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

1 tablet contains: active substance ciprofloxacin 250.0 / 500.0 mg (ciprofloxacin hydrochloride monohydrate 291.1 / 582.2 mg); Excipients: cellulose microcrystalline 36.65 / 73.30 mg, povidone K-30 18.75 / 37.50 mg, croscarmellose sodium 21.00 / 42.00 mg, silicon dioxide colloid 3.75 / 7.50 mg, magnesium stearate 3 , 75/7 .50 mg; sheath Fold white Y-1-7000H: hypromellose 3.125 / 6.250 mg, titanium dioxide 1.5625 / 3.1250 mg, macrogol-400 0.3125 / 0.6250 mg.

Description:

250 mg tablets: round biconvex tablets, coated with a white film shell, engraved "CIP 250 "and the risk on one side.On the cross section, two layers are visible: the core is from white to yellowish white.

Tablets 500 mg: capsular tablets, coated with a white film shell, engraved "CIP 500 "and the risk on one side, two layers are visible on the cross section: the core is from white to yellowish white.

Pharmacotherapeutic group:Antimicrobial agent, fluoroquinolone.

ATX: & nbsp

J.01.M.A.02 Ciprofloxacin

Pharmacodynamics:

Antimicrobial agent of a broad spectrum of action of a group of fluoroquinolones.Suppresses topoisomerases II (bacterial DNA gyruase) 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 and rapid death of the bacterial cell. It acts bactericidal on gram-negative organisms during rest and division (because it affects not only the DNA-gyrase, but also causes lysis of the cell wall), gram-positive microorganisms - only during the fission period.

The low toxicity for macroorganism cells is explained by the absence of DNA-gyrase in them. Against the background of taking ciprofloxacin, there is no parallel development of resistance to other antibiotics not belonging to the group of inhibitors of gyrase, which makes it highly effective against bacteria that are resistant, for example, to aminoglycosides, penicillins, cephalosporins, tetracyclines and other antibiotics. The effectiveness of ciprofloxacin depends to a large extent on the relationship between pharmacokinetic (PK) and pharmacodynamic (PD) parameters - between the maximum serum concentration (C_max) / minimum inhibitory concentration (MIC) and between the area under the concentration-time curve (AUC) / MPC. 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 gene mutations that encode 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.

Sensitivity to ciprofloxacin in vitro

The most sensitive microorganisms

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

- Gram-negative aerobic microorganisms: Aeromonas spp., Brucella spp., Citrobacter koseri, Francisella tularensi, Haemophilus ducreyi, Haemophilus influenzae, Legionella spp, Moraxella catarrhalis, Pasteurella spp, Neisseria meningitidis, Salmonella spp., Shigella spp., Vibrio spp., Yersinia pestis.

- Anaerobic microorganisms: Mobiluncus spp.

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

Microorganisms with varying degrees of sensitivity to ciprofloxacin

- Gram-positive aerobic microorganisms: Enterococcus faecalis, Streptococcus pneumoniae.

- Gram-negative aerobic microorganisms: Acinetobacter baumannii, Burkholderia cepacia, Campylobacter jejuni, Citrobacter freundii, Enterobacter aerobes, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Neisseria gonorrhoeae, Proteus mirabilis, Proteus vulgaris, Providencia spp., Pseudomonas aeruginosa, Pseudomonas fluorescens, Serratia marcescens, Streptococcus pneumoniae.

Resistant microorganisms

- Gram-positive aerobic microorganisms: Actinomyces spp., Enterococcus laecium, Staphylococcus spp. (methicillin-resistant strains).

- Gram-negative aerobic microorganisms: Burkholderia cepacia, Listeria monocytogenes Nocardia asteroids, Stenotrophomonas maltophilia.

- - Anaerobic microorganisms (with the exception of Mobiluncus spp., Peptostreptococcus spp., Propionibacterium acnes).

- Other microorganisms: Bacteroides fragilis, Clostridium difficile, Mycoplasma genitalium, Treponema pallidum, Ureaplasma urealyticum.

