Tsiprobay - Instructions For Use, Price, Reviews, Tablets 500 Mg

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Tsiprobay

Tsiprobay: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. For violations of liver function
12. 12. In case of impaired renal function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Ciprobay

ATX code: J01MA02

Active ingredient: Ciprofloxacin (Ciprofloxacin)

Manufacturer: BAYER PHARMA (Germany)

Description and photo update: 2019-12-08

Tsiprobay is an antibacterial drug of the fluoroquinolone group.

Release form and composition

Dosage forms of release of Tsiprobay:

• solution for infusion: transparent, color - from slightly yellowish to colorless (in bottles of 50 or 100 ml, in a cardboard box 1 bottle);
• film-coated tablets: biconvex, color - white or almost white with a slightly yellowish tinge, shape (depending on the dosage 250/500 mg) - round or capsule; on one side of the risk tablet, on one side of which is CIP embossing, on the other - the indication of the dosage "250" or "500"; on the other side of the tablet there is an embossed image of the manufacturer's logo - the BAYER cross (in blisters of 10 pcs., in a cardboard box 1 blister).

Composition of 1 ml of Tsiprobay infusion solution:

• active substance: ciprofloxacin - 2 mg;
• auxiliary components: 20% lactic acid, hydrochloric acid 1N, sodium chloride, water for injection.

Composition of 1 film-coated tablet Tsiprobay:

• active substance: ciprofloxacin - 250 or 500 mg (ciprofloxacin hydrochloride monohydrate - 291 or 582 mg);
• auxiliary components: anhydrous colloidal silicon dioxide - 2.5 / 5 mg, corn starch - 36.5 / 73 mg, microcrystalline cellulose - 27.5 / 55 mg, magnesium stearate - 2.5 / 5 mg, crospovidone - 15/30 mg;
• shell: macrogol 4000 - 1.3 / 2 mg, titanium dioxide - 1.3 / 2 mg, hypromellose - 3.9 / 6 mg.

Pharmacological properties

Pharmacodynamics

The active substance Tsiprobaia (ciprofloxacin) is a synthetic antibacterial drug from the group of fluoroquinolones, which has a wide spectrum of action.

Mechanism of action

Ciprofloxacin is active in vitro against a wide range of gram-positive and gram-negative microorganisms. The bactericidal effect of the substance is due to the process of inhibiting type II bacterial topoisomerases (topoisomerase II (DNA gyrase) and topoisomerase IV), without which replication, transcription, repair and recombination of bacterial DNA are impossible.

Mechanisms of resistance

In vitro resistance to ciprofloxacin is often influenced by multistep point mutations in DNA gyrase and bacterial topoisomerases. This process is slow.

Single mutations cause a decrease in sensitivity rather than the development of clinical resistance, however, the result of multiple mutations is mainly the development of clinical resistance to ciprofloxacin and cross-resistance to drugs of the quinolone series.

The reason for the formation of resistance to ciprofloxacin may be a decrease in the permeability of the bacterial cell wall (this mechanism is characteristic of Pseudomonas aeruginosa) and / or efflux (activation of excretion from a microbial cell). There are reports of the development of resistance, which is due to the coding gene Qnr, localized on the plasmids. The mechanisms of resistance leading to inactivation of cephalosporins, penicillins, tetracyclines, macrolides and aminoglycosides probably do not affect the antibacterial activity of ciprofloxacin. Microorganisms resistant to these drugs may be sensitive to the action of ciprofloxacin.

The minimum inhibitory concentration (MIC) is usually less than 2 times less than the minimum bactericidal concentration (MBC).

