Ciprofloxacin-Teva, 10 pcs., 500 mg, film-coated tablets
Ciprofloxacin is a synthetic broad-spectrum antibacterial drug from the group of fluoroquinolones. Mechanism of action Ciprofloxacin has in vitro activity against a wide range of gram-negative and gram-positive microorganisms. The bactericidal effect of ciprofloxacin is carried out through the inhibition of bacterial type II topoisomerases (topoisomerase II (DNA gyrase) and topoisomerase IV), which are necessary for the replication, transcription, repair and recombination of bacterial DNA. Mechanisms of resistance In vitro resistance to ciprofloxacin is often caused by point mutations in bacterial topoisomerases and DNA gyrase and develops slowly through multistep mutations. Single mutations may result in decreased susceptibility rather than the development of clinical resistance, but multiple mutations generally lead to the development of clinical resistance to ciprofloxacin and cross-resistance to quinolone drugs. Resistance to ciprofloxacin, as to many other antibiotics, can develop as a result of decreased permeability of the bacterial cell wall (as often occurs in the case of Pseudomonas aeruginosa) and/or activation of elimination from the microbial cell (efflux). The development of resistance caused by the Qnr coding gene localized on plasmids has been reported. Resistance mechanisms that lead to inactivation of penicillins, cephalosporins, aminoglycosides, macrolides and tetracyclines do not likely interfere with the antibacterial activity of ciprofloxacin. Microorganisms resistant to these drugs may be sensitive to ciprofloxacin. The minimum bactericidal concentration (MBC) usually does not exceed the minimum inhibitory concentration (MIC) by more than 2 times. In vitro susceptibility testing Reproducible criteria for susceptibility testing for ciprofloxacin, approved by the European Committee on Antibiotic Susceptibility Testing (EUCAST), are presented in the table below: European Committee on Antibiotic Susceptibility Testing. Clinical MIC breakpoints (mg/L) for ciprofloxacin 1. Staphylococcus spp. — breakpoints for ciprofloxacin and ofloxacin are associated with high-dose therapy. 2. Streptococcus pneumoniae - wild type S. pneumoniae is not considered susceptible to ciprofloxacin and ofloxacin and is therefore classified as intermediately susceptible. 3. Strains with MIC values exceeding the sensitive/moderately sensitive threshold ratio are very rare and have not been reported to date. Identification and antimicrobial susceptibility tests should be repeated when such colonies are detected, and the results should be confirmed by colony testing at a reference laboratory. Until evidence of clinical response is available for strains with confirmed MIC values above the currently used resistance threshold, they should be considered resistant. Haemophilus spp. /Moraxella spp. — it is possible to identify strains of Haemophilus influenzae with low sensitivity to fluoroquinolones (MIC for ciprofloxacin - 0.125-0.5 mg/l). There is no evidence of the clinical significance of low resistance in respiratory tract infections caused by H. influenzae. 4. Non-species-specific breakpoints were determined primarily on the basis of pharmacokinetics/pharmacodynamics data and are independent of species-specific MIC distributions. They are only applicable to species for which a species-specific susceptibility threshold has not been determined, and not to those species for which susceptibility testing is not recommended. For certain strains, the distribution of acquired resistance may vary across geographic regions and over time. Therefore, it is desirable to have local information on resistance, especially when treating serious infections. Clinical and Laboratory Standards Institute data for MIC breakpoints (mg/L) and diffusion testing (zone diameter [mm]) using discs containing 5 mcg ciprofloxacin are presented in the table below. Clinical and Laboratory Standards Institute. Breakpoints for MIC (mg/L) and for diffusion testing (mm) using discs a. This reproducible standard is only applicable to broth dilution tests using cationic adjusted Mueller-Hinton broth (CAMHB) incubated with air at 35 ± 2 °C for 16-20 h for strains of Enterobacleriaceae, Pseudomonas aeruginosa, etc. bacteria not belonging to the family Enterobacteriaceae, Staphylococcus spp., Enterococcus spp. and Bacillus anthracis; 20-24 hours for Acinetobacter spp., 24 hours for Y. pestis (if growth is insufficient, incubate for another 24 hours) b. This reproducible standard is only applicable to disk diffusion tests using Mueller-Hinton agar, which is incubated with air at 35 ± 2 °C for 16-18 h. This reproducible standard is only applicable to susceptibility disk diffusion tests with Haemophilus influenzae and Haemophilus parainfluenzae using broth test medium for Haemophilus spp. (HTM) incubated in air at 35°C ± 2°C for 20-24 hours. This reproducible standard is only applicable to disk diffusion tests using HTM incubated in 5% CO2 at 35°C ± 2°C for 16-18 hours. This reproducible standard is only applicable to susceptibility tests (zone disc diffusion tests and MIC agar solution) using gonococcal agar and 1% specified growth additive at temperature 