Pharmacokinetics:

Absorption. After oral administration ciprofloxacin mainly absorbed in the duodenum and upper parts of the jejunum. FROM_max is achieved 60 to 90 minutes after administration. After taking a single dose of 250 mg or 500 mg C_max is approximately 0.8-2.0 mg / L and 1.5-2.9 mg / L, respectively. Absolute bioavailability is approximately 70-80%; value, С_max and AUC increase in proportion to the dose taken.

Eating food (with the exception of dairy products) slows down absorption, but does not change C_max and bioavailability of ciprofloxacin.

Distribution. The equilibrium volume of distribution (Vd) of ciprofloxacin is 2 - 3.5 l / kg. Large Vd is associated with a high penetration of ciprofloxacin in the tissue. As ciprofloxacin to a small extent binds to blood proteins (20-30%) and is present in the blood plasma in non-ionized form, almost all the accepted dose can freely penetrate into extravascular space. As a result, the concentration of ciprofloxacin in certain body fluids and tissues may exceed its concentration in the blood. The content in the tissues is 2-12 times higher than in the plasma. Therapeutic concentrations are achieved in saliva, tonsils, liver, gall bladder, bile, intestine, abdominal and pelvic organs, uterus, seminal fluid, prostate tissue, endometrium, fallopian tubes and ovaries, kidney and urinary organs, pulmonary tissue, bronchial secretion , paranasal sinuses, bone tissue, muscles, synovial fluid and articular cartilage, peritoneal fluid, skin.In cerebrospinal fluid penetrates in a small amount, where its concentration in non-inflamed meninges is 6-10% of that in serum, and when inflamed - 14-37%. Ciprofloxacin also well penetrates into the eye fluid, bronchial secretion, pleura, peritoneum, lymph, breast milk, through the placenta. The concentration of ciprofloxacin in blood neutrophils is 2-7 times higher than in serum. The activity decreases slightly at acidic pH values.

Metabolism. Metabolised in the liver (15-30%) with the formation of low-activity metabolites (desethylenciprofloxacin (M1), sulfociprofloxacin (M2), oxocycloploxacin (M3) and formyl ciprofloxacin (M4)). M1, M2 and M3 are characterized by similar or lower activity as compared to nalidixic acid. M4, found in the lowest concentrations, has antimicrobial activity similar to norfloxacin.

Is a moderate inhibitor of the isoenzyme CYP1A21

Excretion. Ciprofloxacin is mostly excreted unchanged, mainly by the kidneys. Kidney clearance is 3-5 ml / min / kg, and the total clearance is about 8-10 ml / min / kg. Transport of ciprofloxacin is carried out by, glomerular and tubular secretion.

Excretion of ciprofloxacin after ingestion (in% of the dose of ciprofloxacin)

	Urine	Feces
Ciprofloxacin	44,7	25,0
Metabolites of ciprofloxacin	11,3	7,5

The half-life (T1) of ciprofloxacin is 3-5 hours.

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

Childhood. The pharmacokinetics of ciprofloxacin in children with cystic fibrosis differs from the pharmacokinetics of ciprofloxacin in children without cystic fibrosis, and dosage recommendations are applicable only for children with cystic fibrosis. When 20 mg / kg of ciprofloxacin is administered to children with cystic fibrosis, the observed drug effect is comparable to that in adult patients who receive 750 mg of ciprofloxacin twice daily.

Indications:

Adults

- Respiratory tract infections. Ciprofloxacin recommended for pneumonia caused by Klebsiella spp., Enterobacter spp., Proteus spp., Escherichia coli, Pseudomonas aeruginosa, Haemophilus spp., Moraxella catarrhalis, Legionela spp. and staphylococci;

- infection of the ENT organs (acute sinusitis, otitis media), especially if these infections are caused by gram-negative microorganisms; including Pseudomonas aeruginosa or staphylococci;

- eye infections;

- infection of the kidneys or urinary tract, including cystitis, pyelonephritis;

- infection of the genitals, including adnexitis, prostatitis;

- complicated intra-abdominal infections (in combination with metronidazole) and uncomplicated gonorrhea;

- infections of the gastrointestinal tract, including diarrhea of "travelers";

- skin and soft tissue and skin infections;

- infection of bones and joints;

- sepsis;

- infection or prevention of infection in patients with reduced immunity (patients taking antidepressants 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);

- prevention of invasive infections caused by Neisseria meningitidis.

