Active substanceCiprofloxacinCiprofloxacin
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  • Dosage form: & nbspSolution for infusion.
    Composition:

    Active substance: Ciprofloxacin hydrochloride (monohydrate) - 2.33 mg in terms of ciprofloxacin - 2 mg.

    Excipients: Sodium chloride - 9 mg, Lactic acid in terms of 100% - 0.65 mg, Disodium edetate dihydrate (disodium ethylenediaminetetraacetic acid) - 0.2 mg, 1M sodium hydroxide solution - to pH 3.5-4.6. Water for injection - up to 1 ml.

    Theoretical osmolarity 336.1 mOsm / l

    Description:Transparent colorless or slightly colored liquid.
    Pharmacotherapeutic group:Antimicrobial agent, fluoroquinolone.
    ATX: & nbsp

    J.01.M.A.02   Ciprofloxacin

    Pharmacodynamics:

    Antimicrobial broad-spectrum agent, quinolone derivative. suppresses bacterial DNA-gyrase (topoisomerase II and IV, responsible for the process of supercoiling the chromosomal DNA around the nuclear RNA, which is necessary for the reading of genetic information), disrupts the synthesis of DNA, the growth and division of bacteria; causes significant morphological changes (including the cell wall and membranes) and the rapid death of the bacterial cell.

    It acts bactericidal against gram-negative organisms in the period of rest and division.affects not only DNA-gyrase, but also causes lysis of the cell wall), on gram-positive microorganisms - only during the fission period.

    Low toxicity for macroorganism cells is explained by the absence of DNA-gyrase in them. Against the background of the use of ciprofloxacin, there is no parallel development of resistance to other antibiotics that do not belong to the group of DNA gyrase inhibitors, which makes it highly effective against bacteria that are resistant, for example, to aminoglycosides, penicillins, cephalosporins, tetracyclines and many other antibiotics.

    For certain strains, the spread of acquired resistance may vary depending on the geographical region and over time. When testing the sensitivity of individual strains, it is desirable to have local information on resistance, especially when treating serious infections. If the prevalence of resistance in places is such that the use of the drug, but at least for several types of infections is questionable, it is necessary to consult a specialist.

    The most sensitive microorganisms

    Gram-positive aerobic microorganisms: Bacillus anthracis.Staphylococcus aureus (methicillin-sensitive). Staphylococcus haemolyticus. Staphylococcus hominis. Staphylococcus saprophyticus. Streptococcus pyogenes. Streptococcus agalactiae. Gram-negative aerobic microorganisms. Aeromonas spp., Brucella spp. Citrobacter koseri, Francisella tularensi, Haemophilus ducreyi, Haemophilus influenzae. Legionella pneumophila, Moraxella catarrhalis, Mycobacterium tuberculosis, Mycobacterium kansasii. Pasteurella multocida. Salmonella spp .. Shigella spp .. Vibrio spp .. Yersinia pestis.

    Anaerobic microorganisms: Mobiluncus spp.

    Other microorganisms: Chlamydia trachomatis. Chlamydia pneumoniae, Mycoplasma hominis, Mycoplasma pneumoniae.

    Microorganisms with possible resistance

    Gram-positive aerobic microorganisms: Enterococcus faecalis, Streptococcus pneumoniae.

    Gram-negative aerobic microorganisms: Acinetobacter baumannii. Burkholderia cepacia, Campylobacter jejuni, Citrobacter freundii, Enterobacter aerogenes, Enterobacter cloacae. Escherichia coli. Klebsiella oxytoca, Klebsiella pneumoniae, Mycobacterium avium. Morganella morganii, Neisseria gonorrhoeae, Neisseria meningitidis, Plesiomonas shigelloides, Proteus mirabilis, Proteus vulgaris. Providencia spp .. Pseudomonas aeruginosa. Pseudomonas lluorcsccns, Serratia marcescens.

    Anaerobic microorganisms: Peptostreptococcus spp., Propionibacterium acnes.

    Resistant microorganisms

    Gram-positive aerobic microorganisms: Actinomyces spp. Enterococcus laecium. Staphylococcus spp. (methicillin-resistant).