36°C ± 1°C (not to exceed 37°C) in 5% CO2 for 20-24 h. This reproducible standard is only applicable to broth dilution tests using Cationically Adjusted Mueller-Hinton Broth (CAMHB) with the addition of 5% sheep blood, which is incubated in 5% CO2 at 35 ± 2 ° C for 20-24 hours. This reproducible standard is only applicable to broth dilution tests using cationically adjusted Mueller-Hinton broth (CAMHB) supplemented with a specified 2% growth supplement and incubated in air at 35 ± 2°C for 48 hours. In vitro sensitivity to ciprofloxacin For certain strains, the distribution of acquired resistance may vary depending on the geographical region and over time. Therefore, it is desirable to have local information on resistance when testing strain susceptibility, especially when treating severe infections. If the local prevalence of resistance is such that the benefit of using the drug, at least against several types of infections, is questionable, it is necessary to consult a specialist. In vitro activity of ciprofloxacin has been demonstrated against the following sensitive strains of microorganisms: Aerobic gram-positive microorganisms: Bacillus anthracis, Staphylococcus aureus (methicillin-sensitive), Staphylococcus saprophyticus, Streptococcus spp. Aerobic gram-negative microorganisms: Aeromonas spp., Moraxella catarrhalis, Brucella spp., Neisseria meningitidis, Citrobacter koseri, Pasteurella spp., Francisella tularensi. Salmonella spp., Haemophilus ducreyi. Shigella spp., Haemophilius influenzae, Vibrio spp., Legionella spp., Yersinia pestis. Anaerobic microorganisms: Mobiluncus spp. Other microorganisms: Chlamydia trachomatis, Chlamydia pneumoniae, Mycoplasma hominis, Mycoplasma pneumoniae. Varying degrees of sensitivity to ciprofloxacin have been demonstrated for the following microorganisms: Acinetobacter baumann, Burkholderia cepacia, Campylobacter spp., Citrobacter freundii, Enterococcus faecalis, Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Morganella morganii, Neisseria gonorrhoeae, Proteus mirabilis , Proteus vulgaris, Providencia spp., Pseudomonas aeruginosa, Pseudomonas fluorescens, Serratia marcescens, Streptococcus pneumoniae, Peptostreptococcus spp., Propionibacterium acnes. It is believed that Staphylococcus aureus (methicillin-resistant), Stenotrophomonas maltophilia, Actinomyces spp., Enterococcus faecium, Listeria monocytogenes, Mycoplasma genitalium, Ureaplasma urealitycum, anaerobic microorganisms (with the exception of Mobiluncus spp., Peptostreptococus spp., Propionibacterium) have natural resistance to ciprofloxacin acnes )
Ciprofloxacin-Teva tablets capt/vol 500mg bl N10x1 Teva Private FZ
It is possible to increase the concentration of theophylline (and other xanthines, such as caffeine) in the blood serum and prolong the half-life. As a result, the risk of unwanted effects caused by theophylline may increase. During treatment with ciprofloxacin, more frequent monitoring of theophylline and caffeine levels in the blood serum is recommended. Ciprofloxacin inhibits the CYP1A2 isoenzyme, and this may cause increased plasma concentrations of concomitantly taken drugs that are metabolized by the CYP1A2 isoenzyme. Significant changes in the pharmacokinetic parameters of tizanidine, including an increase in AUC, T1/2, Cmax, an increase in oral bioavailability, and a decrease in plasma clearance were observed when used simultaneously with ciprofloxacin. This pharmacokinetic interaction may result in serious adverse events. A clinically significant decrease in blood pressure (both systolic and diastolic blood pressure decreases) and drowsiness were observed with simultaneous use of ciprofloxacin and a single dose of 4 mg tizanidine. In this regard, the simultaneous use of tizanidine with ciprofloxacin is contraindicated. In patients receiving concomitantly with ciprofloxacin any other drugs that are substrates for the CYP1A2 isoenzyme, caution must be exercised to prevent the onset of symptoms of overdose with these drugs. Plasma concentrations of these drugs should be periodically determined, especially when using theophylline. The absorption of ciprofloxacin is slowed down by the simultaneous use of iron, zinc, sucralfate or antacids and drugs with high buffering activity containing magnesium, aluminum or calcium. This also applies to sucralfate, antiviral drugs containing buffered didanosine, and oral nutritional solutions. This effect is also observed when consuming large amounts of dairy products (milk or liquid dairy products such as yogurt). Thus, ciprofloxacin should be taken either 1-2 hours before or 4 hours after taking the above substances. These restrictions do not apply to H2-histamine receptor blockers. The simultaneous use of very high doses of quinolones and some non-steroidal anti-inflammatory drugs (except acetylsalicylic acid) can provoke the development of seizures. When used simultaneously with uricosuric drugs, the elimination of ciprofloxacin is slowed down by 50% and the plasma concentration of ciprofloxacin increases. With simultaneous use of cyclosporine and ciprofloxacin, a transient increase in creatinine concentration is observed. These patients should have their blood creatinine levels checked regularly. Ciprofloxacin, like