Universal reference book for medicines
Name of the preparation: ECOCYPHOL ® (ECOCIPHOL)

Active substance: ciprofloxacin

Type: Antibacterial drug of the group of fluoroquinolones

Manufacturer: АВВА РУС (Russia)
Composition, form of production and packaging
Tablets covered with a film coat of
white or almost white color, capsular-shaped, biconvex;
on a cross-section of white color.
1 tab.

ciprofloxacin (in the form of hydrochloride monohydrate) 250 mg

Excipients: lactulose (300 mg), povidone low molecular weight, croscarmellose sodium, microcrystalline cellulose, magnesium stearate, corn starch.

Composition of the film membrane: hypromellose, macrogol 4000, talc, titanium dioxide.

10 pieces.
- packings of cellular contour (1) - packs cardboard.
10 pieces.
- packings cellular planimetric (2) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2010.

PHARMACHOLOGIC EFFECT

Pharmacological group: antimicrobial agent, fluoroquinolone.

It has bactericidal action on most gram-negative and gram-positive microorganisms, etc.

The drug inhibits the DNA enzyme enzyme of bacteria, as a result of which DNA replication and the synthesis of bacterial cell proteins are disrupted.
It acts both on multiplying microorganisms, and on those in rest phase. Gram-negative aerobic bacteria are sensitive to ciprofloxacin: enterobacteria (E.coli, Salmonella spp., Shigella spp., Citrobacter spp., Klebsiella spp., Edwardsiella tarda, Enterobacter, spp., Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Hafnia alvei, Providencia spp., Morganella morganii, Vibrio spp., Yersinia spp.), other gram-negative bacteria (Haemophilus spp., Pseudomonas aeruginosa, Plesiomonas shigelloides, Campilobacter jeiuni, 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.haemoliticus, S. hominis, S.saprophyticus), Streptococcus spp. (St. pyogenes, St.agalactiae).
The majority of staphylococci, resistant to methicillin, are resistant to ciprofloxacin.
The sensitivity of bacteria Streptococcus pneumoniae, Enterococcus faecalis is moderate.
To the drug, Resistance Corinebacterium spp., Bacteroides fragilis, Pseudomonas maltophilia, Ureaplasma urealyticum, Clostridium dificile, Nocardia asteroids.
The effect of the drug against Treponema pallidum has not been adequately studied.
Lactulose, which is part of Ecocylol as a bifidogenic factor, is a synthetic disaccharide, the molecule of which consists of the remains of galactose and fructose.Lactulose in the stomach and upper intestine is not absorbed and not hydrolyzed.
The release of Ecotifol lactulose tablets as a substrate is fermented by the normal microflora of the large intestine, stimulating the growth of bifidobacteria and lactobacilli. As a result of hydrolysis of lactulose in the large intestine, organic acids are formed - lactic, acetic and formic, suppressing the growth of pathogenic microorganisms and thereby reducing the production of nitrogen-containing toxic substances.
Thus, lactulose in the composition of Ecocylol
reduces the damaging effect of the antibiotic on the normal intestinal microflora and the risks of side effects associated with dysbiosis.
PHARMACOKINETICS

Pharmacokinetics.
When taken orally, ciprofloxacin is rapidly absorbed from the digestive tract. Bioavailability of the drug is 50-85%. The maximum concentration of the drug in the serum of healthy volunteers with oral intake (before meals) of 250, 500, 750 and 1000 mg of the drug is achieved after 1-1.5 hours and is 0.76; 1.6; 2.5 and 3.4 μg / ml, respectively. Orally taken ciprofloxacin is distributed in tissues and body fluids.
High concentrations of the drug are observed in bile, lung, kidney, liver, gall bladder, uterus, seminal fluid, prostate tissue, tonsils, endometrium, fallopian tubes and ovaries.
The concentration of the drug in these tissues is higher than in the serum. Ciprofloxacin also penetrates well into the bones, eye fluid, bronchial secretion, saliva, skin, muscles, pleura, peritoneum, lymph.
The accumulating concentration of ciprofloxacin in blood neutrophils is 2-7 times higher than in serum.

The volume of distribution in the body is 2-3.5 l / kg.
In the cerebrospinal fluid the drug penetrates in a small amount, where its concentration is 6-10% of that of serum.
The degree of binding of ciprofloxacin to plasma proteins is 30%.
In patients with unchanged kidney function, the elimination half-life is usually 3-5 hours. If the kidney function is impaired, the elimination half-life increases. The main way to remove ciprofloxacin from the body is the kidney. With urine, 50-70% is output. From 15 to 30% is excreted. Patients with severe renal insufficiency (creatinine clearance below 20 ml / min / 1.73 m2) should be prescribed half the daily dose of the drug.
Lactulose, which is part of Ecocylol, does not affect the main pharmacokinetic parameters characterizing the bioavailability of ciprofloxacin.

INDICATIONS

On the prescription of a doctor in adults for the treatment of diseases caused by pathogens that are sensitive to ciprofloxacin:

- infection of the genitourinary system (pyelonephritis, prostatitis, endometritis, gonorrhea, etc.);

- respiratory tract infections;

- infections of the ear, throat and nose;

- infections of the intestines and bile ducts;

- infections of the skin and soft tissues, osteoarticular apparatus (including osteomyelitis);

- prevention of infections in the postoperative period;

- sepsis, peritonitis, endocarditis, meningitis and in other cases as prescribed by the doctor.