Children aged 5-17 years

Acute pneumonia in the background of cystic fibrosis caused by Pseudomonas aeruginosa.

Contraindications:

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

Carefully:Moderate and severe renal dysfunction (CC less than 60 ml / min), hemodialysis, peritoneal dialysis (PD), impaired liver function, myasthenia gravis, elderly age; Postoperative infections (data on effectiveness and safety are limited); interval lengthening QT, congenital lengthening syndrome QT, heart disease (heart failure, myocardial infarction, bradycardia), pirouette-type arrhythmia, glucose-6-phosphate dehydrogenase deficiency, electrolyte imbalance (eg, hypokalemia, hypomagnesemia), concomitant medication prolonging the interval QT (including antiarrhythmic IA and III classes), simultaneous application with inhibitors of isoenzyme CYP450 1A2 (including theophylline, methylxanthine, caffeine, duloxetine, clozapine), tendon disorders in history, associated with quinolone intake, cerebral circulatory insufficiency, history of epilepsy, diseases accompanied by organic changes in the structure of the brain, including states after cerebrovascular accident.

Pregnancy and lactation:

Ciprofloxacin is contraindicated during pregnancy.

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

Dosing and Administration:

Inside, regardless of food intake, without chewing the tablet, squeezed, with water. When used on an empty stomach, the absorption of ciprofloxacin increases. Foods high in calcium (milk, yogurt) can reduce the absorption of ciprofloxacin.

The dose of ciprofloxacin depends on the type and severity of the infection, the age, body weight of the patient and the functional state of the kidneys.

The duration of treatment depends on the severity of the disease, clinical and bacteriological response.In general, treatment should be continued for at least three days after the normalization of body temperature or resolution of clinical symptoms.

Adults

For respiratory infections of mild to moderate severity - 500 mg twice a day for 7-14 days.

With an infection of the ENT organs (acute sinusitis, otitis media) - 500 mg twice a day. The course of treatment is 10 days.

With infections of the gastrointestinal tract, including diarrhea of "travelers":

- diarrhea caused by Shigella spp., with the exception of Shigella dysenteriae, and the empirical treatment of severe traveler's diarrhea - 500 mg twice a day for 1 day;

- diarrhea caused by Shigella dysenteriae - 500 mg twice a day for 3 days;

- typhoid fever - 500 mg twice a day for 5 days;

- diarrhea caused by Vibrio cholerae - 500 mg twice a day for 7 days.

Urinary tract infections, including cystitis, pyelonephritis

- uncomplicated cystitis - 250-500 mg twice a day for 3 days;

- complicated cystitis and uncomplicated pyelonephritis - 500 mg twice a day for 7-14 days.

Infections of the genitourinary system and pelvic organs, including urethritis and cervicitis, caused by Neisseria gonorrhoeae - 500 mg once a day once;

- prostatitis - 500 mg twice a day for 28 days.

Infections of soft tissues and skin caused by gram-negative microorganisms - 500 mg twice a day for 7-14 days.

Infections in patients with neutropenia - 500 mg twice a day for the entire period. neutropenia (in combination with other antibiotics).

Infections of bones and joints - 500 mg twice a day. Duration of treatment is not more than 3 months;

With sepsis, other generalized infectious diseases, for example, with peritonitis (in addition to antibacterial drugs that affect anaerobes), infectious diseases in patients with reduced immunity - 500 mg twice a day (in combination with other antibiotics) for the period required for treatment.

