CIFRAN. 250 mg. 20 tablets
CIFRAN. 250 mg. 20 tablets
Qualitative and quantitative composition :
Each tablet contains ciprofloxacin hydrochloride Ph. Eur equivalent to ciprofloxacin 250 mg or 500 mg, or 750 mg.
3 . formulation
Film-coated tablets for oral use .
4 . clinical data
Cifran tablets are indicated for treatment of the following infections caused by susceptible microorganisms ciprofloxacin :
• Infections of the kidney and urinary tract , uncomplicated and complicated urethritis , cystitis, pyelonephritis
• Infections of the genital organs , prostatitis, epididymitis , salpingitis , endometritis , pelvic inflammatory disease, gonorrhea
• Respiratory tract infections , pneumonia (not the first choice for the treatment of pneumococcal pneumonia) , acute and chronic bronchitis , bronchiectasis , acute exacerbation of cystic fibrosis ( in Gram- negative pathogens , especially P. aeruginosa)
• infection of the middle ear , of the paranasal sinuses caused Gram- negative microorganisms or staphylococci
• Eye Infections
• Infections of the skin and soft tissues of infected wounds, abscesses , cellulitis , infections of the external auditory canal
• Infections of the bones and joints - osteomyelitis , septic arthritis
• Abdominal infections, biliary tract
• Infectious diarrhea
• Typhoid fever
• Prevention of infections in surgery , mainly in gastroenterology , urology
Applies only to treat acute pulmonary infection caused by Pseudomonas aeruginosa in cystic fibrosis in children over 7 years old.
4.2 . Dosage and method of administration
Respiratory tract infections :
According to the severity and causative in 250-500 mg twice daily.
Urinary tract infections :
Uncomplicated acute and - two times of 125 mg twice to 250 mg
Cystitis in women (before menopause) - single 250 mg. Complicated - twice as 250-500 mg
Extragenital - twice 125 mg
Acute uncomplicated - a single 250 mg
One, two times 500 mg
In particularly severe , life-threatening infections , such as pneumonia , recurrent infectious strokes in patients with cystic fibrosis , infection of the abdominal cavity , bones , and joints , sepsis caused by Pseudomonas , staphylococci and streptococci , two times 750 mg.
A single dose of 750 mg, a 60-90 minutes prior to a surgical procedure , providing an adequate prophylactic coating.
Impaired renal function with creatinine clearance <20 ml / minute half of the recommended dose is administered twice daily or once daily administered full dose .
Children over 7 years: the recommended dose of ciprofloxacin was 7.5 -15 mg / kg daily , given in two divided doses.
Hepatic impairment: No adjustment of dozata.Litsa Elderly: Dose is determined depending on the severity of the disease and creatinine clearance.
Duration of treatment :
Determine the severity of the disease, and its clinical course and bacterial findings. As a rule, treatment should be continued for at least three days after the normalization of the temperature , respectively , after the disappearance of clinical symptoms. The median duration of therapy is one day in acute gonorrhea to 7 days of infection of the kidneys , urinary tract and the abdominal cavity , during the period of neutropenia in patients with weakened own defenses , a maximum of 2 months with osteomyelitis and from 7 to 14 days for all other infections. In streptococcal infections and infections caused by chlamydia, because of the risk of late complications , treatment should be continued for at least 10 days.
4.3 . Contraindications
Cifran tablets is contraindicated in patients with known hypersensitivity to ciprofloxacin or other quinolones , or to any of the excipients .
4.4 . Special warnings and precautions for use
The potential risks and benefits should be carefully weighed when ciprofloxacin is given to patients with diseases of the central nervous system, including epilepsy and cerebral arteriosclerosis . For adverse reactions from the CNS (see section 4.8 ), treatment with ciprofloxacin should be discontinued and appropriate measures are taken .
Observed hypersensitivity reactions , sometimes severe , even after the first administration of ciprofloxacin. Severe allergic reactions require immediate use of adrenaline and if necessary oxygen , intravenous corticosteroids , keeping the airways including intubation . At the first appearance of skin rash or any other sign of hypersensitivity , treatment with ciprofloxacin should be discontinued .
The studies have not demonstrated geriatric -specific problems that would limit the use of fluoroquinolones in the elderly .
Ciprofloxacin therapy may lead to development of crystalluria . As a precautionary measure, the patients should be well hydrated , and alkalisation of urine should be izbyagva.Kakto in all drugs of this class has been shown that ciprofloxacin causes arthropathy bearing joints of immature animals . With the use of ciprofloxacin in patients under 18 years of age with cystic fibrosis , no evidence of drug-related damage to the cartilage and joints. Not recommended the use of ciprofloxacin in children and adolescents ( under 18 years ), except for the treatment of acute pulmonary infection caused by P. aeruginosa in cystic fibrosis.
Tendinitis and tendon rupture may occur with quinolone antibiotics , especially in older patients and those treated with corticosteroids together . Importantly , treatment with ciprofloxacin be discontinued at the first appearance of pain or inflammation.
