Nirtsip - instructions for use, doses, side effects, contraindications

Active substance:
Ciprofloxacin	2.0 mg
Excipients:
Sodium chloride	9.0 mg
Disodium Edetate	0.20 mg
Citric acid monohydrate	0.12 mg
Lactic acid	0.70 mg
Sodium hydroxide	0.30 mg
Hydrochloric acid	to adjust the pH
Water for injections	up to 1 ml
Theoretical osmolarity:	314 mOsm / l

Description:

Transparent, from a colorless to light yellow solution.

Pharmacotherapeutic group:antimicrobial agent - fluoroquinolone

ATX: & nbsp

J.01.M.A.02 Ciprofloxacin

Pharmacodynamics:

A broad-spectrum antimicrobial agent, a quinolone derivative, suppresses 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 DNA synthesis, growth and division of bacteria; causes significant morphological changes (including the cell wall and membranes) and the rapid death of the bacterial cell.

It acts bactericidal against gram-negative microorganisms in the period of rest and division (since it affects not only 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. 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.

For certain strains, the spread of acquired resistance may vary depending on the geographical region and over time. In this regard, when testing the sensitivity of a strain, it is desirable to have local information on resistance, especially when treating severe 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.

In vitro was demonstrated ciprofloxacin activity for the following sensitive strains of microorganisms:

Aerobic Gram-positive microorganisms: Bacillus anthracis, Staphylococcus aureus (methicillin-sensitive), Staphylococcus saprophyticus, Streptococcus spp.

Aerobic Gram-negative microorganisms: Aeromonas spp., Moraxella catarrhal is, Brucella spp., Neisseria meningitidis, Citrobacter koseri, Pasteurella spp., Francisella tularensis, Salmonella spp., Haemophilus ducreyi, Shigella spp., Haemophilius influenzae, Vibrio spp., Legionella spp., Yersiniapestis.

Anaerobic microorganisms: Mobiluncus spp.

Other microorganisms: Chlamydia trachomatis, Chlamydia pneumoniae, Mycoplasma hominis, Mycoplasma pneumoniae.

The a varying degree of sensitivity to ciprofloxacin for the following microorganisms: Acinetobacter baumannii, Burkholderia cepacia, Campylobacter spp., Citrobacter freundii, Enterococcus faecalis, Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Morganella morganii, Neisseria gonorrhoeae, Proteus mirabilis, Proteus vulgaris, Providencia spp., Pseudomonas aeruginosa, Pseudomonas fluorescens, Serratia marcescens, Streptococcus pneumoniae, Peptostreptococcus spp., Propionibacterium acnes.

It is considered, what natural resistance to ciprofloxacin have the Staphylococcus aureus (methicillin-resistant), Stenotrophomonas maltophilia, Actinomyces spp., Enteroccus faecium, Listeria monocytogenes, Mycoplasma genitalium, Ureaplasma urealitycum, anaerobic microorganisms (behind exclusion Mobiluncus spp., Peptostreptococus spp., Propionibacterium acnes).

Pharmacokinetics:

Suction

After intravenous infusion of 200 mg of ciprofloxacin, the time to reach the maximum concentration (TC_m_Oh) - 60 min, the maximum concentration (C_mOh) - 2.1 μg / ml, the connection with plasma proteins - 20-40%.

Distribution

It is well distributed in the tissues of the body. The concentration in the tissues is 2-12 times higher than in the blood plasma. Therapeutic concentrations are achieved in saliva, tonsils, liver, gall bladder, bile, intestine, abdominal organs and small pelvis (endometrium,Fallopian tubes and ovaries, uterus), seminal fluid, prostate tissue, kidney and urinary organs, lung tissue, bronchial secretion, bone tissue, muscles, synovial fluid and articular cartilage, peritoneal fluid, skin. In cerebrospinal 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 plasma, and when inflamed - 14-37%. Ciprofloxacin well penetrates also into the eye fluid, pleura, peritoneum, lymph, through the placenta. The concentration of ciprofloxacin in blood neutrophils is 2-7 times higher than in blood plasma.

Metabolism

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

Excretion

The half-life (T_1/2) - 5-6 hours, with chronic renal failure (CRF) - up to 12 hours. It is mainly excreted by the kidneys through tubular filtration and tubular secretion in unchanged form (50-70%) and in the form of 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 blood plasma, 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.

