Ciprolet solution for infusion 2 mg / ml 100 ml vials (Ciprofloxacin)

Latin name

CIPROLET

Release form

Infusion solution.

Packing

100 ml.

is indicated) Indications

Adults.

Bacterial infections caused by microorganisms sensitive to the drug:

lower respiratory tract diseases (acute and chronic (in the acute stage) bronchitis, pneumonia, bronchiectasis, infectious complications of cystic fibrosis)

infections of the ENT organs (acute sinusitis)

infections of the kidneys and urinary tract (cystitis, pyelonephritis)

complicated intraabdominal infections (in combination with metronidazole), including sperlitis peritonitis uncomplicated gonorrhea

typhoid fever, campylobacteriosis, shigellosis, travelers diarrhea

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

bones and joints (osteomyelitis, septic arthritis)

septicemia infection on the background of immunodeficiency (occurring in the treatment of immunosuppressive drugs or in patients with neutropenia).

Prevention of infections during surgical interventions.

Prevention and treatment of pulmonary anthrax.

Children.

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

Prevention and treatment of pulmonary anthrax (Bacillus anthracis infection).

Contraindications

Hypersensitivity to ciprofloxacin and other drugs of the fluoroquinolone group, as well as auxiliary substances,

pregnancy, lactation (breastfeeding), children (up to 18 years old - until the skeleton formation process is completed,

as except for complications aeruginosa in children with pulmonary cystic fibrosis from 5 to 17 years of prevention and treatment of pulmonary anthrax), simultaneous administration with tizanidine (risk of a pronounced decrease in blood pressure, drowsiness).

Precautions: Severe cerebral arteriosclerosis, cerebrovascular accident, mental illness, epilepsy,

severe renal and / or liver failure, old age, increased risk of prolonged QT interval or the development of pirouette type arrhythmias (eg, congenital prolongation interval syndrome QT), heart disease (heart failure,

myocardial infarction, bradycardia), electrolyte imbalance (for example, with hypokalemia, hypomagnesemia),

concomitant use of medicinal media tv prolonging the interval QT (including IA and III antiarrhythmics of classes, the tricyclic antidepressants, macrolides, antipsychotics), the simultaneous application of inhibitors of the CYP450 1A2

(including theophylline, a methylxanthine, caffeine, duloxetine clozapine, ropinirole, olanzapine)

in patients with a history of tendon damage in previous treatment with quinolones,

myasthenia gravis, glucose-6-phosphate dehydrogenase deficiency, seizures, including a history of.

Special instructions

In order to avoid the development of crystalluria, the recommended daily dose should not be exceeded,

also requires sufficient fluid intake and an acidic urine reaction.

Severe infections, staph infections and infections caused by gram-positive and anaerobic bacteria

In the treatment of severe infections, staph 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 the drug of choice for suspected or established pneumonia,

caused by Streptococcus pneumoniae.

Genital tract infections

For infections presumably caused by fluoroquinolone resistant Neisseria gonorrhoeae strains,

, local information on ciprofloxacin resistance should be considered and laboratory susceptibility

should be confirmed.

Diagnosis of Mycobacterium spp.

In vitro in laboratory tests, ciprofloxacin inhibits the growth of Mycobacterium spp.,

, which can lead to false negative results in the diagnosis of this pathogen in patients taking ciprofloxacin.

Cardiac abnormalities

Ciprofloxacin has an effect on lengthening the QT interval (see section “Side effects”).

Given that women have a longer average QT interval compared to men,

they are more sensitive to drugs that cause a prolongation of the QT interval. In elderly patients,

also has an increased sensitivity to the action of such drugs. Therefore, crdrofloxacin should be used

with caution in combination with drugs that extend the QT interval (for example, class IA and III antiarrhythmic drugs, tricyclic antidepressants, macrolides, antipsychotics), in patients with an increased risk of prolonged QT interval or the development of pirouette type arrhythmias (for example , congenital prolongation of the QT interval),

heart disease (heart failure, myocardial infarction, bradycardia), electrolyte imbalance (for example, with hypokalemia, hypomagnesemia).

Use in children

Ciprofloxacin, like other drugs of this class, causes arthropathy of large joints in animals.

When analyzing the current safety data on the use of ciprofloxacin in children under 18 years of age,

, most of which have pulmonary cystic fibrosis, no connection was found between damage to cartilage or joints and taking the drug.

It is not recommended to use CiproletВ® in children for the treatment of other diseases, except for the treatment of complications of pulmonary cystic fibrosis (in children over 5 years old) associated with Pseudomonas aeruginosa, and for the treatment and prevention of pulmonary anthrax.

