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

    Composition per 100 ml

    Active substance: ofloxacin - 200.0 mg;

    auxiliary substances: sodium chloride - 900.0 mg, water for injection - up to 100 ml.

    Theoretical osmolarity is ~ 313.5 mOsmol / l.

    Description:Transparent liquid is greenish-yellow in color.
    Pharmacotherapeutic group:Antimicrobial agent - fluoroquinolone
    ATX: & nbsp

    S.01.A.E.01   Ofloxacin

    J.01.M.A.01   Ofloxacin

    Pharmacodynamics:

    Ofloxacin is a broad-spectrum bactericidal antimicrobial agent from the group of fluoroquinolones. The main mechanism of action of quinolones is specific inhibition of bacterial DNA gyrase. DNA-gyrase is necessary for replication, transcription, repair and recombination of bacterial DNA. Its inhibition leads to unwrapping and destabilization of bacterial DNA and, as a result, to death of a microbial cell.

    Fluoroquinolones have bactericidal activity, dependent on concentration, and moderate post-antibiotic action. The ratio of the area under the "concentration-time" curve (AUC) and the minimum inhibitory concentration (MIC) or the ratio of the maximum concentration in the blood plasma (Cmah) and IPC are a predictive factor for successful therapy.

    Marginal values ​​of the IPC

    The boundary values ​​of MPC (mg / l) of ofloxacin approved by the European Committee for the Determination of Antibiotic Sensitivity (EU-CAST).

    Microorganisms

    Sensitive (mg / L)

    Resistant (mg / L)

    Enterobacteriaceae

    ≤ 0,5

    > 1

    Staphylococcus spp.

    ≤ 1

    > 1

    Streptococcus pneumoniae

    ≤ 0,12

    > 4

    Haemophilus influenzae

    ≤ 0,5

    > 0,5

    Moraxella catarrhalis

    ≤ 0,5

    > 0,5

    Neisseria gonorrhoeae

    ≤ 0,12

    > 0,25

    Boundary values ​​of BMD that are not associated with a particular type of microorganism

    ≤ 0,5

    > 1

    Sensitive microorganisms

    Unreliable sensitive microorganisms (possibly due to acquired resistance): Citrobacter freundii, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Neisseria gonorrhoeae, Proteus mirabilis, Pseudomonas aeruginosa, Serratia spp., Staphylococcus spp. (coagulase-negative strains), Staphylococcus aureus (methicillin-sensitive), Staphylococcus epidermidis, Enterococcus faecalis, Campylobacter jejuni, Streptococcus pneumoniae.

    Resistant microorganisms

    Acinetobacter baumannii, Bacteroides spp., Clostridium difficile, Enterococci (incl. Enterococcus faecium), Listeria monocytogenes, Staphylococcus spp. (methicillin-resistant), Nocardia spp.

    Resistance to ofloxacin develops as a result of a phased mutation process of genes encoding both topoisomerases of the type II: DNA-gyrase and topoisomerase IV. Other mechanisms of resistance, for example, influence the permeability of external microbial cell structures (a mechanism characteristic of Pseudomonas aeruginosa), the mechanism of efflux (active excretion of an antibacterial agent from a microbial cell) may also affect the sensitivity of microorganisms to ofloxacin.

    Pharmacokinetics:

    The maximum serum concentration with a 30-minute intravenous infusion of the drug is achieved at the end of the infusion.

    The concentration of ofloxacin in the serum after a 30-minute intravenous infusion of ofloxacin:

    Dose

    Serum concentration of ofloxacin after infusion

    Serum concentration of ofloxacin 4 hours after infusion

    Serum concentration of ofloxacin 12 hours after infusion

    100 mg

    2.9 mg / L

    0.5 mg / l

    0,2 mg / l

    200 mg

    5.2 mg / l

    1.1 mg / ml

    0.3 mg / l

    With the on-off use of ofloxacin, the serum concentration does not increase significantly (the accumulation factor when administered twice a day is 1.5).

