Ciprofloxacin solution instructions for use for children. When pills don't work: brief instructions for use of ciprofloxacin infusion solution. Release form and composition

  • Instructions for use Ciprofloxacin
  • Ingredients of Ciprofloxacin
  • Indications for Ciprofloxacin
  • Storage conditions of the drug Ciprofloxacin
  • Shelf life of Ciprofloxacin

Release form, composition and packaging

rr d / inf. 2 mg/ml: 100 ml bot.
Reg. No: 16/12/1995 dated 12/21/2016 - Validity of reg. beats is not limited

Solution for infusion clear, slightly yellowish liquid.

Excipients: lactic acid - 64 mg, sodium chloride - 900 mg, disodium edetate - 10 mg, water for injection - up to 100 ml.

pH 3.9 to 4.5

100 ml - glass bottles (1) - packages.
100 ml - glass bottles (20) - group packages (for hospitals).
100 ml - glass bottles (35) - group packages (for hospitals).
100 ml - glass bottles (40) - group packages (for hospitals).

Description of the medicinal product CIPROFLOXACIN was created in 2013 on the basis of instructions posted on the official website of the Ministry of Health of the Republic of Belarus. Date of update: 05/28/2014


pharmachologic effect

Ciprofloxacin is active against most Gram-negative microorganisms:

  • Pseudomonas aeruginosa, hemophilic and Escherichia coli, shigella, salmonella, meningococcus, gonococcus, some varieties of enterococci;
  • many strains of staphylococci (producing and not producing penicillinase), campylobacter, legionella, mycoplasmas, chlamydia, mycobacteria;
  • as well as microorganisms producing beta-lactamase. Resistant to the drug: Ureaplasma urealyticum, Clostridium difficile, Nocardia asteroides. The action against Treponema pallidum has not been studied enough.

The rapid bactericidal action of ciprofloxacin is associated with its unique mode of action. Ciprofloxacin, like other fluoroquinolones, blocks bacterial DNA gyrase and disrupts DNA function, which causes the death of bacteria. Ciprofloxacin damages the bacterial cell membrane, which leads to the release of cellular contents. It is effective both in the phase of reproduction of bacteria and in the resting phase, it is also active against intracellular bacteria. The drug has a significant post-antibiotic effect - up to six hours - and thus prevents the growth of bacteria.

Pharmacokinetics

Serum Cmax after intravenous administration of doses of 100 and 200 mg reaches 2.0 and 3.8 µg/ml, respectively, and is many times higher than MGZh for most microorganisms. Bioavailability is about 70%.

Ciprofloxacin is very well distributed in the body and reaches therapeutic concentrations in most tissues and body fluids, including sputum, bones, peritoneal fluid, prostate and pelvic tissues. Protein binding 19-40%. It is excreted mainly by the kidneys (45% unchanged, 11% as metabolites). The rest of the dose is excreted through the intestines (20% - unchanged, 5-6% - in the form of metabolites). T 1/2 is 3-5 hours.

Indications for use

adults

Uncomplicated and complicated infections caused by pathogens sensitive to ciprofloxacin:

  • respiratory infections. In the outpatient treatment of pneumococcal pneumonia, ciprofloxacin should not be used as the drug of first choice. Ciprofloxacin is recommended for the treatment of pneumonia caused by Klebsiella spp., Enterobacter spp., Proteus spp., Escherichia coli, Pseudomonas aeruginosa, Haemophilus spp., Moraxella catarrhalis, Legionella and staphylococci;
  • infections of the middle ear and paranasal sinuses;
  • eye infections;
  • infections of the abdominal organs, bacterial infections of the gastrointestinal tract, gallbladder and biliary tract, as well as peritonitis;
  • kidney and urinary tract infections;
  • infections of the pelvic organs (gonorrhea, adnexitis, prostatitis);
  • skin and soft tissue infections;
  • bone and joint infections;
  • sepsis;
  • prevention and treatment of infections in immunocompromised patients (including during treatment with immunosuppressants and with neutropenia).

Children

As a second or third line drug for the treatment of complicated urinary tract infections and pyelonephritis caused by E. coli in children over 1 year of age, as well as for the treatment of pulmonary exacerbations caused by Pseudomonas aeruginosa in children with cystic fibrosis of the lungs over the age of 5 years.

For adults and children

Reducing the risk of occurrence or progression of anthrax after aerogenic contact with Bacillus anthracis.

Dosing regimen

The dosage regimen is set individually depending on the location and severity of the infection, as well as on the sensitivity of the pathogen. If the use of ciprofloxacin inside is not possible, it is recommended to start treatment with an intravenous injection. Solution for infusion can be administered undiluted or after adding to other infusion solutions.

For urinary tract infections (including acute uncomplicated cystitis in women, as well as acute uncomplicated gonorrhea), the drug is administered at a dose of 100 mg 2 times / day. For respiratory tract infections and other infections, depending on the severity of the process and the type of pathogen, the drug is administered at a dose of 200-400 mg 2 times / day. For intravenous administration, it is best to use a short infusion (which should last 60 minutes).

For severe infections or recurrent infections, infections of the abdominal cavity, bones and joints caused by Pseudomonas or staphylococci, with peritonitis and sepsis, as well as acute pneumonia caused by Streptococcus pneumoniae, the dose should be increased to 400 mg 3 times / day.

The maximum daily dose in the above cases should not exceed 1200 mg.

Dosing for Elderly Patients

Elderly patients should be given lower doses of ciprofloxacin based on disease severity and creatinine clearance.

For the prevention and treatment of the disease with the pulmonary form of anthrax, the dose is 400 mg 2 times / day, for children - 10 mg per 1 kg of body weight, intravenously 2 times / day. Do not exceed the maximum single dose - 400 mg (maximum daily dose - 800 mg). Start taking the drug immediately after the assumption or confirmation of infection. The duration of taking ciprofloxacin for pulmonary anthrax is 60 days.

Treatment of children in the framework of clinical studies was carried out only according to the above indications. Clinical experience with ciprofloxacin in children for other indications is limited. It is permissible to prescribe to children only after a thorough assessment of the risk / benefit ratio - due to the likelihood of developing effects on the part of the joints and (or) periarticular tissues (the possibility of damage to the articular cartilage during the growth period is not ruled out).

  • With complications of cystic fibrosis of the lungs caused by Pseudomonas aeruginosa, children from 5 years of age are prescribed 10 mg / kg of body weight 3 times / day. The maximum daily dose is 1200 mg. The duration of treatment is 10-14 days.
  • For urinary tract infections or pyelonephritis, the dose is 6 to 10 mg/kg every 8 hours. A single dose should not exceed 400 mg.

Dosing regimen in violation of the functions of the kidneys or liver in adults.

1. Impaired kidney function.

1.1. With CC from 31 to 60 ml / min / 1.73 m 2 or its plasma concentration from 1.4 to 1.9 mg / 100 ml, the maximum dose of ciprofloxacin with intravenous administration should be 800 mg / day;

1.2. With a CC of 30 ml / min / 1.73 m 2 or less or its plasma concentration of 2 mg / 100 ml or more, the maximum dose of ciprofloxacin when administered intravenously should be 400 mg.

2. Impaired kidney function + hemodialysis.

The maximum dose of ciprofloxacin for intravenous administration should be 400 mg / day on the days of hemodialysis. Ciprofloxacin is administered after this procedure.

3.
patients.

Ciprofloxacin solution is attached to the dialysate (intraperitoneal administration):

4. Impaired liver function.

Dose adjustment is not required.

The duration of treatment depends on the severity of the disease, the clinical course and the results of bacteriological studies.

Treatment is recommended to continue for at least three days after the normalization of body temperature or the disappearance of clinical symptoms. The duration of treatment for acute uncomplicated gonorrhea and cystitis is 1 day. For infections of the kidneys, urinary tract and abdominal organs, the duration of treatment is 7 days. With osteomyelitis, the course of treatment is usually 7-14 days. In immunocompromised patients, treatment is carried out during the entire period of neutropenia. For infections caused by streptococci and chlamydia, treatment should continue for at least 10 days.

Side effects

From the hematopoietic and lymphatic systems: infrequently - eosinophilia, leukopenia;

  • rarely - anemia, granulocytopenia, leukocytosis, changes in the level of prothrombin, thrombocytopenia, thrombocytosis;
  • very rarely - including isolated cases: hemolytic anemia, pancytopenia, agranulocytosis, depression of bone marrow function.
  • From the nervous system: infrequently - headache, dizziness, fatigue, insomnia, agitation, confusion;

  • rarely - hallucinations, vertigo, sweating, paresthesia, anxiety (fear, anxiety), nightmares, depression, tremor, convulsions, weakening of sensations, disorientation;
  • very rarely - including isolated cases: unstable behavior, psychosis, increased intracranial pressure, ataxia, hyperesthesia, convulsions, drowsiness, impaired coordination.
  • From the sense organs: infrequently - a violation of taste and visual disturbances;

  • rarely - ringing in the ears, temporary deafness (especially with respect to high frequencies), visual disturbances (diplopia, impaired color perception);
  • very rarely - including isolated cases: loss of taste (usually temporarily).
  • From the side of the cardiovascular system: rarely - tachycardia, migraine, weakness, hot flashes and sweating, peripheral edema, decreased blood pressure, loss of consciousness;

  • very rarely - including isolated cases: vasculitis, prolongation of the QT interval, ventricular arrhythmia, bidirectional ventricular tachycardia.
  • From the respiratory system: rarely - shortness of breath, swelling of the throat.

    From the digestive tract, liver, gallbladder and bile ducts: often - nausea, diarrhea;

  • infrequently - vomiting, abdominal pain, flatulence, loss of appetite;
  • rarely - cholestatic jaundice, pseudomembranous colitis;
  • very rarely - including isolated cases: hepatitis (only life-threatening liver failure occurs), pancreatitis, liver necrosis.
  • From the skin and subcutaneous tissues: often - rash;

  • infrequently - itching, maculopapular rash, urticaria;
  • rarely - photosensitivity;
  • very rarely - including isolated cases: petechiae, papules, hemorrhagic cysts, crusts (as a result of vasculitis), polymorphic exudative erythema, erythema nodosum, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome).
  • From the skeletal system and connective tissue: infrequently - pain in the joints;

  • rarely - muscle pain, swelling of the joints;
  • very rarely - including isolated cases: tendonitis (especially Achilles tendonitis), tendon rupture, myasthenia gravis.
  • From the urinary system: rarely - interstitial nephritis, temporary renal failure, hematuria and crystalluria, tubulointerstitial nephritis.

    General violations: infrequently - pain and vasculitis at the injection site, a feeling of general weakness, prolonged use can lead to an overgrowth of resistant bacteria and fungi (pseudomembranous colitis, candidiasis);

  • rarely - hypersensitivity reactions, drug-induced fever, anaphylactic reactions (swelling of the face, angioedema, shortness of breath, widespread shock), which may occur immediately after the first dose, pain in the extremities, back and chest;
  • very rarely - including isolated cases: reactions similar to serum sickness, exacerbation of myasthenia gravis.
  • Impact on laboratory parameters: infrequently - an increase in the activity of transaminases and alkaline phosphatase, an increase in the level of bilirubin, creatinine and urea in the blood plasma;

  • rarely - hyperglycemia, crastalluria and hematuria;
  • very rarely - including isolated cases: increased levels of amylase and lipase.
  • If severe side effects occur (especially hypersensitivity reactions, pseudomembranous colitis, CNS disorders, hallucinations, or pain in the tendon area), treatment should be discontinued.

    Contraindications for use

    • hypersensitivity to ciprofloxacin or to other components of the drug, as well as to other fluoroquinolones;
    • the simultaneous use of ciprofloxacin and tizanidine due to clinically significant side effects (hypotension, drowsiness) associated with an increase in the concentration of tizanidine in the blood plasma.

    Use during pregnancy and lactation

    The drug is not used during pregnancy and lactation due to lack of clinical experience. There is a possibility of a negative effect of ciprofloxacin on the development of articular cartilage in the child's body.

    Application for violations of kidney function

    Impaired kidney function: with CC from 31 to 60 ml / min / 1.73 m 2 or its plasma concentration from 1.4 to 1.9 mg / 100 ml, the maximum dose of ciprofloxacin for intravenous administration should be 800 mg / day;

  • with a CC of 30 ml / min / 1.73 m 2 or less or its plasma concentration of 2 mg / 100 ml or more, the maximum dose of ciprofloxacin for intravenous administration should be 400 mg.
  • Impaired kidney function + hemodialysis: the maximum dose of ciprofloxacin for intravenous administration should be 400 mg / day on the days of hemodialysis. Ciprofloxacin is administered after this procedure.

    Impaired renal function + peritoneal dialysis in outpatients
    patients:
    ciprofloxacin solution is attached to the dialysate (intraperitoneal administration):

    • 50 mg of ciprofloxacin per 1 liter of dialysate is administered 4 times / day every 6 hours.

    Use in children

    The drug is used as a second or third line drug for the treatment of complicated urinary tract infections and pyelonephritis caused by E. coli in children from 1 year old, as well as for the treatment of pulmonary exacerbations caused by Pseudomonas aeruginosa in children with cystic fibrosis of the lungs aged 5 years and older. .

    The dosage regimen for impaired renal or hepatic function in children has not been studied.

    special instructions

    Severe infections and mixed infections caused by gram-positive bacteria and anaerobic pathogens. Ciprofloxacin monotherapy is not intended for the treatment of severe infections and infections that may be caused by gram-positive bacteria or anaerobic microorganisms. In the case of such infections, appropriate antibacterial agents should be used simultaneously with ciprofloxacin.

    streptococcal infections(including Streptococcus pneumoniae). Ciprofloxacin is not recommended for the treatment of streptococcal infections due to lack of efficacy.

    Genital tract infections. Orchiepididymitis and pelvic inflammatory disease may be caused by fluoroquinolone-resistant Neisseria gonorrhoeae. Ciprofloxacin should be used in conjunction with other appropriate antibacterial agents unless resistance to Neisseria gonorrhoeae cannot be ruled out. If there is no clinical improvement after 3 days of treatment, treatment should be reconsidered.

    Intra-abdominal infections. Data on the effectiveness of ciprofloxacin in the treatment of postoperative intra-abdominal infections are limited.

    Traveler's diarrhea. When prescribing ciprofloxacin, information on the resistance to it of the relevant pathogens in the countries visited by the patient should be taken into account.

    Bone and joint infections. Ciprofloxacin should be used in combination with other antimicrobial agents, depending on the results of microbiological analysis.

