Ciprofloxacin dropper instructions for use. Ciprofloxacin, solution for infusion Ciprofloxacin for intravenous administration instruction

in a blister pack 10 pcs.; in a pack of cardboard 1 pack.

in bottles or dark glass bottles of 100 ml; in a pack of cardboard 1 pc.

in polymer dropper bottles of 5 ml; in a pack of cardboard 1 bottle.

Description of the dosage form

Tablets. Round biconvex, white or white with a grayish tint.

Eye drops. Transparent solution of slightly yellowish or yellowish-greenish color.

Solution for infusion. Clear, slightly yellowish or slightly greenish liquid.

pharmachologic effect

It inhibits the enzyme DNA-gyrase of bacteria, as a result of which DNA replication and the synthesis of cellular proteins of bacteria are disrupted. It acts both on multiplying microorganisms and on those in the resting phase.

Pharmacodynamics

Active against gram-negative aerobic bacteria: enterobacteria (Escherichia coli, Salmonella spp., Shigella spp., Citrobacter spp., Klebsiella spp., Enterobacter spp., Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Hafnia alvei, Edwardsiella tarda, Providencia spp. , Morganella morganii, Vibrio spp., Yersinia spp.), other Gram-negative bacteria (Haemophilus spp., Pseudomonas aeruginosa, Moraxella catarrhalis, Aeromonas spp., Pasteurella multocida, Plesiomonas shigelloides, Campylobacter jejuni, Neisseria spp.); some intracellular pathogens (Legionella pneumophila, Brucella spp., Chlamydia trachomatis, Listeria monocytogenes, Mycobacterium tuberculosis, Mycobacterium kansasii, Mycobacterium avium intracellulare); Gram-positive aerobic bacteria: Staphylococcus spp. (Staphylococcus aureus, Staphylococcus haemolyticus, Staphylococcus saprophyticus, Staphylococcus hominis), to a lesser extent - Streptococcus spp. (Streptococcus pyogenes, Streptococcus agalactiae). Most methicillin-resistant staphylococci are resistant to ciprofloxacin.

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

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

Pharmacokinetics

After oral administration, it is rapidly absorbed from the gastrointestinal tract. Bioavailability is 50-85% Cmax of the drug in the blood serum of healthy volunteers after oral administration (before meals) at a dose of 250, 500, 750 and 1000 mg is achieved after 1-1.5 hours and is 0.76, 1.6, 2 .5, 3.4 µg/ml, respectively; when using eye drops - less than 5 ng / ml, the average concentration is below 2.5 ng / ml. After an intravenous infusion at a dose of 200 or 400 mg, Cmax is 2.1 μg / ml or 4.6 μg / ml, respectively, and is achieved after 60 minutes. The volume of distribution is 2-3 l / kg.

Distributed in tissues and body fluids. High (higher than serum) concentrations are observed in bile, lungs, kidneys, liver, gallbladder, uterus, seminal fluid, prostate tissue, tonsils, endometrium, fallopian tubes and ovaries. Penetrates well into bones eye fluid, bronchial secretions, saliva, skin, muscles, pleura, peritoneum, lymph. The accumulated concentration in blood neutrophils is 2–7 times higher than in serum. It penetrates into the cerebrospinal fluid in a small amount (6-10% of the concentration in the blood serum). The volume of distribution is 2–3.5 l / kg. Degree of protein binding 30%.

Metabolized in the liver (15-30%) with the formation of inactive metabolites (diethylciprofloxacin, sulfocyprofloxacin, oxocyprofloxacin, formylciprofloxacin). T 1/2 (with unchanged renal function) is 3–5 hours. In case of impaired renal function, it increases to 12 hours. 50-70%) and in the form of metabolites (when taken orally - 15%, when administered intravenously - 10%); the rest - through the gastrointestinal tract. A small amount is excreted in breast milk. After intravenous administration, the concentration in the urine during the first 2 hours after administration is almost 100 times higher than in serum, which significantly exceeds the MIC for most infectious agents urinary tract.

Patients with severe renal insufficiency (Cl creatinine below 20 ml / min / 1.73 m 2) should be given half the daily dose.

Ciprofloxacin (for infusion): Indications

Tablets, solution for infusion. infections respiratory tract, ENT organs, kidneys and urinary tract, genital organs, digestive system(including mouth, teeth), gallbladder and biliary tract, skin, mucous membranes and soft tissues, musculoskeletal system, caused by sensitive microorganisms. Sepsis, peritonitis, prevention and treatment of infections in patients with reduced immunity (with immunosuppressant therapy); prevention of infections surgical interventions.

Eye drops. Infectious and inflammatory diseases of the eye: acute and subacute conjunctivitis, blepharitis, blepharoconjunctivitis, keratitis, keratoconjunctivitis, bacterial corneal ulcer, chronic dacryocystitis, meibomitis, infectious eye lesions after injury or contact foreign body. Pre- and postoperative prophylaxis infectious complications in ophthalmic surgery.

Ciprofloxacin (for infusion): Contraindications

For all dosage forms: hypersensitivity to the components of the drug (including other fluoroquinolones).

Tablets: pregnancy, period breastfeeding, children and adolescents up to 18 years of age.

Eye drops: viral keratitis, childhood up to 1 g. With caution - atherosclerosis of cerebral vessels, cerebrovascular accident, convulsive syndrome.

Use during pregnancy and lactation

Tablets. Contraindicated in pregnancy. At the time of treatment should stop breastfeeding.

Eye drops: It is possible to use during pregnancy and during breastfeeding, if the expected effect of therapy outweighs the potential risk to the fetus or child.

Dosage and administration

Tablets. inside on an empty stomach, drinking plenty of fluids. With uncomplicated infections of the kidneys and urinary tract, lower respiratory organs - 0.25 g 2 times a day (with complicated infections - 0.5 g 2 times a day). For the treatment of gonorrhea - 250-500 mg once. With gynecological diseases, enteritis and colitis of severe course and high temperature, prostatitis, osteomyelitis - 0.5 g 2 times a day (for the treatment of banal diarrhea - 250 mg 2 times a day). Duration of treatment - an average of 7-10 days.

In case of impaired renal function, correction of the dosing regimen is necessary: ​​with Cl creatinine more than 50 ml / min - the usual dosing regimen, 30-50 ml / min - 250-500 mg 1 time in 12 hours, 5-29 ml / min - 250-500 mg 1 time in 18 hours, patients on hemo- or peritoneal dialysis - after dialysis 250-500 mg 1 time in 24 hours.

Eye drops. For mild and moderately severe infections - 1-2 drops into the conjunctival sac affected eye (or both eyes) every 4 hours. In severe infection, 2 drops every hour. After improvement of the condition, the dose and frequency of instillations are reduced.

Solution for infusion. I/V, drip. The duration of the infusion is 30 minutes at a dose of 0.2 g and 60 minutes at a dose of 0.4 g. Ready-to-use infusion solutions can be combined with 0.9% sodium chloride solution, Ringer's solution and Ringer's lactate solution, 5% and 10% glucose (dextrose) solution, 10% fructose solution, as well as a solution containing 5% glucose (dextrose) solution with 0.225% or 0.45% sodium chloride solution.

