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

Tsiprolet - 250: 1 coated tablet contains Ciprofloxacin 250.0 mg, Corn starch 57.87 mg, microcrystalline cellulose 7.5 mg, croscarmellose sodium 10.0 mg, colloidal silicon anhydrate 5.0 mg, talc 7.0 mg, magnesium stearate 3.510 mg, hypromellose 6.0 mg, sorbic acid 0.1 mg, titanium dioxide 2.5 mg, macrogol 1.7 mg, polysorbate 0.1 mg, dimethicone 0.1 mg

Tsiprolet - 500: 1 coated tablet contains ciprofloxacin hydrochloride monohydrate at a dose equivalent to 500 mg of ciprofloxacin and auxiliaries - microcrystalline cellulose 5.0 mg, croscarmellose sodium 20 mg, corn starch 37.25 mg, magnesium stearate 4.5 mg, colloidal silica 5.0 mg, talc 8.5 mg , hypromellose 7.0 mg, sorbic acid 0.1 mg, titanium dioxide 2.5 mg, macrogol 1.7 mg, polysorbate 0.1 mg, dimethicone 0.1 mg

Description:

White or almost white round biconvex tablets with a smooth surface on both sides, film-coated. View of the break - White, or almost white mass.

Pharmacotherapeutic group:Antimicrobial agent, fluoroquinolone.

ATX: & nbsp

J.01.M.A.02 Ciprofloxacin

Pharmacodynamics:

A broad-spectrum antimicrobial agent, a derivative of fluoroquinolone, 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 out 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 on gram-negative organisms during 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 and many other antibiotics.

Gram-negative aerobic bacteria are sensitive to ciprofloxacin: enterobacteria (Escherichia coli, Salmonella spp., Shigella spp., Citrobacter spp., Klebsiella spp., Enterobacter spp., Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Hafnia alvei, Edwardsiella tarda, Providencia spp. , Morganella morganii, Vibrio spp., Yersinia spp.), Other gram-negative bacteria (Haemophilus spp., Pseudomonas aeruginosa, Moraxella catarrhalis, Aeromonas spp., Pasteurella multocida, Plesiomonas shigelloides, Campylobacter jejuni, Neisseria spp.), Some intracellular pathogens - Legionella pneumophila, Brucella spp., Listeria monocytogenes, Mycobacterium tuberculosis, Mycobacterium kansasii, Corynebacterium diphtheriae; Gram-positive aerobic bacteria: Staphylococcus spp. (Staphylococcus aureus, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus saprophyticus), Streptococcus spp. (Streptococcus pyogenes, Streptococcus agalactiae).

It is active against Bacillus anthracis in vitro.

The majority of staphylococci, resistant to methicillin, are resistant to ciprofloxacin. Sensitivity Streptococcus pneumoniae, Enterococcus faecalis, Mycobacterium avium(located intracellularly) - moderate (to suppress them, high concentrations are required).

For drug resistant: Bacteroides fragilis, Pseudomonas cepacia, Pseudomonas maltophilia, Ureaplasma urealyticum, Clostridium difficile, Nocardia asteroides. It is effective against Treponema pallidum.

Resistance develops very slowly, because on the one hand, after the action of ciprofloxacin are left with persistent microorganisms, and on the other - the bacterial cells do not have the enzymes that inactivate it.

Pharmacokinetics:

When taken orally, it is quickly and fairly fully absorbed from the gastrointestinal tract (GIT), mainly in the 12-finger and jejunum. Eating slows down absorption, but does not change the maximum concentration (C_max) and bioavailability.Bioavailability is 50-85%, the volume of distribution is 2-3.5 l / kg, the connection with plasma proteins is 20-40%. Time to reach the maximum concentration (TC_max) with oral intake - 60-90 min, C_max linearly depends on the value of the dose taken and is at doses of 250, 500, 750 and 1000 mg, respectively, 1,2; 2.4; 4.3 and 5.4 μg / ml.

After 12 hours after ingestion of 250, 500 and 750 mg, the concentration of the drug in the plasma is reduced to 0.1; 0.2 and 0.4 μg / ml, respectively.