In vitro susceptibility testing

The European Committee for the Testing of Antibiotic Susceptibility provides the following cut-off values for the minimum inhibitory concentration for ciprofloxacin in a clinical setting:

• Enterobacteriaceae and Pseudomonas spp.: sensitive - 0.5 mg / l or less, resistant - more than 1 mg / l;
• Staphylococcus spp. (with high-dose therapy) and Acinetobacter spp.: sensitive - 1 mg / l or less, resistant - more than 1 mg / l;
• Streptococcus pneumoniae: sensitive - less than 0.125 mg / l, resistant - more than 2 mg / l. The wild type of this microorganism is not sensitive to ciprofloxacin and is classified in the category of microorganisms with intermediate sensitivity;
• Haemophilus influenzae and Moraxella catarrhalis: sensitive - 0.5 mg / L or less, resistant - more than 0.5 mg / L. Strains for which the MIC value exceeds the threshold sensitivity / moderately sensitive ratio are very rare - they have not yet been reported. If such colonies are found, the tests for identification and determination of antimicrobial susceptibility must be repeated, and the results obtained must be confirmed by the analysis of the colonies in the reference laboratory. Until evidence of a clinical response is obtained for strains with confirmed MIC values that exceed the currently used resistance threshold, detected microorganisms should be considered resistant. Possible detection of strains of Haemophilus influenzae,with low sensitivity to fluoroquinolones (MIC for ciprofloxacin - from 0.125 to 0.5 mg / l). There is no evidence of the clinical significance of low resistance in H. influenzae respiratory tract infections;
• Neisseria gonorrhoeae and Neisseria meningitidis: sensitive - 0.03 mg / l or less, resistant - more than 0.06 mg / l;
• borderline values that are not associated with the types of microorganisms: sensitive - 0.5 mg / l or less, resistant - more than 1 mg / l. Pharmacodynamic / pharmacokinetic data were mainly used to define criteria independent of the distribution of MICs for specific species. These data are only valid for species with no specific threshold for sensitivity and cannot be applied to species for which susceptibility testing is not recommended. In certain strains, the spread of acquired resistance may differ over time and depend on the geographic region, therefore, when prescribing Tsiprobay (especially for the treatment of serious infections), it is advisable to obtain local information on resistance.

Clinical and Laboratory Standards Institute data for MIC cut-off and diffusion testing using discs containing 5 μg ciprofloxacin are shown below.

For Enterobacteriaceae, Enterococcus spp., Staphylococcus spp., Pseudomonas aeruginosa and other bacteria that do not belong to the Enterobacteriaceae family:

• MIC: sensitive - less than 1 mg / l, intermediate - 2 mg / l, resistant - more than 4 mg / l. This reproducible standard is only valid for tests using dilutions with broth using cationic corrected Mueller-Hinton broth (CAMHB) incubated at 35 ± 2 ° C with air access for 16-20 hours (for Pseudomonas aeruginosa, Enterobacteriaceae, other bacteria not belonging to the family Staphylococcus spp., Enterobacteriaceae, Bacillus anthracis and Enterococcus spp.), within 20-24 hours for Acinetobacter spp. either within 24 hours for. Y. pestis (in case of insufficient growth, incubation should be carried out for another 24 hours);
• diameter of the growth retardation zone: sensitive - more than 21 mm, intermediate - from 16 to 20 mm, resistant - less than 15 mm. This reproducible standard can only be applied to diffusion tests using Mueller-Hinton agar discs incubated for 16-18 hours with air access at 35 ± 2 ° C;

For Haemophilus spp.:

• MIC: sensitive - less than 1 mg / l, intermediate and resistant - no information available. This reproducible standard can only be applied to diffusion tests using Haemophilus parainfluenzae and Haemophilus influenzae susceptibility discs and Haemophilus spp. Broth test medium. (NTM), incubation of which is carried out for 20-24 hours with air access at a temperature of 35 ° ± 2 ° С;
• diameter of the growth retardation zone: sensitive - more than 21 mm, intermediate and resistant - no information available. This reproducible standard can only be applied to diffusion tests using HTM discs incubated in 5% CO2 for 16-18 hours at 35 ° C ± 2 ° C.

For Neisseria gonorrhoeae:

• MIC: sensitive - less than 0.06 mg / l, intermediate - from 0.12 to 0.5 mg / l, resistant - more than 1 mg / l;
• diameter of the growth retardation zone: sensitive - more than 41 mm, intermediate - from 28 to 40 mm, resistant - less than 27 mm.

These reproducible standards only apply to susceptibility tests (MIC agar solution and zone disk diffusion tests) using gonococcal agar and 1% established growth additive for 20-24 hours in 5% CO2 at 36 ± 1 ° C (no more than 37 ° C).