    Aerosol contact with the causative agent of anthrax. The use of the drug in humans is based on in vitro susceptibility data, data from animal models and a small amount of human data. The doctor should familiarize himself with the national and (or) internationally recognized documentation on the treatment of anthrax.

    Complicated urinary tract infections and pyelonephritis. For the treatment of urinary tract infections, ciprofloxacin is used when other treatments are not available, and its use should be based on the results of microbiological analysis.

    Other specific severe infections. For the treatment of other severe infections, ciprofloxacin is used according to official guidelines or after a careful benefit/risk assessment, if other therapies have not been possible, or after conventional treatment has failed, and if microbiological findings justify the use of ciprofloxacin.

    Increased sensitivity. After a single dose of ciprofloxacin, allergic reactions, including anaphylactic and anaphylactoid reactions, which can be life-threatening, may occur. If such reactions occur, the use of ciprofloxacin should be discontinued and, if necessary, appropriate medical attention should be provided.

    Musculoskeletal system. In general, ciprofloxacin should not be used in patients with a history of tendon disease/injury associated with quinolone treatment. However, in some cases, after microbiological identification of the causative agent and assessment of benefit-risk, ciprofloxacin can be prescribed to such patients for the treatment of certain severe infections, in particular in case of failure of standard therapy or bacterial resistance, when microbiological data may justify the use of ciprofloxacin. Tendinitis and tendon rupture (especially Achilles tendon), sometimes bilateral, can occur as early as the first 48 hours after ciprofloxacin. The risk of tendinopathy may be increased in elderly patients or in the case of concomitant use of corticosteroids. If there are any signs of tendonitis (eg, painful swelling, inflammation), ciprofloxacin should be discontinued. Ciprofloxacin should be used with caution in patients with myasthenia gravis.

    Photosensitivity. Ciprofloxacin has been shown to be capable of inducing photosensitivity reactions. Patients treated with ciprofloxacin should be advised to avoid direct exposure to excessive sunlight or ultraviolet radiation during treatment.

    CNS. Quinolones are known to cause seizures or lower their threshold. Ciprofloxacin should be used with caution in patients with CNS disorders who may be susceptible to trial. In the event of seizures, the use of ciprofloxacin should be discontinued. Mental reactions may appear after the first application. In rare cases, depression or psychosis may progress to the point where the patient's behavior becomes threatening. In such cases, the use of ciprofloxacin should be discontinued.

    Cases of polyneuropathy (defined by neurological symptoms such as pain, burning sensation, sensory disturbances or muscle weakness, alone or in combination) have been reported with ciprofloxacin.

    Ciprofloxacin has an effect on prolongation of the QT interval. In elderly patients, there is an increased sensitivity to the action of drugs that cause prolongation of the QT interval. Therefore, ciprofloxacin should be used with caution in combination with drugs that prolong the QT interval (eg, class IA and III antiarrhythmic drugs) or in patients at increased risk of torsades de pointes (eg, known QT interval prolongation, uncorrected hypokalemia). ).

    Overdose

    There are no reports of overdose. An overdose may cause:

    • nausea, vomiting, diarrhea, headache and dizziness, in more severe cases, there may also be impaired consciousness, tremors, hallucinations and convulsions. In case of overdose, symptomatic treatment is recommended. It is necessary to ensure sufficient fluid intake into the body, the creation of an acidic urine reaction (to prevent the formation of crystals). Hemodialysis is not clinically effective for intoxications.

    drug interaction

    Ciprofloxacin is compatible with sodium chloride solution 9 mg/ml, Ringer's solution, Hartman's solution (Ringer's lactate), glucose solutions 50 mg/ml and 100 mg/ml, fructose solution 100 mg/ml and glucose solution 5 mg/ml with sodium chloride 2.25 mg/ml or 4.5 mg/ml. The solution obtained after mixing ciprofloxacin with compatible infusion solutions should be used as soon as possible due to the possibility of contamination by microorganisms, as well as the sensitivity of the drug to light (therefore, the drug should be removed from the box only before use). When stored in sunlight, the stability of the solution is guaranteed - 3 days.

    Ciprofloxacin should not be mixed with infusion solutions and injections that are physically and chemically unstable at pH 3-4 (eg penicillin, heparin). If the patient requires the concomitant use of other drugs, these drugs should be used separately from ciprofloxacin. Visible signs of incompatibility are precipitation, cloudiness or discoloration of the solution.

    Caution should be exercised when using ciprofloxacin with class IA or class III antiarrhythmic drugs, as ciprofloxacin may have an additive effect with prolongation of the QT interval.

    Table of contents [Show]

    In this article, you can read the instructions for using the drug Ciprofloxacin. Reviews of site visitors - consumers of this medicine, as well as opinions of doctors of specialists on the use of Ciprofloxacin in their practice are presented. We kindly ask you to actively add your reviews about the drug: the medicine helped or did not help get rid of the disease, what complications and side effects were observed, perhaps not declared by the manufacturer in the annotation. Ciprofloxacin analogues in the presence of existing structural analogues. Use for the treatment of infectious diseases of various organs and body systems in adults, children, as well as during pregnancy and lactation.

    Ciprofloxacin- a broad-spectrum antimicrobial drug from the group of fluoroquinolones. Acts bactericidal. The drug inhibits the enzyme DNA-gyrase of bacteria, as a result of which DNA replication and the synthesis of cellular proteins of bacteria are disrupted. Ciprofloxacin acts both on multiplying microorganisms and on those in the resting phase.

    Ciprofloxacin is active against gram-negative and gram-positive aerobic bacteria; intracellular pathogens: Legionella pneumophila, Brucella spp., Chlamydia trachomatis, Listeria monocytogenes, Mycobacterium tuberculosis, Mycobacterium kansasii, Mycobacterium avium-intracellulare. Most methicillin-resistant staphylococci are also resistant to ciprofloxacin.

    Streptococcus pneumoniae, Enterococcus faecalis are moderately sensitive to the drug.

    Corynebacterium spp., Bacteroides fragilis, Pseudomonas cepacia, Pseudomonas maltophilia, Ureaplasma urealyticum, Clostridium difficile, Nocardia asteroides are resistant to the drug.

    The effect of the drug against Treponema pallidum has not been studied enough.

    Pharmacokinetics

    Rapidly absorbed from the gastrointestinal tract. Food intake has little effect on the absorption of ciprofloxacin. Distributed in tissues and body fluids. Penetrates into the cerebrospinal fluid: the concentration of ciprofloxacin in non-inflamed meninges reaches 10%, in inflamed - up to 37%. High concentrations are reached in bile. Excreted in urine and bile.

    Indications

    Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

    • respiratory tract;
    • ear, throat and nose;
    • kidneys and urinary tract;
    • genital organs (including gonorrhea, prostatitis);
    • gynecological (including adnexitis) and postpartum infections;
    • digestive system (including the oral cavity, teeth, jaws);
    • gallbladder and biliary tract;
    • skin, mucous membranes and soft tissues;
    • musculoskeletal system;
    • sepsis;
    • peritonitis;
    • prevention and treatment of infections in patients with reduced immunity (with immunosuppressant therapy).

    For topical use:

    • acute and subacute conjunctivitis;
    • blepharoconjunctivitis;
    • blepharitis;
    • bacterial ulcers of the cornea;
    • keratitis;
    • keratoconjunctivitis;
    • chronic dacryocystitis;
    • meibomites;
    • infectious lesions of the eyes after injuries or foreign bodies;
    • preoperative prophylaxis in ophthalmic surgery.

    Release form

    Film-coated tablets 250 mg, 500 mg, 750 mg.

    Drops eye and ear 0.3%.

    Solution for intravenous administration (injections in ampoules for injection) 2 mg/ml.

    Instructions for use and dosage

    Pills

    The dose of ciprofloxacin depends on the severity of the disease, type of infection, body condition, age, body weight and kidney function of the patient.

    Uncomplicated diseases of the kidneys and urinary tract - 250 mg, in complicated cases - 500 mg 2 times a day.

    Diseases of the lower respiratory tract of moderate severity - 250 mg, in more severe cases - 500 mg 2 times a day.

    Gynecological diseases, enteritis and colitis with severe course and high fever, prostatitis, osteomyelitis - 500 mg 2 times a day (for the treatment of banal diarrhea can be used at a dose of 250 mg 2 times a day).

    The drug should be taken on an empty stomach with a sufficient amount of liquid.

    Patients with severe renal impairment should be given a half dose of the drug.

    The duration of treatment depends on the severity of the disease, but treatment should always be continued for at least two more days after the symptoms of the disease have disappeared. Usually the duration of treatment is 7-10 days.

    The drug should be administered intravenously over 30 minutes (dose 200 mg) and 60 minutes (dose 400 mg). The solution for infusion can be combined with 0.9% sodium chloride solution, Ringer's solution, 5% and 10% dextrose (glucose) solution, 10% fructose solution, a solution containing 5% dextrose solution with 0.225% or 0.45% sodium chloride solution.

    The dose of ciprofloxacin depends on the severity of the disease, type of infection, body condition, age, weight and kidney function of the patient.

    A single dose is 200 mg, with severe infections - 400 mg. Frequency rate of introduction — 2 times a day; duration of treatment - 1-2 weeks, if necessary, it is possible to increase the course of treatment.

    In acute gonorrhea, the drug is administered intravenously once at a dose of 100 mg.

    For the prevention of postoperative infections - 30-60 minutes before surgery intravenously at a dose of 200-400 mg.

    Side effect

    • nausea, vomiting;
    • diarrhea;
    • stomach ache;
    • flatulence;
    • anorexia;
    • dizziness;
    • headache;
    • increased fatigue;
    • anxiety;
    • tremor;
    • insomnia;
    • "nightmare" dreams;
    • peripheral paralgesia (anomaly in the perception of pain);
    • sweating;
    • increased intracranial pressure;
    • depression;
    • hallucinations;
    • violations of taste and smell;
    • visual impairment (diplopia, change in color perception);
    • noise in ears;
    • hearing loss;
    • tachycardia;
    • heart rhythm disturbances;
    • decrease in blood pressure;
    • flushes of blood to the skin of the face;
    • leukopenia, granulocytopenia, anemia, thrombocytopenia, leukocytosis, thrombocytosis, hemolytic anemia;
    • hematuria (blood in the urine);
    • glomerulonephritis;
    • urinary retention;
    • arthralgia;
    • tendon ruptures;
    • myalgia;
    • skin itching;
    • hives;
    • the formation of blisters, accompanied by bleeding;
    • medicinal fever;
    • pinpoint hemorrhages (petechiae);
    • swelling of the face or throat;
    • dyspnea;
    • increased photosensitivity;
    • vasculitis;
    • nodular erythema;
    • pain and burning at the injection site;
    • general weakness;
    • superinfection (candidiasis, pseudomembranous colitis).

    Contraindications

    • deficiency of glucose-6-phosphate dehydrogenase;
    • pseudomembranous colitis;
    • children's age up to 18 years (until the process of skeleton formation is completed);
    • pregnancy;
    • lactation period (breastfeeding).

    Use during pregnancy and lactation

    Ciprofloxacin is contraindicated for use during pregnancy and lactation (breastfeeding).

    special instructions

    If severe and prolonged diarrhea occurs during or after treatment with ciprofloxacin, the diagnosis of pseudomembranous colitis should be excluded, which requires immediate discontinuation of the drug and the appointment of appropriate treatment.

    If pain occurs in the tendons or when the first signs of tendovaginitis appear, treatment should be discontinued.

    During the period of treatment with Ciprofloxacin, it is necessary to provide a sufficient amount of fluid while maintaining normal diuresis.

    During treatment with Ciprofloxacin, contact with direct sunlight should be avoided.

    With the simultaneous intake of alcohol, the hepatotoxic effect of the drug is enhanced.

    Influence on the ability to drive vehicles and control mechanisms

    Patients taking Ciprofloxacin should be careful when driving a car and engaging in other potentially hazardous activities that require increased attention and speed of psychomotor reactions (especially while drinking alcohol).

    drug interaction

    Due to a decrease in the activity of microsomal oxidation processes in hepatocytes, ciprofloxacin increases the concentration and lengthens the half-life of theophylline and other xanthines (for example, caffeine), oral hypoglycemic drugs, indirect anticoagulants, and helps to reduce the prothrombin index.

    With simultaneous use with non-steroidal anti-inflammatory drugs (with the exception of acetylsalicylic acid), the risk of convulsions increases.

    Metoclopramide accelerates the absorption of ciprofloxacin, which leads to a decrease in the time to reach the maximum concentration of the latter.

    Co-administration of uricosuric drugs leads to a slowdown in excretion (up to 50%) and an increase in the plasma concentration of ciprofloxacin.

    When combined with other antimicrobials (beta-lactam antibiotics, aminoglycosides, clindamycin, metronidazole), synergism is usually observed. Therefore, ciprofloxacin can be successfully used in combination with azlocillin and ceftazidime in infections caused by Pseudomonas spp.; with mezlocillin, azlocillin and other beta-lactam antibiotics - for streptococcal infections; with isoxazolpenicillins and vancomycin - with staphylococcal infections; with metronidazole and clindamycin - for anaerobic infections.

    Ciprofloxacin enhances the nephrotoxic effect of cyclosporine, there is also an increase in serum creatinine, so in such patients it is necessary to control this indicator 2 times a week.

    When taken simultaneously, Ciprofloxacin enhances the effect of indirect anticoagulants.

    Pharmaceutical interaction

    The infusion solution of the drug is pharmaceutically incompatible with all infusion solutions and drugs that are physicochemically unstable in an acidic environment (pH of the ciprofloxacin infusion solution is 3.5-4.6). Do not mix the solution for intravenous administration with solutions having a pH greater than 7.

    Analogues of the drug Ciprofloxacin

    Structural analogues for the active substance:

    • Alcipro;
    • Aphenoxin;
    • Basijen;
    • Betaciprol;
    • Vero-Ciprofloxacin;
    • Zindolin 250;
    • Ificipro;
    • Quintor;
    • Quipro;
    • Liprokhin;
    • Microflox;
    • Oftocypro;
    • Recipro;
    • Sifloks;
    • Tseprov;
    • ciloxane;
    • Tsipraz;
    • Tsiprinol;
    • Ciprobay;
    • Cyprobid;
    • Ciprobrine;
    • Cyprodox;
    • Ciprolaker;
    • Tsiprolet;
    • Ciprolon;
    • Tsipromed;
    • Cypropane;
    • Tsiprosan;
    • Cyprosin;
    • Ciprosol;
    • Ciprofloxabol;
    • ciprofloxacin bufus;
    • Ciprofloxacin-AKOS;
    • Ciprofloxacin-Promed;
    • Ciprofloxacin-Teva;
    • Ciprofloxacin-FPO;
    • Cifloxinal;
    • Cifran;
    • Number OD;
    • Ecocyfol.

