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

Excipients: Sodium chloride - 900 mg, Disodium edetate dihydrate (in terms of disodium edate) - 10 mg, Lactic acid (in terms of 100% substance) - 64 mg, Water for injection - up to 100 ml.

Description:Transparent colorless or slightly yellowish or slightly greenish liquid.

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. The drug inhibits the enzyme DNA-gyrase (topoisomerase II and IV, responsible for the process of supercoiling the chromosomal DNA around the nuclear RNA, which is necessary for reading the genetic information), violates DNA synthesis, growth and division of bacteria, causes marked morphological changes (including cell wall and membranes) and rapid death of the bacterial cell. Against the background of taking ciprofloxacin, there is no parallel development of resistance to other antibiotics that do not belong to the group of DNA-gyrase inhibitors,which makes it highly effective against bacteria that are resistant, for example, to aminoglycosides, penicillins, cephalosporins, tetracyclines and many other antibiotics.

Ciprofloxacin acts bactericidally on gram-negative microorganisms during rest and division (since it affects not only the DNA-gyrase but also causes lysis of the cell wall), Gram-positive microorganisms are effective only during the fission period. Low toxicity for macroorganism cells is explained by the absence of DNA-gyrase in them.

The effectiveness of ciprofloxacin depends to a large extent on the relationship between pharmacokinetic and pharmacodynamic parameters - between the maximum serum concentration (C_max) / 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. When testing the sensitivity of individual strains, it is desirable to have local information on resistance, especially when treating serious infections. If the local prevalence of resistance is such that the use of the drug, at least for several types of infections, is questionable - it is necessary to consult a specialist.

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., Cilrobacter 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: Mobilnncus spp .: other 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, Enterobcicter 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 jluorescens, Serratia marcescens; 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: Bacleroides fragilis, Clostridium difficile, Listeria monocytogenes, Mycoplasma genitalium. Treponema pallidum, Ureaplasma urealyticum.

Pharmacokinetics:

After intravenous infusion of ciprofloxacin 200 or 400 mg, the maximum concentration (C_max) - 2.1 μg / ml and 4.6 μg / ml, respectively, the time to reach the maximum concentration (TC_max) - 60 min. The connection with plasma proteins is 20-40%. The volume of distribution is 2-3.5 l / kg.

Well distributed in body tissues (excluding tissue, rich in fats, for example, nervous tissue). Concentration in tissues is 2-12 times higher than in plasma.Therapeutic concentrations are counted in saliva, tonsils, liver, gall bladder, bile, intestine, abdominal and pelvic organs, endometrium, fallopian tubes and ovaries, kidney and urinary organs, lung tissue, bronchial secretion, bone tissue, muscles, synovial fluid and articular cartilage, peritoneal fluid, skin.

In spinal fluid penetrates in a small amount, where its concentration, in the absence of inflammation of the meninges, is 6-10% of that in the blood serum, and in the presence of inflammation - 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 blood serum.

Metabolised in the liver (15-30%) with the formation of low-activity metabolites (diethylciprofloxacin, sulfociprofloxacin, oxociprofloxacin, formyl ciprofloxacin).

With intravenous administration, the half-life period (T1 / 2) is about 5-6 hours, with chronic renal insufficiency up to 12 hours. It is mainly excreted by the kidneys by glomerular filtration and tubular secretion in unchanged form (50-70%) and in the form metabolites (10%), the rest - through the gastrointestinal tract.A small amount is excreted in breast milk.

After intravenous administration, the concentration in the urine during the first 2 hours after administration is almost 100 times greater than in the serum, which significantly exceeds the minimum inhibitory concentration (MIC) for most pathogens of urinary tract infections.

Kidney clearance - 3-5 ml / min / kg; total clearance - 8-10 ml / min / kg.

In chronic renal failure (creatinine clearance is above 20 ml / min), the percentage of the drug withdrawn through the kidneys decreases, but cumulation in the body does not occur due to a compensatory increase in the metabolism of the drug and its excretion through the gastrointestinal tract.

Indications:

Uncomplicated and complicated infections caused by susceptible to ciprofloxacin microorganisms.