For Neisseria meningitides:

• MIC: sensitive - less than 0.03 mg / l, intermediate - 0.06 mg / l, resistant - more than 0.12 mg / l. This reproducible standard can only be applied to broth dilution tests using Cationic Adjusted Muller-Hinton Broth (CAMHB) supplemented with 5% sheep blood, incubated in 5% CO2 for 20-24 hours at 35 ± 2 ° FROM;
• diameter of the growth retardation zone: sensitive - more than 35 mm, intermediate - from 33 to 34 mm, resistant - less than 32 mm. This reproducible standard can only be applied to assays using Cationic Adjusted Muller-Hinton Broth (CAMHB) broth dilutions with a specified 2% growth additive and incubated with air access for 48 hours at 35 ± 2 ° C.

The MIC values for Bacillus anthracis and Yersinia pestis are as follows:

• sensitive - less than 0.25 mg / l;
• intermediate and resistant - no information available.

This reproducible standard is only valid for tests using dilutions with broth using cationic corrected Mueller-Hinton broth (CAMHB) incubated at 35 ± 2 ° C with air access for 16-20 hours (for Pseudomonas aeruginosa, Enterobacteriaceae, other bacteria not belonging to the family Staphylococcus spp., Enterobacteriaceae, Bacillus anthracis and Enterococcus spp.), within 20-24 hours for Acinetobacter spp. or within 24 hours for Y. pestis (in case of insufficient growth, incubation should be carried out for another 24 hours).

The MIC values for Francisella tularensis are as follows:

• sensitive - less than 0.5 mg / l;
• intermediate and resistant - no information available.

In vitro susceptibility to ciprofloxacin

The prevalence of acquired resistance to ciprofloxacin in some strains can change over time and also depend on the geographic region. That is why it is advisable to take into account local information on resistance when testing the sensitivity of a strain (especially important in the treatment of severe infections). If it turns out that the local prevalence of resistance makes the use of Tsiprobay doubtful in relation to at least several types of infections, then it is necessary to consult a specialist.

In vitro activity of ciprofloxacin was recorded against such sensitive strains of microorganisms:

• anaerobic microorganisms: Mobiluncus spp.;
• aerobic gram-negative microorganisms: Francisella tularensi, Vibrio spp., Haemophilus influenzae, Aeromonas spp., Moraxella catarrhalis, Shigella spp., Neisseria meningitidis, Citrobacter koseri, Pasteurella spp., Legionella spp., Salmonella spp., Haemcreyppilus Yersinia pestis;
• aerobic gram-positive microorganisms: Staphylococcus aureus (methicillin-sensitive), Streptococcus spp, Staphylococcus saprophyticus, Bacillus anthracis;
• other microorganisms: Chlamydia pneumoniae, Chlamydia trachomatis, Mycoplasma pneumoniae, Mycoplasma hominis.

There is evidence of a variable degree of sensitivity to ciprofloxacin for the following microorganisms: Escherichia coli, Proteus mirabilis, Providencia spp., Enterococcus faecalis, Streptococcus pneumoniae, Acinetobacter baumann, Peptostreptococcus spp., Burkholderia oxybacteri., Enterobacter cloacae, Klebsiella pneumoniae, Morganella morganii, Pseudomonas fluorescens, Neisseria gonorrhoeae, Proteus vulgaris, Pseudomonas aeruginosa, Serratia marcescens, Propionibacterium acnes.

It is believed that the following microorganisms have natural resistance to ciprofloxacin: Staphylococcus aureus (methicillin-resistant), Mycoplasma genitalium, Listeria monocytogene, Stenotrophomonas maltophilia, Ureaplasma urealitycum, with the exception of Actinomyces faecius, Enterococcus spp. Mobiluncus spp.).

Pharmacokinetics

When administered intravenously, the maximum concentration of ciprofloxacin in the blood is reached at the end of the infusion. With this route of administration, the pharmacokinetics of ciprofloxacin in the dose range up to 400 mg was linear.

With the introduction of Tsiprobay 2 or 3 times a day intravenously, no accumulation of ciprofloxacin and its metabolites was noted.

