Ciprofloxacin-Teva - instructions for use, dose, side effects, contraindications

In 1 ml contains: active substance ciprofloxacin (ciprofloxacin lactate) 2 (2.544) mg; Excipients: dextrose monohydrate 50 mg, lactic acid 0.64 mg, hydrochloric acid 2M q.s., water for injection q.s. up to 1 ml.

Description:

Colorless or light yellow transparent solution.

Pharmacotherapeutic group:Antimicrobial agent, fluoroquinolone.

ATX: & nbsp

J.01.M.A.02 Ciprofloxacin

Pharmacodynamics:

Antimicrobial preparation of a broad spectrum of action from the group of fluoroquinolones. It suppresses the bacterial DNA-gyrase (topoisomerases II and IV, responsible for the process of supercoiling the chromosomal DNA around the nuclear RNA, which is necessary for reading the genetic information), disrupts the synthesis of DNA, the growth and division of bacteria, causes marked morphological changes and rapid death of the bacterial cell. It acts bactericidal against gram-negative organisms in the period of rest and division.affects not only DNA-gyrase, but also causes lysis of the cell wall), on gram-positive microorganisms - only during the fission period. Low toxicity for macroorganism cells is explained by the absence of DNA-gyrase in them. Against the background of taking ciprofloxacin, there is no parallel development of resistance to other antibiotics not belonging to the group of inhibitors of gyrase, which makes it highly effective against bacteria that are resistant, for example, to aminoglycosides, penicillins, cephalosporins, tetracyclines and other antibiotics. The effectiveness of ciprofloxacin depends to a large extent on the relationship between pharmacokinetic and pharmacodynamic parameters - between the maximum concentration in the blood serum (CMC) / minimum inhibitory concentration (MIC) and between the area under the concentration-time curve (AUC) / IPC. Resistance develops slowly and gradually ("multistage" type). There is no cross-resistance with other fluoroquinolones. The basis for the formation of resistance to ciprofloxacin are mutations of the gene (amino acid substitutions) in the region of the "quinolone pocket" - the site of the polypeptide chain of topoisomerases II and IV, in which their binding to ciprofloxacin should occur.Another possible mechanism of resistance is associated with mutations in the gene that encodes the membrane proteins involved in the active release (efflux) of ciprofloxacin from the cell and / or a decrease in the permeability of the cell membrane for ciprofloxacin. Usually, single mutations lead to an insignificant (2-4 times) increase in the MIC. A high level of resistance is usually associated with two or more mutations in one or more genes.

The natural resistance of microorganisms to ciprofloxacin depends on time and geographical factors. Therefore, it is desirable that this information is provided by local services to determine the sensitivity of microorganisms to antibiotics.

The most sensitive microorganisms

Gram-positive aerobic microorganisms: Bacillus anthracis, Staphylococcus aureus (methicillin-sensitive), Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus saprophyticus, Streptococcus pyogenes, Streptococcus agalactiae; Gram-negative aerobic microorganisms: Aeromonas spp., Brucella spp., Citrobacter koseri, Francisella tularensis, Haemophilus ducreyi, Haemophilus influenzae, Legionella pneumophila, Moraxella catarrhalis, Mycobacterium tuberculosis, Mycobacterium kansasil, Pasteurella multocida, Salmonella spp., Shigella spp., Vibrio spp., Yersinia pestis ; anaerobic microorganisms: Mobiluncus spp .; others microorganisms: Chlamydia trachomatis, Chlamydia pneumoniae, Mycoplasma hominis, Mycoplasma pneumoniae.

Microorganisms with possible resistance

Gram-positive aerobic microorganisms: Enterococcus faecalis, Streptococcus pneumoniae; Gram-negative aerobic microorganisms: Acinetobacter baumannii, Burkholderia cepacia, Campylobacter jejuni, Citrobacter freundii, Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Mycobacterium avium, Morganella morganii, Neisseria gonorrhoeae, Neisseria meningitides, Plesiomonas shigelloides, Proteus mirabilis, Proteus vulgaris, Providencia spp ., Pseudomonas aeruginosa, Pseudomonas fluorescens, Serratia marces cens; anaerobic microorganisms: Peptostreptococcus spp., Propionibacterium acnes.