The appearance of pseudomembranous colitis has been reported in ;
antibacterial agents , including ciprofloxacin. Therefore, the presence of severe and persistent diarrhea during or after treatment with ciprofloxacin, this diagnosis should be considered and to take appropriate therapeutic measures .
During treatment with ciprofloxacin, patients should avoid excessive exposure to sunlight due to a risk of photosensitivity reactions . If such reactions , the antibiotic should be discontinued.
Prolonged treatment with ciprofloxacin periodic monitoring of renal, hepatic and hematopoietic function.
Ciprofloxacin should be used with caution in patients with glucose- 6 - phosphate dehydrogenase deficiency , since they tend to haemolytic reactions to quinolones .
4.5 . Interactions
Theophylline: ciprofloxacin resulting in increased serum concentrations of theophylline. If concomitant use can not be avoided, the dose should be reduced and serum levels of theophylline should be monitored . Where monitoring of serum levels is not possible , ciprofloxacin should be avoided , especially in patients with convulsive narusheniya.Lekarstveni products containing magnesium, aluminum, calcium or iron salts : absorption of ciprofloxacin reduced by simultaneous use of these drugs , so ciprofloxacin should not be administered within 4 hours of administration of these agenti.Probenecid : Renal tubular secretion of ciprofloxacin is reduced by co-administration of probenecid.
NSAIDs : It has been reported that co-administration enhances the effect of NSAIDs on the CNS and the quinolones may lead to convulsions.
Cyclosporin: reported an increase in serum creatinine. Monitoring of serum creatinine is recommended
Glibenclamide: Coadministration may lead to hypoglycaemia.
Preanestetichni opiates and anticholinergic agents : Concomitant administration of ciprofloxacin should be avoided , as it can not achieve adequate antibiotic coverage during operation.
Oral anticoagulants: reported prolongation of bleeding time . When co-administered with ciprofloxacin should be monitored regularly prothrombin time and other coagulation parameters.
Metoclopramide: Absorption of ciprofloxacin is increased with the use of metoclopramide.
4.6 . Pregnancy and lactation
Studies in mice, rats and rabbits have not produced any evidence of teratogenicity, impairment of fertility or harm to the peri / postnatal development. The administration of ciprofloxacin, and other quinolones may cause arthropathy in immature animals. As a result , ciprofloxacin is not recommended for pregnant women. Also, because ciprofloxacin is excreted in breast milk its use in nursing mothers is not recommended.
4.7 Effects on ability to drive and use machines
Ciprofloxacin can lead to impair the ability of patients to drive or operate machinery , especially when used with alcohol.
4.8 Undesirable effects
Gastrointestinal : Nausea , vomiting , diarrhea, candidiasis of the mouth , abdominal pain, dyspepsia, anorexia , flatulence , and dysphagia . Rarely pseudomembranous colitis.
Skin / Hypersensitivity: Rash, pruritus, urticaria , photosensitivity , drug- induced fever, anaphylactic / anaphylactoid reactions. Rarely erythema nodosum and erythema multiforme . Very rarely, petechiae , hemorrhagic bullae , vaskulyt d syndrome Steven's-Johnson syndrome Lyeil. Lechenieto with ciprofloxacin should be discontinued if any of the above side effects occur in the first application.
Central nervous system: Headache, anxiety, depression, dizziness , tremors , convulsions , confusion , hallucinations, somnolence. Sleep disturbances and anxiety have been reported very rarely . Reported isolated cases of ciprofloxacin -induced psychosis . There are also reports on isolated intracranial hypertension associated with quinolone therapy .
Renal: Transient increases in blood urea nitrogen or serum creatinine, crystalluria , nephritis and renal failure.
Hepatic : Transient elevations of liver enzymes and serum bilirubin (especially in patients with pre-existing liver damage), hepatitis, jaundice and significant liver problems, including liver necrosis, which may rarely progress to liver failure.
Musculoskeletal : Reversible arthralgia , joint swelling , and myalgia .
Rarely tenosynovitis . Has been reported isolated cases of inflammation of the tendon , which can result in tendon rupture . Treatment should be discontinued immediately if these symptoms poyavyat.Hematologichni parameters : eosinophilia , leucopenia, granulocytopenia , thrombocytopenia, thrombocytosis , changes in prothrombin levels and very rarely haemolytic anemia.
Specific senses : visual disturbances , changes in taste and smell , tinnitus and transient hearing loss , especially at high frequencies.
Cardiovascular System: There have been reports of tachycardia , hypertension, ???????????.??????????????? use of ciprofloxacin may result in overgrowth of non-susceptible organisms , including . and fungi.
In case of overdose , the stomach should be emptied by inducing vomiting or by gastric lavage . Antacids containing calcium or magnesium given soon enough can reduce the absorption of ciprofloxacin. In addition to maintenance therapy should ensure adequate hydration . It is also important to monitor renal function, including urinary pH , if necessary acidified to prevent crystalluria . Only a small amount (<10% ) is removed from the body by hemodialysis or peritoneal dialysis.
