Ciprofloxacin 0.25g (10 coated tablets)
- $2.90
The instruction
for medical use
of CIPROFLOXACIN medicine
A trade name
CIPROFLOXACIN
the International unlicensed
name Ciprofloxacin Dosage Form
of the Tablet, coated, 0.25 g and 0.5 g
Odnatabletk's List contains
active agent - hydrochloride ciprofloxacin monohydrate of 295 mg and 590 mg, (in terms of ciprofloxacin) 250 mg and 500 mg,
excipients:
structure of a kernel: starch corn, starch prezhelatinizirovanny, krospovidon, lactoses monohydrate, cellulose microcrystalline, talc, magnesium stearate.
structure of a cover: gipromelloza, macrogoal-4000, propylene glycol, talc, kopovidon, titan E171 dioxide.
The description
of the Tablet of white or almost white color, biconvex, coated, on cross section one layer of white color is visible. Tablets on 250 mg of round shape, tablets on 500 mg oval.
Pharmacotherapeutic group
Antimicrobial drugs for system use. Antimicrobial drugs derivative hinolona. Ftorkhinolona. Ciprofloxacin.
ATXJ01MA02 code
the Pharmacological
Pharmacokinetics At properties oral administration ciprofloxacin is quickly and rather fully soaked up from the digestive tract (DT) (mainly in 12-perstny and a jejunum). Meal slows down absorption, but does not change the maximum concentration (Cmax) and bioavailability. The bioavailability - 50-85%, the volume of distribution is 2-3.5 l/kg, communication with proteins of plasma of 20-40%. Time of achievement of the maximum concentration (TCmax) at oral administration of 60-90 min., Cmax linearly depends on the size of the accepted dose and is at doses 250 and 500 mg respectively of 1.2 and 2.4 mkg/ml. In 12 h after intake of 250 and 500 mg the concentration of drug in plasma decreases to 0.1 and 0.2 mkg/ml respectively.
Ciprofloxacin is well distributed in body tissues (excepting the fabric rich with fats, for example nervous tissue). Concentration in fabrics is 2-12 times higher, than in plasma. Therapeutic concentration are reached in saliva, tonsils, a liver, a gall bladder, bile, intestines, abdominal organs and a small pelvis (endometrium, fallopian pipes and ovaries, a uterus), semen, prostate tissue, kidneys and urinary bodies, pulmonary fabric, a bronchial secret, a bone tissue, muscles, synovial fluid and articulate cartilages, peritoneal liquid, skin. Gets into cerebrospinal fluid (SMZh) in a small amount where its concentration in the absence of inflammation of a meninx makes 6-10% of that in blood serum, and at inflamed 14-37%. Ciprofloxacin well gets also into eye liquid, a bronchial secret, a pleura, a peritoneum, a lymph, through a placenta, Concentration of ciprofloxacin in neutrophils of blood is 2-7 times higher, than in blood serum.
The activity decreases at values rn less than 6 a little.
Ciprofloxacin is metabolized in a liver (15-30%) with formation of low-active metabolites (diethylciprofloxacin, sulfociprofloxacin, oxociprofloxacin, formylciprofloxacin).
Elimination half-life (T1/2) about 4 h, in the chronic kidney disease (CKD) up to 12 h. The rest with a stake is removed generally by kidneys by canalicular filtration and canalicular secretion in not changed look (40-50%) and in the form of metabolites (15%).
Renal clearance of 3-5 ml/min., general clearance of 8-10 ml/min. At HPN (the clearance of creatinine (CC) is higher than 20 ml/min.) the percent of the drug removed through kidneys decreases, but cumulation in an organism does not happen owing to compensatory increase in metabolism of drug and removal through a GIT.
The pharmacodynamics
Ciprofloxacin - antimicrobial drug of a broad spectrum of activity, derivative quinoline, suppresses bacterial DNK-girazu (topoizomerazyII and IV, superspirallings of chromosomal DNA, responsible for process, around nuclear RNA that is necessary for reading of genetic information), breaks DNA synthesis, growth and division of bacteria, causes the significant morphological changes (including a cell wall and membranes) and fast death of a bacterial cell.
Affects bakteritsidno gram-negative organisms during a dormant period and divisions (since influences not only on DNK-girazu, but also causes lysis of a cell wall), on gram-positive microorganisms only in elimination half-life.
The hypotoxicity for cells of a macroorganism is explained by absence in them DNK-girazy. Against the background of intake of ciprofloxacin there is no parallel development of resistance to other antibiotics which are not belonging to group of inhibitors of a giraza that does it highly effective in relation to bacteria which are steady, for example to aminoglycosides, penicillin, cephalosporins, tetracyclines and many other antibiotics.
Gram-negative aerobic bacteria are sensitive to ciprofloxacin: enterobakteriya (Escherichiacoli, Salmonellaspp., Shigellaspp., Citrobacterspp., Klebsiellaspp., Enterobacterspp., Proteusmirabilis, Proteusvulgaris, Serratiamarcescens, Hafniaalvei, Edwardsiellatarda, Providenciaspp., Morganellamorganii, Vibriospp., Yersiniaspp.), other gram-negative bacteria (Haemophilusspp., Pseudomonasaeruginosa, Moraxellacatarrhalis, Aeromonasspp., Pasteurellamultocida, Plesiomonasshigelloides, Campylobacterjejuni, Neisseriaspp.), some intracellular activators - Legionellapneumophila, Brucellaspp., Listeriamonocytogenes, Mycobacteriumtuberculosis, Mycobacteriumkansasii,
gram-positive aerobic bacteria: Staphylococcusspp. (Staphylococcus aureus, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus saprophyticus), Streptococcus spp. (St reptococcuspyogenes, St reptococcus agalactiae). AktivenvotnosheniiBacillusanthracisinvitro.
The majority of the stafilokokk resistant to Methicillinum, rezistentna and to ciprofloxacin. Sensitivity of Streptococcuspneumoniae, Enterococcusfaecalis, Mycobacteriumavium (located intracellularly) moderated (for their suppression high concentrations are required).
To rezistentna drug: Bacteroidesfragilis, Pseudomonascepacia, Pseudomonasmaltophilia, Ureaplasmaurealyticum, Clostridiumdifficile, Nocardiaasteroids. It is not effective concerning Treponemapallidum.
The resistance develops extremely slowly as, on the one hand, after effect of ciprofloxacin there is practically no persistent microorganism left, and with another bacterial cells have no enzymes inactivating it.
