Ciprofloxacin Ecocifol tablets 500 mg instructions for use

Description

Capsule-shaped tablets, with a biconvex surface, film-coated, white or almost white. White in cross section.

Pharmacotherapeutic group

Antimicrobial drugs are quinolone derivatives. Fluoroquinolones.

ATS code

J01MA02

Pharmacological properties

Pharmacokinetics

When taken orally, it is quickly and fairly completely absorbed from the gastrointestinal tract (mainly in the duodenum and jejunum). Eating slows down absorption but does not change maximum concentration (Cmax) or bioavailability. Bioavailability - 50-85%, volume of distribution - 2-3.5 l/kg, binding to plasma proteins - 20-40%. The time to reach the maximum concentration (TCmax) is 60-90 minutes, the maximum concentration linearly depends on the dose taken and is 1.2, 2.4, 4.3 and 5.4 μg/ml at doses of 250, 500, 750 and 1000 mg, respectively. 12 hours after oral administration of 250, 500 and 750 mg, the concentration of the drug in plasma decreases to 0.1, 0.2 and 0.4 mcg/ml, respectively.

Well distributed in body tissues (excluding fat-rich tissue, such as nervous tissue). The concentration in tissues is 2-12 times higher than in plasma. Therapeutic concentrations are achieved in saliva, tonsils, liver, gallbladder, bile, intestines, abdominal and pelvic organs (endometrium, fallopian tubes and ovaries, uterus), seminal fluid, prostate tissue, kidneys and urinary tract, pulmonary tissue, bronchial secretions, bone tissue, muscles, synovial fluid and articular cartilage, peritoneal fluid, skin. It penetrates into the cerebrospinal fluid in a small amount, where its concentration in the absence of inflammation of the meninges is 6-10% of that in the blood serum, and in the case of inflammation - 14-37%. Ciprofloxacin also penetrates well into the ocular fluid, pleura, peritoneum, lymph, and through the placenta. The concentration of ciprofloxacin in blood neutrophils is 2-7 times higher than in blood serum.

Metabolized in the liver (15-30%) with the formation of low-active metabolites (diethylciprofloxacin, sulfociprofloxacin, oxociprofloxacin, formylciprofloxacin).

The half-life is about 4 hours, in case of chronic renal failure - up to 12 hours. It is excreted mainly by the kidneys by tubular filtration and tubular secretion in unchanged form (40-50%) and in the form of metabolites (15%), the rest - through the gastrointestinal tract. intestinal tract. A small amount is excreted in breast milk.

Renal clearance - 3-5 ml/min/kg; total clearance - 8-10 ml/min/kg.

In chronic renal failure (creatinine clearance above 20 ml/min), the percentage of the drug excreted through the kidneys decreases, but accumulation in the body does not occur due to a compensatory increase in drug metabolism and excretion through the gastrointestinal tract.

Pharmacodynamics

A broad-spectrum antimicrobial agent, a quinolone derivative, suppresses bacterial DNA gyrase (topoisomerases II and IV, responsible for the process of supercoiling of chromosomal DNA around nuclear RNA, which is necessary for reading genetic information), disrupts DNA synthesis, growth and division of bacteria; causes pronounced morphological changes (including cell wall and membranes) and rapid death of the bacterial cell.

It has a bactericidal effect on gram-negative microorganisms during the period of rest and division (since it affects not only DNA gyrase, but also causes lysis of the cell wall), on gram-positive microorganisms - only during the period of division.

Low toxicity for the cells of the macroorganism is explained by the absence of DNA gyrase in them. While taking ciprofloxacin, there is no parallel development of resistance to antibacterial drugs that do not belong to the group of gyrase inhibitors, which makes it effective against bacteria that are resistant, for example, to aminoglycosides, penicillins, cephalosporins, tetracyclines.

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., Listeria monocytogenes, Mycobacterium tuberculosis, Mycobacterium kansasii.

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

Active against Bacillus anthracis.

Most staphylococci resistant to methicillin are also resistant to ciprofloxacin. The sensitivity of Streptococcus pneumoniae, Enterococcus faecalis, Mycobacterium avium (located intracellularly) is moderate (high concentrations are required to suppress them).