With uncomplicated urinary tract infections, infections of the lower respiratory tract, a single dose is 0.2 g; with complicated infections of the upper urinary tract, with severe infections (including pneumonia, osteomyelitis), a single dose of 0.4 g. Streptococcus pneumoniae, the dose can be increased to 0.4 g with a frequency of administration up to 3 times a day. The duration of treatment for osteomyelitis can reach up to 2 months.

In chronic carriage of salmonella - 0.2 g 2 times a day; course of treatment - up to 4 weeks. If necessary, the dosage can be increased to 0.5 g 3 times a day.

In acute gonorrhea once - 0.1 g.

For the prevention of infections during surgical interventions - 0.2-0.4 g 0.5-1 hour before surgery; when the duration of the operation is more than 4 hours, it is administered repeatedly at the same dose.

The average duration of treatment: 1 day - with acute uncomplicated gonorrhea and cystitis; up to 7 days - with infections of the kidneys, urinary tract and abdominal cavity, during the entire period of the neutropenic phase - in patients with weakened defensive forces body, but not more than 2 months - with osteomyelitis and 7-14 days - with all other infections. With streptococcal infections due to the risk of late complications, as well as chlamydial infections, treatment should continue for at least 10 days. In patients with immunodeficiency, treatment is carried out during the entire period of neutropenia.

Treatment should be carried out for at least 3 more days after the temperature normalizes or disappears. clinical symptoms.

With a glomerular filtration rate (Cl creatinine 31-60 ml / min / 1.73 m 2 or serum creatinine concentration 1.4-1.9 mg / 100 ml), the maximum daily dose is 0.8 g.

With a glomerular filtration rate below 30 ml / min / 1.73 m 2 or a serum creatinine concentration above 2 mg / 100 ml, the maximum daily dose is 0.4 g.

For elderly patients, the dose is reduced by 30%.

With peritonitis, it is permissible to use intraperitoneal administration of infusion solutions at a dose of 50 mg 4 times a day per 1 liter of dialysate.

After IV administration, treatment can be continued orally.

Ciprofloxacin (for infusion): Side effects

Tablets.

From the digestive tract: nausea, vomiting, diarrhea, abdominal pain, flatulence, anorexia, cholestatic jaundice (especially in patients with previous liver disease), hepatitis, hepatonecrosis.

From the side nervous system and sense organs: dizziness, headache, fatigue, anxiety, tremor, insomnia, nightmares, peripheral paralgesia (pain perception anomaly), increased intracranial pressure, confusion, depression, hallucinations, as well as other manifestations of psychotic reactions (occasionally progressing to conditions in which the patient can harm himself), migraine, fainting, cerebral artery thrombosis; violation of taste, smell, vision (diplopia, change in color perception), tinnitus, hearing loss.

From the side of cardio-vascular system and blood (hematopoiesis, hemostasis): tachycardia, cardiac arrhythmias, lowering blood pressure, flushing of the face; leukopenia, granulocytopenia, anemia, thrombocytopenia, leukocytosis, thrombocytosis, hemolytic anemia.

From the side of laboratory indicators: hypoprothrombinemia, increased activity of "liver" transaminases and alkaline phosphatase, hypercreatininemia, hyperbilirubinemia, hyperglycemia.

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

Allergic reactions: pruritus, urticaria, blistering with bleeding, small nodules that form scabs, drug fever, pinpoint hemorrhages on the skin (petechiae), swelling of the face or throat, shortness of breath, eosinophilia, increased photosensitivity, vasculitis, erythema nodosum, exudative erythema multiforme, Stevens-Johnson syndrome (malignant exudative erythema), toxic epidermal necrolysis (Lyell's syndrome).

Others: candidiasis (associated with chemotherapeutic action), sweating.

Eye drops.

Allergic reactions, itching, burning, mild soreness and hyperemia of the conjunctiva, nausea, vomiting, rarely - swelling of the eyelids, photophobia, lacrimation, sensation of a foreign body in the eye, an unpleasant aftertaste in the mouth immediately after instillation, decreased visual acuity, the appearance of a white crystalline precipitate in patients with corneal ulcer, keratitis, keratopathy, spotting or infiltration of the cornea.

Overdose

Treatment: gastric lavage, carrying out the usual measures emergency care to ensure adequate fluid intake. Hemo- or peritoneal dialysis displays an insignificant part of the drug. The specific antidote is unknown.

Interaction

Tablets: when used simultaneously with didanosine, the absorption of ciprofloxacin is reduced due to the formation of complexes of ciprofloxacin with the aluminum and magnesium salts contained in didanosine. Simultaneous administration of antacids, preparations containing aluminum, zinc, iron, magnesium ions causes a decrease in the absorption of ciprofloxacin (the interval between doses is at least 4 hours). Metoclopramide accelerates absorption, which leads to a decrease in the time to reach C max . Co-administration of uricosuric agents slows down excretion (up to 50%) and increases the plasma concentration of ciprofloxacin. In combination with other antimicrobials (beta-lactams, aminoglycosides, clindamycin, metronidazole), synergism is usually observed. It can be successfully used in combination with azlocillin and ceftazidime for infections caused by Pseudomonas spp., with mezlocillin, azlocillin, and other beta-lactam antibiotics for streptococcal infections, with isoxazolpenicillins and vancomycin for staphylococcal infections, with metronidazole and clindamycin for anaerobic infections.

Due to a decrease in the activity of microsomal oxidation processes in hepatocytes, it increases the concentration and lengthens the T 1/2 of theophylline (and other xanthines, such as caffeine), oral hypoglycemic drugs, indirect coagulants, and helps to reduce the prothrombin index. Enhances the nephrotoxic effect of cyclosporine. NSAIDs (excluding acetylsalicylic acid) increase the risk of seizures. It enhances the nephrotoxic effect of cyclosporine, there is an increase in serum creatinine, in such patients it is necessary to control this indicator 2 times a week.

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

Solution for infusion: pharmaceutically incompatible with all infusion solutions and preparations that are physicochemically unstable in an acidic environment (pH of ciprofloxacin infusion solution is 3.9-4.5). The solution for intravenous administration should not be mixed with solutions having a pH greater than 7.

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

During the treatment period, it is necessary to ensure the intake of a sufficient amount of fluid while maintaining normal diuresis.

During the treatment period, contact with direct sunlight should be avoided.

Eye drops. apply only locally. Do not inject subconjunctivally or directly into the anterior chamber of the eye.

If, with prolonged use, conjunctival hyperemia continues or increases, the use of the drug should be discontinued. During the treatment period, it is not recommended to wear soft contact lenses. Before using hard lenses - they should be removed and put back on no earlier than 15-20 minutes after instillation of the drug.

All dosage forms. Patients taking the drug should be careful when driving a car and engaging in other potentially hazardous activities that require heightened attention and speed of psychomotor reactions.

Manufacturer

Joint Stock Kurgan Society medical preparations and products "Synthesis", Russia.

