Tsiprinol, 500 mg, film-coated tablets, 10 pcs., KRKA buy in Moscow at a low price

Pharmacological properties of the drug Tsiprinol

A synthetic antibacterial drug with a broad spectrum of action from the fluoroquinolone group, which has a bactericidal effect. Tsiprinol acts both on microorganisms that are in the process of rapid growth, and on microorganisms that are in the resting phase. The antimicrobial activity of ciprofloxacin is due primarily to the presence of a cyclopropane ring at the 1st position, a fluorine ring at the 6th position, and a piperazine ring at the 7th position. The mechanism of action of ciprofloxacin in all phases of the cell cycle is due to the inhibition of subunit A of bacterial DNA gyrase, the enzyme responsible for bacterial DNA replication. The drug has a bactericidal effect on most gram-negative and some gram-positive microorganisms, including those resistant to other antibacterial drugs. are sensitive to ciprofloxacin in vitro : enterobacteria - E. coli , Shigella spp ., Salmonella spp ., Citrobacter spp ., Klebsiella spp ., Enterobacter spp ., Proteus mirabilis and vulgaris , Serratia marcescens, Hafnia alvei, Edwardsiella tarda, Providencia spp., Morganella morganii, Vibrio spp., Yersinia spp.; other gram-negative bacteria - Aeromonas spp., Plesiomonas shigelloides, Pasteurella multocida, Haemophilus spp., Campylobacter jejuni, Pseudomonas aeruginosa, Neisseria spp., Moraxella (Branhamella) catarrhalis ; some intracellular pathogens - Legionella pneumophila, Brucella spp., Chlamydia trachomatis, Listeria monocytogenes, Mycobacterium tuberculosis, Mycobacterium kansasii, Mycobacterium avium-intracellulare . in vitro sensitivity of the following gram-positive bacteria has been confirmed: Streptococcus spp. (S. pyogenes, S. agalactiae) ; Staphylococcus spp. (S. aureus, S. haemolyticus, S. hominis and S. saprophyticus ), Bacilus anthracis. The sensitivity of Enterococcus faecalis and Streptococcus pneumoniae is moderate. Bacteria from the group Corynebacterium spp., Bacteroides fragilis, Pseudomonas cepacia and maltophilia, Ureaplasma urealyticum, Clostridium difficile, Nocardia asteroides, Streptococcus faecalis and Treponema pallidum are resistant to ciprofloxacin. The manifestation of bacterial resistance usually indicates cross-resistance to all quinolones and is caused by a decrease in the permeability of the bacterial membrane to the drug, as well as a mutation in the A subunit of DNA gyrase, as a result of which the sensitivity of the bacterium to ciprofloxacin decreases (thus explaining the development of resistance in P. aeruginosa ). Resistance is most often detected in infections caused by Pseudomonas aeruginosa and certain strains of Staphylococcus aureus . In vitro , a synergistic effect has been established between ciprofloxacin and other antibiotics, such as imipenem, against P. aeruginosa , as well as mezlocillin, cefoxitin and clindamycin against B. fragilis , azlocillin against P. aeruginosa and ceftizoxime against P. aeruginosa and S. marcescens . The minimum inhibitory concentration (MIC90) of ciprofloxacin in vitro against the most sensitive bacteria to it is: for Enterobacter cloacae ( E. coli, Enterobacter spp., Citrobacter spp., Klebsiella spp., Proteus spp.) - 0.005–1 mg/l; Providencia spp . — 0.015–3.12 mg/l; Salmonella spp . — 0.015–0.25 mg/l; Serratia marcescens - 0.06–1 mg/l; Shigella spp . — 0.002–0.25 mg/l; Yersinia enterocolitica - 0.015–0.25 mg/l; Acinetobacter calcoaceticus - 0.25–1 mg/l; Neisseria gonorrhoeae - 0.002–0.03 mg/l; Neisseria meningitidis - 0.005–0.015 mg/l; Haemophilus influenzae - 0.007–0.05 mg/l; Pseudomonas aeruginosa - 0.12–4 mg/l; Pseudomonas spp. - 0.25–16 mg/l. The maximum concentration of the drug in the blood plasma is achieved 0.5–1.8 hours after oral administration. Food intake may alter the time to reach maximum plasma concentration but does not affect AUC. The volume of equilibrium distribution of ciprofloxacin after oral or intravenous administration is 1.74–5 l/kg body weight, which indicates good penetration of ciprofloxacin into tissues. The drug in therapeutic concentration accumulates in the bronchial mucosa, lung tissue, pleural exudate, liver and kidney parenchyma, bile, peritoneal fluid, genitals, prostate gland, bones, synovial tissue and fluid, skin and anterior ocular chamber. The highest concentration of ciprofloxacin is determined in the liver, gall bladder, bile, kidneys and prostate secretions. The concentration of the drug in the cerebrospinal fluid is in most cases lower than the concentration in the blood serum, but may increase with meningitis. Ciprofloxacin penetrates the placental barrier and enters breast milk. The drug is excreted from the body mainly through urine. After 48 hours, 30 to 50% of ciprofloxacin is excreted unchanged by the kidneys.

Tsiprinol 500 mg 10 pcs. film-coated tablets

pharmachologic effect

Antimicrobial agent, fluoroquinolone.

Composition and release form Tsiprinol 500 mg 10 pcs. film-coated tablets

Tablets - 1 tablet:

Active substance: ciprofloxacin in the form of ciprofloxacin hydrochloride monohydrate 291 mg and 582 mg (which corresponds to ciprofloxacin - 250 mg, 500 mg);
Excipients: microcrystalline cellulose, sodium carboxymethyl starch (type A), povidone, croscarmellose sodium, colloidal anhydrous silicon dioxide, magnesium stearate;
Shell: hypromellose, talc, titanium dioxide, E171, propylene glycol.

10 tablets in a blister. 1 blister in a cardboard box along with instructions for use.

Description of the dosage form

Oval, biconvex tablets with a notch on one side, white film-coated.

Characteristic

A broad-spectrum antimicrobial drug from the group of fluoroquinolones.