    Gram-negative aerobic microorganisms: Burkholderia cepacia, Nocardia asteroides, Stenotrophomonas maltophilia.

    Anaerobic microorganisms not included in the lists above; other microorganisms: Bacteroides fragilis, Clostridium difficile. Listeria monocytogenes, Mycoplasma genitalium, Treponema pallidum, Ureaplasma urealyticum.

    Resistance develops very slowly, because on the one hand, after the action of ciprofloxacin are left with persistent microorganisms, and on the other - the bacterial cells do not have the enzymes that inactivate it.

    Pharmacokinetics:

    After intravenous infusion of 200 mg or 400 mg, the time to reach the maximum plasma concentration in the plasma is 60 minutes.maximum concentration of drug in plasma - 2.1 and 4.6 ug / ml, respectively, bond to plasma proteins - 20-40%. It is well distributed in the body tissues (excluding fabric, rich in fat, for example. Neural tissue). Concentration in tissues is 2-12 times higher than in plasma. Therapeutic concentrations achieved in saliva, tonsil, liver, gallbladder, bile. intestine, abdominal n pelvis (endometrium, fallopian tubes and ovaries, smear), semen, prostate tissue, kidney and urinary organs, lung tissues, bronchial secretions, bone, muscle, synovial fluid and articular cartilage, peritoneal fluid , the skin. The cerebrospinal fluid penetrates in a small amount where its concentration in the absence of inflammation of the meninges is 6-10% of that in the serum, while the inflamed - 14-37%. Ciprofloxacin well penetrates also into the eye fluid. bronchial secretion, pleura, peritoneum, lymph, through the placenta. The concentration of ciprofloxacin in blood neutrophils is 2-7 times higher than in blood serum.

    The activity is somewhat reduced at pH values ​​less than 6.

    Metabolised in the liver (15-30%) with the formation of low-activity metabolites (diethylciprofloxacin, sulfociprofloxacin, oxocycloploxacin, formyl ciprofloxacin).

    The half-life of the drug - 5-6 hours - with intravenous administration, with chronic renal failure - up to 12 hours. It is excreted mainly by the kidneys by tubular filtration and tubular secretion in unchanged form (50-70%) and in the form of metabolites (10%). the rest is through the gastrointestinal tract. A small amount is excreted in breast milk. After intravenous administration, the concentration in the urine during the first 2 hours after administration is almost 100 times greater than in the serum, which significantly exceeds the minimum inhibitory concentration for most pathogens of urinary tract infections.

    Kidney clearance - 3-5 ml / min / kg; total clearance - 8-10 ml / min / kg.

    In chronic renal insufficiency (creatinine clearance above 20 ml / min), the percentage of the drug withdrawn through the kidneys decreases, but cumulation in the body does not occur due to a compensatory increase in the metabolism of the drug and excretion through the gastrointestinal tract.

    Indications:

    Infectious-inflammatory diseases caused by microorganisms sensitive to ciprofloxacin:

    • diseases of the lower respiratory tract (acute and chronic (at the stage of exacerbation) bronchitis, pneumonia, bronchiectasis, infectious complications of cystic fibrosis);
    • infection of the ENT organs (acute sinusitis);
    • infection of the kidneys and urinary tract (cystitis, pyelonephritis);
    • Complicated intra-abdominal infections (in combination with metronidazole), including peritonitis;
    • chronic bacterial prostatitis;
    • uncomplicated gonorrhea;
    • typhoid fever, campylobacteriosis, shigellosis, diarrhea of ​​"travelers";
    • infections of the skin and soft tissues (infected ulcers, wounds, burns, abscesses, phlegmon);
    • infection of bones and joints (osteomyelitis, septic arthritis);
    • septicemia; infection against the background of immunodeficiency (arising in the treatment of immunosuppressive drugs or in patients with neutropenia);
    • prevention and treatment of pulmonary form of anthrax.

    Children. Therapy of complications caused by Pseudomonas aeruginosa in children with cystic fibrosis of the lungs from 5 to 17 years; prevention and treatment of pulmonary form of anthrax (infection with Bacillus anthracis).