Well distributed in the tissues of the body (excluding the fat-rich tissue, for example, nerve tissue). Concentration in tissues is 2-12 times higher than in 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, bone tissue, muscles, synovial fluid and articular cartilage, peritoneal fluid, skin. In spinal fluid penetrates in a small amount, where the 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 well penetrates also 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 (oxo-, diethyl-, sulfo-, formylciprofloxacin).

The half-life (T1) is about 3-5 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 (40-50%) and in the form of metabolites ( 15%), the rest - through the intestine. A small amount is excreted in breast milk. Kidney clearance - 3-5 ml / min / kg; total clearance is 8-10 ml / min / kg.

When CRF (creatinine clearance (CC) is above 20 ml / min), the percentage of the drug withdrawn 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 its excretion by the intestine.

Indications:

Infectious-inflammatory diseases caused by microorganisms sensitive to ciprofloxacin.

Adults:

- infections 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;

- infection of the genitals, including adnexitis, gonorrhea, prostatitis;

- infection of the abdominal cavity (bacterial infections of the gastrointestinal tract, bile ducts);

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

- infection of bones and joints: osteomyelitis, septic arthritis;

- sepsis and peritonitis;

- infection 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.

Children and adolescents (from 5 to 17 years):

- therapy of complications caused by Pseudomonas aeruginosa in children with cystic fibrosis of the lungs;

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

Contraindications:

Hypersensitivity to ciprofloxacin and other drugs of the quinolone group and auxiliary substances, children's age (up to 18 years before the 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 old, prevention and treatment of the pulmonary form of the Siberian ulcers),simultaneous reception with tizanidine (risk of pronounced reduction in blood pressure, drowsiness), pregnancy, lactation (breastfeeding).

Carefully:

Severe atherosclerosis of cerebral vessels, cerebral circulation disorder, mental illness, epilepsy, marked renal and / or hepatic insufficiency, advanced age, increased risk of QT interval prolongation or the development of pirouette arrhythmia (eg, congenital QT prolongation syndrome), 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 CYP450 1A2 (including theophylline, methylxanthine, caffeine, duloxetine, clozapine, ropinirole, olanzapine), patients who have an anamnesis indication of the defeat of tendons in the previous treatment with quinolones, myasthenia gravis gravis, deficiency of glucose-6-phosphate-dendrogenase.

Dosing and Administration:

Tablets should be taken orally, regardless of food intake, without chewing, squeezed with a small amount of liquid. If the drug is used on an empty stomach, the active substance is absorbed more quickly. In this case, the tablets should not be washed down with milk products or beverages fortified with calcium (for example, milk, yogurt, juices with high calcium content). Calcium, contained in ordinary poverty, does not affect the absorption of ciprofloxacin.

Recommended dosing regimen:

Adults

respiratory tract infections (depending on the severity of the infection and the patient's condition): from 500 mg twice a day, up to 750 mg twice a day;

infections of the genitourinary system: acute, uncomplicated: from 250 mg twice a day to 500 mg twice a day; cystitis in women (before menopause): 500 mg once a day; complicated: from 500 mg twice a day to 750 mg twice a day; infection of the genital organs (except gonorrhea): from 500 mg twice a day to 750 mg twice a day; gonorrhea: 500 mg once a day once; - Diarrhea: 500 mg 2 times a day;

- other infections (see section "Indications for use"): 500 mg 2 times a day; especially severe, which pose a threat to life (especially if Pseudomonas spp., Staphylococcus spp., Streptococcus spp.), in t.ch.streptococcal pneumonia, infections of bones and joints, septicemia, peritonitis: 750 mg 2 times a day.

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

Dosing regimen for 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 1000 mg;

- when the creatinine clearance is less than 30 ml / min / 1.73 m² or plasma concentrations of 2 mg / 100 ml or more, the maximum daily dose of ciprofloxacin is 500 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 1000 mg; at a creatinine clearance of 30 ml / min / 1.73 m² and less or its concentration in blood plasma from 2 mg / 100 ml or more, the maximum daily dose of ciprofloxacin is 500 mg. In days of hemodialysis ciprofloxacin take after the procedure.