Adults:

respiratory tract infections. Ciprofloxacin recommended for pneumonia caused by Klebsiella spp., Enterobacter spp., Proteus spp., Escherichia coli, Pseudomonas aeruginosa, Haemophilus spp., Moraxella catarrhalis, Legionella spp. and Staphylococcus spp.;
infections of the middle ear (otitis media), adnexal sinuses (sinusitis), especially if these infections are caused by gram-negative microorganisms, including Pseudomonas aeruginosa or Staphylococcus spp .;
eye infections;
infections of the kidneys and urinary tract;
infection of the genitals, including adnexitis, gonorrhea, prostatitis;
infection of the abdominal cavity (bacterial infections of the gastrointestinal tract, bile ducts, peritonitis);
infections of the skin and soft tissues;
sepsis;
infection or prevention of infection in patients with reduced immunity (patients using immunosuppressive drugs or patients with neutropenia);
selective decontamination of the intestine in patients with reduced immunity;
prevention and treatment of pulmonary form of anthrax (infection Bacillus anthracis).

Children:

treatment of complications caused by Pseudomonas aeruginosa in children with cystic fibrosis of the lungs from 5 to 17 years;
prevention and treatment of pulmonary form of anthrax (infection Bacillus anthracis).

Contraindications:

Hypersensitivity to ciprofloxacin and other preparations of the group of fluoroquinolones, as well as to auxiliary substances; simultaneous reception with tizanidine (risk of pronounced reduction in blood pressure, drowsiness); pseudomembranous colitis; children under 18 years of age (before completion of the skeletal process, except for the treatment of complications caused by Pseudomonas aeruginosa in children with cystic fibrosis of the lungs from 5 to 17 years, prevention and treatment of the pulmonary form of anthrax); pregnancy; the period of breastfeeding.

Carefully:

Severe atherosclerosis of cerebral vessels, impaired cerebral circulation, increased risk of prolongation of the QT interval or the development of pirouette-type arrhythmias (eg, congenital QT prolongation syndrome, heart disease (heart failure, myocardial infarction, bradycardia), electrolyte imbalance (eg, hypokalemia , hypomagnesemia)), deficiency of glucose-6-phosphate dehydrogenase; simultaneous use of drugs that extend the QT interval (including antiarrhythmic IA and III classes, tricyclic antidepressants, macrolides, neuroleptics), simultaneous application with inhibitors of isoenzymes CYP450 1A2, (including theophylline, methylxanthine, caffeine, duloxetine, clozapine, ropinirole, olanzapine); patients with a history of tendon damage associated with the use of quinolones, mental illness, convulsions, myasthenia gravis, epilepsy, severe renal and / or hepatic insufficiency, and advanced age.

Pregnancy and lactation:

Ciprofloxacin is contraindicated during pregnancy and breastfeeding.

Dosing and Administration:

Intravenously infuzionalno.

The drug should be administered intravenously drip for 30 minutes at a dose of 200 mg and 60 minutes at a dose of 400 mg. Infusion solution should be injected slowly into a large vein, which helps prevent complications at the site of infusion. The infusion solution can be administered alone or together with other compatible infusion solutions. The infusion solution can be mixed with 0.9% sodium chloride solution, Ringer's and Ringer's lactate solution, 5% and 10% dextrose solution, 10% fructose solution, and also a solution containing 5% dextrose solution e 0.225-0.45% solution of sodium chloride.

The solution obtained after mixing ciprofloxacin with compatible infusion solutions should be used as soon as possible to maintain the sterility of the solution. If compatibility with another infusion solution / drug is not confirmed, the infusion solution of ciprofloxacin should be administered separately. Visible signs of incompatibility are precipitation, clouding or discoloration of the solution. Incompatibility occurs with all solutions / preparations,which are physically or chemically unstable at the pH values of the infusion solution of ciprofloxacin (for example, penicillins, heparin solution), and in particular with solutions that change the pH values to the alkaline side (the pH of the infusion solution of ciprofloxacin is 3.5 to 4.6).

When storing the infusion solution of ciprofloxacin at low temperatures, a precipitate may form which dissolves at room temperature. Therefore, it is not recommended to store the infusion solution in the refrigerator and freeze.

Only clean clear solution should be used.

Adults:

For infections of the respiratory tract (depending on the severity of the infection and the patient's condition) - from 400 mg twice a day to 400 mg 3 times a day;

With infections of the genitourinary system: acute, uncomplicated - from 200 mg twice a day to 400 mg twice a day, complicated - from 400 mg twice a day to 400 mg 3 times a day;

With adnexitis, chronic bacterial prostatitis, orchitis, epididymitis - from 400 mg twice a day to 400 mg three times a day;

With diarrhea - 400 mg 2 times a day;

For other infections (see section "Indications for use") - 400 mg 2 times a day.

