The role of antibiotics in the complex therapy of external bacterial otitis

pharmachologic effect

Is Tsiprolet an antibiotic or not? Yes, Tsiprolet is an antibiotic . The main component is ciprofloxacin. The active component is a fluoroquinolone derivative. The mechanism of action is aimed at suppressing DNA gyrase of the bacterial cell, which leads to disruption of DNA synthesis , slowing down the processes of growth and reproduction of microbes. As a result of pronounced morphological changes under the influence of the antibacterial agent Tsiprolet, the microbial cell dies. The bactericidal effect manifests itself during the period of division and dormancy of gram-negative microorganisms. In relation to gram-positive flora, the bactericidal effect is manifested only during division. The cells of the macroorganism do not contain DNA gyrase, which completely eliminates the toxic effect on the human body. The drug does not cause resistance to other antibacterial drugs. Tsiprolet is active against aerobic flora, enterobacteria, gram-negative flora, chlamydia, listeria, mycobacterium tuberculosis, yersinia, campylobacteria, protea, mycoplasma, etc. The drug does not have a bactericidal or bacteriostatic effect on Treponema pallidum (the causative agent of syphilis ).

CIPROLET eye drops 3mg/ml dropper bottle 5ml

The main active component of Ciprolet eye drops, an antibiotic from the fluoroquinolone group, ciprofloxacin, exhibits a bactericidal effect against most gram-negative and gram-positive bacteria. Tsiprolet is effective in the treatment of bacterial eye infections caused by streptococci, staphylococci, E. coli, diphtheria bacteria, listeria, chlamydia, Proteus, etc. The drug does not act on clostridia, Treponema pallidum, ureaplasma, bacteroides and fungi. Broad-spectrum antimicrobial drug, fluoroquinolone derivative. Suppresses bacterial DNA gyrase (topoisomerases II and IV, responsible for the process of supercoiling of chromosomal DNA around nuclear RNA, which is necessary for reading genetic information), disrupts DNA synthesis, growth and division of bacteria; causes pronounced morphological changes (including cell wall and membranes) and rapid death of the bacterial cell. It has a bactericidal effect on gram-negative organisms during the period of rest and division (since it affects not only DNA gyrase, but also causes lysis of the cell wall); it acts on gram-positive microorganisms only during the period of division. Low toxicity for the cells of the macroorganism is explained by the absence of DNA gyrase in them. With the use of ciprofloxacin, there is no parallel development of resistance to other antibiotics that do not belong to the group of DNA gyrase inhibitors, which makes it highly effective against bacteria that are resistant, for example, to aminoglycosides, penicillins, cephalosporins, tetracyclines and many other antibiotics. 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, Corynebacterium diphtheriae; gram-positive aerobic bacteria: Staphylococcus spp. (Staphylococcus aureus, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus saprophyticus), Streptococcus spp. (Streptococcus pyogenes, Streptococcus agalactiae). Most staphylococci resistant to methicillin are also resistant to ciprofloxacin. The sensitivity of Streptococcus pneumoniae, Enterococcus faecalis, Mycobacterium avium (located intracellularly) is moderate (high concentrations are required to suppress them). The following are resistant to the drug: Bacteroides fragilis, Pseudomonas cepacia, Pseudomonas maltophilia, Ureaplasma urealyticum, Clostridium difficile, Nocardia asteroides. Not effective against Treponema pallidum. Resistance develops extremely slowly, since, on the one hand, after the action of ciprofloxacin there are practically no persistent microorganisms left, and on the other hand, bacterial cells do not have enzymes that inactivate it. Pharmacokinetics Absorption After use of eye drops, the Cmax of ciprofloxacin in plasma is less than 5 ng/ml. The average concentration is below 2.5 ng/ml. After instillation, systemic absorption of the drug is possible. Excretion Ciprofloxacin is excreted by the kidneys mainly unchanged (50%) in the form of metabolites (up to 10%), about 15% is excreted through the intestines. Excreted in breast milk.

Indications for use of Tsiprolet

Tsiprolet tablets - what are they for? The drug is prescribed for bacterial lesions of the respiratory system ( cystic fibrosis , bronchitis, bronchiectasis, pneumonia, tonsillitis), ENT organs ( tonsillitis , pharyngitis , otitis media, mastoiditis, sinusitis, sinusitis), genitourinary system (salpingitis, cystitis, pyelonephritis , oophoritis, tubular abscess, adnexitis, prostatitis, gonorrhea, chlamydia , soft chacks , pelivioperitonitis, pelitis), digestive system (peritonitis, typhoid typhoid, salmonellosis, intra -abscesses, yersiniosis , campilobacteriosis , cholera , shigellosis), skin (phlegmon, abscess, abscess, abscess, abscess, abscess, abscess, abscess, abscess, abscess, abscess. Guy, infected ulcers, wounds), osteo-articular system (sepsis, septic arthritis, osteomyelitis ).

What else does Tsiprolet help with? The drug is prescribed for the prevention of infectious lesions after surgery.

Tsiprolet eye drops have the following indications for use: conjunctivitis, blepharitis, stye.

Contraindications

Contraindications for the drug are as follows. Ciprolet is not prescribed in pediatric practice until adulthood (formation of the skeletal system, skeleton), in case of intolerance to ciprofloxacin, pregnancy, or during breastfeeding. In case of cerebrovascular accident, atherosclerosis of cerebral vessels, epileptic syndrome , epilepsy, mental disorders, severe pathology of the liver, kidneys, elderly people are prescribed after consultation with specialists.

Side effects

Digestive tract: vomiting, diarrhea syndrome, flatulence, epigastric pain, nausea, bloating , cholestatic jaundice , decreased appetite, hepatonecrosis, hepatitis.

Nervous system: insomnia, dizziness, anxiety, fatigue, peripheral paralgesia , nightmares, tremors of the extremities, increased intracranial pressure, increased sweating, hallucinations, depression, confusion, various psychotic reactions, thrombosis of the cerebral arteries , fainting, migraine.

Sense organs: hearing loss, tinnitus, taste disturbances, diplopia. Possible development of tachycardia , drop in blood pressure, heart rhythm disturbances, development of anemia, granulocytopenia, leukocytosis.

Genitourinary system: polyuria, dysuria, glomerulonephritis, crystalluria, hematuria, interstitial nephritis, impaired nitrogen excretory function of the kidneys.

Tsiprolet can provoke an allergic response, urticaria, arthralgia , tenosynovitis, arthritis and other side effects.

Tsiprolet drops glazn 3 mg/ml cor 5 ml x1

Ciprolet eye drops 3 mg/ml 5 ml x1, ATX code: J01MA02 (Ciprofloxacin) Active substance: ciprofloxacin Rec.INN registered by WHO

Dosage form

CIPROLET®

solution d/inf. 2 mg/1 ml: vial. 100 ml 1 pcs.reg. No.: P N008395 dated 01.08.11 - Indefinitely

Release form, composition and packaging

Solution for infusion in the form of a clear, colorless or light yellow liquid.

1 ml 1 fl.

ciprofloxacin 2 mg 200 mg

Excipients: sodium chloride - 900 mg, disodium edetate - 10 mg, lactic acid - 75 mg, citric acid monohydrate - 12 mg, sodium hydroxide - 8 mg, hydrochloric acid - 0.0231 ml, water for injection - up to 100 ml.

Clinical-pharmacological group: Antibacterial drug of the fluoroquinolone group Pharmaco-therapeutic group: Antimicrobial agent, fluoroquinolone

pharmachologic effect

A broad-spectrum antibacterial 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 microorganisms that are reproducing and those in the resting phase.

Gram-negative aerobic bacteria are sensitive to ciprofloxacin: Escherichia coli, Salmonella spp., Shigella spp., Citrobacter spp., Klebsiella spp., Enterobacter spp., Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Hafhia 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 staphylococci resistant to methicillin are also resistant to ciprofloxacin.

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

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 sufficiently studied.

Pharmacokinetics

After an intravenous infusion of 200 mg or 400 mg, TCmax is 60 minutes, Cmax is 2.1 mcg/ml and 4.6 mcg/ml, respectively. Vd - 2-3 l/kg, binding to plasma proteins - 20-40%.

It is well distributed in body tissues (excluding fat-rich tissue, such as nervous tissue). The content in tissues is 2-12 times higher than in plasma. Therapeutic concentrations are achieved in saliva, tonsils, liver, gall bladder, 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 CSF 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 ocular fluid, bronchial secretions, pleura, peritoneum, lymph, and through the placenta. The concentration of ciprofloxacin in blood neutrophils is 2-7 times higher than in serum.

Activity decreases slightly at acidic pH values.

Metabolized in the liver (15-30%) with the formation of low-active metabolites (diethylciprofloxacin, sulfociprofloxacin, oxociprofloxacin, formylciprofloxacin).