Indications
- sharp and chronic (in an aggravation stage) bronchitis, pneumonia, a bronchoectatic disease, infectious complications of a mucoviscidosis
- acute sinusitis
- cystitis, pyelonephritis
- the complicated intraabdominal infections (in a combination with metronidazole)
- chronic bacterial prostatitis
- uncomplicated gonorrhea
- a typhoid, campylobacteriosis, a shigellosis, diarrhea of travelers
- the infected ulcers, wounds, burns, abscesses, phlegmon
- osteomyelitis, septic arthritis
- infections at patients with a neutropenia
- prevention and treatment of an inhalation anthrax (infection of Bacillusanthracis)
Children
- therapy of the complications caused by Pseudomonasaeruginosa in children with a mucoviscidosis of easy from 6 to 17 years
- prevention and treatment of an inhalation anthrax (infection of Bacillusanthracis)
the Way of a primeneniyaa of a dose
Inside. Tablets should be swallowed entirely with a small amount of liquid after a meal. At reception of a tablet on an empty stomach active agent is soaked up quicker.
In lower respiratory tract infections of easy and moderately severe 500 mg 2 times a day, at a heavy course of 750 mg 2 times a day. Course of treatment of 7-14 days.
In acute sinusitis on 500 mg 2 times a day. Course of treatment of 7-14 days.
In an infection of skin and soft tissues of easy and average degree of 500 mg 2 times a day, at a heavy course of 750 mg 2 times a day. Course of treatment of 7-14 days.
In infections of bones and joints of easy and average degree of 500 mg 2 times a day, at a heavy course of 750 mg 2 times a day. A course of treatment up to 4-6 weeks.
In infections of urinary tract on 250-500 mg 2 times a day, a course of treatment of 7-14 days, in uncomplicated cystitis at women 3 days.
In chronic bacterial prostatitis on 500 mg 2 times a day, a course of treatment of 28 days.
In uncomplicated gonorrhea of 250-500 mg once.
Infectious diarrhea on 500 mg 2 times a day, a course of treatment of 5-7 days.
In a typhoid on 500 mg 2 times a day, a course of treatment of 7 days.
At the complicated intraabdominal infections on 500 mg each 12 h within 7-14 days.
For prevention and treatment of an inhalation anthrax on 500 mg 2 times a day.
Duration of treatment depends on disease severity, clinical and bacteriological results.
HPN: at KK more than 60 ml/min. of dose adjustment are not required, at KK of 30-50 ml/min. 250-500 mg each 12 h, at KK & lt, 30 ml/min. 250-500 mg each 18 h. If to the patient the hemodialysis or peritoneal dialysis of 250-500 mg/days is carried out, but it is necessary to accept after the hemodialysis session.
In pediatrics:
at treatment of the complications caused by Pseudomonasaeruginosa children with a mucoviscidosis of lungs have from 6 to 17 years of 20 mg/kg 2 times a day (maximum dose of 1.5 g). Duration of treatment is 10-14 days.
in an inhalation anthrax (prevention and treatment) of 15 mg/kg 2 times a day. Maximum single dose of 500 mg, daily 1 g. General duration of intake of ciprofloxacin of 60 days.
Side effects
Often
- nausea, diarrhea
Sometimes
- vomiting, an abdominal pain, a loss of appetite
- dizziness, a headache, increased fatigue, uneasiness,
- disturbance of taste and sense of smell
- a leukopenia, an eosinophilia
Seldom
- the feeling of weakness, prolonged use of an antibiotic can cause emergence of resistant strains of bacteria and mushrooms
- a meteorism
- tachycardia, disturbance of a warm rhythm, peripheral hypostases
- thrombocytopenia
- a prothrombinopenia, increase in activity of hepatic transaminases and alkaline phosphatase, creatinine, bilirubin and urea
- vasculites
Very seldom
- a joint pain, inflammation in joints
- cholestatic jaundice (especially in patients with the postponed liver diseases), hepatitis, gepatonekroz, pseudomembranous colitis
- a tremor, insomnia, dreadful dreams, a peripheral paralgeziya (anomaly of perception of feeling of pain), perspiration, increase in intracranial pressure, instability when walking, uneasiness, confusion of consciousness, a depression, hallucinations and also other manifestations of psychotic reactions (which are occasionally progressing to states in which the patient can do himself harm), migraine, unconscious states
- a disorder of vision (diplopia, change of color perception), sonitus, decrease in hearing
- increase in concentration of a lipase, amylase
- a lowering of arterial pressure, thrombosis of cerebral arteries
- a granulocytopenia, anemia, a leukocytosis, an agranulocytosis, a thrombocytosis, a pancytopenia, hemolytic anemia, oppression of marrow, change of level of a prothrombin
- a giperkreatininemiya, a hyperbilirubinemia, a hyperglycemia
- peripheral neuropathy
- dispnoe, a laryngeal edema
- psychosis, occasionally with suicide trends
- a hamaturia, a crystalluria (first of all at alkalinuria and a hypouresis), an acute renal failure, vaginal candidiasis, a glomerulonephritis, a dysuria, a polyuria, an ischuria, an albuminuria, urethral bleedings, a hamaturia, decrease in azotvydelitelny function of kidneys, interstitial nephrite
- allergic reactions: sometimes a skin itching, seldom urticaria, a face edema or throats, an acute anaphylaxis, formation of the blisters which are followed by bleedings and emergence of the small small knots forming crusts, medicinal fever, dot hemorrhages on skin (petechia), short wind, an eosinophilia, a vasculitis, a nodal erythema, a multiformny exudative erythema (including Stephens-Johnson's syndrome), a toxic epidermal necrolysis (Lyell's disease), reactions of photosensitivity
- other is very rare: the asthenia, the increased photosensitivity, superinfections (candidiasis, pseudomembranous colitis), rushes of blood to the person, the increased sweating, an arthralgia, arthritis, a tendovaginitis, ruptures of sinews, myalgia, reactions like a serum disease
of the Contraindication
- hypersensitivity to drug
- a concomitant use with tizanidiny (risk of the profound lowering of arterial pressure (ABP), drowsiness)
- pregnancy and the period of a lactation
- teenage age up to 18 years (except therapy of the complications caused by Pseudomonasaeruginosa in children with a mucoviscidosis of easy from 6 to 17 years, prevention and treatment of the inhalation anthrax infected with Bacillusanthracis)
- a lactose intolerance
- insufficiency of lactase
- glyukozo-galaktozny malabsorption
- epilepsy
Medicinal interactions
Owing to decrease of the activity of processes of microsomal oxidation in gepatotsitakhtsiprofloksatsin increases concentration and extends theophylline T1/2 (and other xanthines, for example caffeine), oral hypoglycemic medicines, anticoagulating means of indirect action, promotes decrease in the prothrombin ratio.
At a combination to other antimicrobial HP (beta laktamnye antibiotics, aminoglycosides, clindamycin, metronidazole) synergism is usually observed, it is possible to be applied successfully in a combination with azlotsilliny and a ceftazidime in the infections caused by Pseudomonasspp., with mezlotsilliny, azlotsilliny and others beta laktamnymi antibiotics in streptococcal infections, with izoksazolilpenitsillina and Vancomycinum in staphylococcal infections, with metronidazole and clindamycin in mephitic gangrenes.
Ciprofloxacin strengthens nephrotoxic effect of cyclosporine, increase in serumal creatinine is noted, at such patients the control of this indicator 2 times a week is necessary.
At a concomitant use strengthens action of anticoagulating means of indirect action.
