Active substanceLomefloxacinLomefloxacin
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  • Dosage form: & nbspfilm coated tablets
    Composition:

    Each film-coated tablet contains:

    active substance: Lomefloxacin - 400,000 mg in the form of lomsfloxacin hydrochloride 450,400 mg

    Excipients: lactose - 92,100 mg, corn starch - 33,720 mg, pond - 7,500 mg, sodium carboxymethyl starch - 31,280 mg, cross-spondone - 2,000 mg, talc - 10,050 mg, sodium lauryl sulfate - 6,500 mg, magnesium stearate 3,500 mg, macrogol 2,050 mg, silicon colloid dioxide - 5,000 mg

    shell: hypromellose - 6,800 mg, titanium dioxide - 4,100 mg, 2-propanol *, methylene chloride *.

    * - removed during production.

    Description:White or almost white capsular tablets, biconvex, film-coated with a separation risk on one side and the inscription "LOMFLOX 400" on the other hand. Type of tablet on cross-section: thin shell and homogeneous mass of tablet core white or almost whitecolors.
    Pharmacotherapeutic group:Antimicrobial agent - fluoroquinolone
    ATX: & nbsp

    J.01.M.A   Fluoroquinolones

    J.01.M.A.07   Lomefloxacin

    Pharmacodynamics:

    Antimicrobial bactericide of broad spectrum of action from the group of fluoroquinolones. Affects the bacterial enzyme DNA-gyrase, which provides spirxpirlation, forms a complex with the tetramer (subunit of gyrase A2B2) and disrupts the transcription and replication of DNA, leading to the death of the microbial cell.

    Beta-lactamases, produced by pathogens, do not affect the activity of lomsfloxacin.

    It is active against non-negative aerobic microorganisms: Citrobacter diversus, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Proteus mirabilis, Pseudomonas aeruginosa (only for urinary tract infection); non-positive aerobic microorganisms: Staphylococcus saprophyticus; other microorganisms: Chlamydia trachomatis.

    With a minimum inhibitory concentration, 2 μg / ml is active against the following microorganisms (however, clinical efficacy in infections caused by these microorganisms has not been studied in strictly controlled studies): gram-positive aerobic microorganisms: Chlamydia trachomatis, Staphylococcus aureus (including mstcilli-resistant strains).Staphylococcus cpidcrmidis (including methincillin-resistant strains); non-negative aerobic microorganisms: Acromonas hydrophila, Citrobacter freundii, Enterobacter acrogenes, Enterobacter agglomerans, Haemophilus parainfluenzae, Hafnia alvei, Klebsiella oxytoca, Klebsiella ozaenae, Morganella morganii, Proteus vulgaris, Proteus stuartii, Providencia alcalifaciens, Providencia rettgeri, Serratia liquefaciens, Serratia marccscens; other microorganisms: Legionella pneumophila.

    The drug is resistant to: Streptococcus spp. Groups A, B, D and G, Streptococcus pneumoniae, Pseudomonas cepacia, Ureaplasma urealyticum, Mycoplasma hominis and anaerobic bacteria.

    They act both on the extracellular and intracellularly located Mycobacterium tuberculosis, shortens the time of their isolation from the body, provides a faster resolution of inflammatory infiltrates. Most microorganisms act at low concentrations (the concentration necessary to control the growth of 90% of strains, usually not more than 1 μg / ml). Resistance is rare.

    Pharmacokinetics:

    Absorption - 95-98%; food intake reduces absorption by 12%. The time to reach the maximum concentration in the plasma is 0.8-1.5 hours. The maximum concentration in the blood plasma after ingestion of 200 mg is 1.4 μg / ml, 400 mg is 3-5.2 μg / ml. The intake of food reduces the maximum concentration in the blood plasma by 18% and increases the time to reach the maximum concentration in the blood plasma to 2 hours. The equilibrium concentration in the blood plasma is determined after 48 hours. The connection with plasma proteins is 10%. It penetrates well into organs and tissues (respiratory tract, ENT organs, soft tissues, bones, joints,organs of the abdominal cavity, small pelvis, genitals), where the concentration of lomefloxacin is 2-7 times higher than in plasma.

