active ingredient: ciprofloxacin;

1 ml of solution contains ciprofloxacin 2 mg;

excipients: lactic acid, sodium chloride, disodium edetate, sodium hydroxide, hydrochloric acid, water for injection.

Dosage form

Solution for infusion.

Pharmacotherapeutic group

Antibacterial agents of the fluoroquinolone group. Ciprofloxacin. ATC code J01M A02.

Indications

Treatment of uncomplicated and complicated infections caused by pathogens sensitive to ciprofloxacin:

• infections of the middle ear and paranasal sinuses;
• eye infections;
• respiratory tract infections;
• infections of the abdominal organs, bacterial infections of the gastrointestinal tract, gallbladder and biliary tract, as well as peritonitis;
• kidney and urinary tract infections;
• infections of the pelvic organs (gonorrhea, adnexitis and prostatitis inclusive);
• skin and soft tissue infections;
• bone and joint infections;
• sepsis.

Prevention and treatment of infections in patients with weakened immune systems (including those treated with immunosuppressants and neutropenia). Selective intestinal decontamination during treatment with immunosuppressants.

Contraindications

Hypersensitivity to ciprofloxacin or other quinolone chemotherapeutic agents. Pregnancy and lactation period. Children under 18 years of age.

Directions for use and doses

The dosage regimen is set individually depending on the location and severity of the infection, as well as the sensitivity of the pathogen. If it is not possible to take the drug orally, it is recommended to start treatment with intravenous administration. The drug solution can be administered undiluted or after adding to other infusion solutions.

Compatibility with other solutions

Ciprofloxacin infusion solution is compatible with saline, Ringer's solution, lactated Ringer's solution, 5% and 10% glucose, 10% fructose, and 5% glucose with 0.225% NaCl or 0.45% NaCl. The solution obtained after mixing ciprofloxacin with compatible infusion solutions should be used as soon as possible, due to microbiological reasons, as well as the sensitivity of the drug to light.

For urinary tract infections (including acute uncomplicated cystitis in women, as well as acute uncomplicated gonorrhea), Ciprofloxacin can be administered intravenously at a dose of 100 mg twice daily. For respiratory tract infections and other infections, depending on the severity of the process and the type of pathogen, the drug is administered in a dose of 200 - 400 mg twice a day. The duration of the Ciprofloxacin infusion should be 60 minutes.

For severe infections, for recurrent infections in patients with cystic fibrosis, for infections of the abdominal organs, bones and joints caused by Pseudomonas or staphylococci, with peritonitis and septicemia, as well as with acute pneumonia caused by Streptococcus pneumoniae, the dose should be increased to 400 mg three times a day. The maximum daily dose is 1200 mg.

Dosage regimen for impaired renal or hepatic function in adults

1. Renal dysfunction.

1.1. With creatinine clearance from 31 to 60 ml/min/1.73 m2 or its concentration in blood plasma from 1.4 to 1.9 mg/100 ml, the maximum dose of ciprofloxacin for intravenous administration should be 800 mg per day.

1.2. When creatinine clearance is 30 ml/min/1.73 m2 or less or its plasma concentration is 2/100 ml or more, the maximum dose of Ciprofloxacin for intravenous administration should be 400 mg per day.

2. Renal dysfunction + hemodialysis.

The maximum dose of ciprofloxacin when administered intravenously should be 400 mg per day; on days of hemodialysis, ciprofloxacin is taken after this procedure.

3. Impaired renal function + peritoneal dialysis in outpatients.

A solution of ciprofloxacin for infusion is attached to the dialysate (internally peritoneally): 50 mg of ciprofloxacin per liter of dialysate is administered 4 times a day every 6 hours.

4. Liver dysfunction.

No dose adjustment is required.

The duration of treatment depends on the severity of the disease, clinical course and results of bacteriological studies.

It is recommended to continue treatment for at least three days after the temperature normalizes or clinical symptoms disappear. The duration of treatment for acute uncomplicated gonorrhea and cystitis is one day. For infections of the kidneys, urinary tract and abdominal organs, the duration of treatment reaches 7 days. For osteomyelitis, the course of therapy can be extended to two months. For other infections, the duration of treatment is usually 7 to 14 days. In immunocompromised patients, treatment is carried out throughout the entire period of neutropenia. For infections caused by streptococci and chlamydia, treatment should last at least 10 days.

Adverse reactions

Local reactions have been reported after intravenous administration of the drug. These reactions occur more frequently if the infusion time is 30 minutes or less. They may occur in the form of local reactions on the skin, which quickly disappear after the end of the infusion. Subsequent infusions of the drug are not contraindicated, unless such reactions recur or become more complicated.

Frequency 3 1%< 10%.

Organs of the gastrointestinal tract and liver: nausea, diarrhea.

Skin: rash. Frequency 3 0.1%< 1%.

Body as a whole: abdominal pain, candidiasis, asthenia, pathological reactions at the injection site (eg swelling/inflammation, pain).

Cardiovascular system: thrombophlebitis (at the infusion site).

increased levels of liver transaminases: ALT, AST, alkaline phosphatase, vomiting, dyspepsia, abnormal values ​​of liver function tests, anorexia (lack of appetite), flatulence, bilirubinemia.

Hematopoietic system: eosinophilia, leukopenia.

Metabolic disorders: increased creatinine levels, increased urea nitrogen levels.

Musculoskeletal system: arthralgia (joint pain).

Nervous system: dizziness, headache, sleep disorders, agitation, confusion.

Leather: itching, maculopapular rash, urticaria.

Sense organs: taste disturbance.

Frequency 3 0.01%< 0,1%.

The organism as a whole: pain in the limbs, back, chest.

Cardiovascular system: tachycardia, syncope (fainting), vasodilation (flushing), hypotension.

Organs of the gastrointestinal tract: candidiasis (oral), jaundice, cholestatic jaundice, pseudomembranous colitis.

anemia, leukopenia (granulocytopenia), leukocytosis, changes in prothrombin levels, thrombocytopenia, thrombocythemia (thrombocytosis).

Hypersensitivity: allergic reaction, drug fever, anaphylactic (anaphylactic) reaction.

Metabolic disorders: edema (peripheral, vascular, facial), hyperglycemia.

Musculoskeletal system: myalgia (muscle pain), joint swelling.

Nervous system: migraine, hallucinations, sweating, paresthesia (peripheral paralgesia), anxiety (fear, anxiety), sleep disturbances (nightmares), convulsions, hypersthesia, depression, tremor.

Respiratory system: dyspnea, laryngeal edema.

Leather: photosensitivity reaction.

Sense organs: tinnitus, temporary deafness (especially at high frequency sounds), visual impairment (visual abnormalities), diplopia, chromatopsia, loss of taste (taste disturbance).

Genitourinary system: acute renal failure, renal dysfunction, vaginal candidiasis, hematuria, crystalluria, interstitial nephritis.

Frequency< 0,01%.

Cardiovascular system: vasculitis

Organs of the gastrointestinal tract: candidiasis, liver necrosis (very rarely progressing to life-threatening liver failure), pseudomembranous colitis with possible fatal outcome, pancreatitis, hepatitis.

Blood system and lymphatic system: hemolytic anemia, petechiae (intermittent hemorrhage of the skin), agranulocytosis, pancytopenia (life-threatening), bone marrow suppression (life-threatening).

Hypersensitivity: shock (anaphylactic; life-threatening), skin rash, serum sickness-like reaction.

Metabolic disorders: increased amylase activity, increased lipase activity.

Musculoskeletal system: myasthenia gravis, tendinitis (mainly Achilles tendinitis), partial or complete rupture of tendons (mainly Achilles).

Nervous system: severe cramps of large muscles, unsteady gait, psychosis, intracranial (intracranial) hypertension, ataxia, hypersthesia, twitching.

Leather: petechiae, erythema multiforme, erythema nodosum, Stevens-Johnson syndrome, epidermal necrosis (Lyell's syndrome), persistent rashes.

Sense organs: parosmia (impaired sense of smell), loss of smell (usually reversible when the drug is discontinued).

Overdose

There are no specific symptoms of overdose.

A specific antidote is unknown. Routine emergency measures are recommended; Additionally, hemodialysis and peritoneal dialysis can be performed. Only small amounts of Ciprofloxacin are removed by hemodialysis or peritoneal dialysis (< 10 %).

Use during pregnancy or breastfeeding

Ciprofloxacin should not be prescribed to women during pregnancy and lactation because there is no experience with the safe use of the drug in these groups of patients, and, therefore, based on relevant animal data, it cannot be excluded that this drug may cause damage to articular cartilage in the body, which has not developed.

In animal studies, the drug was not proven to have teratogenic activity (deformations, malformations, developmental pathologies, deformities).

Children

As with other drugs in this class, ciprofloxacin has been shown to cause arthropathy in weight-bearing joints in immature animals. Analysis of available data on the safety of the use of Ciprofloxacin in patients under 18 years of age did not reveal any evidence of cartilage or joint damage associated with drug treatment. In children under 18 years of age, the drug can be used only for health reasons.

Special safety precautions

Patients with epilepsy, a history of seizures, vascular diseases and organic brain damage due to the risk of developing adverse reactions from the central nervous system should be prescribed Ciprofloxacin only for health reasons.

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

Features of application

During treatment with ciprofloxacin, changes in some laboratory parameters are possible: the appearance of sediment in the urine; temporary increase in the concentrations of urea, creatinine, bilirubin, liver transaminases in the blood serum; in some cases - hyperglycemia, crystalluria or hematuria; change in prothrombin levels. In patients with impaired liver and/or kidney function, monitoring the concentration of ciprofloxacin in the blood plasma is recommended.

Special precautions and special warnings for use. Digestive tract.

If severe and persistent diarrhea occurs during and after treatment, you should consult a doctor, because this symptom may conceal a serious gastrointestinal disease (for example, pseudomembranous colitis, which can be fatal), which requires immediate treatment. In such cases, the administration of Ciprofloxacin should be stopped and appropriate therapy initiated. Drugs that inhibit peristalsis are contraindicated.

Transient increases in transaminases, alkaline phosphatase, or cholestatic jaundice may occur, especially in patients with previous liver damage.

Nervous system.