Ciprofloxacin: instructions for use and reviews

Latin name: Ciprofloxacinum

ATX code: S03AA07

Active substance: Ciprofloxacin (Ciprofloxacinum)

Producer: Farmak PJSC, Tekhnolog PJSC, Kievmedpreparat OJSC (Ukraine), Ozon LLC, Veropharm OJSC, Sintez OJSC (Russia), C.O. Rompharm Company S.R.L. (Romania)

Description and photo update: 12.08.2019

INN: Ciprofloxacin

Manufacturer: Claris Otsuka Private Limited

Anatomical-therapeutic-chemical classification: Ciprofloxacin

Registration number in the Republic of Kazakhstan: No. RK-LS-5 No. 020205

Registration period: 04.11.2013 - 04.11.2018

ED (Included in the List of drugs in the framework of the guaranteed volume of medical care, subject to purchase from a single distributor)

Instruction

Tradename

International non-proprietary name

Ciprofloxacin

Dosage form

Solution for infusion 0.2% 100 ml

Composition

100 ml of the drug contains

active substance - ciprofloxacin 200 mg,

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

Description

Clear, colorless or slightly yellowish solution without visible particles.

Pharmacotherapeutic group

Antibacterial drugs for systemic use. Antimicrobials are quinolone derivatives. Fluoroquinolones. Ciprofloxacin.

ATX code J01MA02

Pharmacological properties

Pharmacokinetics

Suction

60 minutes after the start of the infusion of the drug at a dose of 200-400 mg, the concentration of ciprofloxacin in the blood plasma is 2.1 μg / ml or 4.6 μg / ml. Bioavailability varies from 50% to 85%.

Distribution

Ciprofloxacin is well distributed in tissues and body fluids, with high concentrations found in bile, lungs, kidneys, liver, gallbladder, uterus, seminal fluid, prostate tissue, tonsils, endometrium, fallopian tubes and ovaries. The concentration of ciprofloxacin in these tissues is higher than in the blood serum. Ciprofloxacin also penetrates well into the liquid media of the eye, bones, bronchial secretions, saliva, skin, muscles, pleura, peritoneum and lymph. Penetrates through the placental barrier. Penetrates into the cerebrospinal fluid in a small amount, the concentration of ciprofloxacin in non-inflamed meninges is 6-10% of that in the blood serum, with inflamed - 14-37%. The concentration of ciprofloxacin in neutrophils is 2-7 times higher than in blood serum. The volume of distribution is 2-3.5 l/kg. Plasma protein binding - 30%.

Metabolism and excretion

Biotransformed in the liver (15-30%) with the formation of inactive metabolites (diethylciprofloxacin, sulfocyprofloxacin, oxyciprofloxacin, formylciprofloxacin). It is excreted mainly in the urine (50-70%); 15-30% - with feces. The half-life is 3-5 hours. In chronic renal failure, the half-life increases to 12 hours.

Pharmacodynamics

A broad-spectrum antimicrobial drug from the group of fluoroquinolones. Acts bactericidal. It 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 multiplying microorganisms and on microorganisms that are in the resting phase.

A drug active against gram-negative bacteria: Escherichia coli, Salmonella spp., Shigella spp., Citrobacter spp., Klebsiella spp., Enterobacter spp., Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Hafnia alvei, Edwardsiella tarda, Providencia spp., Morganella morganii, Vibrio spp., Yersinia spp., Haemophilus spp., Pseudomonas aeruginosa, Moraxella catarrhalis, Aeromonas spp., Pasteurella multocida, Plesiomonas shigelloides, Campylobacter jejuni, Neisseria spp.; intracellular microorganisms: Legionella pneumophila, Brucella spp., Chlamydia trachomatis, Listeria monocytogenes, Mycobacterium tuberculosis, Mycobacterium kansasii, Mycobacterium avium-intracellulare; Gram-positive bacteria: Streptococcus spp. (including Streptococcus pyogenes, Streptococcus agalactiae), Staphylococcus spp. (including Staphylococcus aureus, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus saprophyticus). Most methicillin-resistant staphylococci are also resistant to ciprofloxacin.

to the drug moderately sensitive Streptococcus pneumoniae, Enterococcus faecalis; atpersistent Corynebacterium spp., Bacteroides fragilis, Pseudomonas cepacia, Pseudomonas maltophila, Ureaplasma urealyticum, Clostridium difficile, Nocardia asteroids, Treponema pallidum.

When taking Ciprox, there is no development of parallel resistance to other antibiotics that do not belong to the group of gyrase inhibitors, which makes it highly effective against bacteria that are resistant to aminoglycosides, penicillins, cephalosporins, tetracyclines.

Indications for use

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

acute bronchitis, exacerbation chronic bronchitis, cystic fibrosis, pneumonia

kidney and urinary tract infections (cystitis, pyelonephritis);

gonorrhea, postpartum infections, genital infections (prostatitis, adnexitis)

otitis media, sinusitis

peritonitis, cholecystitis, cholangitis

skin and soft tissue infections caused by Gram-negative bacteria

septic arthritis, osteomyelitis

• prevention and treatment of infections in patients with reduced immunity (against the background of immunosuppressant therapy)

Dosage and administration

Adults at uncomplicated infections urinary tract, infections of the lower respiratory tract a single dose of 400 mg, with complicated urinary tract infections , at severe infections- a single dose of 400 mg; frequency of administration 2 times a day. If necessary, in / in the treatment of particularly severe, life-threatening or recurrent infections caused by Pseudomonas, staphylococcus or Streptococcus pneumoniae, the dose may be increased to 400 mg with a frequency of administration up to 3 times a day.

Prostatitis from 400 mg 2 times a day to 400 mg 3 times a day. The course of treatment is 2-4 weeks.

For treatment of complications of cystic fibrosis of the lungs caused by Pseudomonas aeruginosa, at children aged 5 to 17 years administered intravenously 10 mg/kg body weight 3 times a day ( maximum dose 1200 mg). The duration of treatment is 10-14 days.

Dosage regimen for impaired renal or hepatic function

Adults with creatinine clearance from 30 to 60 ml / min / 1.73 m2 or its plasma concentration from 1.4 to 1.9 mg / 100 ml, the maximum dose of ciprofloxacin intravenously should be 800 mg / day. (200-400 mg every 12 hours). With creatinine clearance below 30 ml / min / 1.73 m2 or its plasma concentration of 2 mg / 100 ml or more, the maximum dose of ciprofloxacin intravenously should be 400 mg / day (200-400 mg every 24 hours).

Patients on hemodialysis, dosing regimen 200-400 mg every 24 hours; on days of hemodialysis, ciprofloxacin is taken after this procedure. Patients on peritoneal dialysis: 200-400 mg every 24 hours. Ciprofloxacin infusion solution is added to the dialysate (intraperitoneally): 50 mg of ciprofloxacin per liter of dialysate is administered 4 times a day every 6 hours.

In case of impaired liver function, dose adjustment is not required.

Dosing regimen in children with renal and liver failure has not been studied. For elderly patients, the dose is reduced by 30%.

Duration of application

The duration of therapy depends on the severity of the disease and its clinical and bacteriological control. It is important to continue treatment for at least another 3 days after the disappearance of fever or other clinical symptoms of the disease.

Average duration of treatment: up to 7 days - with infections kidneys, urinary tract, abdomen; during the entire period of neutropenia in patients with weakened immunity; maximum 2 months osteomyelitis; 7-14 days - at other infections.

At infections caused by streptococci, due to the risk of late complications, treatment should be continued for at least 10 days.

At infections caused by chlamydia, therapy should also be carried out for at least 10 days.

How to use the solution for infusion

The drug is administered intravenously drip for 30 minutes (at a dose of 200 mg) and 60 minutes (at a dose of 400 mg).