Out-patient patients with renal insufficiency,which are on continuous peritoneal dialysis: the maximum daily ciprofloxacin is 500 mg.

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

The duration of treatment depends on the severity of the disease, clinical and bacteriological control. It is important to continue treatment systematically, at least 3 dienes after the disappearance of fever or other clinical symptoms. Average duration of treatment: 1 day with acute uncomplicated gonorrhea and cystitis; up to 7 days for infections of the nights, 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.

For the prevention and treatment of pulmonary form of anthrax - 500 mg twice a day for 60 days.

The drug should be taken immediately after a suspected or confirmed infection.

Children and teens

In the absence of other appointments, the following dosing regimen should be followed:

In the treatment of complications caused by Pseudomonas aeruginosa in children from 5 to 17 years with cystic fibrosis of the lung - 20 mg / kg 2 times a day (maximum dose of 1500 mg). Duration of treatment is 10-14 days. With a pulmonary form of anthrax (prevention and treatment) - 15 mg / kg 2 times a day. The maximum single dose is 500 mg, the daily dose is 1000 mg. The total duration of taking ciprofloxacin is 60 days.

Children with impaired renal function

There is no information on the dose adjustment scheme for children with impaired renal function.

Side effects:

Depending on the frequency of occurrence, the following groups of side effects are identified: frequent (> 1% and <10%), infrequent (> 0.1 and <1%), rare (> 0.01 and <0.1%), very rare (<0.01%).

From the central and peripheral nervous system: infrequently - dizziness, headache, increased fatigue; rarely - insomnia, tremor; very rarely - anxiety, "nightmarish" dreams, peripheral paralysis (anomaly of perception of pain), increased sweating, increased intracranial pressure, including benign intracranial hypertension, confusion,depression (which can lead to self-harming behavior such as suicidal behavior / thoughts, as well as attempted suicide or suicide), hallucinations, as well as other manifestations of psychotic reactions (which can lead to self-damaging behavior such as suicidal behavior / thoughts, and also suicide attempt or suicide), migraine, syncope, cerebral thrombosis, agitation, disorientation, paresthesia and dysesthesia, hypesthesia, seizures, vertigo, impaired coordination of movements, impaired gait, hyperesthesia, peripheral neuropathy and polyneuropathy, seizures of epilepsy.

From the sense organs: infrequently - a violation of taste; rarely - visual disturbances, tinnitus, hearing loss; very rarely - a violation of the sense of smell, a violation of color perception, hearing impairment.

From the cardiovascular system: in very rare cases - tachycardia, other disorders of the heart rhythm, lowering blood pressure, lengthening the QT interval, ventricular arrhythmias (including the "pirouette" type).

From the digestive system: infrequently - nausea, vomiting, diarrhea, abdominal pain, flatulence,decreased appetite and intake of food; rarely - cholestatic jaundice (especially in patients with liver disease), pancreatitis; very rarely - hepatitis, hepatonecrosis.

On the part of the hematopoiesis system: infrequently - eosinophilia, leukopenia, granulocytopenia, thrombocytopenia, anemia; Very rarely - leukocytosis, thrombocytosis, hemolytic anemia, neutropenia, agranulocytosis, pancytopenia, oppression of bone marrow hematopoiesis, serum sickness.

From the urinary system: rarely - hematuria, crystalluria (especially in alkaline urine and low diuresis), dysuria, polyuria, urinary retention, albuminuria; very rarely - glomerulonephritis, urethral bleeding, decreased renal nitrogen function, interstitial nephritis, renal insufficiency.

On the part of the respiratory system: rarely a violation of breathing (including bronchospasm).

Allergic reactions: infrequently - skin itching, urticaria, the formation of blisters accompanied by bleeding, and the appearance of small nodules that form scabs, drug fever, pinpoint hemorrhages on the skin (petechiae); rarely - swelling of the face or larynx, dyspnea,eosinophilia, increased photosensitivity; very rarely vasculitis, nodal erythema, multiforme exudative erythema (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), anaphylactic reactions, anaphylactic shock.