Patients with epilepsy and patients with previous disorders of the central nervous system (for example, a decrease in the seizure threshold, a history of seizures, decreased cerebral circulation, changes in brain structure and stroke) can take Ciprofloxacin only if the benefits of taking the drug exceed the possible risks .

In some cases, adverse reactions from the central nervous system are observed after the first dose of Ciprofloxacin. In isolated cases, depression or psychosis may progress, which creates a self-threat for the patient. In this case, the administration of Ciprofloxacin should be stopped.

Hypersensitivity to the drug.

In some cases, hypersensitivity and allergic reactions are observed after the first administration of Ciprofloxacin, and you must immediately inform your doctor. In isolated cases, anaphylactic/anaphylactoid reactions may progress, up to shock that threatens the patient's life. In some cases, they are observed after the first administration of Ciprofloxacin. Then the administration of Ciprofloxacin must be stopped and drug treatment must be started immediately.

Musculoskeletal system.

If there are any signs of tendonitis (for example, painful swelling), you should stop ciprofloxacin, avoid exercise, and consult your doctor.

Tendon rupture (predominantly Achilles tendon rupture) has occurred primarily in reports in the elderly or in association with previous glucocorticoid treatment.

Leather.

Ciprofloxacin has been shown to cause photosensitivity reactions. Patients being treated with Ciprofloxacin should avoid direct exposure to intense sources of sunlight and ultraviolet light. If photosensitivity reactions (such as sunburn) occur, Ciprofloxacin therapy should be discontinued.

The ability to influence the reaction speed when driving a vehicle or working with other mechanisms.

The drug may affect the reaction rate to such an extent that it interferes with driving or operating machinery. This is especially true when taking the drug and alcohol in combination. When treated with Ciprofloxacin, patients should limit activities that require rapid concentration and the ability to react quickly.

Interaction with other drugs and other types of interactions

The simultaneous use of Ciprofloxacin and theophylline may lead to an undesirable increase in the concentration of the latter in the blood plasma and the development of side effects. Given this, the concentration of theophylline in the blood plasma should be monitored and its dose should be adequately reduced. With the simultaneous use of Ciprofloxacin and cyclosporine, in some cases an increase in serum creatinine concentration was observed, therefore, such patients require frequent monitoring of this indicator (twice a week). With the simultaneous use of Ciprofloxacin and warfarin, the effect of the latter may be enhanced. Due to the interaction of ciprofloxacin and glibenclamide, the effect of the latter may be enhanced, which is manifested by hypoglycemia. Co-administration of Ciprofloxacin and probenecid is accompanied by an increase in the concentration of Ciprofloxacin in the blood plasma. Metoclopramide accelerates the absorption of ciprofloxacin, as a result of which the period for achieving the maximum concentration of ciprofloxacin in the blood plasma is reduced (this does not affect the bioavailability of the latter).

Ciprofloxacin can be successfully used in combination with azlocillin and ceftazidime for infections caused by Pseudomonas; with mezlocillin, azlocillin and other effective beta-lactam antibiotics - for streptococcal infections; with isoxazolepenicillins, vancomycin - for staphylococcal infections; with metronidazole, clindamycin - for anaerobic infections.

Pharmacological properties

Pharmacodynamics. Ciprofloxacin inhibits the enzyme DNA gyrase, which plays an important role in the process of segmental despiralization and spiralization of the chromosome during the reproduction phase of bacteria and prevents the chromosomal transcription of information necessary for the normal metabolism of the bacterial cell, which leads to inhibition of the ability of the pathogen to reproduce. The drug has a rapid and pronounced bactericidal effect on microorganisms that are both in the reproduction phase and in the resting phase. It is highly effective against almost all gram-negative and gram-positive pathogens. Sensitive to Ciprofloxacin Escherichia coli, Shigella spp., Salmonella spp., Citrobacter spp., Klebsiella spp., Enterobacter spp., Serratia spp., Hafnia spp., Edwardsiella spp., Proteus(both indole-positive and indole-negative strains), Morganella spp., Providencia spp., Yersinia, Vibrio spp., Aeromonas spp., Plesiomonas, Pasteurella, Haemophilus, Campylobacter spp., Pseudomonas spp.(including - Pseudomonas aeruginosa), Legionella, Neisseria spp., Moraxella spp., Branhamella spp., Acinetobacter spp., Brucella spp., Staphylococcus spp., Listeria spp., Corynebacterium, Chlamydia, as well as plasmid forms of bacteria. They exhibit different sensitivities Gardnerella spp., Flavobacterium spp., Alcaligenes spp., Streptococcus agalactiae, Streptococcus faecalis, Streptococcus pyogenes, Streptococcus pneumoniae, Streptococcus viridans, Mycoplasma hominis, Mycobacterium tuberculosis, Mycobacterium fortuitum. Anaerobic cocci (Peptococcus, Peptostreptococcus) moderately sensitive to Ciprofloxacin, and Bacteroides - stable. Ciprofloxacin is effective against bacteria that produce beta-lactamases. It is also active against microorganisms resistant to almost all antibiotics, sulfonamide and nitrofuran drugs. In some cases, ciprofloxacin is active against strains of microorganisms resistant to other drugs of the fluoroquinolone group. However, it should be kept in mind that cross-resistance exists between different fluoroquinolones. Typically resistant to the drug Streptococcus faecium, Ureaplasma urealyticum, Nocardia asteroides, Treponema pallidum. Resistance to ciprofloxacin develops slowly and gradually (“multi-stage” type).

Pharmacokinetics. Ciprofloxacin penetrates quickly and well into all tissues of the body. Maximum concentrations in blood plasma after intravenous administration are achieved after 60 - 90 minutes. The volume of distribution in a state of stable equilibrium reaches 2 - 3 l/kg. Since the binding of ciprofloxacin to proteins is insignificant (20 - 30%), and the substance is in the blood plasma mainly in non-ionized form, almost the entire amount of the administered drug can freely diffuse into the extravasal space. In this regard, the concentrations of ciprofloxacin in some body fluids and tissues can significantly exceed the level of the drug in the blood serum (in particular, there is a high concentration of ciprofloxacin in bile). Ciprofloxacin is excreted mainly by the kidneys (almost 45% unchanged, about 11% in the form of metabolites). The rest of the dose is excreted through the intestines (about 20% unchanged, about 5-6% in the form of metabolites). Renal clearance is 3 - 5 ml/min/kg, total clearance is 8 - 10 ml/min/kg. The half-life is 3 - 5 hours. Due to the fact that the drug is excreted in different ways, an increase in the half-life is observed only with significant impairment of renal function (this indicator may increase to 12 hours).

Basic physical and chemical properties

transparent solution from colorless to pale yellow.

Best before date

3 years from the date of manufacture “in bulk”.

Storage conditions

Store at a temperature not exceeding 25 ° C in a place protected from light, out of reach of children.

Package

100 ml or 200 ml of solution in a bottle made of polymer material, 1 bottle in a pack.

Latin name

Release form

Solution for infusion.

Active substance: ciprofloxacin

Excipients: sodium chloride, lactic acid, disodium edetate, citric acid monohydrate, sodium hydroxide, hydrochloric acid, water for injection.

Package

Pharmacological action

TSIPROLET is a broad-spectrum antibacterial drug from the group of fluoroquinolones. Acts bactericidal. The drug inhibits the enzyme DNA gyrase of bacteria, as a result of which DNA replication and the synthesis of cellular proteins of bacteria are disrupted. Ciprofloxacin acts both on microorganisms that are reproducing and those in the resting phase.

Gram-negative aerobic bacteria are sensitive to ciprofloxacin: Escherichia coli, Salmonella spp., Shigella spp., Citrobacter spp., Klebsiella spp., Enterobacter spp., Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Hafhia 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., Chlamydia trachomatis, Listeria monocytogenes, Mycobacterium tuberculosis, Mycobacterium kansasii, Mycobacterium avium-intracellulare.

Gram-positive aerobic bacteria are also sensitive to ciprofloxacin: Staphylococcus spp. (S.aureus, S.haemolyticus, S.hominis, S.saprophyticus), Streptococcus spp. (St. pyogenes, St. agalactiae). Most staphylococci resistant to methicillin are also resistant to ciprofloxacin.

The sensitivity of bacteria Streptococcus pneumoniae and Enterococcus faecalis is moderate.

Corynebacterium spp., Bacteroides fragilis, Pseudomonas cepacia, Pseudomonas maltophilia, Ureaplasma urealyticum, Clostridium difficile, Nocardia asteroides are resistant to the drug. The effect of the drug against Treponema pallidum has not been sufficiently studied.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to ciprofloxacin, including:

• respiratory tract infections;
• ENT infections;
• kidney and urinary tract infections;
• genital infections (gonorrhea, prostatitis, adnexitis) and postpartum infections;
• gastrointestinal infections (including mouth, teeth, jaws);
• infections of the gallbladder and biliary tract;
• infections of the skin, mucous membranes and soft tissues;
• infections of the musculoskeletal system;
• sepsis;
• peritonitis.

Prevention and treatment of infections in patients with reduced immunity (during therapy with immunosuppressants).

Contraindications

• pseudomembranous colitis;
• deficiency of glucose-6-phosphate dehydrogenase;
• pregnancy;
• lactation period (breastfeeding);
• childhood and adolescence up to 18 years of age (until the process of skeletal formation is completed);
• hypersensitivity to ciprofloxacin or other drugs from the fluoroquinolone group.

The drug should be prescribed with caution in cases of severe cerebral atherosclerosis, cerebrovascular accident, mental illness, convulsive syndrome, epilepsy, severe renal and/or liver failure, as well as in elderly patients.

Directions for use and doses

The drug should be administered intravenously over 30 minutes (200 mg) and 60 minutes (400 mg). The infusion solution is compatible with 0.9% sodium chloride solution, Ringer's solution, 5% and 10% dextrose solution, 10% fructose solution, and a solution containing 5% dextrose solution with 0.225% or 0.45% sodium chloride solution.

The dose of Tsiprolet depends on the severity of the disease, type of infection, body condition, age, body weight and kidney function of the patient.

A single dose, on average, is 200 mg (for severe infections - 400 mg), the frequency of administration is 2 times a day. The duration of treatment depends on the severity of the disease and is 1-2 weeks; if necessary, longer administration of the drug is possible.