Ciprofloxacin binds to blood plasma proteins by 20-30% and is present in blood plasma mainly in a non-ionized form. The substance is freely distributed in body fluids and tissues, while the concentration in the blood serum is much lower than the concentration in the tissues. The volume of distribution of the substance in the body is 2–3 l / kg.

Biotransformation of ciprofloxacin occurs in the liver. Small concentrations of four metabolites of ciprofloxacin can be found in the blood:

• diethylcyprofloxacin (M1);
• sulfocyprofloxacin (M2);
• oxocyprofloxacin (M3);
• formylcyprofloxacin (M4).

The in vitro antibacterial activity of the first three metabolites is comparable to that of nalidixic acid. The M4 metabolite exhibits in vitro antibacterial activity, which is present in a smaller amount and corresponds to that of norfloxacin.

The elimination of ciprofloxacin from the body is carried out mainly by the kidneys by glomerular filtration and tubular secretion. An insignificant volume of the substance is excreted through the digestive tract. The total clearance is from 0.48 to 0.60 l / h / kg, renal - from 0.18 to 0.3 l / h / kg. About 1% of the administered dose of Tsiprobay is excreted in the bile, while high concentrations of ciprofloxacin are observed in the bile.

The half-life of Tsiprobay in patients with unchanged renal function is 3 to 5 hours. With impaired renal function, this indicator increases.

Children

Studies with children have shown that the values of the maximum concentration in blood plasma (Cmax) and the area under the concentration-time curve (AUC) do not depend on age. Repeated use of Tsiprobay at a dose of 10 mg per 1 kg of body weight 3 times a day did not lead to a noticeable increase in the values of these indicators.

In ten children under 1 year of age diagnosed with severe sepsis after 1 hour infusion at a dose of 10 mg per 1 kg of body weight, the Cmax value of the drug was 6.1 mg / L (range 4.6–8.3 mg / L), and in children aged 1–5 years - 7.2 mg / l (range 4.7–11.8 mg / l). The AUC values for the respective age groups were 17.4 mg * h / L (range 11.8–32 mg * h / L) and 16.5 mg * h / L (range 11–23.8 mg * h / L) … These values correspond to the range that is relevant when using therapeutic doses for adult patients.

Pharmacokinetic analysis in children with various infections led to the conclusion that the estimated average half-life of Tsiprobay in children is 4 to 5 hours.

Indications for use

According to the instructions, Tsiprobay is prescribed for the treatment of infections (uncomplicated and complicated), which are caused by microorganisms that are sensitive to the action of ciprofloxacin.

Adults

• infections of the following organs / systems of the body: urinary tract, kidneys, eyes, joints, bones, genitals (including prostatitis and adnexitis), abdominal cavity (including peritonitis, bacterial infections of the gastrointestinal tract or biliary tract), soft tissues, skin;
• respiratory tract infections - the drug is recommended for pneumonia caused by Haemophilus spp., Staphylococcus spp., Legionella spp., Branhamella spp., Escherichia coli, Klebsiella spp., Proteus spp., Enterobacter spp., Pseudomonas spp.;
• otitis media and sinusitis (infections of the middle ear and paranasal sinuses, especially if they are caused by gram-negative microorganisms, including Pseudomonas spp. or Staphylococcus spp.);
• sepsis;
• gonorrhea;
• infections (treatment and prevention) in patients with reduced immunity (for example, with neutropenia or against the background of the use of immunosuppressants);
• selective decontamination (disinfection) of the intestine in patients with reduced immunity;
• anthrax in the pulmonary form (treatment and prevention).

Children

• complications caused by Pseudomonas aeruginosa in children 5–17 years old with pulmonary cystic fibrosis (treatment);
• anthrax in the pulmonary form (treatment and prevention).

Contraindications

Absolute:

• combined use with tizanidine (associated with an increase in the plasma concentration of tizanidine in the blood and the development of clinically significant adverse reactions, for example, hypotension, drowsiness);
• age up to 18 years, except for the treatment of complications of pulmonary cystic fibrosis associated with Pseudomonas aeruginosa (children 5–17 years old), and treatment and prevention of pulmonary anthrax (in cases of possible / confirmed infection with Bacillus anthracis);
• pregnancy and lactation (safety / efficacy in this category of patients has not been studied);
• individual intolerance to the components of the drug, as well as hypersensitivity to other drugs from the group of fluoroquinolones.