    Contraindications:

    Hypersensitivity to ciprofloxacin and other fluoroquinolones, as well as to other components of the drug, simultaneous use with tizanidine (the risk of pronounced reduction in blood pressure, drowsiness), children's age (up to 18 years - until the completion of the skeletal process, except for the treatment of complications caused by Pseudomonas aeruginosa in children with cystic fibrosis of the lungs from 5 to 17 years, prevention and treatment of the pulmonary form of anthrax).

    Carefully:

    Severe atherosclerosis of cerebral vessels, cerebral circulation disorder. mental illness, epilepsy, lowering the threshold of convulsive readiness (or convulsive fits in the anamnesis), marked renal and / or hepatic insufficiency, elderly age, tendon damage with prior treatment with quinolones. increased risk of prolongation of the QT interval or the development of pirouette-type arrhythmias (eg, congenital QT prolongation syndrome, heart disease (heart failure, myocardial infarction, bradycardia), electrolyte imbalance (eg, hypokalemia, hypomagnesemia)), simultaneous use of drugs that extend interval QT (including antiarrhythmic IA and III classes, tricyclic antidepressants, macrolides, neuroleptics), simultaneous application with inhibitors of isoenzymes CYP4501A2, (including theophylline, methylxanthine, caffeine, duloxetine, clozapine, ropinirole, olanzapine), myasthenia gravis gravis, deficiency of glucose-6-phosphate dehydrogenase.

    Pregnancy and lactation:

    Contraindicated in pregnancy (safety and effectiveness of use in women during pregnancy is not established), since ciprofloxacin penetrates the placenta.

    Because the ciprofloxacin is excreted in breast milk, it should not be prescribed to nursing mothers. If it is necessary to use ciprofloxacin in the mother during lactation, breastfeeding should be discontinued.

    Dosing and Administration:

    Intravenously.

    Recommended dosing regimen for adults

    - respiratory tract infections (depending on the severity of the infection and the patient's condition): from 400 mg twice a day to 400 mg three times a day;

    - infections of the genitourinary system: acute, uncomplicated: from 200 mg twice a day to 400 mg twice a day: complicated: from 400 mg twice a day to 400 mg three times a day;

    - chronic bacterial prostatitis: from 400 mg twice a day to 400 mg three times a day;

    - diarrhea: 400 mg twice a day;

    - other infections (see section "Indications for use"): 400 mg 2 times a day:

    - particularly serious infections that pose a threat to life (especially if Pseudomonas spp., Staphylococcus spp., Streptococcus spp.), including pneumonia. caused by Streptococcus spp., recurrent infections in cystic fibrosis. infection of bones and joints, septicemia, peritonitis: 400 mg 3 times a day;

    - pulmonary form of anthrax (treatment and prophylaxis): 400 mg 2 times a day.

    Recommended dosing regimen for children

    - infection in cystic fibrosis (for children from 5 to 17 years): single dose of 10 mg / kg body weight 3 times a day (maximum single dose of 400 mg);

    - pulmonary form of anthrax (postcontact): single dose of 10 mg / kg of body weight 2 times a day (maximum single dose of 400 mg).

    Dosing regimen in elderly patients (after 65 years)

    Older patients should be prescribed lower doses of ciprofloxacin, depending on the severity of the disease and the creatinine clearance rate.

    Dosing regimen for adult patients with renal insufficiency

    - with a clearance of creatinine from 30 to 60 ml / min / 1.73 m2 or its concentration in blood plasma from 1.4 to 1.9 mg / 100 ml, the maximum daily dose of ciprofloxacin is 800 mg;

    - when the creatinine clearance is less than 30 ml / min / 1.73 m2 or its concentration in blood plasma from 2 mg / 100 ml or more, the maximum daily dose of ciprofloxacin is 400 mg.

    Patients with renal insufficiency on hemodialysis:

    - with a clearance of creatinine from 30 to 60 ml / min / 1.73 m2 or its concentration in blood plasma from 1.4 to 1.9 mg / 100 ml, the maximum daily dose of ciprofloxacin is 800 mg:

    - at a creatinine clearance of 30 ml / min / 1.73 m2 and less or its concentration in the blood plasma from 2 mg / 100 ml or more the maximum daily dose of ciprofloxacin -400 mg.