For acute gonorrhea, the drug is prescribed intravenously in a single dose of 100 mg.

To prevent postoperative infections, it is administered intravenously 30-60 minutes before surgery at a dose of 200-400 mg.

Side effects

From the digestive system: nausea, diarrhea, vomiting, abdominal pain, flatulence, anorexia, cholestatic jaundice (especially in patients with previous liver diseases), hepatitis, hepatonecrosis, increased activity of liver transaminases and alkaline phosphatase.

From the nervous system: dizziness, headache, increased fatigue, anxiety, tremor, insomnia, nightmares, peripheral paralgesia (anomaly in the perception of pain), sweating, increased intracranial pressure, anxiety, confusion, depression, hallucinations, as well as other manifestations psychotic reactions (occasionally progressing to states in which the patient can harm himself), migraine, fainting, thrombosis of the cerebral arteries.

From the senses: disturbances of taste and smell, visual impairment (diplopia, changes in color vision), tinnitus, hearing loss.

From the cardiovascular system: tachycardia, heart rhythm disturbances, decreased blood pressure, flushing of the face.

From the hematopoietic system: leukopenia, granulocytopenia, anemia, thrombocytopenia, leukocytosis, thrombocytosis, hemolytic anemia.

Laboratory indicators: hypoprothrombinemia, hypercreatininemia, hyperbilirubinemia, hyperglycemia.

From the urinary system: hematuria, crystalluria (primarily with alkaline urine and low diuresis), glomerulonephritis, dysuria, polyuria, urinary retention, albuminuria, urethral bleeding, hematuria, decreased nitrogen excretory function of the kidneys, interstitial nephritis.

Allergic reactions: skin itching, urticaria, formation of blisters accompanied by bleeding and small nodules that form scabs, drug fever, pinpoint hemorrhages (petechiae), swelling of the face or larynx, shortness of breath, eosinophilia, increased photosensitivity, vasculitis, erythema nodosum, exudative erythema multiforme , Stevens-Johnson syndrome (malignant exudative erythema), toxic epidermal necrolysis (Lyell's syndrome).

From the musculoskeletal system: arthralgia, arthritis, tenosynovitis, tendon ruptures, myalgia.

Other: general weakness, superinfections (candidiasis, pseudomembranous colitis).

Local reactions: pain and burning at the injection site, phlebitis.

Special instructions

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

If pain occurs in the tendons or when the first signs of tenosynovitis appear, treatment should be stopped.

During treatment with Tsiprolet, it is necessary to provide a sufficient amount of fluid while maintaining normal diuresis.

During treatment with Tsiprolet, contact with direct sunlight should be avoided.

Impact on the ability to drive vehicles and operate machinery

Patients taking Tsiprolet should be careful when driving a car and engaging in other potentially hazardous activities that require increased attention and speed of psychomotor reactions (especially when consuming alcohol at the same time).

Drug interactions

Due to a decrease in the activity of microsomal oxidation processes in hepatocytes, it increases the concentration and lengthens T1/2 of theophylline (and other xanthines, for example, caffeine), oral hypoglycemic drugs, indirect anticoagulants, and helps reduce the prothrombin index.

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

Metoclopramide accelerates the absorption of ciprofloxacin, which leads to a decrease in the time to reach its Cmax.

Co-administration of uricosuric drugs leads to a slower elimination (up to 50%) and an increase in plasma concentrations of ciprofloxacin.

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

It enhances the nephrotoxic effect of cyclosporine, and there is an increase in serum creatinine, so in such patients it is necessary to monitor this indicator 2 times a week.

When taken simultaneously, it enhances the effect of indirect anticoagulants.

The infusion solution is pharmaceutically incompatible with all infusion solutions and drugs that are physicochemically unstable in an acidic environment (pH of the ciprofloxacin infusion solution is 3.5-4.6). The solution for intravenous administration should not be mixed with solutions having a pH greater than 7.

Overdose

Treatment: specific antidote is unknown. It is necessary to carefully monitor the patient's condition, perform gastric lavage, carry out the usual emergency measures, and ensure sufficient fluid intake. Using hemo- or peritoneal dialysis, only a small (less than 10%) amount of the drug can be removed.

Storage conditions

At temperatures up to 25°C

Catad_pgroup Antibacterial quinolones and fluoroquinolones

Tsiprinol for infusion in ampoules - instructions for use

Registration number:

P N014323/02-220708

Trade name:

Tsiprinol ®

International nonproprietary name:

ciprofloxacin

Dosage form:

concentrate for the preparation of solution for infusion

Compound

1 ampoule contains:
Active substance:
Ciprofloxacin 100.00 mg
Excipients: lactic acid 43.00 mg, disodium edetate 1.00 mg, concentrated hydrochloric acid q.s. to pH = 3.4-3.6, water for injection q.s. up to 10.00 ml

Description

A clear, colorless or slightly yellowish-greenish solution.

Pharmacotherapeutic group:

antimicrobial agent - fluoroquinolone

ATX code: J01MA02

Pharmacological properties

Pharmacodynamics
Ciprofloxacin is a synthetic broad-spectrum antibacterial drug from the group of fluoroquinolones.
Mechanism of action
Ciprofloxacin is active under conditions in vitro against a wide range of gram-negative and gram-positive microorganisms. The bactericidal effect of ciprofloxacin is carried out through the inhibition of bacterial type II topoisomerases (topoisomerase II (DNA gyrase) and topoisomerase IV), which are necessary for the replication, transcription, repair and recombination of bacterial DNA.
Mechanisms of resistance
Resistance under conditions in vitro to ciprofloxacin is often caused by point mutations in bacterial topoisomerases and DNA gyrase and develops slowly through multistep mutations.
Single mutations may result in decreased susceptibility rather than the development of clinical resistance, but multiple mutations generally lead to the development of clinical resistance to ciprofloxacin and cross-resistance to quinolone drugs. Resistance to ciprofloxacin, as well as to many other antibiotics, can develop as a result of a decrease in the permeability of the bacterial cell wall (as often happens in the case of Pseudomonas aeruginosa) and/or activation of removal from the microbial cell (efflux).
The development of resistance due to the coding gene localized on plasmids has been reported Qnr. Resistance mechanisms that lead to inactivation of penicillins, cephalosporins, aminoglycosides, macrolides and tetracyclines do not likely interfere with the antibacterial activity of ciprofloxacin.
Microorganisms resistant to these drugs may be sensitive to ciprofloxacin. The minimum bactericidal concentration (MBC) usually does not exceed the minimum inhibitory concentration (MIC) by more than 2 times.
In vitro susceptibility testing
Reproducible criteria for ciprofloxacin susceptibility testing, approved by the European Committee on Antimicrobial Susceptibility Testing (EUCAST), are presented in the table below.

European Committee on Antibiotic Susceptibility Testing.
Clinical MIC breakpoints (mg/L) for ciprofloxacin.

Microorganism	Sensitive [mg/l]	Resistant [mg/l]
Enterobacteriaceae	≤0,5	>1
Pseudomonas spp.	≤0,5	>1
Acinetobacter spp.	≤1	>1
Staphylococcus 1 spp.	≤1	>1
Streptococcus pneumoniae 2	≤0,125	>2
Haemophilus influenzae and Moraxella catarrhalis 3	≤0,5	>0,5
Neisseria gonorrhoeae	≤0,03	>0,06
Neisseria meningitidis	≤0,03	>0,06
Non-species boundary values microorganisms 4	≤0,5	>1

1. Staphylococcus spp.– breakpoints for ciprofloxacin and ofloxacin are associated with high-dose therapy.
2. Streptococcus pneumoniae– wild type S. pneumoniae is not considered susceptible to ciprofloxacin and ofloxacin and is therefore classified as intermediately susceptible.
3. Strains with MIC values ​​above the sensitive/moderately sensitive threshold are very rare and have not been reported to date. Identification and antimicrobial susceptibility tests should be repeated when such colonies are detected, and the results should be confirmed by colony testing at a reference laboratory. Until evidence of clinical response is available for strains with confirmed MIC values ​​above the currently used resistance threshold, they should be considered resistant. Haemophilus spp./Moraxella spp.– it is possible to identify strains Haemophilus influenzae with low sensitivity to fluoroquinolones (MIC for ciprofloxacin - 0.125-0.5 mg/l). Evidence of the clinical significance of low resistance in respiratory tract infections caused by N. influenzae, no.

4. Non-species-specific breakpoints were determined primarily on the basis of pharmacokinetics/pharmacodynamics data and are independent of species-specific MIC distributions. They are only applicable to species for which a species-specific susceptibility threshold has not been determined, and not to those species for which susceptibility testing is not recommended. For certain strains, the distribution of acquired resistance may vary across geographic regions and over time. Therefore, it is desirable to have local information on resistance, especially when treating severe infections.

Clinical and Laboratory Standards Institute data for MIC breakpoints (mg/L) and diffusion testing (zone diameter [mm]) using discs containing 5 mcg ciprofloxacin are presented in the table below.

Clinical and Laboratory Standards Institute. Breakpoints for MIC (mg/L) and diffusion testing (mm) using disks.