other quinolones, may enhance the effect of coumarin-derived anticoagulants, including warfarin. If these drugs are used concomitantly, monitor prothrombin time (PT) or other appropriate coagulation tests. If necessary, the dose of warfarin should be adjusted appropriately. With the simultaneous use of ciprofloxacin and glibenclamide, the effect of glibenclamide may be enhanced. Probenecid inhibits the renal excretion of ciprofloxacin, leading to increased concentrations of ciprofloxacin. Metoclopramide accelerates the absorption of ciprofloxacin. The maximum concentration of ciprofloxacin is achieved in a shorter time. The bioavailability of ciprofloxacin is not affected. With simultaneous use of ciprofloxacin or phenytoin, both an increase and a decrease in the concentration of phenytoin in plasma is possible, therefore it is recommended to monitor its concentration. The simultaneous use of ciprofloxacin and mexiletine may lead to increased concentrations of mexiletine. Concomitant use of opioid premedications (eg, papaveretum) or opioid premedications with anticholinergic premedications (atropine or hyoscine) with ciprofloxacin is not recommended due to decreased plasma concentrations of ciprofloxacin. The simultaneous use of ciprofloxacin and benzodiazepines does not affect the concentration of ciprofloxacin in plasma. However, due to reports of decreased clearance and increased T1/2 of diazepam with simultaneous use of ciprofloxacin and diazepam and, in some cases, with simultaneous use of ciprofloxacin and midazolam, it is recommended to monitor the effectiveness of benzodiazepine treatment. When ropinirole is used concomitantly with ciprofloxacin, there is a possibility of increased concentrations of ropinirole, which may be accompanied by an increased risk of adverse reactions. In case of simultaneous use, more careful monitoring of ropinirole therapy is necessary. Clinically significant interactions have been reported between ciprofloxacin and didanosine. Concomitant use of ciprofloxacin and methotrexate inhibits renal tubular transport, potentially leading to increased plasma concentrations of methotrexate, which may increase the risk of methotrexate-related toxicities. Therefore, it is necessary to monitor the condition of patients when treated with methotrexate and simultaneously taking ciprofloxacin. When used simultaneously with omeprazole, a slight decrease in the maximum plasma concentration of the drug and a decrease in AUC may be observed. Clinical studies have shown that the simultaneous use of duloxetine and potent inhibitors of the CYP1A2 isoenzyme (such as fluvoxamine) may lead to an increase in the AUC and Cmax of duloxetine. Although there is no clinical data on possible interactions with ciprofloxacin, the likelihood of such an interaction can be anticipated when ciprofloxacin and duloxetine are used concomitantly. In a study on healthy volunteers, it was found that the simultaneous use of drugs containing lidocaine and ciprofloxacin, a moderate inhibitor of the CYP1A2 isoenzyme, leads to a 22% decrease in the clearance of lidocaine when administered intravenously. Despite the good tolerability of lidocaine, when used simultaneously with ciprofloxacin, side effects may increase due to interaction. With simultaneous use of clozapine and ciprofloxacin at a dose of 250 mg for 7 days, an increase in serum concentrations of clozapine and N-desmethylclozapine was observed by 29% and 31%, respectively. The patient's condition should be monitored and, if necessary, the dosage regimen of clozapine should be adjusted during its simultaneous use with ciprofloxacin and for a short time after completion of combination therapy.
Ciprofloxacin-Teva 500 mg tbl p/p about N10
Ciprofloxacin -Teva - instructions for use
Official instructions registered by the Ministry of Health of the Russian Federation (at grls.rosminzdrav.ru) See where the instructions were received from MEDI RU Prices / buy Analogs, articles Comments Indications Contraindications Dosage Warnings Interactions Manufacturer Registration number
:
LP 001280-251111
Trade name: Ciprofloxacin -Teva International nonproprietary name :
ciprofloxacin
Dosage form:
film-coated tablets
Composition 1 tablet contains: active substance ciprofloxacin 250.0/500.0 mg (ciprofloxacin hydrochloride monohydrate 291.1/582.2 mg);
excipients: microcrystalline cellulose 36.65/73.30 mg, povidone K-30 18.75/37.50 mg, croscarmellose sodium 21.00/42.00 mg, colloidal silicon dioxide 3.75/7.50 mg, magnesium stearate 3.75/7.50 mg; shell Opadry white Y-1-7000H: hypromellose 3.125/6.250 mg, titanium dioxide 1.5625/3.1250 mg, macrogol-400 0.3125/0.6250 mg. Description 250 mg tablets: round, biconvex, white film-coated tablets, engraved “CIP 250” and scored on one side.
The cross section shows two layers.
The kernel is white to yellowish-white. Tablets 500 mg: capsule-shaped tablets, white film-coated, engraved “CIP 500” and scored on one side. The cross section shows two layers. The kernel is white to yellowish-white. Pharmacotherapeutic group:
antimicrobial agent - fluoroquinolone
ATX code: J01MA02
Pharmacological properties Pharmacodynamics.
Broad-spectrum antimicrobial agent of the fluoroquinolone group.