    In the absence of analogues of the drug for the active substance, you can follow the links below to the diseases from which the corresponding drug helps and see the available analogues for the therapeutic effect.

    "Ciprofloxacin" is a broad-spectrum antibiotic. The drug has bactericidal properties. It acts on bacteria by disrupting DNA replication and the synthesis of bacterial cell proteins.

    Indications for use

    As a systemic treatment, Ciprofloxacin is used orally or intravenously in the following cases:

    Against venereal infections:

    • soft chancre
    • Chlamydia
    • Gonorrhea

    For skin diseases:

    • Abscess
    • Wounds
    • Phlegmon
    • burns
    • ulcers

    Against lung infections:

    • Bronchitis
    • bronchoectatic
    • cystic fibrosis
    • pneumonia

    Against a group of diseases of the abdominal organs:

    • shigellosis
    • campylobacteriosis
    • salmonellosis
    • Intra-abdominal abscesses
    • Infections of the stomach and intestines
    • Cholera, typhoid
    • yersiniosis
    • peritonitis
    • Diseases of the gallbladder and ducts

    For joint diseases:

    • Septic arthritis
    • Osteomyelitis

    Against diseases of the pelvic organs:

    • tubular abscess
    • Oophoritis
    • Cystitis and pyelonephritis
    • Adnexitis
    • Pelvioperitonitis
    • endometritis
    • Salpingitis
    • Prostatitis

    Against infections of the upper respiratory tract:

    • Tonsillitis
    • sinusitis
    • Sinusitis and pharyngitis
    • mastoiditis
    • Angina
    • Frontita
    • Otitis media.

    Ciprofloxacin is also used against eye and ear infections and as a postoperative therapy.

    One tablet consists of 250 or 500 mg of the main active agent and additional components that make up the antibiotic: titanium dioxide (E 171), silicon dioxide, croscarmellose sodium, hypromellose, potato and corn starch, polysorbate 80, polyethylene glycol 6000, magnesium stearate, hypromellose and microcrystalline cellulose.

    The dropper solution includes 200 mg of ciprofloxacin.

    Medicinal properties

    The drug has a pronounced antimicrobial effect (even better than that of norfloxacin). "Ciprofloxacin" is absorbed in the intestine in a short time, especially if taken on an empty stomach. The highest concentration of the drug in the blood is reached one or two hours after ingestion or 30 minutes after injection.

    The half-life of the antibiotic is approximately four hours. The drug easily penetrates into all cells and tissues of the body, including the brain. During the day, 40% of the antibiotic is excreted in the urine almost unchanged.

    The average price is from 20 to 45 rubles.

    Eye and ear drops "Ciprofloxacin"

    The solution of drops has a concentration of 0.3%, is bottled in 10 ml or 5 ml in convenient dropper bottles.

    The ophthalmic solution has a yellow or yellowish-green tint.

    Mode of application

    Eye solutions are instilled into the conjunctival sac of the diseased eye, one or two drops with an interval of four hours. If the disease is very difficult, you need to drip two drops into the eye with an interval of an hour. The dosage is reduced after the symptoms become less pronounced.

    "Ciprofloxacin", ear drops are instilled 5 drops three times a day. Antibiotic treatment should be continued for another two days after the patient's condition returns to normal.

    The average price is from 20 to 40 rubles.

    Solution for infusions "Ciprofloxacin"

    Solutions for intravenous injection, 1 ml of which contains 2 mg of ciprofloxacin hydrochloride. Poured into jars of 100 ml.

    Mode of application

    If a sore throat or other illness is severe or the patient is unable to take the medicine orally, it is used intravenously. Why is the infusion agent used at 200 mg for half an hour (if the infection is severe, then 400 mg per hour) twice a day.

    The average price is from 15 to 60 rubles.

    Tablets "Ciprofloxacin"

    Tablets, acting prolonged (for a long time), enclosed in a film shell. Each of them contains 500 or 1000 mg of the substance ciprofloxacin. They are packaged in packs of five or seven.

    And tablets containing 250 or 500 mg of the main agent are packed in packs of 10 pieces. Tablets "Ciprofloxacin" are white, coated, convex on both sides.

    Mode of application

    Tablets are swallowed while drinking the right amount of water, 250 mg each (if a sore throat or other infection is severe, then 500-750 mg) twice or thrice a day.

    Long-acting tablets are taken once a day. If the patient has an infection of the bladder and ureters, a dose of 250 mg twice a day is necessary. In the acute form of gonorrheal urethritis, 500 mg is taken as a single dose.

    For the treatment of acute forms of gonorrhea and cystitis, which do not have complications, the antibiotic course is one day. With angina and infections of the bladder, ureter, kidneys and abdominal organs, the course lasts a week. Patients with reduced immune defenses of the body should take "Ciprofloxacin" as much as necessary to end the neutropenic phase. It is necessary to take an antibiotic no longer than two months for osteomyelitis, and one to two weeks for tonsillitis and in other cases. If the patient suffers from chlamydia or streptococcal infection, he is prescribed a course lasting ten days.

    In the presence of severe kidney damage, the drug dose is halved, and for the elderly - by 30%. It is advisable to continue taking the drug for at least three more days after the body temperature returns to normal and other symptoms disappear.

    Contraindications

    "Ciprofloxacin" is used for adults, it is contraindicated in the presence of intolerance to its components, during pregnancy and breastfeeding, with a lack of glucose-phosphate dehydrogenase, in children and adolescents under eighteen years of age. Do not use intravenous infusion during the entire period of active growth of the body.

    Eye drops are forbidden to be instilled in children under one year old and with viral keratitis.

    During pregnancy and breastfeeding

    Since the drug freely penetrates the placenta and into breast milk, it is prohibited to use it during pregnancy and lactation.

    Precautionary measures

    The medicine should be used with caution in the following diseases:

    • Epilepsy
    • Atherosclerosis of cerebral vessels
    • Severe liver and kidney damage
    • Mental illnesses
    • During pregnancy and lactation.

    It is unacceptable to use ciprofloxacin and alcohol at the same time, since the antibiotic will increase the effect of alcohol and increase the toxic effect on the liver. In addition, it will increase the likelihood of side effects.

    Interaction with other drugs

    "Ciprofloxacin" is absorbed worse in the intestine and, accordingly, its effectiveness decreases when it is used simultaneously with:

    • Antacids
    • Didanosine
    • Preparations containing iron, aluminum, magnesium and zinc ions.

    As a result, they should be taken with Ciprofloxacin at intervals of four hours. Also, the simultaneous use of the drug lengthens the elimination period and, therefore, enhances the toxic effect of the following drugs:

    • Cyclosporine
    • Theophylline.

    Side effects

    Swallowing tablets and giving intravenous infusion can disrupt the normal functioning of various body systems.

    Musculoskeletal: Myalgia, tendovaginitis, or arthralgia may occur

    Circulatory: the occurrence of thrombocytosis, anemia, tachycardia, arrhythmia, cardiovascular collapse, as well as a decrease in blood pressure

    Gastrointestinal: possible nausea, vomiting, diarrhea, constipation, dry mouth, abdominal pain, hepatitis

    Genitourinary: vaginitis, hemorrhagic cystitis, acidosis, frequent or difficult urination

    Respiratory: bronchospasm, dyspnea, pulmonary embolism

    Nervous: may begin to hurt or feel dizzy, have nightmares, depression, eye pain, hallucinations, tinnitus, confusion. Read more about tinnitus in the article: ringing, buzzing and tinnitus.

    Allergies are sometimes manifested: urticaria, swelling of the lips, neck, face, arms and legs, skin rashes, itching, anaphylactic shock.

    Possible consequences of the use of drops for the eyes and ear solutions: infiltration of the cornea of ​​​​the eyes, blurred vision, unpleasant taste sensations, swelling of the eyelids, lacrimation, itching, burning in the eyes.

    For information on how to quickly get rid of dry mouth, read the article: xerostomia or dry mouth.

    Overdose

    The consequences of an overdose of "Ciprofloxacin" are similar to the manifestations of side effects: headaches, fatigue, dizziness, convulsions, confusion. A specific symptom is intoxication of the kidney parenchyma. Taking the drug in an amount of 16 g causes severe kidney damage. Therefore, in addition to gastric lavage, antacids containing magnesium and calcium are prescribed, which reduces the absorption of the antibiotic in the body.

    Terms and conditions of storage

    "Ciprofloxacin" is stored in a dark place with low humidity, inaccessible to children, at an air temperature not exceeding 25 ° C. The eye solution is valid for two years from the date of manufacture. Tablets and solution for intravenous infusion - for three years.

    "Cifran"

    Ranbaxy Laboratories Limited, India
    Price from 44 to 360 rubles.

    As part of one tablet of "Cifran" (250 mg), there are 297.07 mg of the main substance - ciprofloxacin hydrochloride. "Cifran" is available: in tablets (250 or 500 mg) and as a solution for intravenous administration. "Cifran" is issued upon presentation of a prescription.

    pros

    • Effective against infectious and inflammatory diseases
    • "Cifran" is approved for use in children over five years of age suffering from cystic fibrosis of the lungs and anthrax

    Minuses

    • Bumpy tasting and large tablets
    • Possible consequences of the use of "Cifran" in the form of nausea, vomiting and diarrhea, etc.

    "Amoxicillin"

    North Star, Russia/Natur Product Europe, Netherlands, etc.
    Price from 84 to 500 rubles.

    The main active agent is amoxicillin, amoxicillin trihydrate. "Amoxicillin" is sold in the form of tablets, granules for making syrup, solutions for injections, which are done intramuscularly.

    pros

    • It has an antibacterial effect, is used against tonsillitis, bronchitis and other infections.
    • Acid resistant

    Minuses

    • Must be taken every 8 hours - inconvenient
    • Negatively affects the gastrointestinal tract.

    "Nolitsin"

    Krka, Slovenia
    Price from 144 to 307 rubles.

    The main active agent of "Nolicin" is norfloxacin (500 mg). "Nolicin" is available in tablets of 10 pcs. packaged. Packed 2 packs in a pack.

    pros

    • "Nolicin" is effective against infections and inflammation of the genitourinary system
    • 80% of the drug is excreted from the body by the kidneys unchanged

    Minuses

    • Tablets are large - difficult to swallow
    • "Nolicin" is not recommended during pregnancy and lactation.

    "Metronidazole"

    Nycomed, Denmark, etc.
    Price from 13 to 129 rubles.

    Each tablet contains 500 mg of metronidazole. "Metronidazole" is available in various forms (tablets, cream, etc.).

    pros

    • Helps kill tumors during radiation therapy
    • Used for adults, in the treatment of bacterial infections and alcoholism

    Minuses

    • "Metronidazole" is contraindicated in pregnancy, disorders of the central motor system, epilepsy, liver failure
    • Tablets have a bitter taste
    • Candles leak onto underwear.

    Download instructions for use

    Ciprofloxacin is an antibiotic that has a wide spectrum of action. The drug belongs to the fluoroquinolones. Accordingly, ciprofloxacin has a pronounced antimicrobial activity. The mechanism of the drug is as follows: the antibiotic disrupts the process of division and synthesis of DNA in bacteria. This causes morphological changes and rapid death of the bacterium.

    Ciprofloxacin has been used for many years. The drug was developed by Bayer in 1983. Already 4 years later, after passing clinical trials, the drug was approved for oral use in the form of tablets.

    Common Applications

    Ciprofloxacin is used for a number of different diseases. Often, an antibiotic is prescribed for bacterial infections, the causative agents of which are sensitive microorganisms. Ciprofloxacin is effective in the fight against staphylococci, mycoplasmas, legionella, chlamydia, mycobacteria, enterococci.

    Ciprofloxacin is often used in the field of surgery. An antibiotic is often prescribed in the postoperative period. In addition, ciprofloxacin, in the form of tablets and injections, is used in the treatment of purulent skin diseases. The medicine can even help with sepsis.

    For many years, ciprofloxacin has been quite successfully used in pulmonology. As a rule, it is referred to as second-line drugs. This means that ciprofloxacin is prescribed in cases where the use of other antibiotics has failed. In addition, the drug is used to treat severe infectious diseases that affect the respiratory tract.

    Ciprofloxacin is effective for the treatment of lung abscess, pleurisy and pneumonia. For the treatment of the above diseases, the drug is used in injection form.

    Other applications

    Ciprofloxacin is also actively used in ENT diseases. For example, an antibiotic may be prescribed to treat sinusitis or chronic inflammation of the middle ear. In addition, ciprofloxacin is used for otitis media, which are difficult to treat. In this case, the course of taking the drug lasts several months.

    Urology is another area in which ciprofloxacin is used. With the help of this antibiotic, such male diseases are treated. For example, the drug is used for cystitis, prostatitis, acute or chronic pyelonephritis. In turn, infectious disease specialists use ciprofloxacin to treat diseases such as dysentery and salmonellosis.

    The drug is used to treat mixed infections (aerobic and anaerobic). However, in addition to ciprofloxacin, lincosamides or metronizadol are also prescribed. This is due to the fact that some pathogens of mixed infections have a certain resistance to the drug.

    Ciprofloxacin is also used in dentistry. Sometimes, after the extraction of a tooth, an inflammatory process may follow. In this case, ciprofloxacin is prescribed. Also, the medication is prescribed after a tooth resection. The drug may be prescribed to relieve pain in periodontitis or osteomyelitis.

    Dosage forms

    Since ciprofloxacin has a wide range of applications, the drug is produced in various drug forms. Depending on the severity and location of the infection, the drug can be prescribed in the form of:

    • tablets;
    • ampoules;
    • ear and eye drops;
    • ointments.

    Tablets are the most common form for ciprofloxacin. In this form, the medicine is easy to store, transport and use. This drug form is recommended for the treatment of intestinal diseases. After all, the drug in tablets provides quick access to the source of infection.

    Ciprofloxacin ampoules are used for injection. The agent is administered in the amount of two hundred milligrams through a dropper. In the form of ampoules, ciprofloxacin is used for almost any infection with complications.

    Ciprofloxacin drops are used when the focus of infection is located in the eye or ears. The drug is produced as a solution containing 0.3% of the active substance. The drops have a yellow tint and contain ciprofloxacin hydrochloride (3 grams).

