Tsiprinol, 10 pcs., 500 mg, film-coated tablets
Directions for use and doses
It is prescribed intravenously, it can be administered intravenously, but drip administration is more preferable for 30 minutes (200 mg) and 60 minutes (400 mg). Before use, 1 ampoule of concentrate for preparing a solution for infusion must be diluted with an adequate amount of infusion solution: 0.9% sodium chloride solution, Ringer's solution, 5% and 10% dextrose solution, 10% solution
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fructose, as well as a solution containing a 5% dextrose solution with 0.225% or 0.45%
sodium chloride solution to a minimum volume of 50 ml.
The dose of ciprofloxacin depends on the severity of the disease, type of infection, condition
the patient's body, age, weight and kidney function. Typically recommended doses:
for intravenous administration single dose - 200 mg (for severe infections - 400 mg), multiplicity
administration - 2 times a day.
If IV treatment is necessary for particularly severe, life-threatening or
recurrent infections caused by Pseudomonas spp., staphylococci or
Streptococcus pneumoniae; sepsis, peritonitis, bone and joint infections, dose may
be increased to 0.4 g with a frequency of administration up to 3 times a day.
For acute uncomplicated gonorrhea - once, 100 mg intravenously.
For the prevention of postoperative infections - 30 - 60 minutes before surgery iv 200 -
400 mg; for long-term surgery over 4 hours, re-administer the same dose.
Average duration of treatment: 1 day - for acute uncomplicated gonorrhea; up to 7
days - for infections of the kidneys, urinary tract and abdominal cavity; throughout
during the neutropenic phase - in patients with weakened defenses
body; but no more than 2 months - for osteomyelitis and 7-14 days - for all others
infections. For streptococcal infections due to the risk of late complications, and
Also, for chlamydial infections, treatment should continue for at least 10 days. U
Patients with immunodeficiency are treated throughout the entire period of neutropenia.
Treatment should be continued for at least 3 more days after body temperature normalizes.
or disappearance of clinical symptoms.
For elderly patients, the dose is reduced by 30%.
With a glomerular filtration rate (CC 31-60 ml/min/1.73 sq.m or serum
creatinine concentrations from 1.4 to 1.9 mg 100 ml) maximum daily dose - 800 mg.
Patients with severe renal failure (creatinine clearance below 30 ml/min/1.73 sq. m;
creatinine concentration above 2 mg/100 ml) it is necessary to prescribe half the daily
doses, maximum daily dose - 400 mg. For peritonitis in patients on
ambulatory peritoneal dialysis, possible intraperitoneal administration
ciprofloxacin at a dose of 50 mg 4 times a day per 1 liter of dialysate.
The solution for infusion can be combined with 0.9% sodium chloride solution, solution
Ringer's, 5% and 10% dextrose solution, 10% fructose solution, as well as a solution
containing a 5% dextrose solution with 0.225% or 0.45% sodium chloride solution.
After IV use, you can continue treatment orally. .
For pulmonary anthrax (prevention and treatment):
Adults: 400 mg IV 2 times a day
Children (5 to 17 years): 10 mg/kg body weight 2 times a day. Should not exceed
the maximum single dose is 400 mg IV (maximum daily dose is 800 mg).
Treatment should begin immediately after suspected or confirmed
infection. The total duration of treatment with ciprofloxacin for pulmonary
form of anthrax is 60 days.
In the treatment of complications caused by Pseudomonas aeruginosa in children with cystic fibrosis
lungs from 5 to 17 years, the recommended dose of ciprofloxacin is 10 mg/kg every 8
h (no more than 400 mg IV every 8 hours). Duration of treatment is 10-14 days.
Side effect
From the digestive system: nausea, diarrhea, vomiting, abdominal pain, flatulence, anorexia, cholestatic jaundice (especially in patients with previous liver diseases), hepatitis, hepatonecrosis, pseudomembranous colitis. From the central and peripheral nervous system: dizziness, headache, fatigue, agitation, convulsions, anxiety, tremor, insomnia, nightmares, peripheral paralgesia (anomaly of perception
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feelings 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 may harm himself, with
suicidal tendencies), migraine, fainting, cerebral thrombosis
arteries.