Suppresses topoisomerases II (bacterial DNA gyrase) and IV, responsible for the process of supercoiling of chromosomal DNA around nuclear RNA, which is necessary for reading genetic information), disrupts DNA synthesis, growth and division of bacteria, causes pronounced morphological changes and rapid death of the bacterial cell. It has a bactericidal effect on gram-negative organisms during the period of rest and division (since it affects not only DNA gyrase, but also causes lysis of the cell wall), on gram-positive microorganisms - only during the period of division. Low toxicity for the cells of the macroorganism is explained by the absence of DNA gyrase in them. While taking ciprofloxacin, there is no parallel development of resistance to other antibiotics that do not belong to the group of gyrase inhibitors, which makes it highly effective against bacteria that are resistant, for example, to aminoglycosides, penicillins, cephalosporins, tetracyclines and other antibiotics. The effectiveness of ciprofloxacin depends largely on the relationship between pharmacokinetic (PK) and pharmacodynamic (PD) parameters - between the maximum serum concentration (Cmax)/minimum inhibitory concentration (MIC) and between the area under the concomitant curve. There is no cross-resistance with other fluoroquinolones. The basis for the formation of resistance to ciprofloxacin are gene mutations (amino acid substitutions) in the “quinolone pocket” - a region of the polypeptide chain of topoisomerases II and IV, in which their binding to ciprofloxacin should occur. Another possible mechanism of resistance is associated with mutations in the gene that encodes membrane proteins involved in the active release (efflux) of ciprofloxacin from the cell and/or a decrease in the permeability of the cell membrane to ciprofloxacin. Typically, single mutations lead to a slight (2-4 times) increase in MIC. High levels of resistance are usually associated with two or more mutations in one or more genes. Sensitivity to ciprofloxacin in vitro The most sensitive microorganisms
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Gram-positive aerobic microorganisms: Bacillus anthracis, Staphylococcus aureus (including methicillin-sensitive strains), Staphylococcus saprophytics, Streptococcus spp. ? Gram-negative aerobic microorganisms: Aeromonas spp., Brucella spp., Citrobacter koseri, Francisella tularensi, Haemophilus ducreyi, Haemophilus influenzae, Legionella spp., Moraxella catarrhalis, Pasteurella spp., Neisseria meningitidis, Salmonella spp., Shigella spp., Vibrio spp., Yersiniapestis. ? Anaerobic microorganisms: Mobiluncus spp. ? Other microorganisms: Microorganisms with varying degrees of sensitivity to ciprofloxacin? Gram-positive aerobic microorganisms: Enterococcus faecalis, Streptococcus pneumoniae. ? Gram-negative aerobic microorganisms: Acinetobacter baumannii, Burkholderia cepacia, Campylobacter jejuni, Citrobacter freundii, Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Neisseria gonorrhoeae, Proteus mirabilis, Proteus vulgaris, Providencia spp., Pseudomonas aeruginosa, Pseudomonas fluorescens, Serratia marcescens, Streptococcus pneumoniae. Resistant microorganisms? Gram-positive aerobic microorganisms: Actinomyces spp., Enterococus faecium, Staphylococcus spp. (methicillin-resistant strains). ? Gram-negative aerobic microorganisms: Burkholderia cepacia, Listeria monocytogenes Nocardia asteroids, Stenotrophomonas maltophilia. ? Anaerobic microorganisms (except for Mobiluncus spp., Peptostreptococcus spp., Propionibacterium acnes). ? Other microorganisms: Bacteroides fragilis, Clostridium difficile, Mycoplasma genitalium, Treponema pallidum, Ureaplasma urealyticum. Pharmacokinetics Absorption.
After oral administration, ciprofloxacin is predominantly absorbed in the duodenum and upper jejunum.
Cmax is achieved 60-90 minutes after administration. After a single dose of 250 mg or 500 mg, Cmax is approximately 0.8-2.0 mg/L and 1.5-2.9 mg/L, respectively. Absolute bioavailability is approximately 70-80%; Cmax and AUC values increase in proportion to the dose taken. Eating (with the exception of dairy products) slows down absorption but does not change the Cmax and bioavailability of ciprofloxacin. Distribution. The equilibrium volume of distribution (Vd) of ciprofloxacin is 2-3.5 l/kg. Large Vd is associated with high tissue penetration of ciprofloxacin. Since ciprofloxacin binds to blood proteins to a small extent (20-30%) and is present in the blood plasma in non-ionized form, almost the entire dose taken can freely penetrate into the extravascular space. As a result, the concentration of ciprofloxacin in some body fluids and tissues may exceed its concentration in the blood. The content in tissues is 2-12 times higher than in plasma. Therapeutic concentrations are achieved in saliva, tonsils, liver, gallbladder, bile, intestines, abdominal and pelvic organs, uterus, seminal fluid, prostate tissue, endometrium, fallopian tubes and ovaries, kidneys and urinary organs, lung tissue, bronchial secretions , paranasal sinuses, bone tissue, muscles, synovial fluid and articular cartilage, peritoneal fluid, skin. It penetrates into the cerebrospinal fluid in a small amount, where its concentration in non-inflamed meninges is 6-10% of that in the blood serum, and in inflamed meninges - 14-37%. Ciprofloxacin also penetrates well into the ocular fluid, bronchial secretions, pleura, peritoneum, lymph, breast milk, and through the placenta. The concentration of ciprofloxacin in blood neutrophils is 2-7 times higher than in serum. Activity decreases slightly at acidic pH values. Metabolism. Metabolized in the liver (15-30%) with the formation of low-active metabolites (desethylene ciprofloxacin (Ml), sulfocyprofloxacin (M2), oxociprofloxacin (MZ) and formyl ciprofloxacin (M4)). Ml, M2 and M3 are characterized by similar or lower activity compared to nalidixic acid. M4, found in the lowest concentrations, has antimicrobial activity similar to norfloxacin. It is a moderate inhibitor of the CYP1A2 isoenzyme. Excretion. Ciprofloxacin is mostly excreted unchanged, primarily by the kidneys. Renal clearance is 3-5 ml/min/kg, and total clearance is about 8-10 ml/min/kg. Transport of ciprofloxacin is carried out by glomerular and tubular secretion. Excretion of ciprofloxacin after oral administration (in% of the dose of ciprofloxacin) Urine Feces Ciprofloxacin 44.7 25.0 Metabolites of ciprofloxacin 11.3 7.5 The half-life (T1/2) of ciprofloxacin is 3-5 hours. With moderate chronic renal failure (creatinine clearance (CC) more than 20 ml/min), the percentage of ciprofloxacin excreted through the kidneys decreases, but accumulation in the body does not occur due to a compensatory increase in ciprofloxacin metabolism and intestinal excretion. In case of severe renal failure (creatinine clearance less than 20 ml/min), T1/2 increases to 12 hours and the daily dose of ciprofloxacin must be reduced by 2 times. Childhood. The pharmacokinetics of ciprofloxacin in children with cystic fibrosis differs from the pharmacokinetics of ciprofloxacin in children without cystic fibrosis, and dosing recommendations apply only to children with cystic fibrosis. When 20 mg/kg ciprofloxacin is administered orally to children with cystic fibrosis, the observed drug effect is comparable to adult patients who receive 750 mg ciprofloxacin twice daily. Indications for use Adults
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Respiratory tract infections. Ciprofloxacin is recommended for use in pneumonia caused by Klebsiella spp., Enterobacter spp., Proteus spp., Esherichia coli, Pseudomonas aeruginosa, Haemophilus spp., Moraxella catarrhalis, Legionela spp. and staphylococci; ? infections of the ENT organs (acute sinusitis, otitis media), especially if these infections are caused by gram-negative microorganisms, including Pseudomonas aeruginosa or staphylococci; ? eye infections; ? kidney or urinary tract infections, including cystitis, pyelonephritis; ? genital infections, including adnexitis, prostatitis; ? complicated intra-abdominal infections (in combination with metronidazole) and? uncomplicated gonorrhea; ? gastrointestinal tract infections, including traveler's diarrhea; ? skin and soft tissue and skin infections; ? bone and joint infections; ? sepsis; ? infections or prevention of infections in immunocompromised patients (patients taking antidepressants or patients with neutropenia); ? selective intestinal decontamination in patients with reduced immunity; ? prevention and treatment of pulmonary anthrax (infection with Bacillus anthracis); ? prevention of invasive infections caused by Neisseria meningitides. Children aged 5-17 years
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Acute pneumonia against the background of cystic fibrosis caused by Pseudomonas aerugenosa. Contraindications Hypersensitivity to ciprofloxacin or other components of the drug, as well as to other antimicrobial agents from the quinolone group, including a history of;
simultaneous use of ciprofloxacin and tizanidine; children under 18 years of age (until the completion of the skeletal formation process, except for the treatment of complications caused by Pseudomonas aerugenosa in children aged 5-17 years with cystic fibrosis of the lungs); tendon diseases, including a history; pregnancy; breastfeeding period. With caution Moderate and severe renal dysfunction (creatinine clearance less than 60 ml/min), hemodialysis, peritoneal dialysis (PD), liver dysfunction, myasthenia gravis, old age; postoperative infections (data on effectiveness and safety are limited); prolongation of the QT interval, congenital long QT syndrome, heart disease (heart failure, myocardial infarction, bradycardia), arrhythmias, glucose-6-phosphate dehydrogenase deficiency, electrolyte imbalance (for example, with hypokalemia, hypomagnesemia), concomitant use of drugs that prolong the QT interval (incl.
antiarrhythmic classes IA and III), simultaneous use with inhibitors of the CYP450 1A2 isoenzyme (including theophylline, methylxanthine, caffeine, duloxetine, clozapine), a history of tendon diseases associated with the use of quinolones, cerebrovascular insufficiency, a history of epilepsy, diseases accompanied by organic changes in the structure of the brain, including conditions after cerebrovascular accident.
Use during pregnancy and breastfeeding Ciprofloxacin is contraindicated during pregnancy.
Since ciprofloxacin is excreted in breast milk, it should not be administered to nursing mothers.
If it is necessary to use ciprofloxacin in a mother during lactation, feeding the child should be stopped before starting treatment. Method of administration and dosage: Orally, regardless of food intake, without chewing the tablet, with water.
When used on an empty stomach, the absorption of ciprofloxacin increases.
Foods high in calcium (milk, yoghurt) may reduce the absorption of ciprofloxacin. The dose of ciprofloxacin depends on the type and severity of the infection, the age, body weight of the patient and the functional status of the kidneys. The duration of treatment depends on the severity of the disease, clinical and bacteriological response. In general, treatment should be continued for at least three days after body temperature normalizes or clinical symptoms resolve. Adults For mild to moderate respiratory tract infections - 500 mg 2 times a day for 7-14 days.
For infections of the ENT organs (acute sinusitis, otitis media) - 500 mg 2 times a day.