    The volume of distribution is 120 liters. Ofloxacin well penetrates into many organs and tissues of the body, including the lung tissue, ear tissue, throat, nose, skin, soft tissue, bone tissue, joints, abdominal organs, bile, small pelvis organs, kidneys, prostate gland, urethra.

    Binding to plasma proteins is 25%. Less than 5% ofloxacin undergoes biotransformation. Excreted mainly by the kidneys (80-90% of the administered dose - in unchanged form). In the urine, two major metabolites are found: N-demethyl-floxacin and ofloxacin N-oxide. About 4% ofloxacin is excreted with bile in the form of glucuronides. The half-life of ofloxacin is 5 hours, the decrease in serum concentration of ofloxacin after infusion occurs linearly. Concentrations of ofloxacin in the urine and infected urinary tracts exceed the concentrations of ofloxacin in serum 5-100 times.

    Special patient groups

    Renal insufficiency

    In patients with impaired renal function, the half-life of ofloxacin increases, the total and renal clearance decreases in proportion to the decrease in creatinine clearance.

    Elderly patients

    In elderly patients, the half-life increases, but the maximum serum concentration does not change.

    Indications:

    Infectious-inflammatory diseases caused by microorganisms sensitive to ofloxacin:

    Pyelonephritis;

    Prostatitis, epididymitis, orchitis;

    Infections of the pelvic organs;

    Sepsis (caused by the above mentioned infections of the genitourinary system);

    Cystitis, urinary tract infections (as an alternative to other antimicrobial drugs).

    As an alternative to other antimicrobials ofloxacin can be used to treat the following infectious-inflammatory diseases:

    Infections of bones and joints;

    Infections of the skin and soft tissues;

    Acute sinusitis;

    Exacerbation of chronic bronchitis, community-acquired pneumonia.

    Prevention of infections caused by orloxacin-sensitive microorganisms in patients with impaired immune status (including neutropenia).

    When using the drug should take into account the official national recommendations for the proper use of antibacterial drugs, as well as the sensitivity of pathogenic microorganisms in a particular country.
    Contraindications:

    Hypersensitivity to ofloxacin, other fluoroquinolones or excipients of the drug; epilepsy; defeat of tendons against the background of previous treatment with fluoroquinolones; children under 18 years of age (the risk of losing cartilage bone growth zones in a child can not be completely ruled out); pregnancy and the period of breastfeeding (the risk of damage to the cartilaginous bone growth zones in the fetus and the child can not be completely excluded); pseudo-paralytic myasthenia gravis.

    Carefully:

    In patients predisposed to developing seizures (in patients with lesions of the central nervous system (CNS): severe atherosclerosis of the cerebral vessels, cerebral circulation, including history, organic lesions of the central nervous system, brain traumas in the anamnesis, in patients, simultaneously receiving drugs that reduce the threshold of convulsive brain readiness, such as fenbufen or other non-steroidal anti-inflammatory drugs (NSAIDs), theophylline;

    In patients with latent or manifested deficiency of glucose-6-phosphate dehydrogenase (increased risk of hemolytic reactions);

    In patients with impaired renal function (mandatory monitoring of renal function, as well as correction of dosing regimen);

    In patients with hepatic insufficiency (control of liver function);

    In patients with porphyria (risk of exacerbation of porphyria);

    In patients with risk factors, lengthening the interval QT; in elderly patients; with uncorrected electrolyte disturbances (hypokalemia, hypomagnesemia); with the syndrome of congenital lengthening of the interval QT; with heart diseases (heart failure, myocardial infarction, bradycardia); with the simultaneous use of drugs that can lengthen the interval QT (antiarrhythmic drugs IA and III classes, tricyclic antidepressants, macrolides, neuroleptics);

    In patients with diabetes mellitus, taking oral hypoglycemic agents (for example, glibenclamide) or insulin (increases the risk of hypoglycemia);

    In patients with severe adverse reactions to other quinolones, such as neurological reactions (increased risk of similar undesirable reactions with ofloxacin);

    In patients with psychoses and other psychiatric disorders in the anamnesis;

    With the simultaneous use of drugs that can reduce blood pressure, drugs for non-general anesthesia from the barbiturate group (an increased risk of developing hypotension).