Directions for use and doses

Orally, 0.25 g 2-3 times a day, for severe infection - 0.5-0.75 g 2 times a day (every 12 hours). The drug should be taken on an empty stomach, the tablets should be swallowed whole with a sufficient amount of liquid. The dose of ciprofloxacin depends on the severity of the disease, type of infection, body condition, age, weight and kidney function of the patient.

Recommended dosage regimens:

uncomplicated kidney and urinary tract infections: 250 mg, and for complicated infections - 500 mg 2 times a day; course of treatment of uncomplicated infections of the lower urinary tract - 3 days; complicated urinary tract infections - 7-10 days;
chronic prostatitis: 500 mg 2 times a day, treatment duration - 28 days;
infectious and inflammatory diseases of the lower respiratory tract of moderate severity - 250 mg - 500 mg, and in more severe cases 750 mg, 2 times a day;
acute gonorrhea: a single dose of ciprofloxacin at a dose of 250 mg - 500 mg; when a gonococcal infection is combined with chlamydial and mycoplasma - 750 mg every 12 hours for 7-10 days;
chancroid: 0.5 g 2 times a day for several days;
S.typhi bacteria carriage: 250 mg 2 times a day; course of treatment up to 4 weeks. If necessary, a single dose can be increased to 500 mg or 750 mg;
severe infections (osteomyelitis, abdominal infections) - 750 mg 2 times a day. The duration of therapy for osteomyelitis can be up to 2 months;
gastrointestinal infections caused by Staphylococcus aureus - 750 mg every 12 hours for 7-28 days;
treatment of traveler's diarrhea: 500 mg 2 times a day, duration from 5 to 7 days, in some cases - up to 14 days;
infections of the ear, nose and throat: moderate severity 250-500 mg 2 times a day, severe 500-750 mg 2 times a day;
in the treatment of complications caused by Pseudomonas aeruginosa in children with cystic fibrosis of the lungs from 5 to 17 years old, the recommended dose of ciprofloxacin is 20 mg/kg body weight 2 times a day (maximum dose 1500 mg). Duration of treatment is 10-14 days;
prevention of infections during surgical interventions: from 500 to 750 mg of Tsiprinol is prescribed 1-1.5 hours before surgery;
treatment and prevention of anthrax in patients: 500 mg of Tsiprinol 2 times a day in adults and 15 mg per kg of body weight of Tsiprinol in children 2 times a day. The drug should be started immediately after suspected or confirmed infection. At the beginning of treatment, the use of parenteral forms is recommended. The total duration of therapy is 60 days.

The duration of treatment depends on the severity of the disease, but treatment should always continue for at least three more days after the temperature has returned to normal. Usually the duration of treatment is 7-10 days.

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

Dosage for CRF (chronic renal failure):

Creatinine clearance >50 ml/min is the usual dosage regimen.
Creatinine clearance 30-50 ml/min - 250-500 mg once every 12 hours.
Creatinine clearance 5-29 ml/min - 250-500 mg once every 18 hours.
Patients on hemodialysis or peritoneal dialysis - 250-500 mg 1 time per 24 hours.

Pharmacodynamics

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. 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 gyrase inhibitors, which makes it highly effective against bacteria that are resistant, for example, to aminoglycosides, penicillins, cephalosporins, tetracyclines and many other antibiotics. Ciprofloxacin acts both on microorganisms that are reproducing and 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 (located intracellularly).

Gram-positive aerobic bacteria are also sensitive to ciprofloxacin: 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 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 drug. The effect of the drug against Treponema pallidum has not been sufficiently studied.

Bacillus anthracis is also sensitive to ciprofloxacin both in vitro and in vivo.

Pharmacokinetics

When taken orally, ciprofloxacin is rapidly absorbed from the gastrointestinal tract. Eating slows down absorption but does not change maximum concentration or bioavailability. The bioavailability of the drug is 50-85%. The maximum concentration of the drug in the blood serum of healthy volunteers when taken orally (before meals) 250, 500, 750 and 1000 mg of the drug is achieved after 1-1.5 hours and is 1.2; 2.4; 4.3 and 5.4 μg/ml, respectively.

Orally taken ciprofloxacin is well distributed in tissues and body fluids. High concentrations of the drug are observed in bile, lungs, kidneys, liver, gall bladder, uterus, seminal fluid, prostate tissue, tonsils, endometrium, fallopian tubes and ovaries. The concentration of the drug in these tissues is higher than in the serum. Ciprofloxacin also penetrates well into bones, eye fluid, bronchial secretions, saliva, skin, muscles, pleura, peritoneum, and lymph. 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 the placenta well. The concentration of ciprofloxacin in blood neutrophils is 2-7 times higher than in serum.

The volume of distribution in the body is 2-3.5 l/kg. The degree of binding of ciprofloxacin to plasma proteins is 30%.

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

The main route of excretion of ciprofloxacin from the body is the kidneys (50-70%). From 15 to 30% is excreted through the intestines. In patients with unchanged renal function, the half-life is usually 3-5 hours. In case of chronic renal failure, it increases to 12 hours. A small amount is excreted in breast milk.

Indications for use Tsiprinol 500 mg 10 pcs. film-coated tablets

Infectious and inflammatory diseases caused by microorganisms sensitive to ciprofloxacin:

respiratory tract: pneumonia (except for pneumococcal pneumonia), acute bronchitis and exacerbation of chronic bronchitis, bronchiectasis, cystic fibrosis (if the causative agent is gram-negative bacteria, especially Pseudomonas aeruginosa);
ear, nose and throat: acute otitis media, sinusitis, mastoiditis;
kidneys and urinary tract: uncomplicated and complicated infections of the lower and upper urinary tract (urethritis, cystitis, pyelonephritis);
pelvic and genital organs (epididymitis, prostatitis, salpingitis, endometritis, oophoritis, tubular abscess and pelvioperitonitis, gonorrhea, chancroid, chlamydia);
abdominal organs: intraperitoneal abscess; cholecystitis, cholangitis (in combination with metronidazole or clindamycin), infectious diarrhea: salmonellosis, campylobacteriosis, yersiniosis, shigellosis, cholera, typhoid fever, travelers' diarrhea, Salmonella typhi carriage;
skin and soft tissues: infected ulcers, infected wounds, abscesses, cellulitis, infections of the external auditory canal, infected burns;
musculoskeletal system: osteomyelitis, septic arthritis;
infections in patients with reduced immunity (during treatment with immunosuppressants or in patients with neutropenia).