Resistant microorganisms

Gram-positive aerobic microorganisms: Actinomyces spp., Enterococus faecium, Staphylococcus spp. (methicillin-resistant); Gram-negative aerobic microorganisms: Burkholderia cepacia, Nocardia asteroids, Stenotrophomonas maltophilia; anaerobic microorganisms not included in the lists above; other microorganisms: Bacteroides fragilis, Clostridium difficile, Listeria monocytogenes, Mycoplasma genitalium, Treponema pallidum, Ureaplasma urealyticum.

Pharmacokinetics:

Suction. With intravenous (iv) ciprofloxacin in doses of 200 and 400 mg, its serum concentration is 2.1 and 4.6 μg / ml, respectively. With IV infusion of 200 mg ciprofloxacin for 60 minutes every 12 hours and ingestion of 250 mg ciprofloxacin every 12 hours AUC are equivalent. With IV infusion of 400 mg of ciprofloxacin for 60 minutes every 12 hours and ingestion of 500 mg of ciprofloxacin every 12 hours the AUC is also equivalent. FROM_max with IV infusion 400 mg ciprofloxacin for 60 minutes every 12 hours is similar to C_max when ingested 750 mg ciprofloxacin every 12 hours.

Distribution. The volume of distribution (Vd) is 2-3 l / kg, the connection with plasma proteins is 20-40%.Large Vd is associated with good penetration of the drug into the tissue. The content in the tissues is 2-12 times higher than in the plasma. Therapeutic concentrations are achieved in saliva, tonsils, liver, gall bladder, bile, intestine, abdominal and pelvic organs, uterus, seminal fluid, prostate tissue, endometrium, fallopian tubes and ovaries, kidney and urinary organs, pulmonary tissue, bronchial secretion, paranasal sinuses, bone tissue, muscles, synovial fluid and articular cartilage, peritoneal fluid, skin. In a small amount, it penetrates into the cerebrospinal fluid, where its concentration in non-inflamed meninges is 6-10% of that in the blood serum, and when inflamed it is 14-37%. Ciprofloxacin also well penetrates into the eye fluid, bronchial secretion, pleura, peritoneum, lymph, through the placenta. The concentration of ciprofloxacin in blood neutrophils is 2-7 times higher than in serum. The activity decreases somewhat in an acid medium.

Metabolism. Metabolised in the liver (15-30%) with the formation of low-activity metabolites (diethylciprofloxacin, sulfociprofloxacin, oxocycloploxacin, formyl ciprofloxacin).It is a moderate inhibitor of the isoenzyme CYP1A2.

Excretion. With iv introduction, the half-life (T1) is 5-6 hours, with chronic renal failure - up to 12 hours. It is excreted mainly by the kidneys by tubular filtration and tubular secretion in unchanged form (with i / in introduction - 61.5%). and in the form of metabolites (with intravenous administration - 9.5%), the rest - intestine (15.2% and 2.6% respectively). A small amount is excreted in breast milk. After intravenous administration, the concentration in the urine during the first 2 hours after injection is almost 100 times greater than in the serum, which is significantly superior to the MIC for most pathogens of urinary tract infections. Kidney clearance is 180-300 ml / min / kg, the total clearance is 480-600 ml / min / kg.

With moderate chronic renal failure (creatinine clearance more than 20 ml / min), the percentage of ciprofloxacin excreted through the kidneys is reduced, but cumulation in the body does not occur due to a compensatory increase in the metabolism of the drug and excretion by the intestine. In severe renal failure (CC less than 20 ml / min), T1 increases to 12 hours, so the daily dose of ciprofloxacin should be reduced by 2 times.

Indications:

For the treatment of severe life-threatening infections caused by microorganisms sensitive to ciprofloxacin.

Adults

- Infections of the lower respiratory tract caused by gram-negative microorganisms, including pneumonia, bronchopulmonary infections in cystic fibrosis.

- Infections of the ENT organs (sinusitis, otitis media).

- Hearing organ infections, including chronic purulent otitis media, malignant external otitis media.

- Urinary tract infections, including cystitis, pyelonephritis.

- Infections of the genitourinary system and pelvic organs, including those caused by Neisseria gonorrhoeae.