With CRF (creatinine clearance (CC) above 20 ml / min), the percentage of the drug released through the kidneys decreases, but no cumulation occurs in the body due to a compensatory increase in the metabolism of the drug and excretion through the gastrointestinal tract.

Indications:

Infectious-inflammatory diseases caused by microorganisms sensitive to ciprofloxacin.

Adults:

- diseases of the lower respiratory tract (acute and chronic (at the stage of exacerbation) bronchitis, pneumonia, bronchiectatic disease, infectious complications of cystic fibrosis);

- infection of the ENT organs (acute sinusitis);

- infection of the kidneys and urinary tract (cystitis, pyelonephritis);

- complicated intra-abdominal infections (in combination with metronidazole), including peritonitis;

- chronic bacterial prostatitis;

- uncomplicated gonorrhea;

- typhoid fever;

- infectious diarrhea (including campylobacteriosis, shigellosis);

- infections of the skin and soft tissues (infected ulcers, wounds, burns, abscesses, phlegmon);

- infection of bones and joints (osteomyelitis, septic arthritis);

- septicemia;

- infection against the background of immunodeficiency (arising in the treatment of immunosuppressive drugs or in patients with neutropenia);

- prevention and treatment of pulmonary form of anthrax.

Children:

- therapy 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, any other component of the drug, or other drugs from the group of fluoroquinolones; simultaneous reception with tizanidine (risk of pronounced reduction in blood pressure, drowsiness).

Children under 18 years of age (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 pulmonary form of anthrax); pregnancy; lactation period.

Carefully:

Severe atherosclerosis of cerebral vessels, cerebral circulation disorder, mental diseases, myasthenia gravis gravis, deficiency of glucose-6-phosphate dehydrogenase, epilepsy, lowering the threshold of convulsive readiness (or convulsive seizures in the anamnesis), marked renal and / or hepatic insufficiency, elderly age, tendon damage with prior quinolone treatment, increased risk of lengthening the interval QT or the development of piruet-type arrhythmias (eg, congenital lengthening syndrome QT, heart disease (heart failure, myocardial infarction, bradycardia), electrolyte imbalance (eg, hypokalemia, hypomagnesemia)), simultaneous use of drugs that extend the interval QT (including, antiarrhythmic IA and III classes, tricyclic antidepressants, macrolides, neuroleptics), simultaneous application with inhibitors of isoenzymes CYP 4501A2 (including theophylline, methylxanthine, caffeine, duloxetine, clozapine, ropinirole, olanzapine).

Pregnancy and lactation:

Ciprofloxacin is contraindicated in pregnancy and during breastfeeding.

Dosing and Administration:

Intravenously.

Recommended dosing regimen for adults:

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

- infections of the genitourinary system: acute, uncomplicated: from 200 mg twice a day to 400 mg 2 times in knocking; complicated: from 400 mg twice a day to 400 mg three times a day;

- chronic bacterial prostatitis: from 400 mg twice a day to 400 mg three times a day;

- diarrhea: 400 mg twice a day;

- 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., Streptococcus spp.), in t.ch. 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 2 times a day.

Recommended dosing regimen for children:

- infections in cystic fibrosis (for children from 5 to 17 years): single dose of 10 mg / kg body weight 3 times a day (maximum single dose of 400 mg);

- pulmonary form of anthrax (postcontact): a single dose of 10 mg / kg of body weight 2 times a day (maximum single dose of 400 mg).

Dosing regimen in elderly patients (after 65 years): patientsolder patients should be prescribed lower doses of ciprofloxacin, depending on the severity of the disease and the creatinine clearance rate.

Dosing regimen for adult patients with renal insufficiency:

- with a clearance of creatinine from 30 to 60 ml / min / 1.73 m² or its concentration in blood plasma from 1.4 to 1.9 mg / 100 ml, the maximum daily dose of ciprofloxacin is 800 mg;

- when the creatinine clearance is less than 30 ml / min / 1.73 m² or its concentration in blood plasma from 2 mg / 100 ml or more, the maximum daily dose of ciprofloxacin is 400 mg;

Patients with renal insufficiency on hemodialysis:

- with a clearance of creatinine from 30 to 60 ml / min / 1.73 m² or its concentration in blood plasma from 1.4 to 1.9 mg / 100 ml, the maximum daily dose of ciprofloxacin is 800 mg;

- at a creatinine clearance of 30 ml / min / 1.73 m² and less or its concentration in the blood plasma from 2 mg / 100 ml or more, the maximum daily dose of ciprofloxacin is 400 mg.

