Ciprofloxacin, 500 mg 10 pcs

Indications

Uncomplicated and complicated infections caused by ciprofloxacin-sensitive microorganisms.

Adults

Respiratory tract infections, pneumonias caused by Klebsiella spp., Enterobacter spp, Proteus spp., Escherichia coli, Pseudomonas aeruginosa, Haemophilus spp., Moraxella catarrhalis, Legionella spp. and staphylococci;

Infections of the middle ear (otitis media), sinuses (sinusitis), especially caused by Gram-negative microorganisms, including Pseudomonas aeruginosa or staphylococci;

eye infections;

Infections of the urogenital system (including cystitis, pyelonephritis, adnexitis, chronic bacterial prostatitis, orchitis, epididymitis, uncomplicated gonorrhea);

complicated intraabdominal infections (in combination with metronidazole);

biliary bladder and biliary tract infections;

skin and soft tissue infections (infected ulcers, wounds, burns, abscesses, phlegmon);

Bone and joint infections (osteomyelitis, septic arthritis);

sepsis;

typhoid fever;

Campylobacteriosis, shigellosis, “traveler’s diarrhea;

Infections or prevention of infections in immunocompromised patients (patients taking immunosuppressants or patients with neutropenia);

selective gut decontamination in immunocompromised patients;

prevention and treatment of inhalational anthrax (infection with Bacillus anthracis);

Prevention of invasive infections caused by Neisseria meningitidis.

Children

Therapy for complications caused by Pseudomonas aeruginosa in children with pulmonary cystic fibrosis from 5 to 17 years of age;

Prevention and treatment of inhalational anthrax (infection with Bacillus anthracis).

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Active ingredient

Ciprofloxacin

Composition

Active ingredient: ciprofloxacin hydrochloride (monohydrate) 582.2 mg in terms of ciprofloxacin 500.0 mg;

excipients: Microcrystalline cellulose 78.0 mg, corn starch 52.4 mg, povidone-K30 40.0 mg, magnesium stearate 7.6 mg; coating: film coating (polyvinyl alcohol 8.800 mg, titanium dioxide 5.500 mg, macrogol 4.444 mg, talc 3.256 mg) 22.0 mg.

How to take, the dosage

The tablets should be taken orally, regardless of meals, without chewing, with a small amount of liquid. If the drug is taken on an empty stomach, the active ingredient is absorbed more quickly. In this case the tablets should not be washed down with dairy products or beverages enriched with calcium (see section “Interaction with other medicinal products”).

The dose of ciprofloxacin depends on the severity of the disease, type of infection, body condition, age, weight and functional state of the kidneys. Recommended dosing regimen:

Adults:

Respiratory tract infections of mild to moderate severity – 500 mg 2 times a day, with a severe course – 750 mg 2 times a day;

Infections of the middle ear (otitis media), sinuses (sinusitis) – 500 mg 2 times a day;

Infections of the urinary tract: acute, uncomplicated – from 250 mg 2 times a day to 500 mg 2 times a day; cystitis in women (before menopause): 500 mg once daily; complicated: 500 mg 2 times daily to 750 mg 2 times daily;

Gonorrhea: 500 mg once daily;

complicated intraabdominal infections (in combination with metronidazole) 500 mg 2 times daily;

Skin and soft tissue infections (infected ulcers, wounds, burns, abscesses, phlegmon) of mild to moderate severity – 500 mg 2 times a day, with a severe course – 750 mg 2 times a day;

bone and joint infections (osteomyelitis, septic arthritis) of mild to moderate severity – 500 mg 2 times a day, with a severe course – 750 mg 2 times a day;

typhoid fever – 500 mg 2 times a day;

campylobacteriosis, shigellosis, traveler’s diarrhea – 500 mg 2 times a day;

infectious diseases in immunocompromised patients – 500 mg 2 times a day (in combination with other antibiotics);

Prevention and treatment of inhalational anthrax – 500 mg 2 times a day;

other infections (see “Indications.

other infections (see section “Indications”) – 500 mg 2 times a day;

particularly severe, life-threatening infections, including streptococcal pneumonia, recurrent cystic fibrosis lung infections, bone and joint infections, sepsis, peritonitis (especially if Pseudomonas spp., Staphylococcus spp. or Streptococcus spp.) – 750 mg 2 times a day;

Prevention of invasive infections caused by Neisseria meningitidis – 500 mg once a day.