The infusion solution should be administered 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

Ciprofloxacin infusion solution is compatible with 0.9% sodium chloride solution, Ringer's solution, Ringer's lactate solution, 5% and 10% dextrose (glucose) solution.

Side effects

Often(≥1/100 to<1/10)

Nausea, diarrhea

Local reactions at the injection site

Infrequently(≥1/1000 to<1/100)

Anorexia

Psychomotor hyperactivity/agitation

Dizziness, headache, insomnia

Taste disturbance, vomiting, abdominal pain, dyspepsia, flatulence

Decreased appetite

Increased activity of "liver" transaminases and alkaline phosphatase, hyperbilirubinemia, increased amylase

Skin itching, rash, urticaria

Pain in limbs, back, chest

Arthralgia

Eosinophilia

kidney failure

Asthenia, fever

Seldom(≥1/10000 to<1/1000)

Superinfections (candidiasis, pseudomembranous colitis, very rarely fatal)

Leukopenia, anemia, neutropenia, leukocytosis, thrombocytopenia, thrombocytosis

allergic reactions

Angioedema, incl. swelling of the face or throat

Hyperglycemia, hypercreatininemia, hypoprothrombinemia

Impaired coordination, increased fatigue, anxiety, "nightmare" dreams

Depression (rarely progressing to suicidal thoughts/behaviors in which the patient may harm themselves, commit suicide), hallucinations

Anxiety, tremor, convulsions, including status epilepticus, peripheral paralgesia (pain perception anomaly), dizziness

Paresthesia, dysesthesia, peripheral neuropathy

Visual impairment (diplopia)

Tinnitus, hearing loss

Tachycardia

Vasodilation, hypotension, ventricular arrhythmia, vasculitis, syncope

Shortness of breath (including asthma)

Cholestatic jaundice (especially in patients with previous liver disease), hepatitis, liver failure

photosensitization

Arthritis, myalgia, increased muscle tone, muscle spasm

Renal failure, hematuria, crystalluria (primarily with alkaline urine and low diuresis), tubulointerstitial nephritis

Swelling, sweating (hyperhidrosis)

Very pcaustically(<1/10000)

- hemolytic anemia, agranulocytosis, pancytopenia (life-threatening), oppression of hematopoiesis (life-threatening)

- anaphylactic reactions, anaphylactic shock (life-threatening), serum sickness

Psychotic reactions (rarely progressing to suicidal thoughts/behaviors in which the patient may harm themselves, commit suicide)

Migraine, impaired coordination, confusion, gait disturbance, taste and smell disorders, increased intracranial pressure

Visual impairment (diplopia, change in color perception)

pancreatitis

Vasculitis

Hepatonecrosis (in very rare cases progressing to life-threatening liver failure)

Dysuria, polyuria, urinary retention, albuminuria, urethral bleeding, albuminuria, decreased nitrogen excretion by the kidneys, interstitial nephritis

Pinpoint hemorrhages on the skin (petechiae), erythema nodosum, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome)

Blistering

Acute generalized pustulosis

- flushes of blood to the face

Tendon ruptures, predominantly Achilles tendon, tendovaginitis,

muscle weakness, exacerbation of symptoms of myasthenia gravis, arthropathy

With an unknown frequency

Peripheral neuropathy

Cardiac arrhythmias, torsades de pointes (mainly in patients with a risk factor for QT interval prolongation), QT prolongation on ECG

Acute generalized exanthematous pustulosis

Elevated INR (international normalized ratio (in patients treated with vitamin K antagonists))

Dyspnea (including asthmatic condition)

Contraindications

hypersensitivity to ciprofloxacin or other drugs from the group of fluoroquinolones, auxiliary components of the drug

pseudomembranous colitis

glucose-6-phosphate dehydrogenase deficiency

pregnancy, lactation

children and adolescents up to 18 years of age

co-administration with tizanidine

FROM caution the drug is prescribed for atherosclerosis of cerebral vessels, cerebrovascular accidents, mental illness, epilepsy, convulsive syndrome, severe renal or hepatic insufficiency, elderly patients.

Drug Interactions

Particular caution should be exercised when taking ciprox (and other fluoroquinolines) in patients who are simultaneously taking drugs that can prolong the QT interval (for example, class IA and III antiarrhythmic drugs, tricyclic antidepressants, macrolides, antipsychotics)

Probenecid affects the excretion of ciprofloxacin in the urine. Co-administration of probenecid and ciprofloxacin increases the serum concentration of ciprofloxacin.

Tizanidine should not be taken concomitantly with ciprofloxacin. In a clinical study in healthy subjects, tizanidine serum concentrations were found to increase (maximum increase in concentration: 7-fold, range: 4-fold to 21-fold; increase in mean urinary concentration: 10-fold, range : from 6-fold to 24-fold) when taken simultaneously with ciprofloxacin. An increase in the concentration of tizanidine in serum is associated with an increase in the hypotensive and sedative effect.

Taking ciprofloxacin adversely affects the transport of methotrexate in the kidneys, which can lead to an increased level of plasma methotrexate concentration and the risk of methotrexate toxic reactions. The simultaneous use of these drugs is not recommended.

Simultaneous administration of ciprofloxacin and theophylline can cause an undesirable increase in the concentration of theophylline in serum. This can lead to a number of side effects, and in rare cases, death. Serum levels of theophylline should be checked regularly when these drugs are taken concomitantly and the theophylline dose should be reduced if necessary.

With the simultaneous administration of ciprofloxacin and caffeine or pentoxifylline in serum, the concentration of these xanthine derivatives increases.

Simultaneous administration of ciprofloxacin and phenytoin can lead to an increase or decrease in serum levels of phenytoin, and therefore regular monitoring of the concentration of the drug is recommended.

With the simultaneous administration of ciprofloxacin and medications containing cyclosporine, a temporary increase in serum creatinine concentration is observed. Thus, it is necessary to carry out measures to control the content of serum creatinine twice a week.

Simultaneous administration of ciprofloxacin and a vitamin K antagonist may enhance its anticoagulant effect. The degree of risk varies depending on latent infections, the age and general condition of the patient, and therefore the effect of ciprofloxacin on increasing the International Normalized Ratio (INR) is difficult to assess. During and for some time after the simultaneous administration of ciprofloxacin and a vitamin K antagonist (for example, warfarin, acenocoumarol, phenprocoumon or fluindione), INR should be checked as often as possible.

In some cases, with the simultaneous use of ciprofloxacin and medicines containing glibenclamide, the effect of glibenclamide on the body may increase, which can lead to hypoglycemia.

As a result of clinical studies, it has been proven that the simultaneous use of duloxetine with strong inhibitors of the CYP450 1A2 isoenzyme can lead to an increase in the maximum concentration and average concentration of duloxetine in the urine. Although there are no clinical data on the interaction of duloxetine with ciprofloxacin, similar effects may occur when these drugs are taken simultaneously (see section 4.4).

As a result of clinical studies, it has been proven that the simultaneous use of ropinirole and ciprofloxacin (a moderate inhibitor of the CYP450 1A2 isoenzyme) can lead to an increase in the maximum concentration and average concentration of ropinorole in urine by 60% and 84%, respectively. During and for some time after the simultaneous administration of ciprofloxacin and ropinirole, it is recommended to monitor the occurrence of side effects and reduce doses accordingly.