Microorganisms	Sensitive	Intermediate	Resistant
Enterobacteriaceae	< l а	2 a	> 4 a
	> 21 b	16-20 b	< 15 б
Pseudomonas aeruginosa and other bacteria not related to the family Enterobacteriaceae	< l а	2 a	> 4 a
	> 21 b	16-20 b	< 15 б
Staphylococcus spp.	< l а	2 a	> 4 a
	> 21 b	16-20 b	< 15 б
Enterococcus spp.	< l а	2 a	> 4 a
	> 21 b	16-20 b	< 15 б
Haemophilus spp.	< 1 в	–	–
	> 21 g	–	–
Neisseria gonorrhoeae	< 0,06 д	0.12-0.5 d	> 1 d
	> 41 d	28-40 d	< 27 д
Neisseria meningitidis	< 0,03 е	0.06 e	> 0.12 e
	> 35 f	33-34 f	< 32 ж
Bacillus anthracis Yersinia pestis	< 0,25 а	–	–
Francisella tularensis	< 0,53	–	–

A. This reproducible standard is only applicable to broth dilution tests using cationic adjusted Mueller-Hinton broth (CAMHB) incubated with air at 35±2°C for 16-20 hours for strains Enterobacteriaceae, Pseudomonas aeruginosa, other bacteria not belonging to the family Enterobacteriaceae, Staphylococcus spp., Enterococcus spp. and Bacillus anthracis; within 20-24 hours for Acinetobacter spp., 24 hours for Y.pestis(if growth is insufficient, incubate for another 24 hours).
b. This reproducible standard is only applicable to disc diffusion tests using air at 35 ± 2 °C for 16-18 hours.
V. This reproducible standard is only applicable to diffusion tests using sensitivity discs with Haemophilus influenzae And Haemophilus parainfluenzae using broth test medium for Haemophilus spp.(HTM), which is incubated with access to air at a temperature of 35 ° C ± 2 ° C for 20-24 hours.
d. This reproducible standard is only applicable to disc diffusion tests using NTM incubated in 5% CO2 at 35°C±2°C for 16-18 hours.
e. This reproducible standard is only applicable to susceptibility tests (zone disc diffusion tests and MIC agar solution) using gonococcal agar and 1% specified growth supplement at 36°C ± 1°C (not to exceed 37°C) in 5% CO2 for 20-24 hours.
e. This reproducible standard is only applicable to broth dilution tests using cationically adjusted Mueller-Hinton broth (CAMHB) supplemented with 5% sheep blood incubated in 5% CO2 at 35 ± 2 °C for 20-24 hours .
and. This reproducible standard is applicable only to broth dilution tests using cationically adjusted Mueller-Hinton broth (CAMHB) supplemented with a specified 2% growth supplement and incubated with air at 35 ± 2 °C for 48 hours.

In vitro sensitivity to ciprofloxacin
For certain strains, the distribution of acquired resistance may vary across geographic regions and over time. Therefore, it is desirable to have local information on resistance when testing strain susceptibility, especially when treating severe infections. If the local prevalence of resistance is such that the benefit of using the drug, at least against several types of infections, is questionable, it is necessary to consult a specialist.
In research in vitro The activity of ciprofloxacin has been demonstrated against the following sensitive strains of microorganisms:
Aerobic gram-positive microorganisms:
Bacillus anthracis, Staphylococcus aureus (methicillin-sensitive). Staphylococcus saprophytics, Streptococcus spp.
Aerobic gram-negative microorganisms:
Aeromonas spp., Moraxella catarrhalis, Brucella spp., Neisseria meningitidis, Citrobacter koseri, Pasteurella spp., Francisella tularensi, Salmonella spp., Haemophilus ducreyi, Shigella spp., Haemophilius influenzae, Vibrio spp., Legionella spp., Yersinia pestis.
Anaerobic microorganisms:
Mobiluncus spp.
Other microorganisms:
Chlamydia trachomatis, Chlamydia pneumoniae, Mycoplasma hominis, Mycoplasma pneumoniae.
Varying degrees of sensitivity to ciprofloxacin have been demonstrated for the following microorganisms: Acinetobacter baumann, Burkholderia cepacia, Campylobacter spp., Citrobacter freundii, Enterococcus faecalis, Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Morganella morganii, Neisseria gonorrhoeae, Proteus mirabilis, Proteus vulgaris, Providencia spp., onas aeruginosa, Pseudomonas fluorescens, Serratia marcescens, Streptococcus pneumoniae, Peptostreptococcus spp., Propionibacterium acnes.
It is believed that natural resistance to ciprofloxacin is present in Staphylococcus aureus(methicillin-resistant), Stenotrophomonas maltophilia, Actinomyces spp., Enterococcus faecium, Listeria monocytogenes, Mycoplasma genitalium, Ureaplasma urealitycum, anaerobic microorganisms (except Mobiluncus spp., Peptostreptococcus spp., Propionibacterium acnes).

Pharmacokinetics
Suction
After intravenous (IV) administration, the maximum concentration (Cmax) of ciprofloxacin is achieved at the end of the infusion. When administered intravenously, the pharmacokinetics of ciprofloxacin were linear in the dose range up to 400 mg.
With intravenous administration 2 or 3 times a day, no accumulation of ciprofloxacin and its metabolites was observed.
Distribution
The binding of ciprofloxacin to plasma proteins is 20-30%; the active substance is present in the blood plasma mainly in non-ionized form.
Ciprofloxacin is freely distributed in tissues and body fluids. The volume of distribution in the body is 2-3 l/kg. The concentration of ciprofloxacin in tissues significantly exceeds the concentration in serum.
Metabolism
Biotransformed in the liver. Four metabolites of ciprofloxacin can be detected in the blood in small concentrations: diethylciprofloxacin (M1), sulfociprofloxacin (M2), oxociprofloxacin (M3), formylciprofloxacin (M4), three of which (M1-M3) exhibit antibacterial activity under conditions in vitro, comparable to the antibacterial activity of nalidixic acid.
Antibacterial activity under conditions in vitro the M4 metabolite, present in smaller quantities, is more consistent with the activity of norfloxacin.
Removal
Ciprofloxacin is excreted from the body primarily by the kidneys by glomerular filtration and tubular secretion, and a small amount is excreted through the intestines. Renal clearance is 0.18-0.3 l/h/kg, total clearance is 0.48-0.60 l/h/kg. Approximately 1% of the administered dose is excreted in bile. Ciprofloxacin is present in bile in high concentrations. In patients with unchanged renal function, the half-life (T1/2) is usually 3-5 hours. If renal function is impaired, T1/2 lengthens.
Children
In a study in children, Cmax and area under the concentration-time curve (AUC) values ​​did not depend on age. There was no noticeable increase in Cmax and AUC with repeated use of ciprofloxacin (at a dose of 10 mg/kg 3 times a day). In ten children with severe sepsis less than 1 year of age, the Cmax was 6.1 mg/L (range, 4.6 to 8.3 mg/L) after a 1-hour infusion at a dose of 10 mg/kg, and in children age from 1 to 5-7.2 mg/l (range from 4.7 to 11.8 mg/l). AUC values ​​in the respective age groups were 17.4 mg*h/L (range, 11.8 to 32.0 mg* h/L) and 16.5 mg* h/L (range, 11.0 to 23.8 mg* h/l). These values ​​correspond to the range reported for adult patients when using therapeutic doses of the drug. Based on pharmacokinetic analysis in children with various infections, the estimated mean elimination half-life in children is approximately 4-5 hours.

Indications for use

Uncomplicated and complicated infections caused by microorganisms sensitive to ciprofloxacin. Adults
Respiratory tract infections. Ciprofloxacin is recommended for pneumonia caused by Klebsiella spp., Enterobacter spp., Proteus spp., Esherichia coli, Pseudomonas aeruginosa, Haemophilus spp., Moraxella catarrhalis, Legionella spp. and staphylococci.
Infections of the middle ear (otitis media), sinuses (sinusitis), especially if these infections are caused by gram-negative microorganisms, including Pseudomonas aeruginosa or staphylococci.
Eye infections.
Kidney and/or urinary tract infections.
Infections of the genital organs, including adnexitis, gonorrhea, prostatitis.
Infections of the abdominal cavity (bacterial infections of the gastrointestinal tract, biliary tract, peritonitis).
Skin and soft tissue infections.
Sepsis.
Infections or prevention of infections in immunocompromised patients (patients taking immunosuppressants or patients with neutropenia).
Selective intestinal decontamination in immunocompromised patients.
Bacillus anthracis).
Children
Treatment of complications caused by Pseudomonas aeruginosa in children with cystic fibrosis of the lungs from 5 to 17 years.
Prevention and treatment of pulmonary anthrax (infection Bacillus anthracis).
Current official guidelines on the use of antibacterial agents must be taken into account.

Contraindications

Hypersensitivity to ciprofloxacin or other drugs from the fluoroquinolone group, as well as to excipients (see section "Composition").
The simultaneous use of ciprofloxacin and tizanidine due to clinically significant side effects (hypotension, drowsiness) associated with an increase in the concentration of tizanidine in the blood plasma (see section “Interactions with other drugs”).

With caution

With severe liver failure and diseases of the central nervous system (CNS): epilepsy, decreased seizure threshold (or history of seizures), severe cerebral atherosclerosis, cerebrovascular accident, organic brain lesions or stroke, mental illness (depression, psychosis ), renal failure, tendon damage with previous quinolone treatment, increased risk of QT prolongation or torsade de pointes (eg, congenital long QT syndrome, heart disease (heart failure, myocardial infarction, bradycardia), electrolyte imbalance (eg , for hypokalemia, hypomagnesemia)), simultaneous use of drugs that prolong the QT interval (including class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics), simultaneous use with inhibitors of the CYP1A2 isoenzyme (including theophylline, methylxanthine, caffeine, duloxetine, clozapine, ropinirole, olanzapine), myasthenia gravis, glucose-6-phosphate dehydrogenase deficiency, use in elderly patients.

Use during pregnancy and breastfeeding

Pregnancy
The safety of ciprofloxacin during pregnancy has not been established. However, based on the results of animal studies, the possibility of adverse effects on the articular cartilage of newborns cannot be completely excluded, and therefore ciprofloxacin should not be prescribed to pregnant women.
At the same time, no teratogenic effects (malformations) were established in animal studies.
Breastfeeding period
Ciprofloxacin is excreted into breast milk. Due to the potential risk of damage to joint cartilage in newborns, ciprofloxacin should not be given to nursing women.

Use in children

Ciprofloxacin is not recommended for use in children under 18 years of age for the treatment of other infectious diseases, except for the treatment of complications of cystic fibrosis of the lungs (in children from 5 to 17 years of age) caused by Pseudomonas aeruginosa, Bacillus anthracis).
The use of ciprofloxacin in children should be started only after assessing the benefit/risk ratio due to possible side effects on joints and tendons.