With intravenous administration, TT1/2 - 5-6 hours, with chronic renal failure - up to 12 hours. Excreted mainly by the kidneys by tubular filtration and tubular secretion in unchanged form (with intravenous administration - 50-70%) and in the form of metabolites (with intravenous administration - 10%), the rest - through the gastrointestinal tract. A small amount is excreted in breast milk. After intravenous administration, the concentration in urine during the first 2 hours after administration is almost 100 times higher than in serum, which significantly exceeds the MIC for most pathogens of urinary tract infections.

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

With chronic renal failure (creatinine clearance above 20 ml/min), the percentage of the drug excreted through the kidneys decreases, but accumulation in the body does not occur due to a compensatory increase in drug metabolism and excretion in the feces. Patients with severe renal failure (creatinine clearance below 20 ml/min/1.73 m2) should be prescribed half the daily dose.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to ciprofloxacin, including:

- respiratory tract infections,

- infections of the ENT organs,

- kidney and urinary tract infections,

- genital infections (gonorrhea, prostatitis, adnexitis) and postpartum infections,

- gastrointestinal infections (including mouth, teeth, jaws),

- infections of the gallbladder and biliary tract,

- infections of the skin, mucous membranes and soft tissues,

- infections of the musculoskeletal system,

- sepsis,

- peritonitis.

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

ICD-10 codes

Dosage regimen

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

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

A single dose, on average, is 200 mg (for severe infections - 400 mg), the frequency of administration is 2 times a day. The duration of treatment depends on the severity of the disease and is 1-2 weeks; if necessary, longer administration of the drug is possible.

For acute gonorrhea, the drug is prescribed intravenously in a single dose of 100 mg.

To prevent postoperative infections, it is administered intravenously 30-60 minutes before surgery at a dose of 200-400 mg.

Side effect

From the digestive system: nausea, diarrhea, vomiting, abdominal pain, flatulence, anorexia, cholestatic jaundice (especially in patients with previous liver diseases), hepatitis, hepatonecrosis, increased activity of liver transaminases and alkaline phosphatase.

From the nervous system: dizziness, headache, increased fatigue, anxiety, tremor, insomnia, nightmares, peripheral paralgesia (anomaly in the perception of pain), sweating, increased intracranial pressure, anxiety, confusion, depression, hallucinations, as well as other manifestations psychotic reactions (occasionally progressing to states in which the patient can harm himself), migraine, fainting, thrombosis of the cerebral arteries.

From the senses: disturbances of taste and smell, visual impairment (diplopia, changes in color vision), tinnitus, hearing loss.

From the cardiovascular system: tachycardia, heart rhythm disturbances, decreased blood pressure, flushing of the face.

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

Laboratory indicators: hypoprothrombinemia, 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 excretory function of the kidneys, interstitial nephritis.

Allergic reactions: skin itching, urticaria, formation of blisters accompanied by bleeding and small nodules that form scabs, drug fever, pinpoint hemorrhages (petechiae), swelling of the face or larynx, shortness of breath, eosinophilia, increased photosensitivity, vasculitis, erythema nodosum, exudative erythema multiforme , Stevens-Johnson syndrome (malignant exudative erythema), toxic epidermal necrolysis (Lyell's syndrome).

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

Other: general weakness, superinfections (candidiasis, pseudomembranous colitis).

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

Contraindications for use

- pseudomembranous colitis,

- deficiency of glucose-6-phosphate dehydrogenase,

- pregnancy,

- lactation period (breastfeeding),

- childhood and adolescence up to 18 years of age (until the completion of the skeletal formation process),

- hypersensitivity to ciprofloxacin or other drugs from the fluoroquinolone group.

The drug should be prescribed with caution in cases of severe cerebral atherosclerosis, cerebrovascular accident, mental illness, convulsive syndrome, epilepsy, severe renal and/or liver failure, as well as in elderly patients.

Use during pregnancy and lactation The drug is contraindicated for use during pregnancy and lactation.

special instructions

If severe and prolonged diarrhea occurs during or after treatment with Tsiprolet, 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 tenosynovitis appear, treatment should be stopped.

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

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

Impact on the ability to drive vehicles and operate machinery

Patients taking Tsiprolet® should be careful when driving a car and engaging in other potentially hazardous activities that require increased attention and speed of psychomotor reactions (especially when consuming alcohol at the same time).

Overdose

Treatment: specific antidote is unknown. It is necessary to carefully monitor the patient's condition, perform gastric lavage, carry out the usual emergency measures, and ensure sufficient fluid intake. Using 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, it increases the concentration and lengthens T1/2 of theophylline (and other xanthines, for example, caffeine), oral hypoglycemic drugs, indirect anticoagulants, and helps reduce the prothrombin index.

NSAIDs (excluding acetylsalicylic acid) increase the risk of seizures.

Metoclopramide accelerates the absorption of ciprofloxacin, which leads to a decrease in the time to reach its Cmax.

Co-administration of uricosuric drugs leads to a slower elimination (up to 50%) and an increase in plasma concentrations of ciprofloxacin.

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

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

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

The infusion solution 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.

Storage conditions and periods

List B. The drug should be stored out of the reach of children, in a dry place, protected from light at temperatures up to 25°C, and not frozen. Shelf life: 3 years.

Conditions for dispensing from pharmacies The drug is dispensed with a prescription.

Instructions for use of Tsiprolet (Method and dosage)

Let's look at how to take the drug.

Tsiprolet tablets, instructions for use

The medicine is taken orally 2-3 times a day, 250 mg; in case of severe disease, the dosage is increased to 0.5-0.75 grams.

Infections of the genitourinary system: twice a day, 0.25-0.5 grams for 7-10 days.

Uncomplicated gonorrhea: once 0.25-0.5 grams.

Gonococcal infection together with mycoplasmosis, chlamydia: 0.75 grams every 12 hours, course – 7-10 days.

Chancroid: Tsiprolet 500 mg twice daily.

The drug in tablets is swallowed completely, washed down with liquid.

Tsiprolet eye drops, instructions for use

Apply 1-2 drops of the product every 4 hours. If the lesion is severe, drop 2 drops every hour. As you recover, you can limit your antibiotic intake in dosage and frequency.

Some doctors believe that drops can be used as ear drops. However, it should be borne in mind that this is not their direct purpose. It must be remembered that these are eye drops.

Instructions for injections of the solution

Intravenous administration is carried out by drip of 0.2 grams over half an hour.

Therapy for osteomyelitis takes about 2 months.

Chronic carriage of salmonella: 0.2 grams twice a day, course 4 weeks.

After intravenous infusions, they switch to taking the tablet form.

Tsiprolet eye drops

INSTRUCTIONS for the use of the medicinal product for medical use

CIPROLET®

Registration number: P N 012765/01 Trade name of the drug: Ciprolet® International nonproprietary name of the drug: ciprofloxacin. Chemical name: 4-oxo-7-(piperazin-1-yl)-6-fluoro-1-cyclopropyl-1,4-dihydroquinoline-3-carboxylic acid hydrochloride monohydrate Dosage form: eye drops

Composition 1 ml of solution contains: Active ingredient: ciprofloxacin hydrochloride (equivalent to 3.0 mg of ciprofloxacin) - 3.49 mg/ml. Excipients: disodium edetate 0.50 mg, sodium chloride 9.00 mg, benzalkonium chloride 50% solution 0.0002 ml, hydrochloric acid 0.000034 mg, water for injection up to 1.0 ml.

Description Transparent, colorless or light yellow solution.

Pharmacotherapeutic group: antimicrobial agent, fluoroquinolone.

ATX code: S01AX13

Pharmacological action Pharmacodynamics A broad-spectrum antimicrobial agent, a fluoroquinolone derivative, suppresses bacterial DNA gyrase (topoisomerases II and IV, responsible for the process of supercoiling of chromosomal DNA around nuclear RNA, which is necessary for reading genetic information), disrupts DNA synthesis, growth and division of bacteria; causes pronounced morphological changes (including cell wall and membranes) and rapid death of the bacterial cell. It has a bactericidal effect on gram-negative organisms during the period of rest and division (since it affects not only DNA gyrase, but also causes lysis of the cell wall); it acts on gram-positive microorganisms only during the period of division. Low toxicity for the cells of the macroorganism is explained by the absence of DNA gyrase in them. While taking ciprofloxacin, there is no parallel development of resistance to other antibiotics that do not belong to the group of DNA gyrase inhibitors, which makes it highly effective against bacteria that are resistant, for example, to aminoglycosides, penicillins, cephalosporins, tetracyclines and many other antibiotics. Gram-negative aerobic bacteria are sensitive to ciprofloxacin: enterobacteria (Escherichiacoli, Salmonellaspp., Shigellaspp., Citrobacterspp., Klebsiellaspp., Enterobacterspp., Proteusmirabilis, Proteusvulgaris, Serratiamarcescens, Hafniaalvei, Edwardsiellatarda, Providencia spp., Morganellamorganii, Vibriospp. , Yersiniaspp.), others gram-negative bacteria (Haemophilus spp., Pseudomonasaeruginosa, Moraxellacatarrhalis, Aeromonasspp., Pasteurellamultocida, Plesiomonasshigelloides, Campylobacterjejuni, Neisseriaspp.), some intracellular pathogens - Legionellapneumophila, Brucellaspp., Chlamydiatrachomatis, Listeria monocytogenes, Mycobacterium tuberculosis, My cobacteriumkansasii, Corynebacteriumdiphtheriae; gram-positive aerobic bacteria: Staphylococcus spp. (Staphylococcus aureus, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus saprophyticus), Streptococcus spp. (Streptococcus pyogenes, Streptococcus agalactiae). Most staphylococci resistant to methicillin are also resistant to ciprofloxacin. The sensitivity of Streptococcus pneumoniae, Enterococcus faecalis, Mycobacterium avium (located intracellularly) is moderate (high concentrations are required to suppress them). The following are resistant to the drug: Bacteroides fragilis, Pseudomonas cepacia, Pseudomonas maltophilia, Ureaplasma urealyticum, Clostridium difficile, Nocardia asteroides. Not effective against Treponema pallidum. Resistance develops extremely slowly, since, on the one hand, after the action of ciprofloxacin there are practically no persistent microorganisms left, and on the other hand, bacterial cells do not have enzymes that inactivate it.

