Cifran OD, 10 pcs., 1000 mg, extended-release film-coated tablets

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CIFRAN OD

Interaction

Due to inhibition of microsomal enzymes in the liver, it increases the concentration of i.
prolongs T1/2 of theophylline and other xanthines (for example, caffeine), oral hypoglycemic drugs (for example, glibenclamide), indirect anticoagulants (for example, warfarin and its derivatives). If it is necessary to use it together with drugs of these groups, it is necessary to monitor the concentration of the drug in the blood and adjust the dosage regimen accordingly. In the presence of antacids containing magnesium hydroxide or aluminum hydroxide, the absorption of ciprofloxacin is reduced. Thus, the simultaneous use of these drugs should be excluded. In such cases, ciprofloxacin should be taken either 1-2 hours before or 4 hours after taking these drugs. Didanosine reduces the absorption of ciprofloxacin. This is due to the formation of complexes with magnesium salts contained in didanosine preparations.

When used together with probenecid and other drugs that block tubular secretion, the renal excretion of ciprofloxacin decreases.

Metoclopramide accelerates the absorption of the drug, which leads to a decrease in the time it takes to reach Cmax.

Co-administration of uricosuric drugs leads to a slower elimination (up to 50%) and an increase in plasma concentrations of ciprofloxacin.

When combined with other antimicrobial drugs (beta-lactam 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 mezlocillin, azlocillin and other beta-lactam antibiotics - for streptococcal infections; with isoxazolylpenicillins and vancomycin - for staphylococcal infections; with metronidazole and clindamycin - for anaerobic infections. Ciprofloxacin enhances the nephrotoxic effect of cyclosporine. There is an increase in serum creatinine concentration. In such patients, it is necessary to monitor this indicator 2 times a week.

Concomitant use of tizanidine with ciprofloxacin, which is an inhibitor of the CYP1A2 isoenzyme, leads to a 10-fold increase in the AUC of tizanidine. The result of combined use may be a clinically significant and prolonged decrease in blood pressure, leading to drowsiness, dizziness, and inhibited psychomotor reactions.

In patients receiving therapy with ciprofloxacin and phenytoin, variability (decrease or increase) in the concentration of phenytoin in the blood plasma was noted.

Combined use with nonsteroidal anti-inflammatory drugs (NSAIDs) increases the likelihood of side effects of ciprofloxacin on the central nervous system (risk of seizures).

Absorption of ciprofloxacin when administered orally decreases after cytotoxic therapy with antitumor and immunosuppressive drugs.