Hypersensitivity

In rare cases, anaphylactic reactions may occur after the first use, up to anaphylactic shock.

In these cases, the use of ciprofloxacin should be discontinued immediately and appropriate treatment should be carried out.

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

Gastrointestinal tract

If severe and prolonged diarrhea occurs during or after treatment, the diagnosis of pseudomembranous colitis should be excluded, which requires immediate withdrawal of the drug and the appointment of appropriate treatment.

The use of drugs that inhibit intestinal motility is contraindicated.

Hepatobiliary system

When using ciprofloxacin, there have been cases of liver necrosis and life-threatening liver failure,

in the presence of symptoms of liver diseases such as anorexia, jaundice, dark urine, pruritus, pain in the abdomen, ciprofloxacin should be discontinued.

Musculoskeletal system

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

When using ciprofloxacin, cases of tendonitis and tendon rupture (mainly the Achilles tendon) may occur,

is sometimes bilateral, already within the first 48 hours after the start of therapy, tendon inflammation and rupture can occur even several months after ciprofloxacin treatment is stopped in elderly patients and in patients with tendon diseases who are simultaneously treated with glucocorticosteroids, there is an increased risk of tendinopathy.

If there are tendon pains or the first signs of tenosynovitis, treatment should be discontinued and physical activity excluded (individual cases of inflammation and even rupture of tendons during treatment with fluoroquinolones are described),

, and consult a doctor.

Nervous system

Adverse reactions from the central nervous system may occur after the first use of the drug.

When using ciprofloxacin, cases of the development of the epileptic status of ciprofloxacin, as well as other fluoroquinolones, have been reported,

can provoke seizures and lower the threshold of convulsive readiness, in case of seizures, the drug should be discontinued. Patients with epilepsy, a history of seizures, vascular diseases and organic brain damage due to the threat of adverse reactions from the central nervous system, ciprofloxacin should be prescribed only for "vital" indications.

Mental reactions can occur even after the first use of fluoroquinolones, including ciprofloxacin,

in rare cases, depression or psychotic reactions can progress to suicidal thoughts and self-harming behavior,

such as suicide attempts, including those that occur if the patient develops one of these reactions , you should stop taking the drug and inform your doctor about it.

When using ciprofloxacin, there have been cases of the development of sensory or sensorimotor polyneuropathy, hypesthesia, dysesthesia, or weakness.

If you experience symptoms such as pain, burning, tingling, numbness, weakness, patients should inform their physician before

than continue to use the drug.

Skin

During treatment, contact with direct sunlight and ultraviolet radiation should be avoided.

Treatment should be discontinued if symptoms of photosensitivity are observed (for example, a change in the skin that resembles sunburn).

Cytochrome P450 isoenzymes

Ciprofloxacin is a moderate inhibitor of CYP450 1A2 isoenzymes.

Caution should be exercised while using ciprofloxacin and drugs

metabolized by these enzymes (including theophylline, methylxanthine, caffeine, duloxetine, clozapine, ropinirole, olanzapine),

since the concentration of these drugs in the blood serum increases, due to the inhibition of their metabolism by ciprofloxacin,

may cause specific adverse reactions.

Local reactions

With intravenous administration of ciprofloxacin, a local inflammatory reaction may occur at the injection site (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.

With simultaneous iv administration of ciprofloxacin and drugs for general anesthesia from the group of barbituric acid derivatives, constant monitoring of heart rate, blood pressure, ECG is necessary.

Sodium chloride content

The sodium chloride content of ciprofloxacin solution should be considered in the treatment of patients

in which sodium intake is limited (heart failure, renal failure, nephrotic syndrome).

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Composition of

Each vial of 100 ml contains:

active ingredient: ciprofloxacin 200 mg

excipients: sodium chloride 900 mg, disodium edetate 10 mg, lactic acid 75 mg, citric acid monohydrate 12 mg, sodium hydroxide 8 mg, hydrochloric acid 0.0231 ml, water for injection up to 100 ml.

Dosage and administration

Intravenous infusion.

Duration of infusion is 30 min at a dose of

200 mg and 60 min at a dose of 400 mg.

Ready-to-use infusion solutions can be mixed with 0.9% sodium chloride solution, Ringer and Ringer-lactate solution, 5% and 10% dextrose solution, 10% fructose solution,

as well as a solution containing 5% dextrose solution with 0.225-0.45% sodium chloride solution.

Adults

For infections of the lower respiratory tract - 200-400 mg 2 times a day, course 7-14 days.

In severe pneumonia, including streptococcal, and infectious complications of cystic fibrosis - 400 mg 3 times a day, course 7-14 days.