From the senses: impaired taste and smell, visual impairment (diplopia,
changes in color perception), tinnitus, hearing loss.
From the cardiovascular system: tachycardia, heart rhythm disturbances,
decreased blood pressure (BP), a feeling of “flushes” of blood to the skin of the face.
From the hematopoietic system: leukopenia, granulocytopenia, anemia,
thrombocytopenia, leukocytosis, thrombocytosis, hemolytic anemia.
From the urinary system: 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.
Allergic reactions: skin itching, hives, blistering,
accompanied by bleeding and small nodules that form scabs,
drug fever, pinpoint hemorrhages (petechiae), swelling of the face or larynx,
shortness of breath, eosinophilia, vasculitis, exanthema, erythema nodosum, exudative
erythema multiforme, Stevens-Johnson syndrome (malignant exudative
erythema), toxic epidermal necrolysis (Lyell's syndrome), anaphylactic
shock.
From the musculoskeletal system: arthralgia, arthritis, tenosynovitis, ruptures
tendons, myalgia, swelling in the joint area.
Other: general weakness, sweating, superinfections (candidiasis), increased
photosensitivity
Laboratory parameters: hypoprothrombinemia, increased activity
“liver” transaminases and alkaline phosphatase, hypercreatininemia,
hyperbilirubinemia, hyperuricemia, hyperglycemia.
Local: pain and burning at the injection site, phlebitis.
Overdose
Symptoms: nausea, vomiting, diarrhea, headache and dizziness, and in more severe cases
cases of confusion, tremors, hallucinations and convulsions.
Treatment: symptomatic, ensure sufficient fluid intake.
A specific antidote is unknown. Hemodialysis has no clinical effect in
intoxication.
Interaction with other drugs
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/or caffeine (and other xanthines), oral hypoglycemic drugs (glibenclamide - which can lead to hypoglycemia), indirect anticoagulants (warfarin, etc.), promotes decrease in prothrombin index (risk of bleeding).
Ciprofloxacin increases Cmax by 7 times (from 4 to 21 times) and AUC by 10 times (from 6 to 24 times) of tizanidine, which increases the risk of a pronounced decrease in blood pressure and drowsiness. Concomitant use with non-steroidal anti-inflammatory drugs (excluding acetylsalicylic acid) increases the risk of developing seizures. With the simultaneous use of ciprofloxacin and cyclosporine, the nephrotoxic effect of cyclosporine is enhanced (it is necessary to monitor blood creatinine levels 2 times a week).
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Concomitant use of ciprofloxacin and glucocorticosteroids may increase the risk of tendon rupture.
The simultaneous administration of ciprofloxacin and phenytoin can lead to
increase or decrease in serum concentration of phenytoin.
Co-administration of uricosuric drugs leads to a slower elimination
(up to 50%) and increased plasma concentrations of ciprofloxanine.
When combined with other antimicrobial drugs (beta-lactams,
aminoglycosides, clindamycin, metronidazole) synergism is usually observed: the drug
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.
The infusion solution is pharmaceutically incompatible with all infusion devices.
solutions and drugs that are physico-chemically unstable in
acidic environment (pH of ciprofloxacin infusion solution - 3.5 - 4.6).
special instructions
Patients with epilepsy, a history of seizures, vascular diseases and
organic brain damage due to the risk of developing adverse reactions with
parts of the central nervous system, ciprofloxacin should be prescribed only
vital indications.
If severe and
prolonged diarrhea, 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 appear
Tenosynovitis treatment should be discontinued due to the fact that isolated cases have been described
inflammation (mainly in elderly patients simultaneously receiving
glucocorticosteroids) and even tendon rupture during treatment with fluoroquinolones.
During therapy with ciprofloxacin, it is recommended to avoid excessive physical activity.
loads
During treatment with ciprofloxacin, in order to avoid the development of crystalluria, it is unacceptable
exceeding the recommended daily dose. It is also necessary to ensure reception
sufficient fluid (under diuresis control) to maintain normal
diuresis and maintaining acidic urine.
During treatment with ciprofloxacin, ultraviolet radiation should be avoided (in
including contact with direct sunlight).
During the therapy period, an increase in the prothrombin index is possible (during
surgical interventions, the state of the coagulation system should be monitored
blood).