    Pregnancy and lactation:

    The drug during pregnancy is contraindicated. As ofloxacin penetrates into breast milk, then in connection with the possible risk to the child, the use of the drug is contraindicated. If you need to use the drug during lactation, breastfeeding should be discontinued.

    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.

    Adult patients with normal renal function (creatinine clearance greater than 50 mL / min)

    In the treatment of infections caused by microorganisms that are sensitive to ofloxacin, the recommended dose is 200 mg twice a day or 400 mg once a day. Usually the daily dose is 400 mg. In case of treatment of severe infections or in patients with overweight, the daily dose can be increased to 600 mg.

    Special patient groups

    Elderly patients

    The age of patients does not require dose adjustment of ofloxacin. However, when using the drug in elderly patients, special attention should be given to kidney function, since in case of its reduction, a corresponding correction of the dosing regimen may be required.

    Patients with hepatic impairment

    When violations of liver function is not recommended to exceed the daily dose of ofloxacin 400 mg.

    Patients with impaired renal function

    For violations of kidney function, the following dosing regimen is recommended, depending on the creatinine clearance:

    Creatinine clearance

    Single dose (mg) *

    Multiplicity of the introduction

    50-20ml / min

    100-200

    1 time per day (every 24 hours)

    <20 ml / min ** or hemodialysis and peritoneal dialysis

    100

    or

    200

    1 time per day (every 24 hours)

    1 every 2 days (every 48 hours)

    * In accordance with the testimony.

    ** It is recommended to monitor serum concentrations of ofloxacin in patients with severe renal dysfunction or in patients on dialysis.

    In cases where it is not possible to determine the clearance of creatinine (CC), it can be calculated from the serum creatinine concentration using the Cockcroft formula for adults: for men:

    Administration of the drug

    The ofloxacin solution is intended only for slow infusion administration. Intravenous infusion is performed once or twice a day. The duration of the infusion should be at least 30 minutes for each dose of ofloxacin 200 mg. This is especially important if ofloxacin is administered concomitantly with other drugs that can reduce blood pressure or means for non-general general anesthesia from the barbiturate group.

    The daily dose to 400 mg ofloxacin can be administered once a day. In this case, it is preferable to administer the drug in the morning.

    A daily dose of more than 400 mg should be divided into two parts and administered at 12-hour intervals.

    Administration of the drug ofloxacin After opening the vial should be done immediately.

    A few days after the improvement of the patient's condition, the onloxacin started in the form of intravenous infusions can be continued by taking the drug inside at the same doses.

    Duration of treatment

    The duration of treatment depends on the severity of the disease. Like any treatment with antimicrobial drugs, ofloxacin should be continued for at least 48-72 hours after the normalization of body temperature or if there is evidence of eradication of the pathogen.

    Side effects:

    The information presented below is based on data obtained from clinical studies and data from a broad post-marketing experience of the drug.

    The following side effects are presented in accordance with the following gradations of their incidence: very often (≥1 / 10); often (≥1 / 100, <1/10); infrequently (≥1 / 1000, <1/100); rarely (≥1 / 10000, <1/1000); very rarely (<1/10000) (including individual messages); unknown frequency (according to available data, it is not possible to establish frequency of occurrence).

    Heart Disease:

    Rarely: tachycardia.

    Infrequently: a feeling of palpitations.

    Frequency unknown: interval lengthening QT, ventricular arrhythmia of the "pirouette" type (especially in patients with risk factors for lengthening the interval QT).

    Vascular disorders

    Often: phlebitis.

    Rarely: increased blood pressure, lower blood pressure. During the infusion of ofloxacin, it is possible to lower arterial pressure, accompanied by the development of tachycardia, and which in very rare cases is strongly pronounced up to the development of collapse. In the case of a significant reduction in blood pressure should immediately stop the infusion of the drug.