Directions for use and doses

Adults
In the absence of other prescriptions, it is recommended to follow the following dosage regimen:

Indications	Single dose for adults, taking into account frequency of administration per day (ciprofloxacin, mg, intravenous administration)
Respiratory tract infections(depending on the severity of the infection and the patient’s condition)
Infections of the genitourinary system: acute, uncomplicated complicated adnexitis, prostatitis, orchitis, epididymitis	from 200 mg x 2 times a day to 400 mg x 2 times a day from 400 mg x 2 times a day to 400 mg x 3 times a day from 400 mg x 2 times a day to 400 mg x 3 times a day
Diarrhea	400 mg x 2 times a day
Other infections(see section "Indications for use")	400 mg x 2 times a day
Particularly severe, life-threatening, especially if there is Pseudomonas spp., Staphylococcus spp. or Streptococcus spp., incl. pneumonia caused Streptococcus spp. recurrent infections in cystic fibrosis bone and joint infections septicemia peritonitis	400 mg x 3 times a day
Pulmonary anthrax (treatment and prevention)	400 mg x 2 times a day (adults)

Children and teenagers
Table 2. Recommended daily dose of Tsiprinol ®, concentrate for solution for infusion, in children and adolescents

Use in certain patient groups
Dosage regimen for elderly patients (over 65 years of age)
Elderly patients should be prescribed lower doses of ciprofloxacin depending on the severity of the disease and creatinine clearance (CC) (see also information for patients with impaired liver and/or kidney function).
Dosage regimen for pulmonary anthrax (treatment and prevention)
See Tables 1 and 2 for information.
Treatment should begin immediately after suspected or confirmed infection.
The total duration of treatment with ciprofloxacin for pulmonary anthrax is 60 days.

Dosage regimen for impaired renal or hepatic function in adults
Table 3. Recommended dosages for patients with renal failure

Dosage regimen for renal impairment in patients on hemodialysis
With CC< 30 мл/мин/1,73 м² (тяжелая почечная недостаточность) или его концентрации в плазме крови ≥2 мг/100 мл максимальная суточная доза препарата Ципринол ® должна составлять 400 мг в дни проведения гемодиализа после осуществления процедуры.
Dosage regimen in patients with renal failure undergoing continuous ambulatory peritoneal dialysis
The drug Ciprinol ® is added to the dialysate (intraperitoneal): 50 mg of ciprofloxacin per liter of dialysate is administered 4 times a day every 6 hours.
Dosage regimen in patients with liver failure
No dose adjustment is required.
Dosage regimen in patients with impaired renal and liver function
With CC 30-60 ml/min/1.73 m² (moderate renal failure) or its plasma concentration 1.4-1.9 mg/100 ml, the maximum daily dose of Tsiprinol ® should be 800 mg.
With CC< 30 мл/мин/1,73 м² (тяжелая почечная недостаточность) или его концентрации в плазме крови ≥2 мг/100 мл максимальная суточная доза препарата Ципринол ® должна составлять 400 мг.
Dosage regimen for impaired renal and/or liver function in children
The dosage regimen has not been studied in children with impaired renal and/or liver function.
Directions for use
Before use, the contents of the concentrate ampoule for preparing a solution for infusion under aseptic conditions must be diluted with an adequate amount of a compatible infusion solution (see subsection “Compatibility with other solutions) to a final solution concentration of 0.2% (2 mg/ml).
To prepare a solution for intravenous infusion containing 200 mg or 400 mg of ciprofloxacin, the contents of 2 or 4 ampoules of the concentrate for preparing the solution for infusion must be diluted in 80 ml or 160 ml, respectively, of a compatible infusion solution to the final concentration of the solution 0.2% (2 mg/ml).
Ciprofloxacin concentrate for solution for infusion is photosensitive, so the ampoule should be removed only before use.
The drug Tsiprinol ® , a ready-to-use 0.2% solution, is administered as an intravenous infusion lasting at least 60 minutes.
The infusion solution should be injected slowly into a large vein to prevent complications at the infusion site.
The infusion solution can be administered alone or together with other compatible infusion solutions.
Compatibility with other solutions
The drug Tsiprinol ® is compatible with 0.9% sodium chloride solution, Ringer's solution, 5% and 10% dextrose solution, 10% fructose solution, as well as 5% dextrose solution with 0.225% NaCl or 0.45% NaCl.
The solution obtained after mixing the drug Tsiprinol ® with compatible infusion solutions should be used as quickly as possible due to the sensitivity of the drug to light and in order to maintain the sterility of the solution. If compatibility with another infusion solution/preparation has not been confirmed, the infusion solution of Tsiprinol ® should be administered separately.
Visible signs of incompatibility are precipitation, turbidity or discoloration of the solution.
Incompatibility occurs with all solutions/preparations that are physically or chemically unstable at the pH value of the infusion solution of the drug Tsiprinol ® (for example, penicillins, heparin solutions), and in particular with solutions that change the pH value to the alkaline side (pH of the infusion solution of the drug Tsiprinol ® is 3.9-4.5).
Only a clean, clear solution should be used.
Duration of therapy
The duration of treatment depends on the severity of the disease, clinical course and cure of the disease. It is important to continue treatment for at least 3 days after the disappearance of fever or other clinical symptoms.
Average duration of treatment
Adults
1 day for acute uncomplicated gonorrhea;
up to 7 days for infections of the kidneys, urinary tract, abdominal organs;
the entire period of neutropenia in immunocompromised patients;
no more than 2 months for osteomyelitis;
from 7 to 14 days for other infections.
For infections caused Streptococcus spp., due to the risk of late complications, treatment should continue for at least 10 days.
For infections caused Chlamydia spp. treatment should also be continued for at least 10 days.
Children and teenagers
for the treatment of complications of cystic fibrosis caused by Pseudomonas aeruginosa(in patients from 5 to 17 years), the duration of therapy is 10-14 days.

Side effect

The adverse reactions listed below were classified as follows: “very often” (≥10), “common” (from ≥1/100 to<1/10), «нечасто» (от ≥1/1000 до <1/100), «редко» (от ≥1/10000 до <1/1000), «очень редко» (≥10000), «частота неизвестна». Нежелательные реакции, которые были зафиксированы только в ходе постмаркетинговых наблюдений, и частота которых не оценивалась, обозначены «частота неизвестна».

The incidence of the following adverse reactions with intravenous administration and with the use of stepwise therapy with ciprofloxacin (with intravenous administration of the drug followed by oral administration) is higher than with oral administration.

Children
Arthropathy has been frequently reported in children.

Overdose

It is necessary to carefully monitor the patient's condition, carry out routine emergency measures, and ensure sufficient fluid intake. To prevent the development of crystalluria, it is recommended to monitor renal function, including urine pH and acidity. Using hemo- or peritoneal dialysis, only a small amount of ciprofloxacin is removed (less than 10%).

Interaction with other drugs

Drugs that cause QT prolongation
Caution should be exercised when ciprofloxacin is used concomitantly, as with other fluoroquinolones, in patients receiving drugs known to prolong the QT interval (for example, class IA and III antiarrhythmic drugs, tricyclic antidepressants, macrolides, antipsychotics) (see section "Special Instructions") .
Theophylline
The simultaneous use of ciprofloxacin and drugs containing theophylline may cause an undesirable increase in the concentration of theophylline in the blood plasma and, accordingly, the occurrence of theophylline-induced side effects; in very rare cases, these side effects can be life-threatening for the patient. If the simultaneous use of these two drugs is unavoidable, it is recommended to constantly monitor the concentration of theophylline in the blood plasma and, if necessary, reduce the dose of theophylline.
Other xanthine derivatives
The simultaneous use of ciprofloxacin and caffeine or pentoxifylline (oxpentifylline) may lead to an increase in the concentration of xanthine derivatives in the blood serum.
Phenytoin
With the simultaneous use of ciprofloxacin and phenytoin, a change (increase or decrease) in the concentration of phenytoin in the blood plasma was observed. To avoid weakening of the anticonvulsant effect of phenytoin due to a decrease in its concentration, as well as to prevent adverse events associated with phenytoin overdose when discontinuing ciprofloxacin, it is recommended to monitor phenytoin therapy in patients taking both drugs, including determining the concentration of phenytoin in the blood plasma during the entire period simultaneous use of both drugs and for a short time after completion of combination therapy.
Nonsteroidal anti-inflammatory drugs
The simultaneous use of very high doses of quinolones (DNA gyrase inhibitors) and some non-steroidal anti-inflammatory drugs (excluding acetylsalicylic acid) can provoke seizures.
Cyclosporine
With the simultaneous use of ciprofloxacin and drugs containing cyclosporine, a short-term transient increase in plasma creatinine concentration was observed. In such cases, it is necessary to determine the concentration of creatinine in the blood plasma 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 is presumably due to an increased effect of oral hypoglycemic agents (see section "Side effects").
Probenecid
Probenecid slows down the rate of excretion of ciprofloxacin by the kidneys. The simultaneous use of ciprofloxacin and drugs containing probenecid leads to an increase in the concentration of ciprofloxacin in the blood serum.
Methotrexate
With the simultaneous use of methotrexate and ciprofloxacin, the renal tubular transport of methotrexate may slow down, which may be accompanied by an increase in the concentration of methotrexate in the blood plasma. This may increase the likelihood of side effects from methotrexate. In this regard, patients receiving concomitant therapy with methotrexate and ciprofloxacin should be closely monitored.
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 the blood plasma was revealed: an increase in Cmax by 7 times (from 4 to 21 times), an increase in AUC by 10 times (from 6 to 21 times). 24 times). An increase in the concentration of tizanidine in the blood serum is associated with hypotensive (lowering blood pressure) and sedative (drowsiness, lethargy) side effects. Therefore, the simultaneous use of ciprofloxacin and drugs containing tizanidine is contraindicated.
Duloxetine
Clinical studies have shown that the simultaneous use of duloxetine and potent inhibitors of the CYP1A2 isoenzyme (such as fluvoxamine) may lead to an increase in the AUC and Cmax of duloxetine. Although there is no clinical data on possible interactions with ciprofloxacin, the likelihood of such an interaction can be anticipated when ciprofloxacin and duloxetine are used concomitantly.
Ropinirole
The simultaneous use of ropinirole and ciprofloxacin, a moderate inhibitor of the CYP1A2 isoenzyme, leads to an increase in the Cmax and AUC of ropinirole by 60 and 84%, respectively. Monitor for adverse effects of ropinirole during concomitant use with ciprofloxacin and for a short time after completion of 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 CYP1A2 isoenzyme, leads to a 22% decrease in the clearance of lidocaine when administered intravenously. Despite the good tolerability of lidocaine, when used simultaneously with ciprofloxacin, side effects may increase due to interaction.
Clozapine
With simultaneous use of clozapine and ciprofloxacin at a dose of 250 mg for 7 days, an increase in serum concentrations of clozapine and N-desmethylclozapine was observed by 29% and 31%, respectively. The patient's condition should be monitored and, if necessary, the dosage regimen of clozapine should be adjusted during its simultaneous use with ciprofloxacin and for a short time after completion of combination therapy.
Sildenafil
With simultaneous use of ciprofloxacin at a dose of 500 mg and sildenafil at a dose of 50 mg in healthy volunteers, a 2-fold increase in Cmax and AUC of sildenafil was observed. In this regard, the use of this combination is possible only after assessing the benefit/risk ratio.
Vitamin K antagonists
The simultaneous use of ciprofloxacin and vitamin K antagonists (for example, warfarin, acenocoumarol, phenprocoumon, fluindione) may lead to an increase in their anticoagulant effect. The magnitude of this effect may vary depending on concomitant infections, age and general condition of the patient, so it is difficult to assess the effect of ciprofloxacin on increasing INR. MHO should be monitored frequently during concomitant use of ciprofloxacin and vitamin K antagonists, and for a short time after completion of combination therapy.