In days of hemodialysis ciprofloxacin apply after the procedure.

Ambulatory patients with renal insufficiency who are on prolonged peritoneal dialysis: the drug is added to the dialysate (intraperitoneally): 50 mg of ciprofloxacin per liter of dialysate is administered 4 times a day every 6 hours.

Adult patients with hepatic insufficiency: correction of the dose is not required.

Dosing regimen in children with impaired renal and hepatic function was not studied.

Mode of application: the drug is administered as an intravenous infusion lasting at least 60 minutes. The infusion solution should be injected slowly into a large vein. The infusion solution can be administered alone or together with other compatible infusion solutions.

The infusion solution of the drug is compatible with 0.9% sodium chloride solution, Ringer's solution, Ringer's lactate solution, 5% and 10% dextrose solution, 10% fructose solution, and 5% solution of dextrose with 0.225% solution of sodium chloride or 0.45% solution of sodium chloride. The solution obtained after mixing the drug with compatible infusion solutions should be used as soon as possible because of the sensitivity of the drug to light and to maintain the sterility of the solution. If compatibility with another infusion solution / drug is not confirmed, the infusion solution of Nirtsip should be administered separately. Visible signs of incompatibility are precipitation, clouding or discoloration of the solution. Only clean clear solution should be used.The duration of treatment depends on the severity, clinical course and cure of the disease. It is important to continue treatment for at least 3 days after the disappearance of fever or other clinical symptoms.

Average duration of treatment: adults: 1 day with acute uncomplicated gonorrhea; up to 7 days for infections of the kidneys, urinary tract, intra-abdominal infections; the entire neutropenia period in immunocompromised patients; no more than 2 months with osteomyelitis; from 7 to 14 days with other infections. In infections caused by Streptococcus spp., because of the risk of late complications, treatment should last at least 10 days; infections caused by Chlamydia spp., treatment should also be continued for at least 10 days.

Treatment for pulmonary form of anthrax in adults and children should begin immediately after the alleged or confirmed infection.

The total duration of treatment with ciprofloxacin in pulmonary form of anthrax is 60 days.

For the treatment of complications of cystic fibrosis of the lungs caused by Pseudomonas aeruginosa (in patients from 5 to 17 years), the duration of therapy is 10-14 days.

Side effects:

ByAccording to the World Health Organization (WHO), adverse events are classified according to their developmental frequency as follows: very often (≥ 1/10), often (≥ 1/100, <1/10), infrequently (≥ 1/1000, <1 / 100), rarely (≥ 1/10000, <1/1000), very rarely (<1/10000), the frequency is unknown (it is not possible to determine the frequency of occurrence according to available data).

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

Violations of the blood and lymphatic system: infrequently - eosinophilia; rarely anemia, neutropenia, thrombocytopenia, leukocytosis, thrombocythemia, leukopenia; very rarely - hemolytic anemia, pancytopenia (life threatening), agranulocytosis, oppression of bone marrow hematopoiesis (life threatening).

Immune system disorders: rarely - allergic reactions, allergic edema / angioedema; very rarely - anaphylactic reactions, anaphylactic shock (life threatening), serum sickness.

Disorders from the metabolism and nutrition: infrequently - anorexia, decreased appetite and intake of food; rarely - hyperglycemia, hypoglycemia.

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

Disturbances from the nervous system: infrequently - dizziness, headache, sleep disturbance, taste disorder; rarely - tremor, convulsions (including epileptic seizures), vertigo, hypoesthesia, paresthesia and dysesthesia; very rarely - migraine, impaired coordination of movements, impaired sense of smell, gait disorders, benign intracranial hypertension, hyperesthesia; frequency is unknown - peripheral neuropathy and polyneuropathy.

Disturbances on the part of the organ of sight: rarely - visual disturbances; very rarely - a violation of color perception.

Hearing disorders and labyrinthine disorders: rarely - tinnitus, hearing loss / hearing loss.

Heart Disease: rarely - tachycardia; frequency unknown - ventricular arrhythmias (including the "pirouette" type), predominantly in patients with risk factors for prolonging the QT interval, prolongation of the QT interval.

Vascular disorders: rarely - vasodilation, lowering blood pressure, fainting, feeling of "tide" of blood to the face; very rarely - vasculitis.