Oral administration together with ferriferous HP, sukralfaty and the antiacid HP containing ions of magnesium, calcium and aluminum leads to decrease in absorption of ciprofloxacin therefore it is necessary to appoint it for 1-2 h to or in 4 h after reception of the above-stated HP.
Non-steroidal anti-inflammatory drugs (excepting acetylsalicylic acid) increase risk of developing spasms.
Didanozin decrease absorption of ciprofloxacin owing to education of complexes with it with contained in the didanozena of ions of aluminum and magnesium.
Metoclopramidum accelerates absorption that leads to reduction of time of achievement of its Cmax.
Combined use of uricosuric HP leads to removal delay (up to 50%) and increase in plasma concentration of ciprofloxacin.
Raises Cmax by 7 times (from 4 to 21 times) and the area under a curve concentration time (AUC) by 10 times (from 6 to 24 times) of a tizanidin that increases risk of the profound lowering of arterial pressure and drowsiness.
Probenetsid: probenetsid breaks renal excretion of ciprofloxacin. Combined use of a probenetsid and ciprofloxacin increases concentration of ciprofloxacin in blood plasma.
Omeprazolum: simultaneous use of ciprofloxacin and omeprazolum leads to insignificant decrease in the maximum plasma concentration and average concentration in ciprofloxacin urine.
Theophylline: at simultaneous use of a sifloks and theophylline the increase in concentration in blood of the last is possible. In such cases it is necessary to korrigirovat a theophylline dose.
Tizanidin: the concomitant use with tizanidiny conducts to a povysheniyukoncentration of a tizanidin in blood serum, hypotension is aggravated and sedation amplifies.
Caffeine: some hinolona, including ciprofloxacin, reduce clearance of caffeine and can prolong the period of its semi-removal from blood serum.
Methotrexate: renal canalicular transport of a methotrexate can be inhibited at a concomitant use of ciprofloxacin that can lead to increase in level of a methotrexate in plasma. As a result the risk of the toxic reactions connected with reception of a methotrexate can increase. Therefore the patients accepting a methotrexate have to be under careful observation at therapy co-administration by ciprofloxacin.
Phenytoinum: simultaneous use of ciprofloxacin and Phenytoinum can lead to increase or lowering of plasma levels of Phenytoinum, therefore, their monitoring is recommended.
Antibiotics: simultaneous a primeneniyetsiprofloksatsin and aminoglycosides and beta laktamnykh antibiotics gives additive and synergy effect.
Effects for CYP: Ciprofloxacin - strong CYP1A2 inhibitor and weak CYP3A4 inhibitor.
Cyclosporine: at simultaneous use of the medicines containing ciprofloxacin and cyclosporine the tranzitorny increase in concentration of creatinine in plasma was observed. Therefore, it is necessary to control often (twice a week) concentration of creatinine in plasma at those patients.
Antagonists of vitamin K: simultaneous use of ciprofloxacin with antagonists of vitamin K can strengthen its anticoagulating action.
Glibenclamide: in certain cases simultaneous use of ciprofloxacin and glibenclamide can strengthen effect of glibenclamide (hypoglycemia).
Duloksetin: in clinical trials it was established that single use of a duloksetin with strong inhibitors of an isoenzyme P450 1A2 cytochrome, such as fluvoksamin, can lead to increase in average concentration in urine and the maximum concentration in plasma of a duloksetin. Though there are no clinical data for possible interaction with ciprofloxacin, similar effects can be expected at their single use.
Ropinirol: it was established during clinical trial that single use of the ropinirol which is isoenzyme inhibitor P450 1A2 cytochrome of average power with ciprofloxacin leads to increase in average concentration in urine and the maximum concentration in plasma of a ropinirol for 84% and 60%, respectively. Monitoring regarding the side effects caused ropiniroly and correction of dosages on an extent and after single use with ciprofloxacin is recommended.
Lidocaine: on healthy people it was established that single use of the medicines containing the lidocaine which is isoenzyme inhibitor P450 1A2 cytochrome of average power with ciprofloxacin, reduces clearance of intravenously entered lidocaine by 22%. Though therapy by lidocaine was well transferred, during single use there can be a possible interaction with ciprofloxacin resulting in side effects.
Clozapine: upon termination of single use of 25 0 mg of ciprofloxacin with clozapine within 7 days the plasma concentration of clozapine and N-desmetilklozapina were increased by 29% and 31%, respectively. Clinical observation and adequate correction of a dosage of clozapine in the course and upon termination of single use with ciprofloxacin are recommended.
Sildenafil: single use of a sildenafil with ciprofloxacin leads to increase in average concentration in urine and the maximum concentration in plasma sildenafit approximately twice after an oral dosage in 50 mg at a time from 500 mg of ciprofloxacin. Therefore, it is necessary to show care when assigning combination therapy taking into account risk and possible advantage.
Food and dairy products: calcium in the form of a battery has no considerable impact on absorption. However, single use of the dairy products or drinks enriched with mineral substances (for example, milk, the yogurt, orange juice enriched with mineral substances) with ciprofloxacin it is necessary to avoid in view of possible decrease in absorption of ciprofloxacin.
Special instructions
With care: the profound atherosclerosis of vessels of a brain, disturbance of cerebral circulation, mental diseases, epilepsy, the profound renal and/or liver failure, advanced age, damages of sinews at earlier carried out therapy of a ftorkhinolonama.
Ciprofloxacin is not choice drug at the suspect or the established pneumonia caused by Streptococcuspneumoniae.
In order to avoid development of a crystalluria the exceeding the recommended daily dose is inadmissible, also sufficient consumption of liquid and maintenance of acid reaction of urine is necessary.
The patient with epilepsy, attacks of spasms in the anamnesis, vascular diseases and an organic brain damage, in connection with threat of development of side reactions from the central nervous system (CNS) it is necessary to appoint ciprofloxacin only according to vital indications.
At emergence in time or after treatment of heavy and long diarrhea it is necessary to exclude the diagnosis of pseudomembranous colitis which demands immediate drug withdrawal and purpose of the corresponding treatment.
Polyneuropathy cases (on the basis of neurologic symptoms, such as pains, burning, disturbances of sensitivity or muscle weakness, separately or in a combination) met at the patients receiving ciprofloxacin. Drug should be cancelled at patients with neuropathy symptoms, including pains, burnings, prickings, numbness, and/or weakness for the purpose of prevention of development of irreversible disturbances.
There are cases about serious and fatal reactions for the patients in parallel applying ciprofloxacin and theophylline. These reactions included cardiac arrest, spasms, an epileptic condition and disturbance of breath. Though these messages concern similar serious negative impacts at the patients receiving only theophylline, but an opportunity that these reactions can be caused by ciprofloxacin, was not excluded. If the accompanying use cannot be avoided, then theophylline level in serum has to be checked and the corresponding corrections of a dosage are made.