The following are resistant to the drug: Bacteroides fragilis, Pseudomonas cepacia, Pseudomonas maltophilia, Ureaplasma urealyticum, Clostridium difficile, Nocardia asteroides. Not effective against Treponema pallidum.

Resistance develops extremely slowly, since, on the one hand, after the action of ciprofloxacin there are practically no persistent microorganisms left, and on the other hand, bacterial cells do not have enzymes that inactivate it.

How much does Ciprofloxacin cost?

The average price of Ciprofloxacin in tablets of 500 mg in Ukraine is 22 UAH (package No. 10), the cost of an antibiotic in tablets of 250 mg (package No. 10) is 9-10 UAH. The price of Ciprofloxacin in the form of a solution for infusion therapy is on average 22.5 UAH. The price of an ampoule with eye/ear drops in Kharkov or Kyiv is 17-19 UAH.

In Russian pharmacies the cost of 500 mg tablets is from 33 rubles, 250 mg tablets are from 18 rubles. The solution can be purchased for an average of 35 rubles. The price of Ciprofloxacin eye drops is from 17 rubles.

Online pharmacies in RussiaRussia
Online pharmacies in UkraineUkraine
Online pharmacies in KazakhstanKazakhstan

ZdravCity

Ciprofloxacin tablets p.p.o.
500 mg 10 pcs. Ozon LLC 39 rub. order
Ciprofloxacin tablets p.p.o. 500 mg 10 pcs Rapharma JSC
74 RUR order
Ciprofloxacin solution for inf. 0.2% fl. 100 ml 120 pcs (for hospitals) Limited Liability Partnership “Kelun-Kazpharm” (“
RUR 3,521 order
Ciprofloxacin eye drops 0.3% tube dropper 10 ml RenewalAO Update PFK
41 rub. order
Ciprofloxacin-AKOS eye drops 0.3% 5ml JSC Sintez
24 RUR order

Pharmacy Dialogue

Ciprofloxacin (tab.p.pl/vol. 500 mg No. 10) Ozone LLC
39 RUR order
Ciprofloxacin (tab.p.p./vol. 500 mg No. 10) Sintez (Kurgan) OJSC
49 RUR order
Ciprofloxacin tablets 500 mg No. 10Teva Pharmaceutical
116 RUR order
Ciprofloxacin bufus (drops 0.3% 10ml)Update PFC JSC
40 rub. order
Ciprofloxacin-AKOS (drops 0.3% 5ml) Sintez (Kurgan) OJSC
20 rub. order

Pharmacy24

Ciprofloxacin 0.2% 100 ml solution
30 UAH. order
Ciprofloxacin 0.25 No. 10 tablets PrAT "Technolog", Uman, Cherkasy region, Ukraine
15 UAH order
Ciprofloxacin 200 mg 100 ml No. 1 solution
36 UAH order
Ciprofloxacin 0.2% 100 ml solution
18 UAH order
Ciprofloxacin 500 mg No. 10 tablets PrAT "Technolog", Uman, Cherkasy region, Ukraine
30 UAH order

PaniPharmacy

Ciprofloxacin infusion Ciprofloxacin infusion solution 0.2% 100ml Ukraine, Novofarm-Biosintez LLC
18 UAH order
Ciprofloxacin infusion Ciprofloxacin infusion solution 0.2% 100ml Ukraine, Yuria-Pharm LLC
37 UAH order
Ciprofloxacin tablets Ciprofloxacin film-coated tablets 0.25g No. 10 Ukraine, OZ GNTsLS LLC
13 UAH order
Ciprofloxacin tablets Ciprofloxacin film-coated tablets 0.25g No. 10 Ukraine, Tekhnolog ChAO
17 UAH order
Ciprofloxacin liquid Ciprofloxacin h/o 0.3% 5ml Ukraine, OZ GNTsLS LLC
31 UAH order