Prevention of infections during surgical interventions (urological, gastrointestinal (in combination with metronidazole) and orthopedic).

Prevention and treatment of pulmonary anthrax.

Contraindications

Hypersensitivity to ciprofloxacin or other drugs from the quinolone group or any other component of the drug.

Pregnancy and lactation period.

Children and adolescents up to 18 years of age (except for the treatment of complications caused by Pseudomonas aeruginosa in children with cystic fibrosis of the lungs in children from 5 to 17 years of age; prevention and treatment of pulmonary anthrax).

Concomitant use with tizanidine (risk of a pronounced decrease in blood pressure (BP), drowsiness).

Carefully:

Severe cerebral atherosclerosis, cerebrovascular accident, mental illness, epileptic syndrome, epilepsy, severe renal and/or liver failure, old age, glucose-6-dehydrogenase deficiency, glucocorticosteroid therapy.

Application Tsiprinol 500 mg 10 pcs. film-coated tablets during pregnancy and breastfeeding

The drug should not be prescribed during pregnancy and lactation.

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 tenosynovitis appear, treatment should be discontinued due to the fact that isolated cases have been described (mainly in elderly patients simultaneously receiving glucocorticosteroids) of inflammation and even tendon rupture during treatment with fluoroquinolones. During therapy with ciprofloxacin, it is recommended to avoid excessive physical activity.

During treatment with ciprofloxacin, in order to avoid the development of crystalluria, exceeding the recommended daily dose is unacceptable. It is also necessary to ensure that a sufficient amount of fluid is taken (under the control of diuresis) to maintain normal diuresis and maintain acidic urine.

During treatment with ciprofloxacin, ultraviolet radiation (including contact with direct sunlight) should be avoided.

During the period of therapy, an increase in the prothrombin index is possible (during surgical interventions, the state of the blood coagulation system should be monitored).

In patients with glucose-6-dehydrogenase deficiency, the administration of ciprofloxacin may cause the development of hemolytic anemia.

During treatment, patients should not drink alcohol.

Impact on the ability to drive vehicles and operate machinery

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 when consuming alcohol at the same time).

Overdose

Symptoms: nausea, vomiting, diarrhea, headache and dizziness, liver and kidney disorders, crystalluria and hematuria, and in more severe cases, confusion, tremors, hallucinations and convulsions.

Treatment: symptomatic, gastric lavage, administration of activated charcoal and laxatives; ensure sufficient fluid supply. A specific antidote is unknown. Hemodialysis has no clinical effect in case of intoxication.

Side effects Tsiprinol 500 mg 10 pcs. film-coated tablets

From the central and peripheral nervous system: dizziness, headache, increased fatigue, agitation, convulsions, anxiety, tremor, insomnia, nightmares, peripheral paralgesia (anomaly in the perception of pain), hyperesthesia, hypoesthesia, sweating, increased intracranial pressure, confusion, depression, hallucinations, as well as other manifestations of psychotic reactions (occasionally progressing to states in which the patient can harm himself, with suicidal tendencies), migraine.

From the senses: impaired taste and smell, loss of taste (transient), visual impairment (diplopia, changes in color vision), tinnitus, hearing loss, transient deafness (especially for high frequencies).

From the cardiovascular system: tachycardia, heart rhythm disturbances, decreased blood pressure (BP), fainting, a feeling of “flushes” of blood to the skin of the face, thrombosis of the cerebral arteries, peripheral edema.

From the hematopoietic system: leukopenia, granulocytopenia, anemia, thrombocytopenia, leukocytosis, thrombocytosis, hemolytic anemia, pancytopenia, agranulocytosis, inhibition of bone marrow hematopoiesis.

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

Allergic reactions: skin itching, urticaria, blistering accompanied by bleeding and small nodules forming scabs, drug fever, pinpoint hemorrhages (petechiae), swelling of the face or larynx, shortness of breath, eosinophilia, vasculitis, exanthema, erythema nodosum, exudative erythema multiforme, syndrome Stevens-Johnson (malignant exudative erythema), toxic epidermal necrolysis (Lyell's syndrome), anaphylactic shock, serum sickness.

From the musculoskeletal system: arthralgia, arthritis, tenosynovitis, tendon ruptures, myalgia, swelling in the joint area.

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

Laboratory parameters: hypoprothrombinemia, increased activity of liver transaminases and alkaline phosphatase, hypercreatininemia, hyperbilirubinemia, hyperuricemia, hyperglycemia.

Drug interactions

With 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. Due to a decrease in the activity of microsomal oxidation processes in hepatocytes, it increases the concentration and lengthens the half-life of theophylline and/or caffeine (and other xanthines), oral hypoglycemic drugs (glibenclamide - which can lead to hypoglycemia), indirect anticoagulants, and helps reduce the prothrombin index.

Concomitant use with non-steroidal anti-inflammatory drugs (excluding acetylsalicylic acid) increases the risk of developing seizures.

Simultaneous use of antacids, sucralfate, as well as drugs containing aluminum, zinc, calcium, iron or magnesium ions may cause a decrease in the absorption of ciprofloxacin, therefore Tsiprinol CP must be taken 2 hours before taking antacids or 6 hours after taking them.

With the simultaneous use of ciprofloxacin and cyclosporine, the nephrotoxic effect of cyclosporine is enhanced (it is necessary to monitor blood creatinine levels 2 times a week).

Concomitant use of ciprofloxacin and glucocorticosteroids may increase the risk of tendon rupture.

The simultaneous administration of ciprofloxacin and phenytoin may lead to an increase or decrease in the serum concentration of phenytoin. Metoclopramide accelerates the absorption of ciprofloxacin, which leads to a decrease in the time to reach its maximum concentration in the blood plasma.

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: the drug 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.

