Ciprofloxacin Ecocifol 500 mg, 10 pcs.

АВВА РУС, Russia

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Product Overview

Structure

One tablet contains: 

Active substance:

 ciprofloxacin hydrochloride monohydrate (in terms of ciprofloxacin) 500 mg; 

Excipients:

 lactulose 600.0 mg

low molecular weight povidone 28.0 mg,

croscarmellose sodium 65.0 mg,

microcrystalline cellulose 60.0 mg,

magnesium stearate 10.0 mg,

a sufficient amount of corn starch to obtain a tablet without a shell weighing 1400.0 mg; 

Shell Excipients :

hypromellose 19.04 mg, macrogol-4000 8.32 mg, talc 2.2 mg, titanium dioxide 10.44 mg.

pharmachologic effect

A broad-spectrum antimicrobial agent, a derivative of quinolone, suppresses bacterial DNA gyrase, disrupts DNA synthesis, growth and division of bacteria; causes pronounced morphological changes (including cell wall and membranes) and the rapid death of a bacterial cell.

It acts bactericidal on gram-negative organisms during dormancy and division, on gram-positive microorganisms - only during division.

Indications

Infectious and inflammatory diseases caused by susceptible microorganisms: 

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


Children: 

  • therapy of complications caused by Pseudomonas aeruginosa in children with pulmonary cystic fibrosis from 5 to 17 years;
  • prevention and treatment of pulmonary anthrax (infection of Bacillus anthracis).

Contraindications

Hypersensitivity, concomitant use with tizanidine (risk of a pronounced decrease in blood pressure, drowsiness), age up to 18 years (until the completion of the skeleton formation process, except for treatment of complications caused by Pseudomonas aeruginosa in children with pulmonary cystic fibrosis from 5 to 17 years; prevention and treatment of pulmonary form anthrax), pregnancy, lactation.

Carefully 


Severe cerebral arteriosclerosis, cerebrovascular accident, mental illness, epilepsy, severe renal and / or liver failure, advanced age.

Side effects

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

From the side of the central nervous system: dizziness, headache, fatigue, anxiety, tremors, insomnia, “nightmare” dreams, peripheral paralgesia (anomaly in the perception of pain), sweating, increased intracranial pressure, confusion, depression, hallucinations, and other manifestations of psychotic reactions (occasionally progressing to conditions in which the patient may harm himself), migraine, fainting, cerebral artery thrombosis. 

On the part of the sensory organs: impaired taste and smell, visual impairment (diplopia, color perception), tinnitus, hearing loss. 

From the cardiovascular system: tachycardia, cardiac arrhythmias, decreased blood pressure. 

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

Laboratory indicators: hypoprothrombinemia, increased activity of hepatic transaminases and alkaline phosphatase, hypercreatininemia, hyperbilirubinemia, hyperglycemia.

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

Allergic reactions: itching, hives, the formation of blisters accompanied by bleeding, and the appearance of small nodules forming scabs, drug fever, spot hemorrhages on the skin (petechiae), swelling of the face or larynx, shortness of breath, eosinophilia, vasculitis, erythema nodosum, exudative , Stevens-Johnson syndrome (malignant exudative erythema), toxic epidermal necrolysis (Lyell's syndrome). 

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

Other: general weakness, increased photosensitivity, superinfection (candidiasis, pseudomembranous colitis), flushing of the face.

Interaction

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

When combined with other antimicrobial drugs (betalactam 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 meslocillin, azlocillin and other beta-lactam antibiotics - with streptococcal infections; with isoxazolylpenicillins and vancomycin - with staphylococcal infections; with metronidazole and clindamycin - with anaerobic infections.

Enhances the nephrotoxic effect of cyclosporine, an increase in serum creatinine is noted, in such patients, control of this indicator 2 times a week is necessary.

At the same time, it enhances the effect of indirect anticoagulants.

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

Nonsteroidal anti-inflammatory drugs (excluding acetylsalicylic acid) increase the risk of seizures. 
Fluoroquinolones form chelating compounds with magnesium and aluminum ions of the didanosine dosage form buffer system, which dramatically reduces the absorption of antibiotics, so ciprofloxacin is taken 2 hours before taking didanosine or 2 hours after taking the drug

Metoclopramide accelerates absorption, which leads to a decrease in the time to reach its maximum concentration. 
The combined use of uricosuric drugs leads to a slowdown in elimination (up to 50%) and an increase in the plasma concentration of ciprofloxacin.

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

How to take, course of administration and dosage

Inside.

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

In infections of the lower respiratory tract of mild and moderate degree - 0.5 g 2 times a day, in severe cases - 0.75 g 2 times. The course of treatment is 7-14 days.

In acute sinusitis - 0.5 g 2 times a day. The course of treatment is 10 days.

In case of infection of the skin and soft tissues of mild and moderate degree - 0.5 g 2 times a day, in severe cases - 0.75 g 2 times. The course of treatment is 7-14 days.

With infections of bones and joints - mild and moderate degree - 0.5 g 2 times a day, with severe course - 0.75 g 2 times. The course of treatment is up to 4-6 weeks.

In case of urinary tract infections - 0.25-0.5 g 2 times a day; the course of treatment is 7-14 days, with uncomplicated cystitis in women - 3 days.

In chronic bacterial prostatitis - 0.5 g 2 times, the course of treatment - 28 days.

With uncomplicated gonorrhea - 0.25-0.5 g once.

Acute intestinal infections (salmonellosis, shigellosis, campylobacteriosis, etc.) - 0.5 g 2 times, the course of treatment - 5-7 days.

With typhoid fever - 0.5 g 2 times; the course of treatment is 10 days.

With 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. Antibiotic therapy is carried out during the entire period of neutropenia.

In pediatrics:

in the treatment of complications caused by Pseudomonas aeruginosa in children with pulmonary cystic fibrosis from 5 to 17 years - 20 mg / kg 2 times a day (maximum dose 1.5 g). The duration of treatment is 10-14 days.

With 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 ciprofloxacin is 60 days.

Chronic renal failure: with creatinine clearance (CC) more than 50 ml / min dose adjustment is not 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 undergoes hemodialysis or peritoneal dialysis - 0.25-0.5 g / day, the drug should be taken after a hemodialysis session .

Overdose

The specific antidote is unknown.

 It is necessary to carefully monitor the patient's condition, do gastric lavage, carry out the usual emergency measures, ensure an adequate flow of fluid. 

With the help of hemo- or peritoneal dialysis, only a small (less than 10%) amount of the drug can be removed.

Special instructions

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

In order to avoid the development of crystalluria, the recommended daily dose should not be exceeded, sufficient fluid intake and the maintenance of an acidic urine reaction are also necessary. 

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

In patients with a history of seizures, a history of seizures, vascular diseases, and organic brain damage due to the risk of adverse reactions from the central nervous system, ciprofloxacin should be prescribed 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 withdrawal of the drug and the appointment of appropriate treatment. 

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

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

Release form

 Tablets, film-coated white or almost white, capsule-shaped, biconvex. The cross section is white.

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