From the laboratory indicators: infrequently - increased activity of "liver" transaminases and alkaline phosphatase, hyperbilirubinemia; rarely - a change in the content of prothrombin (including hypoprothrombinemia), hyperglycemia or hypoglycemia, increased activity of amylase; frequency is unknown - hypercreatininaemia.

Other: infrequently - the "tides" of blood to the face; rarely - arthralgia, arthritis, tendovaginitis; very rarely - ruptures of tendons (mainly Achilles), asthenia, myalgia, increased muscle tone, muscle weakness, exacerbation of myasthenia gravis, superinfection (candidiasis, pseudomembranous colitis); frequency unknown - acute generalized pustular exanthema, increased international normalized ratio (in patients receiving vitamin K antagonists).

Overdose:

Symptoms: nausea, vomiting, confusion, mental agitation.Treatment: a specific antidote is unknown. It is necessary to carefully monitor the patient's condition, perform gastric lavage and other emergency measures, 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:

Medicinal products that cause an elongation of the RT interval

Caution should be exercised while using ciprofloxacin, as well as other fluoroquinolones, in patients receiving medications that induce prolongation of the QT interval (for example, antiarrhythmic drugs of class IA and III, tricyclic antidepressants, macrolides, antipsychotics).

Formation of chelate compounds

Simultaneous administration of tablet forms of ciprofloxacin and cation-containing preparations, mineral supplements containing calcium, magnesium, aluminum, iron, sucralfate, antacids, polymeric phosphate compounds (sevelamer, lanthanum carbonate) and preparations with a large buffer capacity (such as didanosine tablets) containing magnesium, aluminum or calcium, reduces the absorption of ciprofloxacin. In such cases ciprofloxacin should be taken or in 1-2 hours before, or after 4 hours after reception of these drugs.

This restriction does not apply to drugs belonging to the class of H2-histamine receptor blockers.

Admission of Poverty and Dairy Products

Ciprofloxacin and dairy products or beverages enriched with minerals (milk, yogurt, calcium-fortified orange juice) should be avoided at the same time, as the absorption of ciprofloxacin may decrease. However, calcium, which is part of other foods, does not significantly affect the absorption of ciprofloxacin.

Omeprazole

With the combined use of ciprofloxacin and omeprazole, there may be a slight decrease in C_maxin the plasma and a decrease in the area under the pharmacokinetic curve "concentration-time" (AUC).

Theophylline

Simultaneous use of ciprofloxacin and preparations containing theophylline, can cause an undesirable increase in the concentration of theophylline in the blood plasma and, accordingly, the occurrence of theophylline-induced adverse events; in very rare cases, these adverse events can be life threatening to the patient. If the simultaneous use of these two drugs is necessary, it is recommended that a continuous control of the concentration of theophylline in the blood plasma and, if necessary, reduce the dose of theophylline.

Other xanthine derivatives

Simultaneous use of ciprofloxacin and caffeine or pentoxifylline (oxpentifylline) may lead to an increase in the concentration of xanthine derivatives in the blood serum.

Nonsteroidal anti-inflammatory drugs

The combination of very high doses of quinolones and some non-steroidal anti-inflammatory drugs (excluding acetylsalicylic acid) can provoke convulsions.

Cyclosporin

With the simultaneous use of ciprofloxacin and drugs containing ciclosporin, it was observed

a transient transient increase in the concentration of creatinine in the blood plasma. In such cases, the concentration of creatinine in the blood should be determined twice a week.

Oral hypoglycemic agents

With the simultaneous use of ciprofloxacin and oral hypoglycemic agents, mainly sulfonylureas (for example, glibenclamide, glimepiride), the development of hypoglycemia may be due to the increased effect of oral hypoglycemic agents.

Probenecid

Probenecid slows the rate of excretion of ciprofloxacin by the kidneys. Simultaneous use of ciprofloxacin and preparations containing probenecid, leads to an increase in the concentration of ciprofloxacin in the blood serum.