Relative (the appointment of Tsiprobay requires caution in cases of the following diseases / conditions):

• diseases of the central nervous system: epilepsy, lowering the threshold of convulsive readiness or a burdened history of seizures, decreased blood flow in the cerebral vessels, stroke or organic brain damage;
• renal failure, including accompanied by hepatic failure;
• mental illness: psychosis, depression;
• elderly age.

Instructions for use of Tsiprobay: method and dosage

Tsiprobay tablets are taken orally, without chewing, with a small amount of liquid, on an empty stomach.

You can take the drug regardless of food. The active substance is absorbed faster when taking Tsiprobay on an empty stomach. It is not recommended to drink tablets with dairy products or foods that are fortified with calcium (for example, milk, yogurt, juices with a high calcium content). Subject to the usual diet, the absorption of the drug is not disturbed.

If it is impossible to take the drug orally, Tsiprobay is prescribed in the form of an infusion solution. After improving the patient's condition, they are transferred to the drug intake.

The infusion solution of Tsiprobay is injected intravenously slowly into a large vein, the duration of the infusion is at least 1 hour. The drug can be administered in combination with other compatible infusion solutions.

In the absence of other prescriptions, adults are advised to comply with the following dosing regimen (tablets / infusion solution):

• respiratory tract infections (the dose depends on the patient's condition and the severity of the disease): 2 times a day, 250 or 500 mg / 2 times a day, 200-400 mg;
• uncomplicated urinary tract infections in acute course: 2 times a day, 125 mg, or 1-2 times a day, 250 mg / 2 times a day, 100 mg;
• complicated urinary tract infections: 2 times a day, 250 or 500 mg / 2 times a day, 200 mg;
• cystitis in women before menopause: 250 mg once / 100 mg once;
• extragenital gonorrhea: 2 times a day, 125 mg / 2 times a day, 100 mg;
• uncomplicated gonorrhea in acute course: 250 mg once / 100 mg once;
• diarrhea: 1-2 times a day, 500 mg / 2 times a day, 200 mg;
• other infections: 2 times a day, 500 mg / 2 times a day, 200-400 mg;
• anthrax in the pulmonary form (treatment and prevention): 2 times a day, 500 mg / 2 times a day, 400 mg;
• infections in a particularly severe course that pose a threat to life, including peritonitis, septicemia, streptococcal pneumonia, infections of the joints and bones, especially in the presence of Pseudomonas, Streptococcus or Staphylococcus: 2 times a day, 750 mg / 3 times a day, 400 mg.

For the treatment of elderly patients, the use of the lowest possible doses of Tsiprobay is indicated, which are selected based on the severity of the condition and creatinine clearance.

For children, in the absence of other prescriptions, it is recommended to observe the following dosage regimen of Tsiprobay (tablets / infusion solution):

• complications of pulmonary cystic fibrosis caused by Pseudomonas aeruginosa (treatment in children 5–17 years old): 2 times a day, 20 mg / kg (maximum - 1500 mg) / 3 times a day, 10 mg / kg (maximum - 1200 mg); course - from 10 to 14 days;
• pulmonary anthrax: 2 times a day, 15 mg / kg (maximum: single dose - 500 mg, daily - 1000 mg) / 2 times a day, 10 mg / kg (maximum: single dose - 400 mg, daily - 800 mg). Therapy should be started immediately after infection (suspected or confirmed). The total duration of the course is 60 days.

Maximum daily doses of Tsiprobay for adults with impaired renal function (depending on creatinine clearance or plasma creatinine concentration in the blood) (tablets / infusion solution):

• 31-60 ml / min / 1.73 m ² or 1.4-1.9 mg / 100 ml: 1000 mg / 800 mg;
• up to 30 ml / min / 1.73 m ² or from 2 mg / 100 ml: 500 mg / 400 mg.

