Ciprofloxacin-Teva pills 500mg 10pcs

Composition

of 1 tab. Ciprofloxacin (in the form of monohydrate hydrochloride) 500 mgsupport substances: microcrystalline cellulose 73.3 mg, povidone K-30 37.5 mg, croscarmellose sodium 42 mg, colloidal silicon dioxide 7.5 mg, magnesium stearate 7.5 mg. Composition of the film shell: Opadray white Y-1-7000H (hypromellose 6.25 mg, titanium dioxide 3.125 mg, macrogol-400 0.625 mg).

Pharmacological action

Ciprofloxacin is a synthetic broad-spectrum antibacterial drug from the group of fluoroquinolones. Ciprofloxacin has in vitro activity against a wide range of gram-negative and gram-positive microorganisms. The bactericidal action of ciprofloxacin is carried out by inhibiting bacterial topoisomerases of type II (topoisomerase II (DNA gyrase) and topoisomerase IV), which are necessary for replication, transcription, repair and recombination of bacterial DNA. Mechanisms of resistance Ciprofloxacin resistance in vitro is often caused by point mutations of bacterial topoisomerases and DNA gyrase and develops slowly through multi-step mutations. Single mutations can lead to a decrease in sensitivity rather than to the development of clinical resistance, but multiple mutations mainly lead to the development of clinical resistance to ciprofloxacin and cross-resistance to quinolone-type drugs. Resistance to ciprofloxacin, as with many other antibiotics, can be formed as a result of a decrease in the permeability of the bacterial cell wall (as often occurs in the case of Pseudomonas aeruginosa) and/or activation of excretion 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 probably do not interfere with the antibacterial activity of ciprofloxacin. Microorganisms that are 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 sensitivity testing Reproducible criteria for ciprofloxacin sensitivity testing approved by the European Committee for the Determination of Antibiotic Sensitivity (EUCAST) are presented in the table below: European Committee for the Determination of Antibiotic Sensitivity. Borderline MIC values (mg / L) in clinical settings for ciprofloxacin 1. Staphylococcus spp. – borderline values for ciprofloxacin and ofloxacin are associated with high-dose therapy. 2. Streptococcus pneumoniae-wild type S. pneumoniae is not considered sensitive to ciprofloxacin and ofloxacin and thus belongs to the category of microorganisms with intermediate sensitivity. 3. Strains with a MIC value exceeding the threshold sensitive/moderately sensitive ratio are very rare, and so far there have been no reports of them. Identification and antimicrobial sensitivity tests for detecting such colonies should be repeated, and the results should be confirmed by colony analysis in a reference laboratory. Until evidence of a clinical response is obtained for strains with confirmed MIC values exceeding the currently used resistance threshold, they should be considered as resistant. Haemophilus spp. /Moraxella spp. – it is possible to detect strains of Haemophilus influenzae with low sensitivity to fluoroquinolones (MIC for ciprofloxacin – 0.125-0.5 mg/l). There is no evidence for the clinical significance of low resistance in H. Influenzae-related respiratory tract infections. 4. Borderline values not related to microbial species were determined mainly on the basis of pharmacokinetic/ pharmacodynamic data and do not depend on the distribution of MICS for specific species. They are only applicable for species for which a species-specific sensitivity threshold has not been defined, and not for those species for which sensitivity testing is not recommended. For certain strains, the spread of acquired resistance may vary by geographic region and over time. In this regard, it is advisable to have local information about resistance, especially in the treatment of serious infections. Data from the Institute of Clinical and Laboratory Standards for MIC boundary values (mg / L) and diffusion testing (zone diameter [mm]) using disks containing 5 micrograms of ciprofloxacin are presented in the table below. Institute of Clinical and Laboratory Standards. Boundary values for MIC (mg / L) and for diffusion testing (mm) using disks a. This reproducible standard applies only to tests using dilutions with broth using cationic corrected Muller-Hinton broth (CAMNB), which is incubated with air access at a temperature of 35 ± 2 °C for 16-20 hours for strains of Enterobacleriaceae, Pseudomonas aeruginosa, other bacteria not belonging to the family Enterobacteriaceae, Staphylococcus spp., Enterococcus spp. and Bacillus anthracis; 20-24 h for Acinetobacter spp.,24 h for Y. pestis (incubate for another 24 h in case of insufficient growth) b. This reproducible standard applies only to diffusion tests using disks using Muller-Hinton agar, which is incubated with air access at a temperature of 35 ± 2 °C for 16-18 h. c. This reproducible standard applies only to diffusion tests using disks for determining sensitivity with Haemophilus influenzae. infuenzae and Haemophilus parainfluenzae using a broth test medium for Haemophilus spp. (HTM), which is incubated with air access at 35°C ± 2°C for 20-24 hours. This reproducible standard applies only to diffusion tests using disks using HTM, which is incubated in 5% CO2 at 35°C ± 2°C for 16-18 hours. This reproducible standard applies only to sensitivity tests (diffusion tests using zone discs and agar solution for MICS) using gonococcal agar and 1% of the established growth additive at a temperature of 36°C ± 1°C (not exceeding 37°C) in 5% CO2 for 20-24 h. e. This reproducible standard applies only to tests using dilutions with broth using cationic corrected Muller-Hinton broth (SAMNV) with 5% sheep blood added, which is incubated in 5% CO2 at 35 ± 2 °C for 20-24 hours. g. This reproducible standard applies only to tests using dilutions with broth using cationic corrected Muller-Hinton broth (SAMNV) with a certain 2% growth additive added, which is incubated with air access at 35 ± 2 °C for ± 2 ° C for 48 h. In vitro sensitivity to ciprofloxacin For certain strains, the spread of acquired resistance may vary depending on the geographical region and over time. Therefore, when testing strain sensitivity, it is desirable to have local information about resistance, especially in the treatment of severe infections. If the local prevalence of resistance is such that the benefit of using the drug, at least in relation to several types of infections, is doubtful, you should consult a specialist. In vitro activity of ciprofloxacin was 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 were 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. 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 acnes)