For infections of ENT organs - 200-400 mg 2 times a day, course 10 days.

In case of urinary tract infections: acute uncomplicated - 100 mg 2 times a day, course 7-14 days

cystitis in women (before menopause) - once 100 mg complicated -

200 mg 2 times a day, course 7-14 days.

In case of chronic bacterial prostatitis, 400 mg 2 times a day, course 28 days.

With uncomplicated gonorrhea - 100 mg once, with extragenital - 100 mg 2 times a day.

With typhoid fever - 400 mg 2 times a day, course 10 days.

With infectious diarrhea - 200 mg 2 times, the course of treatment is 5-7 days.

For mild and moderate infections of the skin and soft tissues - 400 mg 2 times a day, for severe - 400 mg 3 times a day, course 7-14 days.

Particularly severe infections (bone and joint infections, septicemia, peritonitis),

especially caused by Pseudomonas, Staphylococcus - 400 mg 3 times a day.

Pulmonary anthrax (treatment and prevention) - 400 mg 3 times a day, 60 days.

For the prevention of infections during surgical interventions - 200-400 mg 0.5-1 h before surgery

with a duration of surgery over 4 hours is re-administered in the same dose.

For other infections (depending on the severity) - 200-400 mg 2 times a day.

Elderly patients are prescribed lower doses depending on the severity of the infection and the rate of QC.

In pediatrics

In the treatment of complications caused by Pseudomonas aeruginosa in children with pulmonary cystic fibrosis from 5 to 17 years - 10 mg / kg 3 times a day (maximum dose 1200 mg). The duration of treatment is 10-14 days.

With pulmonary anthrax (prophylaxis and treatment) - 10 mg / kg 2 times a day.

The maximum single dose is 400 mg, the daily dose is 800 mg. The total duration of ciprofloxacin is 60 days.

Dosing in special cases

Patients with impaired renal function

With a QC of 31-60 ml / min / 1.73 sq. m or a serum creatinine concentration of 1.4 to 1.9 mg / 100 ml, the maximum daily dose is 800 mg.

With a CC below 30 ml / min / 1.73 sq. m or serum creatinine concentration above 2 mg / 100 ml and during hemodialysis, the maximum daily dose is 400 mg.

During hemodialysis, ciprofloxacin is administered after a hemodialysis session.

Patients on hemodialysis or peritoneal dialysis

During peritoneal dialysis, the infusion solution is added to the dialysate (intraperitoneally) at a dose of 50 mg per 1 liter of dialysate 4 times a day (every 6 hours).

Average course of treatment: 1 day - for acute uncomplicated gonorrhea and cystitis up to 7 days - for infections of the kidneys, urinary tract and abdominal cavity for no more than 2 months - for osteomyelitis and 7-14 days - for all other infections.

For streptococcal infections, due to the danger of late complications, treatment should last at least 10 days.

In patients with immunodeficiency, treatment is carried out during the entire period of neutropenia.

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

After intravenous administration of ciprofloxacin, treatment can be continued with oral administration of the drug.

Side effects

Depending on the frequency of occurrence, the following groups of side effects are distinguished: often - more than 1%, infrequently - 0.1-1%, rarely - 0.01-0.1%, very rarely - less than 0.01% .

Adverse reactions that were recorded only during post-marketing observations,

whose frequency was not estimated, are marked with “frequency unknown”.

From the central and peripheral nervous system: infrequently - psychomotor hyperactivity / agitation, sleep disturbances, dizziness, headache, fatigue

rarely - tremor, anxiety, "nightmare" dreams, increased sweating, confusion, disorientation, srdl can lead to self-harming behavior, such as suicidal behavior / thoughts,

as well as attempted suicide or successful suicide), hallucinations, paresthesia and dysesthesia, hypesthesia,

convulsions (including upy epilepsy), vertigo very rarely - peripheral paralgesia

(anomaly in the perception of pain) increased intracranial pressure (including benign intracranial hypertension), psychotic reactions (which can lead to self-harming behavior, such as suicidal behavior / thoughts,

as well as attempted suicide or successful suicide), migraine, cerebral artery thrombosis,

impaired movements, gait disturbance, hyperesthesia, peripheral neuropathy and polyneuropathy.

On the part of the sensory organs: infrequently - impaired taste rarely - impaired vision, tinnitus, hearing loss

very rarely - impaired sense of smell, impaired hearing.

From the cardiovascular system: rarely - tachycardia, vasodilation, low blood pressure very rarely - other heart rhythm disturbances, frequency is unknown - lengthening of the QT interval, ventricular arrhythmias (including pirouette type). digestive system: often - nausea, diarrhea - pancreatitis, hepatitis, hepatonecrosis.