With the simultaneous administration of ciprofloxacin and a drug for general
anesthesia from the group of barbituric acid derivatives requires constant
control of heart rate (HR), blood pressure, ECG.
In patients with glucose-6-phosphate dehydrogenase deficiency, the administration of Tsiprinol may
cause the development of hemolytic anemia.
During treatment, patients should not drink alcohol.
Impact on the ability to drive vehicles and other mechanisms
Patients taking ciprofloxacin should be careful when
driving a car and engaging in other potentially dangerous activities that require increased attention and speed of psychomotor reactions (especially while drinking alcohol).
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Release form
Concentrate for solution for infusion, 10 mg/ml.
10 ml in ampoules made of neutral transparent glass. A colored dot is applied to the ampoule at the fracture site. 5 ampoules in a blister or 5 ampoules in a plastic blister pack. 1 blister or 1 plastic blister pack in a cardboard box along with instructions for use.
Storage conditions
Store in a place protected from light, at a temperature not exceeding 25 °C. Do not freeze! Keep out of the reach of children.
Best before date
4 years.
Do not use after expiration date.
Conditions for dispensing from pharmacies
On prescription.
Manufacturer: KRKA, d.d., Novo Mesto, Šmarješka cesta 6, 8501 Novo Mesto, Slovenia
For any questions, please contact the Representative Office in the Russian Federation:
123022, Moscow, 2nd Zvenigorodskaya st., 13, building 41 Tel. (495) 739-66-00, fax
When packaging and/or packaging at a Russian enterprise, the following is indicated:
LLC "KRKA-RUS", 143500, Russia, Moscow region, Istra, st. Moskovskaya, 50
Tel.: (495)994-70-70
Fax
Or
JSC "VECTOR-MEDICA", 630559 Russia, Koltsovo village, Novosibirsk region, tel./fax
M.O.1
. Director IDKELS tZs J&K? At A.N. Vasiliev
Representative of the company O.A. Tsibulskaya
Pharmacological properties of the drug Tsiprinol
A synthetic antibacterial drug with a broad spectrum of action from the fluoroquinolone group, which has a bactericidal effect. Tsiprinol acts both on microorganisms that are in the process of rapid growth, and on microorganisms that are in the resting phase. The antimicrobial activity of ciprofloxacin is due primarily to the presence of a cyclopropane ring at the 1st position, a fluorine ring at the 6th position, and a piperazine ring at the 7th position. The mechanism of action of ciprofloxacin in all phases of the cell cycle is due to the inhibition of subunit A of bacterial DNA gyrase, the enzyme responsible for bacterial DNA replication. The drug has a bactericidal effect on most gram-negative and some gram-positive microorganisms, including those resistant to other antibacterial drugs. are sensitive to ciprofloxacin in vitro : enterobacteria - E. coli , Shigella spp ., Salmonella spp ., Citrobacter spp ., Klebsiella spp ., Enterobacter spp ., Proteus mirabilis and vulgaris , Serratia marcescens, Hafnia alvei, Edwardsiella tarda, Providencia spp., Morganella morganii, Vibrio spp., Yersinia spp.; other gram-negative bacteria - Aeromonas spp., Plesiomonas shigelloides, Pasteurella multocida, Haemophilus spp., Campylobacter jejuni, Pseudomonas aeruginosa, Neisseria spp., Moraxella (Branhamella) catarrhalis ; some intracellular pathogens - Legionella pneumophila, Brucella spp., Chlamydia trachomatis, Listeria monocytogenes, Mycobacterium tuberculosis, Mycobacterium kansasii, Mycobacterium avium-intracellulare . in vitro sensitivity of the following gram-positive bacteria has been confirmed: Streptococcus spp. (S. pyogenes, S. agalactiae) ; Staphylococcus spp. (S. aureus, S. haemolyticus, S. hominis and S. saprophyticus ), Bacilus anthracis. The sensitivity of Enterococcus faecalis and Streptococcus pneumoniae is moderate. Bacteria from the group Corynebacterium spp., Bacteroides fragilis, Pseudomonas cepacia and maltophilia, Ureaplasma urealyticum, Clostridium difficile, Nocardia asteroides, Streptococcus faecalis and Treponema pallidum are resistant to