    An antibiotic in the form of an ointment is usually used to treat eye diseases. In small quantities, the medicine is placed under the lower eyelid several times a day. Also, the ointment is prescribed for the treatment of skin areas that have been affected by infection.

    Ciprofloxacin. Instruction

    The dosage of the drug depends on the disease and its severity. For example, for the treatment of urinary tract infections, ciprofloxacin is used in the form of tablets (0.25 - 0.5 grams twice a day). In more severe diseases, the dose is increased to 0.75 grams every 12 hours.

    Sometimes there are severe cases when the patient is simply not able to take pills or their use is ineffective. Then ciprofloxacin is used as an injection.

    Ampoules containing 1% of the active substance are diluted in a solution of sodium chloride or glucose.

    The need to prescribe ciprofloxacin is determined by the attending physician. He, having assessed the severity of the disease and the location of the infection, determines the dosage and dosage form. The duration of the course also varies. The duration of treatment can vary from 10 days to a couple of months.

    Contraindications

    Ciprofloxacin, like most drugs, has certain contraindications. The drug is dangerous for children, pregnant women and lactating women. In addition, the drug should not be used until the age of 18. This is due to the fact that ciprofloxacin affects the formation of bone tissue. It is for this reason that the drug is not prescribed during intensive growth.

    However, there are also exceptions. For example, a disease called cystic fibrosis, which is hereditary. This disease disrupts the production of secretions in the bronchi. Because of this, the patient suffers from persistent respiratory tract infections. In the treatment of cystic fibrosis in children, other antibiotics are ineffective. Therefore, the use of ciprofloxacin is a necessity.

    Side effects

    It is worth noting that ciprofloxacin can be called safe. The drug does not have a negative effect on the cells of an adult. And the structures that ciprofloxacin destroys are present only in bacteria. Therefore, the drug causes side effects in only 10% of cases.

    These include gastrointestinal disorders (vomiting, diarrhea, etc.), headache, sleep problems, allergic reactions, etc. In rare cases, the number of lymphocytes or leukocytes in the blood may decrease.

    Analogues

    Ciprofloxacin has been popular for many years. This is due to the fact that the drug is incredibly effective. Most bacteria are not resistant to this antibiotic. In addition, ciprofloxacin is inexpensive and completely safe for adults. The popularity of the tool has led to the fact that in the modern market there are a huge number of analogues from various companies. Ciprofloxacin in pharmacies has more than 30 items. Eg:

    • Floximed;
    • citeral;
    • Cyprosandosis;
    • Ciprobay;
    • Tsiprinol.

    Ciprofloxacin has indirect analogues. These include antibiotics, which also belong to the group of fluoroquinolones, but at the same time belong to other generations. The difference between ciprofloxacin and other drugs of the fluoroquinol group lies in the sensitivity to different types of bacteria. It is worth noting that only the attending physician can replace ciprofloxacin with a drug of another generation.

    The drug "Ciprofloxacin" - an antibiotic or not? This question is most often of interest to those patients who, having received the appropriate doctor's prescription, are looking for additional information, as they do not want to deal with the consequences of taking an antibiotic. You can find the answer in the materials of this article. We will also tell you in detail about what this medicine is intended for, in what forms it can be used, what is included in its composition, whether the drug has side effects, what contraindications you should know about and how to use the remedy correctly.

    Forms of release, packaging of the drug and its composition

    Before telling you about what the medicine "Ciprofloxacin" is (an antibiotic or not, you will learn a little later), you need to tell in what form it can be purchased at a pharmacy.

    Currently, this drug can be bought in three different forms. Let's consider them in more detail.

    1. In liquid form, the drug "Ciprofloxacin" is a solution for infusion. The active ingredient in this drug is ciprofloxacin hydrochloride. The drug goes on sale in bottles of 100 ml.
    2. Tablets "Ciprofloxacin". A photo of the medicine is presented below. Its active element is also ciprofloxacin hydrochloride. One tablet may contain 500 and 250 mg of the drug. The product goes on sale in cartons of 10, 20, 30, 40, 50, 60 or 100 tablets.
    3. Another liquid form of the drug "Ciprofloxacin" - eye and ear drops. This is a local 0.3% remedy that contains such an active element as ciprofloxacin hydrochloride. The product goes on sale in dropper bottles of 5 or 3 ml (placed in a cardboard box).

    Pharmacological characteristics of the drug

    What is the drug "Ciprofloxacin"? Antibiotic or not? According to the instructions that came with this product, this medication is an antimicrobial drug with a wide spectrum of action. It belongs to the group of fluoroquinolones.

    The agent acts bactericidal, inhibiting an enzyme such as bacterial DNA gyrase, which, in fact, disrupts DNA replication, as well as protein synthesis of cells of harmful microorganisms. It should also be noted that the medication in question is able to have a good effect on both multiplying bacteria and microorganisms that are at rest.

    For which bacteria is the drug "Ciprofloxacin" effective? The action of this agent is aimed at gram-negative aerobic microorganisms and gram-positive ones. It cannot be said that most of the staphylococci that are resistant to methicillin are also resistant to ciprofloxacin.

    It should also be noted that streptococci and enterococci are moderately sensitive to the drug.

    Pharmacokinetics of the drug

    Solution for infusion

    In what cases is this remedy prescribed as injections? "Ciprofloxacin" is used for injection only when the patient cannot take oral forms of the drug, and also if the maximum therapeutic effect is required.

    After intravenous infusions, the highest concentration of the drug is reached after about 60 minutes. The solution is well distributed throughout the tissues of the body. At the same time, it does not fall into areas rich in fats.

    The content of the drug in tissues is 5-11 times higher than in plasma. Therapeutic concentrations of the drug are found in the tonsils, saliva, gallbladder, liver, intestines, bile, pelvic organs, abdominal cavity, seminal fluid, uterus, endometrium, prostate tissues, ovaries, kidneys, fallopian tubes, urinary organs, bronchial secretions, lung tissue , muscles, bone tissue, synovial and peritoneal fluids, articular cartilage and skin.

    The drug penetrates into the cerebrospinal fluid in a small volume. At the same time, its concentration is about 7-10% (compared to serum) in non-inflamed meninges and approximately 15-37% in inflamed ones.

    The drug "Ciprofloxacin", a photo of which you can see in this article, penetrates well into the bronchial secretion, lymph, eye fluid, peritoneum, pleura, and also through the placenta. At the same time, the activity of the drug decreases somewhat at low pH values.

    The drug is metabolized in the liver (about 15-30%) with the formation of inactive metabolites. With the intravenous route of entry into the body, the half-life is 5-6 hours. The drug is excreted mainly by the kidneys in unchanged form and in the form of metabolites.

    Pills

    Most often, patients are prescribed oral administration of Ciprofloxacin. In this case, the active substance of the tablets is rapidly absorbed from the digestive tract. The bioavailability of the drug is approximately 50-86%. Its maximum serum concentration is reached after approximately 1-1.6 hours.

    Orally taken drug is distributed in body fluids and tissues. Its high concentrations are found in the lungs, bile, kidneys, gallbladder, seminal fluid, liver, uterus, tonsils, prostate tissues, fallopian tubes, endometrium, and ovaries. In addition, the drug "Ciprofloxacin" penetrates well into the bones, eye fluid, saliva, bronchial secretions, muscles, skin, peritoneum, pleura and lymph.

    In the cerebrospinal fluid, the drug is found in a small amount (compared to serum, the concentration is about 6-10%).

    The main organ for excretion of the drug from the body is the kidneys.

    What is the pharmacokinetics of the local remedy "Ciprofloxacin"? Ear drops (as well as eye drops) are prescribed to patients least often. After their use, the maximum concentration of the active ingredient is less than 5 ng / ml.

    The drug "Ciprofloxacin": indications for use

    Depending on one or another form of release, this medication can be prescribed for various diseases. Consider the indications for use in more detail.

    Tablets and solution for infusion

    These forms of medication are prescribed for infectious and inflammatory diseases that were caused by microorganisms sensitive to ciprofloxacin.

    Thus, this drug is used to treat the respiratory tract, ear, nose and throat, urinary tract and kidneys, genitals, digestive system (including teeth, mouth and jaws), biliary tract, mucous membranes, skin, gallbladder, musculoskeletal system and soft tissues. It should also be noted that this medication is indicated for the treatment of peritonitis and sepsis. In addition, it is used to treat and prevent infections in people with reduced immunity (during immunosuppressant therapy).

    Eye drops

    In ophthalmology, the remedy is used for infectious and inflammatory diseases of the eyes. Such abnormalities include blepharitis, keratitis, blepharoconjunctivitis, keratoconjunctivitis, bacterial corneal ulcer, subacute and acute conjunctivitis, meibomitis (or the so-called "barley") and chronic dacryocystitis. In addition, "Ciprofloxacin" drops are used to treat infectious eye lesions after foreign bodies get into them or are injured. It should also be noted that this drug is often prescribed for pre- and postoperative prevention of infectious complications in ophthalmic surgery.

    Ear drops

    In otorhinolaryngology, this drug can be prescribed for otitis externa, as well as for the treatment of postoperative complications of an infectious nature.

    Contraindications to the use of the drug

    In what cases is it forbidden to use the drug "Ciprofloxacin"? Analogues and the drug in question should in no case be prescribed under the following conditions:

    • with pseudomembranous colitis;
    • with a deficiency of glucose-6-phosphate dehydrogenase;
    • during pregnancy;
    • in children under 18 years of age (until the formation of the skeleton is completed);
    • with hypersensitivity to a drug or other drugs from the group of fluoroquinolones;
    • during lactation.

    It should also be noted that with extreme caution this medication is prescribed to patients with severe atherosclerosis of the vessels of the brain (head), cerebrovascular accidents, mental illness, convulsive syndrome, severe renal / hepatic insufficiency, epilepsy, as well as elderly patients.

    Instructions for use of the medicinal product

    Depending on the form of release of the drug, it can be prescribed in different dosages. Which one, we will tell right now.

    Tablets "Ciprofloxacin"

    Analogues of the drug and this remedy itself can be prescribed in different volumes. It depends on the severity of the disease, the condition of the patient's body, the type of infection, the weight of the patient and his age, as well as the characteristics of the kidneys. Recommended oral dosages (500 and 250 mg each) may be as follows:

    1. In diseases of the respiratory tract, or rather their lower parts (moderate severity), - 250 mg twice a day (in severe cases - 500 mg).
    2. In uncomplicated diseases of the urinary tract and kidneys - 250 mg twice a day (in complicated cases - 500 mg).
    3. For the treatment of gonorrhea - a single dose at a dosage of 500 or 250 mg.
    4. With gynecological abnormalities, colitis, enteritis, prostatitis, osteomyelitis (with severe course) - 500 mg twice a day.

    According to the instructions, the medication should only be taken on an empty stomach with a clean liquid. Patients with severe disorders of the kidneys are prescribed ½ dosage of the drug. The duration of therapy with this remedy depends on the severity of the disease. However, treatment should continue for at least 2 more days after the disappearance of signs of the disease. As a rule, the duration of treatment with this remedy is 7-10 days.

    Solution for infusion

    How should I use Ciprofloxacin solution? Analogues of this remedy and the medication itself must be administered intravenously drip for half an hour (at a dosage of 200 mg).

    It should be especially noted that the solution for infusion is allowed to be combined with 10% glucose solution, 0.9% sodium chloride solution, 10% fructose solution and Ringer's solution.

    A single dosage of the drug is 200 mg. If the patient has severe infections, then 400 mg. The frequency of administration of the drug is twice a day. The duration of therapy is usually 1-2 weeks. If necessary, the course of treatment can be increased.

    Eye (0.3%) drops

    Eye drops "Ciprofloxacin" for children under one year of age are prohibited. In other cases, it is safely applied topically. For moderately severe and mild infections, the drug is instilled into the conjunctival sac of the affected eye, 1-2 drops every 4 hours. In severe infections, the dosage remains the same, but the medicine should be instilled every hour. After the patient's condition improves, the volume and frequency of instillations are reduced.

    With a corneal ulcer (bacterial), the medication is prescribed 1 drop every ¼ hour for 6 hours. Then - 1 drop every half an hour. On the second day - 1 drop every hour. From 3 to 14 days - 1 drop every 4 hours.

    If, after two weeks of therapy, epithelialization has not occurred, then treatment is allowed to continue.

    Ear (0.3%) drops

    How is the drug "Ciprofloxacin" used in otorhinolaryngology? Ear drops are used only after the external auditory canal has been thoroughly cleaned. Before use, the drug must be warmed to body temperature in order to avoid vestibular stimulation.

    The drug is instilled into the ear canal in the amount of 3-4 drops 2-4 times a day (more often). After instillation, the patient should lie on the opposite side for 5-11 minutes.

    If necessary, after local cleansing of the ear, a cotton swab soaked with a solution of Ciprofloxacin can be placed in it. By the way, it should be in the passage until the next procedure.

    The duration of therapy with this drug should not exceed 5-11 days. Sometimes treatment can be extended. But this is only if the local flora is too sensitive.

    Is the drug an antibiotic?

    Medication "Ciprofloxacin" - an antibiotic or not? Referring to the group of fluoroquinolones, this drug is a synthetic antibacterial agent. In view of this, it is not an antibiotic, since these substances are of exclusively natural origin.

    Adverse reactions

    Does the drug "Ciprofloxacin" have side effects? For children and adults, it should be prescribed only according to indications. This is due to the fact that such a drug has a fairly large number of side effects. Most often they manifest themselves in relation to the digestive tract (vomiting, abdominal pain, nausea, flatulence, diarrhea), from the nervous system (fatigue, tremor, dizziness, insomnia, headache), from the senses (tinnitus, impaired sense of smell , change in color perception), as well as from the hematopoietic, urinary and musculoskeletal systems. Also, treatment with "Ciprofloxacin" can provoke the appearance of allergic reactions (skin itching, papules, urticaria, shortness of breath, blisters, swelling of the face, eosinophilia, nodular erythema, and others).

    Analogues of funds and its cost

    The price of the drug "Ciprofloxacin" is very low, and it is about 30-50 Russian rubles. Moreover, this cost applies to all forms of medicine. But what if, for one reason or another, Ciprofloxacin is not suitable for you? Analogues of this drug are always available in pharmacies. These include drugs such as Tsipraz, Alcipro, Ecocyfol, Afenoxin, Cyprex, Cifracid, Basigen, Cifran, Betaciprol, Cifloxinal, Vero -Ciprofloxacin", "Citeral", "Zindolin-250", "Ificipro", "Ciprofloxabol", "Quintor", "Ciprosol", "Quipro", "Ciprosin", "Liprokhin", "Ciprosan", "Microflox", "Tsipropan", "Oftotsipro", "Tsipronat", "Protsipro", "Tsiprolet", "Recipro", "Tsiprolaker", "Sifloks", "Tsiprodoks", "Tseprova", "Tsiprobrin", "Ciloxan", "Tsiprobid ”, “Ciplox”, “Ciprinol” and others.

