydrazole providing super-shrinkage and,thus, the stability of bacterial DNA (the destabilization of DNA chains leads to their death). Has a bactericidal effect.

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

    Different sensitivity to the drug has: Enterococcus faecalis, Streptococcus pyogenes, pneumoniae and viridans, Serratio marcescens, Pseudomonas aeruginosa, Acinetobacter, Mycoplasma hominis and pneumoniae, Mycobacterium tuberculosis, and Mycobacterium fortuim, Ureaplasma urealyticum, Clostridium perfringens, Corynebacterium spp., Helicobacter pylori, Listeria monocytogenes, Gardnerella vaginalis.

    In most cases, they are insensitive: Nocardia asteroides, anaerobic bacteria (for example, Bacteroides spp., Peptococcus spp., Peptostreptococcus spp., Eubacterium spp., Fusobacterium spp., Clostridium difficile). He acts on Treponema pallidum.

    Pharmacokinetics:

    After a single 60-minute intravenous infusion of 200 mg ofloxacin, the mean maximum plasma concentration is 2.7 μg / ml; 12 hours after the administration, the concentration is 0.3 μg / ml. Equilibrium concentrations are achieved after the administration of four doses.

    The mean peak and minimum equilibrium concentrations are achieved after intravenous administration of 200 mg ofloxacin every 12 hours for 7 days and are 2.9 and 0.5 μg / ml, respectively.

    Ofloxacin widely penetrates into many body fluids and tissues, including saliva, bronchial secretions, bile, tear and spinal fluid, pus, into the lungs, the prostate gland, the skin. Ofloxacin is subject to partial (5%) metabolism in the liver. Binding to plasma proteins is 20-25%. The half-life of ofloxacin is 6-7 hours. Up to 80% of the ingested drug is excreted by the kidneys unchanged, a small part of the active substance is also excreted with feces. When hemodialysis is removed 10-30% of the drug.

    In patients with impaired renal function (creatinine clearance 50 ml or less), the half-life of ofloxacin increases.

    Indications:

    - Respiratory tract infections (bronchitis, pneumonia), LOP(sinusitis, pharyngitis, otitis media, laryngitis), skin, soft tissues, bones, joints, infectious and inflammatory diseases of the abdominal cavity and bile ducts (except for bacterial enteritis), kidneys (pyelonephritis), urinary tract (cystitis, urethritis) , pelvic organs (endometritis, salpingitis, oophoritis, cervicitis, parametritis, prostatitis), genital organs (colpitis, orchitis, epididymitis), gonorrhea, chlamydia; septicemia (only for intravenous administration), meningitis; prevention of infections in patients with impaired immune status (incl.with neutropenia).

    - Prevention of infectious complications in surgery

    Contraindications:

    Hypersensitivity, deficiency of glucose-6-phosphate dehydrogenase, epilepsy (including in the anamnesis), reduction of convulsive threshold (including after cerebrospinal trauma, stroke or inflammatory processes in the central nervous system); age to 18 years (until the growth of the skeleton is completed), pregnancy, lactation.

    Carefully:

    - Atherosclerosis of cerebral vessels, cerebral circulatory disorders (in the anamnesis), chronic renal failure, organic lesions of the central nervous system.

    Pregnancy and lactation:contraindicated
    Dosing and Administration:

    Intravenously calves. 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.

    Intravenous drip introduction begins with a single dose of 200 mg, which is injected slowly for 30-60 minutes. With the improvement of the patient's condition, they switch to taking the drug inside at the same daily dose.

    Urinary tract infections - 100 mg 1-2 times a day

    Infections of the kidneys and genital organs - from 100 mg twice a day to 200 mg twice a day Respiratory tract infections, and JIOP-organ, skin and soft tissue infection, bone and joint infections, abdominal infection, bacterial enteritis, septic infections - 200 mg 2 times a day. If necessary, increase the dose to 400 mg twice a day.

    For the prevention of infections in patients with a marked decrease in immunity - 400-600 mg / day.

    If necessary, iv in kalelno 200 mg ofloxacin in a 5% solution of dextrose. Duration of infusion - 30 min. Use only freshly prepared solutions.

    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 per day, or a full single dose is administered once a day. At CC less than 20 ml / min single dose - 200 mg, then - 100 mg per day every other day.

    With hemodialysis and peritoneal dialysis - 100 mg every 24 hours. The maximum daily dose for liver failure is 400 mg / day.