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to Ciprofloxacin:

• respiratory tract;
• ear, throat and nose;
• kidneys and urinary tract;
• genitals;
• digestive system (including mouth, teeth, jaws);
• gallbladder and biliary tract;
• skin, mucous membranes and soft tissues;
• musculoskeletal system.

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

Contraindications

• hypersensitivity to Ciprofloxacin;
• pseudomonas;
• glucose-6-phosphate dehydrogenase deficiency;
• embranous colitis;
• children under 18 years of age (before the skeletal formation process is completed);
• pregnancy;
• lactation (breastfeeding);
• hypersensitivity to Ciprofloxacin or other drugs from the fluoroquinolone group.

With caution, the drug should be prescribed in patients with severe atherosclerosis of the cerebral vessels, cerebral circulation disorders, mental illnesses, convulsive syndrome, epilepsy, severe renal and/or liver failure, and elderly patients.

Side effects

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

From the central nervous system and peripheral nervous system: dizziness, headache, fatigue, anxiety, tremor, insomnia, “nightmare” dreams, peripheral paralgesia (abnormal perception of pain), sweating, increased intracranial pressure, anxiety, confusion, depression, hallucinations, manifestations of psychotic reactions (sometimes progressing to conditions in which the patient can harm himself), migraine, fainting, cerebral artery thrombosis.

From the side of the senses: disorders of taste and smell, visual impairment (diplopia, color perception changes), tinnitus, hearing loss.

From the cardiovascular system: tachycardia, cardiac arrhythmias, decreased blood pressure, flushes of blood to the skin of the face.

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

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

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

Musculoskeletal disorders: arthralgia, arthritis, tendovaginitis, tendon tears, myalgia.

Allergic reactions: skin pruritus, urticaria, blistering accompanied by bleeding, scab-forming papules, drug fever, spot hemorrhages (petechiae), facial or laryngeal edema, shortness of breath, eosinophilia, increased photosensitivity, vasculitis, erythema nodosum, exudative erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome).

Other services: arthralgia, arthritis, tendovaginitis, tendon tears, general weakness, myalgia, superinfections (candidiasis, pseudomembranous colitis), pain and burning at the injection site, phlebitis.