    A small part of the drug is metabolized. The half-life is 8-9 h; the average renal clearance is 145 ml / min. In elderly patients, plasma clearance is reduced by 25%. With a decrease in creatinine clearance to 10-40 ml / min / 1.73 m2, the elimination half-life increases.

    The kidneys produce 70-80% of the tubular secretion (mostly unchanged, 9% - in the form of glucuronides, 0.5% - in the form of other metabolites); through the intestine - 20-30%.

    Indications:

    Infectious-inflammatory diseases caused by microorganisms sensitive to lomsfloxacin:

    - uncomplicated urinary tract infections caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis or Staphylococcus saprophyticus;

    - Complicated urinary tract infections caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis Pseudomonas aeruginosa, Citrobacter diversus or Entcrobacter cloacae;

    - prophylaxis of urinary tract infections with transrectal biopsy of the prostate gland, transurethral surgical interventions;

    urogenital chlamydia;

    - exacerbation of chronic bronchitis caused by Haemophilus influenzae or Moraxella catarrhalis;

    - pulmonary tuberculosis (as part of complex therapy): extensive caseous-necrotic tissue damage, pronounced nonspecific component of inflammation,drug resistance of mycobacteria to rifampicin or poor tolerance of rifampicin.

    Contraindications:Hypersensitivity (including other fluoroquinolones), pregnancy, lactation period, age to 18 years, lactose intolerance, lactase insufficiency, glucose-galactose malabsorption (since the formulation includes lactose).
    Carefully:Cerebral atherosclerosis, epilepsy and other diseases of the central nervous system with epileptic syndrome, renal failure, electrolyte imbalance (eg, hypokalemia, hypomagnesemia), prolongation of the QT interval, congenital QT interval prolongation syndrome, heart disease (heart failure, myocardial infarction, bradycardia) , simultaneous administration of antiarrhythmic drugs class IA (quinidine, procainamide) and III class (amnodaron, sotalol), elderly age.
    Dosing and Administration:

    Inside (regardless of food intake, squeezed a sufficient amount of liquid), 1 time per day. The dose and duration of treatment depends on the severity of the disease and the sensitivity of the pathogen.

    Uncomplicated cystitis in women caused by Escherichia coli: 400 mg / day for 3 days.

    Uncomplicated cystitis caused by Klebsiella pneumoniae. Proteus mirabilis or Stanhvlococcus sanrophvticus: 400 mg / day for 10 days.

    Complicated urinary tract infections: 400 mg / day for 14 days.

    Exacerbation of chronic bronchitis: 400 mg / day for 14 days.

    Prevention of urinary tract infections: with a transrectal biopsy of the prostate - 400 mg once for 1-6 hours before the procedure; transurethral surgery - 400 mg once 2 to 6 hours before surgery.

    Urogenital chlamydia: 400 mg / day for 14-28 days.

    Tuberculosis of the lungs (as part of complex therapy): 400 mg / day for 14-28 days or more.

    In patients with moderate or severe renal dysfunction (with a QC less than 30 ml / min) and in patients on hemodialysis, the initial dose is 400 mg / day, followed by a decrease to 200 mg / day.

    Side effects:

    From the digestive system: nausea, vomiting, dryness of the oral mucosa, gastralgia, abdominal pain, diarrhea or constipation, flatulence, pseudomembranous colitis, dysphagia, discoloration of the tongue, decreased appetite or bulimia, taste distortion, dysbiosis, increased activity of "liver" transaminases.

    From the nervous system: fatigue, malaise, asthenia, headache, dizziness, fainting, insomnia, hallucinations, convulsions, hyperkinesia, tremors, parasthesias, nervousness, anxiety, depression, agitation.