The course of treatment is 10 days. For gastrointestinal tract infections, including traveler's diarrhea: ? diarrhea caused by Shigella spp., with the exception of Shigella dysenteriae, and empirical treatment of severe traveler's diarrhea - 500 mg 2 times a day for 1 day; ? diarrhea caused by Shigella dysenteriae - 500 mg 2 times a day for 3 days; ? typhoid fever - 500 mg 2 times a day for 5 days; ? diarrhea caused by Vibrio cholerae - 500 mg 2 times a day for 7 days. Urinary tract infections, including cystitis, pyelonephritis? uncomplicated cystitis - 250-500 mg 2 times a day for 3 days; ? complicated cystitis and uncomplicated pyelonephritis - 500 mg 2 times a day for 7-14 days. Infections of the genitourinary system and pelvic organs, including urethritis and cervicitis caused by Neisseria gonorrhoeae - 500 mg once a day once; ? prostatitis - 500 mg 2 times a day for 28 days. Infections of soft tissues and skin caused by gram-negative microorganisms - 500 mg 2 times a day for 7-14 days. Infections in patients with neutropenia - 500 mg 2 times a day during the entire period of neutropenia (in combination with other antibiotics). Infections of bones and joints - 500 mg 2 times a day. Duration of treatment is no more than 3 months; For sepsis, other generalized infectious diseases, for example, peritonitis (in addition to antibacterial drugs that affect anaerobes), infectious diseases in patients with reduced immunity - 500 mg 2 times a day (in combination with other antibiotics) for the period required for treatment. For particularly severe, life-threatening infections (especially those caused by Pseudomonas aeruginosa, Staphylococcus spp. or Streptococcus spp., for example, osteomyelitis, sepsis, pneumonia caused by Streptococcus pneumoniae, recurrent infections in cystic fibrosis, severe skin and soft tissue infections or peritonitis) recommended the dose is 750 mg twice daily. In elderly patients, the dose depends on the severity of the disease and the state of renal function. In patients with impaired renal function: CC (ml/min) Creatinine concentration (mg/dl) Dose 30-60 1.4-1.9 250-500 mg every 12 hours less than 30 more than 2.0 250-500 mg every 24 hours The condition of patients must be strictly monitored. The intervals between doses should be the same as when used in patients with normal renal function. In patients with impaired renal function and hemodialysis Recommended dose: 250-500 mg 1 time per day after the hemodialysis procedure. In patients with impaired renal function and permanent outpatient PD, the recommended dose is 250-500 mg once a day after the PD procedure. In patients with hepatic impairment No dosage adjustment is required in mild to moderate hepatic impairment, but may be necessary in severe hepatic impairment. In patients with impaired liver and kidney function Dose adjustment as for impaired renal function. Patients must be closely monitored. In some cases, it may be necessary to determine the concentration of ciprofloxacin in plasma. Children aged 5-17 years Acute pneumonia against the background of cystic fibrosis caused by Pseudomonas aerugenosa - 20 mg/kg 2 times a day for 10-14 days.
The maximum daily dose is 1.5 g. In children aged 5-17 years with impaired renal and/or liver function and cystic fibrosis of the lungs, complicated by Pseudomonas aerugenosa infection, the use of ciprofloxacin has not been studied.
Side effects Adverse reactions were noted in 5-14% of patients taking ciprofloxacin.
The most common side effects are nausea, vomiting and skin rash.
The incidence of side effects is classified according to the recommendations of the World Health Organization: very often - at least 10%; often - at least 1%, but less than 10%; infrequently - not less than 0.1%, but less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rarely - less than 0.01%, including isolated cases. Infections and infestations: uncommon - fungal superinfection, candidiasis (including oral cavity, vaginal candidiasis, gastrointestinal candidiasis (GIT)). From the digestive system: often - nausea, diarrhea, vomiting, indigestion, loss of appetite, flatulence, abdominal pain; rarely - dysphagia, pancreatitis, hepatitis, jaundice, including cholestatic, liver necrosis, in isolated cases leading to life-threatening liver failure; very rarely - antibiotic-associated pseudomembranous colitis, in isolated cases taking life-threatening forms. From the nervous system: often - dizziness, headache, agitation, tremor; infrequently - insomnia, taste perversion (reversible, disappears after discontinuation of ciprofloxacin); rarely - hallucinations, paresthesia (peripheral paralgesia), nightmares, depression, convulsions, hypoesthesia, drowsiness, exacerbation of myasthenia gravis symptoms, confusion, disorientation, peripheral neuropathy, polyneuropathy; very rarely - grand mal seizures, gait disturbance, psychosis (the development of which can cause harm to patients), increased intracranial pressure, ataxia, hyperesthesia, muscle hypertension, impaired sense of smell, loss of smell (usually disappears after discontinuation of ciprofloxacin), migraine , anxiety, loss of taste. On the part of the organ of vision: very rarely - visual impairment, double vision, impaired color vision. On the part of the organ of hearing and balance: very rarely - tinnitus, temporary deafness (especially with frequent use of ciprofloxacin). From the musculoskeletal system: infrequently - joint pain; rarely - muscle pain, joint swelling, pain in the limbs, back pain, increased muscle tone, muscle weakness, exacerbation of myasthenia gravis symptoms; very rarely - convulsive muscle contraction, inflammation of the tendon (mainly the Achilles tendon, including tenosynovitis), partial or complete rupture of the tendon (mainly the Achilles tendon). From the cardiovascular system: infrequently - palpitations; rarely - tachycardia, vasodilation, fainting, flushing of the face, decreased blood pressure (BP); very rarely - tachycardia, vasculitis (petechial, hemorrhagic bullae, papules, scab-like formations), arrhythmia, arrhythmia, prolongation of the QTc interval (mainly in patients with other risk factors for prolongation of the QTc interval). From the respiratory system: infrequently - pulmonary embolism, pulmonary edema, hemoptysis, hiccups, shortness of breath, nosebleeds; rarely - shortness of breath. From the blood system and hematopoietic organs: often - eosinophilia; uncommon - leukopenia, neutropenia, anemia, granulocytopenia, thrombocytopenia; rarely - leukocytosis, thrombocytosis; very rarely - hemolytic anemia, agranulocytosis, pancytopenia (life-threatening), suppression of bone marrow function (life-threatening). From the urinary system: rarely - acute renal failure, hematuria, crystalluria, interstitial nephritis. Allergic reactions: often - skin rash; infrequently - skin itching, macular nodular rash, urticaria; rarely - photosensitivity, erythema multiforme, erythema nodosum, facial edema; very rarely - anaphylactoid reactions, laryngeal edema, Steven-Johnson syndrome, Lyell's syndrome, petechiae, anaphylactic shock, serum sickness, angioedema. Laboratory data: uncommon - increased activity of alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, hyperbilirubinemia, increased urea concentration in the blood; rarely - changes in prothrombin levels, hyperglycemia; very rarely - increased activity of amylase and lipase. Other: infrequently - general weakness, sweating, drug fever; rarely - chest pain, peripheral edema. Overdose Symptoms: dizziness, tremor, headache, fatigue, seizures, hallucinations, prolongation of the QTc interval, gastrointestinal disorders, liver and kidney dysfunction, crystalluria, hematuria.