Interaction

Due to a decrease in the activity of microsomal oxidation processes in hepatocytes, ciprofloxacin increases the concentration and prolongs the half-life of theophylline and other xanthines (for example, caffeine), oral hypoglycemic drugs, indirect anticoagulants, and helps to reduce the prothrombin index. Concomitant use with NSAIDs (with the exception of acetylsalicylic acid) increases the risk of seizures. Metoclopramide accelerates the absorption of ciprofloxacin, which reduces the time to reach the maximum concentration of the latter. Co-use of uricosuric drugs leads to a slowdown in excretion (up to 50%) and an increase in the plasma concentration of ciprofloxacin. When combined with other antimicrobials (beta-lactam antibiotics, aminoglycosides, clindamycin, metronidazole), synergy is usually observed. Therefore, Ciprofloxacin 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 isoxazolpenicillins and vancomycin – for staphylococcal infections; with metronidazole and clindamycin – for anaerobic infections. Ciprofloxacin enhances the nephrotoxic effect of cyclosporine, an increase in serum creatinine is also noted, so in such patients it is necessary to monitor this indicator 2 times a week. When taken simultaneously, Ciprofloxacin enhances the effect of indirect anticoagulants.

How to take, course of use and dosage

The dose of Ciprofloxacin depends on the severity of the disease, type of infection, body condition, age, weight, and kidney function of the patient. Usually recommended doses: Ciprofloxacin in dosage form tablets of 250 mg and 500 mg for oral use:For urinary tract infections, take Ciprofloxacin 0.125-0.5 g 2 times a day, in more severe cases – up to 0.75 g 2 times a day. The course of treatment is usually 5-15 days.

Diseases of the lower respiratory tract of moderate severity-250 mg, and in more severe cases,500 mg,2 times a day;For the treatment of gonorrhea, a single dose of Ciprofloxacin 250-500 mg is recommended;

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

The drug should be taken on an empty stomach, washed down with a sufficient amount of liquid. Patients with severe renal impairment should be given a half – dose of the drug.

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

Overdose

Treatment: the specific antidote is unknown.

It is necessary to carefully monitor the patient’s condition, perform gastric lavage, carry out the usual emergency measures, and ensure sufficient fluid intake.

With the help of hemo-or peritoneal dialysis, only a small amount (less than 10%) of the drug can be removed.

Description

White film-coated tablets, capsule-shaped, with the inscription “CIP 500” and a risk on one side; two layers are visible on the cross-section, the core is white to yellowish-white in color.

Special instructions

If severe and prolonged diarrhea occurs during or after Ciprofloxacin treatment, the diagnosis of pseudomembranous colitis should be excluded, which requires immediate discontinuation of the drug and appropriate treatment. During treatment with Ciprofloxacin, it is necessary to provide a sufficient amount of fluid while maintaining normal diuresis. During treatment with Ciprofloxacin, avoid contact with direct sunlight.

Patients with epilepsy, seizures in the anamnesis, vascular diseases and organic brain damage due to the threat of adverse reactions from the central nervous system Ciprofloxacin should be prescribed only for vital indications. If severe and prolonged diarrhea occurs during or after Ciprofloxacin treatment, the diagnosis of pseudomembranous colitis should be excluded, which requires immediate discontinuation of the drug and appropriate treatment. If there is pain in the tendons or if the first signs of tendovaginitis appear, treatment should be discontinued due to the fact that individual cases of inflammation and even tendon rupture have been described during treatment with fluoroquinolones.

Influence on the ability to drive motor vehicles and manage mechanismsPatients taking Ciprofloxacin should exercise caution when driving a car or engaging in other potentially dangerous activities that require increased attention and speed of psychomotor reactions (especially when drinking alcohol at the same time).

Storage conditions

Store in a dark place at a temperature of 5 ° C to 20°C out of the reach of children.

Active ingredient

Ciprofloxacin

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as prescribed by a doctor, for children as prescribed by a doctor

Indications

Otitis Media, Infectious Diseases, Urinary Tract Infections, Respiratory Tract Infections, Bronchitis, Pneumonia, Intestinal Infections, Salmonellosis, Adnexitis, Skin Infections, Inflammatory eye diseases