    It should be noted that the price of these funds is not much higher than the cost of the original drug. Therefore, it will not be difficult for you to purchase a medicine for the treatment of a particular disease.

    Summing up

    Now you know what the drug "Ciprofloxacin" is. I would like to emphasize that it can be used only according to the indications and prescription of the attending physician.

    Name: Ciprofloxacin (Ciprofloxacin) solution for infusion

    Release form, composition and pack

    Solution for infusion 0.2% transparent, colorless.

    1 ml 1 vial ciprofloxacin (as lactate) 2 mg 200 mg.

    Excipients: sodium edetate, sodium chloride, water for injections.

    pharmachologic effect

    A broad-spectrum antimicrobial product from the group of fluoroquinolones. Acts bactericidal. The drug inhibits the enzyme DNA-gyrase of bacteria, as a result of which DNA replication and the synthesis of cellular proteins of bacteria are disrupted. Ciprofloxacin acts both on multiplying microorganisms and on those in the resting phase.

    Gram-negative aerobic bacteria are sensitive to Ciprofloxacin: enterobacteria (Escherichia coli, Salmonella spp., Shigella spp., Citrobacter spp., Klebsiella spp., Enterobacter spp., Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Hafnia alvei, Edwardsiella tarda, Providencia spp. , Morganella morganii, Vibrio spp., Yersinia spp.), other Gram-negative bacteria (Haemophilus spp., Pseudomonas aeruginosa, Moraxella catarrhalis, Aeromonas spp., Pasteurella multocida, Plesiomonas shigelloides, Campylobacter jejuni, Neisseria spp.); some intracellular pathogens: Legionella pneumophila, Brucella spp., Chlamydia trachomatis, Listeria monocytogenes, Mycobacterium tuberculosis, Mycobacterium kansasii, Mycobacterium avium-intracellulare.

    Gram-positive aerobic bacteria are also sensitive to Ciprofloxacin: Staphylococcus spp. (S.aureus, S.haemolyticus, S.hominis, S.saprophyticus), Streptococcus spp. (St. pyogenes, St. agalactiae). Most methicillin-resistant staphylococci are also resistant to ciprofloxacin.

    The sensitivity of bacteria Streptococcus pneumoniae, Enterococcus faecalis is moderate.

    Corynebacterium spp., Bacteroides fragilis, Pseudomonas cepacia, Pseudomonas maltophilia, Ureaplasma urealyticum, Clostridium difficile, Nocardia asteroides are resistant to the product.

    The action of the product against Treponema pallidum has not been studied enough.

    Pharmacokinetics

    With the on / in the introduction of 200 mg or 400 mg of ciprofloxacin 60 minutes after the start of the infusion, the concentration of the active substance in the serum is 2.1 μg / ml or 4.6 μg / ml.

    Vd in the equilibrium state is 2-3 l / kg. There is a high concentration of ciprofloxacin in bile, several times higher than its concentration in plasma.

    After intravenous administration, the concentration in the urine during the first 2 hours is almost 100 times greater than in serum.

    In patients with unchanged renal function, T1 / 2 is usually 3-5 hours. In case of impaired renal function, T1 / 2 increases.

    The main route of excretion of ciprofloxacin from the body is the kidneys. 50-70% is excreted in the urine. From 15 to 30% is excreted with feces.

    Indications for use of the product

    Infectious and inflammatory diseases caused by microorganisms sensitive to Ciprofloxacin:

      respiratory tract;

      ear, throat and nose;

      kidneys and urinary tract;

      genital organs;

      digestive system (including mouth, teeth, jaws);

      gallbladder and biliary tract;

      skin, mucous membranes and soft tissues;

      musculoskeletal system.

    Ciprofloxacin is indicated for the treatment of sepsis and peritonitis, as well as for the prevention and treatment of infections in patients with reduced immunity (with immunosuppressant therapy).

    Dosing regimen

    For intravenous administration, a single dose is 200-400 mg, the frequency of administration is 2; duration of treatment - 1-2 weeks, if necessary, and more. It can be administered by intravenous bolus, but drip administration over 30 minutes is more preferable.

    Side effect

      From the digestive system: nausea, vomiting, diarrhea, abdominal pain, increased activity of hepatic transaminases, alkaline phosphatase, LDH, bilirubin, pseudomembranous colitis.

      From the side of the central nervous system: headache, dizziness, fatigue, sleep disorders, nightmares, hallucinations, fainting, visual disturbances.

      From the urinary system: crystalluria, glomerulonephritis, dysuria, polyuria, albuminuria, hematuria, transient increase in serum creatinine.

      From the hematopoietic system: eosinophilia, leukopenia, neutropenia, changes in platelet count.

      From the side of the cardiovascular system: tachycardia, cardiac arrhythmias, arterial hypotension.

    Allergic reactions: pruritus, urticaria, angioedema, Stevens-Johnson syndrome, arthralgia.

    Adverse reactions associated with chemotherapeutic action: candidiasis.

      On the part of laboratory parameters: an increase in the concentration of urea, creatinine.

    Other: arthralgia; not often - photosensitivity.

    Contraindications to the use of the product

      pregnancy;

      lactation period;

      childhood and adolescence;

      high susceptibility to ciprofloxacin or other products from the group of fluoroquinolones.

    Application for violations of kidney function

    Patients with severe renal insufficiency (creatinine clearance below 20 ml / min / 1.73 m2) should be given half the daily dose of the product.

    special instructions

    Patients with epilepsy, a history of seizures, vascular diseases and organic brain damage due to the threat of adverse reactions from the central nervous system, Ciprofloxacin should be prescribed only for health reasons.

    If severe and prolonged diarrhea occurs during or after treatment with Ciprofloxacin, the diagnosis of pseudomembranous colitis should be excluded, which requires immediate discontinuation of the product and the appointment of appropriate treatment.

    If pain occurs in the tendons or when the first signs of tendovaginitis appear, treatment should be stopped due to the fact that isolated cases of inflammation and even tendon rupture during treatment with fluoroquinolones have been described.

    During the period of treatment with Ciprofloxacin, it is necessary to provide a sufficient amount of fluid while maintaining normal diuresis.

    During treatment with Ciprofloxacin, contact with direct sunlight should be avoided.

    Influence on the ability to drive vehicles and control mechanisms

    Patients taking Ciprofloxacin should be careful when driving a car and engaging in other potentially hazardous activities that require increased attention and speed of psychomotor reactions (especially while drinking alcohol).

    Overdose

    The specific antidote is unknown. It is necessary to carefully monitor the condition of the patient, do a gastric lavage, carry out the usual emergency measures, ensure sufficient fluid intake. With the help of hemo- or peritoneal dialysis, only a non-cordial (less than 10%) amount of the product can be removed.

    drug interaction

    With the simultaneous use of ciprofloxacin with didanosine, the absorption of ciprofloxacin is reduced due to the formation of complexes of ciprofloxacin with the aluminum and magnesium salts contained in didanosine.

    When used simultaneously with warfarin, the risk of bleeding increases.

    Simultaneous administration of ciprofloxacin and theophylline can lead to an increase in the concentration of theophylline in blood plasma, due to competitive inhibition in the binding sites of cytochrome P450, which leads to an increase in T1 / 2 of theophylline and an increase in the risk of developing toxic effects associated with theophylline.

    Simultaneous intake of antacids, as well as products containing aluminum, zinc, iron or magnesium ions, can cause a decrease in the absorption of ciprofloxacin, so the interval between the appointment of these products should be at least 4 hours.

    With the simultaneous use of ciprofloxacin and anticoagulants, the bleeding time is prolonged.

    With the simultaneous use of ciprofoxacin and cyclosporine, the nephrotoxic effect in the aftermath is enhanced.

    Pharmaceutical interaction

    Ciprofloxacin solution is incompatible with solutions or medicinal products with a pH of 3-4 that are physically or chemically unstable.

    Terms of dispensing from pharmacies

    The drug is dispensed by prescription.

    Storage conditions and periods

    List B. In a dry, dark place, at room temperature. Keep out of the reach of children. The shelf life is 3 years.

    Attention!
    Before using the medication "Ciprofloxacin (Ciprofloxacin) solution for infusion" it is necessary to consult a doctor.
    The instructions are provided solely for familiarization with " Ciprofloxacin (Ciprofloxacin) solution for infusion».

    Catad_pgroup Antibacterial quinolones and fluoroquinolones

    Tsiprinol for infusion in ampoules - instructions for use

    Registration number:

    P N014323/02-220708

    Tradename:

    Tsiprinol ®

    International non-proprietary name:

    ciprofloxacin

    Dosage form:

    concentrate for solution for infusion

    Compound

    1 ampoule contains:
    Active substance:
    Ciprofloxacin 100.00 mg
    Excipients: lactic acid 43.00 mg, disodium edetate 1.00 mg, concentrated hydrochloric acid q.s. up to pH = 3.4-3.6, water for injection q.s. up to 10.00 ml

    Description

    Clear, colorless or slightly yellowish-greenish solution.

    Pharmacotherapeutic group:

    antimicrobial agent - fluoroquinolone

    ATX code: J01MA02

    Pharmacological properties

    Pharmacodynamics
    Ciprofloxacin is a synthetic broad-spectrum antibacterial drug from the group of fluoroquinolones.
    Mechanism of action
    Ciprofloxacin is active under conditions in vitro against a wide range of gram-negative and gram-positive microorganisms. The bactericidal action of ciprofloxacin is carried out through the inhibition of type II bacterial topoisomerases (topoisomerase II (DNA-gyrase) and topoisomerase IV), which are necessary for replication, transcription, repair and recombination of bacterial DNA.
    Mechanisms of resistance
    Resistance under conditions in vitro to ciprofloxacin is often due to point mutations in bacterial topoisomerases and DNA gyrase and develops slowly through multi-step mutations.
    Single mutations may lead to reduced susceptibility rather than clinical resistance, but multiple mutations generally lead to clinical resistance to ciprofloxacin and cross-resistance to quinolone drugs. Resistance to ciprofloxacin, as well as to many other antibiotics, can form as a result of a decrease in the permeability of the bacterial cell wall (as often happens in the case of Pseudomonas aeruginosa) and/or activation of excretion from the microbial cell (efflux).
    The development of resistance due to a coding gene localized on plasmids has been reported. qnr. Resistance mechanisms that lead to inactivation of penicillins, cephalosporins, aminoglycosides, macrolides, and tetracyclines do not appear to impair the antibacterial activity of ciprofloxacin.
    Microorganisms resistant to these drugs may be sensitive to ciprofloxacin. The minimum bactericidal concentration (MBC) usually does not exceed the minimum inhibitory concentration (MIC) by more than 2 times.
    In vitro susceptibility testing
    Reproducible ciprofloxacin susceptibility testing criteria approved by the European Committee for Antibiotic Susceptibility Testing (EUCAST) are presented in the table below.

    European Committee for Antibiotic Susceptibility Testing.
    Clinical MIC breakpoints (mg/l) for ciprofloxacin.

    MicroorganismSensitive
    [mg/l]
    resistive
    [mg/l]
    Enterobacteriaceae ≤0,5 >1
    Pseudomonas spp. ≤0,5 >1
    Acinetobacter spp. ≤1 >1
    Staphylococcus 1 spp. ≤1 >1
    Streptococcus pneumoniae 2 ≤0,125 >2
    Haemophilus influenzae and Moraxella catarrhalis 3 ≤0,5 >0,5
    Neisseria gonorrhoeae ≤0,03 >0,06
    Neisseria meningitidis ≤0,03 >0,06
    Non-species breakpoints
    microorganisms 4
    ≤0,5 >1
    1. Staphylococcus spp.– breakpoints for ciprofloxacin and ofloxacin are associated with high-dose therapy.
    2. Streptococcus pneumoniae- wild type S. pneumoniae is not considered susceptible to ciprofloxacin and ofloxacin and thus is classified as intermediate.
    3. Strains with a MIC value above the sensitive/moderately sensitive threshold ratio are very rare and have not been reported so far. Identification and antimicrobial susceptibility tests should be repeated when such colonies are found, and the results should be confirmed by colony analysis at the reference laboratory. Until evidence of a clinical response is obtained for strains with confirmed MIC values ​​above the currently used resistance threshold, they should be considered resistant. Haemophilus spp./Moraxella spp.– it is possible to detect strains haemophilus influenzae with low sensitivity to fluoroquinolones (MIC for ciprofloxacin - 0.125-0.5 mg / l). Evidence of the clinical significance of low resistance in respiratory tract infections caused by H. influenzae, no.

    4. Non-species-specific breakpoints were determined primarily on the basis of pharmacokinetic/pharmacodynamic data and are independent of species-specific MIC distributions. They are applicable only to species for which no species-specific sensitivity threshold has been determined, and not to those species for which susceptibility testing is not recommended. For certain strains, the spread of acquired resistance may vary by geographic region and over time. In this regard, it is desirable to have local information on resistance, especially when treating severe infections.

    Clinical and Laboratory Standards Institute data for MIC breakpoints (mg/L) and diffusion testing (zone diameter [mm]) using disks containing 5 µg ciprofloxacin are presented in the table below.

    Institute of Clinical and Laboratory Standards. Limit values ​​for MIC (mg/l) and for diffusion testing (mm) using discs.

