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indications:
Adults. Infections of the lower respiratory tract caused by Gram-negative bacteria (exacerbations of COPD, bronchopulmonary infections in the course of cystic fibrosis or bronchiectasis, pneumonia). Chronic purulent otitis media. Exacerbation of chronic sinusitis, especially caused by Gram-negative bacteria. Urinary tract infections. Inflammation of the testis and epididymis, including those caused byNeisseria gonorrhoeae. Pelvic organs inflammation, including those induced byNeisseria gonorrhoeae. If you suspect or recognize that the above-mentioned genital tract infections are caused byN. gonorrhoeae, it is particularly important to obtain local data on the prevalence of resistance to Ciprofloxacin and confirmation of sensitivity based on laboratory tests. Gastrointestinal infections (eg traveler's diarrhea). Infections in the abdominal cavity. Infections of the skin and soft tissues caused by Gram-negative bacteria. Malignant external otitis. Infections of bones and joints. Treatment of infections in patients with neutropenia. Prevention of infection in patients with neutropenia. Pulmonary form of anthrax (prevention of infections after contact with bacteria and treatment).Children and youth. Pulmonary-bronchial infections in cystic fibrosis caused byPseudomonas aeruginosa. Complicated urinary tract infections and pyelonephritis. Pulmonary form of anthrax (prevention of infections after contact with bacteria and treatment). Ciprofloxacin can also be used to treat severe infections in children and adolescents if deemed necessary. The official guidelines for the proper use of antibacterial drugs should be taken into account.
Composition:
1 bag (100 ml or 200 ml) contains 200 mg or 400 mg ciprofloxacin respectively (in 5% w / v Glucose monohydrate).
Action:
A chemotherapeutic agent from the fluoroquinolone group. Species usually sensitive to ciprofloxacin - Gram-positive aerobic bacteria:Bacillus anthracis; Gram-negative aerobic bacteria:Aeromonas spp., Brucella spp., Citrobacter koseri, Francisella tularensis, Haemophilus ducreyi, Haemophilus influenzae, Legionella spp., Moraxella catarrhalis, Neisseria meningitidis, Pasteurella spp., Salmonella spp., Shigella spp., Vibrio spp., Yersinia pestis; anaerobic bacteria:Mobiluncus spp.; other microorganisms:Chlamydia trachomatis, Chlamydia pneumoniae, Mycoplasma hominis, Mycoplasma pneumoniae. Bacteria that may have acquired resistance:Enterococcus faecalis, Staphylococcus spp., Acinetobacter baumannii, Burkholderia cepacia, Campylobacter spp., 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, Peptostreptococcus spp., Propionibacterium acnes. Resistant bacteria:Actinomyces spp., Enteroccus faecium, Listeria monocytogenes, Stenotrophomonas maltophilia, Mycoplasma genitalium, Ureaplasma urealyticum, anaerobic bacteria with the exception of those mentioned above. Methicillin resistant strainsS. aureus they are very often resistant to fluoroquinolones. Ciprofloxacin is 20-30% bound to plasma proteins. It achieves high concentrations in various tissues, such as: lung (epithelial fluid, alveolar macrophages, biopsy tissue), sinuses, inflammatory changes and urogenital tract (urine, prostate gland, endometrium), in which the total concentrations exceed plasma concentrations. 4 ciprofloxacin metabolites have been defined, with partial but definitely less antibacterial activity than the parent drug. Ciprofloxacin is excreted mainly unchanged, in the urine and partly in the faeces. T0,5 is 4-7 hours.
Contraindications:
Hypersensitivity to cipr Ofloxacin, other quinolones or other components of the preparation. Do not use with tizanidine.