    Side effects:

    From the digestive system: gastralgia, anorexia, nausea, vomiting, diarrhea, flatulence, abdominal pain, increased activity of "liver" transaminases, hyperbilirubinemia, cholestatic jaundice, pseudomembranous enterocolitis.

    From the nervous system: headache, dizziness, motion uncertainty, tremor, convulsions, numbness and paresthesia of the limbs, intense dreams, nightmarish dreams, psychotic reactions, anxiety, psychomotor excitation, phobia, depression, confusion, hallucinations, increased intracranial pressure.

    From the musculoskeletal system: tendonitis, myalgia, arthralgia, tendosynovitis, tendon rupture.

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

    From the cardiovascular system: tachycardia, lowering blood pressure (with / in the introduction, with a sharp decrease in blood pressure, the introduction is discontinued), vasculitis, collapse.

    Allergic reactions, skin rash, itchy skin, hives, allergic pneumonitis, allergic nephritis, eosinophilia, fever, Quincke's edema, bronchospasm, Stevens-Johnson and Lyell syndrome, photosensitivity, multiforme exudative erythema, anaphylactic shock.

    From the skin: point hemorrhages (petechiae), dermatitis bullous hemorrhagic, papular rash with a cortex, indicating the defeat of blood vessels (vasculitis).

    From the hematopoiesis: leukopenia, agranulocytosis, anemia, thrombocytopenia, pancytopenia, hemolytic and aplastic anemia.

    From the urinary system: acute interstitial nephritis,

    impaired renal function, hypercreatininaemia, increased urea levels.

    Other: dysbacteriosis, superinfection, hypoglycemia (in patients with diabetes mellitus), vaginitis.

    Local Reactions: pain, redness at the injection site, thrombophlebitis (with iv introduction).

    Overdose:

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

    Treatment: gastric lavage, symptomatic therapy.

    Interaction:

    Compatible with the following infusion solutions: isotonic sodium chloride solution, Ringer's solution, 5% fructose solution, 5% dextrose solution.

    Do not mix with heparin (risk of precipitation).

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

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

    Increases the concentration of glibenclamide in plasma.

    At simultaneous admission with antagonists of vitamin K, it is necessary to control the blood coagulation system.

    When administered with non-steroidal anti-inflammatory drugs, derivatives of nitroimidazole and methylxanthines, 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 bicarbonate), the risk of crystalluria and nephrotoxic effects increases.

    Special instructions:

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

    It is not recommended to use more than 2 months, exposed to sunlight, ultraviolet rays (mercury-quartz lamps, solarium).

    In the event of side effects from the central nervous system, allergic reactions, pseudomembranous colitis, drug withdrawal is necessary. With pseudomembranous colitis, confirmed colonoscopically and / or histologically, oral administration of vancomycin and metronidazole is indicated.

    Rarely developing tendonitis can lead to rupture of tendons (mainly Achilles tendon), especially in elderly patients. In case of signs of tendinitis, it is necessary to immediately stop treatment, tendons and consult an orthopedist.



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

    Against the backdrop of treatment, myasthenia flow may worsen, and porphyria attacks may be more frequent in predisposed patients.

    Can lead to false-negative results in the bacteriological diagnosis of tuberculosis (prevents the isolation Mycobacterium tuberculosis).

    In patients with impaired liver or kidney function, it is necessary to monitor the concentration of ofloxacin in plasma. In severe renal and hepatic insufficiency, the risk of toxic effects increases (dose adjustment is required).

    Children are only used in case of a life threat, taking into account the expected benefit and the potential risk of side effects when it is impossible to use other, less toxic drugs. The average daily dose in this case is 7.5 mg / kg, the maximum - 15 mg / kg.

    Effect on the ability to drive transp. cf. and fur:During the period of treatment it is necessary to refrain from driving motor vehicles and practicing potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions, one should not use ethanol.
    Form release / dosage:Solution for infusion 200mg / 100ml.
    Packaging: For 100 ml of the solution for infusion in a sterile sealed polyethylene bottle (type FFS) with a lid; 1 bottle is packed in a plastic bag and placed along with instructions for use in a cardboard box.
    Storage conditions:

    List B. In the dark place at a temperature of no higher than 25 ° C. Protect from light when removed from a cardboard bundle. Do not freeze.

    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 N012456 / 01
    Date of registration:12.12.2007
    The owner of the registration certificate:Ranbaxy Laboratories LimitedRanbaxy Laboratories Limited India
    Manufacturer: & nbsp
    Representation: & nbspRABBAYS LABORATORY LIMITEDRABBAYS LABORATORY LIMITED
    Information update date: & nbsp29.10.2009
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