Concomitant use of probenecid and ciprofloxacin reduces the renal clearance of ciprofloxacin, increasing its plasma concentrations.

Concomitant administration of ciprofloxacin and mexiletine may lead to increased concentrations of mexiletine.

When used simultaneously with ciprofloxacin, the tubular transport of methotrexate is reduced, which could potentially lead to an increase in its plasma concentrations. This increases the risk of toxic effects of methotrexate. Patients receiving methotrexate therapy should be under close medical supervision during treatment with ciprofloxacin.

Indications for use of the drug Tsiprinol

Adults Uncomplicated and complicated infections caused by pathogens sensitive to ciprofloxacin:

respiratory tract infections; 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, gall bladder 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);
selective intestinal decontamination during treatment with immunosuppressants.

Children As a second or third line drug, it is used for the treatment of complicated urinary tract infections and pyelonephritis caused by E. coli in children aged 1–17 years, as well as for the treatment of exacerbations of respiratory system diseases caused by Pseudomonas aeruginosa in children with cystic fibrosis of the lungs aged 5–17 years. Adults and children Reduced risk of developing or progressing anthrax after aerogenic exposure to Bacillus anthracis .

Use of the drug Tsiprinol

The following doses are recommended: uncomplicated urinary tract infections and gonorrhea : 125 mg 2 times a day; complicated urinary tract infections and respiratory tract infections : 250–500 mg 2 times a day; severe infections, recurrent infections in patients with cystic fibrosis, infections of the abdominal organs, bones and joints caused by Pseudomonas or staphylococci, with peritonitis and septicemia, as well as with acute pneumonia caused by Streptococcus pneumoniae: the dose should be increased to 750 mg 2 times a day. The maximum daily dose is 1500 mg. When treating outpatients with pneumonia caused by Pneumococcus , ciprofloxacin should not be used as the first choice drug. The tablets should be swallowed without chewing and washed down with a small amount of liquid. The drug can be taken regardless of meals, however, taking it on an empty stomach accelerates the absorption of ciprofloxacin. If the patient’s condition does not allow taking tablets, it is recommended to carry out parenteral therapy with ciprofloxacin infusion solution, and after the patient’s condition improves, proceed to treatment with the tablet form of the drug. Elderly patients should be prescribed lower doses of ciprofloxacin based on the severity of the disease and creatinine clearance (for example, with a creatinine clearance of 30-50 ml/min, the recommended dose of ciprofloxacin is 250-500 mg every 12 hours). to children is permissible only after a careful assessment of the risk/benefit ratio due to the likelihood of developing side effects from the joints and/or periarticular tissues. Treatment of children in clinical trials was carried out only for the indications listed above. Clinical experience with ciprofloxacin in children for other indications is limited. The following dosage regimen should be followed:

for complications of pulmonary cystic fibrosis caused by Pseudomonas aeruginosa , children aged 5–17 years are prescribed 20 mg/kg body weight orally 2 times a day. The maximum daily dose is 1500 mg. The duration of treatment is 10–14 days.
for urinary tract infections or pyelonephritis, the dose should be 6–10 mg/kg body weight every 8 hours, but not more than the maximum dose of 400 mg, or 19–20 mg/kg body weight every 12 hours, but not more than the maximum dose of 750 mg.

To reduce the risk of occurrence or progression of anthrax after aerogenic contact with Bacillus anthracis , the dose for adults is 500 mg 2 times a day, for children - 15 mg/kg body weight 2 times a day. Do not exceed the maximum single dose of 500 mg and the maximum daily dose of 1000 mg. The drug should be taken immediately after infection is suspected or confirmed. The total duration of use of ciprofloxacin for pulmonary anthrax is 60 days. Renal dysfunction. With a creatinine clearance of 31–60 ml/min/1.73 m2 or a plasma creatinine concentration of 1.4–1.9 mg/100 ml, the maximum daily dose of ciprofloxacin for oral use should be 1000 mg. For creatinine clearance ≤30 ml/min/1.73 m2 or plasma creatinine concentration ≥2 mg/100 ml, the maximum daily oral dose of ciprofloxacin should be 500 mg. Renal dysfunction + hemodialysis. For creatinine clearance ≤30 ml/min/1.73 m2 or plasma creatinine concentration ≥2 mg/100 ml, the maximum daily oral dose of ciprofloxacin should be 500 mg; on days of hemodialysis, ciprofloxacin is taken after the procedure. Impaired renal function + peritoneal dialysis in outpatients: 1 tablet of 500 mg ciprofloxacin or 2 tablets of 250 mg. Liver dysfunction. There is no need for dose adjustment. The duration of treatment depends on the severity of the disease, clinical course and results of bacteriological studies. It is recommended to continue treatment for at least 3 days after the temperature normalizes or clinical symptoms disappear. 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 reaches 7 days. For osteomyelitis, the course of therapy can be extended to 2 months. For other infections, the duration of treatment is usually 7–14 days. In immunocompromised patients, treatment is carried out throughout the entire period of neutropenia. For infections caused by streptococci and chlamydia, treatment should last at least 10 days.

Tsiprinol, 10 pcs., 500 mg, film-coated tablets

Directions for use and doses

It is prescribed intravenously, it can be administered intravenously, but drip administration is more preferable for 30 minutes (200 mg) and 60 minutes (400 mg). Before use, 1 ampoule of concentrate for preparing a solution for infusion must be diluted with an adequate amount of infusion solution: 0.9% sodium chloride solution, Ringer's solution, 5% and 10% dextrose solution, 10% solution

P N014323/02-220708

fructose, as well as a solution containing a 5% dextrose solution with 0.225% or 0.45%

sodium chloride solution to a minimum volume of 50 ml.

The dose of ciprofloxacin depends on the severity of the disease, type of infection, condition

the patient's body, age, weight and kidney function. Typically recommended doses:

for intravenous administration single dose - 200 mg (for severe infections - 400 mg), multiplicity

administration - 2 times a day.

If IV treatment is necessary for particularly severe, life-threatening or

recurrent infections caused by Pseudomonas spp., staphylococci or

Streptococcus pneumoniae; sepsis, peritonitis, bone and joint infections, dose may

be increased to 0.4 g with a frequency of administration up to 3 times a day.