Pharmacokinetics The maximum concentration of the drug (Cmax) in plasma when using eye drops is less than 5 ng/ml. The average concentration is below 2.5 ng/ml. After instillation, systemic absorption of the drug is possible. The drug is excreted through the kidneys mainly unchanged (50%) in the form of metabolites (up to 10%), about 15% is excreted through the intestines, and in nursing mothers it passes into breast milk.

Indications for use Local treatment of various infectious diseases of the eye and its appendages caused by bacteria sensitive to the drug: acute and subacute conjunctivitis, blepharoconjunctivitis, blepharitis, bacterial corneal ulcers, bacterial keratitis and keratoconjunctivitis, chronic dacryocystitis and meibomitis. Preoperative prophylaxis in ophthalmic surgery. Treatment of postoperative infectious complications. Treatment and prevention of infectious complications of the eyes after injuries or foreign bodies.

Contraindications: Hypersensitivity to ciprofloxacin and other quinolone drugs, viral keratitis, pregnancy, lactation (breastfeeding), children (up to 1 year).

with caution in patients with cerebral atherosclerosis, cerebrovascular accident, and convulsive syndrome.

Method of administration and dosage Locally. For mild and moderately severe infections, instill 1-2 drops into the conjunctival sac of the affected eye every 4 hours, for severe infections - 2 drops every hour. After the condition improves, the dose and frequency of instillations are reduced. For bacterial corneal ulcers: 1 drop every 15 minutes for 6 hours, then 1 drop every 30 minutes during waking hours; on day 2 – 1 drop every hour during waking hours; from days 3 to 14 – 1 drop every 4 hours during waking hours. If after 14 days of therapy epithelialization has not occurred, treatment can be continued.

Side effects Allergic reactions, itching, burning, mild soreness and hyperemia of the conjunctiva, nausea, rarely - swelling of the eyelids, photophobia, lacrimation, sensation of a foreign body in the eyes, unpleasant taste in the mouth immediately after instillation, decreased visual acuity, the appearance of a white crystalline precipitate in patients with corneal ulcer, keratitis, keratopathy, corneal infiltration, development of superinfection.

Overdose There are no data on overdose of the drug when applied topically. If the drug is accidentally taken orally, there are no specific symptoms. Nausea, vomiting, diarrhea, headache, fainting, and anxiety may occur. Treatment: standard emergency measures, adequate fluid intake, acidification of urine to prevent crystalluria.

Interaction When combined with other antimicrobial drugs (beta-lactam antibiotics, aminoglycosides, clindamycin, metronidazole), synergism is usually observed; can be successfully used in combination with azlocillin and ceftazidime for infections caused by Pseudomonas spp.; with mezlocillin, azlocillin and other beta-lactam antibiotics - for streptococcal infections; with isoxazolepenicillins and vancomycin - for staphylococcal infections; with metronidazole and clindamycin - for anaerobic infections. Ciprofloxacin solution is pharmaceutically incompatible with drugs with a pH value of 3-4 that are physically or chemically unstable.

Special instructions Eye drops can only be used topically; the drug cannot be administered subconjunctivally or into the anterior chamber of the eye. When using Tsiprolet® eye drops and other ophthalmic solutions, the interval between their administrations should be at least 5 minutes. During treatment with the drug, wearing contact lenses is not recommended. Patients who temporarily lose clarity of vision after application are not recommended to drive a car or work with complex machinery, or any complex equipment that requires clarity of vision, immediately after instillation of the drug.

Release form: Eye drops 3 mg/ml. 5 ml of the drug in a plastic dropper bottle with a screw cap. 1 bottle is placed in a cardboard box along with instructions for use.

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

Shelf life 2 years. Use the drug within 1 month after opening the bottle. Do not use after the expiration date stated on the packaging.

Conditions for dispensing from pharmacies By prescription.

Manufacturer Dr. Reddy's Laboratories Ltd. Hyderabad, Andhra Pradesh, India.

Manufacturing Location Plot No.2, Sudarshanpur Industrial Estate, Bais Godam, Jaipur 302006, SP-918, Phase III, Industrial Estate, Bhiwadi District, Alwar, India.

Address for sending claims: Representative office 115035, Moscow, Ovchinnikovskaya embankment, 20, building 1 tel., 783-29-01; Fax

Interaction

Tsiprolet extends the half-life, increases the concentration of indirect anticoagulants , oral hypoglycemic drugs due to a decrease in the activity of microsomal oxidation in liver cells and hepatocytes. Ciprofloxacin reduces the prothrombin index . Combination with other antibacterial agents leads to synergy. Tsiprolet is effectively used in conjunction with azlocillin, ceftazidime , beta-lactams, isoxazolepenicillins, vancomycin , clindamycin, metronidazole. The drug increases the nephrotoxicity of cyclosporine and increases serum creatinine levels. NSAIDs, except acetylsalicylic acid , can cause seizures. The infusion solution is incompatible with pharmaceutical infusion solutions. It is unacceptable to mix solutions for intravenous infusions with solutions whose pH exceeds 7.

special instructions

Monitoring of blood pressure, heart rate, and ECG is required with the simultaneous administration of general anesthesia drugs (barbituric acid derivatives) and ciprofloxacin. Exceeding the daily dosage may lead to crystalluria . Tsiprolet affects transport control and concentration. For patients with organic brain lesions, vascular pathology, epilepsy, or a history of seizures, the drug Tsiprolet is prescribed in exceptional cases, for “vital” indications. Before antibacterial therapy, it is necessary to exclude pseudomembranous colitis . Treatment is stopped at the first signs of tendovaginitis , the appearance of pain in the tendons. It is important to avoid sun exposure during treatment.

There is no article on the drug on Wikipedia; the online encyclopedia contains only information about the active ingredient ciprofloxacin.

Tsiprolet (500mg)

INSTRUCTIONS for the use of the medicinal product for medical use CIPROLET®

Registration number: P N016161/01

Trade name of the drug: Tsiprolet®

International nonproprietary name of the drug: ciprofloxacin.

Dosage form: film-coated tablets

Composition Each 250 mg film-coated tablet contains: Active ingredient: ciprofloxacin hydrochloride monohydrate 291.106 mg, equivalent to ciprofloxacin 250 mg. Excipients: corn starch 50.323 mg, microcrystalline cellulose 7.486 mg, croscarmellose sodium 10.000 mg, corn starch 7.561 mg, colloidal silicon dioxide 5.000 mg, talc 5.000 mg, magnesium stearate 3.514 mg. Shell: hypromellose (6 cps) 4.800 mg, sorbic acid 0.080 mg, titanium dioxide 2.000 mg, talc 1.600 mg, macrogol-6000 1.360 mg, polysorbate-80 0.080 mg, dimethicone 0.080 mg. Each 500 mg film-coated tablet contains: Active ingredient: ciprofloxacin hydrochloride monohydrate 582.211 mg, equivalent to ciprofloxacin 500 mg. Excipients: corn starch 27.789 mg, microcrystalline cellulose 5.000 mg, croscarmellose sodium 20.000 mg, corn starch 9.500 mg, colloidal silicon dioxide 5.000 mg, talc 6.000 mg, magnesium stearate 4.500 mg. Shell: hypromellose (6 cps) 5.000 mg, sorbic acid 0.072 mg, titanium dioxide 1.784 mg, talc 1.784 mg, macrogol-6000 1.216 mg, polysorbate-80 0.072 mg, dimethicone 0.072 mg.

Description White or almost white, round, biconvex tablets with a smooth surface on both sides, film-coated. The appearance of the fracture is a white or almost white mass.

Pharmacotherapeutic group: antimicrobial agent – ​​fluoroquinolone.