    Violations of the blood and lymphatic system

    Rarely: anemia, hemolytic anemia, leukopenia, eosinophilia, thrombocytopenia.

    Frequency unknown: agranulocytosis, pancytopenia, oppression bone marrow hematopoiesis.

    Disturbances from the nervous system

    Infrequently: dizziness, headache.

    Rarely: drowsiness, paresthesia, dysgeusia (a disorder of perception of taste), parosmia (a disorder of perception of a smell).

    Rarely: peripheral sensory neuropathy, peripheral sensory-motor neuropathy, seizures, extrapyramidal symptoms, including tremor, and other disorders of muscle coordination.

    Frequency unknown: agesia, increased intracranial pressure.

    Disorders of the psyche

    Infrequently: agitation, sleep disorders, insomnia.

    Rarely: psychotic reactions (for example, hallucinations), anxiety, nervousness, confusion, nightmares, depression.

    Frequency unknown: psychotic reactions and depression with self-harm, in rare cases, up to suicidal thoughts or attempts.

    Disturbances on the part of the organ of sight

    Infrequently: irritation of the mucous membrane of the eye, conjunctivitis.

    Rarely: visual impairment (diplopia, violation of color perception).

    Frequency unknown: uveitis.

    Hearing disorders and labyrinthine disorders

    Infrequently: Vertigo.

    Rarely: hearing impairment (ringing in the ears), hearing loss.

    Disturbances from the respiratory system, organs of the chest and mediastinum

    Infrequently: cough, nasopharyngitis.

    Rarely: shortness of breath, bronchospasm.

    Frequency unknown: allergic pneumonitis, pronounced dyspnea.

    Disorders from the digestive system

    Infrequently: abdominal pain, diarrhea, nausea, vomiting, decreased appetite.

    Rarely: enterocolitis (sometimes hemorrhagic).

    Rarely: pseudomembranous colitis.

    Frequency unknown: dyspepsia, constipation, flatulence, pancreatitis, stomatitis.

    Disturbances from the liver and bile ducts

    Rarely: an increase in the activity of "hepatic" enzymes, such as alanine aminotransferase (ALT), aspartate aminotransferase (ACAT), lactate dehydrogenase (LDH), gamma-glutamyltransferase (GGT) and / or alkaline phosphatase (ACF) and / or bilirubin concentrations in the blood.

    Rarely: cholestatic jaundice

    Frequency unknown: hepatitis, which can be severe; when applyingofloxacin (predominantly in patients with hepatic impairment) reported cases of severe hepatic insufficiency, including acute hepatic insufficiency, sometimes fatal.

    Disorders from the kidneys and urinary tract

    Rarely: increased serum creatinine concentration.

    Rarely: acute renal failure.

    Frequency unknown: acute interstitial nephritis, increased urea concentration in the blood.

    Disturbances from the skin and subcutaneous tissues

    Infrequently: itching, rash.

    Rarely: urticaria, hyperhidrosis, pustular rash, "tides" of blood to the skin.

    Rarely: exudative erythema multiforme, toxic epidermal necrolysis, photosensitivity reactions, drug rash, vascular purpura, vasculitis, which in exceptional cases can lead to skin necrosis.

    Frequency unknown: Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, exfoliative dermatitis.

    Disturbances from the musculoskeletal and connective tissue.

    Rarely: tendonitis.

    Rarely: arthralgia; myalgia; tendon rupture (for example,Achilles tendon) (as with the use of other fluoroquinolones, this side effect can develop within 48 hours after the initiation of treatment and can be bilateral).

    Frequency unknown: rhabdomyolysis and / or myopathy, muscle weakness, which is especially important for patients with pseudo-paralytic myasthenia, muscle tear, muscle rupture, ligament rupture, arthritis.

    Disorders from the metabolism and nutrition

    Rarely: anorexia.