In especially severe, life-threatening infections (especially those caused by Pseudomonas aeruginosa ,, Staphylococcus spp. or Streptococcus spp., for example, with osteomyelitis, sepsis, pneumonia caused by Streptococcus pneumoniae, recurrent infections in cystic fibrosis, severe infections of the skin and soft tissues, or with peritonitis) the recommended dose is 750 mg twice daily.

In elderly patients, the dose depends on the severity of the disease and the state of kidney function.

In patients with impaired renal function:

CK (ml / min)	Concentration of creatinine (mg / dL)	Dose
30-60	1,4-1,9	250-500 mg every 12 hours
less than 30	more than 2,0	250-500 mg every 24 hours

The condition of patients requires strict control. The intervals between doses should be the same as when used in patients with normal renal function.

In patients with impaired renal function and hemodialysis

Recommended dose: 250-500 mg once a day after the procedure of hemodialysis.

In patients with impaired renal function and constant outpatient PD

The recommended dose is 250-500 mg once a day after the PD procedure.

In patients with impaired liver function

Dose correction is not required for mild and moderate hepatic insufficiency, but may be necessary in severe hepatic insufficiency.

In patients with impaired liver and kidney function

Correction of a dose as at disturbance of function of kidneys. Patients should be closely monitored. In some cases, it may be necessary to determine the concentration of ciprofloxacin in plasma.

Children aged 5-17 years

Acute pneumonia in the background of cystic fibrosis caused by Pseudomonas aeruginosa - at 20 mg / kg 2 times a day for 10-14 days. The maximum daily dose is 1.5 g.

Have children aged 5-17 years with impaired renal and / or liver function and mucoviscidosis of the lungs, complicated by infection Pseudomonas aerugenosa, the use of ciprofloxacin has not been studied.

Side effects:

Undesirable reactions were noted in 5-14% of patients taking ciprofloxacin. The most common side effects are nausea, vomiting and skin rashes.

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

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

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

From the nervous system: often - dizziness, headache, agitation,tremor; infrequently - insomnia, perversion of taste (reversible, disappears after ciprofloxacin withdrawal); rarely - hallucinations, paresthesia (peripheral paralgesia), "nightmarish" dreams, depression, convulsions, hypesthesia, drowsiness, exacerbation of myasthenia symptoms, confusion, disorientation, peripheral neuropathy, polyneuropathy; very rarely convulsive seizures such as grand mal, gait disturbance, psychosis (in which patients can cause harm), increased intracranial pressure, ataxia, hyperesthesia, muscle hypertension, impaired sense of smell, loss of smell (usually disappears after ciprofloxacin withdrawal), migraine , anxiety, loss of taste.

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

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

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

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

From the respiratory system: infrequently - pulmonary embolism, pulmonary edema, hemoptysis, hiccough, shortness of breath, nosebleed; rarely - shortness of breath.

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

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

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

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

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

Overdose:

Symptoms: dizziness, tremor, headache, fatigue, convulsive attacks, hallucinations, QTc interval elongation, gastrointestinal disturbances, liver and kidney dysfunction, crystalluria, hematuria.

Treatment: induction of vomiting or gastric lavage, the reception of activated carbon, antacids containing calcium and magnesium, to reduce absorption of ciprofloxacin, symptomatic therapy. The patient should be under close medical supervision. It is necessary to constantly monitor the kidney function. Ciprofloxacin when hemodialysis or peritoneal dialysis is withdrawn in small amounts (less than 10%). Support for an adequate water regime minimizes the risk of crystalluria.

Interaction:

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

Ciprofloxacin inhibits the isoenzyme CYP1A2, and this can cause an increase in plasma concentrations of concomitant drugs that are metabolized by the CYP1A2 isoenzyme.