    From the genitourinary system: glomerulonephritis, dysuria, polyuria, anuria, albuminuria, urethral bleeding, crystalluria, hematuria, urinary retention, edema; in women - vaginitis, leukorrhea, intermenstrual bleeding, pain in the perineum, vaginal candidiasis; in men - orchitis, epididymitis.

    From the side of metabolism: hypoglycemia, gout.

    From the musculoskeletal system: arthralgia, vasculitis, calf muscle cramps, pain in the back and chest.

    On the part of the organs of hematopoiesis and the system of hemostasis: bleeding from the organs of the gastrointestinal tract, thrombocytopenia, purpura, increased fibrinolysis, epistaxis, lymphadenopathy.

    From the respiratory system: shortness of breath, bronchospasm, cough, hypersecretion of sputum, flu-like symptoms.

    From the sense organs: impaired vision, pain and noise in the ears, pain in the eyes.

    From the cardiovascular system: lowering of arterial pressure, tachycardia, bradycardia, extrasystole, arrhythmias, progression of heart failure and angina, pulmonary embolism, cardiomyopathy, phlebitis.

    Allergic reactions: skin itching, hives, photosensitivity, malignant exudative erythema (Stevens-Johnson syndrome).

    Other: Candidiasis, increased sweating, chills, thirst, superinfection.

    Overdose:

    Information about overdose is very limited.

    Treatment: induction of vomiting or gastric lavage, adequate hydration, symptomatic therapy. Hemo- and peritoneal dialysis with an overdose is ineffective (less than 3% is output).

    Interaction:

    Does not affect the pharmacokinetics of isonaside. Does not interact with theophylline, caffeine.

    Increases the activity of indirect anticoagulants and increases the toxicity of non-steroidal anti-inflammatory drugs.

    Do not take antacid medicines and sucralfate for 4 hours before and 2 hours after taking Lomefloxacin (forms with them chelate compounds, which reduces its bioavailability).

    In the treatment of patients with tuberculosis lomefloxacin use together with isoniazid, pyrazinamide, streptomycin and ethambutol (not recommended combination with rifampicin - antagonism).

    Drugs that block tubular secretion slow down excretion. There is no cross-resistance with penicillins, cephalosporins, aminoglycosides, co-trimoxazole, metronidazole.

    Vitamins with mineral supplements should be taken for 2 hours or 2 hours after the application of Lomefloxacin.

    Joint application with antiarrhythmic drugs IA class (quinidine, procainamide) and III class (amnodaron, sotalol) can cause an extension of the Q-T interval.

    Special instructions:

    With cirrhosis of the liver, there is no need for correction of the dosing regimen (with normal kidney function).

    During the treatment should avoid sunlight and ultraviolet irradiation (evening reception reduces the risk of reaction to ultraviolet radiation). At the first sign of photosensitization (increased skin sensitivity, burn, redness, swelling, blisters, rashes, itching, dermatitis) or hypersensitivity, neurotoxicity (excitation, convulsions, tremors, photophobia, confusion, toxic psychosis, hallucinations) therapy should be discontinued.

    If you miss a dose of Lomflox®, the missed dose should be taken as soon as possible, and the subsequent dose should be taken at intervals of 24 hours.

    Effect on the ability to drive transp. cf. and fur:During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.
    Form release / dosage:Film-coated tablets, 400 mg.
    Packaging:

    5 tablets per blister Al / PVC.

    1 or 2 blisters in a cardboard box together with instructions for use.

    Storage conditions:

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

    Keep out of the reach of children.

    When eliminating unused packages of the drug, special precautions are not required.

    Shelf life:3 years. Do not use after the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:П N014121 / 01
    Date of registration:21.07.2008 / 24.11.2015
    Expiration Date:Unlimited
    The owner of the registration certificate:Ipka Laboratories Ltd.Ipka Laboratories Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspIPKA LABORATORIES LTD. IPKA LABORATORIES LTD. India
    Information update date: & nbsp02.04.2018
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