Indications for use

Infectious and inflammatory diseases caused by sensitive microorganisms:

lower respiratory tract infections (acute bronchitis and chronic bronchitis in the acute stage, pneumonia, bronchiectasis, infectious complications of cystic fibrosis); ENT infections (acute sinusitis); kidney and urinary tract infections (cystitis, pyelonephritis); complicated intra-abdominal infections (in combination with metronidazole); chronic bacterial prostatitis; uncomplicated gonorrhea; typhoid fever, campylobacteriosis, shigellosis, traveler's diarrhea; infections of the skin and soft tissues (infected ulcers, wounds, burns, abscesses, phlegmon); infections of bones and joints (osteomyelitis, septic arthritis); infections due to immunodeficiency (occurring during treatment with immunosuppressive drugs or in patients with neutropenia); prevention and treatment of pulmonary anthrax;

Children:

prevention and treatment of pulmonary anthrax (infection with Bacillus anthracis) from 6 years of age.

Reviews of Ciprofloxacin

Reviews about Ciprofloxacin tablets can be found very different: some consider the drug to be effective, others have the opposite opinion about it. Moreover, almost every review contains references to side effects that occurred during treatment with the drug.

Eye drops are rated by patients as having no disadvantages. They “really heal and heal quickly.”

According to doctors, the advantages of Ciprofloxacin are:

high bactericidal activity;
a wide spectrum of antimicrobial action, including Gram (-) and Gram (+) aerobes , mycoplasma , chlamydia , mycobacteria ;
the ability to penetrate well into the cells and tissues of the macroorganism, creating concentrations there that exceed serum levels or are close to them;
long T1/2 and the presence of a post-antibiotic effect (thanks to this, it is enough to take the drug only 2 times a day);
proven effectiveness in the treatment of hospital-acquired and community-acquired infections of any (practically) localization (it is used for sore throat , UTI, infections of bones , skin, etc.);
Possibility of use for severe infections (in a hospital setting) as
empirical antibiotic therapy;
good tolerance.

Directions for use and doses

Inside. The tablets should be swallowed whole with a small amount of liquid after meals. When taking the tablet on an empty stomach, the active substance is absorbed faster.

For mild and moderate lower respiratory tract infections - 0.5 g 2 times a day, for severe infections - 0.75 g 2 times. The course of treatment is 7-14 days.
For acute sinusitis - 0.5 g 2 times a day. The course of treatment is 10 days.
For mild to moderate skin and soft tissue infections - 0.5 g 2 times a day, for severe infections - 0.75 g 2 times. The course of treatment is 7-14 days.
For infections of bones and joints - mild and moderate - 0.5 g 2 times a day, for severe infections - 0.75 g 2 times. The course of treatment is up to 4-6 weeks.
For uncomplicated urinary tract infections - 0.25-0.5 g 2 times a day; course of treatment - 7-14 days, for complicated urinary tract infections 0.5 g every 12 hours for 7-14 days.
For chronic prostatitis - 0.5 g 2 times, course of treatment - 28 days.
For uncomplicated gonorrhea - 0.25 g once.
Acute intestinal infections with severe course (salmonellosis, shigellosis, campylobacteriosis, etc.) - 0.5 g 2 times, course of treatment - 5-7 days.
For typhoid fever - 0.5 g 2 times; course of treatment - 10 days.
For complicated intra-abdominal infections - 0.5 g every 12 hours for 7-14 days.
For the prevention and treatment of pulmonary anthrax - 0.5 g 2 times a day for 60 days.
In patients with immunodeficiency, treatment is prescribed depending on the severity of the infection and the type of pathogen. Therapy is carried out throughout the entire period of neutropenia.
Chronic renal failure: when creatinine clearance (CC) is more than 50 ml/min, no dose adjustment is required; with CC 30-50 ml/min - 0.25-0.5 every 12 hours; with CC 5-29 ml/min - 0.25-0.5 g every 18 hours. If the patient is undergoing hemodialysis or peritoneal dialysis - 0.25-0.5 g/day, the drug should be taken after the hemodialysis session.
In pediatrics: for
pulmonary anthrax (prevention and treatment) - 15 mg/kg 2 times a day. The maximum single dose is 0.5 g, the daily dose is 1 g. The total duration of taking ciprofloxacin is 60 days.