Disturbances from the respiratory system, chest and mediastinal organs: rarely - violation of breathing (including bronchospasm).

Disorders from the gastrointestinal tract: often - nausea, diarrhea; infrequently - dyspepsia, vomiting, pain in the abdomen, flatulence; very rarely - pancreatitis.

Disturbances from the liver and bile ducts: infrequently - increased activity of "liver" transaminases, increased bilirubin concentration; rarely - violations of the liver, cholestatic jaundice, hepatitis; very rarely - necrosis of liver tissue (in extremely rare cases progressing to life-threatening liver failure).

Disturbances from the skin and subcutaneous tissues: infrequently - itching, rash, hives; rarely photosensitivity reactions,formation of blisters of unspecified etiology; very rarely - petechia, erythema multiforme, erythema nodosum, Stevens-Johnson syndrome (potentially life-threatening), toxic epidermal necrolysis (Lyell syndrome) (potentially life-threatening); frequency unknown - acute generalized pustular exanthema.

Disturbances from musculoskeletal and connective tissue: infrequently - arthralgia, musculoskeletal pain (including pain in the extremities, back pain, chest pain); rarely - myalgia, arthritis, increased muscle tone, muscle cramps; very rarely - muscle weakness, tendonitis, rupture of tendons (mainly Achilles), exacerbation of myasthenia gravis symptoms.

Disorders from the kidneys and urinary tract: infrequently - impaired renal function; rarely - renal failure, hematuria, crystalluria, tubulointerstitial nephritis.

General disorders and disorders at the site of administration: often - reactions at the injection site (pain, burning, redness, phlebitis); infrequently - general weakness, fever; rarely - swelling, increased sweating.

Laboratory and instrumental data: infrequently - increased activity of alkaline phosphatase in the blood; rarely - changes in the concentration of prothrombin (including hypoprothrombinemia), increased activity of amylase; frequency unknown - an increase in the international normalized ratio (INR) (in patients taking vitamin K antagonists).

The frequency of development of the following side effects with intravenous administration and with the use of stepwise therapy of ciprofloxacin (with intravenous administration of the drug with subsequent ingestion) is higher than with oral administration:

Often: vomiting, transient increase in the activity of "liver" transaminases, rash.

Infrequently: thrombocytopenia, thrombocythemia, confusion and disorientation, hallucinations, paresthesia and dysesthesia, convulsions, vertigo, visual impairment, hearing loss, tachycardia, vasodilation, lowering of blood pressure, reversible liver function abnormalities, cholestatic jaundice, kidney failure, edema.

Rarely: pancytopenia, bone marrow suppression, anaphylactic shock, psychotic reactions, migraine, olfactory impairment, hearing impairment, vasculitis, pancreatitis, liver tissue necrosis, petechiae, tendon rupture.

Children: children more often than adults reported on the development of arthropathies.

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 other emergency measures, ensure sufficient fluid intake. With the help of hemo- or peritoneal dialysis, only a small amount (less than 10%) of the drug can be excreted.

In order to prevent the development of crystallaria, it is recommended to monitor renal function, including pH and acidity of urine.

Interaction:

With simultaneous application with drugs that extend the interval QT (antiarrhythmic drugs class IA and III, tricyclic antidepressants, macrolides, neuroleptics), it is possible to extend the interval QT.

With the simultaneous use of ciprofloxacin and methotrexate there is an increase in concentration methotrexate in the blood plasma. This may increase the likelihood of side effects methotrexate, which requires careful monitoring of patients receiving co-therapy.

With the simultaneous use of ciprofloxacin and omeprazole there may be a slight decrease in the maximum concentration of the drug in the blood plasma and a decrease in the area under the "concentration-time" curve.

Simultaneous application probenecid and ciprofloxacin increases the concentration of ciprofloxacin in the blood plasma (probenecid slows the rate of excretion of ciprofloxacin by the kidneys).

Simultaneous application duloxetine and potent inhibitors of isoenzyme CYP4501A2 (such as fluvoxamine) can lead to an increase in the area under the "concentration-time" curve (AUC) and C_mOh duloxetine. Despite the lack of clinical data on the possible interaction with ciprofloxacin, it is possible to foresee the likelihood of such interaction with the simultaneous use of ciprofloxacin and duloxetine.