- Gastrointestinal infections.

- Infections of the abdominal cavity, including peritonitis, intraperitoneal abscesses, cholecystitis, cholangitis.

- Infections of bones and joints.

- Infections of soft tissues and skin caused by gram-negative microorganisms.

- Infections against the background of immunodeficiency, which occurs in the treatment of immunosuppressive drugs or in patients with neutropenia.

- Prevention and treatment of pulmonary form of anthrax (infection with Bacillus anthracis).

Children aged 5-17 years

Therapy of complications caused by Pseudomonas aeruginosa in children with cystic fibrosis of the lungs.

Contraindications:

Hypersensitivity to ciprofloxacin or any component of the drug, as well as to other antimicrobial drugs from the quinolone group; simultaneous application of ciprofloxacin and tizanidine; children under 18 years of age (before completion of the skeletal process, except for the treatment of complications caused by Pseudomonas aeruginosa, in children aged 5-17 years with cystic fibrosis); diseases of the tendons, including in the anamnesis; pregnancy; the period of breastfeeding.

Carefully:

Impaired renal function (CC less than 60 ml / min); hemodialysis; peritoneal dialysis; abnormal liver function; myasthenia gravis; elderly age; Postoperative infections (data on effectiveness and safety are limited); deficiency of glucose-6-phosphate dehydrogenase; epilepsy in the anamnesis; insufficiency of cerebral circulation; diseases accompanied by organic changes in the structure of the brain, including conditions after cerebrovascular accident; arrhythmia of the "pirouette" type; prolongation of the QT interval; syndrome of congenital extension of the QT interval; heart disease (heart failure, myocardial infarction, bradycardia); electrolyte imbalance (eg, hypokalemia, hypomagnesemia); simultaneous administration of drugs that extend the QT interval (incl.antiarrhythmic drugs IA and III classes); simultaneous application with inhibitors of isoenzymes CYP1A2 (including theophylline, methylxanthine, caffeine, duloxetine, clozapine); mental illness.

Pregnancy and lactation:

Ciprofloxacin is contraindicated during pregnancy.

Because the ciprofloxacin is excreted in breast milk, it should not be prescribed to nursing mothers. If it is necessary to use ciprofloxacin in the mother during lactation, breastfeeding should be terminated before treatment begins.

Dosing and Administration:

In the form of IV infusion for 60 min to reduce venous irritation and patient discomfort. In the absence of full confidence in the compatibility of the drug Ciprofloxacin-Teva with other infusion solutions, this drug should always be administered to the patient separately. Visible signs of incompatibility: turbidity, precipitation, change in solution color.

Adults

Lower respiratory tract infections caused by gram-negative microorganisms, including pneumonia, bronchopulmonary infectious complications in cystic fibrosis: 400 mg twice a day, in especially severe cases, 400 mg every 8 hours for 7-14 days; the maximum daily dose is 1.2 g.

Infections of the ENT organs (sinusitis, otitis media), infections of the hearing organ, including chronic suppurative otitis media: 400 mg twice a day, in especially severe cases, 400 mg every 8 hours for 7-14 days; the maximum daily dose of 1.2 g; with malignant external otitis: 400 mg every 8 hours for 28 days - 3 months, the maximum daily dose of 1.2 g.

Urinary tract infections, including cystitis, pyelonephritis: 400 mg twice a day, in especially severe cases, 400 mg every 8 hours, usually within 7-21 days. The duration of treatment can be increased in case of serious complications, including abscesses. The maximum daily dose is 1.2 g.

Infections of the genitourinary system and pelvic organs, including those caused by Neisseria gonorrhoeae: 400 mg twice a day, in especially severe cases, 400 mg every 8 hours, for 14 days.

Gastrointestinal infections:

- Caused Shigella spp., Besides Shigella dysenteriae: 400 mg twice a day for 1 day.

- Caused Shigella dysenteriae: 400 mg twice a day for 5 days.

- Caused Vibrio cholerae: 400 mg twice a day for 3 days.

- Typhoid fever: 400 mg twice a day for 7 days; the maximum daily dose is 1.2 g.