For acute uncomplicated gonorrhea - once, 100 mg intravenously.

For the prevention of postoperative infections - 30 - 60 minutes before surgery iv 200 -

400 mg; for long-term surgery over 4 hours, re-administer the same dose.

Average duration of treatment: 1 day - for acute uncomplicated gonorrhea; up to 7

days - for infections of the kidneys, urinary tract and abdominal cavity; throughout

during the neutropenic phase - in patients with weakened defenses

body; but no more than 2 months - for osteomyelitis and 7-14 days - for all others

infections. For streptococcal infections due to the risk of late complications, and

Also, for chlamydial infections, treatment should continue for at least 10 days. U

Patients with immunodeficiency are treated throughout the entire period of neutropenia.

Treatment should be continued for at least 3 more days after body temperature normalizes.

or disappearance of clinical symptoms.

For elderly patients, the dose is reduced by 30%.

With a glomerular filtration rate (CC 31-60 ml/min/1.73 sq.m or serum

creatinine concentrations from 1.4 to 1.9 mg 100 ml) maximum daily dose - 800 mg.

Patients with severe renal failure (creatinine clearance below 30 ml/min/1.73 sq. m;

creatinine concentration above 2 mg/100 ml) it is necessary to prescribe half the daily

doses, maximum daily dose - 400 mg. For peritonitis in patients on

ambulatory peritoneal dialysis, possible intraperitoneal administration

ciprofloxacin at a dose of 50 mg 4 times a day per 1 liter of dialysate.

The solution for infusion can be combined with 0.9% sodium chloride solution, solution

Ringer's, 5% and 10% dextrose solution, 10% fructose solution, as well as a solution

containing a 5% dextrose solution with 0.225% or 0.45% sodium chloride solution.

After IV use, you can continue treatment orally. .

For pulmonary anthrax (prevention and treatment):

Adults: 400 mg IV 2 times a day

Children (5 to 17 years): 10 mg/kg body weight 2 times a day. Should not exceed

the maximum single dose is 400 mg IV (maximum daily dose is 800 mg).

Treatment should begin immediately after suspected or confirmed

infection. The total duration of treatment with ciprofloxacin for pulmonary

form of anthrax is 60 days.

In the treatment of complications caused by Pseudomonas aeruginosa in children with cystic fibrosis

lungs from 5 to 17 years, the recommended dose of ciprofloxacin is 10 mg/kg every 8

h (no more than 400 mg IV every 8 hours). Duration of treatment is 10-14 days.

Side effect

From the digestive system: nausea, diarrhea, vomiting, abdominal pain, flatulence, anorexia, cholestatic jaundice (especially in patients with previous liver diseases), hepatitis, hepatonecrosis, pseudomembranous colitis. From the central and peripheral nervous system: dizziness, headache, fatigue, agitation, convulsions, anxiety, tremor, insomnia, nightmares, peripheral paralgesia (anomaly of perception

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feelings of pain), sweating, increased intracranial pressure, confusion,

depression, hallucinations, as well as other manifestations of psychotic reactions (occasionally

progressing to conditions in which the patient may harm himself, with

suicidal tendencies), migraine, fainting, cerebral thrombosis

arteries.

From the senses: impaired taste and smell, visual impairment (diplopia,

changes in color perception), tinnitus, hearing loss.

From the cardiovascular system: tachycardia, heart rhythm disturbances,

decreased blood pressure (BP), a feeling of “flushes” of blood to the skin of the face.

From the hematopoietic system: leukopenia, granulocytopenia, anemia,

thrombocytopenia, leukocytosis, thrombocytosis, hemolytic anemia.

From the urinary system: hematuria, crystalluria (primarily with

alkaline urine and low diuresis), glomerulonephritis, dysuria, polyuria, urinary retention,

albuminuria, urethral bleeding, decreased nitrogen excretory function of the kidneys,

interstitial nephritis.

Allergic reactions: skin itching, hives, blistering,

accompanied by bleeding and small nodules that form scabs,

drug fever, pinpoint hemorrhages (petechiae), swelling of the face or larynx,

shortness of breath, eosinophilia, vasculitis, exanthema, erythema nodosum, exudative

erythema multiforme, Stevens-Johnson syndrome (malignant exudative

erythema), toxic epidermal necrolysis (Lyell's syndrome), anaphylactic

shock.

From the musculoskeletal system: arthralgia, arthritis, tenosynovitis, ruptures

tendons, myalgia, swelling in the joint area.

Other: general weakness, sweating, superinfections (candidiasis), increased

photosensitivity

Laboratory parameters: hypoprothrombinemia, increased activity

“liver” transaminases and alkaline phosphatase, hypercreatininemia,

hyperbilirubinemia, hyperuricemia, hyperglycemia.

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

Overdose

Symptoms: nausea, vomiting, diarrhea, headache and dizziness, and in more severe cases

cases of confusion, tremors, hallucinations and convulsions.

Treatment: symptomatic, ensure sufficient fluid intake.

A specific antidote is unknown. Hemodialysis has no clinical effect in

intoxication.

Interaction with other drugs

Due to a decrease in the activity of microsomal oxidation processes in hepatocytes, it increases the concentration and lengthens the half-life of theophylline and/or caffeine (and other xanthines), oral hypoglycemic drugs (glibenclamide - which can lead to hypoglycemia), indirect anticoagulants (warfarin, etc.), promotes decrease in prothrombin index (risk of bleeding).

Ciprofloxacin increases Cmax by 7 times (from 4 to 21 times) and AUC by 10 times (from 6 to 24 times) of tizanidine, which increases the risk of a pronounced decrease in blood pressure and drowsiness. Concomitant use with non-steroidal anti-inflammatory drugs (excluding acetylsalicylic acid) increases the risk of developing seizures. With the simultaneous use of ciprofloxacin and cyclosporine, the nephrotoxic effect of cyclosporine is enhanced (it is necessary to monitor blood creatinine levels 2 times a week).

P N014323/02-220708

Concomitant use of ciprofloxacin and glucocorticosteroids may increase the risk of tendon rupture.