Therapy of a hinolonama can be connected with reactions of hypersensitivity, even after single dose. Therapy by drug has to stop at the first signs of allergic reaction. At heavy anaphylactic reactions the immediate emergency aid is required.
As well as in a case with other antimicrobic broad-spectrum agents, prolonged use of drug can lead to the excess growth of insensitive microorganisms and superinfection. As well as in a case with other strongly operating drugs, against the background of long therapy periodic assessment of functions of bodies and systems, including renal, hepatic and hemopoietic functions is recommended.
CYP450: Ciprofloxacin - inhibitor of a way of hepatic CYP1A2 of enzyme. Joint use of ciprofloxacin with other medicines, first of all metaboliziruemymiCYP1A2 (for example, theophylline, methylxanthines, tizanidin), results in the increased concentration in plasma of the drugs administered in common and can result in clinically considerable pharmakodinamichesky side effects of the drugs administered in common.
Heavy infections and mikst infections of grams positive and anaerobic pathogens.
Monoterapiyatsiprofloksatsin it is not intended for treatment of heavy infections and infections, perhaps, the caused grams by positive or anaerobic pathogens. In such infections ciprofloxacin should be applied together with other adequate antibacterial drugs.
Streptococcal infections (including the caused StreptococcusPneumoniae).
Ciprofloxacin is not recommended to use for the purpose of therapy of streptococcal infections in view of the inadequate level of efficiency.
Infections of urinogenital ways.
Ftorkhinolon resistant gonococcal uretrita, tservitsita, epididimo orkhita and inflammatory processes of a small pelvis can be caused by the isolated NeisseriaGonorrhoeae strains.
Therefore, ciprofloxacin should be applied to therapy of gonococcal uretrit or tservitsit only in case of an exception ciprofloxacin of resistant microorganisms.
For therapy epididimo orkhit and inflammatory processes of a small pelvis empirical use of ciprofloxacin should be considered only in a combination with other adequate antibacterial substances (for example, cephalosporin) if only ciprofloxacin resistant microorganisms are not excluded on the basis of data. If there is no clinical improvement on third day of therapy, it should be cancelled.
Urinary tract infections.
Resistance to ftorkhinolona from colibacillus of the most often met pathogen involved in development of urinary tract infections. Doctors are recommended to consider local prevalence of colibacillus, resistant to ftorkhinolona.
Single administration of ciprofloxacin by estimates is connected with lower efficiency, than long therapy. It also should be taken into account of rather increasing level of resistance of colibacillus to hinolona.
Intra abdominal infections.
There is a limited volume of the postoperative intra abdominal infections given concerning efficiency of therapy.
Diarrhea of travelers.
When choosing ciprofloxacin it is necessary to consider information on resistance to ciprofloxacin of relevant pathogens in the visited countries.
Infectious pathologies of bones and joints.
Ciprofloxacin should be applied in a combination with other antibacterial substances depending on results of a microbiological research.
Skeletno muscular system.
In general ciprofloxacin should not be applied at the patients with diseases/disturbances of tendinous fabric in the anamnesis connected with ciprofloxacin use. Nevertheless, seldom or never, after the microbiological research of the etiological agent and the careful analysis of a ratio of risk and benefit such patients can appoint ciprofloxacin for therapy of some heavy infections, in particular in case of failure of standard therapy or presence of resistance of microorganisms provided that microbiological inspection proves ciprofloxacin use.
In the conditions of application of ciprofloxacin tendinites and ruptures of sinews (especially the Achilles tendon), sometimes in bilateral option, and even in the first 48 hours after the beginning of therapy can develop. Inflammations and ruptures of sinews can happen even after several months after therapy cancellation by ciprofloxacin. The risk of a tendinopatiya can increase at the elderly patients or patients who are at the same time receiving therapy by corticosteroids.
In the presence of any symptoms of a tendinitis (for example, painful hypostasis, inflammation), ciprofloxacin it is necessary to cancel therapy. It is necessary to observe rest of the affected extremity.
Ciprofloxacin should be applied with care at patients with a heavy pseudoparalytic myasthenia.
Photosensitization.
Ciprofloxacin as it was proved, causes reactions of a photosensitization. The patients accepting ciprofloxacin should avoid direct contact with sunshine or UF of radiation during treatment.
Disturbances from a cardiovascular system.
It is necessary to apply hinolona with care at patients with the known risk factors concerning lengthening of QT of an interval, such as:
- a hereditary syndrome of the extended interval QT,
- simultaneous use of the drugs extending QT an interval (for example, antiarrhytmic means of classes 1A and 3, tricyclic antidepressants, macroleads, antipsychotic drugs).
- not adjusted electrolytic disturbances (for example, a hypopotassemia, a hypomagnesiemia),
- cardiac pathologies (for example, heart failure, a myocardial infarction, bradycardia).
Elderly patients and women can be more sensitive to QT to the extending drugs.
Therefore, at use of ftorkhinolon, including ciprofloxacin here, in these populations it is necessary to show care.
It was reported about cases of the crystalluria connected with ciprofloxacin. The patients receiving ciprofloxacin have to drink adequately, and it is necessary to avoid excessively alkali reaction of urine.
Renal failures.
As ciprofloxacin is generally emitted in not changed look through kidneys the correction of dosages, in order to avoid aggravation of side effects of drug is required from patients with disturbance of renal function in view of ciprofloxacin accumulation.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
during treatment should abstain from control of vehicles and service of the machines and mechanisms demanding the increased concentration of attention and speed of psychomotor reactions.
At use of ciprofloxacin it is necessary to avoid direct sunshine and intensive ultraviolet radiation. In case of photosensitivity (emergence of ozhogopodobny skin reactions) the administration of drug should be stopped.
Overdose
Symptoms: strengthening of side effects of drug.
Treatment: specific antidote is unknown. Gastric lavage and other measures of emergency aid, careful control of a condition of the patient, ensuring sufficient intake of liquid. By means of haemo - or peritoneal dialysis the amount of drug can be removed only insignificant (less than 10%).
A form of release and packing
of the Tablet, coated, 0.25 g and 0.5 g
of 10 tablets on 250 mg, 5 tablets on 500 mg in blister strip packagings from a film of polyvinylchloride and aluminum foil of the varnished printing.
1 blister strip packaging with 10 tablets on 250 mg, 2 blister strip packagings with 5 tablets on 500 mg with the instruction for medical use in the state and Russian languages is placed in packs from cardboard.
To Store storage conditions in dry, protected from mestepra light to temperature it is not higher than 25C
to Store out of children's reach!
Not to use a period of storage of 5 years after an expiration date.
Prescription status
According to the prescription
JSC Sintez Producer,
Russian Federation 640008, Kurgan, Konstitutsii Avenue, 7
Ph./fax (3522) 48-16-89
E-mail: real@kurgansintez.ru
Website: http://www.kurgansintez.ru
the Owner of the registration certificate
of JSC Sintez, the Russian Federation
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products
of STOFARM LLP,
000100, Republic of Kazakhstan, Kostanay region, Kostanay, Uralskaya St., 14
ph. 714 228 01 79.