    In days of hemodialysis ciprofloxacin take after the procedure.

    Ambulatory patients with renal failure who are on prolonged peritoneal dialysis: the drug is added to the dialysate (intraperitoneally) - 50 mg ciprofloxacin per liter dialysate, administered 4 times a day every 6 hours.

    Adult patients with hepatic insufficiency: dose adjustment is not required.

    Dosing regimen the children with impaired renal and hepatic function was not studied.

    Mode of application: the drug is administered as an intravenous infusion lasting at least 60 minutes.The infusion solution should be injected slowly into a large vein. The infusion solution can be administered alone or together with other compatible infusion solutions. The infusion solution of the drug is compatible with 9% sodium chloride solution, Ringer's solution, Ringer's lactate solution, 5% and 10% dextrose solution, 10% fructose solution, and 5% dextrose solution with 0.225% sodium chloride solution or 0.45% sodium chloride solution . The solution obtained after mixing the drug with compatible infusion solutions should be used as soon as possible because of the sensitivity of the drug to light and to maintain the sterility of the solution. If compatibility with another infusion solution / drug is not confirmed, the infusion solution of the drug Ciprofloxacin should be entered separately.

    Visible signs of incompatibility are precipitation, clouding or discoloration of the solution. Only clean clear solution should be used.

    The duration of treatment depends on the severity, clinical course and cure of the disease. It is important to continue treatment at least 3 days after the disappearance of the fever or otherclinical symptoms.

    Average duration of treatment:

    Adults:

    - with acute uncomplicated gonorrhea - 1 day;

    - renal infections, urinary tract infections, intra-abdominal infections - up to 7 days;

    - at a neutropenia at patients with the weakened or easied immunity - all period;

    - with osteomyelitis - no more than 2 months;

    - with other infections - from 7 to 14 days.

    - infections caused by Streptococcus spp .. because of the risk of late complications of treatment should last at least 10 days;

    - for infections caused by Chlamydia spp. - not less than 10 days.

    V adults and children Treatment for an anthrax pulmonary form should be started immediately after an alleged or confirmed infection. The total duration of treatment with ciprofloxacin in pulmonary form of anthrax is 60 days.

    Patients from 5 to 17 years old for the treatment of cystic fibrosis pulmonary complications caused by Pseudomonas aeruginosa, duration of therapy is 10-14 days.

    Side effects:

    From the digestive system: nausea, diarrhea, vomiting, abdominal pain, flatulence, loss of appetite and food intake, pseudomembranous colitis, pancreatitis, cholestatic jaundice (especially in patients with liver disease migrated), hepatitis, gepatonekroz.

    From the nervous system: dizziness, headache, fatigue, anxiety, tremor, muscle cramps, insomnia, nightmarish dreams, increased intracranial pressure, confusion, hallucinations, psychotic reactions (which can lead to self-damaging behavior such as suicidal behavior / thoughts, and also suicide attempts, or suicide), depression (which can lead to self-harming behavior, such as suicidal behavior / thoughts, as well as attempted suicide or suicide), migraines, seizures ilepsii, agitation, confusion, paresthesia and dysesthesia, hypoesthesia and hyperesthesia, convulsions, vertigo, incoordination, peripheral neuropathy and neuropathy, respiratory failure (including bronchospasm), increased muscle tone, muscle weakness, exacerbation of symptoms of myasthenia, impaired gait.

    From the sense organs: violation of taste and smell, visual impairment (diplopia, change in color perception), tinnitus, hearing loss.

    From the cardiovascular system: paroxysmal tachycardia, prolongation of the QT interval.ventricular arrhythmias (including "pirouette" type), vasodilation, lowering of arterial pressure, cardiovascular collapse, benign intracranial hypertension.

    From the hematopoietic system: leukopenia, granulocytopenia, hemolytic anemia, thrombocytopenia, anemia, neutropenia, agranulocytosis, pancytopenia, oppression of bone marrow hematopoiesis, leukocytosis, thrombocytosis, prothrombin content change. an increase in the international normalized relationship (INR) (in patients receiving vitamin K antagonists).