The simultaneous administration of ciprofloxacin and phenytoin can lead to

increase or decrease in serum concentration of phenytoin.

Co-administration of uricosuric drugs leads to a slower elimination

(up to 50%) and increased plasma concentrations of ciprofloxanine.

When combined with other antimicrobial drugs (beta-lactams,

aminoglycosides, clindamycin, metronidazole) synergism is usually observed: the drug

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.

The infusion solution is pharmaceutically incompatible with all infusion devices.

solutions and drugs that are physico-chemically unstable in

acidic environment (pH of ciprofloxacin infusion solution - 3.5 - 4.6).

special instructions

Patients with epilepsy, a history of seizures, vascular diseases and

organic brain damage due to the risk of developing adverse reactions with

parts of the central nervous system, ciprofloxacin should be prescribed only

vital indications.

If severe and

prolonged diarrhea, 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 appear

Tenosynovitis treatment should be discontinued due to the fact that isolated cases have been described

inflammation (mainly in elderly patients simultaneously receiving

glucocorticosteroids) and even tendon rupture during treatment with fluoroquinolones.

During therapy with ciprofloxacin, it is recommended to avoid excessive physical activity.

loads

During treatment with ciprofloxacin, in order to avoid the development of crystalluria, it is unacceptable

exceeding the recommended daily dose. It is also necessary to ensure reception

sufficient fluid (under diuresis control) to maintain normal

diuresis and maintaining acidic urine.

During treatment with ciprofloxacin, ultraviolet radiation should be avoided (in

including contact with direct sunlight).

During the therapy period, an increase in the prothrombin index is possible (during

surgical interventions, the state of the coagulation system should be monitored

blood).

With the simultaneous administration of ciprofloxacin and a drug for general

anesthesia from the group of barbituric acid derivatives requires constant

control of heart rate (HR), blood pressure, ECG.

In patients with glucose-6-phosphate dehydrogenase deficiency, the administration of Tsiprinol may

cause the development of hemolytic anemia.

During treatment, patients should not drink alcohol.

Impact on the ability to drive vehicles and other mechanisms

Patients taking ciprofloxacin should be careful when

driving a car and engaging in other potentially dangerous activities that require increased attention and speed of psychomotor reactions (especially while drinking alcohol).

P N014323/02-220708

Release form

Concentrate for solution for infusion, 10 mg/ml.

10 ml in ampoules made of neutral transparent glass. A colored dot is applied to the ampoule at the fracture site. 5 ampoules in a blister or 5 ampoules in a plastic blister pack. 1 blister or 1 plastic blister pack in a cardboard box along with instructions for use.

Storage conditions

Store 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

4 years.

Do not use after expiration date.

Conditions for dispensing from pharmacies

On prescription.

Manufacturer: KRKA, d.d., Novo Mesto, Šmarješka cesta 6, 8501 Novo Mesto, Slovenia

For any questions, please contact the Representative Office in the Russian Federation:

123022, Moscow, 2nd Zvenigorodskaya st., 13, building 41 Tel. (495) 739-66-00, fax

When packaging and/or packaging at a Russian enterprise, the following is indicated:

LLC "KRKA-RUS", 143500, Russia, Moscow region, Istra, st. Moskovskaya, 50

Tel.: (495)994-70-70

Fax

JSC "VECTOR-MEDICA", 630559 Russia, Koltsovo village, Novosibirsk region, tel./fax

M.O.1

. Director IDKELS tZs J&K? At A.N. Vasiliev

Representative of the company O.A. Tsibulskaya

Side effects of the drug Tsiprinol

Adverse reactions that may occur during the use of ciprofloxacin are classified into the following groups according to frequency:

very often 1/10,
often 1/100, ≤1/10,
uncommon 1/1,000, ≤1/100,
rarely 1/10,000, ≤1/1,000,
very rare ≤1/10,000, including isolated cases.

The frequency of adverse reactions is classified according to organ systems. From the blood and lymphatic systems: infrequently - eosinophilia, leukopenia; rarely - anemia, granulocytopenia, leukocytosis, altered prothrombin levels, thrombocytopenia, thrombocytosis; very rare, including isolated cases - hemolytic anemia, pancytopenia, agranulocytosis, suppression of bone marrow function. From the nervous system: infrequently - headache, dizziness, fatigue, insomnia, agitation, confusion; rarely - hallucinations, perspiration, paresthesia, feeling of fear, nocturnal delirium, depression, tremor, convulsions, hypoesthesia; very rare, including isolated cases - lability of behavior, psychosis, increased intracranial pressure, ataxia, hyperesthesia, convulsive contractions. From the senses: infrequently - changes in taste and blurred vision; rarely - tinnitus, transient deafness (especially for high frequencies), visual impairment (diplopia, impaired color perception); very rarely, including isolated cases - loss of taste (usually transient). From the cardiovascular system: rarely - tachycardia, migraine, loss of consciousness, hot flushes and perspiration, peripheral edema; very rarely, including isolated cases - vasculitis. From the respiratory system: rarely - shortness of breath, laryngeal edema. From the gastrointestinal tract and hepatobiliary system: often - nausea, diarrhea; uncommon - vomiting, abdominal pain, flatulence, anorexia; rarely - cholestatic jaundice, pseudomembranous colitis; very rarely, including isolated cases - hepatitis (liver failure occurs exclusively, which is life-threatening). From the skin and subcutaneous tissues: often - rash; uncommon - itching, maculopapular rash, urticaria; rarely - photosensitivity reactions; very rare, including isolated cases - petechiae, papules, hemorrhagic cysts, crusts/scabs (as a result of vasculitis), erythema multiforme, erythema nodosum, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome). From the musculoskeletal system: infrequently - arthralgia; rarely - myalgia, joint swelling; very rare, including isolated cases - tendonitis (especially Achilles tendinitis), tendon rupture, myasthenia gravis. From the kidneys and urinary tract: rarely - interstitial nephritis, transient renal failure, hematuria and crystalluria. General disorders: infrequently - a feeling of weakness, prolonged use can lead to excessive growth of resistant bacteria and fungi (pseudomembranous colitis, candidiasis); rarely - hypersensitivity reactions, drug-induced increase in body temperature, anaphylactic reactions (facial swelling, angioedema, difficulty breathing, threat of shock), which may occur after the first dose, pain in the limbs, back and sternum; very rarely, including isolated cases - reactions similar to serum sickness, exacerbation of myasthenia gravis. Laboratory indicators: infrequently - increased activity of transaminases and alkaline phosphatase, increased levels of urea, creatinine and bilirubin in the blood plasma; rarely - hyperglycemia, crystalluria and hematuria; very rare, including isolated cases - increased levels of amylase and lipase. If severe side effects occur (especially in the case of hypersensitivity reactions, pseudomembranous colitis, central nervous system disorders, hallucinations or tendon pain), treatment should be discontinued.