ATX code: J01MA02

Pharmacological properties Pharmacodynamics A broad-spectrum antimicrobial agent, a fluoroquinolone derivative, suppresses bacterial DNA gyrase (topoisomerases II and IV, responsible for the process of supercoiling of chromosomal DNA around nuclear RNA, which is necessary for reading genetic information), disrupts DNA synthesis, growth and division of bacteria; causes pronounced morphological changes (including cell wall and membranes) and rapid death of the bacterial cell. It has a bactericidal effect on gram-negative organisms during the period of rest and division (since it affects not only DNA gyrase, but also causes lysis of the cell wall); it acts on gram-positive microorganisms only during the period of division. Low toxicity for the cells of the macroorganism is explained by the absence of DNA gyrase in them. While taking ciprofloxacin, there is no parallel development of resistance to other antibiotics that do not belong to the group of DNA gyrase inhibitors, which makes it highly effective against bacteria that are resistant, for example, to aminoglycosides, penicillins, cephalosporins, tetracyclines and many other antibiotics. Gram-negative aerobic bacteria are sensitive to ciprofloxacin: enterobacteria (Escherichiacoli, Salmonellaspp., Shigellaspp., Citrobacterspp., Klebsiellaspp., Enterobacterspp., Proteusmirabilis, Proteusvulgaris, Serratiamarcescens, Hafniaalvei, Edwardsiellatarda, Providencia spp., Morganellamorganii, Vibriospp. , Yersiniaspp.), others gram-negative bacteria (Haemophilus spp., Pseudomonasaeruginosa, Moraxellacatarrhalis, Aeromonasspp., Pasteurellamultocida, Plesiomonasshigelloides, Campylobacterjejuni, Neisseriaspp.), some intracellular pathogens - Legionellapneumophila, Brucellaspp., Chlamydiatrachomatis, Listeria monocytogenes, Mycobacterium tuberculosis, My cobacteriumkansasii, Corynebacteriumdiphtheriae; gram-positive aerobic bacteria: Staphylococcus spp. (Staphylococcus aureus, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus saprophyticus), Streptococcus spp. (Streptococcus pyogenes, Streptococcus agalactiae). Most staphylococci resistant to methicillin are also resistant to ciprofloxacin. The sensitivity of Streptococcus pneumoniae, Enterococcus faecalis, Mycobacterium avium (located intracellularly) is moderate (high concentrations are required to suppress them). The following are resistant to the drug: Bacteroides fragilis, Pseudomonas cepacia, Pseudomonas maltophilia, Ureaplasma urealyticum, Clostridium difficile, Nocardia asteroides. Not effective against Treponema pallidum. Resistance develops extremely slowly, since, on the one hand, after the action of ciprofloxacin there are practically no persistent microorganisms left, and, on the other hand, bacterial cells do not have enzymes that inactivate it. Pharmacokinetics When taken orally, it is quickly and fairly completely absorbed from the gastrointestinal tract (GIT), mainly in the duodenum and jejunum. Eating slows down absorption but does not change maximum concentration (Cmax) or bioavailability. Bioavailability – 50-85%, volume of distribution – 2-3.5 l/kg, binding to plasma proteins – 20-40%. The time to reach maximum concentration (TCmax) after oral administration is 60-90 minutes, Cmax linearly depends on the dose taken and is 1.2 at doses of 250, 500, 750 and 1000 mg, respectively; 2.4; 4.3 and 5.4 μg/ml. 12 hours after oral administration of 250, 500 and 750 mg, the concentration of the drug in plasma decreases to 0.1; 0.2 and 0.4 μg/ml, respectively. Well distributed in body tissues (excluding fat-rich tissue, such as nervous tissue). The concentration in tissues is 2-12 times higher than in plasma. Therapeutic concentrations are achieved in saliva, tonsils, liver, gall bladder, 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 the concentration in the absence of inflammation of the meninges is 6-10% of that in the blood serum, and in the presence of inflammation - 14-37%. Ciprofloxacin also penetrates well into the ocular fluid, bronchial secretions, pleura, peritoneum, lymph, and through the placenta. The concentration of ciprofloxacin in blood neutrophils is 2-7 times higher than in blood serum. Metabolized in the liver (15-30%) with the formation of low-active metabolites (oxo-, diethyl-, sulfo-, formylciprofloxacin). The half-life (T1/2) is about 3-5 hours, in chronic renal failure (CRF) - up to 12 hours. It is excreted mainly by the kidneys by tubular filtration and tubular secretion in unchanged form (40-50%) and in the form of metabolites ( 15%), the rest through the intestines. A small amount is excreted in breast milk. Renal clearance – 3-5 ml/min/kg; total clearance – 8-10 ml/min/kg. With chronic renal failure (creatinine clearance (CC) above 20 ml/min), the percentage of the drug excreted through the kidneys decreases, but accumulation in the body does not occur due to a compensatory increase in the metabolism of the drug and its excretion by the intestines.

Indications for use

Infectious and inflammatory diseases caused by microorganisms sensitive to ciprofloxacin. Adults :

• lower respiratory tract infections: acute and chronic (in the acute stage) bronchitis, pneumonia, bronchiectasis, infectious complications of cystic fibrosis;
• ENT infections: acute sinusitis;
• kidney and urinary tract infections: cystitis, pyelonephritis;
• genital infections, including adnexitis, gonorrhea, prostatitis;
• abdominal infections (bacterial infections of the gastrointestinal tract, biliary tract);
• infections of the skin and soft tissues: infected ulcers, wounds, burns, abscesses, phlegmon;
• infections of bones and joints: osteomyelitis, septic arthritis;
• sepsis and peritonitis;
• infections due to immunodeficiency that occurs during treatment with immunosuppressive drugs or in patients with neutropenia;
• prevention and treatment of pulmonary anthrax.

Children and teenagers (from 5 to 17 years):

• treatment of complications caused by Pseudomonas aeruginosa in children with cystic fibrosis;
• prevention and treatment of pulmonary anthrax (infection with Bacillus anthracis).

Contraindications for use

Hypersensitivity to ciprofloxacin and other drugs of the quinolone group and excipients, children's age (up to 18 years - until the completion of the skeletal formation process, except for the treatment of complications caused by Pseudomonas aeruginosa, in children with cystic fibrosis of the lungs from 5 to 17 years; prevention and treatment of the pulmonary form anthrax), simultaneous use with tizanidine (risk of a pronounced decrease in blood pressure, drowsiness), pregnancy, lactation (breastfeeding).

With caution Severe atherosclerosis of cerebral vessels, cerebrovascular accident, mental illness, epilepsy, severe renal and/or liver failure, old age, increased risk of prolongation of the QT interval or development of ari (for example, congenital long QT syndrome), heart disease (cardiac failure, myocardial infarction, bradycardia), electrolyte imbalance (for example, with hypokalemia, hypomagnesemia), simultaneous use of drugs that prolong the QT interval (including class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics), simultaneous use with isoenzyme inhibitors CYP450 1A2 (including theophylline, methylxanthine, caffeine, duloxetine, clozapine, ropinirole, olanzapine), patients with a history of tendon damage during previous treatment with quinolones, myasthenia gravis, glucose-6-phosphate dehydrogenase deficiency.