The scheme of use for disorders of renal function and hemodialysis is similar to that described above. On the days of hemodialysis, Tsiprobay is taken after the hemodialysis procedure. In the presence of impaired renal and liver function, the drug is used in the same way as described above.

In outpatients with functional disorders of the kidneys and peritoneal dialysis, Tsiprobay 500 mg is prescribed orally or intraperitoneally, adding an infusion solution to the dialysate at the rate of 50 mg of ciprofloxacin per 1 liter of dialysate (every 6 hours).

The safety and efficacy of the drug in children with renal / hepatic insufficiency have not been studied.

The duration of the course of application of Tsiprobay is determined by the severity of the disease and its clinical / bacteriological control. It is important not to interrupt therapy for at least another 3 days after the disappearance of fever or other clinical symptoms of the disease.

Average course duration:

• acute uncomplicated gonorrhea and cystitis: 1 day;
• infections of the urinary tract, kidney, abdominal cavity: 1 week;
• osteomyelitis: up to 2 months;
• neutropenia in patients with weakened immunity: throughout the entire period of neutropenia;
• other infections: 1–2 weeks.

With infectious processes caused by streptococci, therapy is recommended for at least 10 days, which is associated with the likelihood of developing late complications. Chlamydial infections should be treated for the same period.

Tsiprobay is compatible with the following solutions:

• saline;
• Ringer's solution;
• Ringer's lactate solution;
• 5% and 10% glucose solution (dextrose);
• 10% fructose solution;
• 5% glucose (dextrose) solution with 0.225% or 0.45% sodium chloride solution.

The solution obtained after mixing is recommended to be used as soon as possible, due to microbiological reasons, as well as the sensitivity of the preparation to light.

In the absence of confirmed compatibility, drugs / solutions should not be administered together. Visible signs of incompatibility: precipitation, discoloration or turbidity of the solution.

Side effects

The incidence of adverse reactions (> 10% - very often;> 1% and 0.1% and 0.01% and <0.1% - rarely; <0.01% - very rare):

• hematopoietic system: infrequently - eosinophilia; rarely - leukocytosis, anemia, leukopenia (granulocytopenia), change (decrease / increase) in the level of prothrombin, thrombocytosis, thrombocytopenia; very rarely - hemolytic anemia, pancytopenia (including life-threatening forms), agranulocytosis (the development of bone marrow suppression in life-threatening forms is extremely rare);
• digestive system: often - nausea, diarrhea; infrequently - abdominal pain, vomiting, anorexia, changes in liver function tests (alkaline phosphatase, alanine aminotransferase and aspartate aminotransferase), hyperbilirubinemia; rarely - oral candidiasis, jaundice (including cholestatic), pseudomembranous colitis; very rarely - hepatitis, candidiasis, liver tissue necrosis (extremely rarely progresses to liver failure in life-threatening forms), pancreatitis, pseudomembranous colitis in life-threatening forms, including the likelihood of death;
• genitourinary system: infrequently - increased levels of creatinine and urea nitrogen; rarely - urethral bleeding, acute renal failure, glomerulonephritis, vaginal candidiasis, polyuria, dysuria, albuminuria, urinary retention, hematuria, interstitial nephritis, crystalluria, decreased nitrogen excretion function of the kidneys;
• central nervous system: infrequently - confusion, anxiety, headache, sleep disorders, dizziness, agitation; rarely - sweating, migraine, hallucinations, paresthesia (including peripheral paralgesia), depression, tremors, convulsions, anxiety, nightmares, hyperesthesia; very rarely - insomnia, fainting, large seizures (based on literature data - cerebral artery thrombosis, intracranial hypertension, psychosis, ataxia, muscle twitching, increased muscle tone, unsteady gait);
• respiratory system: rarely - dyspnea, laryngeal edema;
• cardiovascular system: rarely - tachycardia, symptoms of vasodilation (in the form of a feeling of heat, flushing of the face), decreased blood pressure, fainting; very rarely - vasculitis (hemorrhagic bullae, petechiae, papules with crusts);
• musculoskeletal system: infrequently - arthralgia; rarely - muscle pain, joint swelling; very rarely - myasthenia gravis, tendonitis (mainly Achilles tendons), exacerbation of myasthenia gravis symptoms, partial / complete rupture of tendons (mainly Achilles);
• sense organs: infrequently - taste disturbances; rarely - tinnitus, short-term hearing impairment, visual disturbances (in the form of diplopia, color perception disorders); very rarely - anosmia, parosmia;
• skin: often - rash; infrequently - urticaria, itching, maculopapular rash; rarely - photosensitivity reactions; very rarely - persistent skin rashes, erythema multiforme, petechiae, erythema nodosum;
• allergic reactions: rarely - anaphylactic reactions, fever; very rarely - skin rash, anaphylactic shock, reactions similar to serum sickness, Lyell and Stevens-Johnson syndromes;
• local reactions (occur with the infusion of the drug, develop at the injection site): infrequently - thrombophlebitis, local inflammatory reactions (in the form of edema, pain);
• the body as a whole: infrequently - asthenia (in the form of increased fatigue, feelings of weakness), candidiasis; rarely - pain in the back, limbs, chest;
• others: rarely - hyperglycemia, peripheral edema; very rarely - an increase in the activity of amylase, lipase.