Special instructions

Severe infections, staphylococcal infections and infections caused by gram-positive and anaerobic bacteria
When treating severe infections, staphylococcal infections and infections caused by anaerobic bacteria, ciprofloxacin should be used in combination with appropriate antibacterial agents.
Infections caused by Streptococcus pneumoniae
The drug Tsiprinol ® is not recommended for the treatment of infections caused by Streptococcus pneumoniae, due to its lack of effectiveness against the pathogen.
Genital tract infections
For genital infections suspected of being caused by strains Neisseria gonorrhoeae, resistant to fluoroquinolones, information on local resistance to ciprofloxacin should be taken into account and the sensitivity of the pathogen should be confirmed in laboratory tests.
Heart disorders
Ciprofloxacin has an effect on prolongation of 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 QT prolongation. Elderly patients also have increased sensitivity to the effects of drugs that prolong the QT interval. Caution should be exercised when using the drug Tsiprinol ® simultaneously with drugs that prolong the QT interval (for example, antiarrhythmic drugs of classes IA and III, tricyclic antidepressants, macrolides and antipsychotic drugs) (see section "Interaction with other drugs"), or in patients with increased risk of prolongation of the QT interval or development of torsade de pointes (for example, with congenital long QT syndrome, electrolyte imbalance (for example, with hypokalemia, hypomagnesemia), as well as with heart diseases such as heart failure, myocardial infarction, bradycardia).
Use in children
It was found that 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, no connection has been established between cartilage or joint damage with the drug. It is not recommended to use the drug Tsiprinol ® in children for the treatment of diseases other than the treatment of complications of cystic fibrosis of the lungs (in children from 5 to 17 years old) associated with Pseudomonas aeruginosa and for the treatment and prevention of pulmonary anthrax (after suspected or proven infection Bacillus anthracis).
Hypersensitivity
Sometimes, after taking the first dose of ciprofloxacin, hypersensitivity to the drug may develop (see section “Side effects”), including allergic reactions, which should be reported to your doctor immediately. In rare cases, after the first use, anaphylactic reactions up to anaphylactic shock may occur. In these cases, the use of the drug Tsiprinol ® should be stopped immediately and appropriate treatment should be carried out.
Gastrointestinal tract
If severe and prolonged diarrhea occurs during or after treatment with ciprofloxacin, the diagnosis of pseudomembranous colitis should be excluded, which requires immediate discontinuation of the drug and the appointment of appropriate treatment (vancomycin orally at a dose of 250 mg 4 times a day) (see section “Side effects”). The use of drugs that suppress intestinal motility is contraindicated.
Hepatobiliary system
Cases of liver necrosis and life-threatening liver failure have been reported with the use of ciprofloxacin. If you have the following signs of liver disease, such as anorexia, jaundice, dark urine, itching, a painful abdomen, you should stop taking the drug Tsiprinol ® (see section “Side effects”). Patients taking the drug Tsiprinol ® and who have had liver disease may experience a temporary increase in the activity of liver transaminases and alkaline phosphatase or cholestatic jaundice (see section “Side effects”).
Musculoskeletal system
Patients with myasthenia gravis should use the drug Ciprinol ® with caution, as an exacerbation of symptoms is possible.
When taking the drug Tsiprinol ®, cases of tendonitis and tendon rupture (mainly the Achilles tendon), sometimes bilateral, may occur within the first 48 hours after the start of therapy. Inflammation and rupture of the tendon may occur even several months after stopping treatment with Ciprinol ® . Elderly patients and patients with tendon diseases who are simultaneously treated with glucocorticosteroids have an increased risk of tendinopathy.
At the first signs of tendonitis (painful swelling in the joint area, inflammation), use of the drug Tsiprinol ® should be stopped, physical activity should be avoided, as there is a risk of tendon rupture, and a doctor should be consulted.
The drug Ciprinol ® should be used with caution in patients with a history of tendon diseases associated with taking quinolones.
Nervous system
The drug Tsiprinol ®, like other fluoroquinolones, can provoke convulsions and reduce the threshold for convulsive readiness. In patients with epilepsy and a history of central nervous system diseases (for example, a decrease in the seizure threshold, a history of seizures, cerebrovascular accidents, organic brain lesions or stroke), due to the risk of developing adverse reactions from the central nervous system, ciprofloxacin should be used only in cases where the expected clinical effect exceeds the possible risk of side effects of the drug. When using ciprofloxacin, cases of status epilepticus have been reported (see section "Side effects"). If seizures occur, use of the drug Tsiprinol ® should be discontinued.
Psychotic reactions can occur even after the first use of fluoroquinolones, including the drug Ciprinol ®. In rare cases, depression or psychotic reactions may progress to suicidal thoughts and suicide attempts, including completed ones (see section "Side effects"). If the patient develops one of these reactions, you should stop taking Cyprinol ® and tell your doctor.
Cases of sensory or sensorimotor polyneuropathy, hypoesthesia, dysesthesia or weakness have been reported in patients taking fluoroquinolones, including Ciprinol ® . If symptoms such as pain, burning, tingling, numbness, or weakness occur, patients should inform their doctor before continuing to use the drug.
Skin
When taking the drug Ciprinol ®, a photosensitivity reaction may occur, so patients should avoid contact with direct sunlight and UV light. Treatment should be discontinued if symptoms of photosensitivity are observed (for example, changes in the skin reminiscent of sunburn) (see section "Side effects").
Cytochrome P450
Ciprofloxacin is known to be a moderate inhibitor of the CYP1A2 isoenzyme. Caution should be exercised during the simultaneous use of the drug Tsiprinol ® and drugs metabolized by these isoenzymes, such as theophylline, methylxanthine, caffeine, duloxetine, clozapine, olanzapine, ropinirole, etc., since the increase in the concentration of these drugs in the blood serum is due to inhibition of their metabolism by ciprofloxacin , may cause specific adverse reactions.
Local reactions
With intravenous administration of the drug Tsiprinol ®, a local inflammatory reaction may occur at the site of drug administration (swelling, pain). This reaction is more common if the infusion time is 30 minutes or less. The reaction passes quickly after the end of the infusion and is not a contraindication for subsequent administration of the drug, unless its course is complicated.
To avoid the development of crystalluria, it is unacceptable to exceed the recommended daily dose; sufficient fluid intake and maintaining an acidic urine reaction are also necessary.
With simultaneous intravenous administration of ciprofloxacin and drugs for general anesthesia from the group of barbituric acid derivatives, constant monitoring of the heart rate, blood pressure, and electrocardiogram is necessary.
In conditions in vitro ciprofloxacin may interfere with bacteriological testing Mycobacterium tuberculosis, suppressing its growth, which can lead to false negative results when diagnosing this pathogen in patients taking the drug Tsiprinol ® .
NaCl content
Concentrate for solution for infusion Tsiprinol ® contains less than 1 mmol sodium (23 mg) per dose (10 ml), that is, essentially a “sodium-free” drug.

Impact on the ability to drive vehicles and machinery

Fluoroquinolones, including ciprofloxacin, may impair the ability of patients to drive a car and engage in other potentially hazardous activities that require increased attention and speed of psychomotor reactions due to their effect on the central nervous system.

Release form

Concentrate for the preparation of solution for infusion 10 mg/ml.
10 ml in ampoules made of neutral transparent glass (type 1). A colored dot is applied to the ampoule at the fracture site. 5 ampoules in a blister made of PVC/aluminum foil or 5 ampoules in a plastic blister pack. 1 blister or 1 plastic blister pack in a cardboard box along with instructions for use.

Storage conditions

In a place protected from light, at a temperature not exceeding 25 ° C. Do not freeze!
Keep out of the reach of children.

Best before date

5 years.
Do not use the drug after the expiration date.

Vacation conditions

Dispensed by prescription.

Manufacturer:

JSC "Krka d.d., Novo Mesto", Šmarješka cesta 6, 8501 Novo Mesto, Slovenia

When packaging and/or packing at a Russian enterprise, it is indicated
LLC "KRKA-RUS", 143500, Russia, Moscow region, Istra, st. Moskovskaya, 50
or
CJSC "Vector-Medica", 630559, Russia, Novosibirsk region, Novosibirsk district, r.p. Koltsovo, bldg. 13, bldg. 15, bldg. 38

Representative office of JSC "KRKA, d.d., Novo mesto" in the Russian Federation /
Organization receiving consumer complaints:
125212, Moscow, Golovinskoe highway, building 5, building 1

Broad-spectrum antibiotics act as the main group of drugs prescribed for colds, viral or infectious diseases in humans. Thanks to antibiotics, further development of the disease is prevented; in some cases, these drugs help stop the disease during the incubation period.

Particularly popular, as well as having corresponding medicinal properties, are antimicrobial drugs with bactericidal action belonging to the group of fluoroquinolones. These drugs include Ciprofloxacin, intended for intravenous injections. The drug has repeatedly proven its effectiveness, which has earned it popularity among patients. It is necessary to review the instructions for intravenous use in order to know the characteristics of the drug, its contraindications, possible side effects and spectrum of action.