To develop
for medical use
of CIPROFLOXACIN medicine
A trade name
CIPROFLOXACIN
the International unlicensed
name Ciprofloxacin Dosage Form
of the Tablet, coated, 0.25 g and 0.5 g
Odnatabletk's List contains
active agent - hydrochloride ciprofloxacin monohydrate of 295 mg and 590 mg, (in terms of ciprofloxacin) 250 mg and 500 mg,
excipients:
structure of a kernel: starch corn, starch prezhelatinizirovanny, krospovidon, lactoses monohydrate, cellulose microcrystalline, talc, magnesium stearate.
structure of a cover: gipromelloza, macrogoal-4000, propylene glycol, talc, kopovidon, titan E171 dioxide.
The description
of the Tablet of white or almost white color, biconvex, coated, on cross section one layer of white color is visible. Tablets on 250 mg of round shape, tablets on 500 mg oval.
Pharmacotherapeutic group
Antimicrobial drugs for system use. Antimicrobial drugs derivative hinolona. Ftorkhinolona. Ciprofloxacin.
ATXJ01MA02 code
the Pharmacological
Pharmacokinetics At properties oral administration ciprofloxacin is quickly and rather fully soaked up from the digestive tract (DT) (mainly in 12-perstny and a jejunum). Meal slows down absorption, but does not change the maximum concentration (Cmax) and bioavailability. The bioavailability - 50-85%, the volume of distribution is 2-3.5 l/kg, communication with proteins of plasma of 20-40%. Time of achievement of the maximum concentration (TCmax) at oral administration of 60-90 min., Cmax linearly depends on the size of the accepted dose and is at doses 250 and 500 mg respectively of 1.2 and 2.4 mkg/ml. In 12 h after intake of 250 and 500 mg the concentration of drug in plasma decreases to 0.1 and 0.2 mkg/ml respectively.
Ciprofloxacin is well distributed in body tissues (excepting the fabric rich with fats, for example nervous tissue). Concentration in fabrics is 2-12 times higher, than in plasma. Therapeutic concentration are reached in saliva, tonsils, a liver, a gall bladder, bile, intestines, abdominal organs and a small pelvis (endometrium, fallopian pipes and ovaries, a uterus), semen, prostate tissue, kidneys and urinary bodies, pulmonary fabric, a bronchial secret, a bone tissue, muscles, synovial fluid and articulate cartilages, peritoneal liquid, skin. Gets into cerebrospinal fluid (SMZh) in a small amount where its concentration in the absence of inflammation of a meninx makes 6-10% of that in blood serum, and at inflamed 14-37%. Ciprofloxacin well gets also into eye liquid, a bronchial secret, a pleura, a peritoneum, a lymph, through a placenta, Concentration of ciprofloxacin in neutrophils of blood is 2-7 times higher, than in blood serum.
The activity decreases at values rn less than 6 a little.
Ciprofloxacin is metabolized in a liver (15-30%) with formation of low-active metabolites (diethylciprofloxacin, sulfociprofloxacin, oxociprofloxacin, formylciprofloxacin).
Elimination half-life (T1/2) about 4 h, in the chronic kidney disease (CKD) up to 12 h. The rest with a stake is removed generally by kidneys by canalicular filtration and canalicular secretion in not changed look (40-50%) and in the form of metabolites (15%).
Renal clearance of 3-5 ml/min., general clearance of 8-10 ml/min. At HPN (the clearance of creatinine (CC) is higher than 20 ml/min.) the percent of the drug removed through kidneys decreases, but cumulation in an organism does not happen owing to compensatory increase in metabolism of drug and removal through a GIT.
The pharmacodynamics
Ciprofloxacin - antimicrobial drug of a broad spectrum of activity, derivative quinoline, suppresses bacterial DNK-girazu (topoizomerazyII and IV, superspirallings of chromosomal DNA, responsible for process, around nuclear RNA that is necessary for reading of genetic information), breaks DNA synthesis, growth and division of bacteria, causes the significant morphological changes (including a cell wall and membranes) and fast death of a bacterial cell.
Affects bakteritsidno gram-negative organisms during a dormant period and divisions (since influences not only on DNK-girazu, but also causes lysis of a cell wall), on gram-positive microorganisms only in elimination half-life.
The hypotoxicity for cells of a macroorganism is explained by absence in them DNK-girazy. Against the background of intake of ciprofloxacin there is no parallel development of resistance to other antibiotics which are not belonging to group of inhibitors of a giraza that does it highly effective in relation to bacteria which are steady, for example to aminoglycosides, penicillin, cephalosporins, tetracyclines and many other antibiotics.
Gram-negative aerobic bacteria are sensitive to ciprofloxacin: enterobakteriya (Escherichiacoli, Salmonellaspp., Shigellaspp., Citrobacterspp., Klebsiellaspp., Enterobacterspp., Proteusmirabilis, Proteusvulgaris, Serratiamarcescens, Hafniaalvei, Edwardsiellatarda, Providenciaspp., Morganellamorganii, Vibriospp., Yersiniaspp.), other gram-negative bacteria (Haemophilusspp., Pseudomonasaeruginosa, Moraxellacatarrhalis, Aeromonasspp., Pasteurellamultocida, Plesiomonasshigelloides, Campylobacterjejuni, Neisseriaspp.), some intracellular activators - Legionellapneumophila, Brucellaspp., Listeriamonocytogenes, Mycobacteriumtuberculosis, Mycobacteriumkansasii,
gram-positive aerobic bacteria: Staphylococcusspp. (Staphylococcus aureus, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus saprophyticus), Streptococcus spp. (St reptococcuspyogenes, St reptococcus agalactiae). AktivenvotnosheniiBacillusanthracisinvitro.
The majority of the stafilokokk resistant to Methicillinum, rezistentna and to ciprofloxacin. Sensitivity of Streptococcuspneumoniae, Enterococcusfaecalis, Mycobacteriumavium (located intracellularly) moderated (for their suppression high concentrations are required).
To rezistentna drug: Bacteroidesfragilis, Pseudomonascepacia, Pseudomonasmaltophilia, Ureaplasmaurealyticum, Clostridiumdifficile, Nocardiaasteroids. It is not effective concerning Treponemapallidum.
The resistance develops extremely slowly as, on the one hand, after effect of ciprofloxacin there is practically no persistent microorganism left, and with another bacterial cells have no enzymes inactivating it.
Indications
- sharp and chronic (in an aggravation stage) bronchitis, pneumonia, a bronchoectatic disease, infectious complications of a mucoviscidosis
- acute sinusitis
- cystitis, pyelonephritis
- the complicated intraabdominal infections (in a combination with metronidazole)
- chronic bacterial prostatitis
- uncomplicated gonorrhea
- a typhoid, campylobacteriosis, a shigellosis, diarrhea of travelers
- the infected ulcers, wounds, burns, abscesses, phlegmon
- osteomyelitis, septic arthritis
- infections at patients with a neutropenia
- prevention and treatment of an inhalation anthrax (infection of Bacillusanthracis)
Children
- therapy of the complications caused by Pseudomonasaeruginosa in children with a mucoviscidosis of easy from 6 to 17 years
- prevention and treatment of an inhalation anthrax (infection of Bacillusanthracis)
the Way of a primeneniyaa of a dose
Inside. Tablets should be swallowed entirely with a small amount of liquid after a meal. At reception of a tablet on an empty stomach active agent is soaked up quicker.