Precautions:
Ciprofloxacin monotherapy is not intended to treat severe infections or infections that may be caused by Gram-positive and anaerobic bacteria - in such infections, ciprofloxacin should be given in combination with other appropriate antimicrobial agents. Ciprofloxacin is not recommended for the treatment of respiratory infections caused by Streptococci, due to insufficient efficacy. Inflammation of the testis, epididymis and pelvic inflammatory disease may be caused by a fluoroquinolone-resistant strainNeisseria gonorrhoeae - ciprofloxacin should be given in combination with another antibacterial agent, unless it has been confirmed in a laboratory study that the infection is caused by the strainN. gonorrhoeae sensitive to ciprofloxacin; if no clinical improvement is observed after 3 days of treatment, other treatments should be considered. Data on the efficacy of ciprofloxacin in the treatment of post-operative infections in the abdominal cavity are limited. When selecting ciprofloxacin for the treatment of traveler's diarrhea, information on the resistance of microorganisms in the countries visited should be taken into account. For the treatment of bone and joint infections, ciprofloxacin should be used with other antimicrobials in accordance with the results of microbiological tests. Data on use in the pulmonary form of anthrax are limited - national and / or international recommendations for the treatment of anthrax should be followed. During or after treatment with Ciprofloxacin, a bacterial strain resistant to ciprofloxacin may be isolated that may not cause symptoms of superinfection. As a result of long-term treatment or treatment of nosocomial infections and / or infections caused by speciesstaphylococcus andPseudomonas there is an increased risk of selecting resistant bacterial strains. Ciprofloxacin in children and adolescents should be used in accordance with the official guidelines available; ciprofloxacin should only be prescribed to doctors who have experience in the treatment of cystic fibrosis and / or severe infections in children and adolescents. Because of possible side effects associated with joints and / or surrounding tissues, ciprofloxacin treatment in children and adolescents can only be started after careful risk-benefit assessment. In the case of cystic-bronchial infections in cystic fibrosis, clinical trials included patients aged 5 to 17 years; Experience in treating children aged one to five years is limited. In complicated urinary tract infections and pyelonephritis in children and adolescents, treatment with ciprofloxacin should only be considered if other therapies can not be used and the decision should be based on the results of microbiological documentation; clinical trials included children and adolescents from one to 17 years of age. In other severe infections in children and adolescents, ciprofloxacin is used in accordance with official guidelines or after careful risk-benefit assessment if no other treatment can be given or in the event of failure of conventional therapy and when microbiological documentation justifies the use of ciprofloxacin; no clinical trials have been conducted regarding the use of ciprofloxacin in specific severe infections other than those listed above - caution is recommended in the treatment of patients with such infections. Ciprofloxacin should not be used in patients with tendon diseases associated with prior quinolone treatment, except for the treatment of serious infections, when other standard treatments have failed or there is resistance to bacteria, and microbiological data may justify the use of ciprofloxacin; in such a situation, the benefit / risk ratio should be evaluated before starting treatment with ciprofloxacin. The risk of tendon disorders may be greater in elderly patients or in patients treated concurrently with corticosteroids. Avoid using patients deficient in glucose-6-phosphate dehydrogenase; if ciprofloxacin treatment is necessary, the patient should be monitored for haemolysis. Ciprofloxacin should be used with caution in patients with myasthenia gravis; with disturbances o.u.n. which may predispose to convulsions; with impaired renal function (dosage modification needed); with risk factors for QT prolongation; treated with preparations metabolised by CYP1A2 (such as theophylline, clozapine, ropinirole) - observe the patient for signs of overdose with these medicines.The use of ciprofloxacin concomitantly with Methotrexate is not recommended. Treatment with ciprofloxacin should be discontinued if signs of tendinitis (no strain on the affected limb), seizures, psychotic reactions with self-destructive behavior, neuropathy, liver dysfunction and also anaphylactic or anaphylactoid reactions occur. For any patient who has experienced diarrhea after treatment, the possibility of pseudomembranous colitis should be considered; after diagnosis of this disease, ciprofloxacin should be discontinued and appropriate treatment instituted. UV exposure should be avoided during treatment. During treatment, the patient should be well hydrated to prevent crystalluria. Excess alkalinisation of urine should not be allowed. The glucose content of the preparation (5 g glucose in 100 ml, 10 g glucose in 200 ml) should be taken into account in patients with diabetes mellitus.
Pregnancy and lactation:
Available data on the administration of ciprofloxacin to pregnant women do not indicate that it causes malformations or toxic to the fetus and newborn. It can not be ruled out that the drug may cause damage to the articular cartilage in the fetus or immature organism. The use of ciprofloxacin during pregnancy should be avoided. Ciprofloxacin is excreted in human milk. Due to the risk of cartilage damage to the joints, the use of ciprofloxacin during breast-feeding is contraindicated.
Side effects:
Frequency analysis was performed jointly for oral and intravenous forms of ciprofloxacin. Common: nausea, diarrhea, local reaction to puncture and infusion. Uncommon: fungal infections, eosinophilia, lack of appetite, excessive psychomotor activity, agitation, headache, dizziness, disturbed sleep, disturbed taste, vomiting, stomach and intestinal pain, abdominal pain, indigestion, bloating, increased transaminase, increased bilirubin in the blood, rash, pruritus, urticaria, musculoskeletal pain (eg pain in the limbs, back pain, chest pain), joint pain, renal dysfunction, weakness, fever, increase in alkaline phosphatase in the blood. Rare: colitis associated with the use of antibiotics (very rarely life-threatening), leukopenia, anemia, neutropenia, leukocytosis, thrombocytopenia, thrombocythaemia, allergic reactions, allergic edema, angioneurotic edema, hyperglycemia, confusion, disorientation, anxiety, unusual dreams, depression hallucinations, paresthesias, dyesthesias, hypoaesthesia, tremor, convulsions, visual disturbances, tinnitus, hearing loss or hearing impairment, tachycardia, vasodilatation, hypotension, syncope, dyspnoea (including asthmatic status), liver dysfunction, cholestatic jaundice, inflammation liver disease, hypersensitivity reactions to light, muscle pain, arthritis, increased tension and muscle spasms, renal failure, hematuria, crystalluria, renal tubular interstitial nephritis, edema, hyperhidrosis, abnormal prothrombin concentration, increased amylase activity. Very rare: haemolytic anemia, aplastic anemia, pancytopenia (life threatening), bone marrow suppression (life threatening), anaphylactic reaction, anaphylactic shock (life threatening), reaction similar to serum sickness, psychotic reactions, migraine, coordination disorders, gait disturbances , olfactory disorders, intracranial hypertension, distorted color vision, vasculitis, pancreatitis, hepatic necrosis (very rarely progressive to life-threatening liver failure), ecchymosis, erythema multiforme, erythema nodosum, Stevens-Johnson syndrome (life-threatening), toxic necrosis -difficult epidermis (which may be life-threatening), muscle weakness, tendinitis, tendon rupture (mainly Achilles tendon), worsening of myasthenia gravis. Not known: peripheral neuropathy, ventricular arrhythmias andtorsades de pointes (reported primarily in patients with risk factors for QT prolongation). In children, arthropathy often occurs.