Method of administration and dosage Tablets should be taken orally, regardless of meals, without chewing, with a small amount of liquid. If the drug is used on an empty stomach, the active substance is absorbed faster. In this case, the tablets should not be taken with dairy products or drinks fortified with calcium (for example, milk, yogurt, juices with a high calcium content). Calcium contained in regular food does not affect the absorption of ciprofloxacin. Recommended dosage regimen: Adults - respiratory tract infections (depending on the severity of the infection and the patient's condition): from 500 mg 2 times a day to 750 mg 2 times a day; - infections of the genitourinary system: acute, uncomplicated: from 250 mg 2 times a day to 500 mg 2 times a day; cystitis in women (before menopause): 500 mg 1 time per day; complicated: from 500 mg 2 times a day to 750 mg 2 times a day; genital infections (except gonorrhea): from 500 mg 2 times a day to 750 mg 2 times a day; gonorrhea: 500 mg once a day once; - diarrhea: 500 mg 2 times a day; - other infections (see section “Indications for use”): 500 mg 2 times a day; especially severe, life-threatening (especially in the presence of Pseudomonaspp., Staphylococcusspp., Streptococcusspp.), incl. streptococcal pneumonia, infections of bones and joints, septicemia, peritonitis: 750 mg 2 times a day. Dosage regimen in elderly patients (after 65 years): Elderly patients should be prescribed lower doses of ciprofloxacin depending on the severity of the disease and creatinine clearance. Dosage regimen for patients with renal failure: - with creatinine clearance from 30 to 60 ml/min/1.73 m2 or its concentration in blood plasma from 1.4 to 1.9 mg/100 ml, the maximum daily dose of ciprofloxacin is 1000 mg; - with creatinine clearance below 30 ml/min/1.73 m2 or plasma concentrations of 2 mg/100 ml or more, the maximum daily dose of ciprofloxacin is 500 mg; - patients with renal failure on hemodialysis: with creatinine clearance from 30 to 60 ml/min/1.73 m2 or its concentration in blood plasma from 1.4 to 1.9 mg/100 ml, the maximum daily dose of ciprofloxacin is 1000 mg; with a creatinine clearance of 30 ml/min/1.73 m2 or less or its concentration in the blood plasma of 2 mg/100 ml or more, the maximum daily dose of ciprofloxacin is 500 mg. On hemodialysis days, ciprofloxacin is taken after the procedure. Outpatients with renal failure on continuous peritoneal dialysis: maximum daily dose of ciprofloxacin is 500 mg. Patients with hepatic impairment: no dose adjustment is required. The duration of treatment depends on the severity of the disease, clinical and bacteriological control. It is important to continue treatment systematically for at least 3 days after the disappearance of fever or other clinical symptoms. Average duration of treatment: 1 day - for acute uncomplicated gonorrhea and cystitis; up to 7 days - for kidney infections, urinary tract infections, intra-abdominal infections; the entire period of neutropenia in immunocompromised patients; no more than 2 months - for osteomyelitis; from 7 to 14 days - for other infections. For infections caused by Streptococcus spp., due to the risk of late complications, treatment should continue for at least 10 days; for infections caused by Chlamydiasp., treatment should also be continued for at least 10 days. For the prevention and treatment of pulmonary anthrax - 500 mg 2 times a day for 60 days. The drug should be started immediately after suspected or confirmed infection. Children and adolescents In the absence of other prescriptions, the following dosage regimen should be followed: For the treatment of complications caused by Pseudomonas aeruginosa in children from 5 to 17 years old with cystic fibrosis - 20 mg/kg 2 times a day (maximum dose 1500 mg). Duration of treatment is 10-14 days. For pulmonary anthrax (prevention and treatment) – 15 mg/kg 2 times a day. The maximum single dose is 500 mg, daily dose is 1000 mg. The total duration of taking ciprofloxacin is 60 days. Children with renal impairment There is no information available on dosage adjustment patterns for children with renal impairment.

Side effect

Depending on the frequency of occurrence, the following groups of side effects are distinguished: frequent (>1% and <10%), infrequent (>0.1 and <1%), rare (>0.01 and <0.1%), very rare (<0.01%).

From the central and peripheral nervous system: infrequently - dizziness, headache, increased fatigue; rarely – insomnia, tremor; very rarely - anxiety, “nightmare” dreams, peripheral paralgesia (anomaly in the perception of pain), increased sweating, increased intracranial pressure, including benign intracranial hypertension, confusion, depression (which can lead to self-harmful behavior such as suicidal behavior/ thoughts, as well as attempted or successful suicide), hallucinations, as well as other manifestations of psychotic reactions (which can lead to self-injurious behavior such as suicidal acts/thoughts, as well as attempted or successful suicide), migraines, fainting states, cerebral thrombosis arteries, agitation, disorientation, paresthesia and dysesthesia, hypoesthesia, convulsions, vertigo, impaired coordination of movements, gait disturbance, hyperesthesia, peripheral neuropathy and polyneuropathy, epileptic attacks.

From the senses: infrequently - taste disturbances; rarely – visual disturbances, tinnitus, hearing loss; very rarely - impaired sense of smell, impaired color perception, impaired hearing.

From the cardiovascular system: in very rare cases - tachycardia, other heart rhythm disturbances, decreased blood pressure, prolongation of the QT interval, ventricular arrhythmias (including pirouette type).

From the digestive system: infrequently - nausea, vomiting, diarrhea, abdominal pain, flatulence, decreased appetite and amount of food taken; rarely – cholestatic jaundice (especially in patients with previous liver diseases), pancreatitis; very rarely - hepatitis, hepatonecrosis.

From the hematopoietic system: uncommon – eosinophilia, leukopenia, granulocytopenia, thrombocytopenia, anemia; very rarely - leukocytosis, thrombocytosis, hemolytic anemia, neutropenia, agranulocytosis, pancytopenia, suppression of bone marrow hematopoiesis, serum sickness.

From the urinary system: rarely - hematuria, crystalluria (primarily with alkaline urine and low diuresis), dysuria, polyuria, urinary retention, albuminuria; very rarely - glomerulonephritis, urethral bleeding, decreased nitrogen excretory function of the kidneys, interstitial nephritis, renal failure.

From the respiratory system: rarely - respiratory distress (including bronchospasm). Allergic reactions: infrequently - skin itching, urticaria, the formation of blisters accompanied by bleeding, and the appearance of small nodules that form scabs, drug fever, pinpoint hemorrhages on the skin (petechiae); rarely - swelling of the face or larynx, shortness of breath, eosinophilia, increased photosensitivity; very rarely - vasculitis, erythema nodosum, exudative erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), anaphylactic reactions, anaphylactic shock. From laboratory parameters: infrequently - increased activity of liver transaminases and alkaline phosphatase, hyperbilirubinemia; rarely - changes in prothrombin levels (including hypoprothrombinemia), hyperglycemia or hypoglycemia, increased amylase activity; frequency unknown - hypercreatininemia. Other: infrequently - “flushes” of blood to the face; rarely - arthralgia, arthritis, tenosynovitis; very rarely - tendon ruptures (mainly Achilles), asthenia, myalgia, increased muscle tone, muscle weakness, exacerbation of myasthenia gravis symptoms, superinfections (candidiasis, pseudomembranous colitis); frequency unknown - acute generalized pustular exanthema, increase in international normalized ratio (in patients receiving vitamin K antagonists).

Overdose Symptoms: nausea, vomiting, confusion, mental agitation. Treatment: specific antidote is unknown. It is necessary to carefully monitor the patient's condition, perform gastric lavage and other emergency measures, and ensure sufficient fluid intake. To prevent the development of crystalluria, it is recommended to monitor renal function, including urine pH and acidity. Using hemo- or peritoneal dialysis, only a small (less than 10%) amount of the drug can be removed.