Particularly serious infections that pose a threat to life, especially if Pseudomonas spp., Staphylococcus spp. or Streptococcus spp., including pneumonia caused by Streptococcus spp., recurrent infections in cystic fibrosis, infections of bones and joints, septicemia, peritonitis - 400 mg 3 times a day.

Pulmonary form of anthrax (treatment and prevention) - 400 mg twice a day, 60 days.

To patients of advanced age prescribe lower doses of ciprofloxacin, depending on the severity of the infection and the creatinine clearance rate.

Children:

In the treatment of complications caused by Pseudomonas aeruginosa in children with cystic fibrosis of the lungs from 5 to 17 years - 10 mg / kg 3 times a day (maximum daily dose of 1200 mg). The duration of the course of treatment is 10-14 days. With a pulmonary form of anthrax (prevention and treatment) - 10 mg / kg 2 times a day. The maximum single dose is 400 mg, the daily dose is 800 mg. The total duration of the use of ciprofloxacin is 60 days.

Dosing in special cases:

In chronic renal failure: with clearance of creatinine

30-60 ml / min / 1.73 square meters or serum creatinine concentration from 1.4 to 1.9 mg / 100 ml, the maximum daily dose is 800 mg. When creatinine clearance is less than 30 ml / min / 1.73 square meters or serum creatinine concentration is above 2 mg / 100 ml and during hemodialysis the maximum daily dose is 400 mg.With hemodialysis ciprofloxacin injected after a hemodialysis session.

With hepatic insufficiency: in patients with hepatic insufficiency, dose adjustment is not required.

With peritoneal dialysis The infusion solution is added to the dialysate (intraperitoneally) at a dose of 50 mg per liter of dialysate 4 times a day (every 6 hours).

The average course of treatment: 1 day - with acute uncomplicated gonorrhea; up to 7 - days with infections of the lobes, urinary tract and abdominal cavity; no more than 2 months - with osteomyelitis and 7-14 days - with all other infections. With streptococcal infections, due to the danger of late complications, treatment should last at least 10 days. In patients with immunodeficiency treatment is carried out throughout the neutropenia period.

Treatment should be carried out at least 3 days after the normalization of body temperature or the disappearance of clinical symptoms.

Side effects:

According to the World Health Organization (WHO), the undesirable effects are classified according to their frequency of development as follows: very often (> 1/10), often (1/10-1 / 100), infrequently (1 / 100-1 / 1000) , rarely (1 / 1000-1 / 10000), very rarely (<1/10000), the frequency is unknown (the frequency can not be determined based on the available data).

Infectious and parasitic diseases: infrequently - fungal superinfections; rarely - pseudomembranous colitis (in very rare cases with possible fatal outcome).

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

From the immune system: rarely - allergic reactions, allergic edema / angioedema, very rarely - anaphylactic reactions, anaphylactic shock (life threatening), serum sickness.

From the side of metabolism and nutrition: infrequent - a decrease in appetite and intake of food; rarely - hypoglycemia, hyperglycemia.

Disorders of the psyche: infrequently - psychomotor hyperactivity / agitation; rarely confusion, disorientation, anxiety, depression (which can lead to self-damaging behavior, such as suicidal behavior / thoughts, as well as attempted suicide or suicide), "nightmarish" dreams,hallucinations; very rarely - psychotic reactions (which can lead to self-damaging behavior, such as suicidal behavior / thoughts, as well as attempted suicide or suicide).

From the nervous system: infrequently - dizziness, headache, sleep disturbance, increased fatigue, a taste disorder; rarely - tremor, convulsions (including epileptic seizures), vertigo, hypesthesia, paresthesia and dysesthesia, peripheral paralysis (anomaly of perception of pain), thrombosis of the cerebral arteries; very rarely - migraine, impaired coordination of movements, impaired sense of smell, hyperesthesia, benign intracranial hypertension; frequency is unknown - peripheral neuropathy and polyneuropathy.

From the side of the organ of vision: rarely - impaired vision; very rarely - a violation of color perception.

From the side of the hearing organ and labyrinthine disorders: rarely - temporary hearing loss, noise in the ears, hearing loss.

From the heart: rarely - tachycardia, other disorders of the heart rhythm; the frequency is unknown - prolongation of the QT interval, ventricular arrhythmias (including "pirouette" type).