Phenytoin

With the simultaneous use of ciprofloxacin and phenytoin, there was a change (increase or decrease) in the content of phenytoin in the blood plasma. It is recommended to monitor phenytoin therapy in patients taking both drugs, including the determination of phenytoin in the blood plasma.

Methotrexate

With the simultaneous use of methotrexate and ciprofloxacin, the renal tubular transport of methotrexate may be slowed, which may be accompanied by an increase in the concentration of methotrexate in the blood plasma. This may increase the likelihood of side effects of methotrexate.In this regard, for patients receiving concomitant therapy with methotrexate and ciprofloxacin, careful monitoring must be established.

Tizanidine

As a result of a clinical study involving healthy volunteers with simultaneous use of ciprofloxacin and drugs containing tizanidine, an increase in the concentration of tizanidine in blood plasma: an increase in C_max in 7 times (from 4 to 21 times), increase in AUC by 10 times (from 6 to 24 times). With increasing tizanidine concentration in the blood serum, hypotensive and sedative side effects are associated. Thus, the simultaneous use of ciprofloxacin and preparations containing tizanidine, is contraindicated.

Duloxetine

Clinical studies have shown that the simultaneous use of duloxetine and potent inhibitors of the CYP450 1A2 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 interaction with the simultaneous use of ciprofloxacin and duloxetine.

Ropinirole

The simultaneous use of ropinirole and ciprofloxacin, a moderate inhibitor of the isoenzyme CYP450 1A2, leads to an increase in C_max and AUC of ropinirole by 60% and 84%, respectively. It is necessary to control the adverse effects of ropinirole during its joint use with ciprofloxacin and for a short time after the completion of the combination therapy.

Lidocaine

In a study on healthy volunteers, it was found that the simultaneous use of drugs containing lidocaine, and ciprofloxacin, a moderate inhibitor of the isoenzyme CYP450 1A2, leads to a decrease in clearance of lidocaine by 22% with its intravenous administration. Despite the good tolerability of lidocaine, simultaneous use with ciprofloxacin may increase the side effects due to interaction.

Clozapine

With the simultaneous administration of chlamydia and ciprofloxacin at a dose of 250 mg for 7 days, an increase in serum concentrations of chlamydia and N-desmethylclozapine by 29% and 31%, respectively. It is necessary to monitor the patient's condition and, if necessary, to correct the dosage regimen is chicken when combined with ciprofloxacin and for a short time after the completion of the combination therapy.

Sildenafil

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

Antagonists of vitamin K

The combined use of ciprofloxacin and vitamin K antagonists (eg, warfarin, acenocoumarol, fenprocumone, fluindone) may lead to an increase in their anticoagulant effect. The magnitude of this effect may vary depending on the concomitant infections, age and general condition of the patient, so it is difficult to assess the effect of ciprofloxacin on increasing the international normalized ratio (INR). It is often enough to monitor INR during joint use of ciprofloxacin and vitamin K antagonists, and also for a short time after the completion of combination therapy.

Special instructions:

Severe infections, staphylococcal infections and infections caused by Gram-positive anaerobic bacteria

In the treatment of severe infections, staphylococcal infections and infections caused by anaerobic bacteria, ciprofloxacin should be used in combination with appropriate antibacterial agents.

Infections due to Streptococcus pneumoniae

Ciprofloxacin is not recommended for the treatment of infections caused by Streptococcus pneumoniae, due to limited effectiveness against the pathogen.

Infections of the reproductive tract

In genital 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 causative agent should be confirmed by laboratory tests.

Heart Disease

Ciprofloxacin has an effect on the prolongation of the QT interval. Given that women have a larger average duration of the QT interval than men, they are more sensitive to drugs that cause prolongation of the QT interval. In elderly patients, too, there is an increased sensitivity to the action of such drugs. Use with caution ciprofloxacin in combination with drugs that extend the QT interval (for example, antiarrhythmic drugs of classes IA and III, tricyclic antidepressants,macrolides, neuroleptics), or in patients with an increased risk of prolonging the QT interval or developing pirouette-type arrhythmias, (eg QT syndrome), heart disease (heart failure, myocardial infarction, bradycardia), corrected electrolyte imbalance (eg, hypokalemia, hypomagnesemia).