Interactions with other drugs Drugs known to prolong the QT interval Caution should be exercised when ciprofloxacin, like other fluoroquinolones, is used concomitantly in patients receiving drugs known to prolong the QT interval (e.g., class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, neuroleptics). Formation of chelate compounds Simultaneous intake of tablet forms of ciprofloxacin and cation-containing drugs, mineral supplements containing calcium, magnesium, aluminum, iron; sucralfate, antacids, polymeric phosphate compounds (sevelamer, lanthanum carbonate) and drugs with a large buffer capacity (such as didanosine tablets) containing magnesium, aluminum or calcium reduce the absorption of ciprofloxacin. In such cases, ciprofloxacin should be taken either 1-2 hours before or 4 hours after taking these drugs. This restriction does not apply to drugs belonging to the class of H2-histamine receptor blockers. Ingestion of food and dairy products The concomitant use of ciprofloxacin and dairy products or mineral-fortified drinks (milk, yogurt, calcium-fortified orange juice) should be avoided as the absorption of ciprofloxacin may be reduced. However, calcium contained in other foods does not significantly affect the absorption of ciprofloxacin. Omeprazole With the combined use of ciprofloxacin and omeprazole, a slight decrease in Cmax in plasma and a decrease in the area under the concentration-time pharmacokinetic curve (AUC) may be observed. Theophylline The simultaneous use of ciprofloxacin and drugs containing theophylline may cause an undesirable increase in the concentration of theophylline in the blood plasma and, accordingly, the occurrence of theophylline-induced adverse events; in very rare cases, these adverse events can be life-threatening for the patient. If the simultaneous use of these two drugs is necessary, 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) may lead to an increase in the concentration of xanthine derivatives in the blood serum. Non-steroidal anti-inflammatory drugs The combination of very high doses of quinolones and some non-steroidal anti-inflammatory drugs (except acetylsalicylic acid) can provoke seizures. Cyclosporine With simultaneous use of ciprofloxacin and drugs 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 the blood twice a week. Oral hypoglycemic agents With simultaneous use of ciprofloxacin and oral hypoglycemic agents, mainly sulfonylureas (for example, glibenclamide, glimepiride), the development of hypoglycemia may be due to an increase in the effect of oral hypoglycemic agents. Probenecid Probenecid slows the rate of renal excretion of ciprofloxacin. The simultaneous use of ciprofloxacin and drugs containing probenecid leads to an increase in the concentration of ciprofloxacin in the blood serum. Phenytoin With the simultaneous use of ciprofloxacin and phenytoin, a change (increase or decrease) in the content of phenytoin in the blood plasma was observed. It is recommended to monitor phenytoin therapy in patients taking both drugs, including determination of phenytoin plasma levels. Methotrexate With 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 developing side effects of methotrexate. In this regard, patients receiving concomitant therapy with methotrexate and ciprofloxacin should be closely monitored. Tizanidine As a result of a clinical study involving healthy volunteers with simultaneous use of ciprofloxacin and drugs containing tizanidine, an increase in the concentration of tizanidine in the blood plasma was detected: an increase in Cmax by 7 times (from 4 to 21 times), an increase in AUC by 10 times (from 6 to 24 once). Hypotensive and sedative side effects are associated with increased serum concentrations of tizanidine. Therefore, the simultaneous use of ciprofloxacin and drugs containing tizanidine is contraindicated. Duloxetine During clinical studies, it was shown that the simultaneous use of duloxetine and strong inhibitors of the CYP450 1A2 isoenzyme (such as fluvoxamine) may lead to an increase in the AUC and Cmax of duloxetine. Although there is no clinical data on possible interactions with ciprofloxacin, the likelihood of such an interaction can be anticipated when ciprofloxacin and duloxetine are used concomitantly. Ropinirole The simultaneous use of ropinirole and ciprofloxacin, a moderate inhibitor of the CYP450 1A2 isoenzyme, leads to an increase in the Cmax and AUC of ropinirole by 60 and 84%, respectively. Monitor for adverse effects of ropinirole during coadministration 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 CYP450 1A2 isoenzyme, leads to a 22% decrease in the clearance of lidocaine when administered intravenously. Despite the good tolerability of lidocaine, when used simultaneously with ciprofloxacin, side effects may increase due to interaction. Clozapine With 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 was observed by 29% and 31%, respectively. The patient's condition should be monitored and, if necessary, the dosage regimen of clozapine should be adjusted during its combined use with ciprofloxacin and for a short time after completion of combination therapy. Sildenafil When ciprofloxacin at a dose of 500 mg and sildenafil at a dose of 50 mg was used simultaneously in healthy volunteers, a 2-fold increase in the Cmax and AUC of sildenafil was observed. In this regard, the use of this combination is possible only after assessing the benefit/risk ratio. Vitamin K antagonists The combined use of ciprofloxacin and vitamin K antagonists (for example, warfarin, acenocoumarol, phenprocoumon, fluindone) may lead to an increase in their anticoagulant effect. The magnitude of this effect may vary depending on concomitant infections, age and general condition of the patient, so it is difficult to assess the effect of ciprofloxacin on increasing the international normalized ratio (INR). The INR should be monitored fairly frequently during co-administration 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 caused by gram-positive and anaerobic bacteria When treating severe infections, staphylococcal infections and infections caused by anaerobic bacteria, ciprofloxacin should be used in combination with appropriate antibacterial agents. Infections due to Streptococcus pneumoniae Ciprofloxacin is not recommended for the treatment of infections caused by Streptococcus pneumoniae due to limited effectiveness against the pathogen. Genital tract infections For genital infections suspected of being caused by fluoroquinolone-resistant strains of Neisseria gonorrhoeae, local information on resistance to ciprofloxacin should be considered and susceptibility confirmed by laboratory tests. Cardiac disorders Ciprofloxacin has the effect of prolonging the QT interval. Given that women have a longer average QT interval compared to men, they are more sensitive to drugs that cause QT prolongation. Elderly patients also have increased sensitivity to the effects of such drugs. Use ciprofloxacin with caution in combination with drugs that prolong the QT interval (e.g., class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics) or in patients with an increased risk of QT prolongation or development of QT syndrome (e.g., congenital long interval syndrome). QT), heart disease (heart failure, myocardial infarction, bradycardia), uncorrected electrolyte imbalance (for example, hypokalemia, hypomagnesemia). Use in children Ciprofloxacin, like other drugs of this class, causes arthropathy of large joints in animals. When analyzing the current data on the safety of ciprofloxacin in children under 18 years of age, most of whom have cystic fibrosis, no connection has been established between cartilage or joint damage with the drug. It is not recommended to use ciprofloxacin in children for the treatment of diseases other than the treatment of complications of cystic fibrosis of the lungs (in children from 5 to 17 years old) associated with Pseudomonas aeruginosa and for the treatment and prevention of pulmonary anthrax. Hypersensitivity In rare cases, after the first use, anaphylactic reactions up to anaphylactic shock may occur. In these cases, the use of ciprofloxacin should be stopped immediately and appropriate treatment should be instituted. Gastrointestinal tract If severe and prolonged diarrhea occurs during or after treatment, the diagnosis of pseudomembranous colitis should be excluded, which requires immediate discontinuation of the drug and the appointment of appropriate treatment. Hepatobiliary system Cases of liver necrosis and life-threatening liver failure have been reported with the use of ciprofloxacin. If you have symptoms of liver disease such as anorexia, jaundice, dark urine, itching, a painful abdomen, the use of ciprofloxacin should be discontinued. Patients taking ciprofloxacin who have had liver disease may experience a temporary increase in the activity of liver transaminases and alkaline phosphatase or cholestatic jaundice. Musculoskeletal system In patients with myasthenia gravis, ciprofloxacin should be used with caution, as an exacerbation of symptoms is possible. At the first signs of tendinitis (painful swelling, inflammation in the joint area), treatment with ciprofloxacin should be stopped and physical activity should be avoided. When using ciprofloxacin, cases of tendinitis and tendon rupture (mainly Achilles tendon), sometimes bilateral, may occur within the first 48 hours after the start of therapy; inflammation and tendon rupture can occur even several months after stopping treatment with ciprofloxacin. Elderly patients and patients with tendon diseases who are simultaneously treated with glucocorticosteroids have an increased risk of tendinopathy. Ciprofloxacin should be used with caution in patients with a history of tendon diseases associated with quinolones. Nervous system Ciprofloxacin, like other fluoroquinolones, can provoke seizures and lower the seizure threshold. In patients with epilepsy and a history of central nervous system diseases (lowered seizure threshold, history of seizures, cerebrovascular accidents, organic brain lesions or stroke) due to the risk of developing adverse reactions from the central nervous system, ciprofloxacin should be used only after assessing the benefit/risk ratio . Cases of status epilepticus have been reported with the use of ciprofloxacin. If seizures occur, use of the drug should be discontinued. Psychiatric reactions may occur even after the first use of fluoroquinolones, including ciprofloxacin. In rare cases, depression or psychotic reactions may progress to suicidal thoughts and self-harmful behavior, such as attempted or completed suicide; if the patient develops one of these reactions, the drug should be stopped and the doctor informed. Cases of sensory or sensorimotor neuropathy have been reported in patients taking fluoroquinolones. If symptoms such as pain, burning, tingling, numbness, or weakness occur, the patient should inform the doctor before continuing to use ciprofloxacin. Skin During the treatment period, contact with direct sunlight and UV irradiation in a solarium should be avoided. Cytochrome P450 Ciprofloxacin is a moderate inhibitor of CYP450 1A2 isoenzymes. Caution should be exercised during the simultaneous use of ciprofloxacin and drugs metabolized by these enzymes (including tizanidine, theophylline, methylxanthine, caffeine, duloxetine, ropinirole, clozapine, olanzapine), 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. Prevention of crystalluria To avoid the development of crystalluria, exceeding the recommended daily dose is unacceptable; sufficient fluid intake and maintaining an acidic urine reaction are also necessary. Diagnosis of infection caused by Mycobacterium spp. In vitro, ciprofloxacin may interfere with the bacteriological study of Mycobacterium tuberculosis, inhibiting its growth, which can lead to false negative results when diagnosing this pathogen in patients taking ciprofloxacin.

Impact on the ability to drive vehicles and machinery

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Release form Film-coated tablets, 250 mg and 500 mg. 10 tablets in a PVC/aluminum blister. 1 or 2 blisters along with instructions for use in a cardboard pack.

Storage conditions : Protected from light at a temperature not exceeding 25 °C. Keep out of the reach of children!

Shelf life 3 years. Do not use after the expiration date stated on the packaging.

Conditions for dispensing from pharmacies By prescription.

Manufacturer Dr. Reddy's Laboratories Ltd., India Dr. Reddy's Laboratories Ltd., India

Address of the place of production 1. Survey No. 42, 45 & 46, Bachupally Village, Qutbullapur Mandal, Ranga Reddy District, Telangana State, India. 2. Khol, Nalagarh Road, Baddi, Dist. Solan, Himachal Pradesh, India.

Information about complaints and adverse drug reactions should be sent to the following address: Representative office: 115035, Moscow, Ovchinnikovskaya embankment, 20, building 1 tel. fax

Analogues of Tsiprolet

Level 4 ATX code matches:
Dancil

Oftadek

Signitsef

Oftaquix

Vitabact

Okomistin

Analogues of Tsiprolet in composition are the following drugs: Alox , Floximed , Ciloxan , Ciproxol , Tsipromed , Tsipropharm , Ciprofloxacin , Tsifran , Tsiprol , Cipronate , Ificipro , Medociprin and others.

Are Tsiprolet and Tsifran the same thing?

Tsifran is an analogue of the drug in terms of the active substance.