Dosing regimenin patients of advanced age (after 65 years)

. Older patients should be prescribed lower doses of ciprofloxacin depending on disease severity and creatinine clearance rate.

Children

To treat complications caused by Pseudomona aeruginosa In children with pulmonary cystic fibrosis from 5 to 17 years of age, the recommended dose is 20 mg/kg body weight 2 times daily (maximum dose 1500 mg). The duration of therapy is 10-14 days.

Prevention and treatment of pulmonary anthrax – 15 mg/kg of body weight 2 times a day (maximum single dose is 500 mg, daily dose – 1000 mg). The drug should be started immediately after the supposed or confirmed infection. The duration of use is 60 days.

Dosing regimen for renal or hepatic impairment in adults

Recommended doses for patients with renal impairment:

When creatinine clearance is 30 to 60 mL/min/1.73 m² or its plasma concentration is 1.4 to 1.9 mg/100 mL, the maximum daily dose of ciprofloxacin is 1000 mg;

If creatinine clearance is below 30 ml/min/1.73 m or its plasma concentration of 2 mg/100 ml or more, the maximum daily dose of ciprofloxacin is 500 mg;

Patients with renal insufficiency on hemodialysis:

With a creatinine clearance of 30 to 60 ml/min/1.73 m² or its plasma concentration of 1.4 to 1.9 mg/100 ml, the maximum daily dose of ciprofloxacin is 1000 mg;

If creatinine clearance is 30 mL/min/1.73 m or less or its plasma concentration is 2 mg/100 mL or more, the maximum daily dose of ciprofloxacin is 500 mg.

On days of hemodialysis, ciprofloxacin is taken after the procedure.

Ambulatory patients with renal failure who are on continuous peritoneal dialysis:

The maximum daily dose of ciprofloxacin is 500 mg.

Patients with hepatic impairment

Dose adjustment is not required.

Patients with renal and hepatic impairment

The dosing regimen is similar to that for renal impairment.

Children with renal and/or hepatic impairment

The dosing regimen in children with renal and hepatic impairment has not been studied.

Duration of therapy

The duration of treatment depends on the severity of the disease and clinical and bacteriological control. It is important to continue treatment systematically, at least 3 days after fever or other clinical symptoms disappear. Average duration of treatment: 1 day for acute uncomplicated gonorrhea and cystitis; up to 7 days for kidney, urinary tract, and intra-abdominal infections; the entire period of neutropenia in immunocompromised patients; no more than 2 months for osteomyelitis; 7 to 14 days for other infections. In infections caused by Streptococcus spp. because of the risk of late complications, treatment should be continued for at least 10 days; in infections caused by Chlamydia spp., treatment should also be continued for at least 10 days.

Interaction

Drugs that cause interval prolongation QT

Cautious concomitant use of ciprofloxacin (as well as other fluoroquinolones) should be used in patients receiving drugs that cause interval prolongation.u>QT (e.g., antiarrhythmic drugs of classes IA and III, tricyclic antidepressants, macrolides, neuroleptics, see section “Indications”). See section “Special Indications”).

Theophylline

The concomitant use of ciprofloxacin and drugs containing theophylline may cause an undesirable increase in plasma concentration of theophylline and therefore the occurrence of theophylline-induced adverse events; in very rare cases, these adverse events may be life-threatening for the patient. If concomitant use of the two drugs is unavoidable, continuous monitoring of plasma theophylline concentrations and, if necessary, reduction of theophylline dose is recommended (see section “Special Precautions”, cytochrome P450).

Other xanthine derivatives

The simultaneous use of ciprofloxacin and caffeine or pentoxifylline (oxpentifylline) may increase the serum concentration of xanthine derivatives.