Use in children

Ciprofloxacin, like other drugs of this class, causes arthropathy of large joints in animals. When analyzing the current data on the safety of ciprofloxacin in children under 18 years of age, most of whom have cystic fibrosis of the lung, there is no association between cartilage damage and joints with drug administration. It is not recommended to use ciprofloxacin in children for the treatment of other diseases, except for the treatment of complications of cystic fibrosis of the lungs (in children from 5 to 17 years) associated with Pseudomonas aeruginosa and for the treatment and prevention of the pulmonary form of anthrax.

Hypersensitivity

In 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.

Gastrointestinal tract

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.

Hepatobiliary system

When ciprofloxacin was used, cases of liver necrosis and life-threatening liver failure were noted. In the presence of such symptoms of liver disease as anorexia, jaundice, darkening of the urine, itching, painful abdomen, the use of ciprofloxacin should be discontinued.

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

Musculoskeletal system

Patients with severe myasthenia gravis ciprofloxacin should be used with caution, as possible exacerbation of symptoms. At the first signs of tendonitis (painful swelling, inflammation in the joint region), ciprofloxacin treatment should be discontinued and physical activity eliminated.

When ciprofloxacin is used, tendonitis and tendon rupture (mainly Achilles tendon) can occur, sometimes bilateral, within the first 48 hours after initiation of therapy, inflammation and rupture of the tendon may occur even a few months after discontinuation of ciprofloxacin treatment. In elderly patients and patients with diseases of the tendons, simultaneously receiving treatment with glucocorticosteroids, there is an increased risk of tendonopathy. Ciprofloxacin should be used with caution in patients with a history of indications of tendon diseases associated with the administration of quinolones.

Nervous system

Ciprofloxacin, like other fluoroquinolones, can provoke convulsions and reduce the threshold of convulsive readiness. Patients with epilepsy and advanced CNS disease (lowering the threshold of convulsive readiness, convulsive seizures in the history, cerebral circulatory disorders, organic brain lesions or stroke) due to the threat of the development of adverse reactions from the central nervous system, ciprofloxacin It should be applied only after the benefit / risk ratio is evaluated.

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.

In patients taking fluoroquinolones, there have been cases of sensory or sensorimotor neuropathy. If symptoms such as pain, burning, tingling, numbness, weakness occur, the patient should be informed by the doctor before continuing ciprofloxacin use.

Skin covers

During the treatment period, avoid contact with direct sunlight and UV irradiation in the solarium.

Cytochrome P450

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 tizanidine, theophylline, methylxanthine, caffeine, duloxetine, ropinirole, clozapine, 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.

Prophylaxis of crystalluria

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.

Diagnosis of infection caused by Mycobacterium spp.

In conditions in vitro ciprofloxacin may interfere with bacteriological research Mycobacterium tuberculosis, suppressing all growth, which can lead to false negative results in the diagnosis of this pathogen in patients taking ciprofloxacin.

Effect on the ability to drive transp. cf. and fur:During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Form release / dosage:

Film coated tablets, 250 mg and 500 mg.

Packaging:

For 10 tablets in PVC / aluminum blister.For 1 or 2 blisters together with instructions for use in a pack of cardboard.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° 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:П N016161 / 01

Date of registration:07.05.2010

The owner of the registration certificate:Dr. Reddy's Laboratories Ltd.Dr. Reddy's Laboratories Ltd. India

Manufacturer: & nbsp

DR. REDDY`S LABORATORIES, LTD. India

Representation: & nbspDr. Reddy`c Laboratoris Ltd.Dr. Reddy`c Laboratoris Ltd.

Information update date: & nbsp22.10.2015

Illustrated instructions

Instructions

Ciprolet® (Ciprolet®)