    MicroorganismsSensitiveIntermediateresistive
    Enterobacteriaceae < l а 2 a> 4 a
    > 21 b16-20 b< 15 б
    Pseudomonas aeruginosa
    and other bacteria
    non-family
    Enterobacteriaceae
    < l а 2 a> 4 a
    > 21 b16-20 b< 15 б
    Staphylococcus spp. < l а 2 a> 4 a
    > 21 b16-20 b< 15 б
    Enterococcus spp. < l а 2 a> 4 a
    > 21 b16-20 b< 15 б
    Haemophilus spp. < 1 в
    > 21 g
    Neisseria gonorrhoeae < 0,06 д 0.12-0.5 d> 1 d
    > 41 d28-40 days< 27 д
    Neisseria meningitidis < 0,03 е 0.06 e> 0.12 e
    > 35 w33-34 w< 32 ж
    Bacillus anthracis
    Yersinia pestis
    < 0,25 а
    Francisella tularensis < 0,53
    A. This reproducible standard is only applicable to tests using broth dilutions using cationic adjusted Mueller-Hinton broth (CAMHB) incubated with air at 35±2°C for 16-20 hours for strains Enterobacteriaceae, Pseudomonas aeruginosa, other bacteria not belonging to the family Enterobacteriaceae, Staphylococcus spp., Enterococcus spp. and Bacillus anthracis; within 20-24 hours for Acinetobacter spp., 24 hours for Y. pestis(In case of insufficient growth, incubate for another 24 hours).
    b. This reproducible standard is only applicable to diffusion tests using discs using air at 35 ± 2°C for 16-18 hours.
    V. This reproducible standard is only applicable to diffusion tests using susceptibility discs with haemophilus influenzae And haemophilus parainfluenzae using broth test medium for Haemophilus spp.(HTM), which is incubated with air at a temperature of 35 °C ± 2 °C for 20-24 hours.
    d. This reproducible standard is only applicable to diffusion tests using discs using HTM that is incubated in 5% CO2 at 35°C±2°C for 16-18 hours.
    e. This reproducible standard is only applicable to sensitivity tests (diffusion tests using zone discs and MIC agar solution) using gonococcal agar and 1% of the established growth supplement at 36 °C ± 1 °C (not exceeding 37 °C) in 5% CO2 for 20-24 hours.
    e. This reproducible standard is only applicable to broth dilution tests using cationic adjusted Mueller-Hinton broth (CAMHB) supplemented with 5% sheep blood, incubated in 5% CO2 at 35±2°C for 20-24 hours .
    and. This reproducible standard is only applicable to broth dilution tests using cationic adjusted Mueller-Hinton broth (CAMHB) supplemented with a specified 2% growth supplement, incubated under air at 35 ± 2°C for 48 hours.

    In vitro sensitivity to ciprofloxacin
    For certain strains, the spread of acquired resistance may vary by geographic region and over time. In this regard, it is desirable to have local information on resistance when testing the susceptibility of a strain, especially when treating severe infections. If the local prevalence of resistance is such that the benefit of using the drug, at least in relation to several types of infections, is doubtful, a specialist should be consulted.
    In research in vitro the activity of ciprofloxacin against the following susceptible strains of microorganisms has been demonstrated:
    Aerobic gram-positive microorganisms:
    Bacillus anthracis, Staphylococcus aureus (methicillin-sensitive). Staphylococcus saprophytics, Streptococcus spp.
    Aerobic gram-negative microorganisms:
    Aeromonas spp., Moraxella catarrhalis, Brucella spp., Neisseria meningitidis, Citrobacter koseri, Pasteurella spp., Francisella tularensi, Salmonella spp., Haemophilus ducreyi, Shigella spp., Haemophilius influenzae, Vibrio spp., Legionella spp., Yersinia pestis.
    Anaerobic microorganisms:
    Mobiluncus spp.
    Other microorganisms:
    Chlamydia trachomatis, Chlamydia pneumoniae, Mycoplasma hominis, Mycoplasma pneumoniae.
    A varying degree of susceptibility to ciprofloxacin has been demonstrated for the following organisms: Acinetobacter baumann, Burkholderia cepacia, Campylobacter spp., Citrobacter freundii, Enterococcus faecalis, Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Morganella morganii, Neisseria gonorrhoeae, Proteus mirabilis, Proteus vulgar is, Providencia spp., Pseudomonas aeruginosa, Pseudomonas fluorescens, Serratia marcescens, Streptococcus pneumoniae, Peptostreptococcus spp., Propionibacterium acnes.
    It is believed that natural resistance to ciprofloxacin have Staphylococcus aureus(methicillin-resistant), Stenotrophomonas maltophilia, Actinomyces spp., Enterococcus faecium, Listeria monocytogenes, Mycoplasma genitalium, Ureaplasma urealitycum, anaerobic microorganisms (except Mobiluncus spp., Peptostreptococcus spp., Propionibacterium acnes).

    Pharmacokinetics
    Suction

    After intravenous (IV) administration, the maximum concentration (Cmax) of ciprofloxacin is reached at the end of the infusion. With intravenous administration, the pharmacokinetics of ciprofloxacin was linear in the dose range up to 400 mg.
    With intravenous administration 2 or 3 times a day, no accumulation of ciprofloxacin and its metabolites was noted.
    Distribution
    The relationship of ciprofloxacin with plasma proteins is 20-30%, the active substance is present in the blood plasma mainly in a non-ionized form.
    Ciprofloxacin is freely distributed in tissues and body fluids. The volume of distribution in the body is 2-3 l / kg. The concentration of ciprofloxacin in tissues significantly exceeds the concentration in blood serum.
    Metabolism
    Biotransformed in the liver. Four metabolites of ciprofloxacin can be detected in the blood at low concentrations: diethylciprofloxacin (M1), sulfocyprofloxacin (M2), oxocyprofloxacin (M3), formylciprofloxacin (M4), three of which (M1-M3) exhibit antibacterial activity under conditions in vitro, comparable to the antibacterial activity of nalidixic acid.
    Antibacterial activity under conditions in vitro metabolite M4, which is present in a smaller amount, is more consistent with the activity of norfloxacin.
    breeding
    Ciprofloxacin is excreted from the body mainly by the kidneys by glomerular filtration and tubular secretion, a small amount - through the intestines. Renal clearance is 0.18-0.3 l/h/kg, total clearance is 0.48-0.60 l/h/kg. Approximately 1% of the administered dose is excreted in the bile. In bile, ciprofloxacin is present in high concentrations. In patients with unchanged renal function, the half-life (T1 / 2) is usually 3-5 hours. In case of impaired renal function, T1 / 2 lengthens.
    Children
    In a study in children, Cmax and area under the concentration-time curve (AUC) did not depend on age. A noticeable increase in Cmax and AUC with repeated use of ciprofloxacin (at a dose of 10 mg/kg 3 times a day) was not observed. In ten children with severe sepsis less than 1 year of age, the Cmax was 6.1 mg/l (range 4.6 to 8.3 mg/l) after a 1 hour infusion at a dose of 10 mg/kg, and in children at age from 1 to 5-7.2 mg/l (range from 4.7 to 11.8 mg/l). AUC values ​​in the respective age groups were 17.4 mg*h/L (range 11.8 to 32.0 mg* h/L) and 16.5 mg* h/L (range 11.0 to 23.8 mg*h/l). These values ​​correspond to the range reported for adult patients using therapeutic doses of the drug. Based on pharmacokinetic analysis in children with various infections, the estimated mean half-life in children is approximately 4-5 hours.

    Indications for use

    Uncomplicated and complicated infections caused by microorganisms sensitive to ciprofloxacin. adults
    Respiratory tract infections. Ciprofloxacin is recommended for pneumonia caused by Klebsiella spp., Enterobacter spp., Proteus spp., Escherichia coli, Pseudomonas aeruginosa, Haemophilus spp., Moraxella catarrhalis, Legionella spp. and staphylococci.
    Infections of the middle ear (otitis media), paranasal sinuses (sinusitis), especially if these infections are caused by gram-negative microorganisms, including Pseudomonas aeruginosa or staphylococci.
    Eye infections.
    Infections of the kidneys and / or urinary tract.
    Genital infections, including adnexitis, gonorrhea, prostatitis.
    Infections of the abdominal cavity (bacterial infections of the gastrointestinal tract, biliary tract, peritonitis).
    Skin and soft tissue infections.
    Sepsis.
    Infections or prevention of infections in immunosuppressed patients (patients taking immunosuppressants or patients with neutropenia).
    Selective intestinal decontamination in immunocompromised patients.
    Bacillus anthracis).
    Children
    Treatment of complications caused by Pseudomonas aeruginosa in children with cystic fibrosis of the lungs from 5 to 17 years.
    Prevention and treatment of pulmonary anthrax (infection Bacillus anthracis).
    Current official guidelines on the rules for the use of antibacterial agents should be taken into account.

    Contraindications

    Hypersensitivity to ciprofloxacin or other drugs from the group of fluoroquinolones, as well as to excipients (see section "Composition").
    Simultaneous use of ciprofloxacin and tizanidine due to clinically significant side effects (arterial hypotension, drowsiness) associated with an increase in the concentration of tizanidine in the blood plasma (see section "Interactions with other drugs").

    Carefully

    With severe liver failure and diseases of the central nervous system (CNS): epilepsy, reduced threshold for convulsive readiness (or a history of convulsive seizures), severe cerebral atherosclerosis, cerebrovascular accident, organic brain damage or stroke, mental illness (depression, psychosis ), renal insufficiency, tendon damage with prior quinolone treatment, increased risk of QT prolongation or torsades de pointes (eg, congenital long QT syndrome, heart disease (heart failure, myocardial infarction, bradycardia), electrolyte imbalance (eg , with hypokalemia, hypomagnesemia)), simultaneous use of drugs that prolong the QT interval (including antiarrhythmic classes IA and III, tricyclic antidepressants, macrolides, neuroleptics), simultaneous use with inhibitors of the CYP1A2 isoenzyme (including theophylline, methylxanthine, caffeine, duloxetine, clozapine, ropinirole, olanzapine), myasthenia gravis, glucose-6-phosphate dehydrogenase deficiency, use in elderly patients.

    Use during pregnancy and during breastfeeding

    Pregnancy
    The safety of ciprofloxacin during pregnancy has not been established. However, based on the results of animal studies, the possibility of an adverse effect on the articular cartilage of newborns cannot be completely excluded, and therefore ciprofloxacin should not be prescribed to pregnant women.
    At the same time, no teratogenic effects (malformations) have been established in animal studies.
    breastfeeding period
    Ciprofloxacin is excreted in breast milk. Due to the potential risk of damage to the articular cartilage of newborns, ciprofloxacin should not be given to nursing women.

    Use in children

    Ciprofloxacin is not recommended for use in children under 18 years of age for the treatment of other infectious diseases, except for the treatment of complications of pulmonary cystic fibrosis (in children aged 5 to 17 years) caused by Pseudomonas aeruginosa, Bacillus anthracis).
    The use of ciprofloxacin in children should only be initiated after a benefit/risk assessment due to possible joint and tendon side effects.

    Dosage and administration

    adults
    In the absence of other appointments, it is recommended to observe the following dosing regimen:

    IndicationsSingle dose for adults, taking into account
    frequency of administration per day
    (ciprofloxacin, mg, i.v. administration)
    Respiratory tract infections(depending on the severity of the infection and the condition of the patient)
    Urinary tract infections:
    acute, uncomplicated
    complicated
    adnexitis, prostatitis, orchitis, epididymitis

    from 200 mg x 2 times a day to 400 mg x 2 times a day
    from 400 mg x 2 times a day to 400 mg x 3 times a day
    from 400 mg x 2 times a day to 400 mg x 3 times a day
    Diarrhea 400 mg x 2 times a day
    Other infections(see section "Indications for use")400 mg x 2 times a day
    Particularly severe, posing a threat to life, especially in the presence of Pseudomonas spp., Staphylococcus spp. or Streptococcus spp., including
    pneumonia caused by Streptococcus spp.
    recurrent infections in cystic fibrosis
    bone and joint infections
    septicemia
    peritonitis
    400 mg x 3 times a day
    Pulmonary anthrax (treatment and prevention) 400 mg x 2 times a day (adults)

    Children and teenagers
    Table 2. Recommended daily dose of the drug Tsiprinol ® , a concentrate for solution for infusion, in children and adolescents

    Application in certain groups of patients
    Dosing regimen in elderly patients (over 65 years of age)

    Elderly patients should be prescribed lower doses of ciprofloxacin depending on the severity of the disease and the creatinine clearance (CC) (see also information on patients with impaired liver and / or kidney function).
    Dosing regimen for pulmonary anthrax (treatment and prevention)
    See information in tables 1 and 2.
    Treatment should begin immediately after suspected or confirmed infection.
    The total duration of treatment with ciprofloxacin for pulmonary anthrax is 60 days.

    Dosage regimen for impaired renal or hepatic function in adults
    Table 3. Recommended doses for patients with renal insufficiency

    Dosing regimen for impaired renal function in patients on hemodialysis
    With QC< 30 мл/мин/1,73 м² (тяжелая почечная недостаточность) или его концентрации в плазме крови ≥2 мг/100 мл максимальная суточная доза препарата Ципринол ® должна составлять 400 мг в дни проведения гемодиализа после осуществления процедуры.
    Dosing regimen in patients with renal insufficiency on continuous ambulatory peritoneal dialysis
    The drug Ciprinol ® is added to the dialysate (intraperitoneally): 50 mg of ciprofloxacin per liter of dialysate is administered 4 times a day every 6 hours.
    Dosing regimen in patients with hepatic insufficiency
    Dose adjustment is not required.
    Dosing regimen in patients with impaired renal and hepatic function
    With CC 30-60 ml / min / 1.73 m² (moderate renal failure) or its plasma concentration of 1.4-1.9 mg / 100 ml, the maximum daily dose of Tsiprinol ® should be 800 mg.
    With QC< 30 мл/мин/1,73 м² (тяжелая почечная недостаточность) или его концентрации в плазме крови ≥2 мг/100 мл максимальная суточная доза препарата Ципринол ® должна составлять 400 мг.
    Dosage regimen for impaired renal and / or liver function in children
    The dosage regimen in children with impaired renal and / or liver function has not been studied.
    Mode of application
    Before use, the contents of the concentrate ampoule for the preparation of a solution for infusion under aseptic conditions must be diluted with an adequate amount of a compatible infusion solution (see subsection "Compatibility with other solutions") to a final solution concentration of 0.2% (2 mg / ml).
    To prepare a solution for intravenous infusion containing 200 mg or 400 mg of ciprofloxacin, it is necessary to dilute the contents of 2 or 4 ampoules of the concentrate for solution for infusion in 80 ml or 160 ml, respectively, of a compatible infusion solution to the final concentration of the solution 0.2% (2 mg/ml).
    Ciprofloxacin concentrate for solution for infusion is photosensitive, so the ampoule should be removed only before use.
    The drug Tsiprinol ® , a ready-to-use 0.2% solution, is administered as an intravenous infusion lasting at least 60 minutes.
    The infusion solution should be injected slowly into a large vein to prevent complications at the infusion site.
    The infusion solution can be administered alone or together with other compatible infusion solutions.
    Compatibility with other solutions
    Ciprinol ® is compatible with 0.9% sodium chloride solution, Ringer's solution, 5% and 10% dextrose solution, 10% fructose solution, and 5% dextrose solution with 0.225% NaCl or 0.45% NaCl.
    The solution obtained after mixing the drug Tsiprinol ® with compatible infusion solutions should be used as soon as possible due to the sensitivity of the drug to light and in order to maintain the sterility of the solution. If compatibility with another infusion solution / drug is not confirmed, the infusion solution of the drug Tsiprinol ® should be administered separately.
    Visible signs of incompatibility are precipitation, cloudiness or discoloration of the solution.
    Incompatibility occurs with all solutions / preparations that are physically or chemically unstable at the pH value of the infusion solution of the drug Tsiprinol ® (for example, penicillins, heparin solutions), and especially with solutions that change the pH value to the alkaline side (pH of the infusion solution of the drug Tsiprinol ® is 3.9-4.5).
    Only a clear, clear solution should be used.
    Duration of therapy
    The duration of treatment depends on the severity of the disease, the clinical course and cure of the disease. It is important to continue treatment for at least 3 days after the disappearance of fever or other clinical symptoms.
    Average duration of treatment
    adults

    1 day for acute uncomplicated gonorrhea;
    up to 7 days for infections of the kidneys, urinary tract, abdominal organs;
    the entire period of neutropenia in immunocompromised patients;
    no more than 2 months for osteomyelitis;
    7 to 14 days for other infections.
    For infections caused Streptococcus spp., due to the risk of late complications, treatment should be continued for at least 10 days.
    For infections caused Chlamydia spp. treatment should also be continued for at least 10 days.
    Children and teenagers
    for the treatment of complications of cystic fibrosis of the lungs caused by Pseudomonas aeruginosa(in patients from 5 to 17 years), the duration of therapy is 10-14 days.