DOSING MODE

Ciprofloxacin tablets are taken orally.
Duration of treatment is 7-14 days.
With infections of the urinary tract appoint to 0.125 - 0.25 g 2 times / day.
The daily dose can be increased to 1.0 g (0.5 g 2 times / day). In acute gonorrhea in a dose prescribed by a doctor.
With systemic infections, the drug is prescribed 0.5 g 2 times / day;
in the treatment of sepsis, peritonitis, lung abscess, osteomyelitis, and the like. appoint 1.5 g per day (0.75 g 2 times / day or 0.5 g 3 times / day). The maximum daily dose is 2.0 g.
In acute intestinal infections (dysentery, salmonella), the drug is used for 0.5 g 2 times / day or 0.25 g 4 times / day.
Duration of treatment 3 - 5 days.
With a mixed aerobic-anaerobic infection, the drug is combined with anaerobic agents (metronidazole, clindamycin, dioxidine).

When violations of the function of the excretory system of the kidneys, breaks between doses increase or decrease the dose (0.5 g once / day or 0.25 g 2 times / day).

SIDE EFFECT

Allergic reactions : a rash, skin itch, eosinophily.
In this case, stop taking the drug and spend desensitizing therapy.
From the gastrointestinal tract : gastrointestinal disorders are possible (nausea, vomiting, the phenomenon of colitis, etc.);

From the side of the central nervous system : headache;
insomnia;
From the musculoskeletal system: arthralgia, myalgia;

On the part of the organs of the hematopoiesis system : eosinophilia, leukopenia, granulocytopenia.

These phenomena are reversible and disappear after discontinuation of treatment with the drug.

The drug has a photosensitizing effect, therefore, during treatment and 3 to 4 days after the termination of treatment, patients should avoid exposure to direct sunlight or ultraviolet rays.

CONTRAINDICATIONS

- Pregnancy;

- the period of breastfeeding;

- age up to 18 years;

- hypersensitivity to ciprofloxacin or other drugs from the group of fluoroquinolones.

- patients with epilepsy, seizures in the anamnesis, vascular diseases and organic brain lesions in connection with the threat of the development of adverse reactions from the central nervous system ciprofloxacin should be prescribed only for vital indications.

PREGNANCY AND LACTATION

Contraindicated in pregnancy and during breastfeeding.

APPLICATION FOR FUNCTIONS OF THE LIVER

When violations of the function of the excretory system of the kidneys, breaks between doses increase or decrease the dose (0.5 g once / day or 0.25 g 2 times / day).

APPLICATION FOR CHILDREN

Contraindicated in children under 18 years of age.

SPECIAL INSTRUCTIONS

Do not use ciprofloxacin concomitantly with antacids (preparations of aluminum, magnesium, etc.), reducing the absorption of the drug;
their reception should be separated by a 2-3 hour interval.
If a 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 tendovaginitis appear, treatment should be discontinued due to the fact that individual cases of inflammation and even rupture of tendons during treatment with fluoroquinolones are described.

During the treatment with ciprofloxacin it is necessary to provide a sufficient amount of fluid while observing a normal diuresis.
During treatment with ciprofloxacin, contact with direct sunlight should be avoided.
It is necessary to avoid co-administration of ciprofloxacin with milk and other dairy products, which can reduce the absorption of ciprofloxacin in the gastrointestinal tract and, accordingly, reduce its therapeutic effectiveness.

Influence on the ability to drive vehicles and control mechanisms: patients taking ciprofloxacin, caution should be exercised when driving a car and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

DRUG INTERACTION

Live vaccines and ciprofloxacin: vaccinations with live vaccines are possible only after the end of ciprofloxacin therapy.

Preparations containing salts of aluminum and magnesium, zinc, iron and calcium: form chelated compounds with quinolone derivatives, reducing the absorption and clinical effectiveness of ciprofloxacin.
It is necessary to avoid the simultaneous administration of ciprofloxacin and antacids containing magnesium and aluminum salts, preparations of iron, zinc and calcium and quinolone derivatives. The recommended regimen for co-administration of these drugs is 6 hours before or 2 hours after taking ciprofloxacin.
Sucralfate: reduces the absorption of certain quinolones, reducing their effectiveness.
It is necessary to avoid simultaneous administration of sucralfate and ciprofloxacin. Ciprofloxacin should be taken at least 2 hours before taking sucralfate.
Clozapine, ropenirol and theophylline : ciprofloxacin can inhibit the metabolism of clozapine, ropenirol and theophylline with microsomal liver enzymes (including cytochrome P450-1A2), which may lead to an increase in the concentration of these drugs in the blood, their clinical efficacy and / or toxicity.
If it is necessary to co-administer with ciprofloxacin, it is necessary to monitor the concentrations of these drugs in the blood and to adequately reduce their dosage
Anticoagulants: with simultaneous use of ciprofloxacin and anticoagulants, bleeding time is prolonged.

Phenytoin: Ciprofloxacin can lower levels of phenytoin concentrations in the blood and increase the frequency of seizures .

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

Storage conditions:

The drug is stored in a dry, dark place out of the reach of children.

Shelf life:

3 years.

Do not use after the expiry date printed on the package.

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