From the hemopoietic system: infrequently - granulocytopenia

rarely - leukopenia, leukocytosis, thrombocytopenia, thrombocytosis, anemia, neutropenia

very rarely - hemolytic anemia, agranulocytosis, pancytopenia, suppression of hemorrhage.

From the kidneys and urinary tract: rarely - hematuria, crystalluria (especially with alkaline urine and low diuresis), dysuria, polyuria, urinary retention, albuminuria, renal failure, tubulointerstitial nephritis is very rare - a decrease in the excretory function of the kidneys.

From the respiratory system, chest and mediastinal organs: rarely - respiratory failure (including bronchospasm).

From the side of musculoskeletal muscle and connective tissue: infrequently -

arthralgia rarely - increased muscle tone, muscle cramps, arthritis, tendovaginitis,

myalgia very rarely - tendon ruptures (mainly Achilles), asthenia, muscle weakness, exacerbation of symptoms of mi.

Allergic reactions: infrequently - skin itching, rash, urticaria, drug fever, eosinophilia

rarely - the formation of blisters accompanied by bleeding, and the appearance of small nodules forming scabs,

swelling of the face or larynx, shortness of breath, increased photosensitivity is very rare - pinpoint hemorrhages on the skin (petechiae), vasculitis, erythema nodosum, erythema multiforme exudative (including Stevens-Johnson syndrome),

toxic epidermal necrolysis (Lyell's syndrome), anaphylactic reactions, anaphylactic shock.

Changes in laboratory parameters: infrequently - increased activity of hepatic transaminases and alkaline phosphatase,

rarely hyperbilirubinemia - hypoprothrombinemia, increased activity of amylase, hypercreatininemia, hyperglycemia, hypoglycemia.

Local reactions: often - pain at the injection site is rare - edema.

Other: infrequently - flushing of the face, pain of a non-specific etiology, superinfection (candidiasis)

rarely - swelling, pseudomembranous colitis (in very rare cases with a possible fatal outcome)

frequency is unknown - acute generalized pustular exanthema,

increased international normalized ratio (in patients receiving vitamin K antagonists).

Drug interaction

Due to the decrease in the activity of microsomal oxidation processes in hepatocytes,

increases the concentration and lengthens T1 / 2 of theophylline (and other xanthines, for example, caffeine), oral hypoglycemic drugs,

indirect anticoagulants, helps to reduce the prothrombin index.

NSAIDs (excluding acetylsalicylic acid) increase the risk of seizures.

Metoclopramide accelerates the absorption of ciprofloxacin, which reduces the time it takes to reach Cmax.

Co-administration of uricosuric drugs slows down excretion (up to 50%) and increases the plasma concentration of ciprofloxacin.

When combined with other antimicrobials (beta-lactams, aminoglycosides, clindamycin, metronidazole)

, synergism is usually observed. It can be successfully used in combination with azlocillin and ceftazidime for infections caused by pseudomonas spplompas

. with meslocillin, azlocillin and other beta-lactam antibiotics - for streptococcal

infections with isoxazolylpenicillins and vancomycin - for staphylococcal

infections with metronidazole and clindamycin - for anaerobic infections.

Enhances the nephrotoxic effect of cyclosporine, an increase in serum creatinine is noted, therefore, in such patients, this indicator needs to be monitored 2 times a week.

When taken concomitantly, it enhances the effects of indirect anticoagulants.

The infusion solution is pharmaceutically incompatible with all infusion solutions and preparations that are physically and chemically unstable in an acidic environment (the pH of the ciprofloxacin infusion solution is 3.5-4.6),

The IV solution must not be mixed with solutions having a pH greater than 7.



overdose Treatment:

The specific antidote is unknown.

It is necessary to carefully monitor the condition of the patient, do a stomach wash, carry out the usual emergency measures, ensure sufficient fluid intake.

Only a small (less than 10%) amount of the drug can be removed by hemo- or peritoneal dialysis.

Storage Conditions

In a dark place at a temperature not exceeding 25 ° C.

Do not freeze.

Keep out of the reach and sight of children!

Shelf life

3 years

Deystvuyushtee substance

Ciprofloxacin

dosage form

infusion solution

Possible product names

CIPROLET 0.002 / ML 100ML R-R INF

Ciprolet r-r d / inf 2mg / ml 100ml fl

Ciprolet r-r d / inf 2mg / ml 100ml x r-r srlk d / inf fl. 200mg 100ml India

CIPROLET RR D / INF. 2 MG / ML FL. 100ML



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