From the side of the vessels: rarely - vasodilation, lowering blood pressure, fainting, "tides" of blood to the face; very rarely - vasculitis.

From the respiratory system, chest and mediastinum: rarely - a violation of breathing (including bronchospasm), dyspnea.

From the gastrointestinal tract: often - nausea, diarrhea; infrequently - dyspepsia, vomiting, abdominal pain, flatulence; very rarely - pancreatitis.

From the liver and bile ducts: infrequently - increased activity of "liver" transaminases; rarely - violations of the liver, cholestatic jaundice (especially in patients with liver disease), hepatitis; very rarely - hepatonecrosis (progressing to life-threatening liver failure).

From the skin and subcutaneous tissues: infrequently - itching, rash, hives; rarely - photosensitivity reactions, the formation of blisters accompanied by bleeding, and the appearance of small nodules that form scabs; very rarely - spot hemorrhages on the skin (petechiae), multiforme exudative erythema (including Stevens-Johnson syndrome), erythema nodosum, toxic epidermal necrolysis (Lyell's syndrome); frequency unknown - generalized pustular exanthema.

From the side of the musculoskeletal and connective tissue: infrequently - arthralgia; rarely - myalgia, arthritis, tendovaginitis, increased muscle tone, muscle cramps; very rarely - muscle weakness, tendonitis, asthenia, tendon ruptures (mainly Achilles), exacerbation of myasthenia gravis symptoms.

From the side of the kidneys and urinary tract: infrequently - impaired renal function; rare - renal failure, hematuria, crystalluria (especially with alkaline urine and low diuresis), dysuria, polyuria, urinary retention, albuminuria, glomerulonephritis, urethral bleeding, decreased renal nitrogen function, interstitial nephritis.

General disorders and disorders at the site of administration: often - pain at the injection site; infrequently, fever; rarely - swelling, increased sweating; very rarely - a violation of gait.

Laboratory and instrumental data: infrequently - increased activity of alkaline phosphatase; rarely - a change in the content of prothrombin (including hypoprothrombinemia), increased activity of amylase, hypercreatininaemia, hyperbilirubinemia; frequency is unknown - an increase in the international normalized ratio (in patients receiving vitamin K antagonists).

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:

Symptoms: nausea, vomiting, confusion, mental agitation.

Treatment: the specific antidote is unknown. It is necessary to carefully monitor the patient's condition, carry out symptomatic therapy, and ensure sufficient fluid intake. In order to prevent the development of crystallaria, it is recommended to monitor renal function, including pH and acidity of urine. With the help of hemo- or peritoneal dialysis, only a small amount (less than 10%) of the drug can be excreted.

Interaction:

Due to the decrease in the activity of microsomal oxidation in hepatocytes, it increases the concentration and lengthens T1 theophylline (and other xanthines, for example, caffeine), oral hypoglycemic drugs, indirect anticoagulants, and helps to reduce the prothrombin index.

With simultaneous use of ciprofloxacin and oral hypoglycemic agents, mainly sulfonylureas (for example, glibenclamide,glimepiride), the development of hypoglycemia may be due to an increase in the effect of oral glycemic agents (see the "Side effect" section).

When combined with other antimicrobial drugs (beta-lactam antibiotics, aminoglycosides, clindamycin, metronidazole) synergy is usually observed; can be successfully used in combination with azlocillin and ceftazidime in infections caused by Pseudomonas spp .; with mezlocillin, azlocillin and other beta-lactam antibiotics - with streptococcal infections; with isoxazolylpenicillins and vancomycin - with staphylococcal infections; with metronidazole and clindamycin - with anaerobic infections.

Increases the nephrotoxic effect of cyclosporine, there is an increase in serum creatinine, so these patients need to monitor this indicator 2 times a week.

With simultaneous application increases the effect of indirect anticoagulants, therefore it is often necessary to monitor the international normalized ratio (INR) during co-administration with ciprofloxacin and for a short time after completion of the combination therapy.

Non-steroidal anti-inflammatory drugs (excluding acetylsalicylic acid) increase the risk of seizures.

Joint use with uricosuric medicines leads to a delay in excretion (up to 50%) and an increase in the plasma concentration of ciprofloxacin.

Increases the maximum concentration of tizanidine by 7 times (from 4 to 21) and the area under the pharmacokinetic curve "concentration-time" by 10 times (from 6 to 24), which increases the risk of pronounced decrease in blood pressure and drowsiness. Thus, the simultaneous use of ciprofloxacin and preparations containing tizanidine, is contraindicated.