Reviews about Tsiprolet

Reviews of Tsiprolet tablets

In general, the drug, of course, helps, since it is an antibiotic. However, it is worth remembering that it is for this reason that it should be taken only in extreme cases, so as not to harm health, especially in doses exceeding 500 mg. In particular, the annotation says that you should not take Tsiprolet before reaching adulthood, as this can negatively affect the skeleton. There are also reviews on the Internet about the side effects of this drug, such as weakness, dizziness, and difficulty breathing.

The drug is successfully taken for cystitis, but it is not recommended to stay in the sun for a long time while taking this antibiotic.

Reviews of Tsiprolet eye drops

Effective for conjunctivitis, blepharitis, stye. The drops are inexpensive.

Tsiprolet price, where to buy

The price of Tsiprolet in tablets of 500 mg is 110 rubles per pack of 10 pieces.

The price of 250 mg tablets is approximately 55 rubles per pack.

The price of Tsiprolet in eye drops is 60 rubles.

You can always check the current cost of an antibiotic in online pharmacies, for which you can use our selection below. How much the drug costs depends on the country.

• Online pharmacies in RussiaRussia
• Online pharmacies in UkraineUkraine
• Online pharmacies in KazakhstanKazakhstan

ZdravCity

• Ciprolet tablets p.p.o.
  250mg 10 pcs.Dr. Reddy's lab. 57 RUR order
• Ciprolet tablets p.p.o. 500mg 10 pcs.Dr. Reddy's lab.

  112 rub. order

• Tsiprolet eye drops 3mg/ml 5mlDr. Reddy's lab.

  56 RUR order

• Tsiprolet A tablets p.p.o. 500mg+600mg 10pcsDr. Reddy's lab.

  220 rub. order

Pharmacy Dialogue

• Tsiprolet 250 tablets p/o 250 mg No. 10Dr. Reddy's

  57 RUR order

• Tsiprolet 500 tablets p/o 500 mg No. 10Dr. Reddy's

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• Tsiprolet ch. drops (5ml bottle)Dr. Reddy's

  57 RUR order

• Tsiprolet A tablets 500mg+600mg No. 10Dr. Reddy's

  RUB 204 order

• Tsiprolet Ch. drops (head drops 3 mg/ml 5 ml)Dr. Reddy's

  56 RUR order

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Pharmacy24

• Ciprolet 500 mg No. 10 tablets Dr. Reddy's Laboratories Ltd., India
  82 UAH.order
• Ciprolet 25 mg N10 tablets Dr. Reddy's Laboratories Ltd., India

  53 UAH order

• Ciprolet A N10 tablets Dr. Reddy's Laboratories Ltd., India

  147 UAH order

PaniPharmacy

• Tsiprolet tablets Tsiprolet tablets, film-coated 250 mg No. 10 India, Dr. Reddy's

  58 UAH order

• Tsiprolet A tablets Tsiprolet A tablet. No. 10 India, Dr. Reddy's

  161 UAH order

• Tsiprolet tablets Tsiprolet film-coated tablets 500 mg No. 10 India, Dr. Reddy's

  107 UAH order

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The role of antibiotics in the complex therapy of external bacterial otitis

Inflammatory ear diseases are one of the most pressing problems in otorhinolaryngology. In outpatient settings, the proportion of patients with various forms of otitis reaches 38%, while the proportion of patients with external otitis, on average, is 50% [3, 7]. The incidence of various diseases of the outer ear tends to increase. This is due to the adverse effects of the environment, the widespread and uncontrolled use of medications that cause immunological changes in the body, and an increase in the number of patients with an allergic background. According to epidemiological data, 65% of dermatitis of the external auditory canal is caused by bacterial flora, and the leading pathogen in this group remains Pseudomonas aeruginosa, which accounts for up to 38% of the total structure of otitis pathogens [1, 5]. Sometimes Pseudomonas aeruginosa is found in combination with other microorganisms: E.coli, P.vulgaris, S.aureus and rarely - fungi. With otitis externa, the skin of the external auditory canal and the periosteum lying directly under the skin are affected. The disease is usually accompanied by ear pain, decreased hearing acuity, itching and purulent discharge. The diagnosis is based on the presence of typical signs of diffuse inflammation of the skin of the external auditory canal, which sometimes extends to the eardrum. The process has an acute or chronic course with exacerbations.

In some cases, external otitis caused by Pseudomonas aeruginosa can take a malignant course and develop into pseudomonas osteomyelitis of the temporal bone. At first, this is a sluggish process with rather minor manifestations (for example, discharge from the ear, inflammation of the skin of the external auditory canal). But if left untreated, the infection progresses, spreading to the ear, scalp and parotid salivary gland. Subsequently, the lesion affects the middle and inner ear, which can lead to the development of meningitis and otogenic brain abscesses [2].

Therapy for external otitis is prescribed taking into account the clinical picture and the nature of the pathogenic microflora. In uncomplicated cases, it is sufficient to prescribe a short course of local composite drugs containing antibacterial drugs and glucocorticosteroids. For patients with moderate and severe disease - with an increase in body temperature, spread of the inflammatory process beyond the auditory canal, in the presence of regional lymphadenopathy, if there is suspected spread of infection to the middle ear or signs of necrotization of the process, as well as in the case of a protracted course, the use of systemic antibiotic therapy is recommended [ 6].

When prescribing antibiotic therapy, one should take into account the fact that the doctor can obtain information about the composition of the microbial flora only 4–6 days after the patient’s application based on the results of a bacteriological study. Therefore, to achieve the desired effect when empirically prescribing therapy, preference is given to antimicrobial drugs (AMPs) that have a broad spectrum of action and are active against most possible pathogens of these conditions and, in particular, P. aeruginosa. That is why, in case of external otitis, characterized by an unfavorable, malignant course, it is necessary to promptly prescribe AMPs, which include, first of all, antipseudomonas cephalosporins (ceftazidime, cefepime) and fluoroquinolones (ciprofloxacin). In some cases, in the presence of highly reactive processes, as well as in the absence of effect on the second or third day of therapy, aminoglycosides (gentamicin, etc.) are prescribed. All of these AMPs are usually administered in high doses subject to intravenous administration; the duration of therapy is up to 4 weeks or more. Once the condition has stabilized, it is possible to switch to oral therapy with tablet forms of ciprofloxacin [4].

One of these drugs is Ciprolet (ciprofloxacin), an antimicrobial drug from the fluoroquinolone group. In laboratory conditions, ciprofloxacin exhibits activity against a wide range of gram-negative and gram-positive microorganisms. The bactericidal activity of ciprofloxacin is due to the ability to inhibit enzymes necessary for replication, transcription, repair and recombination of bacterial DNA. An important advantage of ciprofloxacin, based on its mechanism of action, is that it has a bactericidal effect on gram-negative microorganisms not only in the division phase, but also in the resting phase, while penicillins, cephalosporins and aminoglycosides act only on reproducing bacteria. This property of ciprofloxacin ensures its high clinical effectiveness in the treatment of chronic and localized infections. Ciprofloxacin is rightfully considered one of the most powerful antibacterial drugs acting on “problem” microorganisms - Staphylococcus aureus (including some methicillin-resistant strains) and P. aeruginosa (including multidrug-resistant strains). In terms of activity against P.aeruginosa, ciprofloxacin is comparable to meropenem and the most effective third-generation antipseudomonas cephalosporin, ceftazidime, and is the drug of choice for the treatment of infection caused by P.aeruginosa. And, which is very important in clinical practice, ciprofloxacin exhibits high activity against multiresistant strains of microorganisms. The sensitivity of P. aeruginosa to ciprofloxacin (including strains isolated from the ear) in outpatients is up to 93.7%. At the same time, ciprofloxacin has high bioavailability, which makes it indispensable for the treatment of a number of infections of all degrees of severity in all tissues.

The purpose of the scientific research conducted on the basis of the Moscow Scientific and Practical Center of Otorhinolaryngology named after L.I. Sverzhevsky" DZM, was the study and assessment of clinical and microbiological effectiveness, tolerability and determination of the optimal duration of treatment with AMP Tsiprolet in the complex therapy of bacterial otitis externa (EBO). Materials and methods. When carrying out research work (R&D), clinical observation was carried out on 60 patients with NBO, identified when contacting an ENT doctor of the consultative and diagnostic department of the Moscow Research and Clinical Center. Of these, 24 were men and 36 women aged from 19 to 60 years (median age 34.7 ± 5.6 years). All patients associated the onset of the disease with the fact that water entered the external auditory canal during bathing, while most patients, on the eve of bathing or immediately after it, toileted the external auditory canal using a cotton swab or other means. The duration of the disease (exacerbation) ranged from 2 to 5 days.

All patients, depending on the nature of the disease, were divided into two groups, including 30 people: the first group - patients with acute NBO and the second group - with exacerbation of chronic NBO.