Pharmacological properties of the drug Tsifran OD

Pharmacodynamics. in vitro activity against a wide range of gram-negative and gram-positive microorganisms. The bactericidal effect of ciprofloxacin is the result of inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV, which are necessary for replication, transcription, repair and recombination of bacterial DNA. The mechanism of action of fluoroquinolones, including ciprofloxacin, differs from the mechanism of action of penicillins, cephalosporins, aminoglycosides, macrolides and tetracyclines. Therefore, microorganisms resistant to these classes of drugs may be sensitive to ciprofloxacin and other quinolones. There is no known cross-resistance between ciprofloxacin and other classes of antibacterial drugs. In vitro resistance to ciprofloxacin develops slowly. Ciprofloxacin is active against most strains of the following microorganisms both in vitro and in clinical infections; aerobic gram-positive microorganisms: Enterococcus faecalis (many strains are moderately sensitive), Staphylococcus aureus (MSSA), Staphylococcus epidermidis (MSSA), Staphylococcus saprophyticus, Streptococcus pneumoniae (PSSP), Streptococcus pyogenes ; aerobic gram-negative microorganisms: Campylobacter jejuni, Citrobacter diversus, Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Moraxella morganii, Neisseria gonorrhoeae, Proteus mirabilis, Proteus vulgaris, Providencia rett geri, Providencia stuartii, Pseudomonas aeruginosa, Salmonella typhi, Serratia marcescens, Shigella sonnei, Shigella boydii, Shigella dysenteriae, Shigella flexneri. Ciprofloxacin is also active in vitro and through the use of a surrogate marker for Bacillus anthracis. Ciprofloxacin has in vitro minimum inhibitory concentration (MIC) of ≤1 μg/ml against the majority (90%) of strains of the following microorganisms: aerobic gram-positive microorganisms: Staphylococcus haemolyticus, Staphylococcus hominis, Streptococcus pneumoniae (PRSP); aerobic gram-negative microorganisms: Acinetobacter iwoffi, Pasteurella multocida, Aeromonas hydrophila, Salmonella enteritidis, Edwardsiella tarda, Vibrio Cholerae, Enterobacter aerogenes, Vibrio parahaemolyticus, Klebsiella oxytoca, Vibrio vulnificus, Legionella pneumophila, Yersinia enterocolitica. Most strains of Burkholderia cepacia and some strains of Stenotrophomonas maltophilia are resistant to ciprofloxacin, as are most anaerobic bacteria, including Bacteroides fragilis and Clostridium difficile. Pharmacokinetics. Extended-release ciprofloxacin tablets are formulated to release the drug more slowly than traditional immediate-release tablets. Extended-release ciprofloxacin tablets and immediate-release ciprofloxacin tablets are not interchangeable. The pharmacokinetic profile of ciprofloxacin extended-release tablets 500 and 1000 mg once daily is similar to that of the immediate-release 250 and 500 mg tablets twice daily in terms of AUC over a 24-hour period. The volume of distribution for intravenously administered ciprofloxacin is approximately 2.1–2.7 L/kg body weight. The results of studies conducted with oral and intravenous use of ciprofloxacin indicate that, depending on the route of administration, the drug penetrates into different tissues. The binding of ciprofloxacin to serum proteins is 20–40%. There were 4 metabolites identified in urine. These metabolites have less pronounced antimicrobial activity than unchanged ciprofloxacin. Excretion of these metabolites occurs almost completely within 24 hours after administration of the drug. The elimination kinetics of extended-release ciprofloxacin are similar to those of immediate-release ciprofloxacin tablets. Approximately 35% of an orally administered dose is excreted unchanged in the urine. Excretion in urine occurs almost completely within 24 hours after administration of the drug. Approximately 20–35% of an orally administered immediate-release ciprofloxacin dose is excreted in the feces over a 5-day period. In patients with reduced renal function, the half-life of ciprofloxacin is prolonged to a small extent.

Use of the drug Cifran OD

The drug is taken after meals. Swallow the tablet whole. Do not cut, crush or chew the tablet. The dose for each patient is selected taking into account body weight, type of infectious agent, sensitivity of the pathogen, the state of the patient’s immune system, as well as kidney and liver function. The duration of treatment depends on the severity of the infection and is usually 7–14 days. However, for severe or complicated infections, longer therapy may be necessary.

Recommended dosage for adults *Usually, ciprofloxacin should be continued for at least 2 days after signs and symptoms of infection have resolved. **Used in combination with metronidazole.

The transition from the injection to the oral form of the drug in adult patients whose treatment was started with intravenous administration of ciprofloxacin is possible if there are indications for transferring to oral administration. Dosing regimens providing equivalent AUC:

In patients with impaired renal function, especially with severe renal failure, dose adjustment is required. The following table contains dosing recommendations for use in patients with reduced renal function.

*In patients with creatinine clearance ≤30 ml/min with complicated urinary tract infections and acute uncomplicated pyelonephritis, the dose is 500 mg Cifran OD 1 time per day.

If only the serum creatinine concentration is known, the following formula can be used to estimate creatinine clearance:

• for men:
  

  creatinine clearance (ml/min)=	Body weight (kg) × (140 – age)
  	72 (blood plasma creatinine (mg/dl))

• for women: 0.85 • (value calculated for men).