Infections of the abdominal cavity, including peritonitis, intraperitoneal abscesses, cholecystitis, cholangitis: 400 mg twice a day, in especially severe cases, 400 mg every 8 hours, for 5-14 days; the maximum daily dose is 1.2 g.

Infections of bones and joints: 400 mg twice a day, in especially severe cases, 400 mg every 8 hours; duration of treatment is not more than 3 months; the maximum daily dose is 1.2 g.

Infections of soft tissues and skin caused by gram-negative microorganisms: 400 mg twice a day, in especially severe cases, 400 mg every 8 hours, for 7-14 days; the maximum daily dose is 1.2 g.

Infections against the background of immunodeficiency arising in the treatment of immunosuppressive drugs or in patients with neutropenia: 400 mg twice a day, in especially severe cases, 400 mg every 8 hours, throughout the neutropenia period (in combination with other antibiotics); the maximum daily dose is 1.2 g.

Prevention and treatment of pulmonary form of anthrax (infection Bacillus anthracis): 400 mg twice a day for 60 days from the moment of contact with the pathogen; the maximum daily dose is 1.2 g.

Children aged 5-17 years

Therapy of complications caused by Pseudomonas aeruginosa in children with cystic fibrosis of the lungs: 10-20 mg / kg 3 times a day for 10-14 days; the maximum daily dose is 1.2 g.

Patients with impaired hepatic function: correction of the dose is not required.

Patients with impaired renal function: a dose adjustment is necessary depending on the degree of severity of renal dysfunction.

KK (ml / min / 1.73 m2)	Concentration of creatinine in plasma (μmol / L)	Dose for intravenous administration (mg)
More than 60	Less than 124	Ordinary dosing
30 to 60	More than 169	200-400 mg 2 times a day
Less than 30	More than 169	200-400 mg once daily
Hemodialysis	More than 169	200-400 mg once a day (after hemodialysis)
Peritoneal dialysis	More than 169	200-400 mg once daily

Older patients: a dose adjustment is necessary depending on the magnitude of the CC, the type of infection and the severity of the disease.

Treatment with ciprofloxacin is recommended starting with parenteral administration with a possible subsequent transition to taking the drug inside.

Compatibility with other solutions

The infusion solution of ciprofloxacin is compatible with saline solution, Ringer's solution, lactated Ringer's solution, 5% and 10% glucose solutions, 10% fructose solution, and 5% glucose solution with 0.225% sodium chloride or 0.45% sodium chloride.

Side effects:

The incidence of side effects is classified according to the recommendations of the World Health Organization: very often - not less than 10%; often - not less than 1%, but less than 10%; infrequently - not less than 0,1%, but less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rarely - less than 0.01%, including isolated cases; frequency is unknown - insufficient data for estimating the frequency of the phenomenon in the population.

Infections and infestations: infrequently - fungal superinfection, candidiasis (including the oral cavity, vaginal candidiasis, candidiasis of the gastrointestinal tract).

From the digestive system: often - nausea, diarrhea, vomiting, indigestion, loss of appetite, flatulence, abdominal pain; rarely - dysphagia, pancreatitis, hepatitis, jaundice, including cholestatic, necrosis of the liver, in single cases leading to life-threatening liver failure; very rarely - antibiotic-associated pseudomembranous colitis, in isolated cases taking life-threatening forms.

From the nervous system: often - dizziness, headache, agitation, tremor; infrequently - insomnia, perversion of taste (reversible, disappears after ciprofloxacin withdrawal); rarely - hallucinations,paresthesia (peripheral paralgesia), dysesthesia, nightmares, depression, convulsions, hypoesthesia, drowsiness, exacerbation of myasthenia gravis symptoms, vertigo; very rarely - gait disturbance, psychoses (with the development of which patients can do themselves harm), increased intracranial pressure, ataxia, disorientation, confusion, psychotic reactions, hyperesthesia, muscle hypertension, impaired sense of smell, loss of smell (usually disappears after ciprofloxacin withdrawal), Migraine, anxiety, loss of taste, violation of coordination of movements; frequency unknown - peripheral neuropathy, polyneuropathy.

From the side of the organ of vision: very rarely - a violation of vision, double vision, violation of color perception.

From the side of the organ of hearing and balance: very rarely - noise in the ears, temporary deafness (especially with frequent admission of ciprofloxacin).