Other possible disorders (the cause-and-effect relationship of their appearance with therapy has not been established): polyuria, cerebral artery thrombosis, albuminuria, urinary retention.

Overdose

During the period of taking Tsiprobay, it is necessary to ensure careful monitoring of the patient's condition, carry out the usual emergency measures and ensure an adequate supply of fluid. To prevent the development of crystalluria, it is also recommended to constantly monitor kidney function (including pH and acidity of urine). With the help of peritoneal or hemodialysis, less than 10% of ciprofloxacin is excreted.

special instructions

When treating pneumonia caused by bacteria of the genus Pneumococcus on an outpatient basis, Tsiprobay should not be used as the first choice drug.

In some cases, disorders of the central nervous system may appear at the beginning of the course. Very rarely, psychosis can be accompanied by suicidal attempts (treatment is immediately canceled).

If prolonged and severe diarrhea appears during / after the end of the use of Tsiprobay, pseudomembranous colitis should be excluded, which requires an immediate cancellation of therapy and appropriate measures. It is impossible to use drugs that suppress intestinal peristalsis.

In patients, especially those who have had liver disease, there may be the development of cholestatic jaundice, as well as a short increase in hepatic transaminases and alkaline phosphatase.

Simultaneous intravenous administration of Tsiprobay with drugs for general anesthesia from the group of barbituric acid derivatives should be carried out under constant monitoring of heart rate, blood pressure and electrocardiogram.

In cases of the appearance of the first signs of tendinitis (in the form of pain and swelling in the tendon area), the drug must be canceled, the exclusion of physical exertion and consultation with a specialist.

In elderly patients who have previously received glucocorticosteroids, rupture of the Achilles tendon may occur.

During the period of therapy, it is recommended to avoid contact with direct sunlight, which is associated with the likelihood of developing photosensitization reactions.

To avoid the occurrence of crystalluria, do not exceed the recommended daily dose. In addition, you need to drink plenty of fluids and maintain an acidic urine reaction.

When driving and performing other potentially hazardous work, care must be taken, especially when used in conjunction with alcohol.

Application during pregnancy and lactation

There are no data on the safety of using ciprofloxacin in the treatment of pregnant women, however, the results of animal studies do not completely exclude the possibility of an adverse effect of this substance on the articular cartilage of newborns. Given this information, it is not recommended to prescribe Tsiprobay to pregnant women.

Animal studies have not revealed a teratogenic effect of ciprofloxacin.

Ciprofloxacin is able to penetrate into breast milk, therefore, to eliminate the risk of damage to the articular cartilage of newborns, Tsiprobay should not be prescribed during lactation.

Pediatric use

It is not recommended to use ciprofloxacin in the treatment of children under the age of 18. The exception is the treatment of complications of pulmonary cystic fibrosis caused by Pseudomonas aeruginosa in children 5–17 years old, as well as treatment and prevention of pulmonary anthrax (after proven or suspected infection with Bacillus anthracis).