Significant changes in pharmacokinetic parameters of tizanidine, includingincrease in AUC, T1, C_max, increased bioavailability with ingestion, decreased plasma clearance were observed with simultaneous use with ciprofloxacin. Such pharmacokinetic interaction can lead to serious undesirable phenomena. Clinically significant decrease in blood pressure (both systolic and diastolic blood pressure decreases), drowsiness was observed with simultaneous application of ciprofloxacin and a single dose of 4 mg of tizanidine. In this regard, the simultaneous use of tizanidine with ciprofloxacin is contraindicated. In patients receiving concomitantly with ciprofloxacin any other drugs that are a substrate for the CYP1A2 isoenzyme, care must be taken to prevent the appearance of overdose symptoms with these drugs. Periodically determine the concentration of these drugs in the plasma, especially when using theophylline.

Absorption of ciprofloxacin is slowed by the simultaneous use of iron, zinc, sucralfate or antacids and drugs with high buffering activity, containing magnesium, aluminum, or calcium.This also applies to sucralfate, antiviral drugs containing a buffer didanosine, solutions for oral nutrition. This effect is also observed with the use of large quantities of dairy products (milk or liquid dairy products, such as yogurt). In this way, ciprofloxacin should be taken either 1-2 hours before, or 4 hours after taking the above substances. These limitations do not apply to H2-histamine receptors to blockers.

The simultaneous use of very high doses of quinolones and some non-steroidal anti-inflammatory drugs (other than acetylsalicylic acid) may provoke the development of seizures.

With simultaneous application with uricosuric drugs, the elimination is slowed down by 50% and the plasma concentration of ciprofloxacin is increased.

With the simultaneous use of cyclosporine, and ciprofloxacin, a transient increase in the creatinine concentration is observed. Such patients should regularly check the concentration of creatinine in the blood.

Ciprofloxacin, like other quinolones, can enhance the effect of anticoagulant drugs - coumarin derivatives, including warfarin. With the simultaneous use of these drugs should monitor prothrombin time (PV) or other appropriate coagulation tests. If necessary, adequately adjust the dose of warfarin.

With the simultaneous use of ciprofloxacin and glibenclamide, the effect of glibenclamide may be enhanced.

Probenecid inhibits the excretion of ciprofloxacin by the kidneys, leading to an increase in the concentration of ciprofloxacin.

Metoclopramide accelerates absorption. ciprofloxacin. The maximum concentration of ciprofloxacin is achieved in a shorter time. Bioavailability of ciprofloxacin does not change.

With the simultaneous use of ciprofloxacin or phenytoin, both an increase and decrease in the concentration of phenytoin in the plasma is possible, so it is recommended to monitor its concentration.

Simultaneous use of ciprofloxacin and mexiletine may lead to an increase in the concentration of mexiletine.

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

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

With the simultaneous use of ropinirole with ciprofloxacin, there is a possibility of an increase in the concentration of ropinirole, which may be accompanied by an increased risk of unwanted reactions. In the case of simultaneous use, more careful control of ropinirole therapy is necessary.

Clinically significant interactions between ciprofloxacin and didanosine have been reported.

With the simultaneous use of ciprofloxacin and methotrexate, renal tubule transport is suppressed, potentially leading to an increase in plasma concentrations of methotrexate, which may increase the risk of toxic reactions associated with methotrexate. Therefore, it is necessary to monitor the patients' state in the treatment of methotrexate and simultaneous administration of ciprofloxacin.

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

Clinical studies have shown that the simultaneous use of duloxetine and potent inhibitors of the CYP1A2 isoenzyme (such as fluvoxamine) can lead to an increase in AUC and C_maxduloxetine. 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.

In a study on healthy volunteers, it was found that simultaneous application. preparations containing lidocaine, and ciprofloxacin, a moderate inhibitor of the isoenzyme CYP1A2, leads to a decrease in lidocaine clearance by 22% when administered intravenously. Despite the good tolerability of lidocaine, simultaneous use with ciprofloxacin may increase the side effects due to interaction.

With the simultaneous use of clozapine and ciprofloxacin at a dose of 250 mg for 7 days, there was an increase in serum concentrations of clozapine and N-desmethylclozapine by 29% and 31%, respectively.It is necessary to monitor the patient's condition and, if necessary, adjust the dosage regimen of clozapine during its simultaneous use with ciprofloxacin and for a short time after the completion of the combination therapy.