Dosage:
Intravenously. When treating infections caused by some bacteria (Pseudomonas aeruginosa, Acinetobacter spp. orStaphylococcus spp.) it may be necessary to administer higher doses of ciprofloxacin and use in combination with other suitable antibacterial agents. Depending on the microorganism causing the infection, during the treatment of some infections (e.g.pelvic inflammatory disease, intra-abdominal infection, infection in patients with neutropenia and bone and joint infections) may be needed in combination with another suitable antibacterial agent.Adults. Infections of the lower respiratory tract, upper respiratory tract infections (exacerbation of chronic sinusitis, chronic purulent otitis media): 400 mg 2-3 times a day, for 7-14 days. Malignant otitis externa: 400 mg 3 times a day, for 28 days-3 months. Complicated and uncomplicated pyelonephritis: 400 mg 2-3 times a day for 7-21 days; in special cases (eg abscesses) the treatment can be continued for more than 21 days. Prostatitis (acute): 400 mg 2-3 times a day for 2-4 weeks. Epithelial and epididymal inflammation and pelvic inflammatory disease: 400 mg 2-3 times a day for at least 14 days. Diarrhea caused by pathogenic bacteria, inclShigella spp. different thanShigella dysenteriae type 1 and empiric treatment of travelers' diarrhea: 400 mg 2 times a day for 1 day. Diarrhea caused byShigella dysenteriae type 1: 400 mg 2 times daily for 5 days. Diarrhea caused byVibrio cholerae400 mg 2 times a day for 3 days. Typhoid fever: 400 mg 2 times a day for 7 days. Intra-abdominal infections caused by Gram-negative bacteria: 400 mg 2-3 times a day for 5-14 days. Infections of the skin and soft tissues: 400 mg 2-3 times a day, for 7-14 days. Infections of bones and joints: 400 mg 2-3 times a day, for a maximum of 3 months. Treating or preventing infection in patients with neutropenia (ciprofloxacin given in combination with other antimicrobial agents): 400 mg 2-3 times a day, throughout the period of neutropenia. Pulmonary form of anthrax (prevention of infection after contact and treatment) in patients in need of parenteral treatment (if contact with anthrax is suspected or confirmed), 400 mg 2 times a day for 60 days from confirmation of contact fromBacillus anthracis. Children and youth. Cystic fibrosis: 10 mg / kg 3 times a day, up to 400 mg per dose, for 10-14 days. Complicated urinary tract infections and pyelonephritis: 6-10 mg / kg 3 times a day, up to 400 mg per dose, for 10-21 days. The pulmonary form of anthrax (prevention of contamination after contact and treatment) in patients in need of parenteral treatment (if you suspect or confirm contact with the anthrax bursal should be started as soon as possible): 10-15 mg / kg. 2 times a day, up to 400 mg for one dose, for 60 days from confirmation of contact withBacillus anthracis. Other serious infections: 10 mg / kg 3 times a day, up to 400 mg per dose.Patients with impaired renal function. The recommended initial and maintenance dose depends on the severity of the infection and the creatinine clearance (CCr): CCr> 60 ml / min, creatinine concentration <124 μmol / l: typical dosage according to the above recommendations; CCr 30-60 ml / min, creatinine concentration 124-168 μmol / l: 200-400 mg every 12 h; CCr <30 ml / min, creatinine concentration> 169 μmol / l: 200-400 mg every 24 h; patients undergoing hemodialysis, creatinine> 169 μmol / l: 200-400 mg every 24 hours (after dialysis); patients undergoing peritoneal dialysis, creatinine> 169 μmol / l: 200-400 mg every 24 h. Elderly patients should be given a dose adjusted to the severity of infection and creatinine clearance. No dosage adjustment is necessary for patients with hepatic impairment. Doses have not been studied in children with impaired renal function and / or liver function. The drug should be administered as an intravenous infusion. For adult patients, the 400 mg dose is given as an infusion lasting 60 min, a dose of 200 mg - an infusion lasting 30 min. The duration of infusion in children is 60 minutes. Slow infusion into a large venous vessel will minimize patient discomfort and reduce the risk of venous irritation. During the administration of the drug local skin reaction may appear (especially when the infusion lasts 30 minutes or shorter), which disappears shortly after completion of the infusion. There are no contraindications to the Next intravenous administration, unless the reaction is recurrent or worse. Due to the lack of compatibility tests, the preparation should not be mixed with other medicines.