From the musculoskeletal system: infrequently - pain in the joints; rarely - pain in the muscles, swelling of the joint, pain in the limbs, back pain; very rarely - convulsive muscle contraction, tendon inflammation (mainly Achilles tendon, including tenosynovitis), partial or complete rupture of the tendon (mainly Achilles tendon).

From the cardiovascular system: infrequent - a feeling of heartbeat; rarely - tachycardia, fainting, "tides" of blood to the face, lowering of blood pressure, vasodilation; very rarely vasculitis (petechial, hemorrhagic bullae, papules, scablike formations), arrhythmia, pirouette-type arrhythmia, prolongation of the QT interval, (mainly in patients with other risk factors for prolonging the QT interval).

From the respiratory system: infrequently - pulmonary embolism, pulmonary edema, hemoptysis, hiccough, shortness of breath, nosebleed; rarely - a violation of breathing (including bronchospasm).

On the part of the blood system and hemopoiesis: often - eosinophilia; infrequently - leukopenia, anemia, granulocytopenia, thrombocytopenia; rarely - leukocytosis, thrombocytosis, neutropenia; very rarely - hemolytic anemia, agranulocytosis, pancytopenia (life-threatening), oppression of bone marrow function (life-threatening).

From the urinary system: rarely acute renal failure, hematuria, crystalluria, interstitial nephritis.

Allergic reactions: often - skin rash; infrequently - itchy skin, patchy-nodular rash, hives; rarely - photosensitivity reaction,erythema multiforme, erythema nodosum, facial edema; very rarely - anaphylactoid reactions, laryngeal edema, Stephen-Johnson syndrome, Lyell syndrome, petechiae, anaphylactic shock, serum sickness, angioedema.

Laboratory data: infrequently - increased activity of alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, hyperbilirubinemia, increased urea concentration in the blood; rarely - changes in prothrombin, hyperglycemia; very rarely - increased activity of amylase, lipase.

Other: infrequently - general weakness, sweating, drug fever; rarely - pain in the chest, peripheral edema.

Overdose:

Symptoms. Dizziness, tremor, headache, fatigue, convulsions, hallucinations, QT interval prolongation, gastrointestinal disturbances, liver and kidney dysfunction, crystalluria, hematuria.

Treatment. The patient should be under close medical supervision. It is necessary to constantly monitor the kidney function. Ciprofloxacin when hemodialysis or peritoneal dialysis is withdrawn in small amounts (less than 10%).Support for an adequate water regime minimizes the risk of crystalluria.

Interaction:

Parenteral drugs can be administered concurrently with ciprofloxacin only if they are confirmed to be compatible. Ciprofloxacin is incompatible with all infusion solutions and drugs that are physically or chemically unstable in an acidic environment (pH of the ciprofloxacin solution is 3.9-4.5), for example, solutions of penicillin and heparin, especially solutions with a pH greater than 7.

It is possible to increase the concentration of theophylline (and other xanthines, for example, caffeine) in the serum and prolong the half-life. As a result, the risk of unwanted effects caused by theophylline may increase. During treatment with ciprofloxacin, more frequent monitoring of the content of theophylline and caffeine in the serum is recommended.

Ciprofloxacin inhibits the isoenzyme CYP1A2, and this can cause an increase in plasma concentrations of concomitant drugs (theophylline, clozapine, Tacrine, ropinirole, tizanidine), which are metabolized by the isoenzyme CYP1A2.

In patients receiving simultaneously with ciprofloxacin any drugs,which are the substrate for the isoenzyme CYP1A2, care must be taken to prevent the overdose symptoms of these drugs. Periodically determine the concentration of these drugs in the plasma, especially when using theophylline.

Ciprofloxacin increases the nephrotoxicity of cyclosporine when used concomitantly.

With simultaneous use of ciprofloxacin with anticoagulants, the time of bleeding may be prolonged, therefore prothrombin time should be regularly determined.

During treatment with ciprofloxacin, patients at the same time taking glucocorticosteroids (GCS) are at increased risk of rupture of tendons.

When used simultaneously with ciprofloxacin, a decrease or increase in the concentration of phenytoin in the blood serum may be possible.