    Frequency unknown: hyperglycemia, hypoglycemia; hypoglycemic coma (in patients with diabetes mellitus receiving treatment with hypoglycemic agents).

    Infectious and parasitic diseases

    Infrequently: fungal infections, resistance of pathogenic microorganisms.

    Immune system disorders

    Rarely: anaphylactic reactions, anaphylactoid reactions, angioedema.

    Rarely: anaphylactic shock

    Congenital, hereditary and genetic disorders

    Frequency unknown: exacerbation of porphyria in patients with porphyria.

    General disorders and disorders at the site of administration

    Often: pain and redness at the site of infusion.

    Frequency unknown: asthenia, fever, pain in the back, chest, limbs.

    Overdose:

    Symptoms; dizziness, confusion, disorientation, convulsions, lengthening of the interval QT, nausea and erosion on the mucous membrane. Treatment: In case of an overdose, careful monitoring of the patient, including ECG monitoring, is required. Treatment is symptomatic. Ofloxacin can be removed from the body by hemodialysis. The specific antidote is not known.

    Interaction:

    FROM theophylline, fenbuphene, or other non-steroidal anti-inflammatory drugs that reduce the threshold of seizure activity in the brain

    In clinical studies, no pharmacokinetic interactions of ofloxacin with theophylline have been established. However, with the simultaneous use of quinolones and theophylline, non-steroidal anti-inflammatory drugs and other drugs that lower the threshold for convulsive brain readiness, there may be a marked decrease in the threshold of seizure activity in the brain.

    With medications that extend the interval QT

    Ofloxacin, like other fluoroquinolones, should be used with caution in patients receiving drugs that extend the interval QT (for example, antiarrhythmic drugs of class IA and III, tricyclic antidepressants, macrolides, neuroleptics).

    With antagonists of vitamin K

    An increase in prothrombin time / normalized international relations and / or development of bleeding, including severe, was noted with simultaneous use of ofloxacin and vitamin K antagonists (eg, warfarin). Therefore, with the simultaneous use of antagonists of vitamin K and ofloxacin, regular monitoring of blood clotting parameters is necessary.

    With glibenclamide

    With simultaneous use with glibenclamide, a slight increase in the concentration of glibenclamide and, as a consequence, hypoglycemia may be observed, which requires monitoring of blood glucose concentration.

    With other hypoglycemic agents for oral administration and insulin

    When used simultaneously with other hypoglycemic agents for ingestion and insulin, the risk of developing hypoglycemia increases, and more careful monitoring of the glucose concentration in the blood is required.

    With probenecid, cimetidine, furosemide, methotrexate

    With the simultaneous use of quinolones and drugs released from the body by renal tubular secretion (such as probenecid, cimetidine, furosemide, methotrexate), there may be a mutual delay in excretion and an increase in plasma concentrations (especially if high doses are used).

    With drugs that can reduce blood pressure, drugs for non-general anesthesia from the barbiturate group

    With simultaneous application with ofloxacin, a sharp and significant reduction in blood pressure is possible, so in this case, a particularly careful monitoring of the functional state of the cardiovascular system is required.

    With glucocorticosteroids

    Simultaneous reception of glucocorticosteroids increases the risk of rupture of tendons, especially in elderly patients.

    FROM drugs that alkalinize urine (inhibitors of carbohydrazide, citrates, sodium hydrogen carbonate)

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

    Compatibility with other drugs and infusion solutions

    A solution of ofloxacin should not be mixed with heparin because of the risk of precipitation in solution.

    The drug is compatible with 0.9% solution of sodium chloride, Ringer's solution, 5% solution of dextrose.

    Special instructions:

    Renal insufficiency

    As ofloxacin is excreted mainly by the kidneys, in patients with impaired renal function, correction of the dosing regimen is required.

    Prevention of photosensitization

    When using ofloxacin, due to the risk of photosensitization, exposure to strong sunlight or artificial ultraviolet irradiation should be avoided.