    From the laboratory indicators: increased activity of "liver" transaminases and alkaline phosphatase, hypercreatininemia, hyperbilirubinemia, hyperglycemia, hypoglycemia, increased activity of amylase.

    From the urinary system: hematuria, crystalluria (primarily with alkaline urine and low diuresis), interstitial nephritis, impaired renal function, renal insufficiency.

    Allergic reactions: skin rash, rash, urticaria, the formation of blisters accompanied by bleeding, and the appearance of small nodules that form scabs, drug fever,point hemorrhages on the skin (petechiae), swelling of the face or larynx, angioedema, serum sickness, anaphylactic reactions, anaphylactic shock, dyspnea, eosinophilia, increased photosensitivity, vasculitis, erythema nodosum, acute generalized pustular exanthema, multiforme exudative erythema (including syndrome Stevens-Johnson), toxic epidermal necrolysis (Lyell's syndrome).

    Local reactions: edema, tenderness, phlebitis (at the site of administration of the drug).

    Other: arthralgia, arthritis, tendovaginitis, tendon ruptures (mainly Achilles), asthenia, myalgia. superinfection (candidiasis), "tides" of blood to the face, increased sweating.

    Overdose:

    Symptoms: there are no specific symptoms.

    Treatment: a specific antidote is unknown. It is necessary to carefully monitor the patient's condition, introduce a large amount of fluid, create an acid reaction of urine, additionally - hemodialysis and peritoneal dialysis (only 10% of the drug can be withdrawn): all activities are held against the backdrop of maintaining vital functions. In order to prevent the development of crystallaria, it is recommended to monitor renal function, including pH and acidity of urine.

    Interaction:

    Due to the decrease in the activity of microsomal oxidation in hepatocytes, it increases the concentration and prolongs the half-life of the theophylline preparation (and other xanthines, for example, caffeine), oral hypoglycemic drugs, indirect anticoagulants, and decreases the pro thrombin index. When combined with other antimicrobial drugs (beta-lactam antibiotics, aminoglycosides, clindamycin, metronidazole) synergy is usually observed; can be successfully used in combination with azlocillin and ceftazidime in infections caused by Pseudomonas spp .; with mezlocillin, azlocillin and other beta-lactam antibiotics - with streptococcal infections; with isoxazolylpenicillins and vancomycin - with staphylococcal infections; with metronidazole and clindamycin - with anaerobic infections.

    Increases the nephrotoxic effect of cyclosporine, there is an increase in serum creatinine, in such patients monitoring of this indicator is required 2 times a week.

    With simultaneous application increases the effect of indirect anticoagulants.

    Non-steroidal anti-inflammatory drugs (excluding acetylsalicylic acid) increase the risk of seizures.

    The combined use of uricosuric drugs leads to slower elimination (50%) and increase plasma concentration of ciprofloxacin. Increases the maximum plasma concentration in the plasma 7 times (from 4 to 21 times) and the area under the concentration-time curve by 10 times (from 6 to 24 times) of tizanidine, which increases the risk of pronounced reduction in blood pressure and drowsiness.

    The infusion solution is pharmaceutically incompatible with all infusion solutions and drugs that are physico-chemically unstable under acidic conditions (the pH of the infusion solution of ciprofloxacin is 3.9-4.5). Do not mix the intravenous solution with solutions that have a pH of more than 7.

    In some cases, simultaneous use of ciprofloxacin and oral hypoglycemic agents (for example, glibenclamide, glimepiride) may increase the intensity of action of the latter (hypoglycemia).

    Ciprofloxacin inhibits the isoenzyme CYP4501A2, and this can cause an increase in plasma concentrations of concomitantly taken drugs (theophylline, clozapine, Tacrine, ropinirole, tizanidine), which are metabolized by the isoenzyme CYP4501A2.

    Simultaneous use of ciprofloxacin and preparations containing theophylline, can cause the occurrence of theophylline-induced adverse events; in very rare cases, these side effects can be life threatening. With simultaneous application with theophylline it is recommended to conduct a constant control of the theophylline concentration in the blood plasma and. if necessary, reduce the dose of theophylline. It is often necessary to monitor the international normalized relationship during the combined use of ciprofloxacin and indirect anticoagulants, and also for a short time after the completion of the combination therapy.

