Gatispan (Gatispan)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceGatifloxacinGatifloxacin
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    • Dosage form: & nbspfilm coated tablets
    Composition:

    One tablet contains:

    Active substance: gatifloxacin sesquihydrate, in terms of anhydrous (gatifloxacin) 200 mg or 400 mg.

    Excipients: silicon dioxide colloid, corn starch, microcrystalline cellulose, crospovidone, talc, magnesium stearate.

    Composition shell: hypromellose-E15, hypromellose-E5, macragol-4000 (polyethylene glycol-4000), talc, titanium dioxide, simethicone emulsion 30%.

    Description:From white to almost white, biconvex, film-coated, smooth on both sides of the tablet in the form of a drop.
    Pharmacotherapeutic group:Antimicrobial agent - fluoroquinolone
    ATX: & nbsp

    J.01.M.A.16   Gatifloxacin

    S.01.A.E.06   Gatifloxacin

    Pharmacodynamics:

    Gatifloxacin has a bactericidal effect by affecting the replication of bacterial DNA. Its target is equally the two bacterial topoisomerases (II, the same DNA-gyrase, and IV) - the enzymes that change the spatial configuration of the DNA molecule at various stages of its replication. Interacting with topoisomerase IV, gatifloxacin is capable of causing discontinuities of two strands of the kidney DNA molecule after replication. The disabling of any of the topoisomerases causes the death of the bacterial cell.

    Gatifloxacin is active against the following microorganisms:

    Aerobic Gram-positive microorganisms: Staphylococcus aureus (only methicillin-sensitive strains), Staphylococcus saprophyticus, Streptococcus pneumoniae (including penicillin-resistant strains), Streptococcus pyogenes.

    Aerobic Gram-negative microorganisms: Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Neisseria gonorrhoeae, Proteus mirabilis, Acinetobacter lwoffii, Citrobacter koseri, Citrobacter ffeundii, Enterobacter aerogenes, Enterobacter cloacae, Klebsiella oxytoca, Morganella morganii, Proteus vulgaris, Salmonella spp., Shigella spp.

    Other microorganisms: Chlamydia pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae.

    Anaerobic microorganisms: Bacteroides spp., Clostridium spp., Prevotella spp., Peptostreptococcus spp., Peptococcus spp.

    Pharmacokinetics:

    Gatifloxacin is well absorbed from the gastrointestinal tract after oral administration. Absorption is not dependent on food intake. Bioavailability is 96%. The maximum plasma concentration is 4.21 mg / l after taking the drug at a dose of 400 mg. The time to reach the maximum concentration is 1-2 hours. Average volume of distribution (Vdss) is between 1.5 and 2.0 l / kg. The area under the concentration-time curve is 51.3 mg / l / h. Binding to plasma proteins is approximately 20%.Well penetrates into many tissues and fluids, including alveolar and pulmonary tissue, genital organs, saliva. Gatifloxacin slightly metabolized. The half-life is between 7 and 14 hours. Less than 1% of the accepted dose is excreted from the body by the kidneys in the form of metabolites - ethylenediamine and methylethylenediamine. It is excreted mainly by the kidneys in unchanged form. In urine is determined by more than 70% of the dose. 5% are excreted from the body by the intestine.

    Indications:

    Infectious-inflammatory diseases caused by micro-organisms sensitive to gatifloxacin:

    - exacerbation of chronic bronchitis;

    - community acquired pneumonia.

    Contraindications:

    - Hypersensitivity to gatifloxacin or any member of the quinolone class;

    - children and adolescents under 18;

    - pregnancy, lactation;

    - diabetes;

    - interval lengthening QT on the ECG;

    - while taking antiarrhythmic drugs class IA (incl. quinidine, procainamide) or class III (incl. amiodarone, sotalol);

    - uncontrolled hypokalemia.