Simultaneous application ropinirole and ciprofloxacin, a moderate isoenzyme inhibitor CYP4501A2, leads to an increase AUC and C_mOh 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 application lidocaine and ciprofloxacin leads to a decrease in clearance lidocaine by 22% with its intravenous administration (there may be an increase in side effects lidocaine).

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

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

Metoclopramide accelerates absorption, which leads to a decrease in the time to reach its C_mOh.

Due to a decrease in the activity of microsomal oxidation in hepatocytes ciprofloxacin increases concentration and lengthens half-life theophylline and other xanthines (eg, caffeine).

Simultaneous use of ciprofloxacin and preparations containing theophylline, may cause the occurrence of theophylline-induced adverse events; in very rare cases, these side effects can be life threatening.

When used simultaneously with theophylline It is recommended to carry out constant concentration monitoring theophylline in blood plasma and, if necessary, reduce the dose theophylline.

With the simultaneous use of ciprofloxacin and phenytoin possibly both an increase and a decrease in concentration phenytoin in blood plasma, therefore it is recommended to monitor its concentration during the entire period of simultaneous application of drugs and shortly after the completion of combination therapy.

Simultaneous use of ciprofloxacin and antagonists of vitamin K (eg, warfarin, acenocoumarol, fenprocumone, fluindone) can enhance their anticoagulant effect. The severity of this effect may vary depending on the concomitant infections, age and general condition of the patient, so the degree of effect of ciprofloxacin on increasing INR is difficult to assess. It is often enough to monitor INR during the combined use of ciprofloxacin with antagonists of vitamin K, and also for a short time after the completion of the combination therapy.

With the simultaneous use of ciprofloxacin and oral hypoglycemic drugs, mainly Sulfonylureas (eg, glibenclamide, glimepiride), may enhance the effect of the latter.

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

Strengthens nephrotoxic action cyclosporine, there is an increase in the serum creatinine concentration, in such patients monitoring of this indicator 2 times a week is necessary.

When used simultaneously with nonsteroidal anti-inflammatory drugs (excluding acetylsalicylic acid) the risk of seizures increases.

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

Increases C_mOh in 7 times (from 4 to 21 times) and AUC in 10 times (from 6 to 24 times) tizanidine, which increases the risk of a marked decrease in blood pressure and drowsiness. Thus, the simultaneous use of ciprofloxacin and preparations containing tizanidine, it is contraindicated.

Special instructions:

Before prescribing the drug, it is necessary to make sure that strains of microorganisms causing an infectious disease are sensitive to ciprofloxacin.

Ciprofloxacin is not recommended for the treatment of infections caused by Streptococcus pneumoniae because of insufficient effectiveness against the pathogen.

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

In the treatment of severe infections, staphylococcal infections and infections caused by anaerobic bacteria, ciprofloxacin should be used in combination with appropriate antibacterial agents. In infections presumably caused by strains Neisseria gonorrhoeae, resistant to fluoroquinolones, local information on resistance to ciprofloxacin should be taken into account and the susceptibility of the pathogen in laboratory tests should be confirmed.

Ciprofloxacin has an effect on lengthening the interval QT. Given that women are characterized by a large average duration of the interval QT compared with men, they are more sensitive to drugs that cause lengthening of the interval QT. In elderly patients there is also an increased sensitivity to the action of drugs that cause lengthening of the interval QT. Therefore, it is necessary to use caution ciprofloxacin with drugs that extend the interval QT (for example, antiarrhythmic drugs classes IA and III, tricyclic antidepressants, macrolides, neuroleptics), in patients with an increased risk of lengthening the interval QT or the development of piruet-type arrhythmias (eg, congenital lengthening syndrome QT, heart disease (heart failure, myocardial infarction, bradycardia), uncorrected imbalance of electrolytes (eg, hypokalemia and hypomagnesemia)).

Sometimes, even after the first dose of ciprofloxacin is administered, hypersensitivity to the drug may develop, including allergic reactions, which should be reported immediately to the treating physician.

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 given.

With intravenous administration of ciprofloxacin, a local reaction may occur at the site of administration (edema, pain). This reaction is more common 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 is complicated.

Ciprofloxacin is a mild inhibitor of isoenzymes CYP4501A2. Caution should be exercised while using ciprofloxacin and drugs metabolized by these enzymes (including theophylline, methylxanthine, caffeine, duloxetine, clozapine), since an increase in the concentration of these drugs in the blood serum due to inhibition of their metabolism by ciprofloxacin can cause specific unwanted reactions.