ciprofloxacin. The manifestation of bacterial resistance usually indicates cross-resistance to all quinolones and is caused by a decrease in the permeability of the bacterial membrane to the drug, as well as a mutation in the A subunit of DNA gyrase, as a result of which the sensitivity of the bacterium to ciprofloxacin decreases (thus explaining the development of resistance in P. aeruginosa ). Resistance is most often detected in infections caused by Pseudomonas aeruginosa and certain strains of Staphylococcus aureus . In vitro , a synergistic effect has been established between ciprofloxacin and other antibiotics, such as imipenem, against P. aeruginosa , as well as mezlocillin, cefoxitin and clindamycin against B. fragilis , azlocillin against P. aeruginosa and ceftizoxime against P. aeruginosa and S. marcescens . The minimum inhibitory concentration (MIC90) of ciprofloxacin in vitro against the most sensitive bacteria to it is: for Enterobacter cloacae ( E. coli, Enterobacter spp., Citrobacter spp., Klebsiella spp., Proteus spp.) - 0.005–1 mg/l; Providencia spp . — 0.015–3.12 mg/l; Salmonella spp . — 0.015–0.25 mg/l; Serratia marcescens - 0.06–1 mg/l; Shigella spp . — 0.002–0.25 mg/l; Yersinia enterocolitica - 0.015–0.25 mg/l; Acinetobacter calcoaceticus - 0.25–1 mg/l; Neisseria gonorrhoeae - 0.002–0.03 mg/l; Neisseria meningitidis - 0.005–0.015 mg/l; Haemophilus influenzae - 0.007–0.05 mg/l; Pseudomonas aeruginosa - 0.12–4 mg/l; Pseudomonas spp. - 0.25–16 mg/l. The maximum concentration of the drug in the blood plasma is achieved 0.5–1.8 hours after oral administration. Food intake may alter the time to reach maximum plasma concentration but does not affect AUC. The volume of equilibrium distribution of ciprofloxacin after oral or intravenous administration is 1.74–5 l/kg body weight, which indicates good penetration of ciprofloxacin into tissues. The drug in therapeutic concentration accumulates in the bronchial mucosa, lung tissue, pleural exudate, liver and kidney parenchyma, bile, peritoneal fluid, genitals, prostate gland, bones, synovial tissue and fluid, skin and anterior ocular chamber. The highest concentration of ciprofloxacin is determined in the liver, gall bladder, bile, kidneys and prostate secretions. The concentration of the drug in the cerebrospinal fluid is in most cases lower than the concentration in the blood serum, but may increase with meningitis. Ciprofloxacin penetrates the placental barrier and enters breast milk. The drug is excreted from the body mainly through urine. After 48 hours, 30 to 50% of ciprofloxacin is excreted unchanged by the kidneys.
Indications for use of the drug Tsiprinol
Adults Uncomplicated and complicated infections caused by pathogens sensitive to ciprofloxacin:
- respiratory tract infections; treatment of pneumonia caused by Klebsiella spp., Enterobacter spp., Proteus spp, Escherichia coli, Pseudomonas aeruginosa, Haemophilus spp., Moraxella catarrhalis, Legionella and staphylococci;
- infections of the middle ear and paranasal sinuses;
- eye infections;
- infections of the abdominal organs, bacterial infections of the gastrointestinal tract, gall bladder and biliary tract, as well as peritonitis;
- kidney and urinary tract infections;
- infections of the pelvic organs (gonorrhea, adnexitis, prostatitis);
- skin and soft tissue infections;
- bone and joint infections;
- sepsis;
- prevention and treatment of infections in immunocompromised patients (including during treatment with immunosuppressants and with neutropenia);
- selective intestinal decontamination during treatment with immunosuppressants.
Children As a second or third line drug, it is used for the treatment of complicated urinary tract infections and pyelonephritis caused by E. coli in children aged 1–17 years, as well as for the treatment of exacerbations of respiratory system diseases caused by Pseudomonas aeruginosa in children with cystic fibrosis of the lungs aged 5–17 years. Adults and children Reduced risk of developing or progressing anthrax after aerogenic exposure to Bacillus anthracis .
