Description
Release form
Tablets, covered with a film membrane of white or almost white, capsule-shaped, biconvex. The cross section is white.
Pharmacological action
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 rapid death of the 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:
lower respiratory tract diseases (acute and chronic (acute) bronchitis, pneumonia, bronchiectasis, infectious complications of cystic fibrosis)
acute sinus infection and urinary tract (cystitis, pyelonephritis)
complicated intra-abdominal infections (in combination with metronidazole)
chronic bacterial prostatitis
uncomplicated gonorrhea
bru Noah fever, campylobacteriosis, shigellosis, diarrhea travelers
skin and soft tissue infections (infected ulcers, wounds, burns, abscesses, phlegmon)
bones and joints (osteomyelitis, septic arthritis)
infection due to immunodeficiency (occurring in the treatment of immunosuppressive drugs or in patients with neutropenia)
prevention and treatment of pulmonary anthrax.
Children:
therapy for complications caused by Pseudomonas aeruginosa in children with pulmonary cystic fibrosis 5-17 years old
prevention and treatment of pulmonary anthrax (infection with Bacillus anthracis).
Composition of
One tablet contains:
Active ingredient: ciprofloxacin hydrochloride monohydrate (in terms of ciprofloxacin) 500 mg
Excipients: lactulose 600.0 mg, povidone low molecular weight 28.0 mg, croscarmell 60.0 mg cellulose 65.0% , 0 mg, magnesium stearate 10.0 mg, corn starch sufficient to obtain tablets without a shell weighing 1400.0 mg
Coating aids: hypromellose 19.04 mg, macrogol-4000 8.32 mg, talc 2.2 mg, titanium dioxide 10.44 mg.
Dosage and Administration
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.
For 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.
For infections 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.
In infections of bones and joints – mild to moderate – 0.5 g 2 times a day, in severe cases – 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 case of 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 a 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. 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.
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 is 60 days.
Chronic renal failure: with creatinine clearance (CC) of more than 50 ml / min, dose adjustment is not required with CC of 30-50 ml / min – 0.25-0.5 every 12 hours with CC of 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.
Side effects of the
From the digestive system: nausea, diarrhea, vomiting, abdominal pain, flatulence, anorexia, cholestatic jaundice (especially in patients with liver disease), hepatitis, hepatonecrosis.
From 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 also 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 (especially 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, erythematous erythema erythema erythema, 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.
Drug interaction
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, indirect anticoagulants, helps to reduce 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 – for streptococcal infections with isoxazolylpenicillins and vancomycin – for staph infections with metronidazole and clindamycin – for anaerobic infections.
Enhances the nephrotoxic effect of cyclosporine, an increase in serum creatinine is noted, in these patients, this indicator needs to be monitored 2 times a week.
When taken concomitantly, it enhances the effects 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 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 buffer system of the dosage form, which dramatically reduces the absorption of antibiotics, so ciprofloxacin is taken 2 hours before taking didanosine or 2 hours after taking the indicated drug
Metoclopramide accelerates absorption, which leads to a decrease in the time to reach its maximum concentration.
The combined use of uricosuric drugs slows down excretion (up to 50%) and increases the plasma concentration of ciprofloxacin.
Increases the maximum concentration by 7 times (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.
Overdose
No specific antidote known.
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 hemo- or peritoneal dialysis, only a small (less than 10%) amount of the drug can be excreted.
Storage conditions
In a dry, dark place at a temperature of no higher than 25 ° C.
Keep out of the reach of children.
Expiration
2 years. Do not use after the expiry date.
pharmacy terms for prescription
Form of Treatment
tablets
Appointment
Adult doctor’s appointment, Children 15 years old , Prescribing To Children
Indications
From respiratory tract infections, From intestinal infections, From urinary tract infections, From otitis media, inusitis, From skin infections, From lung inflammation, From bile duct infections, From prostatitis, From infectious diseases, From osteomyelitis
Possible product names
ciprofloxacin ecocifol tablets coated film 500 mg 10 pcs.
£ ¡, Russia