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

In patients with a deficiency of glucose-6-phosphate dehydrogenase, ciprofloxacin, hemolytic reactions were noted. The appointment of ciprofloxacin in this category of patients is possible only if the potential benefit of the application exceeds the possible risk. Patient monitoring is necessary.

With simultaneous intravenous administration of ciprofloxacin and medications for general anesthesia, barbituric acid derivatives need constant monitoring of heart rate, blood pressure, and electrocardiograms.

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

Adverse reactions from the central nervous system may occur after the first use of the drug. In rare cases, depression or psychotic reactions may manifest as suicidal attempts,including those that have occurred, in these cases, immediately stop taking ciprofloxacin and inform the doctor about it. Patients with epilepsy, seizures in the anamnesis, vascular diseases and organic brain lesions, in connection with the threat of development of adverse reactions from the central nervous system, ciprofloxacin should be prescribed only for "vital" indications.

When ciprofloxacin was used, cases of epileptic status were reported. Ciprofloxacin, like other fluoroquinolones, can provoke cramps and reduce the threshold of convulsive readiness. In case of seizures, the drug should be discontinued.

If a severe and prolonged diarrhea occurs during or after treatment, the diagnosis of pseudomembranous colitis should be deleted, which requires immediate discontinuation of the drug and the appointment of appropriate treatment. Contraindicated use of drugs that inhibit intestinal peristalsis.

In patients who use fluoroquinolones, including ciprofloxacin, cases of sensory and sensorimotor axonal polyneuropathy affecting small and (or) large axons, and leading to paresthesia, hypesthesia, dysesthesia and weakness are reported.Symptoms may appear soon after the onset of use and be irreversible. If the patient develops symptoms of neuropathy, including pain, burning, tingling, numbness and / or weakness or other sensitivity disorders, including tactile, pain, temperature, vibration sensitivity and a sense of position, the use of the drug ciprofloxacin must be discontinued immediately.

When using ciprofloxacin, there may be cases of tendinitis and rupture of tendons (mainly Achilles tendon), sometimes bilateral, within the first 48 hours after the initiation of therapy. Inflammation and rupture of the tendon can occur even a few months after cessation of ciprofloxacin treatment. In elderly patients with diseases of the tendons, simultaneously receiving treatment with glucocorticosteroids, there is an increased risk of tendonopathy. At the first signs of tendonitis (painful swelling in the joint area, inflammation), the use of ciprofloxacin should be discontinued, exclude physical activity, since there is a risk of rupture of the tendon, it is also necessary to consult a doctor. Ciprofloxacin should be used with caution in patients with a history of indications of tendon diseases associated with the administration of quinolones.

When ciprofloxacin was used, cases of liver necrosis and life-threatening liver failure were noted. In the presence of signs of liver disease, such as anorexia, jaundice, darkening of the urine, itching, abdominal tenderness, taking ciprofloxacin should be discontinued.

In patients receiving ciprofloxacin and those suffering liver disease, there may be a temporary increase in activity of "liver" transaminases, alkaline phosphatase or cholestatic jaundice.

Patients with severe myasthenia gravis gravis should be applied ciprofloxacin with caution, as possible exacerbation of symptoms.

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).

Caution should be exercised with the simultaneous use of ciprofloxacin and drugs metabolized by isoenzymes CYP4501A2, such as ropinirole, olanzapine.

During the treatment should avoid contact with direct sunlight, artificial UV-irradiation.

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

During treatment, one should refrain from driving vehicles and from practicing potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:Solution for infusion, 2 mg / ml.

Packaging:

For 100 ml of the drug in a bottle of low-density polyethylene, closed with a lid of polypropylene.

Each vial, provided with a self-adhesive label, is placed in a package of polypropylene BOPP film together with instructions for use in a cardboard pack.

Storage conditions:

In the dark place at a temperature of no higher than 30 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

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

Terms of leave from pharmacies:On prescription

Registration number:LP-003406

Date of registration:13.01.2016 / 13.07.2016

Expiration Date:13.01.2021

The owner of the registration certificate:Akulayf Helskea Pvt. Ltd.Akulayf Helskea Pvt. Ltd. India

Manufacturer: & nbsp

Nirma Limited India

Representation: & nbspCompany AlkemiCompany Alkemi

Information update date: & nbsp05.08.2016

Illustrated instructions

Instructions

Nircip (Nircip)