In lower respiratory tract infections of easy and moderately severe 500 mg 2 times a day, at a heavy course of 750 mg 2 times a day. Course of treatment of 7-14 days.
In acute sinusitis on 500 mg 2 times a day. Course of treatment of 7-14 days.
In an infection of skin and soft tissues of easy and average degree of 500 mg 2 times a day, at a heavy course of 750 mg 2 times a day. Course of treatment of 7-14 days.
In infections of bones and joints of easy and average degree of 500 mg 2 times a day, at a heavy course of 750 mg 2 times a day. A course of treatment up to 4-6 weeks.
In infections of urinary tract on 250-500 mg 2 times a day, a course of treatment of 7-14 days, in uncomplicated cystitis at women 3 days.
In chronic bacterial prostatitis on 500 mg 2 times a day, a course of treatment of 28 days.
In uncomplicated gonorrhea of 250-500 mg once.
Infectious diarrhea on 500 mg 2 times a day, a course of treatment of 5-7 days.
In a typhoid on 500 mg 2 times a day, a course of treatment of 7 days.
At the complicated intraabdominal infections on 500 mg each 12 h within 7-14 days.
For prevention and treatment of an inhalation anthrax on 500 mg 2 times a day.
Duration of treatment depends on disease severity, clinical and bacteriological results.
HPN: at KK more than 60 ml/min. of dose adjustment are not required, at KK of 30-50 ml/min. 250-500 mg each 12 h, at KK & lt, 30 ml/min. 250-500 mg each 18 h. If to the patient the hemodialysis or peritoneal dialysis of 250-500 mg/days is carried out, but it is necessary to accept after the hemodialysis session.
In pediatrics:
at treatment of the complications caused by Pseudomonasaeruginosa children with a mucoviscidosis of lungs have from 6 to 17 years of 20 mg/kg 2 times a day (maximum dose of 1.5 g). Duration of treatment is 10-14 days.
in an inhalation anthrax (prevention and treatment) of 15 mg/kg 2 times a day. Maximum single dose of 500 mg, daily 1 g. General duration of intake of ciprofloxacin of 60 days.
Side effects
Often
- nausea, diarrhea
Sometimes
- vomiting, an abdominal pain, a loss of appetite
- dizziness, a headache, increased fatigue, uneasiness,
- disturbance of taste and sense of smell
- a leukopenia, an eosinophilia
Seldom
- the feeling of weakness, prolonged use of an antibiotic can cause emergence of resistant strains of bacteria and mushrooms
- a meteorism
- tachycardia, disturbance of a warm rhythm, peripheral hypostases
- thrombocytopenia
- a prothrombinopenia, increase in activity of hepatic transaminases and alkaline phosphatase, creatinine, bilirubin and urea
- vasculites
Very seldom
- a joint pain, inflammation in joints
- cholestatic jaundice (especially in patients with the postponed liver diseases), hepatitis, gepatonekroz, pseudomembranous colitis
- a tremor, insomnia, dreadful dreams, a peripheral paralgeziya (anomaly of perception of feeling of pain), perspiration, increase in intracranial pressure, instability when walking, uneasiness, confusion of consciousness, a depression, hallucinations and also other manifestations of psychotic reactions (which are occasionally progressing to states in which the patient can do himself harm), migraine, unconscious states
- a disorder of vision (diplopia, change of color perception), sonitus, decrease in hearing
- increase in concentration of a lipase, amylase
- a lowering of arterial pressure, thrombosis of cerebral arteries
- a granulocytopenia, anemia, a leukocytosis, an agranulocytosis, a thrombocytosis, a pancytopenia, hemolytic anemia, oppression of marrow, change of level of a prothrombin
- a giperkreatininemiya, a hyperbilirubinemia, a hyperglycemia
- peripheral neuropathy
- dispnoe, a laryngeal edema
- psychosis, occasionally with suicide trends
- a hamaturia, a crystalluria (first of all at alkalinuria and a hypouresis), an acute renal failure, vaginal candidiasis, a glomerulonephritis, a dysuria, a polyuria, an ischuria, an albuminuria, urethral bleedings, a hamaturia, decrease in azotvydelitelny function of kidneys, interstitial nephrite
- allergic reactions: sometimes a skin itching, seldom urticaria, a face edema or throats, an acute anaphylaxis, formation of the blisters which are followed by bleedings and emergence of the small small knots forming crusts, medicinal fever, dot hemorrhages on skin (petechia), short wind, an eosinophilia, a vasculitis, a nodal erythema, a multiformny exudative erythema (including Stephens-Johnson's syndrome), a toxic epidermal necrolysis (Lyell's disease), reactions of photosensitivity
- other is very rare: the asthenia, the increased photosensitivity, superinfections (candidiasis, pseudomembranous colitis), rushes of blood to the person, the increased sweating, an arthralgia, arthritis, a tendovaginitis, ruptures of sinews, myalgia, reactions like a serum disease
of the Contraindication
- hypersensitivity to drug
- a concomitant use with tizanidiny (risk of the profound lowering of arterial pressure (ABP), drowsiness)
- pregnancy and the period of a lactation
- teenage age up to 18 years (except therapy of the complications caused by Pseudomonasaeruginosa in children with a mucoviscidosis of easy from 6 to 17 years, prevention and treatment of the inhalation anthrax infected with Bacillusanthracis)
- a lactose intolerance
- insufficiency of lactase
- glyukozo-galaktozny malabsorption
- epilepsy
Medicinal interactions
Owing to decrease of the activity of processes of microsomal oxidation in gepatotsitakhtsiprofloksatsin increases concentration and extends theophylline T1/2 (and other xanthines, for example caffeine), oral hypoglycemic medicines, anticoagulating means of indirect action, promotes decrease in the prothrombin ratio.
At a combination to other antimicrobial HP (beta laktamnye antibiotics, aminoglycosides, clindamycin, metronidazole) synergism is usually observed, it is possible to be applied successfully in a combination with azlotsilliny and a ceftazidime in the infections caused by Pseudomonasspp., with mezlotsilliny, azlotsilliny and others beta laktamnymi antibiotics in streptococcal infections, with izoksazolilpenitsillina and Vancomycinum in staphylococcal infections, with metronidazole and clindamycin in mephitic gangrenes.
Ciprofloxacin strengthens nephrotoxic effect of cyclosporine, increase in serumal creatinine is noted, at such patients the control of this indicator 2 times a week is necessary.
At a concomitant use strengthens action of anticoagulating means of indirect action.