Ciprofloxacin can enhance the action of glibenclamide, so it should be administered with extreme caution to patients with diabetes (due to the risk of hypoglycemia).

The simultaneous use of non-steroidal anti-inflammatory drugs, such as fenbufen, and very high doses of quinolones, can cause seizures.

Methotrexate secretion by the renal tubules can be reduced with simultaneous use of ciprofloxacin as a result of competitive inhibition, leading to an increase in the concentration of methotrexate in the blood plasma. Patients receiving methotrexate therapy require careful monitoring, as the risk of developing toxic reactions caused by methotrexate is increased.

Due to a decrease in plasma concentrations of ciprofloxacin, the drug is not used concomitantly with opioid preparations for premedication (for example, papaveretum) or opioid preparations together with anticholinergic drugs (atropine or hyoscine) for premedication.

Simultaneous use of ciprofloxacin and benzodiazepines for premedication does not affect the concentration of ciprofloxacin in plasma. However, in connection with reports of a decrease in clearance and an increase in T1 / 2 diazepam with simultaneous use of ciprofloxacin and diazepam, and in some cases with simultaneous use of ciprofloxacin and midazolam, it is recommended to monitor the effectiveness of benzodiazepine treatment.

When used simultaneously with drugs that extend the QT interval (antiarrhythmic IA and III classes), the QT interval can be extended.

With the simultaneous use of ciprofloxacin and omeprazole, there may be a slight decrease in the maximum plasma concentration in the plasma and a decrease in AUC.

The simultaneous use of probenecid and ciprofloxacin increases the concentration of ciprofloxacin in the blood plasma (probenecid slows the rate of excretion of ciprofloxacin by the kidneys).

The simultaneous use of duloxetine and potent inhibitors of the CYP1A2 isoenzyme (such as fluvoxamine) can lead to an increase in AUC and C_max duloxetine. Despite the lack of clinical data on the possible interaction with ciprofloxacin, it is possible to foresee the likelihood of such a possible interaction with the simultaneous use of ciprofloxacin and duloxetine. The simultaneous use of ropinirole and ciprofloxacin, a moderate inhibitor of the isoenzyme CYP1A2, leads to an increase in C_max and AUC of ropinirole by 60% and 84%, respectively. It is necessary to monitor the side effects of ropinirole during its simultaneous use with ciprofloxacin and for a short time after completion of the combination therapy.

Simultaneous use of lidocaine and ciprofloxacin leads to a decrease in clearance of lidocaine by 22% with its intravenous administration (possibly increasing side effects of lidocaine).

With the simultaneous use of clozapine and ciprofloxacin at a dose of 250 mg for 7 days, an increase in serum concentrations of clozapine and N-desmethylclozapine by 29% and 31%, respectively (correction of the dosage regimen of clozapine during its simultaneous use with ciprofloxacin and for a short time after completion combination therapy).

With the simultaneous use of ciprofloxacin in a dose of 500 mg and sildenafil at a dose of 50 mg, there was an increase in C_max and AUC of sildenafil in 2 times (application of this combination is possible only after evaluation of the benefit / risk ratio).

Special instructions:

In the treatment of severe and mixed infections caused by gram-positive or anaerobic microorganisms, ciprofloxacin are used only as part of complex therapy together with antibiotics that have bactericidal activity against them.

Ciprofloxacin is not a drug of choice for the treatment of pneumococcal pneumonia.

In connection with the possibility of reducing sensitivity Neisseria gonorrhoeae to ciprofloxacin for the treatment of gonorrheal epididymoorkhitis and prostatitis use a combination of ciprofloxacin with other etiotropic drugs.

For genital infections presumably caused by strains of Neisseria gonorrhoeae resistant to fluoroquinolones, local information on ciprofloxacin resistance should be taken into account and the susceptibility of the causative agent in laboratory tests should be confirmed.

In the treatment of infection of bones and joints ciprofloxacin is used in combination with other antibiotics.

If severe and persistent diarrhea occurs during or after treatment, the diagnosis of pseudomembranous colitis should be deleted, in most cases associated with Clostridium difficile, or antibiotic-associated colitis, which require immediate withdrawal of the drug and the appointment of appropriate treatment.