For children

In children, Ciprofloxacin can be used as a 2nd and 3rd line drug for the treatment of complicated UTIs and pyelonephritis caused by E. coli (clinical studies were conducted in children 1-17 years old), to reduce the risk of developing or progressing anthrax in case of aerogenic contact with B. anthracis.

It is also prescribed for the treatment of pulmonary complications caused by P. aeruginosa in children with cystic fibrosis (clinical studies were conducted in a group of patients 5-17 years old).

During the studies, treatment was prescribed only to patients with the above diagnoses. Experience with other indications is limited.

The dosage for children is selected depending on the diagnosis.

Side effects

anorexia, nausea, vomiting, abdominal pain, flatulence, diarrhea, cholestatic jaundice (especially in patients with previous liver diseases), hepatitis, hepatonecrosis; dizziness, headache, increased fatigue, anxiety, tremor, insomnia, nightmares, peripheral paralgesia (anomaly in the perception of pain), sweating, increased intracranial pressure, confusion, depression, hallucinations, as well as other manifestations of psychotic reactions (rarely progressing to conditions in which the patient may harm himself).

Rarely:

migraine, fainting, thrombosis of cerebral arteries; disturbances of taste and smell, visual disturbances (diplopia, changes in color vision), tinnitus, hearing loss; tachycardia, heart rhythm disturbances, prolongation of the QT interval, decreased blood pressure; leukopenia, granulocytopenia, anemia, thrombocytopenia, leukocytosis, thrombocytosis, hemolytic anemia; hypoprothrombinemia, increased activity of liver transaminases and alkaline phosphatase, hypercreatininemia, hyperbilirubinemia, hyperglycemia; hematuria, crystalluria (primarily with alkaline urine and low diuresis), glomerulonephritis, dysuria, polyuria, urinary retention, albuminuria, urethral bleeding, decreased nitrogen excretory function of the kidneys, interstitial nephritis; pruritus, urticaria, blistering accompanied by bleeding and the appearance of small nodules that form scabs, drug fever, pinpoint hemorrhages on the skin (petechiae), swelling of the face or larynx, shortness of breath, eosinophilia, vasculitis, erythema nodosum, exudative erythema multiforme, Stevens syndrome -Johnson (malignant exudative erythema), toxic epidermal necrolysis (Lyell's syndrome); arthralgia, arthritis, tendovaginitis, tendon ruptures, myalgia; general weakness, increased photosensitivity, superinfections (candidiasis, pseudomembranous colitis), “flushes” of blood to the face.

Contraindications

hypersensitivity to ciprofloxacin, other fluoroquinolones, auxiliary components of the drug; simultaneous use with tizanidine (risk of a pronounced decrease in blood pressure, drowsiness); childhood and adolescence up to 18 years of age (until the process of skeletal formation is completed), prevention and treatment of pulmonary anthrax - children up to 6 years of age; pregnancy and lactation; tendon damage due to previous treatment with fluoroquinolones; tendon lesions, including tenosynovitis, tendon rupture, muscle lesions (rhabdomyolysis); pseudomembranous colitis.

Ciprofloxacin during pregnancy

The safety and effectiveness of the drug during pregnancy have not been established.

Animal experiments showed that the drug caused arthropathy . The use of doses exceeding 6 times the average daily dose for humans in pregnant female rats and mice did not provoke any abnormalities in fetal development.

In rabbits receiving 30 and 100 mg/kg Ciprofloxacin orally, gastrointestinal dysfunction was observed and, as a consequence, weight loss and an increase in miscarriage cases. No teratogenic effect was detected.

When the drug was administered into a vein at a dose of 20 mg/kg, there was also no teratogenic effect or toxic effect on the embryo and the mother’s body.

The use of topical Ciprofloxacin during pregnancy is possible if indicated and provided that the benefits to the mother's body outweigh the risks to the fetus.

According to the FDA classification, the drug belongs to category C.

Ciprofloxacin is excreted into milk, so nursing women must decide (taking into account the importance of the drug for the mother) to stop breastfeeding or refuse treatment with Ciprofloxacin.

Local forms are used with caution during lactation, because It is unknown whether the medicine passes into breast milk in this case.