Oral administration together with ferriferous HP, sukralfaty and the antiacid HP containing ions of magnesium, calcium and aluminum leads to decrease in absorption of ciprofloxacin therefore it is necessary to appoint it for 1-2 h to or in 4 h after reception of the above-stated HP.
Non-steroidal anti-inflammatory drugs (excepting acetylsalicylic acid) increase risk of developing spasms.
Didanozin decrease absorption of ciprofloxacin owing to education of complexes with it with contained in the didanozena of ions of aluminum and magnesium.
Metoclopramidum accelerates absorption that leads to reduction of time of achievement of its Cmax.
Combined use of uricosuric HP leads to removal delay (up to 50%) and increase in plasma concentration of ciprofloxacin.
Raises Cmax by 7 times (from 4 to 21 times) and the area under a curve concentration time (AUC) by 10 times (from 6 to 24 times) of a tizanidin that increases risk of the profound lowering of arterial pressure and drowsiness.
Probenetsid: probenetsid breaks renal excretion of ciprofloxacin. Combined use of a probenetsid and ciprofloxacin increases concentration of ciprofloxacin in blood plasma.
Omeprazolum: simultaneous use of ciprofloxacin and omeprazolum leads to insignificant decrease in the maximum plasma concentration and average concentration in ciprofloxacin urine.
Theophylline: at simultaneous use of a sifloks and theophylline the increase in concentration in blood of the last is possible. In such cases it is necessary to korrigirovat a theophylline dose.
Tizanidin: the concomitant use with tizanidiny conducts to a povysheniyukoncentration of a tizanidin in blood serum, hypotension is aggravated and sedation amplifies.
Caffeine: some hinolona, including ciprofloxacin, reduce clearance of caffeine and can prolong the period of its semi-removal from blood serum.
Methotrexate: renal canalicular transport of a methotrexate can be inhibited at a concomitant use of ciprofloxacin that can lead to increase in level of a methotrexate in plasma. As a result the risk of the toxic reactions connected with reception of a methotrexate can increase. Therefore the patients accepting a methotrexate have to be under careful observation at therapy co-administration by ciprofloxacin.
Phenytoinum: simultaneous use of ciprofloxacin and Phenytoinum can lead to increase or lowering of plasma levels of Phenytoinum, therefore, their monitoring is recommended.
Antibiotics: simultaneous a primeneniyetsiprofloksatsin and aminoglycosides and beta laktamnykh antibiotics gives additive and synergy effect.
Effects for CYP: Ciprofloxacin - strong CYP1A2 inhibitor and weak CYP3A4 inhibitor.
Cyclosporine: at simultaneous use of the medicines containing ciprofloxacin and cyclosporine the tranzitorny increase in concentration of creatinine in plasma was observed. Therefore, it is necessary to control often (twice a week) concentration of creatinine in plasma at those patients.
Antagonists of vitamin K: simultaneous use of ciprofloxacin with antagonists of vitamin K can strengthen its anticoagulating action.
Glibenclamide: in certain cases simultaneous use of ciprofloxacin and glibenclamide can strengthen effect of glibenclamide (hypoglycemia).
Duloksetin: in clinical trials it was established that single use of a duloksetin with strong inhibitors of an isoenzyme P450 1A2 cytochrome, such as fluvoksamin, can lead to increase in average concentration in urine and the maximum concentration in plasma of a duloksetin. Though there are no clinical data for possible interaction with ciprofloxacin, similar effects can be expected at their single use.
Ropinirol: it was established during clinical trial that single use of the ropinirol which is isoenzyme inhibitor P450 1A2 cytochrome of average power with ciprofloxacin leads to increase in average concentration in urine and the maximum concentration in plasma of a ropinirol for 84% and 60%, respectively. Monitoring regarding the side effects caused ropiniroly and correction of dosages on an extent and after single use with ciprofloxacin is recommended.
Lidocaine: on healthy people it was established that single use of the medicines containing the lidocaine which is isoenzyme inhibitor P450 1A2 cytochrome of average power with ciprofloxacin, reduces clearance of intravenously entered lidocaine by 22%. Though therapy by lidocaine was well transferred, during single use there can be a possible interaction with ciprofloxacin resulting in side effects.
Clozapine: upon termination of single use of 25 0 mg of ciprofloxacin with clozapine within 7 days the plasma concentration of clozapine and N-desmetilklozapina were increased by 29% and 31%, respectively. Clinical observation and adequate correction of a dosage of clozapine in the course and upon termination of single use with ciprofloxacin are recommended.
Sildenafil: single use of a sildenafil with ciprofloxacin leads to increase in average concentration in urine and the maximum concentration in plasma sildenafit approximately twice after an oral dosage in 50 mg at a time from 500 mg of ciprofloxacin. Therefore, it is necessary to show care when assigning combination therapy taking into account risk and possible advantage.
Food and dairy products: calcium in the form of a battery has no considerable impact on absorption. However, single use of the dairy products or drinks enriched with mineral substances (for example, milk, the yogurt, orange juice enriched with mineral substances) with ciprofloxacin it is necessary to avoid in view of possible decrease in absorption of ciprofloxacin.
Special instructions
With care: the profound atherosclerosis of vessels of a brain, disturbance of cerebral circulation, mental diseases, epilepsy, the profound renal and/or liver failure, advanced age, damages of sinews at earlier carried out therapy of a ftorkhinolonama.
Ciprofloxacin is not choice drug at the suspect or the established pneumonia caused by Streptococcuspneumoniae.
In order to avoid development of a crystalluria the exceeding the recommended daily dose is inadmissible, also sufficient consumption of liquid and maintenance of acid reaction of urine is necessary.
The patient with epilepsy, attacks of spasms in the anamnesis, vascular diseases and an organic brain damage, in connection with threat of development of side reactions from the central nervous system (CNS) it is necessary to appoint ciprofloxacin only according to vital indications.
At emergence in time or after treatment of heavy and long diarrhea it is necessary to exclude the diagnosis of pseudomembranous colitis which demands immediate drug withdrawal and purpose of the corresponding treatment.
Polyneuropathy cases (on the basis of neurologic symptoms, such as pains, burning, disturbances of sensitivity or muscle weakness, separately or in a combination) met at the patients receiving ciprofloxacin. Drug should be cancelled at patients with neuropathy symptoms, including pains, burnings, prickings, numbness, and/or weakness for the purpose of prevention of development of irreversible disturbances.
There are cases about serious and fatal reactions for the patients in parallel applying ciprofloxacin and theophylline. These reactions included cardiac arrest, spasms, an epileptic condition and disturbance of breath. Though these messages concern similar serious negative impacts at the patients receiving only theophylline, but an opportunity that these reactions can be caused by ciprofloxacin, was not excluded. If the accompanying use cannot be avoided, then theophylline level in serum has to be checked and the corresponding corrections of a dosage are made.
Therapy of a hinolonama can be connected with reactions of hypersensitivity, even after single dose. Therapy by drug has to stop at the first signs of allergic reaction. At heavy anaphylactic reactions the immediate emergency aid is required.