    Methotrexate secretion by the renal tubules can be reduced with simultaneous use of ciprofloxacin as a result of competitive inhibition, leading to an increase in the concentration of methotrexate in the blood plasma. Patients receiving methotrexate therapy require careful monitoring, as the risk of developing toxic reactions caused by methotrexate is increased.

    When used simultaneously with drugs that extend the QT interval (antiarrhythmic IA and III classes, tricyclic antidepressants, macrolides, antipsychotics), an extension of the QT interval is possible.

    The simultaneous use of duloxetine and potent inhibitors of the CYP4501A2 isoenzyme (such as fluvoxamine) can lead to an increase in BMD (minimum suppressive concentration) and Cmax (maximum concentration) of duloxetine. Despite the lack of clinical data on the possible interaction with ciprofloxacin. it is possible to foresee the likelihood of such a possible interaction with the simultaneous use of ciprofloxacin and duloxetine.

    The simultaneous use of ropinirole and ciprofloxacin. moderate inhibitor of the isoenzyme CYP4501A2, leads to an increase in the maximum concentration (Cmax) and the minimum inhibitory concentration (MIC) of ropinirole by 60% and 84%, respectively. It is necessary to monitor the side effects of ropinirole during its simultaneous use with ciprofloxacin and for a short time after completion of the combination therapy.

    Simultaneous use of lidocaine and ciprofloxacin leads to a decrease in clearance of lidocaine by 22% with its intravenous administration (possibly increasing side effects of lidocaine).

    With the simultaneous use of clozapine and ciprofloxacin at a dose of 250 mg for 7 days, an increase in serum concentrations of clozapine and N-desmethylclozapine by 29% and 31%, respectively (correction of the dosage regimen of clozapine during its simultaneous use with ciprofloxacin and for a short time after completion of combination therapy is necessary).

    With the simultaneous use of ciprofloxacin in a dose of 500 mg and sildenafil at a dose of 50 mg, an increase in the maximum concentration (Cmax) and the minimum inhibitory concentration (MIC) of sildenafil 2 times (this combination is possible only after the benefit / risk ratio is evaluated).

    With the simultaneous use of ciprofloxacin and phenytoin, both an increase and a decrease in the plasma phenytoin concentration is possible, so it is recommended to monitor its concentration during the entire period of simultaneous use of the drugs and shortly after the completion of the combination therapy.

    Special instructions:

    Ciprofloxacin is not a drug of choice in suspected or established pneumonia caused by Streptococcus pneumoniae.

    With simultaneous intravenous administration of ciprofloxacin and drugs for general anesthesia from the group of barbituric acid derivatives, continuous monitoring of the heart rate, blood pressure, and electrocardiogram is necessary.

    To avoid the development of crystalluria, exceeding the recommended daily dose is inadmissible, adequate fluid intake and maintenance of acid urine reaction are also necessary.

    Patients with epilepsy, episodes of seizures in history, vascular diseases and organic brain damage, due to the threat of development of adverse reactions from the central nervous system ciprofloxacin should be prescribed only for "vital" indications.

    If a severe and prolonged diarrhea occurs during or after treatment, the diagnosis of pseudomembranous colitis should be deleted, which requires immediate discontinuation of the drug and the appointment of appropriate treatment. Contraindicated use of drugs that inhibit intestinal peristalsis.

    In patients who use fluoroquinolones, including ciprofloxacin, cases of sensory and sensorimotor axonal polyneuropathy affecting small and (or) large axons are recorded, leading to paresthesia, hyposthenia, dysesthesia and weakness. Symptoms may appear soon after the onset of use and be irreversible.If a patient develops symptoms of neuropathy, including pain, burning, tingling, numbness, and (or) weakness or other sensory disturbances, including tactile, pain, temperature, vibration sensation and a feeling of use of the drug situation ciprofloxacin must be discontinued immediately.