Tizanidine

Concomitant use of ciprofloxacin and drugs containing tizanidine has shown increased serum concentrations of tizanidine: an increase in maximum concentration (C_max) by 7 (4 to 21) times, an increase in AUC (area under the pharmacokinetic concentration-time curve) by an average of 10 (6 to 24) times. Since an increase in serum concentration of tizanidine may cause clinically significant adverse effects: decreased blood pressure and drowsiness, concomitant use of ciprofloxacin and drugs containing tizanidine is contraindicated.

Non-steroidal anti-inflammatory drugs

The combination of very high doses of quinolones (DNA lyase inhibitors) and some non-steroidal anti-inflammatory drugs (excluding acetylsalicylic acid) may provoke seizures.

Cyclosporine

In concomitant use of ciprofloxacin and drugs containing cyclosporine a transient transient increase in plasma creatinine concentration was observed. In cases of concomitant use of ciprofloxacin and cyclosporine, blood creatinine concentration should be determined twice a week.

Peroral hypoglycemic agents (glibenclamide, glimepiride) and insulin

. When ciprofloxacin is coadministered with oral hypoglycemic agents, primarily sulfonylureas or insulin, the increased effect of the hypoglycemic agents is presumed to be responsible for the development of the hypoglycemia (see “Adverse effects”). section “Side effects”). Close monitoring of blood glucose levels is necessary.

Probenecid

Probenecid slows the rate of renal excretion of ciprofloxacin. Concomitant use of ciprofloxacin and drugs containing probenecid leads to increased concentrations of ciprofloxacin in the blood plasma.

Phenytoin

Concomitant use of ciprofloxacin and phenytoin has shown changes (increase or decrease) in plasma phenytoin. To avoid impairing the anticonvulsant effect of phenytoin due to decreased concentrations, and to prevent adverse events associated with phenytoin overdose when ciprofloxacin is discontinued, monitoring of phenytoin therapy in patients is recommended, including determination of plasma phenytoin levels throughout the period of concurrent use of both drugs and for a short time after completion of combined therapy.

Methotrexate

Concomitant use of methotrexate and ciprofloxacin may inhibit renal channel transport of methotrexate, which may be accompanied by increased plasma concentrations of methotrexate and the potential for methotrexate side effects. Therefore, patients receiving concomitant therapy with methotrexate and ciprofloxacin should be closely monitored.

Omeprazole

When combined use of ciprofloxacin and drugs containing omeprazole, a slight decrease in maximum plasma concentration of ciprofloxacin and reduction of the area under the pharmacokinetic curve “concentration-time” may be observed.

Duloxetine

. Concomitant use of duloxetine and fluvoxamine, a potent inhibitor of the CYP450 1A2 isoenzyme, may result in increased AUC and C_max of duloxetine. We can foresee the possibility of such interaction when ciprofloxacin and duloxetine are used concomitantly.

Ropinirole

The concomitant use of ropinirole and ciprofloxacin, a moderate inhibitor of the CYP450 1A2 isoenzyme, results in increased C_max and AUC of ropinirole by 60% and 84%, respectively. The adverse effects of ropinirole should be monitored during its co-administration with ciprofloxacin and for a short time after completion of combined therapy.

Lidocaine

The concomitant use of drugs containing lidocaine and ciprofloxacin, a moderate inhibitor of CYP450 1A2 isoenzyme, may decrease lidocaine clearance by 22 % when administered intravenously. When concomitant use with ciprofloxacin, there may be increased side effects due to the interaction (see section “Special Precautions”, cytochrome P450).

Clozapine

Concomitant use of clozapine and ciprofloxacin may increase serum concentrations of clozapine and N-desmethylclozapine. The patient’s condition should be monitored and, if necessary, the dosage regimen of clozapine should be adjusted during its co-administration with ciprofloxacin and for a short time after completion of combined therapy (see section “Special indications”, cytochrome P450).