5 . pharmacological
5.1. Pharmacodynamic properties
ATC code : J01MA02 - Ciprofloxacin
Mode of action
Fluoroquinolones exert their antibacterial activity by inhibiting the enzyme bacterial topoisomerase | [( DNA gyrase ) . Topoisomerases are responsible for the continuous introduction of negative svrahspirali DNA . This reaction is ATP -dependent , requires that the two strands of the DNA to be cut to allow passage of a segment of DNA through the break , and then the suspension is released . Fluoroquinolones decrease the introduction of negative svrahspirali DNA and cause a rapid cessation of DNA synthesis by interfering with DNA replication advocating .
Ciprofloxacin is indicated for treatment of infections caused by one or more susceptible organisms . With ciprofloxacin can treat infections caused by organisms resistant to other antibiotics , including aminoglycosides, penicillins and tsefalosporini.S view of the extensive tissue penetration of ciprofloxacin, combined with its powerful antibacterial activity (including antipsevdomonazna activity) , it can be used in combination with aminoglycoside antibiotics or betalaktamny . Such administration may be indicated in cases where there is severe neutropenia . When the suspected presence of anaerobic microorganisms , ciprofloxacin can be combined with metronidazole or clindamycin .
Antibacterial spectrum of ciprofloxacin includes most Gram- negative and Gram- positive microorganisms : Escherichia coli, Klebsiella spp., Salmonella typhi and other Salmonella spp., Proteus mirabilis, Proteus vulgaris, Yersinia enterocolitica, Providencia spp., Pseudomonas aeruginosa, Shigella flexneri, Shigella sonnei, Neisseria gonorrhoeae, Neisseria meningitidis, Moraxella catarrhalis, Vibrio cholerae, Citrobacter spp., Edwardsiella tarda, Enterobacter spp., Morganella morganii, Serratia spp., Aeromonas spp., Plesiomonas, Hafnia alvei, Campylobacter spp., Hemophilus spp., Moraxella spp., Legionella spp., Brucella melitensis, Staphylococcus spp. ( methicillin - susceptible) and Corynebacterium spp.Ciprofloxacin is less active against these , microorganisms. Before starting treatment should be conducted sensitivity test :
Acinetobacterspp., Alcaligenes spp., Flavobacterium spp .. pop -aeruginosa Pseudomonas spp., Gardnerella vaginalis, Chlamydia spp., Mycoplasma spp., U Mycobacterium tuberculosis, Mycobacterium fortuitum, Enterococcus faecalis, Streptococcus agalactiae, Streptococcus pneumoniae, Streptooccus pyogenes, viridans group streptococci.
Anaerobes vary in their sensitivity intermediately susceptible to resistant. Especially Bacteroides fragilis group and Clostridium difficile are resistant .
In addition , the following microorganisms are resistant Ciprofloxacin: Ureaplasma urealyticum, Nocardia asteroides, Enterococcus faecium, Listeria monocytogenes.
Ciprofloxacin is not active against Treponema pallidum.
In-vitro studies have shown the results of the additive activity when ciprofloxacin was coadministered with other antibacterial agents.
5.2 . pharmacokinetics
Ciprofloxacin is well absorbed when given orally and bioavailability of 70 %. Mean maximum plasma reached after a single dose of 250 mg and 500 mg ciprofloxacin are 1,2 ? / ml and 2.4 ? / ml , respectively , achieved within 1-2 hours of administration . Absorption is delayed when ciprofloxacin is given with food.
Plasma protein binding ranged from 20 to 40%. Ciproioxacin extensively partitioned into the tissues and body fluids , including lung, skin , fat, muscle , cartilage , bone, and genital tissues , including the prostate . It is present in active form in the saliva , nasal and bronchial secretions, sputum , vesicular fluid , lymph, peritoneal fluid , bile , and prostatic secretions .
Ciprofloxacin is partly metabolised in the liver. About 50% of an oral dose is otkriva.nepromenena in urine and 15% as active metabolite primarily oxociprofloxacin. The rest undergoes biliary and transluminal secretion in intestinal mucosa .
The serum half-life is about 3.5 - 4.5 hours . The half-life may be prolonged in severe renal insufficiency and in patients in the elderly.
5.3 . Preclinical safety data
Damage of weight bearing joints of young animals has been observed in studies with ciprofloxacin and other quinolones . Ciprofloxacin is not a major nephrotoxic substance , but in high doses reduced urine volume and alkaline urine appears crystalluria . It causes mechanical damage and triggers a reaction type something in the renal tubules.
With the exception of the two in vitro tests ( unscheduled DNA synthesis assay and mouse lymphoid cells ) all in vitro and in vivo mutagenic studies were negative . In addition , studies of chronic toxicity in rats several months , did not provide any evidence of tumorigenicity of ciprofloxacin. Teratogenic or embryolethal effects were observed in monkeys. Toxicity of CNS in interaction between ciprofloxacin and NSAIDs was observed in rats only at therapeutically inappropriate high dose levels .
6.2 . incompatibilities
6.3 Shelf life
For 2 years.
6.4 . Special precautions for storage
Do not store above 25 ° C. Protect from moisture.
6.5. Packaging Data
The tablets are supplied in blister strips of PVC foil Blisterot 10tabletki box 1x10, 2x10, box 10x10, 5x2x10