    Carefully:

    - in elderly patients;

    - in patients with impaired renal function (creatinine clearance <40 ml / min);

    - with diseases of the central nervous system, predisposing to the onset of seizures and reducing the threshold of convulsive activity;

    - simultaneous reception with drugs that extend the interval QT (cisapride, erythromycin, antipsychotic drugs, tricyclic antidepressants), conditions predisposing to arrhythmias (bradycardia, acute myocardial ischemia).

    Dosing and Administration:

    Inside, 400 mg once a day, regardless of food intake, 7-10 days.

    For patients with renal dysfunction, with creatinine clearance less than 40 ml / min, including patients on hemodialysis and perma- nent ambulatory peritoneal dialysis, correction of the daily dose is necessary. The use of gatifloxacin in patients on hemodialysis should be performed after completion of the hemodialysis procedure.

    Recommended doses of gatifloxacin for patients with renal insufficiency.

    (creatinine clearance <40 ml / min)

    Creatinine clearance

    Initial dose

    Subsequent doses

    <40 ml / min

    400 mg

    200 mg daily, starting from 2 days

    Hemodialysis

    400 mg

    200 mg daily, starting from 2 days

    Continuous ambulatory peritoneal dialysis

    400 mg

    200 mg daily, starting from 2 days

    Side effects:

    FROM frequency of development> 3%:

    Nausea, vaginitis, diarrhea, headache, dizziness.

    FROM frequency of development ≥0,1% <3%:

    Allergic reactions: urticaria, angioedema, itching, bronchospasm, Stevens-Johnson syndrome, anaphylactic shock.

    From the cardiovascular system: increased blood pressure, palpitations.

    From the digestive system: abdominal pain, loss of appetite, constipation, dyspepsia, gastritis, glossitis, tongue ulcers, stomatitis, flatulence, candidiasis.

    From the respiratory system: shortness of breath, pharyngitis.

    From the genitourinary system: painful urination.

    From the nervous system: excitement, anxiety, anxiety, excitement, paresthesia, insomnia, drowsiness, tremor.

    From the skin: dry skin, rash.

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

    From the sense organs: impaired vision, perversion of taste, ringing in the ears.

    Others: chills, fever, peripheral edema, sweating, asthenia, back pain, chest pain, hyperglycemia.

    With a development rate of <0.1%:

    From the digestive system: colitis, pseudomembranous colitis, dysphagia, gingivitis, bad breath, tongue edema, gastrointestinal, incl. rectal bleeding.

    From the respiratory system: bronchospasm, hyperventilation.

    From the cardiovascular system: bradycardia, tachycardia.

    From the genitourinary system: hematuria, metrorrhagia.

    From the nervous system: ataxia, convulsions, depersonalization, depression, hallucinations, hostility, hyperesthesia, migraine, panic attacks, euphoria.

    From the skin: maculopapular rash, vesicle rash.

    From the musculoskeletal system: arthritis, bone pain, myalgia, myasthenia gravis.

    From the endocrine system: diabetes mellitus, hypoglycemia.

    From the sense organs: parosmia, ptosis, loss of taste, pain in the ears, eyes, photophobia.

    Others: intolerance to ethanol, cyanosis, lymphadenopathy, neck pain, retrosternal pain. Changes in laboratory indicators: neutropenia, increased ALT (alanine aminotransferase), ACT (aspartate aminotransferase), alkaline phosphatase, bilirubin, blood amylase, electrolyte disturbances.

    Overdose:

    Symptoms: vomiting, rapid breathing, convulsions, tremors, agitation.

    Treatment: gastric lavage, symptomatic therapy. Adequate hydration and monitoring, including ECG monitoring, are necessary. The drug is slightly excreted by hemodialysis and ambulatory peritoneal dialysis.

    Interaction:

    Gatifloxacin should be taken 4 hours before the use of drugs containing salts of zinc, magnesium or iron; antacids; didanosine. These drugs may reduce the effectiveness of gatifloxacin.