Sildenafil

The simultaneous use of ciprofloxacin and sildenafil may increase C_max and AUC of sildenafil by 2-fold. Therefore, the use of this combination is possible only after assessing the benefit/risk ratio.

Vitamin K antagonists (warfarin, acenocoumarol. phenprocoumon. fluindone)

The combined use of ciprofloxacin and vitamin K antagonists may increase their anticoagulant effect. The magnitude of this effect may vary depending on co-infections, age and general condition of the patient. INR should be monitored during co-administration of ciprofloxacin and vitamin K antagonists, and for a short time after completion of combined therapy.

Cation-containing drugs

Concomitant administration of ciprofloxacin and cation-containing drugs; mineral supplements containing calcium, magnesium, aluminum, iron; sucralfate, antacids, polymeric phosphate compounds (e.g., sevelamer, lanthanum carbonate) and drugs with a large buffer capacity (e.g., didanosine tablets) containing magnesium, aluminum or calcium, reduces absorption of ciprofloxacin. In such cases, ciprofloxacin should be taken either 1-2 hours before or 4 hours after taking these drugs.

Eating food and dairy products

Combined use of ciprofloxacin and dairy products or drinks fortified with minerals (e.g., milk, yogurt, calcium-rich juices) should be avoided because the absorption of ciprofloxacin may be reduced. Calcium in regular foods has no significant effect on absorption of ciprofloxacin.

Special Instructions

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

The drug ciprofloxacin is not the drug of choice for the treatment of infections caused by Streptococcus pneumoniae because of its limited effectiveness against the pathogen.

In genital infections suspected to be caused by strains of Neisseria gonorrhoeae, resistant to fluoroquinolones, information about local resistance to ciprofloxacin should be considered and sensitivity of the causative agent should be confirmed with laboratory tests.

Ciprofloxacin has an effect on QT interval prolongation (see section “Side effects”). Considering that women are characterized by a longer average duration of the QT interval compared to men, they are more sensitive to the drugs that cause QT interval prolongation. Elderly patients also have an increased sensitivity to the action of drugs that cause prolongation of the QT interval. Caution should be exercised when using ciprofloxacin in combination with drugs that prolong the QT interval (e.g. antiarrhythmic drugs of classes IA and III, tricyclic antidepressants, macrolides, neuroleptics) (see.

In patients with increased risk of QT interval prolongation or pirouette arrhythmia (e.g., congenital prolongation of QT, heart disease (heart failure, myocardial infarction, bradycardia), electrolyte imbalance (e.g., hypokalemia, hypomagnesemia).

In some cases hypersensitivity to the drug may develop after the first dose of ciprofloxacin (see section “Side effects”), including allergic reactions, and the attending physician must be informed immediately. In rare cases anaphylactic reactions up to anaphylactic shock may occur after the first use. In these cases the use of ciprofloxacin should be stopped immediately and appropriate treatment should be carried out.

In case of severe and prolonged diarrhea during or after ciprofloxacin therapy the diagnosis of pseudomembranous colitis should be excluded which requires immediate drug withdrawal and appropriate treatment (oral vancomycin 250 mg 4 times daily). In this situation the use of drugs suppressing intestinal peristalsis is contraindicated.

When using ciprofloxacin there have been cases of liver necrosis and life-threatening liver failure; if there are symptoms of liver disease, such as anorexia, jaundice, darkened urine, itching, abdominal pain, ciprofloxacin should be stopped.

In patients taking ciprofloxacin who have had liver disease, there may be a transient increase in hepatic transaminases and alkaline phosphatase activity or cholestatic jaundice.

Patients with severe myasthenia gravis should use ciprofloxacin with caution because exacerbation of symptoms is possible.