During treatment with ciprofloxacin, a reversible increase in the activity of "liver" transaminases, alkaline phosphatase, or cholestasis can occur, especially in patients with a history of liver disease. When signs and symptoms of liver disease appear during treatment (loss of appetite, jaundice, darkening of urine, fecal discoloration, skin itching, abdominal pain), ciprofloxacin should be discontinued and a patient should be examined to prevent the development of liver necrosis and hepatic insufficiency that threaten the patient's life .

In patients with epilepsy or other CNS lesions (eg, with convulsive readiness, fits in the anamnesis, changes in brain structure, with reduced cerebral blood flow or after a stroke) ciprofloxacin It can only be used if the benefits of such use exceed the possible risk.

In some cases, after the use of ciprofloxacin may develop allergic reactions or hypersensitivity, which should be reported immediately to the doctor. Anaphylactic / anaphylactoid reactions that appear after the use of the drug may lead to the development of a life-threatening shock. In such cases, ciprofloxacin treatment should be stopped immediately and appropriate anti-shock therapy should be performed.

With intravenous administration of ciprofloxacin, the development of reactions at the site of injection was noted. Reactions often develop with an injection time of 30 minutes or less. Reactions at the injection site are local in nature and disappear shortly after the end of the injection. If the reactions repeat, or their severity increases, then / in the introduction of the drug is contraindicated.

At the first signs of tendovaginitis (pain and swelling of joints), ciprofloxacin treatment should be discontinued, the affected limbs should be treated and consult a doctor.Cases of inflammation and rupture of tendons (predominantly Achilles tendon) are described, especially in elderly patients who had previously received systemic treatment with SCS. Ciprofloxacin it is necessary to cancel if there are symptoms of polyneuropathy (pain, burning, sensation, tingling, numbness, muscle weakness) to prevent the development of irreversible phenomena.

Ciprofloxacin should be used with caution in patients with pirouette-type arrhythmias due to the possibility of prolonging the QT interval during treatment. Ciprofloxacin can cause photosensitivity. During the treatment, patients should avoid direct sunlight and ultraviolet radiation (for example, in a solarium). If signs of photosensitivity (like sunburn) appear, ciprofloxacin treatment should be discontinued.

Ciprofloxacin can cause hemolytic anemia in patients with deficiency of glucose-6-phosphate dehydrogenase.

During the treatment with ciprofloxacin, an acidic urine reaction must be maintained to prevent the development of crystalluria. Before and during treatment, it is necessary to ensure that sufficient fluids are taken.

During the treatment with ciprofloxacin, alcohol consumption is prohibited.

Prolonged and repeated use of ciprofloxacin, as well as the treatment of nosocomial infections and / or infections caused by ciprofloxacin-resistant microorganisms, can lead to superinfection with resistant bacteria or infectious agents of fungal infections.

Because the ciprofloxacin has some activity in relation to Mycobacterium tuberculosis, when taking samples during treatment with ciprofloxacin, false negative results of culture testing can be obtained.

The preparation contains 5 g of glucose in 100 ml. This should be considered when used in patients with diabetes mellitus.

Effect on the ability to drive transp. cf. and fur:During treatment, one should refrain from engaging in potentially dangerous activities that require increased attention and speed of mental and motor reactions.

Form release / dosage:

Solution for infusions 2 mg / ml.

Packaging:

For 100 and 200 ml of the drug in single-use infusion bags of a multilayer film (polypropylene / polyolefin / copolymer of styrene, ethylene and butylene), equipped with a device for connection to the infusion system made of polypropylene with a plug of synthetic isoprene.

10 bags sealed one by one in a laminated foil, along with instructions for use in a cardboard box.

Storage conditions:

Store at a temperature of no higher than 30 ° C in the original packaging. Do not freeze. Keep out of the reach of children.

Shelf life:

3 years. Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-001596

Date of registration:21.03.2012

The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel

Manufacturer: & nbsp

TEVA Pharmaceutical Works Private, Ltd. Co. Hungary

Representation: & nbspTeva Teva Israel

Information update date: & nbsp23.10.2015

Illustrated instructions

Instructions

Ciprofloxacin-Teva (Ciprofloxacin-Teva)