Treatment: induction of vomiting or gastric lavage, taking activated charcoal, antacids containing calcium and magnesium to reduce the absorption of ciprofloxacin, symptomatic therapy.
The patient should be under close medical supervision. Kidney function should be constantly monitored. Ciprofloxacin is excreted in small quantities (less than 10%) during hemodialysis or peritoneal dialysis. Maintaining adequate hydration minimizes the risk of crystalluria. Interaction with other drugs Possible increase in the concentration of theophylline (and other xanthines, such as caffeine) in the blood serum and prolongation of the half-life.
As a result, the risk of unwanted effects caused by theophylline may increase.
During treatment with ciprofloxacin, more frequent monitoring of theophylline and caffeine levels in the blood serum is recommended. Ciprofloxacin inhibits the CYP1A2 isoenzyme, and this may cause increased plasma concentrations of concomitantly taken drugs that are metabolized by the CYP1A2 isoenzyme. Significant changes in the pharmacokinetic parameters of tizanidine, including an increase in AUC, T1/2, Cmax, an increase in oral bioavailability, and a decrease in plasma clearance were observed when used simultaneously with ciprofloxacin. This pharmacokinetic interaction may result in serious adverse events. A clinically significant decrease in blood pressure (both systolic and diastolic blood pressure decreases) and drowsiness were observed with simultaneous use of ciprofloxacin and a single dose of 4 mg tizanidine. In this regard, the simultaneous use of tizanidine with ciprofloxacin is contraindicated. In patients receiving concomitantly with ciprofloxacin any other drugs that are substrates for the CYP1A2 isoenzyme, caution must be exercised to prevent the onset of symptoms of overdose with these drugs. Plasma concentrations of these drugs should be periodically determined, especially when using theophylline. The absorption of ciprofloxacin is slowed down by the simultaneous use of iron, zinc, sucralfate or antacids and drugs with high buffering activity containing magnesium, aluminum or calcium. This also applies to sucralfate, antiviral drugs containing buffered didanosine, and oral nutritional solutions. This effect is also observed when consuming large amounts of dairy products (milk or liquid dairy products such as yogurt). Thus, ciprofloxacin should be taken either 1-2 hours before or 4 hours after taking the above substances. These restrictions do not apply to H2-histamine receptor blockers. The simultaneous use of very high doses of quinolones and some non-steroidal anti-inflammatory drugs (except acetylsalicylic acid) can provoke the development of seizures. When used simultaneously with uricosuric drugs, the elimination of ciprofloxacin is slowed down by 50% and the plasma concentration of ciprofloxacin increases. With simultaneous use of cyclosporine and ciprofloxacin, a transient increase in creatinine concentration is observed. These patients should have their blood creatinine levels checked regularly. Ciprofloxacin, like other quinolones, may enhance the effect of coumarin-derived anticoagulants, including warfarin. If these drugs are used concomitantly, monitor prothrombin time (PT) or other appropriate coagulation tests. If necessary, the dose of warfarin should be adjusted appropriately. With the simultaneous use of ciprofloxacin and glibenclamide, the effect of glibenclamide may be enhanced. Probenecid inhibits the renal excretion of ciprofloxacin, leading to increased concentrations of ciprofloxacin. Metoclopramide accelerates the absorption of ciprofloxacin. The maximum concentration of ciprofloxacin is achieved in a shorter time. The bioavailability of ciprofloxacin is not affected. With simultaneous use of ciprofloxacin or phenytoin, both an increase and a decrease in the concentration of phenytoin in plasma is possible, therefore it is recommended to monitor its concentration. The simultaneous use of ciprofloxacin and mexiletine may lead to increased concentrations of mexiletine. Concomitant use of opioid premedications (eg, papaveretum) or opioid premedications with anticholinergic premedications (atropine or hyoscine) with ciprofloxacin is not recommended due to decreased plasma concentrations of ciprofloxacin. The simultaneous use of ciprofloxacin and benzodiazepines does not affect the concentration of ciprofloxacin in plasma. However, due to reports of decreased clearance and increased T1/2 of diazepam with simultaneous use of ciprofloxacin and diazepam and, in some cases, with simultaneous use of ciprofloxacin and midazolam, it is recommended to monitor the effectiveness of benzodiazepine treatment. When ropinirole is used concomitantly with ciprofloxacin, there is a possibility of increased concentrations of ropinirole, which may be accompanied by an increased risk of adverse reactions. In case of simultaneous use, more careful monitoring of ropinirole therapy is necessary. Clinically significant interactions have been reported between ciprofloxacin and didanosine. Concomitant use of ciprofloxacin and methotrexate inhibits renal tubular transport, potentially leading to increased plasma concentrations of methotrexate, which may increase the risk of methotrexate-related toxicities. Therefore, it is necessary to monitor the condition of patients when treated with methotrexate and simultaneously taking ciprofloxacin. When used simultaneously with omeprazole, a slight decrease in the maximum plasma concentration of the drug and a decrease in AUC may be observed. Clinical studies have shown that the simultaneous