The use of Tsiprobay in children is possible only after a careful assessment of the ratio of potential benefits and risks in connection with possible side effects on tendons and joints.

For violations of liver function

With hepatic insufficiency, dose adjustment of Tsiprobay is not required.

With impaired renal function

The dosage regimen in patients with renal insufficiency is prescribed in the section "Method of administration and dosage".

Use in the elderly

When treating patients in this category, it is necessary to use lower doses of Tsiprobay.

Drug interactions

The combined use of Tsiprobay with certain drugs / substances can lead to the development of the following effects:

• cationic preparations and supplements containing minerals (for example, aluminum, calcium, iron), sucralfate or antacids, medicines with a high buffering capacity (for example, antiretroviral drugs) containing magnesium, calcium or aluminum, antacids, which are related to blockers of histamine H ₂ -receptors (in combination with the tablet form of Tsiprobay): decrease in the absorption of ciprofloxacin (recommended intervals are 1-2 hours before using such drugs or 4 hours after them);
• dairy products or beverages enriched with minerals with an increased calcium content (for example, yogurt, milk, fortified juices): decreased absorption of ciprofloxacin (the combination is recommended to be avoided; if you follow a normal diet, significant violations of the absorption of ciprofloxacin due to calcium are not observed);
• omeprazole: a slight decrease in C _max (maximum concentration of a substance in blood plasma) and a decrease in AUC (area under the curve that determines the concentration-time ratio);
• theophylline: an undesirable increase in its plasma concentration in the blood and, accordingly, the development of theophylline-induced adverse reactions; in very rare cases, these disorders can be life-threatening for the patient (the combination is not recommended; if a combined use is necessary, it is necessary to constantly monitor the level of theophylline in the blood plasma, if necessary, reduce the dose);
• quinolones (gyrase inhibitors) in high doses and some non-steroidal anti-inflammatory drugs (with the exception of acetylsalicylic acid): an increase in the likelihood of seizures;
• cyclosporine: a short-term increase in the plasma concentration of creatinine in the blood (it is recommended to carry out monitoring at least 2 times a week);
• warfarin, glibenclamide: enhancing their effect;
• drugs with uricosuric action, including probenecid: slowing down the rate of excretion of ciprofloxacin by the kidneys and increasing its plasma concentration in the blood;
• methotrexate: slowing down its renal metabolism, which can be combined with an increase in its plasma concentration in the blood and the likelihood of adverse reactions (the condition of patients receiving such a combination of drugs should be closely monitored);
• metoclopramide: accelerating the absorption of ciprofloxacin, shortening the period of time required to reach its maximum plasma concentration in the blood while its bioavailability remains unchanged;
• tizanidine: a significant increase in its plasma concentration in the blood (the combination is contraindicated).

Tsiprobay can be used in combination with other antibiotics, while a predominantly additive and indifferent effect is observed, relatively rarely the effect of both drugs is enhanced, very rarely - weakened.

Possible combinations:

• ceftazidime, azlocillin: causative agent - Pseudomonas spp.;
• antibiotics of the beta-lactam group, in particular vancomycin, isoxazolylpenicillins: the causative agent is Staphylococcus spp.;
• azlocillin, mezlocillin, other effective antibiotics of the beta-lactam group: pathogen - Streptococcus spp.;
• clindamycin, metronidazole: the causative agent is anaerobes.

Analogs

Analogues of Tsiprobay are: Ciprofloxacin, Ciprofloxacin-AKOS, Tsiprinol, Tsipromed, Tsifran, Tsiprolet, Ophtocipro.

Terms and conditions of storage

Store in a dry and dark place at temperatures up to 25 ° C. Keep out of the reach of children.

Shelf life:

• infusion solution - 4 years;
• tablets - 5 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Tsiprobay

Reviews of Tsiprobae indicate the high effectiveness of the drug in the treatment of pneumonia, as well as infections of soft tissues and skin.

Price for Tsiprobay in pharmacies

The price for Tsiprobai 250 mg (10 tablets per pack) is approximately 255 rubles.

The price for Tsiprobai 500 mg (10 tablets per pack) is approximately 386 rubles.

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!