    With the simultaneous administration of gatifloxacin with the following drugs: quinidine, procainamide, amiodarone, sotalol; tricyclic antidepressants, including amitriptyline, amoxapine, imipramine, nortriptyline, doxepin; derivatives of phenothiazine, including chlorpromazine, fluphenazine, perphenazine, mesoridazine, thioridazine; erythromycin; cisapride, interval lengthening possible QT.

    It can increase the concentration of digoxin (it is necessary to monitor the concentration of digoxin in the blood plasma, if necessary, to correct its dose, as well as monitor patients for the first signs of glycosidic intoxication).Probenecid can increase the systemic exposure of gatifloxacin.

    With simultaneous administration with warfarin, prothrombin time control is necessary, since some fluoroquinolones can alter the effect of warfarin and its derivatives.

    Simultaneous reception of non-steroidal anti-inflammatory drugs is a risk of stimulation of the central nervous system and seizures.

    Single cases of hypo- or hyperglycemia in diabetic patients who received glibenclamide or insulin.

    Special instructions:

    When gatifloxacin is used, it is possible to develop symptomatic hypo- or hyperglycemia, more often in patients with diabetes, elderly, with renal insufficiency, while taking hypoglycemic drugs. It is necessary to monitor the level of glucose in such patients. When hypoglycemic or hyperglycemic symptoms appear, Gatipan should be discontinued and appropriate therapy initiated.

    The use of drugs quinolone series is associated with a possible risk of seizures. Gatispan should be used with caution in patients with CNS diseases and with conditions suspicious of CNS involvement predisposing to seizures or reducing the threshold of seizure activity.

    When applying gatifloksatsina, as well as other drugs quinolone series, and macrolides, in some patients, there may be an extension of the interval QT. During the treatment, ECG monitoring is necessary.

    Degree of lengthening interval QT may increase with increasing drug concentration, therefore, do not exceed the recommended dose. Interval lengthening QT is associated with an increased risk of ventricular arrhythmias, including flicker-flutter.

    In patients with lengthening interval QT, hypokalemia, as well as those who receive antiarrhythmic drugs of class IA (quinidine, procainamide) or class III (amiodarone, sotalol), gatifloxacin should be avoided because the experience of using this drug in patients is organic.

    Against the background of therapy with fluoroquinolones, including gatifloxacin, especially in elderly people and patients receiving glucocorticosteroids, tendonitis and tendon rupture may develop. With the first symptoms of pain. or inflammation at the site of damage, the drug should be stopped and immobilized.

    The use of broad-spectrum antibacterial drugs is associated with a risk of developing pseudomembranouscolitis. This diagnosis should be borne in mind in patients who have severe diarrhea on the background of treatment with gatifloxacin. In this case, it is necessary to stop taking the drug and prescribe appropriate therapy.

    In some cases, after the first use of the drug, allergic reactions may develop. Very rarely, anaphylactic reactions can progress to life-threatening anaphylactic shock. In these cases gatifloxacin it is necessary to cancel and conduct the necessary medical measures (including anti-shock).

    When applying quinolones, photosensitivity reactions are noted. but gatifloxacin does not possess phototoxic properties. Nevertheless, patients receiving gatifloxacin, should avoid ultraviolet irradiation (including direct sunlight).

    Effect on the ability to drive transp. cf. and fur:
    Form release / dosage:

    The film-coated tablets are 200 mg and 400 mg.

    Packaging:5 tablets in a blister of PVC / aluminum foil. 1, 2, 3, 4, 5 or 10 blisters together with the instructions for use are placed in a cardboard box.
    Storage conditions:

    In dry, the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:2 years. Do not use after the expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-009402/09
    Date of registration:23.11.2009 / 02.07.2013
    Expiration Date:Unlimited
    The owner of the registration certificate:MOSFARM, LLCMOSFARM, LLC
    Manufacturer: & nbsp
    Representation: & nbspMOSFARM, LLCMOSFARM, LLC
    Information update date: & nbsp16.03.2017
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