    Given that women are characterized by a large average duration of the interval QT compared to men, they are more sensitive to drugs that cause lengthening of the interval QT; Ciprofloxacin should be used with caution in combination with drugs that extend the interval QT (for example, antiarrhythmic drugs classes IA and III, tricyclic antidepressants, macrolides, neuroleptics), in patients with an increased risk of lengthening the interval QT or the development of piruet-type arrhythmias (eg, congenital lengthening syndrome QT, heart disease (heart failure, myocardial infarction, bradycardia), electrolyte imbalance (e.g., hypokalemia, hypomagnesemia)).

    When ciprofloxacin was used, cases of liver necrosis and life-threatening liver failure were noted.In the presence of symptoms of liver disease, such as anorexia, jaundice, darkening of the urine, itching, abdominal tenderness, the use of ciprofloxacin should be discontinued.

    Patients with severe myasthenia gravis ciprofloxacin should be used with caution, as possible exacerbation of symptoms.

    When ciprofloxacin is used, cases of tendinitis and tendon rupture (predominantly Achilles tendon), sometimes bilateral, can occur within the first 48 hours after the initiation of therapy, inflammation and rupture of the tendon may occur even several months after discontinuation of ciprofloxacin treatment. In elderly patients and patients with diseases of the tendons, simultaneously receiving treatment with glucocorticosteroids, there is an increased risk of tendonopathy.

    When pain occurs in the tendons or the first signs of tendovaginitis treatment should be discontinued.

    When ciprofloxacin was used, cases of epileptic status were reported, ciprofloxacin, like other fluoroquinolones, can provoke cramps and reduce the threshold of convulsive readiness. In case of seizures, the drug should be discontinued.

    Mental reactions may occur even after the first use of fluoroquinolones, including ciprofloxacin. In rare cases, depression or psychotic reactions can progress to suicidal thoughts and self-damaging behavior, such as suicide attempts, including those that have occurred. If a patient develops one of these reactions, stop taking the medication and tell the doctor about it.

    During the treatment period, avoid direct sunlight.

    In the treatment of severe infections, staphylococcal infections and infections caused by gram-positive and anaerobic bacteria, ciprofloxacin should be used in combination with appropriate antibacterial agents. For genital infections presumably caused by strains of Neisseria gonorrhoeae resistant to fluoroquinolones, local information on ciprofloxacin resistance should be taken into account and the susceptibility of the causative agent in laboratory tests should be confirmed.

    In rare cases, after the first application, anaphylactic reactions may occur up to anaphylactic shock. In these cases, the use of ciprofloxacin should be stopped immediately and appropriate treatment should be given.

    Ciprofloxacin is a moderate inhibitor of CYP4501A2 isoenzymes.Caution should be exercised with the simultaneous use of ciprofloxacin and drugs metabolized by these enzymes (including theophylline, methylxanthine, caffeine, duloxetine, clozapine, ropinirole, olanzapine), since an increase in the concentration of these drugs in the blood serum, due to inhibition of their metabolism by ciprofloxacin, can cause specific undesirable reactions.

    Local reaction (inflammatory reaction of the skin at the injection site: edema, occurs more often if the infusion time is 30 minutes or less). The reaction quickly passes after the end of the infusion and is not a contraindication for the next administration of the drug, unless its course is complicated.

    In vitro in laboratory tests ciprofloxacin suppresses the growth of Mycobacterium spp., which can lead to false-negative results in the diagnosis of this pathogen in patients taking ciprofloxacin.

    Consider the sodium chloride content of the ciprofloxacin solution. in the treatment of patients who have limited sodium intake (heart failure, kidney failure, nephrotic syndrome).

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

    During the treatment should refrain from driving and from activities potentially hazardous activities that require high concentration and speed of psychomotor reactions

    Form release / dosage:

    Solution for infusions 2 mg / ml.

    Packaging:

    100 ml in a glass bottle, sealed with rubber stopper and crimped aluminum or combined cap.

    A bottle with instructions for use is placed in a pack of cardboard.

    For hospitals: 56 bottles of 100 ml with an equal number of instructions for use are placed in boxes of cardboard corrugated.

    Storage conditions:

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

    Freezing is not allowed.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-003119
    Date of registration:29.07.2015
    The owner of the registration certificate:BIOSINTEZ, PAO BIOSINTEZ, PAO Russia
    Manufacturer: & nbsp
    Information update date: & nbsp20.10.2015
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