There is no need to adjust the dose of ciprofloxacin for patients with stable chronic liver cirrhosis. However, the pharmacokinetics of ciprofloxacin in individuals with acute liver failure have not yet been fully studied.

Overdose of the drug Cifran OD, symptoms and treatment

Symptoms: reversible renal failure. Treatment: rinse the stomach, induce vomiting; the patient should be carefully monitored and receive supportive care, including monitoring of renal function; administration of antacids containing magnesium, aluminum or calcium, which may reduce the absorption of ciprofloxacin; maintaining adequate water regime. Only a small amount of ciprofloxacin (≤10%) is removed from the body by hemodialysis or peritoneal dialysis.

Indications for use of the drug Tsifran OD

Uncomplicated and complicated infections caused by pathogens sensitive to ciprofloxacin:

• respiratory tract infections: 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;
• 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;
• infections of bones and joints.

Side effects of the drug Cifran OD

Frequency ≥1, ≤10% Gastrointestinal tract: nausea, diarrhea. Skin: skin rash. Frequency ≥0.1, ≤≤1% Body as a whole: abdominal pain, candidiasis, asthenia. Gastrointestinal organs: increased levels of liver transaminases: ALT, AST, ALP, vomiting, dyspepsia, anorexia, flatulence, bilirubinemia. Hematopoietic system: eosinophilia, leukopenia. Urinary system: increased levels of creatinine, urea nitrogen. Musculoskeletal system: arthralgia. CNS: dizziness, headache, sleep disturbance, agitation, confusion. Skin: itching, maculopapular skin rash, urticaria. Sense organs: taste disturbance. Frequency ≥0.01, ≤≤0.1% Body as a whole: pain, pain in the extremities, pain in the back, in the chest. Cardiovascular system: tachycardia, migraine, syncope, vasodilation, hypotension. Gastrointestinal organs: candidiasis (oral), jaundice, cholestatic jaundice, pseudomembranous colitis. Blood system and lymphatic system: anemia, leukopenia (granulocytopenia), leukocytosis, changes in prothrombin levels, thrombocytopenia, thrombocythemia (thrombocytosis). Hypersensitivity: allergic reaction, drug fever, anaphylactic reactions. Metabolic disorders: edema (peripheral, vascular, facial), hyperglycemia. Musculoskeletal system: myalgia, joint swelling. CNS: migraine, hallucinations, sweating, paresthesia (peripheral paralgesia), anxiety (fear, anxiety), sleep disturbance (nightmares), convulsions, hypersthesia, depression, tremor. Respiratory system: dyspnea, laryngeal edema. Skin: photosensitivity reaction. Sense organs: tinnitus, temporary deafness (especially at high frequency sounds), visual impairment (visual abnormalities), diplopia, chromatopsia, loss of taste (taste disturbance). Genitourinary system: acute renal failure, renal dysfunction, vaginal candidiasis, hematuria, crystalluria, interstitial nephritis. Frequency ≤0.01% Cardiovascular system: vasculitis. Gastrointestinal organs: candidiasis, liver necrosis (very rarely - progressing with the development of life-threatening liver failure), pseudomembranous colitis with a possible fatal outcome, pancreatitis, hepatitis. Blood system and lymphatic system: hemolytic anemia, petechiae, agranulocytosis, pancytopenia (life-threatening), bone marrow suppression (life-threatening). Hypersensitivity: shock (anaphylactic, life-threatening), skin rash, serum sickness-like reaction. Metabolic disorders: increased activity of amylase and/or blood lipase. Musculoskeletal system: myasthenia gravis, tendinitis (mainly Achilles tendonitis), partial or complete tendon rupture (mainly Achilles tendon). CNS: severe cramps of large muscles, gait instability, psychosis, intracranial hypertension, ataxia, hypersthesia, tic. Skin: petechiae, erythema multiforme, erythema nodosum, Stevens-Johnson syndrome, epidermal necrolysis (Lyell's syndrome), persistent skin rash. Sense organs: parosmia, loss of smell (usually reversible when the drug is discontinued).