The infusion solution is not pharmaceutically compatible with all infusion solutions and drugs that are physico-chemically unstable in an acidic environment. Do not mix the intravenous solution with solutions that have a pH of more than 7.

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 the area under the concentration-time curve.

When used simultaneously with drugs that extend the QT interval (antiarrhythmic IA and III classes, tricyclic antidepressants, macrolides and antipsychotics), an extension of the QT interval is possible.

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

With the simultaneous use of ciprofloxacin, renal metabolism of methotrexate may be slowed, which may be accompanied by an increase in the concentration of methotrexate in the blood plasma (the probability of side effects of methotrexate increases). Concomitant use with methotrexate is not recommended.

The simultaneous use of duloxetine and potent inhibitors of the isoenzyme CYP450 1A2 (such as fluvoxamine) can lead to an increase in the area under the pharmacokinetic curve "concentration-time" and C_max duloxetine. Despite the lack of clinical data on the possible interaction of e-ciprofloxacin, it is possible to foresee the likelihood of such interaction with the simultaneous use of ciprofloxacin and duloxetine.

The simultaneous use of ropinirole and ciprofloxacin, a moderate inhibitor of the isoenzyme CYP450 1A2, leads to an increase in C_max and the area under the pharmacokinetic concentration-time curve of ropinirole by 60% and 84%, respectively. It is necessary to monitor the side effects of ropinirole during its combined 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. It is necessary to correct the dosage regimen of clozapine during its simultaneous application with ciprofloxacin and for a short time after the completion of the 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 the area under the pharmacokinetic curve "concentration-time" sildenafil in 2 times (the application of this combination is possible only after the evaluation of the benefit / risk ratio).

With the simultaneous use of ciprofloxacin and phenytoin, both an increase and decrease in the concentration of phenytoin in plasma is possible. In order to avoid the occurrence of convulsions associated with a decrease in the concentration of phenytoin, and also to prevent undesirable phenomena associated with a phenytoin overdose when ciprofloxacin is discontinued, it is recommended to monitor phenytoin therapy in patients taking both drugs, including the determination of the phenytoin content in the blood plasma throughout the whole period of simultaneous application of both drugs and a short time after the completion of combination therapy.

Special instructions:

In severe infections, staphylococcal infections and infections caused by gram-positive and anaerobic bacteria, ciprofloxacin should be used in combination with appropriate antibacterial agents.

Ciprofloxacin is not a drug of choice in suspected or established pneumonia caused by Streptococcus pneumoniae. In genital infections presumably caused by strains Neisseria gonorrhoeae, resistant to fluoroquinolones,Local information on the degree of resistance to ciprofloxacin should be taken into account and the susceptibility of the causative agent to the drug in laboratory tests should be confirmed.

Violations from the heart. Ciprofloxacin may cause prolongation of the QT interval (see section "Side effect"). Women are characterized by a large average duration of the QT interval compared to men, they are more sensitive to drugs that cause prolongation of the QT interval. In elderly patients, there is also increased sensitivity to the action of drugs that cause prolongation of the QT interval. It should be used with caution ciprofloxacin in combination with QT prolonging drugs (for example, antiarrhythmic drugs of classes IA and III, tricyclic antidepressants, macrolides, antipsychotics), or in patients with an increased risk of developing pirouette arrhythmias (eg, congenital prolongation of the QT interval, electrolyte imbalance , hypokalemia, hypomagnesemia)), in patients with heart disease (heart failure, myocardial infarction, bradycardia).

In extremely rare cases, after the first application, anaphylactic reactions may occur up to anaphylactic shock.In these cases, the use of ciprofloxacin should be stopped immediately and appropriate treatment should be carried out.

In the event of severe and prolonged diarrhea during or after treatment with ciprofloxacin should exclude the diagnosis of pseudomembranous colitis, which requires immediate discontinuation of the drug and appropriate treatment. Contraindicated use of drugs that inhibit intestinal peristalsis.

Hepatobiliary system. When ciprofloxacin was used, cases of liver necrosis and life-threatening liver failure were noted. If you experience any of the following symptoms: anorexia, jaundice, dark urine, itching, abdominal pain - stop taking the drug.

Patients with myasthenia gravis ciprofloxacin should be used with caution because of possible exacerbation of symptoms.