    Side effect

    The adverse reactions listed below were classified as follows: "very often" (≥10), "often" (from ≥1/100 to<1/10), «нечасто» (от ≥1/1000 до <1/100), «редко» (от ≥1/10000 до <1/1000), «очень редко» (≥10000), «частота неизвестна». Нежелательные реакции, которые были зафиксированы только в ходе постмаркетинговых наблюдений, и частота которых не оценивалась, обозначены «частота неизвестна».

    The incidence of the following adverse reactions with intravenous administration and with the use of stepwise therapy with ciprofloxacin (with intravenous administration of the drug followed by oral administration) is higher than with oral administration.

    Children
    Arthropathy has been frequently reported in children.

    Overdose

    It is necessary to carefully monitor the patient's condition, carry out the usual emergency measures, ensure sufficient fluid intake. In order to prevent the development of crystalluria, it is recommended to monitor kidney function, including pH and urine acidity. With the help of hemo- or peritoneal dialysis, only a small amount of ciprofloxacin (less than 10%) is excreted.

    Interaction with other drugs

    Drugs that prolong the QT interval
    Caution should be exercised with the simultaneous use of ciprofloxacin, as well as other fluoroquinolones, in patients receiving drugs that cause a prolongation of the QT interval (for example, class IA and III antiarrhythmic drugs, tricyclic antidepressants, macrolides, antipsychotics) (see section "Special Instructions") .
    Theophylline
    The simultaneous use of ciprofloxacin and preparations containing theophylline can cause an undesirable increase in the concentration of theophylline in the blood plasma and, accordingly, the occurrence of theophylline-induced side effects, in very rare cases, these side effects can be life-threatening for the patient. If the simultaneous use of these two drugs is unavoidable, then it is recommended to constantly monitor the concentration of theophylline in the blood plasma and, if necessary, reduce the dose of theophylline.
    Other xanthine derivatives
    The simultaneous use of ciprofloxacin and caffeine or pentoxifylline (oxpentifylline) can lead to an increase in the concentration of xanthine derivatives in the blood serum.
    Phenytoin
    With the simultaneous use of ciprofloxacin and phenytoin, a change (increase or decrease) in the concentration of phenytoin in the blood plasma was observed. In order to avoid weakening the anticonvulsant effect of phenytoin due to a decrease in its concentration, as well as to prevent adverse events associated with an overdose of phenytoin, when stopping taking ciprofloxacin, it is recommended to monitor phenytoin therapy in patients taking both drugs, including determining the concentration of phenytoin in blood plasma during the entire period simultaneous use of both drugs and a short time after completion of combination therapy.
    Non-steroidal anti-inflammatory drugs
    Simultaneous use of very high doses of quinolones (DNA gyrase inhibitors) and some non-steroidal anti-inflammatory drugs (excluding acetylsalicylic acid) can provoke convulsions.
    Cyclosporine
    With the simultaneous use of ciprofloxacin and preparations containing cyclosporine, a short-term transient increase in plasma creatinine concentration was observed. In such cases, it is necessary to determine the concentration of creatinine in blood plasma twice a week.
    Oral hypoglycemic agents
    With the simultaneous use of ciprofloxacin and oral hypoglycemic agents, mainly sulfonylurea drugs (for example, glibenclamide, glimepiride), the development of hypoglycemia is presumably due to an increase in the action of oral hypoglycemic agents (see section "Side Effects").
    probenecid
    Probenecid slows down the rate of excretion of ciprofloxacin by the kidneys. The simultaneous use of ciprofloxacin and preparations containing probenecid leads to an increase in the concentration of ciprofloxacin in the blood serum.
    Methotrexate
    With the simultaneous use of methotrexate and ciprofloxacin, the renal tubular transport of methotrexate may slow down, which may be accompanied by an increase in the concentration of methotrexate in the blood plasma. This may increase the likelihood of side effects of methotrexate. In this regard, patients receiving concomitant therapy with methotrexate and ciprofloxacin should be closely monitored.
    Tizanidin
    As a result of a clinical study involving healthy volunteers with the simultaneous use of ciprofloxacin and drugs containing tizanidine, an increase in the concentration of tizanidine in blood plasma was revealed: an increase in Cmax by 7 times (from 4 to 21 times), an increase in AUC - by 10 times (from 6 to 24 times). With an increase in the concentration of tizanidine in the blood serum, hypotensive (lowering blood pressure) and sedative (drowsiness, lethargy) side effects are associated. Thus, the simultaneous use of ciprofloxacin and drugs containing tizanidine is contraindicated.
    Duloxetine
    In clinical studies, it has been shown that the simultaneous use of duloxetine and potent inhibitors of the CYP1A2 isoenzyme (such as fluvoxamine) can lead to an increase in the AUC and Cmax of duloxetine. Despite the lack of clinical data on a possible interaction with ciprofloxacin, it is possible to foresee the possibility of such an interaction with the simultaneous use of ciprofloxacin and duloxetine.
    Ropinirole
    The simultaneous use of ropinirole and ciprofloxacin, a moderate inhibitor of the CYP1A2 isoenzyme, leads to an increase in Cmax and AUC of ropinirole by 60% and 84%, respectively. Adverse effects of ropinirole should be monitored during concomitant use with ciprofloxacin and for a short time after completion of combination therapy.
    Lidocaine
    In a study on healthy volunteers, it was found that the simultaneous use of drugs containing lidocaine and ciprofloxacin, a moderate inhibitor of the CYP1A2 isoenzyme, leads to a decrease in the clearance of lidocaine by 22% when administered intravenously. Despite the good tolerability of lidocaine, with simultaneous use with ciprofloxacin, side effects may increase due to the interaction.
    Clozapine
    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, was observed. The patient's condition should be monitored and, if necessary, the dosage regimen of clozapine should be adjusted during its simultaneous use with ciprofloxacin and for a short time after completion of combination therapy.
    Sildenafil
    With simultaneous use in healthy volunteers of ciprofloxacin at a dose of 500 mg and sildenafil at a dose of 50 mg, there was a 2-fold increase in Cmax and AUC of sildenafil. In this regard, the use of this combination is possible only after assessing the benefit / risk ratio.
    Vitamin K antagonists
    The simultaneous use of ciprofloxacin and vitamin K antagonists (for example, warfarin, acenocoumarol, phenprocoumon, fluindione) may lead to an increase in their anticoagulant effect. The magnitude of this effect may vary depending on co-infections, age and general condition of the patient, so it is difficult to assess the effect of ciprofloxacin on the increase in MHO. INR should be monitored frequently during concomitant use of ciprofloxacin and vitamin K antagonists, as well as for a short time after completion of combination therapy.

    special instructions

    Severe infections, staphylococcal infections and infections due to gram-positive and anaerobic bacteria
    In the treatment of severe infections, staphylococcal infections and infections caused by anaerobic bacteria, ciprofloxacin should be used in combination with appropriate antibacterial agents.
    Streptococcus pneumoniae infections
    The drug Tsiprinol ® is not recommended for the treatment of infections caused by Streptococcus pneumoniae, due to its lack of effectiveness against the pathogen.
    Genital tract infections
    For genital infections suspected to be caused by strains Neisseria gonorrhoeae, resistant to fluoroquinolones, information on local resistance to ciprofloxacin should be taken into account and the sensitivity of the pathogen should be confirmed in laboratory tests.
    Heart disorders
    Ciprofloxacin has an effect on the prolongation of the QT interval (see section "Side effect"). Given that women have a longer mean QT interval than men, they are more sensitive to drugs that prolong the QT interval. In elderly patients, there is also an increased sensitivity to the action of drugs that cause a prolongation of the QT interval. Caution should be exercised when using the drug Ciprinol ® simultaneously with drugs that prolong the QT interval (for example, antiarrhythmic drugs of classes IA and III, tricyclic antidepressants, macrolides and antipsychotic drugs) (see section "Interaction with other drugs"), or in patients with increased risk of QT prolongation or torsades de pointes (eg, congenital long QT interval syndrome, electrolyte imbalances (eg, hypokalemia, hypomagnesaemia), and heart disease such as heart failure, myocardial infarction, bradycardia).
    Use in children
    Ciprofloxacin, like other drugs of this class, has been found to cause arthropathy of large joints in animals. When analyzing the current data on the safety of using ciprofloxacin in children under 18 years of age, most of whom have cystic fibrosis of the lungs, no relationship has been established between cartilage or joint damage with taking the drug. It is not recommended to use the drug Tsiprinol ® in children for the treatment of other diseases, except for the treatment of complications of pulmonary cystic fibrosis (in children from 5 to 17 years old) associated with Pseudomonas aeruginosa and for the treatment and prevention of inhalational anthrax (after suspected or proven infection Bacillus anthracis).
    Hypersensitivity
    Sometimes, after taking the first dose of ciprofloxacin, hypersensitivity to the drug may develop (see the "Side Effects" section), including allergic reactions, which should be reported to your doctor immediately. In rare cases, after the first application, anaphylactic reactions may occur up to anaphylactic shock. In these cases, the use of the drug Tsiprinol ® should be immediately discontinued and appropriate treatment should be carried out.
    Gastrointestinal tract
    If severe and prolonged diarrhea occurs during or after treatment with ciprofloxacin, the diagnosis of pseudomembranous colitis should be excluded, which requires immediate discontinuation of the drug and the appointment of appropriate treatment (vancomycin orally at a dose of 250 mg 4 times a day) (see section "Side Effects"). The use of drugs that suppress intestinal motility is contraindicated.
    Hepatobiliary system
    Cases of liver necrosis and life-threatening liver failure have been reported with ciprofloxacin. In the presence of the following signs of liver disease, such as anorexia, jaundice, dark urine, itching, painful abdomen, taking the drug Tsiprinol ® should be discontinued (see section "Side Effects"). In patients taking the drug Tsiprinol ® and who have had a liver disease, a temporary increase in the activity of "liver" transaminases and alkaline phosphatase or cholestatic jaundice may be observed (see section "Side Effects").
    Musculoskeletal system
    In patients with severe myasthenia gravis, Ciprinol® should be used with caution, as symptoms may worsen.
    When taking the drug Tsiprinol ®, there may be cases of tendonitis and tendon rupture (mainly the Achilles tendon), sometimes bilateral, already within the first 48 hours after the start of therapy. Inflammation and rupture of the tendon may occur even several months after discontinuation of treatment with Tsiprinol ® . There is an increased risk of tendinopathy in elderly patients and in patients with tendon diseases who are simultaneously treated with glucocorticosteroids.
    At the first signs of tendonitis (painful swelling in the joint area, inflammation), the use of the drug Tsiprinol ® should be stopped, physical activity should be excluded, since there is a risk of tendon rupture, and a doctor should be consulted.
    The drug Ziprinol ® should be used with caution in patients with a history of indications of tendon disease associated with the use of quinolones.
    Nervous system
    The drug Tsiprinol ® , like other fluoroquinolones, can provoke convulsions and reduce the threshold for convulsive readiness. In patients with epilepsy and a history of CNS disease (eg, reduced seizure threshold, history of seizures, cerebrovascular accident, organic brain damage, or stroke), due to the risk of developing adverse reactions from the CNS, ciprofloxacin should be used only in cases where the expected clinical effect outweighs the possible risk of side effects of the drug. When using ciprofloxacin, cases of status epilepticus have been reported (see section "Side Effects"). If convulsions occur, the use of the drug Tsiprinol ® should be discontinued.
    Psychotic reactions may occur even after the first use of fluoroquinolones, including the drug Ziprinol ® . In rare cases, depression or psychotic reactions can progress to suicidal thoughts and suicidal attempts, including completed ones (see section "Side Effects"). If the patient develops one of these reactions, you should stop taking the drug Tsiprinol ® and inform the doctor about it.
    Cases of sensory or sensorimotor polyneuropathy, hypesthesia, dysesthesia or weakness have been reported in patients taking fluoroquinolones, including the drug Ziprinol ®. If symptoms such as pain, burning, tingling, numbness, weakness occur, patients should inform the doctor before continuing to use the drug.
    Skin
    When taking the drug Ziprinol ®, a photosensitivity reaction may occur, so patients should avoid contact with direct sunlight and UV light. Treatment should be discontinued if symptoms of photosensitivity are observed (for example, a change in the skin resembles sunburn) (see section "Side Effects").
    Cytochrome P450
    It is known that ciprofloxacin is a moderate inhibitor of the CYP1A2 isoenzyme. Caution should be exercised while using the drug Cyprinol ® and drugs metabolized by these isoenzymes, such as theophylline, methylxanthine, caffeine, duloxetine, clozapine, olanzapine, ropinirole, etc., since an increase in the concentration of these drugs in the blood serum due to inhibition of their metabolism by ciprofloxacin may cause specific adverse reactions.
    Local reactions
    With the on / in the introduction of the drug Tsiprinol ®, a local inflammatory reaction may occur at the injection site (edema, pain). This reaction is more common if the infusion time is 30 minutes or less. The reaction quickly resolves after the end of the infusion and is not a contraindication for subsequent administration of the drug, unless its course is complicated.
    In order to avoid the development of crystalluria, it is unacceptable to exceed the recommended daily dose, it is also necessary to have sufficient fluid intake and maintain an acidic urine reaction.
    With simultaneous intravenous administration of ciprofloxacin and drugs for general anesthesia from the group of barbituric acid derivatives, constant monitoring of the number of heartbeats, blood pressure, and electrocardiogram is necessary.
    In conditions in vitro ciprofloxacin may interfere with bacteriological examination mycobacterium tuberculosis, suppressing its growth, which can lead to false-negative results in the diagnosis of this pathogen in patients taking the drug Tsiprinol ® .
    NaCl content
    The concentrate for solution for infusion of Ciprinol ® contains less than 1 mmol sodium (23 mg) per dose (10 ml), that is, essentially a "sodium-free" preparation.