Release form and composition

Ciprofloxacin is available in several forms, but the most effective form of release is considered to be an injection solution. An intravenous injection allows the active substance hydrochloride monohydrate to quickly disperse throughout the patient’s body and influence the source of inflammation.

Let's consider the main features of the release form, as well as the composition of the drug:

• Ciprofloxacin is produced in the form of a solution for infusion in bottles of 100 milliliters. As a rule, one package contains from 5 to 10 bottles of solution, it all depends on the manufacturer;
• The liquid is colorless or has a slightly yellow tint. Very important: the solution should not be cloudy or oily; if you see such a liquid in the bottle, it is a fake or expired product. Beware of such products;
• The main active ingredient is ciprofloxacin (hydrochloride monohydrate). Per 100 ml – 2 mg;
• Additional components include lactic acid, sodium, ethylenediaminetetraacetic acid and water for injections.

As you can see, the drug has a specific composition, which does not contain active chemical additives that negatively affect the patient’s health. The active ingredients react quickly; after 30-40 minutes you can feel the first results.

Pharmacological properties

Ciprofloxacin is a broad-spectrum antimicrobial antibiotic. Thanks to the quinolone derivatives that form the basis of this medicine, the total destruction of harmful microorganisms occurs, which leads to a significant inhibition of the further development of the disease and a speedy recovery of the patient.

It is worth noting that the drug affects microbes that are in the stage of anabiosis or division, which allows not only to cure the current disease, but also to prevent relapse or the emergence of a new source of inflammation due to weakened human immune defense.

The active substances of Ciprofloxacin are non-toxic, which makes it possible to simultaneously combine antibiotic drugs of two different types and specificity of action. When taking the drug, resistance to other antibiotics, as well as other medications, does not develop. The simultaneous use of Ciprofloxan and other antibiotics that are not included in the group of DNA gyrase inhibitors is allowed. This makes it possible to increase the intensity of damage to harmful bacteria that are resistant to the action of quinolone derivatives.

According to medical statistics, after a full therapeutic course of Ciprofloxacin, the chance of relapse is extremely small. The drug affects 95% of harmful microorganisms; for the remaining 5%, an unfavorable environment is created in which they cannot divide.

Pharmacokinetics

As for pharmacokinetics, the drug quickly interacts with the body. The end products of metabolism are metabolized in the liver and ultimately excreted in feces and urine. It is worth noting in advance that the uncharacteristic color of urine during a therapeutic course of Ciprofloxacin is only a side effect and does not signal a violation.

The active substances of the drug are evenly distributed throughout the body through blood circulation. It is worth noting that the medication leaves the blood only after 24-36 hours.

When performing an intravenous injection, interaction with the body occurs within 50-60 minutes, which is quite fast compared to other drugs.

As noted earlier, drugs are excreted along with excrement, as well as through urine. The final concentration of Ciprofloxacin in the urine exceeds the norm by 50-60 times, at which all harmful bacteria that lead destructive activities in the urethra die. Thus, a kind of prevention of the urinary canal, in particular the bladder and urethra, is performed.

Important. Ciprofloxacin is not intended for intramuscular injections.

Indications for use

Ciprofloxacin is prescribed to children and adults for acute viral or infectious lesions. As a rule, children are prescribed a form of release in the form of tablets, but in emergency situations requiring urgent medical intervention, the child is prescribed injections for intravenous use.

Indications for use for adults are as follows:

• Diseases of the bronchi (bronchitis), lesions of the respiratory tract of varying severity;
• Infectious diseases of the ears, oral cavity (otitis media, pharyngitis, sinusitis, etc.);
• Lesions of the urinary tract and renal system;
• Infectious and viral diseases of the genitourinary system. It is worth noting that Ciprofloxacin is used to prevent and eliminate the risk factor for relapse of male sexually transmitted diseases;
• Lesions of the digestive tract, the presence of intraperitoneal infection;
• Severe infectious manifestations on the skin (ulcers, purulent neoplasms, etc.);
• The drug is used for the treatment and prevention of diseases of the bone structure and joints. Doctors strongly recommend Ciprofloxacin for intravenous use in people over 60 years of age;
• As a preventive measure and speedy recovery of the patient after a surgical procedure;
• Mild form of anthrax (for intensive care in acute form);
• To naturally stimulate the restoration of a person’s immune defense, as a result of its weakening after a long course of other medications.

The medication is prescribed to children over 5 years of age. As a rule, the general list of indications for use also applies to children, but for children and adolescents, Ciprofloxacin is prescribed for the prevention and treatment of cystic fibrosis and the elimination of severe symptoms of anthrax.

In addition, the solution for intravenous injection is used for the prevention and treatment of infectious diseases affecting the eyes. In some cases, patients are prescribed Ciprofloxacin for sepsis, an acute infectious lesion of the body.

Contraindications

The drug has undergone appropriate medical examinations and testing and is absolutely safe for the patient’s health. However, there are a number of absolute and relative contraindications that must be observed in order to eliminate the risk factor of causing serious harm to the patient’s health.

The list of absolute contraindications includes:

• It is strictly forbidden to inject Ciprofloxacin and take Tizanidine at the same time. With such a combination of medications, hypotension occurs, followed by a transition to a chronic form, malaise and weakness appear;
• It is strictly forbidden to take the drug for intravenous administration to pregnant women, as well as during breastfeeding;
• It is not allowed to give injections to children under 5 years of age. If possible, it is not recommended to use the product until adulthood, with the exception of the treatment of anthrax;
• Individual intolerance to the active substances of the drug, allergic reaction to fluoroquinolone and its derivatives;
• It is not recommended to take the medication for people suffering from acute heart disease and who have suffered an ischemic stroke or myocardial infarction.

Important. All contraindications given above are classified as restrictions that cannot be violated. Otherwise, complications may occur or side effects of the drug may appear.

Relative contraindications (which can be circumvented or eliminated) include:

• For atherosclerotic plaques;
• In case of circulatory disorders in the lymph;
• It is necessary to treat diseases of a psycho-emotional nature with caution;
• People over 70 years of age (with the exception of cases when an elderly person is not allergic to medications and does not have acute chronic diseases);
• Any heart rhythm disturbances (arrhythmia, bradycardia).

In case of relative contraindications, it is also not recommended to use it, but in case of urgent need, the attending physician may authorize intravenous injection, provided that this action does not harm the patient’s health.

Instructions for use of Ciprofloxacin

A very important part is the instructions for use. Proper calculation of the dosage will allow you to avoid the negative consequences associated with an overdose, as well as eliminate the risk factor of improper use of the drug. The solution for infusion is used in the following way:

• The medicine is injected into a vein through a dropper. In some cases, an injection is allowed provided that the patient does not have an acute allergic reaction to the active substance of the medication;
• From 50 to 200 ml of solution is administered intravenously, depending on the severity of the disease and the individual characteristics of the patient. Ciprofloxacin is mixed with sodium chloride, Ringer's solution and dextrose solution. Other components are selected by the attending physician on an individual basis. After the medicine is ready for use, it is necessary to use it as directed within half an hour to prevent loss of sterile properties;
• If the drug is administered intravenously through a syringe, then take 10 ml of Ciprofloxacin and 5 ml of a special solution;
• If the patient has allergic reactions to certain solutions used to install the IV, the attending physician selects similar products.

It is worth noting in advance that the independent use of Ciprofloxacin is strictly prohibited. The medicine is injected (or administered) exclusively in a medical facility.

Dosage

Let's consider what is the optimal dosage regimen for the medication recommended for adults:

• In case of infection of the respiratory tract, the drug is administered several times a day, 350-400 ml;
• For lesions of the urinary tract, Ciprofloxacin is used exclusively by drip. Place 150 ml twice a day. In case of exacerbations or severe forms of the disease - several times a day with the same dosage;
• For bronchial lesions - 2 times a day, 400 ml;
• All other diseases noted in the list of “Indications for use” are prescribed with a basic dosage of 200 ml several times a day.

The general dosage does not apply to children from 5 to 14 years of age, as well as elderly people over 70 years of age. The dosage is adjusted by the attending physician and calculated based on the individual characteristics of the patient’s body. For general infectious lesions, it is recommended to reduce the dosage to eliminate the risk factor of drug overdose.

The therapeutic course lasts from 7 to 21 days. After seven days, a comprehensive diagnosis is carried out, which includes laboratory tests and instrumental diagnostics.

If the patient shows improvement, the therapeutic course is suspended and further treatment is carried out with conventional antibiotic drugs. Provided there is no obvious improvement in the patient’s condition, the therapeutic course is extended for another seven days.

Side effects

Ciprofloxacin is recognized as an absolutely safe broad-spectrum antibiotic, but, unfortunately, has a number of side effects. They occur in patients with incompatibility with the drug or violation of established contraindications.

It is important to know what side effects there may be in order to stop injections in a timely manner:

• Disorders in the gastrointestinal tract. Vomiting occurs and appetite may decrease. If these effects are present, injections must be stopped immediately;
• Serious side effects are deviations in the nervous system, expressed by chronic migraines, fainting or fainting, heavy, morally unpleasant dreams, lack of proper sleep (deviation from the norm is considered to be from 2 to 4 hours of sleep per day). In especially severe cases, there is a depressed moral state, stress occurs, possibly sharp aggressive behavior, temporary hallucinations;
• Imbalance in the five basic senses. Different tastes and aromas are felt, vision deteriorates (short-term color blindness is possible), there are extraneous sounds or noises in the ears;
• Particularly dangerous side effects are problems with the cardiovascular system. As soon as these deviations occur, it is necessary to urgently stop Ciprofloxacin injections and postpone the continuation of the therapeutic course to a more appropriate time. Abnormalities in the functioning of the heart include irregularities in rhythm, hypotension (due to abnormalities in the cardiovascular system);
• With a long therapeutic course, due to an excess of active substances in the liver, the enzymes responsible for neutralizing foreign elements in the human body may increase;
• Problems arise with the urinary tract, there are disturbances in the renal structure;
• If the drug is abused, arthritis may worsen and tendon mobility may be impaired.

Important. Children have slightly different side effects. As a rule, this is an extensive allergic reaction to the active substance - ciprofloxacin, manifested in the form of a rash on the body and severe itching of the skin.