Drug interactions

Due to a decrease in the activity of microsomal oxidation processes in hepatocytes, it increases the concentration and lengthens the half-life of theophylline (and other xanthines, such as caffeine), oral hypoglycemic drugs, and indirect anticoagulants.

When combined with other antimicrobial drugs (beta-lactam antibiotics, 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, there is an increase in serum creatinine; in such patients it is necessary to monitor this indicator 2 times a week.

When taken simultaneously, it enhances the effect of indirect anticoagulants and helps reduce the prothrombin index.

Oral administration together with iron-containing drugs, sucralfate and antacid drugs containing magnesium, calcium and aluminum salts leads to decreased absorption of ciprofloxacin, so it should be prescribed 1-2 hours before or 4 hours after taking the above drugs.

Non-steroidal anti-inflammatory drugs (excluding acetylsalicylic acid) increase the risk of developing seizures.

Fluoroquinolones form chelate compounds with magnesium and aluminum ions contained in the dosage form of didanosine, which sharply reduces the absorption of fluoroquinolone, so ciprofloxacin is taken 2 hours before taking didanosine or 2 hours after taking this drug.

Metoclopramide accelerates absorption, which leads to a decrease in the time to reach its maximum concentration in the blood plasma.

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

Increases the maximum concentration by 7 times (from 4 to 21 times) and the area under the concentration-time curve by 10 times (from 6 to 24 times) of tizanidine, which increases the risk of a pronounced decrease in blood pressure and drowsiness.

Ciprofloxacin analogs

Level 4 ATC code matches:
Norfloxacin

Synonyms: Ciprofloxacin-Teva , Basijen , Ciprofloxacin-FPO , Ificipro , Ciprofloxacin-Promed , Procipro , Ciprofloxacin-AKOS , Tsiprinol , Ciprodox , Cifran , Ecotsifol , Tseprova .

Analogues of Ciprofloxacin with a similar mechanism of action: Abaktal , Gatispan , Zanotsin , Ivacin , Levotek , Levofloxacin , Moximac , Nolitsin , Ofloxacin , Oflocid , Pefloxacin , Eleflox .

special instructions

Ciprofloxacin is not the drug of choice for suspected or established pneumonia caused by Streptococcus pneumoniae.

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.

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 should be prescribed ciprofloxacin only for “vital” indications.

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.

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

During treatment with ciprofloxacin, UV radiation (including contact with direct sunlight) should be avoided.

Features of the effect of the drug on the ability to drive a vehicle or other potentially dangerous mechanisms.

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

Overdose

There are no specific symptoms for an overdose of Ciprofloxacin. The patient is advised to lavage the stomach, take emetics, create an acidic urine reaction, and administer a large volume of fluid. All activities should be carried out against the background of maintaining the function of vital systems and organs.

Peritoneal dialysis and hemodialysis help remove 10% of the dose taken.

The drug does not have a specific antidote.

Release form and packaging

10 tablets with a dosage of 250 mg or 5 tablets with a dosage of 500 mg are placed in a blister pack made of polyvinyl chloride film and printed varnished aluminum foil (PVC/Al) or soft aluminum foil and hard aluminum foil (Al/Al).

1 or 2 blister packs with a dosage of 250 mg or 2 blister packs with a dosage of 500 mg, together with instructions for medical use in the state and Russian languages, are placed in a cardboard pack.

Compound

Ciprofloxacin ear and eye drops contain ciprofloxacin hydrochloride at a concentration of 3 mg/ml (in terms of pure substance), Trilon B, benzalkonium chloride, sodium chloride, purified water.
The active substance is also contained in the eye ointment at a concentration of 3 mg/ml.

Ciprofloxacin tablets: 250, 500 or 750 mg of ciprofloxacin, MCC, potato starch, corn starch, hypromellose, croscarmellose sodium, talc, magnesium stearate, colloidal anhydrous silicon dioxide, macrogol 6000, additive E171 (titanium dioxide), polysorbate 80.

The solution for infusion contains the active substance at a concentration of 2 mg/ml. Excipients: sodium chloride, disodium edetate, lactic acid, diluted hydrochloric acid , water for injection.