    Superinfection

    As with the use of other antimicrobial agents, the use of ofloxacin, especially for a long time, can lead to increased reproduction of insensitive microorganisms (bacteria and fungi). Therefore, during the treatment, it is mandatory to reevaluate the patient's condition and, in case of development during treatment of superinfection, appropriate measures should be taken to treat it.

    Peripheral Neuropathy

    In patients receiving fluoroquinolones, including ofloxacin, was reported on the development of sensory and sensory-motor peripheral neuropathy, which can have a rapid onset. If the patient develops symptoms of neuropathy, the use of ofloxacin should be discontinued. This minimizes the possible risk of irreversible changes.

    Patients with deficiency of glucose-6-phosphate dehydrogenase

    Patients with diagnosed glucose-6-phosphate dehydrogenase deficiency have a predisposition to hemolytic reactions in the treatment with quinolones. Therefore, such patients should be careful when using ofloxacin.

    Pseudomembrane colitis caused by Clostridium difficile

    The appearance of diarrhea, especially in severe form, persistent and / or with an admixture of blood, during or after treatment, may be a manifestation of pseudomembranous colitis. If there is a suspected development of pseudomembranous colitis, ofloxacin should be stopped immediately, and appropriate specific therapy should be immediately given (Vancomycin inside, teicoplanin inside or metronidazole inside).In the emergence of this clinical situation, drugs that inhibit intestinal motility are contraindicated.

    Patients who are predisposed to develop seizures

    Like other fluoroquinolones, ofloxacin should be used with caution in patients with a predisposition to the development of seizures: in patients with previous lesions of the central nervous system, in patients simultaneously receiving drugs that reduce the threshold of seizure readiness of the brain (theophylline, fenbufen and other such non-steroidal anti-inflammatory drugs). With the development of seizures, ofloxacin should be discontinued.

    Tendonitis

    Tendinitis, which rarely occurs with the use of quinolones, can sometimes lead to the rupture of tendons, including the Achilles tendon, especially in elderly patients and in patients taking glucocorticosteroids simultaneously. This side effect can develop within 48 hours after the start of treatment and can be bilateral. In case of signs of tendonitis (inflammation of the tendon), it is recommended to stop the drug immediately. Appropriate treatment of the affected tendon, for example,providing him with sufficient immobilization.

    Interval lengthening QT

    Some caution is needed when using fluoroquinolones, including ofloxacin, in patients with known risk factors for lengthening interval QT, such as: old age; unadjusted electrolyte disturbances (hypokalemia, hypomagnesemia); congenital lengthening of the interval QT; diseases of the cardiovascular system (heart failure, myocardial infarction, bradycardia); simultaneous use with other drugs that extend the interval QT (antiarrhythmic agents IA and class III, tricyclic antidepressants, macrolides, neuroleptics).

    Exacerbation of pseudo-paralytic myasthenia gravis (myasthenia gravis gravis)

    Fluoroquinolones, including ofloxacin, can block neuromuscular activity and increase muscle weakness in patients with pseudo-paralytic myasthenia gravis. In the post-marketing period, serious adverse reactions were observed, including pulmonary insufficiency requiring artificial ventilation and fatal outcome, which were associated with the use of fluoroquinolones in patients with pseudo-paralytic myasthenia gravis.The use of ofloxacin in patients with established diagnosis of pseudo-paralytic myasthenia is not recommended.

    Severe skin reactions

    With the use of ofloxacin, cases of severe bullous reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, have been observed. Patients should be informed that, in the event of any reaction from the skin or mucous membranes, the patient should immediately consult a doctor and do not continue treatment until his consultation.

    Hypersensitivity reactions and allergic reactions

    With the use of fluoroquinolones, the development of hypersensitivity reactions and allergic reactions (anaphylactic shock and anaphylactoid reactions that can progress to a life-threatening state) has been reported. In these cases, it is necessary to stop the treatment with ofloxacin and start the necessary medical measures.