Children develop hypersensitivity, and their vision is greatly affected by bright colors. In the worst cases, there is swelling of the larynx, which can lead to respiratory arrest. If these side effects occur, you must promptly contact a medical facility to eliminate the risk factor for serious consequences.

Is it possible to overdose?

Unfortunately, if this drug is abused, an overdose is possible. Since the active substances have a strong therapeutic effect, they have a huge impact on the body, as a result of which there are disturbances in the functioning of the digestive tract, there may be loose stools (in some cases constipation), vomiting, and deviations in the psycho-emotional plan of the patient. What to do in this case?

According to general medical statistics for patients undergoing a therapeutic course with Ciprofloxacin, there were no cases of overdose. Because of this situation, a specific antidote was not found. If an overdose occurs, the first step is to induce vomiting and perform gastric lavage. Next, call an ambulance and provide the victim with the proper amount of fluid. Warm or cool boiled water is required.

A dangerous amount per day is considered to be 800-1000 ml of the drug per adult and 400-500 for a child.

In some situations, when there is a threat to human life, attending physicians administer a dosage close to the dangerous limit, but cases of overdose have not been recorded. To exclude unforeseen circumstances, it is enough to contact your treating specialist and undergo a full consultation.

Content

People's attitudes towards antibiotics vary greatly due to the specific nature of their action, but no one denies that the discovery of the drug was a real breakthrough in medicine. Drugs of this type effectively fight most infectious diseases and purulent complications. The antibiotic Ciprofloxacin has become one of the most popular anti-inflammatory medications of this kind. It is widely used by dentists to treat ENT diseases and infectious inflammation of human internal organs.

What is Ciprofloxacin

The action of the antibiotic Ciprofloxacin is based on its ability to inhibit the enzyme bacterial cells (DNA gyrase) with impaired division, DNA synthesis, and growth of microorganisms. According to the manufacturer, while taking the drug, resistance to other antibiotics that do not belong to the group of gyrase inhibitors does not develop. The drug is effective against infections caused by the following strains:

• staphylococci;
• chlamydia;
• legionella;
• mycoplasmas;
• enterococci;
• mycobacteria.

If the patient has a mixed infection (aerobic and anaerobic), in addition to the antibiotic ciprofloxacin, metronidazole or lincosamides are prescribed. This is due to the moderate sensitivity of such pathogens and some resistance to the drug. The following strains have resistance to the drug, which develops gradually:

• nocardia asteroides;
• ureaplasma urealyticum;
• treponema pallidum;
• streptococcus faecium.

When using the medication, 20 to 40 percent of the substance binds to plasma proteins. The product distributes well in body tissues through biological fluids. Sometimes the concentration of the drug exceeds the plasma concentration. The drug is able to penetrate into the cerebrospinal fluid through the placenta, into breast milk, and a lot of the substance accumulates in the bile. Naturally, up to 40% of the drug is excreted from the body through the kidneys in the first 24 hours, and another part along with bile.

Release forms

The antibiotic ciprofloxacin has a wide range of uses and is therefore available in different forms. Based on the active substance (fluoroquinolone), there is an impressive list of analogues, which have the following names: “Tsiprolet”, “Tsipraz”, “Cipralone”, “Mikroflokos”, “Ciproxin”, “Tsiprobay”, “Ificipro”, “Ciprofan”, “ Ciproflox,” etc. Based on the location of the infection and the degree of severity, the following forms of medication can be prescribed:

• ointment;
• drop for eyes and ears;
• coated tablets;
• ampoules for injections;
• solution for infusion.

Pills

The most popular form of the antibiotic Ciprofloxacin is tablets. This is due to the ease of storage, transportation and reception of the product. Unlike intramuscular or intravenous injections of the drug, the risk of complications is significantly lower. Moreover, the tablets are not inferior in effectiveness to ampoules. It is preferable to use this form of medication for intestinal diseases, which will ensure rapid access of the treatment substance to the site of infection. The coating of the drug is designed to protect gastric juice during absorption.

Eye and ear drops

Another popular form of the antibiotic ciprofloxacin is drops. Used if the inflammatory or purulent process is in the eye or ears. Drops are produced in the form of a solution with 0.3% of the active substance. The drug has a yellow or yellow-green color, with the presence of ciprofloxacin hydrochloride in an amount of 3 g. The drug is prescribed for the following diseases:

• blepharitis;
• corneal ulcer;
• chronic eye diseases;
• bacterial conjunctivitis;
• complications after ophthalmic surgery.

Solution for infusion

For intravenous injections of the drug, an infusion solution is used. Externally, the product looks like a suspension, which is prescribed to children for oral use. The solution has a clear, slightly green or yellow tint. The medication is administered to the patient using a dropper over 30 minutes in the amount of 200 mg and 60 minutes - 400 mg. This method of drug administration is used for almost any type of infectious disease.

Ointment

This dosage form of the antibiotic ciprofloxacin is typically used to treat eye diseases. It is placed in small quantities under the lower eyelid several times a day. For infectious skin lesions, the product is applied once to the affected area, 1 g or as a compression bandage. The duration of use of the medication is determined by the attending physician, based on the severity of the patient’s condition, the extent of the lesion, and the rate of tissue regeneration.

Ampoules for injections

For ease of storage of the drug, it is produced in the form of ampoules with a solution, which is used for drip infusion or injections. The dosage of the medication depends on the disease, for example, 200-400 mg is prescribed for people with damage to bones and joints, urogenital infections, and damage to the ENT organs. If the intra-abdominal area, respiratory tract, and soft skin tissues are affected, the single dose is 400 mg.

Instructions for use

Infectious bacteria can infect almost any human organ. Due to this feature, antibiotic drugs are used in all areas of medicine by doctors of various specializations. Depending on the affected area and the location of the infection, only the dosage form of the drug changes. The modern antibiotic ciprofloxacin in its annotation has a wide group of diseases to combat which it should be prescribed:

1. Infectious diseases of the genitourinary system: salpingoophoritis, prostatitis, urethritis, cystitis, adnexitis, pyelonephritis.
2. Peritonitis.
3. Bone and skin lesions: erysipelas, furunculosis, arthritis, bedsores, osteomyelitis.
4. Infectious diarrhea.
5. Sepsis.
6. Anthrax.
7. ENT organs and respiratory system: tonsillitis, bronchitis, otitis media, pneumonia, sinusitis.
8. Infectious diseases of the organs of vision.

In dentistry

The need to prescribe an antibiotic is determined by the attending physician. An inflammatory, infectious process can be caused by damaged gums after tooth extraction. For ordinary toothache, the drug is prescribed in case of osteomyelitis or periodontitis. Prescribing ciprofloxacin after resection is highly recommended. The product is often used for flux treatment at home. An antibiotic is used for infectious and purulent diseases in the form of tablets of 0.25 and 0.5 g. The dosage of the drug should be determined by a specialist on an individual basis.

For sore throat

The antibiotic ciprofloxacin actively fights most bacteria that can cause sore throat: meningococcus, pneumococcus, Haemophilus influenzae. The drug is effective even against strains resistant to tetracyclines, penicillins, and aminoglycosides. The medication deals with staphylococcus and streptococcus selectively, depending on the type of bacteria. Before prescribing the drug, a culture should be done to ensure the effectiveness of the drug.

For the treatment of prostatitis

The inflammation that occurs with prostatitis can be effectively treated with antibiotics. Often, the doctor prescribes taking ciprofloxacin-promed, which can be called the primary indication for getting rid of the problem. The drug is used in the treatment of acute and chronic prostatitis in men at any age. It is recommended to take the medication as part of complex therapy. The dosage during treatment is as follows:

1. For chronic prostatitis, 125-750 mg is prescribed twice a day for 4-6 weeks.
2. In the acute form of bacterial prostatitis, 500 mg of the drug is prescribed 2 times a day for 2 weeks.

For cystitis

The unique antibacterial properties of ciprofloxacin allow the drug to be used to combat any form of cystitis. This remedy will be the first thing that the doctor prescribes when drawing up a course of therapy. The dosage and method of application of the drug will differ depending on the form of cystitis. In tablet form, according to the rules, the drug is taken on an empty stomach with plenty of liquid. The duration of treatment and dosage depend on the severity of cystitis, as a rule, it is up to 10 days. The antibiotic is taken for another 2 days after the symptoms disappear.

ENT diseases

ENT organs are very susceptible to inflammatory processes. Because of this, the drug ciprofloxacin is effective in treating such diseases. Prescribing the drug is permissible only after appropriate tests have been carried out by a doctor. The medicine acts on the infection, killing it. The dosage for ENT diseases depends on the infection; as a rule, the doctor prescribes ciprofloxacin in the form of tablets of 250 mg or 500 mg.

Contraindications and side effects

1. It should not be taken by a child under 18 years of age, because the drug may affect the process of skeletal formation.
2. Diseases of tendons and ligaments.
3. During pregnancy, during breastfeeding.
4. Do not take if epilepsy attacks occur.
5. If you have a personal intolerance to the components of the drug.
6. Do not take simultaneously with tizandine.

Some patients are interested in whether it is possible to drink alcohol while taking the drug. It should be understood that ciprofloxacin is a potent medication, so combining it with alcohol is prohibited. Interaction of the drug with strong drinks can lead to unpleasant side effects or a decrease in the effect of medicinal components, for example:

1. The drug and alcohol have a double toxic effect on the liver, destroying it.
2. The presence of alcohol in the blood increases the risk of side effects.
3. The medication enhances the effect of alcohol on a person’s condition, and the effectiveness of the drug is significantly reduced.

Doctors strongly recommend giving up alcohol not only during the course of therapy, but also over the next 2 days, so that the medication is completely removed from the body. The daily dosage of the drug is prescribed by the doctor based on tests. There are situations in which overdose symptoms appear or side effects occur.

Overdose

• abdominal pain;
• dizziness;
• diarrhea;
• vomit;
• hand tremors;
• headache;
• hallucinations;
• seizure activity;
• blood in urine;
• liver, kidney failure.

Side effects

• skin rash, itching;
• bloating;
• diarrhea, nausea, vomiting;
• sleep disturbance;
• double vision;
• intestinal dysbiosis;
• weakness;
• hepatitis;
• rapid heartbeat;
• anemia;
• dizziness.