As a result of studies conducted on healthy volunteers, it was proved that while taking ciprofloxacin (a moderate inhibitor of the CYP450 1A2 isoenzyme) and medications containing lidocaine, the clearance of intravenously administered lidocaine is reduced by 22%. Despite the fact that lidocaine is well tolerated, the possible interaction of this drug with ciprofloxacin can cause side effects.

After 7 days of simultaneous administration of 250 mg of ciprofloxacin and clozapine, the concentrations of clozapine and N-desmethylclozapine increased by 29% and 31%, respectively. During and for some time after the simultaneous administration of ciprofloxacin and clozapine, it is recommended to conduct clinical monitoring of patients and reduce the dose of clozapine accordingly.

The maximum and mean urinary concentrations of sildenafil approximately doubled in healthy volunteers after they simultaneously took 50 mg of sildenafil and 500 mg of ciprofloxacin orally. Thus, special care should be taken when prescribing ciprofloxacin concomitantly with sildenafil, taking into account all the risks and benefits.

special instructions

Severe infections and mixed infections caused by gram-positive and anaerobic pathogens

Ciprofloxacin monotherapy is not suitable for the treatment of severe infections and infections caused by gram-positive or anaerobic pathogens. In such infections, Ciprox should be administered with other appropriate antibacterial agents.

Streptococcal infections (includingStreptococcus pneumoniae)

Genital tract infections

Orchiepididymitis and pelvic inflammatory disease can be caused by fluoroquinolone-resistant gonococci. In orchiepididymitis and pelvic inflammatory disease, the use of Ciprox should only be considered in combination with another appropriate antibacterial agent (eg, cephalosporins), as resistance gonococci to ciprofloxacin cannot be ruled out. If clinical improvement is not achieved after 3 days of treatment, therapy should be reconsidered.

Urinary tract infections

Intra-abdominal infections

There are limited data on the effectiveness of ciprofloxacin in the treatment of postoperative intra-abdominal infections.

Traveler's diarrhea

When choosing a drug, information on resistance to ciprofloxacin of the relevant pathogens in the countries visited should be taken into account.

Bone and joint infections

Ciprox should be used in combination with other antimicrobials, depending on the results of microbiological data.

Complicated urinary tract infections and pyelonephritis

Treatment with Ciprox for urinary tract infections should only be considered when other treatments cannot be used and should be based on microbiological findings.

Other severe infections

Treatment of other severe infections is carried out in accordance with official recommendations, or after a careful assessment of the benefit / risk when other methods of treatment cannot be used, or after inconsistency with conventional therapy, and when microbiological data can justify the use of Ciprox. The use of ciprofloxacin for specific severe infections other than those mentioned above has not been studied in clinical trials and clinical experience is limited.

Hypersensitivity

Hypersensitivity and allergic reactions, including anaphylactic shock and anaphylactoid reactions, may occur after a single dose of ciprofloxacin and may be life-threatening. If such a reaction occurs, Ciprox should be discontinued.

Musculoskeletal system

Ciprox should not be used in patients with a history of quinolone-related tendon disease. Ciprox may be prescribed after microbiological studies and benefit/risk evaluation, in the treatment of certain serious infections, in the event of failure of standard therapy or bacterial resistance. Tendonitis and tendon rupture (especially Achilles tendon), sometimes bilateral, may occur with Ciprox, even within the first 48 hours of treatment. Inflammation and tendon ruptures can occur even after several months of stopping Ciprox therapy. The risk of tendinopathy may be increased in elderly patients or in patients receiving concomitant corticosteroid treatment. If tendonitis (painful swelling, inflammation) is suspected, treatment with Ciprox should be discontinued. The affected limb should be kept at rest. Ciprofloxacin should be used with caution in patients with myasthenia gravis.

photosensitization

Patients taking Ciprox should avoid direct exposure to sunlight during treatment.

central nervous system

Ciprox, like other quinolones, may cause seizures or lower the seizure threshold. Cases of status epilepticus have been reported. Ciprox should be used with caution in patients with CNS disorders who may be predisposed to seizures. If seizures occur, Ciprox should be discontinued. Mental reactions may occur even after the first intake of Ciprox. In rare cases, depression or psychosis may progress to suicidal thoughts/behaviors, in which the patient may self-harm or commit suicide. In such cases, Ciprox should be canceled.

Cases of polyneuropathy (based on neurological symptoms such as pain, burning, sensory disturbances or muscle weakness, alone or in combination) have been reported in patients treated with ciprofloxacin. Ciprox should be discontinued in patients with symptoms of neuropathy, including pain, burning, tingling, numbness and/or weakness, in order to prevent the development of irreversible conditions.

Heart disease

Caution should be exercised when using fluoroquinolones, including Ciprox, in patients with known risk factors for QT prolongation, such as, for example:

Congenital long QT syndrome

Concomitant use of drugs that prolong the QT interval (class IA and III antiarrhythmic drugs, tricyclic antidepressants, macrolides, antipsychotics)

With electrolyte imbalance (hypokalemia, hypomagnesemia)

Heart disease (heart failure, myocardial infarction, bradycardia)

Use Ciprox with caution in elderly patients and women who may be more sensitive to drugs that prolong the QT interval.

Gastrointestinal tract

If severe and prolonged diarrhea occurs during or after treatment with Ciprox, the diagnosis of pseudomembranous colitis should be excluded, which requires immediate discontinuation of Ciprox and appropriate treatment. Antiperistaltic drugs are contraindicated in this situation.

Diseases of the kidneys and urinary system

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

Impaired kidney function

Since Ciprox is mainly excreted unchanged through the kidneys, dose adjustment is necessary in patients with impaired renal function in order to avoid an increase in adverse reactions due to the accumulation of ciprofloxacin.

Hepatobiliary system

Liver necrosis and life-threatening liver failure have been reported. In case of any signs and symptoms of liver disease (anorexia, jaundice, dark urine, itching), treatment should be discontinued.

Glucose-6-phosphate dehydrogenase deficiency

Hemolytic reactions have been reported in patients with glucose-6-phosphate dehydrogenase deficiency. Do not prescribe Ciprox to such patients if the potential benefit does not outweigh the possible risk.

Sustainability

During or after a course of treatment with Ciprox, bacteria that show resistance to ciprofloxacin may cause superinfections. With long-term treatment, nosocomial infections and / or infections caused by strains become resistant Staphylococcus And Pseudomonas.

Cytochrome P450

Ciprofloxacin inhibits CYP1A2 and may lead to elevated concentrations of substances metabolized by this enzyme (eg, theophylline, clozapine, olanzapine, ropinirole, tizanidine, duloxetine).

Interaction with laboratory tests

In laboratory studies, the activity of ciprofloxacin against Mycobacterium tuberculosis can give false-negative bacteriological results in samples from patients currently taking Ciprox.

Reactions at the injection site

Injection site reactions occur with intravenous administration if the infusion time is 30 minutes or less. They may appear as local skin reactions that disappear quickly after the infusion is completed. Subsequent intravenous injections are not contraindicated unless reactions recur or worsen.

NaCl load

Patients for whom sodium intake has medical contraindications (patients with congestive heart failure, renal failure, nephrotic syndrome, etc.) should take into account the sodium chloride content of Ciprox.