    Psychotic reactions

    Psychotic reactions, including suicidal thoughts / attempts, have been reported in patients taking fluoroquinolones, including ofloxacin. In case of development of such reactions in patients it is necessary to cancel ofloxacin and prescribe appropriate treatment. Ofloxacin should be used with caution in patients with psychotic disorders, including in the anamnesis.

    Dysfunction of the liver

    Ofloxacin should be used with caution in patients with impaired liver function, as liver damage may occur. With the use of fluoroquinolones, cases of fulminant hepatitis have been reported, leading to the development of hepatic insufficiency (including fatal cases). Patients should be advised to stop treatment and consult a doctor if symptoms and signs of liver disease such as anorexia, jaundice, darkening of the urine, pruritus, abdominal pain are observed.

    Disglycemia (hypo- and hyperglycemia)

    When using fluoroquinolones, including ofloxacin, reported the development of both hypoglycemia and hyperglycemia. In patients with diabetes mellitus, receiving simultaneous treatment with oral hypoglycemic drugs (eg, glibenclamide) or insulin preparations, the development of hypoglycemic coma has been reported. Patients with diabetes require careful monitoring of the concentration of glucose in the blood.

    Patients, taking antagonists of vitamin K

    Due to a possible increase in the prothrombin time / international normalized ratio and / or the development of bleeding in patients taking both ofloxacin and vitamin K antagonists (eg, warfarin), regular monitoring of blood clotting indices is necessary.

    Risk of development of resistance

    The prevalence of acquired resistance can vary geographically and over time for individual species of microorganisms. Therefore, local information on resistance is required; it is necessary to carry out microbiological diagnostics with isolation of the pathogen and determination of its sensitivity, especially in severe infections or lack of response to treatment.

    Infections caused by Escherichia coli

    Resistance to fluoroquinolones Escherichia coli - the most common pathogen of urinary tract infections - varies in different geographic regions. Doctors are advised to take into account local resistance Escherichia coli to fluoroquinolones.

    Infections caused by Neisseria gonorrhoeae

    In connection with the increase in resistance Neisseria gonorrhoeae, ofloxacin should not be used as an empirical treatment for suspected gonococcal urinary tract infection.It is necessary to perform tests for the sensitivity of the pathogen to ofloxacin in order to provide targeted therapy.

    Methicillin-resistant Staphylococcus aureus

    There is a high probability that Staphylococcus aureus (methicillin-resistant strains) will be resistant to fluoroquinolones, including ofloxacin. therefore ofloxacin It is not recommended for the treatment of established or suspected infections caused by Staphylococcus aureus (methicillin-resistant strains) in the case that laboratory tests did not confirm the sensitivity of this microorganism to ofloxacin.

    Infections of bones and joints

    When infections of bones and joints should consider the need for combined use ofloxacin with other antibacterial drugs.

    Impact on laboratory performance and diagnostic tests

    Ofloxacin can suppress growth Mycobacterium tuberculosis, leading to false-negative results in microbiological diagnosis of tuberculosis.

    Effect on the ability to drive transp. cf. and fur:

    During the treatment period, care must be taken when driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.In case of occurrence of the undesirable phenomena from nervous system it is necessary to refrain from the specified kinds of activity.

    Form release / dosage:

    Solution for infusions 2 mg / ml.

    Packaging:

    100 ml in bottles of glass for blood, transfusion and infusion preparations, corked with rubber stoppers and crimped with aluminum caps.

    Each bottle, together with instructions for use, is placed in a pack of cardboard.

    35 bottles with a capacity of 100 ml are placed in boxes of corrugated paperboard with the application instructions for the appropriate number of bottles (for hospitals).

    Storage conditions:

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

    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:LP-004448
    Date of registration:01.09.2017
    Expiration Date:01.09.2022
    The owner of the registration certificate:Promomed Rus, Open CompanyPromomed Rus, Open Company Russia
    Manufacturer: & nbsp
    Information update date: & nbsp06.10.2017
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