As well as in a case with other antimicrobic broad-spectrum agents, prolonged use of drug can lead to the excess growth of insensitive microorganisms and superinfection. As well as in a case with other strongly operating drugs, against the background of long therapy periodic assessment of functions of bodies and systems, including renal, hepatic and hemopoietic functions is recommended.
CYP450: Ciprofloxacin - inhibitor of a way of hepatic CYP1A2 of enzyme. Joint use of ciprofloxacin with other medicines, first of all metaboliziruemymiCYP1A2 (for example, theophylline, methylxanthines, tizanidin), results in the increased concentration in plasma of the drugs administered in common and can result in clinically considerable pharmakodinamichesky side effects of the drugs administered in common.
Heavy infections and mikst infections of grams positive and anaerobic pathogens.
Monoterapiyatsiprofloksatsin it is not intended for treatment of heavy infections and infections, perhaps, the caused grams by positive or anaerobic pathogens. In such infections ciprofloxacin should be applied together with other adequate antibacterial drugs.
Streptococcal infections (including the caused StreptococcusPneumoniae).
Ciprofloxacin is not recommended to use for the purpose of therapy of streptococcal infections in view of the inadequate level of efficiency.
Infections of urinogenital ways.
Ftorkhinolon resistant gonococcal uretrita, tservitsita, epididimo orkhita and inflammatory processes of a small pelvis can be caused by the isolated NeisseriaGonorrhoeae strains.
Therefore, ciprofloxacin should be applied to therapy of gonococcal uretrit or tservitsit only in case of an exception ciprofloxacin of resistant microorganisms.
For therapy epididimo orkhit and inflammatory processes of a small pelvis empirical use of ciprofloxacin should be considered only in a combination with other adequate antibacterial substances (for example, cephalosporin) if only ciprofloxacin resistant microorganisms are not excluded on the basis of data. If there is no clinical improvement on third day of therapy, it should be cancelled.
Urinary tract infections.
Resistance to ftorkhinolona from colibacillus of the most often met pathogen involved in development of urinary tract infections. Doctors are recommended to consider local prevalence of colibacillus, resistant to ftorkhinolona.
Single administration of ciprofloxacin by estimates is connected with lower efficiency, than long therapy. It also should be taken into account of rather increasing level of resistance of colibacillus to hinolona.
Intra abdominal infections.
There is a limited volume of the postoperative intra abdominal infections given concerning efficiency of therapy.
Diarrhea of travelers.
When choosing ciprofloxacin it is necessary to consider information on resistance to ciprofloxacin of relevant pathogens in the visited countries.
Infectious pathologies of bones and joints.
Ciprofloxacin should be applied in a combination with other antibacterial substances depending on results of a microbiological research.
Skeletno muscular system.
In general ciprofloxacin should not be applied at the patients with diseases/disturbances of tendinous fabric in the anamnesis connected with ciprofloxacin use. Nevertheless, seldom or never, after the microbiological research of the etiological agent and the careful analysis of a ratio of risk and benefit such patients can appoint ciprofloxacin for therapy of some heavy infections, in particular in case of failure of standard therapy or presence of resistance of microorganisms provided that microbiological inspection proves ciprofloxacin use.
In the conditions of application of ciprofloxacin tendinites and ruptures of sinews (especially the Achilles tendon), sometimes in bilateral option, and even in the first 48 hours after the beginning of therapy can develop. Inflammations and ruptures of sinews can happen even after several months after therapy cancellation by ciprofloxacin. The risk of a tendinopatiya can increase at the elderly patients or patients who are at the same time receiving therapy by corticosteroids.
In the presence of any symptoms of a tendinitis (for example, painful hypostasis, inflammation), ciprofloxacin it is necessary to cancel therapy. It is necessary to observe rest of the affected extremity.
Ciprofloxacin should be applied with care at patients with a heavy pseudoparalytic myasthenia.
Photosensitization.
Ciprofloxacin as it was proved, causes reactions of a photosensitization. The patients accepting ciprofloxacin should avoid direct contact with sunshine or UF of radiation during treatment.
Disturbances from a cardiovascular system.
It is necessary to apply hinolona with care at patients with the known risk factors concerning lengthening of QT of an interval, such as:
- a hereditary syndrome of the extended interval QT,
- simultaneous use of the drugs extending QT an interval (for example, antiarrhytmic means of classes 1A and 3, tricyclic antidepressants, macroleads, antipsychotic drugs).
- not adjusted electrolytic disturbances (for example, a hypopotassemia, a hypomagnesiemia),
- cardiac pathologies (for example, heart failure, a myocardial infarction, bradycardia).
Elderly patients and women can be more sensitive to QT to the extending drugs.
Therefore, at use of ftorkhinolon, including ciprofloxacin here, in these populations it is necessary to show care.
It was reported about cases of the crystalluria connected with ciprofloxacin. The patients receiving ciprofloxacin have to drink adequately, and it is necessary to avoid excessively alkali reaction of urine.
Renal failures.
As ciprofloxacin is generally emitted in not changed look through kidneys the correction of dosages, in order to avoid aggravation of side effects of drug is required from patients with disturbance of renal function in view of ciprofloxacin accumulation.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
during treatment should abstain from control of vehicles and service of the machines and mechanisms demanding the increased concentration of attention and speed of psychomotor reactions.
At use of ciprofloxacin it is necessary to avoid direct sunshine and intensive ultraviolet radiation. In case of photosensitivity (emergence of ozhogopodobny skin reactions) the administration of drug should be stopped.
Overdose
Symptoms: strengthening of side effects of drug.
Treatment: specific antidote is unknown. Gastric lavage and other measures of emergency aid, careful control of a condition of the patient, ensuring sufficient intake of liquid. By means of haemo - or peritoneal dialysis the amount of drug can be removed only insignificant (less than 10%).
A form of release and packing
of the Tablet, coated, 0.25 g and 0.5 g
of 10 tablets on 250 mg, 5 tablets on 500 mg in blister strip packagings from a film of polyvinylchloride and aluminum foil of the varnished printing.
1 blister strip packaging with 10 tablets on 250 mg, 2 blister strip packagings with 5 tablets on 500 mg with the instruction for medical use in the state and Russian languages is placed in packs from cardboard.
To Store storage conditions in dry, protected from mestepra light to temperature it is not higher than 25C
to Store out of children's reach!
Not to use a period of storage of 5 years after an expiration date.
Prescription status
According to the prescription
JSC Sintez Producer,
Russian Federation 640008, Kurgan, Konstitutsii Avenue, 7
Ph./fax (3522) 48-16-89
E-mail: real@kurgansintez.ru
Website: http://www.kurgansintez.ru
the Owner of the registration certificate
of JSC Sintez, the Russian Federation
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products
of STOFARM LLP,
000100, Republic of Kazakhstan, Kostanay region, Kostanay, Uralskaya St., 14
ph. 714 228 01 79.
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