Pregnancy and lactation

As a precaution, it is preferable to avoid the use of ciprofloxacin during pregnancy.

Lactation

Ciprofloxacin is isolated in breast milk. Due to the potential risk of joint damage, ciprofloxacin should not be used during breastfeeding.

Features of the influence of the drug on the ability to drive a vehicle and potentially dangerous mechanisms

When using the drug, one should refrain from engaging in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Overdose

Symptoms: dizziness, tremor, headache, fatigue, convulsions, hallucinations, feeling of disorientation, abdominal discomfort, impaired renal and hepatic function, as well as crystalluria and hematuria

Treatment: specific antidote is unknown. It is necessary to wash the stomach, monitor the patient's condition, if necessary, carry out symptomatic therapy. It is necessary to ensure sufficient fluid intake in the body. With the help of hemodialysis or peritoneal dialysis, a small amount of ciprofloxacin (less than 10%) can be removed.

Name: Ciprofloxacin (Ciprofloxacin) solution for infusion

Release form, composition and pack

Solution for infusion 0.2% transparent, colorless.

1 ml 1 vial ciprofloxacin (as lactate) 2 mg 200 mg.

Excipients: sodium edetate, sodium chloride, water for injections.

pharmachologic effect

A broad-spectrum antimicrobial product 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 multiplying microorganisms and on those in the resting phase.

Gram-negative aerobic bacteria are sensitive to Ciprofloxacin: enterobacteria (Escherichia coli, Salmonella spp., Shigella spp., Citrobacter spp., Klebsiella spp., Enterobacter spp., Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Hafnia alvei, Edwardsiella tarda, Providencia spp. , Morganella morganii, Vibrio spp., Yersinia spp.), other Gram-negative bacteria (Haemophilus spp., Pseudomonas aeruginosa, Moraxella catarrhalis, Aeromonas spp., Pasteurella multocida, Plesiomonas shigelloides, Campylobacter jejuni, Neisseria spp.); some intracellular pathogens: Legionella pneumophila, Brucella spp., 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 methicillin-resistant staphylococci are also resistant to ciprofloxacin.

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

Corynebacterium spp., Bacteroides fragilis, Pseudomonas cepacia, Pseudomonas maltophilia, Ureaplasma urealyticum, Clostridium difficile, Nocardia asteroides are resistant to the product.

The action of the product against Treponema pallidum has not been studied enough.

Pharmacokinetics

With the on / in the introduction of 200 mg or 400 mg of ciprofloxacin, 60 minutes after the start of the infusion, the concentration of the active substance in the serum is 2.1 μg / ml or 4.6 μg / ml.

Vd in the equilibrium state is 2-3 l / kg. There is a high concentration of ciprofloxacin in bile, several times higher than its concentration in plasma.

After intravenous administration, the concentration in the urine during the first 2 hours is almost 100 times greater than in serum.

In patients with unchanged renal function, T1 / 2 is usually 3-5 hours. In case of impaired renal function, T1 / 2 increases.

The main route of excretion of ciprofloxacin from the body is the kidneys. 50-70% is excreted in the urine. From 15 to 30% is excreted with feces.

Indications for use of the product

Infectious and inflammatory diseases caused by microorganisms sensitive to Ciprofloxacin:

respiratory tract;

ear, throat and nose;

kidneys and urinary tract;

genital organs;

digestive system (including mouth, teeth, jaws);

gallbladder and biliary tract;

skin, mucous membranes and soft tissues;

musculoskeletal system.

Ciprofloxacin is indicated for the treatment of sepsis and peritonitis, as well as for the prevention and treatment of infections in patients with reduced immunity (with immunosuppressant therapy).

Dosing regimen

For intravenous administration, a single dose is 200-400 mg, the frequency of administration is 2; duration of treatment - 1-2 weeks, if necessary, and more. It can be administered by intravenous bolus, but drip administration over 30 minutes is more preferable.

Side effect

From the digestive system: nausea, vomiting, diarrhea, abdominal pain, increased activity of hepatic transaminases, alkaline phosphatase, LDH, bilirubin, pseudomembranous colitis.

From the side of the central nervous system: headache, dizziness, fatigue, sleep disorders, nightmares, hallucinations, fainting, visual disturbances.

From the urinary system: crystalluria, glomerulonephritis, dysuria, polyuria, albuminuria, hematuria, transient increase in serum creatinine.

From the hematopoietic system: eosinophilia, leukopenia, neutropenia, changes in platelet count.

From the side of the cardiovascular system: tachycardia, cardiac arrhythmias, arterial hypotension.

Allergic reactions: pruritus, urticaria, angioedema, Stevens-Johnson syndrome, arthralgia.

Adverse reactions associated with chemotherapeutic action: candidiasis.

On the part of laboratory parameters: an increase in the concentration of urea, creatinine.

Other: arthralgia; not often - photosensitivity.

Contraindications to the use of the product

pregnancy;

lactation period;

childhood and adolescence;

high susceptibility to ciprofloxacin or other products from the group of fluoroquinolones.

Application for violations of kidney function

Patients with severe renal insufficiency (creatinine clearance below 20 ml / min / 1.73 m2) should be given half the daily dose of the product.

special instructions

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

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

If pain occurs in the tendons or when the first signs of tendovaginitis appear, treatment should be discontinued due to the fact that isolated cases of inflammation and even tendon rupture during treatment with fluoroquinolones have been described.

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

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

Influence on the ability to drive vehicles and control mechanisms

Patients taking Ciprofloxacin should be careful when driving a car and engaging in other potentially hazardous activities that require increased attention and speed of psychomotor reactions (especially while drinking alcohol).

Overdose

The specific antidote is unknown. It is necessary to carefully monitor the condition of the patient, do a gastric lavage, carry out the usual emergency measures, ensure sufficient fluid intake. With the help of hemo- or peritoneal dialysis, only a non-cordial (less than 10%) amount of the product can be removed.

drug interaction

With the simultaneous use of ciprofloxacin with didanosine, the absorption of ciprofloxacin is reduced due to the formation of complexes of ciprofloxacin with the aluminum and magnesium salts contained in didanosine.

When used simultaneously with warfarin, the risk of bleeding increases.

Simultaneous administration of ciprofloxacin and theophylline can lead to an increase in the concentration of theophylline in the blood plasma, due to competitive inhibition in the binding sites of cytochrome P450, which leads to an increase in T1 / 2 of theophylline and an increase in the risk of developing toxic effects associated with theophylline.

Simultaneous intake of antacids, as well as products containing aluminum, zinc, iron or magnesium ions, can cause a decrease in the absorption of ciprofloxacin, so the interval between the appointment of these products should be at least 4 hours.

With the simultaneous use of ciprofloxacin and anticoagulants, the bleeding time is prolonged.

With the simultaneous use of ciprofoxacin and cyclosporine, the nephrotoxic effect in the aftermath is enhanced.

Pharmaceutical interaction

Ciprofloxacin solution is incompatible with solutions or medicinal products with a pH of 3-4 that are physically or chemically unstable.

Terms of dispensing from pharmacies

The drug is dispensed by prescription.