    Influence on the ability to drive vehicles, mechanisms

    Fluoroquinolones, including ciprofloxacin, may interfere with the ability of patients to drive a car and engage in other potentially hazardous activities that require increased attention and speed of psychomotor reactions due to effects on the central nervous system.

    Release form

    Concentrate for solution for infusion 10 mg/ml.
    10 ml in neutral transparent glass ampoules (type 1). A colored dot is applied to the ampoule at the fracture site. 5 ampoules in a PVC / aluminum foil blister or 5 ampoules in a plastic blister pack. 1 blister or 1 plastic blister pack in a carton box along with instructions for use.

    Storage conditions

    In a place protected from light, at a temperature not exceeding 25 ° C. Do not freeze!
    Keep out of the reach of children.

    Best before date

    5 years.
    Do not use the drug after the expiration date.

    Holiday conditions

    Released by prescription.

    Manufacturer:

    JSC Krka, d.d., Novo Mesto, 6 Smarjeska cesta, 8501 Novo Mesto, Slovenia

    When packing and / or packaging at a Russian enterprise, it is indicated
    KRKA-RUS LLC, 143500, Russia, Moscow region, Istra, st. Moscow, d. 50
    or
    CJSC "Vector-Medica", 630559, Russia, Novosibirsk region, Novosibirsky district, r.p. Koltsovo, bldg. 13, bldg. 15, bldg. 38

    Representative office of JSC Krka, d.d., Novo mesto in the Russian Federation /
    Organization accepting consumer claims:

    125212, Moscow, Golovinskoe shosse, building 5, building 1


    ATX Code: J01MA02
    CFG: Antibacterial drug of the fluoroquinolone group
    ICD-10 codes (indications): A40, A41, A54, J01, J02, J03, J04, J15, J20, J31, J32, J35.0, J37, J42, K65.0, K81.0, K81.1, K83.0, L01, L02, L03, L08.0, M00, M86, N10, N11, N15.1, N30, N34, N41, N70, N71, N72, Z29.2
    KFU code: 06.17.02.01
    Manufacturer: SYNTHESIS JSC (Russia)

    PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

    Solution for infusion transparent, slightly yellowish or slightly greenish in color.

    Excipients: solution of sodium chloride 0.9%, lactic acid, disodium salt of EDTA, water for injection.

    100 ml - dark glass bottles (1) - cardboard packs.

    PHARMACHOLOGIC EFFECT

    A broad-spectrum antimicrobial drug from the group of fluoroquinolones. Acts bactericidal. The drug inhibits the enzyme DNA-gyrase of bacteria, as a result of which DNA replication and the synthesis of cellular proteins of bacteria are disrupted. Ciprofloxacin acts both on multiplying microorganisms and on those in the resting phase.

    Ciprofloxacin active against gram-negative aerobic bacteria: Escherichia coli, Salmonella spp., Shigella spp., Citrobacter spp., Klebsiella spp., Enterobacter spp., Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Hafnia alvei, Edwardsiella tarda, Providencia spp., Morganella morganii, Vibrio spp., Yersinia spp., Haemophilus spp., Pseudomonas aeruginosa, Moraxella catarrhalis, Aeromonas spp., Pasteurella multocida, Plesiomonas shigelloides, Campylobacter jejuni, Neisseria spp.; intracellular pathogens: Legionella pneumophila, Brucella spp., Chlamydia trachomatis, Listeria monocytogenes, Mycobacterium tuberculosis, Mycobacterium kansasii, Mycobacterium avium-intracellulare; Gram-positive aerobic bacteria: Staphylococcus spp. (Staphylococcus aureus, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus saprophyticus), Streptococcus spp. (Streptococcus pyogenes, Streptococcus agalactiae). Most methicillin-resistant staphylococci are also resistant to ciprofloxacin.

    To the drug moderately sensitive Streptococcus pneumoniae, Enterococcus faecalis.

    To the drug resistant Corynebacterium spp., Bacteroides fragilis, Pseudomonas cepacia, Pseudomonas maltophilia, Ureaplasma urealyticum, Clostridium difficile, Nocardia asteroides.

    The effect of the drug against Treponema pallidum has not been studied enough.

    PHARMACOKINETICS

    Suction

    After an intravenous infusion of the drug at a dose of 200 mg or 400 mg, Cmax is reached after 60 minutes and is 2.1 μg / ml and 4.6 μg / ml, respectively.

    Distribution

    Plasma protein binding - 20-40%. V d - 2-3 l / kg. Ciprofloxacin is well distributed in body tissues (with the exception of tissues rich in fats, such as nervous tissue). The content of the antibiotic in tissues is 2-12 times higher than in plasma. Therapeutic concentrations are achieved in saliva, tonsils, liver, gallbladder, bile, intestines, abdominal and pelvic organs, uterus, seminal fluid, prostate tissue, endometrium, fallopian tubes and ovaries, kidneys and urinary organs, lung tissue, bronchial secretions , bone tissue, muscles, synovial fluid and articular cartilage, peritoneal fluid, skin. It penetrates into the cerebrospinal fluid in a small amount, where its concentration in non-inflamed meninges is 6-10% of that in the blood serum, and in inflamed meninges - 14-37%. Ciprofloxacin also penetrates well 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 serum. The activity of ciprofloxacin is somewhat reduced at acidic pH values.

    It is allocated with breast milk.

    Metabolism

    Metabolized in the liver (15-30%) with the formation of inactive metabolites (diethylciprofloxacin, sulfocyprofloxacin, oxocyprofloxacin, formylciprofloxacin).

    breeding

    With the / in the introduction of T 1 / 2 - 5-6 hours. It is excreted mainly by the kidneys by tubular filtration and tubular secretion unchanged (with the / in the introduction - 50-70%) and in the form of metabolites (with the / in the introduction - 10%), the rest - through the gastrointestinal tract. After intravenous administration, the concentration in the urine during the first 2 hours after administration is almost 100 times greater than in serum, which significantly exceeds the MIC for most pathogens of urinary tract infections.

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

    Pharmacokinetics in special clinical situations

    In chronic renal failure (CC> 20 ml / min), the percentage of the drug excreted through the kidneys decreases, but cumulation in the body does not occur due to a compensatory increase in drug metabolism and excretion through the gastrointestinal tract. T 1/2 in chronic renal failure increases to 12 hours.

    INDICATIONS

    Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

    Respiratory tract;

    Ear, throat and nose;

    Kidney and urinary tract;

    Genital organs (including gonorrhea, prostatitis);

    Gynecological (including adnexitis) and postpartum infections;

    Digestive system (including oral cavity, teeth, jaws);

    Gallbladder and biliary tract;

    Skin, mucous membranes and soft tissues;

    musculoskeletal system;

    Peritonitis;

    Prevention and treatment of infections in patients with reduced immunity (with immunosuppressant therapy).

    DOSING MODE

    The drug should be administered intravenously over 30 minutes (dose 200 mg) and 60 minutes (dose 400 mg). The solution for infusion can be combined with 0.9% sodium chloride solution, Ringer's solution, 5% and 10% dextrose (glucose) solution, 10% fructose solution, a solution containing 5% dextrose solution with 0.225% or 0.45% sodium chloride solution.

    The dose of ciprofloxacin depends on the severity of the disease, type of infection, body condition, age, weight and kidney function of the patient.

    A single dose is 200 mg, with severe infections - 400 mg. Multiplicity of introduction - 2 times / day; duration of treatment - 1-2 weeks, if necessary, it is possible to increase the course of treatment.

    At acute gonorrhea the drug is prescribed in / in a single dose of 100 mg.

    For prevention of postoperative infections- 30-60 minutes before surgery, IV at a dose of 200-400 mg.

    Patients with severe renal insufficiency (KK<20 мл/мин/1.73 кв.м) it is necessary to appoint a half of a daily dose.

    SIDE EFFECT

    From the digestive system: nausea, diarrhea, vomiting, abdominal pain, flatulence, anorexia, cholestatic jaundice (especially in patients with previous liver disease), hepatitis, hepatonecrosis.

    From the side of the central nervous system and peripheral nervous system: dizziness, headache, fatigue, anxiety, tremor, insomnia, "nightmare" dreams, peripheral paraalgesia (anomaly in the perception of pain), sweating, increased intracranial pressure, anxiety, confusion, depression, hallucinations, manifestations of psychotic reactions (sometimes progressing to conditions in which the patient may harm himself), migraine, syncope, cerebral artery thrombosis.

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

    From the side of the cardiovascular system: tachycardia, cardiac arrhythmias, decreased blood pressure, flushing of the face.

    From the hematopoietic system: leukopenia, granulocytopenia, anemia, thrombocytopenia, leukocytosis, thrombocytosis, hemolytic anemia.

    From the side of laboratory indicators: hypoprothrombinemia, increased activity of hepatic transaminases and alkaline phosphatase, hypercreatininemia, hyperbilirubinemia, hyperglycemia.

    From the urinary system: hematuria, crystalluria (primarily with alkaline urine and low diuresis), glomerulonephritis, dysuria, polyuria, urinary retention, albuminuria, urethral bleeding, hematuria, decreased nitrogen excretion of kidney function, interstitial nephritis.

    From the musculoskeletal system: arthralgia, arthritis, tendovaginitis, tendon ruptures, myalgia.

    Allergic reactions: pruritus, urticaria, blistering with bleeding, papules that form scabs, drug fever, pinpoint hemorrhages (petechiae), swelling of the face or throat, dyspnoea, eosinophilia, photosensitivity, vasculitis, erythema nodosum, exudative erythema multiforme, Stevens-Johnson syndrome , toxic epidermal necrolysis (Lyell's syndrome).

    Local reactions: pain and burning at the injection site, phlebitis.

    Others: general weakness, superinfection (candidiasis, pseudomembranous colitis).

    CONTRAINDICATIONS

    Deficiency of glucose-6-phosphate dehydrogenase;

    pseudomembranous colitis;

    Children's age up to 18 years (until the completion of the process of skeletal formation);

    Pregnancy;

    The period of lactation (breastfeeding).

    WITH caution the drug should be prescribed for severe cerebral atherosclerosis, cerebral circulation disorders, mental illness, convulsive syndrome, epilepsy, severe renal and / or liver failure, elderly patients.

    PREGNANCY AND LACTATION

    Ciprofloxacin is contraindicated for use during pregnancy and lactation (breastfeeding).

    SPECIAL INSTRUCTIONS

    If severe and prolonged diarrhea occurs during or after treatment with ciprofloxacin, the diagnosis of pseudomembranous colitis should be excluded, which requires immediate discontinuation of the drug and the appointment of appropriate treatment.

    If pain occurs in the tendons or when the first signs of tendovaginitis appear, treatment should be discontinued.

    During the period of treatment with Ciprofloxacin, it is necessary to provide a sufficient amount of fluid while maintaining normal diuresis.

    During treatment with Ciprofloxacin, contact with direct sunlight should be avoided.

    Influence on the ability to drive vehicles and control mechanisms

    Patients taking Ciprofloxacin should be careful when driving a car and engaging in other potentially hazardous activities that require increased attention and speed of psychomotor reactions (especially while drinking alcohol).

    OVERDOSE

    Treatment: specific antidote is unknown. It is necessary to carefully monitor the patient's condition, make a gastric lavage, carry out the usual emergency measures, ensure sufficient fluid intake. With the help of hemo- or peritoneal dialysis, only a small (less than 10%) amount of the drug can be removed.

    DRUG INTERACTIONS

    Due to a decrease in the activity of microsomal oxidation processes in hepatocytes, ciprofloxacin increases the concentration and lengthens the half-life of theophylline and other xanthines (for example, caffeine), oral hypoglycemic drugs, indirect anticoagulants, and helps to reduce the prothrombin index.

    With simultaneous use with NSAIDs (with the exception of acetylsalicylic acid), the risk of developing seizures increases.

    Metoclopramide accelerates the absorption of ciprofloxacin, which leads to a decrease in the time to reach the maximum concentration of the latter.

    Co-administration of uricosuric drugs leads to a slowdown in excretion (up to 50%) and an increase in the plasma concentration of ciprofloxacin.

    When combined with other antimicrobials (beta-lactam antibiotics, aminoglycosides, clindamycin, metronidazole), synergism is usually observed. Therefore, ciprofloxacin can be successfully used in combination with azlocillin and ceftazidime in infections caused by Pseudomonas spp.; with mezlocillin, azlocillin and other beta-lactam antibiotics - for streptococcal infections; with isoxazolpenicillins and vancomycin - with staphylococcal infections; with metronidazole and clindamycin - for anaerobic infections.

    Ciprofloxacin enhances the nephrotoxic effect of cyclosporine, there is also an increase in serum creatinine, so in such patients it is necessary to control this indicator 2 times a week.

    When taken simultaneously, Ciprofloxacin enhances the effect of indirect anticoagulants.

    Pharmaceutical interaction

    The infusion solution of the drug is pharmaceutically incompatible with all infusion solutions and drugs that are physicochemically unstable in an acidic environment (pH of the ciprofloxacin infusion solution is 3.5-4.6). The solution for intravenous administration should not be mixed with solutions having a pH greater than 7.

    TERMS AND CONDITIONS OF DISCOUNT FROM PHARMACIES

    The drug is dispensed by prescription.

    TERMS AND CONDITIONS OF STORAGE

    List B. The drug should be stored in a place protected from light at a temperature of 5 ° to 20 ° C in places inaccessible to children. Do not freeze! Shelf life - 2 years.

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