Special instructions for the use of the drug Tsiprinol

Since taking ciprofloxacin can cause severe reactions from the central nervous system (convulsions, increased intracranial pressure, psychosis, depression, dizziness, impaired consciousness, nervousness), this drug should be prescribed with particular caution to elderly patients with impaired central nervous system function (epilepsy, decreased seizure threshold , history of convulsions, decreased cerebral circulation, apoplexy, mental disorders), patients with severe liver damage or any type of renal failure (the patient's condition may worsen) or kidney failure and glucose-6-phosphate dehydrogenase deficiency (can cause hemolytic anemia). It is known that the very first use of this drug can cause severe allergic reactions. Alkaline urine may promote the formation of urinary stones, so alkalinization of urine should be avoided during treatment with ciprofloxacin. Before treatment and during the use of ciprofloxacin, the patient must have adequate fluid intake. Patients with renal failure should reduce the dose or increase the interval between doses of the drug, depending on the severity of the failure. Patients should avoid exposure to direct sunlight during treatment with ciprofloxacin, as phototoxic reactions may develop. During treatment with the drug, an increase in the resistance of microorganisms may be observed. In case of severe and prolonged diarrhea, which may be a manifestation of pseudomembranous colitis, treatment with the drug should be discontinued. There are reports of cases of inflammation or even rupture of the tendon during treatment with quinolones. Although the causal relationship with this particular group of drugs has not been clearly established, it is recommended to stop taking the drug if pain occurs along the tendon or at the first sign of tendinitis. During treatment and immediately after its discontinuation, the patient should avoid excessive physical activity. During treatment, patients should not drink alcohol. During pregnancy and breastfeeding. There is not enough data regarding the use of ciprofloxacin during pregnancy. During pregnancy and lactation, the use of the drug is allowed only if the expected benefit outweighs the potential risk, for example, in the presence of aerogenic contact with Bacillus anthracis . There is a possibility of a negative effect of ciprofloxacin on the development of articular cartilage in the child’s body. Since ciprofloxacin passes into breast milk, the use of the drug is not recommended during breastfeeding. If treatment with ciprofloxacin is necessary, breastfeeding should be discontinued. Children. During the treatment of children and adolescents under 18 years of age (5–17 years), the use of the drug is allowed only for appropriate indications when the expected benefit outweighs the potential risk, for example, in the presence of aerogenic contact with Bacillus anthracis . The number of studies on the use of the drug in such patients is insufficient; the possibility of damage to articular cartilage during growth cannot be ruled out. An analysis of the safety data of ciprofloxacin in patients under 18 years of age with cystic fibrosis showed no cartilage or joint damage. There is no experience with the use of the drug in children with impaired renal or liver function. Impact on the ability to drive vehicles and operate other machinery . Usual doses of ciprofloxacin may reduce alertness, especially during treatment initiation, dose titration, or if alcohol is consumed during treatment with the drug. The ability to drive vehicles and operate other machinery may be reduced during treatment, of which the patient should be warned.

Instructions for use CIPRINOL®

Severe infectious diseases and mixed infectious processes caused by gram-positive and anaerobic pathogenic flora

Monotherapy with ciprofloxacin is not suitable for the treatment of severe infections and diseases that may be caused by gram-positive or anaerobic pathogenic flora. In these cases, ciprofloxacin should be prescribed simultaneously with other antibacterial drugs.

Streptococcal infection (including Streptococcus pneumoniae)

Ciprofloxacin is not recommended for the treatment of streptococcal infections due to lack of effectiveness.

Genital tract infections

Orchitis, epididymitis and pelvic diseases can be caused by fluoroquinolone-resistant Neisseria gonorrhoeae. Ciprofloxacin should be co-administered with other antibacterial drugs, unless ciprofloxacin-resistant Neisseria gonorrhoeae can be excluded. If clinical improvement is not observed within 3 days, then treatment should be reconsidered.

Intraperitoneal infectious diseases

There is limited data on the effectiveness of ciprofloxacin for the treatment of postoperative intraperitoneal infections.

Traveler's diarrhea

When choosing ciprofloxacin, it is necessary to take into account information about drug resistance of the relevant pathogenic microorganism in the country being visited.

Infectious diseases of bones and joints

Ciprofloxacin should be prescribed in combination with other antimicrobial drugs and only after a microbiological study.

anthrax

Use in humans is based on in vitro susceptibility studies and animal studies. Information on the use of the drug in humans is limited. The treating doctor should refer to national and/or international documents related to the treatment of the specified disease.

Children and teenagers

Treatment can only be prescribed by a specialist experienced in the treatment of cystic fibrosis and/or severe infectious diseases in children and adolescents. Safety data obtained from randomized, double-blind studies of ciprofloxacin in children have identified cases of possible drug-related arthropathy (identified by clinical signs and symptoms). The incidence of the disease over a one-year period was 9% and 5.7%. Treatment should be started only after assessing the benefit/risk ratio, because Adverse reactions related to joints may occur.

Bronchopulmonary infectious diseases

Clinical studies included children and adolescents. There are limited data regarding treatment in children aged 5 years and older.

Complicated urinary tract infections and pyelonephritis

Clinical studies included children and adolescents aged 1 to 17 years. Treatment with ciprofloxacin should be considered in cases where treatment with other drugs is not possible, and only after microbiological analysis.