When using ciprofloxacin, cases of tendonitis and tendon rupture (mainly Achilles tendon) may occur, sometimes bilaterally, within the first 48 hours of starting therapy. Inflammation and tendon rupture may occur even several months after ciprofloxacin treatment is discontinued. There is an increased risk of tendinopathy in elderly patients and in patients with tendon diseases simultaneously treated with glucocorticosteroids. Cases of epileptic status have been reported when using ciprofloxacin. Ciprofloxacin, like other fluoroquinolones, may provoke seizures and lower the seizure threshold; if seizures occur, 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 may progress to suicidal thoughts and self-harming behavior, such as suicide attempts, including fatal ones, if a patient develops one of these reactions, the drug should be discontinued and reported to the doctor. In patients with epilepsy and patients who have CNS diseases (for example, decreased seizure threshold, history of seizures, cerebral circulation disorders, organic brain lesions or stroke) due to the risk of CNS adverse reactions, ciprofloxacin should be used only in cases when the expected clinical effect exceeds the possible risk of the drug adverse effect.

In case of sensory or sensorimotor polyneuropathy, hypoesthesia, dysesthesia, weakness have been reported when taking fluoroquinolones. If symptoms such as pain, burning, tingling, numbness, weakness occur, do not continue using the drug until you have consulted your doctor.

Because photosensitization reactions may occur when taking the drug, patients should avoid contact with direct sunlight and ultraviolet light. If photosensitization symptoms occur, discontinue treatment.

Caution should be exercised when using ciprofloxacin concomitantly with drugs metabolized by CYP450 1A2 isoenzymes (such as theophylline, methylxanthine, caffeine, duloxetine, clozapine, ropinirole, olanzapine).

In order to avoid development of crystalluria, the recommended daily dose should not be exceeded, and adequate fluid intake and maintenance of an acidic urine reaction are also necessary.

In in vitro conditions, ciprofloxacin may interfere with bacteriological testing of Mycobacterium tuberculosis, suppressing its growth, which can lead to false-negative results when diagnosing this pathogen in patients taking the drug.

Long-term and repeated use of ciprofloxacin can lead to superinfection with resistant bacteria or fungal pathogens.

Children

. Based on a review of safety data on the use of ciprofloxacin in children under 18 years of age, although there is no proven association between cartilage or joint damage and ingestion of the drug, it is not recommended that ciprofloxacin be used in children to treat conditions other than treatment of complications of pulmonary cystic fibrosis (in children 5-17 years) associated with Pseudomonas aeruginosa, and for the treatment and prevention of inhalational anthrax (after suspected or proven infection with Bacillus anthracis).

Influence on driving and operating machinery

Ciprofloxacin may impair patients’ ability to drive and engage in other potentially dangerous activities requiring increased attention and rapid psychomotor reactions due to the effect on the CNS. Potential side effects such as dizziness, vertigo, confusion and somnolence should be taken into account. If the above adverse events occur, the above activities should be avoided.

Synopsis

Dosage 500 mg: oval tablets, biconvex, film-coated white or almost white, cross-section of the core is white to slightly yellowish.

Contraindications

Hypersensitivity to ciprofloxacin or other drugs from the group of fluoroquinolones, as well as to other components of the drug;
concomitant administration of ciprofloxacin and tizanidine (see section “Interaction with other drugs”).
children under 18 years of age (before the completion of skeleton formation, except for indications indicated in section “Indications for use”, children);
pregnancy;
breast-feeding period.
With caution. Severe atherosclerosis of cerebral blood vessels, cerebral blood circulation disorders, organic brain lesions or stroke, mental illness (depression, psychosis), epilepsy, decreased seizure threshold (or history of seizures), Severe renal and/or hepatic insufficiency, advanced age, tendon involvement in previous treatment with quinolones, increased risk of QT interval prolongation or development of “pirouette”-type arrhythmias (e.g., congenital prolongation of the QT interval syndrome heart disease (heart failure, myocardial infarction, bradycardia), electrolyte imbalance (e.g., hypokalemia, hypomagnesemia), concurrent use of drugs that prolong the QT interval (including class IA and III antiarrhythmic tricyclic antidepressants, macrolides, neuroleptics), concomitant use with inhibitors of CYP450 1A2 isoenzymes (including theophylline, methylxanthine, caffeine, duloxetine, clozapine, ropinirole, olanzapine), mental diseases, myasthenia gravis, glucose-6-phosphate dehydrogenase deficiency.