Special instructions:

In patients with epilepsy or other lesions of the central nervous system (CNS) (for example, with convulsive readiness, fits in the anamnesis, reduced cerebral - blood flow, changes in the structure of the brain or after a stroke) ciprofloxacin can be used only if the benefit from such use exceeds the possible risk, because the possibility of side effects from the CNS exposes these patients to an increased risk.

Unwanted effects on the CNS can occur after the first use of ciprofloxacin. Depression or psychosis in some cases can lead to self-harm. In case of occurrence of such reactions, treatment with ciprofloxacin should be discontinued immediately.

Ciprofloxacin is not a drug of choice in suspected or established pneumonia caused by Streptococcus pneumoniae.

Cases of crystalluria associated with the use of ciprofloxacin have been reported.Patients receiving ciprofloxacin, an adequate water regime should be ensured. Avoid excessive urine alkalinization.

Pseudomembranous colitis is a special form of enterocolitis, it can develop against the background of taking antibiotics (in most cases it is associated with Clostridium difficile). If severe and persistent diarrhea occurs during or after treatment, a doctor's consultation is necessary. Even with a suspicion of an etiological role Clostridium difficile Ciprofloxacin should be discontinued immediately and appropriate treatment prescribed. Anti-peristaltic drugs should not be used.

Patients with a hereditary or personal anamnesis of a defect of glucose-6-phosphate dehydrogenase are prone to hemolytic reactions when taking quinolones, so in such patients ciprofloxacin should be used with caution. Ciprofloxacin should be used with caution in patients with clinically significant hepatic or renal insufficiency.

Although ciprofloxacin rarely causes photosensitivity, during treatment should avoid prolonged exposure to direct sunlight or ultraviolet radiation.

Inflammation and rupture of tendons (mainly Achilles tendon) have been described in the treatment with quinolones. The elderly patients and patients receiving corticosteroids were most often affected. When pain or inflammation occurs, interrupt ciprofloxacin treatment and relieve the affected limb.

If the symptoms of inflammation have arisen in the Achilles tendon on one of the extremities, precautions should be taken to prevent / prevent the rupture of the Achilles, tendon, and on. Another limb, i.e. treatment should be aimed at preventing the rupture of both tendons (by using tires or supporting both heels).

Because the ciprofloxacin has some activity in relation to Mycobacterium tuberculosis, when taking samples during treatment with ciprofloxacin, false negative results of culture testing can be obtained. Ciprofloxacin should be used with caution in patients with myasthenia gravis. The use of ciprofloxacin according to indications different from the treatment of pneumonia caused by Pseudomonas aeruginosa on the background of cystic fibrosis in children older than 5 years has not been adequately studied, and there is no clinical experience.

The use of fluoroquinolones is associated with the prolongation of the QTc interval. Ciprofloxacin refers to a group of drugs with a low potential for this undesirable phenomenon.

Caution should be exercised when using ciprofloxacin in patients at risk of arrhythmias of the type "pirouette".

Prolonged and repeated use of ciprofloxacin can lead to superinfection with resistant bacteria or pathogens of fungal infections.

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

During treatment, one should refrain from engaging in potentially dangerous activities that require increased attention and speed of mental and motor reactions.

Form release / dosage:

Film coated tablets, 250 mg and 500 mg.

Packaging:

For 10 tablets in PVC / PVDC / Al foil blisters; 1, 2 or 10 blisters with instructions for use in a cardboard pack.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

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

Terms of leave from pharmacies:On prescription

Registration number:LP-001280

Date of registration:25.11.2011

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

Manufacturer: & nbsp

TEVA Pharmaceutical Works Private, Ltd. Co. Hungary

Representation: & nbspTeva Teva Israel

Information update date: & nbsp23.10.2015

Illustrated instructions

Instructions

Ciprofloxacin-Teva (Ciprofloxacin-Teva)