Ciprofloxacin Ecocifol pills 500 mg, 10 pcs.

Composition

One tablet contains: 

Active ingredient:

ciprofloxacin hydrochloride monohydrate (based on ciprofloxacin) 500 mg;

Auxiliary substances:

lactulose 600.0 mg,

povidone low molecular weight 28.0 mg,

croscarmellose sodium 65.0 mg,

microcrystalline cellulose 60.0 mg,

magnesium stearate 10.0 mg,

corn starch sufficient amount 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

. Pharmacological action

A broad-spectrum antimicrobial agent derived from quinolone inhibits bacterial DNA gyrase, disrupts DNA synthesis, growth and division of bacteria; causes pronounced morphological changes (including cell walls and membranes) and rapid bacterial cell death.

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 sensitive microorganisms: 

• diseases of the lower respiratory tract (acute and chronic (in the acute stage) bronchitis, pneumonia, bronchiectasis, infectious complications of cystic fibrosis);
• infections of ENT organs (acute sinusitis);
• and 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, diarrhea “travelers”;
• infections of skin and soft tissue (infected ulcers, wounds, burns, abscesses, cellulitis);
• bones and joints (osteomyelitis, septic arthritis);
• infection on the background of immunodeficiency (occurring in the treatment of immunosuppressive drugs or in patients with neutropenia);
• prevention and treatment of pulmonary anthrax.

Children:

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

Contraindications

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

Severe arteriosclerosis of the cerebral vessels, impaired cerebral circulation, mental illnesses, epilepsy, severe renal and / or liver failure, elderly age.

Side effects

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

From the central nervous system: dizziness, headache, fatigue, anxiety, tremor, insomnia, “nightmarish” dreams, peripheral paralgesia (abnormal perception of pain), sweating, 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), migraines, syncope, cerebral artery thrombosis.

From the side of the senses: disorders of taste and smell, visual disturbances (diplopia, color perception changes), tinnitus, hearing loss.

From the cardiovascular system: tachycardia, heart rhythm disorders, low blood pressure.

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

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

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

Allergic reactions: skin pruritus, urticaria, blistering 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 erythema multiforme, Stevens-Johnson syndrome (malignant exudative erythema), toxic epidermal necrolysis (Lyell’s syndrome).

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

Other services: general weakness, increased photosensitivity, superinfections (candidiasis, pseudomembranous colitis), “hot flashes” of blood to the face.

Interaction

Due to a decrease in the activity of microsomal oxidation processes in hepatocytes, it increases the concentration and prolongs 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), synergy is usually observed; it can be successfully used in combination with azlocillin and ceftazidime for infections caused by Pseudomonas spp. ; with mezlocillin, azlocillin, etc. beta-lactam antibiotics – for streptococcal infections; with isoxazolylpenicillins and vancomycin-for staphylococcal infections; with metronidazole and clindamycin – for anaerobic infections.

Increases 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.

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, so it should be prescribed 1-2 hours before or 4 hours after taking the above medications.

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

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

How to take, course of administration and dosage

Inside.

Tablets should be swallowed whole with a small amount of liquid after a meal. When taking the tablet on an empty stomach, the Active ingredient is absorbed faster.

For mild and moderate lower respiratory tract infections-0.5 g 2 times a day, for 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.

For mild and moderate skin and soft tissue infections-0.5 g 2 times a day, for severe cases-0.75 g 2 times. The course of treatment is 7-14 days.

For infections of bones and joints-mild to moderate – 0.5 g 2 times a day, for severe cases-0.75 g 2 times. The course of treatment is up to 4-6 weeks.

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

For chronic bacterial prostatitis-0.5 g 2 times, the course of treatment is 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 is 5-7 days.

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

For complicated intraabdominal 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 cystic fibrosis of the lungs from 5 to 17 years – 20 mg / kg 2 times a day (maximum dose of 1.5 g). The duration of treatment is 10-14 days.

In the pulmonary form of 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 administration is 60 days.

Chronic renal failure: if creatinine clearance is greater than 50 ml/min, no dose adjustment is required; if creatinine clearance is 30-50 ml/min,0.25 – 0.5 g every 12 hours; if creatinine clearance is 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.

Overdose

No specific antidote is known.

It is necessary to carefully monitor the patient’s condition, perform gastric lavage, carry out the usual emergency measures, and ensure sufficient fluid intake.

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

Special instructions

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

To avoid the development of crystalluria, it is unacceptable to exceed the recommended daily dose, as well as sufficient fluid intake and maintaining an acidic urine reaction.

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

Patients with epilepsy, seizures in the anamnesis, vascular diseases and organic brain damage due to the threat 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 ciprofloxacin treatment, the diagnosis of pseudomembranous colitis should be excluded, which requires immediate discontinuation of the drug and appropriate treatment.

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

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

Form of production

Film-coated tablets of white or almost white color, capsule-shaped, biconvex. The cross-section is white.

Active ingredient

Ciprofloxacin

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Weight

Weight: 36 gr.