On the day of treatment, in addition to a general clinical examination and otomicroscopy, all patients underwent a microscopic and bacteriological examination of discharge from the external auditory canal of the affected ear before the start of therapy. In each group, patients received Tsiprolet in tablet form 500 mg as a basic AMP, 2 times a day until a clinically significant result was achieved, no more than 10 days. In addition to systemic antibacterial therapy, local NBO therapy was carried out, provided for by the standards for the treatment of external otitis, using osmotic drugs on a cotton swab (microcompress according to Tsitovich). In addition, patients received hyposensitizing therapy, in some cases combining it with non-steroidal anti-inflammatory drugs for pain relief during the entire course of antibacterial therapy for otitis externa in dosage regimens according to the instructions for their use. results

In all patients, microscopy of an ear smear stained using the Gram method revealed both gram-positive and gram-negative microflora, which served as a criterion for including the patient in the study.

An increase in body temperature to febrile values ​​occurred in one patient of the first group, while low-grade fever was observed in 23 patients of the first group (77%) and 18 patients of the second group (60%), in the remaining patients the temperature did not exceed normal values ​​(Fig. . 1).

During the therapy, by the 3rd day the increase in body temperature to subfebrile values ​​persisted in 19 patients of the first group (64%) and 14 patients of the second group (47%). By the 5th day of treatment, the temperature at the level of subfebrile values ​​remained in 14 patients of the first and 10 patients of the second group. By the 10th day of treatment, body temperature returned to normal in all patients.

On the day of treatment, all patients complained of ear pain, assessing it as severe. By the second visit (on the 3rd day of treatment), severe pain in the ear remained in 4 patients (13%) of the first group and in 1 patient (3%) of the second group, moderate pain in 8 patients of the first group (27%). By the third visit (5th day of therapy), the pain in the affected ear had completely stopped in 21 (70%) patients of the first group and in 24 (80%) of the second group. By the fourth visit (10th day of treatment), minor pain in the external auditory canal persisted in only 1 patient of the first group, while in the remaining patients this symptom was completely relieved (Figure 2). Hearing loss was subjectively noted by 28 patients (94%) of the first group and 25 patients (83%) of the second group. At the same time, 19 patients (63%) of the first group and 5 patients (16%) of the second group complained of pronounced hearing loss. By the 3rd day of treatment, pronounced hearing loss persisted in 7 patients of the first group (23%) and in 1 patient (3%) of the second group, which was due not only to severe swelling of the skin of the cartilaginous part of the external auditory canal, but also to the presence of a large amount of pathological discharge in him. Figure 3. Dynamics of changes in hearing acuity in patients of groups 1 and 2 On the 5th day of therapy, pronounced hearing loss continued to bother 2 patients (6%) of the first group, moderately pronounced - 5 patients (17%) and slight - 2 (6%) patients, while in 21 patients (70%) hearing was completely restored. Among the patients of the second group, moderate hearing loss persisted in 2 (6%) and slight hearing loss in 3 (10%) patients, while complete recovery was achieved in 25 patients (83%). By the 10th day of therapy, hearing was restored to the previous level in all patients of both groups (Fig. 3).

On the day of the first visit, pathological discharge from the ear occurred in all patients of both groups. At the same time, copious purulent discharge was noted by 25 patients (83%) of the first group and 5 patients (16%) of the second group. During the therapy, on the 3rd day of treatment, heavy discharge from the ear of a mucopurulent nature persisted in 20 patients of the first group (66%) and in 4 patients (13%) of the second group. By the 5th day of treatment, heavy discharge from the ear continued to bother 2 patients of the first group (6%), moderate discharge - 5 (17%), while in 21 patients (70%) the discharge from the ear stopped completely. Among the patients of the second group, a similar picture was observed. Heavy discharge remained in only 1 patient (3%), moderate discharge in 3 (10%), complete cessation of suppuration was achieved in 24 (80%) patients. By the 10th day of therapy, ear discharge completely stopped in all patients of both groups (Fig. 4).

All patients in both groups were also bothered by itching of the skin of the external auditory canal. By the second visit, severe itching of the skin of the external auditory canal continued to be noted by 27 patients of the first group (90%) and 23 patients of the second group (77%). This was probably due to the constant presence of fluid in the external auditory canal. By the 5th day of treatment, intense itching in the ear canal persisted in 2 patients of the first group (6%) and in 1 patient (3%) of the second group. By the fourth visit, intense itching of the ear canal was relieved in patients of both groups (Fig. 5).

During the initial examination, severe pain when pressing on the tragus was noted in 27 patients of the first group (90%) and in 15 patients (50%) of the second group. By the second visit, a severe pain symptom when pressing on the tragus remained in 11 patients of the first group (37%) and in 6 patients of the second group (20%). By the third visit, a positive tragus symptom of low and insignificant intensity remained in 8 patients (27%) of the first and 6 patients (20%) of the second group. In 22 patients (73%) of the first and 24 patients (80%) of the second group, the symptom completely regressed. By the fourth visit, the tragus symptom was negative in all patients of both groups (Fig. 6).

According to the results of an otoscopy performed on the day of treatment, hyperemia and infiltration of the skin of the cartilaginous part of the external auditory canal was strongly expressed in all patients of both groups. By the 3rd day of treatment, a pronounced regression of these symptoms was achieved. Thus, severe hyperemia persisted in 5 patients (17%) of the first and 3 patients (10%) of the second group. By the third visit, moderate and slight hyperemia of the cartilaginous part of the skin of the external auditory canal remained in 17 patients (57%) of the first and 13 patients (43%) of the second group. By the 10th day of therapy, this symptom was relieved in all patients of both groups (Figure 7).

Intense narrowing of the lumen of the cartilaginous part of the external auditory canal was noted in 25 patients (83%) of the first group and in 21 patients (70%) of the second group. By the second visit, infiltration of the skin of the cartilaginous part of the external auditory canal also decreased and was largely preserved only in 13 patients of the first (44%) and 9 patients (30%) of the second group. By the 5th day of treatment, the lumen of the external auditory canal increased in half of the patients, and its severe narrowing, making it impossible to examine the eardrum, persisted in 15 patients (50%) of the first and 11 (37%) patients of the second group. By the 10th day of treatment, hyperemia and infiltration of the skin of the cartilaginous part of the external auditory canal, which interfered with the view of the eardrum, completely regressed in all patients (Fig. 8).

Based on the results of a bacteriological study of discharge from the external auditory canal, the following results were obtained (Table 1)

When assessing microbiological study data, S. aureus strains dominated among patients with ONBO, which were isolated in 15 cases, P. aeruginosa - in 14, E. coli - in 1 case. The following strains of microorganisms were isolated during CNBO: S.aureus in 11 patients, P.aeruginosa in 8, E.coli in 3, E.aerogenes in 3, Acinetobacter spp. – in 2, Klebsiella spp. – in 2, K.ascorbata – in 1 patient. As a result of the treatment, bacteriological effectiveness was confirmed in 28 patients in the ONBO group and in 27 patients in the CNBO group. At the same time, in 5 patients with exacerbation of CNBO and 3 patients with ONBO, epidermal staphylococcus, which is a representative of the normal microflora of the ear canal, was isolated. In 2 patients with CNBO, according to the results of the study, strains of S.aureus and Klebsiella spp., resistant to ciprofloxacin, were isolated, which required additional therapy with drugs to which these microorganisms are sensitive.

It should also be noted that during treatment, no adverse events or adverse reactions associated with the use of drugs were reported in any patient. The overall subjective assessment of the tolerability of the therapy by the 10th day of treatment is “good”. The overall subjective assessment of the effectiveness of the therapy by the 10th day of treatment is “pronounced effect.”

conclusions

According to the results of the study, the pronounced clinical effectiveness of the drug Tsiprolet is noted. The percentage of patients with complete resolution of the inflammatory process in the external auditory canal when using the drug by the 10th day of treatment was 93% among patients with ONBO (28 patients), 90% among patients with exacerbation of CNBO (27 patients). While taking the drug Tsiprolet, there was a good positive dynamics of the otoscopic picture in case of inflammation of the external auditory canal. By the 10th day of treatment, the proportion of patients with positive dynamics of otoscopic signs of NBO in the first and second groups was 100%.

The pronounced bacteriological effectiveness of the drug Tsiprolet against strains of S.aureus and P.aeruginosa was also noted. The lack of effect of therapy in 2 observations was due to the presence of antibiotic-resistant strains of microorganisms. The optimal duration of treatment of adult patients with ONBO and exacerbation of CNBO with Tsiprolet should be from 7 to 10 days of daily twice-daily dosing at a dose of 500 mg.

During the entire observation period, no adverse events or adverse reactions associated with the medications used were reported in any patient.

Thus, the drug Tsiprolet (500 mg every 12 hours for 7-10 days) is an effective and safe treatment for ONBO and exacerbations of CNBO caused by bacterial flora, accompanied by severe diffuse swelling of the skin of the cartilaginous part of the external auditory canal, which complicates the use of topical antibacterial agents.

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