use of duloxetine and potent inhibitors of the CYP1A2 isoenzyme (such as fluvoxamine) may lead to an increase in the AUC and Cmax of duloxetine. Although there is no clinical data on possible interactions with ciprofloxacin, the likelihood of such an interaction can be anticipated when ciprofloxacin and duloxetine are used concomitantly. In a study on healthy volunteers, it was found that the simultaneous use of drugs containing lidocaine and ciprofloxacin, a moderate inhibitor of the CYP1A2 isoenzyme, leads to a 22% decrease in the clearance of lidocaine when administered intravenously. Despite the good tolerability of lidocaine, when used simultaneously with ciprofloxacin, side effects may increase due to interaction. With simultaneous use of clozapine and ciprofloxacin at a dose of 250 mg for 7 days, an increase in serum concentrations of clozapine and N-desmethylclozapine was observed by 29% and 31%, respectively. The patient's condition should be monitored and, if necessary, the dosage regimen of clozapine should be adjusted during its simultaneous use with ciprofloxacin and for a short time after completion of combination therapy. Special instructions In patients with epilepsy or other disorders of the central nervous system (CNS) (for example, with convulsive readiness, a history of seizures, reduced cerebral blood flow, changes in brain structure or after a stroke), ciprofloxacin should be used only if there is benefit from such use exceeds the possible risk because the possibility of CNS side effects puts these patients at increased risk.
Undesirable effects on the central nervous system may occur after the first use of ciprofloxacin.
Depression or psychosis can in some cases lead to self-harm. If such reactions occur, treatment with ciprofloxacin should be interrupted immediately. Ciprofloxacin is not the drug of choice for suspected or established pneumonia caused by Streptococcus pneumoniae. Cases of crystalluria have been reported associated with the use of ciprofloxacin. Patients receiving ciprofloxacin should provide an adequate water regime. Excessive alpeony of urine should be avoided. Pseudomembranous colitis is a special form of enterocolitis, can develop against the background of antibiotics (in most cases is associated with Clostridium difficile). If severe and constant diarrhea occurred during or after treatment, a doctor’s consultation is necessary. Even with suspicion of the etiological role of Clostridium difficile, taking ciprofloxacin should immediately be discontinued and appropriate treatment should be prescribed. Antipoperistaltical drugs should not be used. Patients with a hereditary or personal history of the glucose-6-phosphate dehydrogenase defect are prone to hemolytic reactions when taking chinolons, therefore, in such patients, ciprofloxacin should be used with caution. Ciprofloxacin should be used with caution in patients with clinically significant liver or renal failure. Although ciprofloxacin rarely causes photosensitization, during the treatment course, a long stay under direct sunlight or ultraviolet radiation should be avoided. Inflammation and rupture of tendons (mainly Achilles tendon suffers) were described in the treatment of chinolons. Most often, elderly patients and patients receiving corticosteroids suffered. When pain or inflammation occurs, treatment with ciprofloxacin should be interrupted and unloaded the affected limb. If the symptoms of inflammation occurred in the area of the Achilles tendon on one of the limbs, it is necessary to take precautions to prevent the rupture of the Achilles tendon and on the other limbs, i.e. Treatment should be aimed at preventing the rupture of both tendons (by using tires or supporting both heels). Since ciprofloxacin has some activity against Mycobacterium Tuberculosis, with the samples of samples during treatment with cyprofloxacin, false negative results of cultural examination can be obtained. Ciprofloxacin should be used with caution in patients with myastenia. The use of ciprofloxacin according to indications that differ from the treatment of pneumonia caused by Pseudomonas aerugenosa against a background of churecycidosis in children over 5 years of age is not sufficiently studied, and there is no clinical experience. The use of fluoroquinolons is associated with the elongation of the QTC interval. Ciprofloxacin refers to a group of drugs with the low potential of this undesirable phenomenon. Caution must be observed when using ciprofloxacin to patients with the risk of ari. Long -term and repeated use of ciprofloxacin can lead to superinfection with resistant bacteria or pathogens of fungal infections. The influence on the ability to drive transport and other mechanisms during treatment should refrain from classes with potentially dangerous activities that require increased attention and speed of mental and motor reactions.
Release form Film-coated tablets, 250 mg and 500 mg.
10 tablets in blisters made of PVC/PVDC/A1 foil;
1, 2 or 10 blisters with instructions for use in a cardboard box. Storage conditions Store at a temperature not exceeding 25C.
Keep out of the reach of children.
Shelf life: 3 years.
Do not use after the expiration date stated on the package.
Conditions for dispensing from pharmacies By prescription.
Legal entity in whose name the RU was issued: Teva Pharmaceutical Enterprises Ltd.,
Israel.
Manufacturer:
Pharmaceutical plant Teva Private Co.
Ltd., st. Pallagi 13, H-4042 Debrecen, Hungary. Address for receiving claims: 119049, Moscow, st.
Shabolovka, 10, building 1. August 1, 2012
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