Storage conditions and periods

List B. In a dry, dark place, at room temperature. Keep out of the reach of children. The shelf life is 3 years.

in a blister pack 10 pcs.; in a pack of cardboard 1 pack.

in bottles or dark glass bottles of 100 ml; in a pack of cardboard 1 pc.

in polymer dropper bottles of 5 ml; in a pack of cardboard 1 bottle.

Description of the dosage form

Tablets. Round biconvex, white or white with a grayish tint.

Eye drops. Transparent solution of slightly yellowish or yellowish-greenish color.

Solution for infusion. Clear, slightly yellowish or slightly greenish liquid.

Characteristic

Fluoroquinolone.

pharmachologic effect

It inhibits the enzyme DNA-gyrase of bacteria, as a result of which DNA replication and the synthesis of cellular proteins of bacteria are disrupted. It acts both on multiplying microorganisms and on those in the resting phase.

Pharmacodynamics

Active against gram-negative aerobic bacteria: enterobacteria (Escherichia coli, Salmonella spp., Shigella spp., Citrobacter spp., Klebsiella spp., Enterobacter spp., Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Hafnia alvei, Edwardsiella tarda, Providencia spp. , Morganella morganii, Vibrio spp., Yersinia spp.), other Gram-negative bacteria (Haemophilus spp., Pseudomonas aeruginosa, Moraxella catarrhalis, Aeromonas spp., Pasteurella multocida, Plesiomonas shigelloides, Campylobacter jejuni, Neisseria spp.); some intracellular pathogens (Legionella pneumophila, Brucella spp., Chlamydia trachomatis, Listeria monocytogenes, Mycobacterium tuberculosis, Mycobacterium kansasii, Mycobacterium avium intracellulare); Gram-positive aerobic bacteria: Staphylococcus spp. (Staphylococcus aureus, Staphylococcus haemolyticus, Staphylococcus saprophyticus, Staphylococcus hominis), to a lesser extent - Streptococcus spp. (Streptococcus pyogenes, Streptococcus agalactiae). Most methicillin-resistant staphylococci are resistant to ciprofloxacin.

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

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

Pharmacokinetics

After oral administration, it is rapidly absorbed from the gastrointestinal tract. Bioavailability is 50-85% Cmax of the drug in the blood serum of healthy volunteers after oral administration (before meals) at a dose of 250, 500, 750 and 1000 mg is achieved after 1-1.5 hours and is 0.76, 1.6, 2 .5, 3.4 µg/ml, respectively; when using eye drops - less than 5 ng / ml, the average concentration is below 2.5 ng / ml. After an intravenous infusion at a dose of 200 or 400 mg, Cmax is 2.1 μg / ml or 4.6 μg / ml, respectively, and is achieved after 60 minutes. The volume of distribution is 2-3 l / kg.

Distributed in tissues and body fluids. High (higher than serum) concentrations are observed in bile, lungs, kidneys, liver, gallbladder, uterus, seminal fluid, prostate tissue, tonsils, endometrium, fallopian tubes and ovaries. It penetrates well into bones, intraocular fluid, bronchial secretion, saliva, skin, muscles, pleura, peritoneum, lymph. The accumulated concentration in blood neutrophils is 2-7 times higher than in serum. It penetrates into the cerebrospinal fluid in a small amount (6-10% of the concentration in the blood serum). The volume of distribution is 2-3.5 l / kg. Degree of protein binding 30%.

Metabolized in the liver (15-30%) with the formation of inactive metabolites (diethylciprofloxacin, sulfocyprofloxacin, oxocyprofloxacin, formylciprofloxacin). T 1/2 (with unchanged renal function) is 3-5 hours. In case of impaired renal function, it increases to 12 hours. 50-70%) and in the form of metabolites (when taken orally - 15%, with intravenous administration - 10%); the rest is through the gastrointestinal tract. A small amount is excreted in breast milk. After intravenous administration, the concentration in the urine during the first 2 hours after administration is almost 100 times higher than in serum, which significantly exceeds the MIC for most pathogens of urinary tract infections.

Patients with severe renal insufficiency (Cl creatinine below 20 ml / min / 1.73 m 2) should be given half the daily dose.

Ciprofloxacin-AKOS indications

Tablets, solution for infusion. Infections of the respiratory tract, ENT organs, kidneys and urinary tract, genital organs, digestive system (including mouth, teeth), gallbladder and biliary tract, skin, mucous membranes and soft tissues, musculoskeletal system caused by sensitive microorganisms. Sepsis, peritonitis, prevention and treatment of infections in patients with reduced immunity (with immunosuppressant therapy); prevention of infections during surgical interventions.

Eye drops. Infectious and inflammatory eye diseases: acute and subacute conjunctivitis, blepharitis, blepharoconjunctivitis, keratitis, keratoconjunctivitis, bacterial corneal ulcer, chronic dacryocystitis, meibomitis, eye infections after trauma or foreign body ingestion. Pre- and postoperative prevention of infectious complications in ophthalmic surgery.

Contraindications

For all dosage forms: hypersensitivity to the components of the drug (including other fluoroquinolones).

Tablets: pregnancy, breastfeeding, children and adolescents up to 18 years of age.

Eye drops: viral keratitis, children under 1 year of age. With caution - cerebral atherosclerosis, cerebrovascular accident, convulsive syndrome.

Use during pregnancy and lactation

Tablets. Contraindicated in pregnancy. At the time of treatment should stop breastfeeding.

Eye drops: It is possible to use during pregnancy and during breastfeeding, if the expected effect of therapy outweighs the potential risk to the fetus or child.

Side effects

Tablets.

From the digestive tract: nausea, vomiting, diarrhea, abdominal pain, flatulence, anorexia, cholestatic jaundice (especially in patients with previous liver disease), hepatitis, hepatonecrosis.

From the nervous system and sensory organs: dizziness, headache, fatigue, anxiety, tremor, insomnia, nightmares, peripheral paralgesia (an anomaly in the perception of pain), increased intracranial pressure, confusion, depression, hallucinations, and other manifestations of psychotic reactions (occasionally progressing to conditions in which which the patient can harm himself), migraine, syncope, cerebral artery thrombosis; violation of taste, smell, vision (diplopia, change in color perception), tinnitus, hearing loss.

From the side of the cardiovascular system and blood (hematopoiesis, hemostasis): tachycardia, heart rhythm disturbance, decrease in blood pressure, flushing of the face; leukopenia, granulocytopenia, anemia, thrombocytopenia, leukocytosis, thrombocytosis, hemolytic anemia.

From the side of laboratory indicators: hypoprothrombinemia, increased activity of "liver" transaminases and alkaline phosphatase, hypercreatininemia, hyperbilirubinemia, hyperglycemia.

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

Allergic reactions: pruritus, urticaria, blistering with bleeding, small nodules that form scabs, drug fever, pinpoint hemorrhages on the skin (petechiae), swelling of the face or throat, shortness of breath, eosinophilia, increased photosensitivity, vasculitis, erythema nodosum, exudative erythema multiforme, Stevens-Johnson syndrome (malignant exudative erythema), toxic epidermal necrolysis (Lyell's syndrome).

Others: candidiasis (associated with chemotherapeutic action), sweating.

Eye drops.

Allergic reactions, itching, burning, mild soreness and hyperemia of the conjunctiva, nausea, vomiting, rarely - swelling of the eyelids, photophobia, lacrimation, sensation of a foreign body in the eye, an unpleasant aftertaste in the mouth immediately after instillation, decreased visual acuity, the appearance of a white crystalline precipitate in patients with corneal ulcer, keratitis, keratopathy, spotting or infiltration of the cornea.