Other specific severe infectious diseases

Ciprofloxacin is used in the treatment of other serious infectious diseases according to official guidelines or after a careful assessment of the benefit/risk ratio in cases where other treatment is not possible or after an unfavorable outcome of conventional treatment, and only after microbiological analysis.

Hypersensitivity

After taking a single dose of the drug, hypersensitivity reactions may occur, including anaphylactic and anaphylactoid reactions. If these reactions occur, it is necessary to stop taking the drug and prescribe appropriate conservative treatment.

Musculoskeletal system

Ciprofloxacin should not be used in patients with a history of tendon disease or quinolone-related disorders. However, in rare cases, ciprofloxacin may be prescribed to such patients for the treatment of certain severe infectious diseases after microbiological confirmation of the causative agent and assessment of the risk/benefit ratio. Because there have been isolated cases of tendinitis or tendon rupture during treatment with fluoroquinolones (primarily in elderly patients or in patients concomitantly taking corticosteroids), if any signs of this disease, for example, painful swelling or inflammation, the drug should be discontinued and immobilize the affected limb. Ciprofloxacin should also be used with caution in patients with myasthenia gravis.

Photosensitivity

Ciprofloxacin has been shown to cause photosensitivity reactions. Patients taking ciprofloxacin should avoid direct exposure to sunlight and UV radiation.

Nervous system

It is known that quinolones can initiate seizures and lower the seizure threshold. Ciprofloxacin should be used with caution in patients with diseases of the central nervous system that provoke seizures, and if these phenomena occur, the drug should be discontinued.

Cases of polyneuropathy (accompanied by neurological symptoms such as pain, burning, agitation) have been reported in patients receiving ciprofloxacin. If symptoms of this disease occur, including pain, burning, tinnitus, numbness and/or weakness, the drug should be discontinued to prevent the development of an irreversible condition.

The cardiovascular system

Since the use of ciprofloxacin has been associated with cases of QT prolongation, caution should be exercised when treating patients at risk of developing torsade de pointes (TdP).

Gastrointestinal tract

The presence of severe and persistent diarrhea during or after treatment with the drug (including several weeks after treatment) may indicate pseudomembranous colitis (life-threatening, possibly fatal), requiring immediate treatment. In such cases, ciprofloxacin should be immediately discontinued and appropriate treatment initiated. The use of antiperistaltic drugs in this situation is contraindicated.

Renal and urinary system

During treatment with ciprofloxacin, to avoid the development of crystalluria, it is necessary to ensure that the patient receives a sufficient amount of fluid.

Hepatobiliary system

Cases of liver necrosis and life-threatening liver failure associated with the use of ciprofloxacin have been reported. If any signs or symptoms of liver disease (such as anorexia, jaundice, dark urine, itching or a tense abdomen) appear, treatment with the drug should be stopped.

Glucose-6-phosphate dehydrogenase deficiency

In patients with glucose-6-phosphate dehydrogenase deficiency, the use of ciprofloxacin may cause hemolytic reactions. It is necessary to avoid prescribing the drug to such patients, except in cases where the potential benefit outweighs the possible risk. In this case, the potential for hemolysis should be monitored.

Resistance

During long-term therapy and in cases of treatment of nosocomial infections and/or infections caused by Staphylococcus spp. and Pseudomonas spp., there may be a potential risk for the release of ciprofloxacin-resistant bacteria.

Cytochrome P450

Ciprofloxacin inhibits CYP1A2, thereby causing an increase in serum concentrations of drugs metabolized by this enzyme (for example, theophylline, clozapine, ropinirole, tizanidine). Patients taking these drugs concomitantly with ciprofloxacin should be under medical supervision to identify clinical signs of overdose.

Tests

When assessing the results of bacteriological tests, the in vitro activity of ciprofloxacin against Mycobacterium tuberculosis should be taken into account.

Impact on the ability to drive vehicles and operate machinery

Ciprofloxacin may affect the patient's reaction speed, as a result of which the ability to drive a car or engage in other activities that require increased attention and speed of psychomotor reactions may be impaired. Patients taking the drug should be careful when performing these types of work (especially when consuming alcohol at the same time).

Drug interactions Tsiprinol

When ciprofloxacin is used in combination with antacids (containing aluminum, magnesium or calcium) or sucralfate, the absorption of ciprofloxacin is reduced. Therefore, it is recommended to use ciprofloxacin 4 hours before or 2–4 hours after the use of antacids or sucralfate. Medicines containing iron or zinc reduce the absorption of ciprofloxacin. The combined use of ciprofloxacin and theophylline may cause an increase in the concentration of theophylline in the blood serum and prolong its elimination time. Parallel administration of ciprofloxacin and cyclosporine increases the nephrotoxicity of cyclosporine. It is recommended to check serum theophylline and cyclosporine concentrations more frequently. The simultaneous use of ciprofloxacin and oral anticoagulants may increase bleeding time, so it is recommended to periodically monitor the prothrombin time. During treatment with ciprofloxacin, there is an increased risk of tendon rupture in patients receiving concurrent corticosteroid therapy. The combined administration of ciprofloxacin and phenytoin may lead to changes in the concentration of phenytoin in the blood serum. The drug should be prescribed with extreme caution when treating patients with diabetes mellitus, since the effect of oral hypoglycemic drugs (glibenclamide) may be enhanced and cause hypoglycemia. Concomitant use of NSAIDs (eg, fenbufen) and quinolones in very high doses may cause seizures.

Ciprinol®

Concomitant use with non-steroidal anti-inflammatory drugs (excluding acetylsalicylic acid) increases the risk of developing seizures.

With the simultaneous use of ciprofloxacin and cyclosporine, the nephrotoxic effect of cyclosporine is enhanced (it is necessary to monitor blood creatinine levels 2 times a week).

Concomitant use of ciprofloxacin and glucocorticosteroids may increase the risk of tendon rupture.

Concomitant use of probenecid and ciprofloxacin reduces the renal clearance of ciprofloxacin, increasing its plasma concentrations.

Concomitant administration of ciprofloxacin and mexiletine may lead to increased concentrations of mexiletine.