In the application of ciprofloxacin may occur instances tendonitis, and tendon rupture (predominantly Achilles tendon), sometimes bilateral, already during the first 48 h after initiation of therapy. Inflammation and rupture of the tendon can occur even a few months after cessation of ciprofloxacin treatment.In elderly people and patients with diseases of the tendons, simultaneously receiving treatment with glucocorticosteroids, there is an increased risk of tendonopathy.

If pain occurs in the tendons or at the first signs of tendovaginitis, ciprofloxacin treatment should be discontinued.

Ciprofloxacin, like other fluoroquinolones, can provoke convulsions and reduce the threshold of convulsive readiness. When ciprofloxacin was used, cases of epileptic status were reported. In case of seizures, the drug should be discontinued. Mental reactions may occur even after the first use of fluoroquinolones, including ciprofloxacin. In rare cases, depression or psychotic reactions can progress to suicidal thoughts and self-damaging behavior, such as suicide attempts, including those that have occurred. If a patient develops one of these reactions, stop taking the medication and tell the doctor about it. Patients with epilepsy, seizures in the anamnesis, vascular diseases and organic brain damage, in connection with the threat of development of adverse reactions from the central nervous system, ciprofloxacin should be prescribed only for "vital" indications.

In patients taking fluoroquinolones, including ciprofloxacin, there were cases of sensory or sensorimotor neuropathy.

During the treatment period, avoid direct exposure to sunlight and ultraviolet radiation sources.

Ciprofloxacin is a moderate inhibitor of CYP450 1A2 isoenzymes. Caution should be exercised with the simultaneous use of ciprofloxacin and drugs metabolized by these enzymes (including, theophylline, methylxanthine, caffeine, duloxetine, clozapine, ropinirole, olanzapine), since an increase in the concentration of these drugs in the blood serum, due to inhibition of their metabolism by ciprofloxacin, can cause specific undesirable reactions.

In patients with a deficiency of glucose-6-phosphate dehydrohease, receiving ciprofloxacin, hemolytic reactions were noted. The administration of ciprofloxacin to the patient category of patients is possible only if the potential benefit from the application exceeds the possible risk. Patient monitoring is necessary.

Local reaction (inflammatory reaction of the skin at the site of administration of the drug - edema) occurs more often if the infusion time is 30 minutes or less. The reaction quickly passes after the end of the infusion and is not a contraindication for the subsequent administration of the drug, unless its course becomes complicated.

To avoid the development of crystalluria, exceeding the recommended daily dose is inadmissible, sufficient fluid intake and maintenance of acid urine reaction are also necessary.

During prolonged therapy with ciprofloxacin it is recommended to conduct regular general blood tests and kidney and liver function.

With simultaneous intravenous administration of ciprofloxacin and drugs for general anesthesia from the barbituric acid derivative group, continuous monitoring of cardiac activity (heart rate, arterial pressure, ECG monitoring) is necessary.

Ciprofloxacin in vitro in laboratory tests suppresses growth Mycobacterium spp., which can lead to false-negative results in the diagnosis of this pathogen in patients taking the drug.

It is necessary to take into account the content of sodium chloride in the solution of ciprofloxacin in the treatment of patients in whom sodium intake is limited (heart failure, kidney failure, nephrotic syndrome).

Effect on the ability to drive transp. cf. and fur:

During the period of treatment, care must be taken when driving vehicles and mechanisms, as well as when engaging in other potentially dangerous forks that require an increased concentration of attention and speed of psychomotor reactions. If unwanted reactions from the nervous system develop (for example, dizziness, convulsions), one should refrain from driving and practicing other activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Solution for infusions 2 mg / ml.

Packaging:For 100 ml in PVC containers for single-use infusion solutions with two sterile ports. Each container is placed in a bag of polyethylene or polyethylene-polyamide film (a double sterile vacuum package). Containers in bags are placed in a box of corrugated cardboard to 50.75, 96 pieces. Instructions for the medical use of the drug and guidance on the use of infusion solutions in polymer containers in an amount equal to the number of containers (for hospitals) are put in a container box.

Storage conditions:

In a dry, protected from light place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-002848

Date of registration:02.02.2015

The owner of the registration certificate:MEDSINTEZ FACTORY, LTD. MEDSINTEZ FACTORY, LTD. Russia

Manufacturer: & nbsp

MEDSINTEZ FACTORY, LTD. Russia

Information update date: & nbsp19.10.2015

Illustrated instructions

Instructions

Ciprofloxacin (Ciprofloxacin)