Interaction

Tablets: when used simultaneously with didanosine, the absorption of ciprofloxacin is reduced due to the formation of complexes of ciprofloxacin with the aluminum and magnesium salts contained in didanosine. Simultaneous administration of antacids, preparations containing aluminum, zinc, iron, magnesium ions causes a decrease in the absorption of ciprofloxacin (the interval between doses is at least 4 hours). Metoclopramide accelerates absorption, which leads to a decrease in the time to reach C max . Co-administration of uricosuric agents slows down excretion (up to 50%) and increases the plasma concentration of ciprofloxacin. In combination with other antimicrobials (beta-lactams, aminoglycosides, clindamycin, metronidazole), synergism is usually observed. It can be successfully used in combination with azlocillin and ceftazidime for infections caused by Pseudomonas spp., with mezlocillin, azlocillin, and other beta-lactam antibiotics for streptococcal infections, with isoxazolpenicillins and vancomycin for staphylococcal infections, with metronidazole and clindamycin for anaerobic infections.

Due to a decrease in the activity of microsomal oxidation processes in hepatocytes, it increases the concentration and lengthens the T 1/2 of theophylline (and other xanthines, such as caffeine), oral hypoglycemic drugs, indirect coagulants, and helps to reduce the prothrombin index. Enhances the nephrotoxic effect of cyclosporine. NSAIDs (excluding acetylsalicylic acid) increase the risk of seizures. It enhances the nephrotoxic effect of cyclosporine, there is an increase in serum creatinine, in such patients it is necessary to control this indicator 2 times a week.

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

Solution for infusion: pharmaceutically incompatible with all infusion solutions and preparations that are physicochemically unstable in an acidic environment (pH of ciprofloxacin infusion solution - 3.9-4.5). The solution for intravenous administration should not be mixed with solutions having a pH greater than 7.

Dosage and administration

Tablets. inside on an empty stomach, drinking plenty of fluids. With uncomplicated infections of the kidneys and urinary tract, lower respiratory organs - 0.25 g 2 times a day (with complicated infections - 0.5 g 2 times a day). For the treatment of gonorrhea - 250-500 mg once. For gynecological diseases, severe enteritis and colitis and high fever, prostatitis, osteomyelitis - 0.5 g 2 times a day (for the treatment of banal diarrhea - 250 mg 2 times a day). The duration of treatment is an average of 7-10 days.

In case of impaired renal function, correction of the dosing regimen is necessary: ​​with Cl creatinine more than 50 ml / min - the usual dosing regimen, 30-50 ml / min - 250-500 mg 1 time in 12 hours, 5-29 ml / min - 250-500 mg 1 time in 18 hours, patients on hemo- or peritoneal dialysis - after dialysis 250-500 mg 1 time in 24 hours.

Eye drops. For mild and moderately severe infections - 1-2 drops into the conjunctival sac affected eye (or both eyes) every 4 hours. For severe infection, 2 drops every hour. After improvement of the condition, the dose and frequency of instillations are reduced.

Solution for infusion. I/V, drip. The duration of the infusion is 30 minutes at a dose of 0.2 g and 60 minutes at a dose of 0.4 g. Ready-to-use infusion solutions can be combined with 0.9% sodium chloride solution, Ringer's solution and Ringer's lactate solution, 5% and 10% glucose (dextrose) solution, 10% fructose solution, as well as a solution containing 5% glucose (dextrose) solution with 0.225% or 0.45% sodium chloride solution.

For uncomplicated urinary tract infections, infections of the lower respiratory tract, a single dose is 0.2 g; with complicated infections of the upper urinary tract, with severe infections (including pneumonia, osteomyelitis), a single dose is 0.4 g. Streptococcus pneumoniae, the dose can be increased to 0.4 g with a frequency of administration up to 3 times a day. The duration of treatment for osteomyelitis can reach up to 2 months.

In chronic carriage of salmonella - 0.2 g 2 times a day; course of treatment - up to 4 weeks. If necessary, the dosage can be increased to 0.5 g 3 times a day.

In acute gonorrhea once - 0.1 g.

For the prevention of infections during surgical interventions - 0.2-0.4 g 0.5-1 hour before surgery; when the duration of the operation is more than 4 hours, it is administered repeatedly at the same dose.

Average duration of treatment: 1 day for acute uncomplicated gonorrhea and cystitis; up to 7 days - with infections of the kidneys, urinary tract and abdominal cavity, during the entire period of the neutropenic phase - in patients with weakened body defenses, but not more than 2 months - with osteomyelitis and 7-14 days - with all other infections. With streptococcal infections due to the risk of late complications, as well as chlamydial infections, treatment should continue for at least 10 days. In patients with immunodeficiency, treatment is carried out during the entire period of neutropenia.

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

With a glomerular filtration rate (Cl creatinine 31-60 ml / min / 1.73 m 2 or serum creatinine concentration 1.4-1.9 mg / 100 ml), the maximum daily dose is 0.8 g.

With a glomerular filtration rate below 30 ml / min / 1.73 m 2 or a serum creatinine concentration above 2 mg / 100 ml, the maximum daily dose is 0.4 g.

For elderly patients, the dose is reduced by 30%.

With peritonitis, it is permissible to use intraperitoneal administration of infusion solutions at a dose of 50 mg 4 times a day per 1 liter of dialysate.

After IV administration, treatment can be continued orally.

Overdose

Treatment: lavage of the stomach, carrying out the usual measures of emergency care, ensuring sufficient fluid intake. Hemo- or peritoneal dialysis displays an insignificant part of the drug. The specific antidote is unknown.

Precautionary measures

Tablets. If pain occurs in the tendons or when the first signs of tendovaginitis appear, treatment should be discontinued due to the high risk of inflammation and rupture of the tendon.

Patients with epilepsy, a history of seizures, vascular diseases and organic brain lesions should be prescribed the drug only for health reasons.

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

During the treatment period, it is necessary to ensure the intake of a sufficient amount of fluid while maintaining normal diuresis.

During the treatment period, contact with direct sunlight should be avoided.

Eye drops. apply only locally. Do not inject subconjunctivally or directly into the anterior chamber of the eye.

If, with prolonged use, conjunctival hyperemia continues or increases, the use of the drug should be discontinued. It is not recommended to wear soft contact lenses during the treatment period. Before using hard lenses - they should be removed and put back on no earlier than 15-20 minutes after instillation of the drug.

All dosage forms. Patients taking the drug should be careful when driving a car and engaging in other potentially hazardous activities that require increased attention and speed of psychomotor reactions.

special instructions

When instilling the drug, do not touch the tip of the pipette to the eye. The bottle must be closed after each use.

Manufacturer

Joint Stock Kurgan Society of Medical Preparations and Products "Synthesis", Russia.

Storage conditions of the drug Ciprofloxacin-AKOS

Keep out of the reach of children.

Shelf life of the drug Ciprofloxacin-AKOS

250 mg film-coated tablets - 2 years.

eye drops 0.3% - 2 years. After opening - 1 month.

solution for infusion 2 mg / ml - 2 years.

Do not use after the expiry date stated on the packaging.

Synonyms of nosological groups