CIFRAN ST 500mg+600mg 10 pcs. film-coated tablets

Tsifran st 500mg+600mg 10 pcs. film-coated tablets

pharmachologic effect

Combined drug.
Tinidazole is an antiprotozoal and antimicrobial agent, an imidazole derivative, effective against anaerobic microorganisms such as Clostridium difficile, Clostridium perfringens, Bacteroides fragilis, Peptococcus and Peptostreptococcus anaerobius. ; Ciprofloxacin is a broad-spectrum antibiotic, active against most aerobic gram-positive and gram-negative microorganisms, such as Escherichia coli, Klebsiella spp., Salmonella typhi and other strains of Salmonella, Proteus mirabilis, Proteus vulgaris, Yersinia enterocoilitica, Pseudomonas aeruginosa, Shigella sonflexneri, Shigella nei , Haemophilus ducreyi, Haemophilus influenzae, Neisseria gonorrhoeae, Moraxella catarrhalis, Vibrio cholerae, Bacteroides fragilis, Staphylococcus aureus (including methicillin-resistant strains), Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Mycoplasma, Legionella and Mycobacterium tuberculosis .

Composition and release form Tsifran st 500mg+600mg 10 pcs. film-coated tablets

Tablets - 1 tablet: ciprofloxacin (in the form of monohydrate hydrochloride) 500 mg, tinidazole 600 mg.

10 pieces. — cellular contour packages (1) — cardboard packs.

Description of the dosage form

Film-coated tablets.

Characteristic

Antimicrobial combination agent.

Directions for use and doses

Inside, after meals, with plenty of water. Do not break, chew, or crush the tablet.

Recommended dose: tablets with a ciprofloxacin/tinidazole ratio of 250/300 mg - 2 tablets. 2 times/day, 500/600 mg - 1 tablet. 2 times/day.

Pharmacodynamics

Tinidazole is effective against anaerobic microorganisms such as Clostridium difficile, Clostridium perfringens, Bacteroides fragilis, Peptococcus, Peptostreptococcus anaerobius. In an anaerobic infection, a mixture of anaerobic and aerobic bacteria is most often present. Therefore, in case of mixed anaerobic infection, an antibiotic active against aerobic bacteria is added to therapy. Tinidazole is also effective against protozoa (Trichomonas vaginalis, Lamblia intestinalis, Entamoeba histolytica. Ciprofloxacin is a broad-spectrum antibiotic, active against most aerobic gram-positive and gram-negative microorganisms, including Escherichia coli, Klebsiella spp., Salmonella typhi and other strains Salmonella, Proteus mirabilis, Proteus vulgaris, Yersinia enterocolitica, Pseudomonas aeruginosa, Shigella flexneri, Shigella sonnei, Haemophilus ducreyi, Haemophilus influenzae, Neisseria gonorrhoeae, Moraxella catarrhalis, Vibrio cholerae, Bacteroides fragilis, Staphylococcus aureus (including met cillin-resistant strains), Staphylococcus epidermidis , Streptococcus pyogenes, Streptococcus pneumoniae, Chlamydia, Mycoplasma, Legionella and Mycobacterium tuberculosis.

Pharmacokinetics

Both ciprofloxacin and tinidazole are well absorbed from the gastrointestinal tract after oral administration. The time to reach C max for each component is 1-2 hours. The drug quickly penetrates the body tissues, reaching high concentrations there. It is found in high concentrations in saliva, nasal and bronchial secretions, semen, lymph, peritoneal fluid, bile and prostate secretions.

Bioavailability of tinidazole is 100%, protein binding is 12%. T1/2 ;- 12-14 hours. Tinidazole penetrates into the cerebrospinal fluid in a concentration equal to that in plasma and is reabsorbed in the renal tubules. Tinidazole is excreted into bile in concentrations slightly below 50% of its plasma concentration. About 25% is excreted unchanged in the urine, 12% in the form of metabolites. Minor amounts are excreted in the feces.

The bioavailability of ciprofloxacin is about 70%. Concomitant food intake slows down absorption. Connection with proteins - 20-40%. Ciprofloxacin penetrates well into fluids and tissues of the body: lungs, skin, fat, muscle and cartilage tissue, as well as bone tissue and organs of the urinary system, including the prostate gland. Ciprofloxacin is partially metabolized in the liver. T1/2; - about 3.5-4.5 hours, can be prolonged with severe renal failure and in elderly patients. About 50% is excreted unchanged in the urine, 15% is excreted in the form of active metabolites (including oxoprofloxacin). The rest is excreted in bile, partially reabsorbed. About 15-30% of ciprofloxacin is excreted in the feces.

Indications for use Tsifran st 500mg+600mg 10 pcs. film-coated tablets

Mixed infections caused by sensitive anaerobic and aerobic microorganisms:

chronic sinusitis;
lung abscess;
empyema;
intra-abdominal infections;
inflammatory gynecological diseases;
postoperative infections with the possible presence of aerobic and anaerobic bacteria;
chronic osteomyelitis;
skin and soft tissue infections;
skin ulcers in diabetic foot;
bedsores;
Oral infections (including periodontitis and periostitis).

Diarrhea or dysentery of amoebic or mixed (amebic and bacterial) etiology.

Contraindications

Hypersensitivity (including to fluoroquinolone or imidazole derivatives);
blood diseases (history);
inhibition of bone marrow hematopoiesis;
acute porphyria;
organic diseases of the central nervous system;
age under 18 years;
pregnancy;
lactation period.

With caution: severe cerebral atherosclerosis, cerebrovascular accident, mental illness, epilepsy, history of seizures, severe renal and/or liver failure, old age.

Application of Tsifran st 500mg+600mg 10 pcs. film-coated tablets during pregnancy and breastfeeding

The use of the drug during pregnancy is not recommended. Tinidazole may be carcinogenic and mutagenic. Ciprofloxacin penetrates the placental barrier.

Tinidazole and ciprofloxacin are excreted into breast milk. Therefore, if it is necessary to use the drug during lactation, breastfeeding should be stopped.

Use in children

Contraindicated in children and adolescents under 18 years of age.

special instructions

It is recommended to avoid excessive exposure to sunlight during treatment. If photosensitivity reactions occur, you should immediately stop using the drug.

When using tinidazole (imidazole derivative), it is possible (rarely) to develop generalized urticaria, swelling of the face and larynx, decreased blood pressure, bronchospasm and dyspnea. Therefore, patients with hypersensitivity to other imidazole derivatives may develop cross-sensitivity to tinidazole; the development of a cross-allergic reaction to ciprofloxacin is also possible in patients with hypersensitivity to other fluoroquinolone derivatives. The possibility of cross-allergic reactions should be taken into account.

During the treatment period, it is not recommended to take ethanol (risk of developing disulfiram-like reactions against the background of tinidazole, which is part of the drug).

To avoid the development of crystalluria, the recommended daily dose should not be exceeded; sufficient fluid intake and maintaining an acidic urine reaction are also necessary. Causes dark coloration of urine, which has no clinical significance.

For patients with epilepsy, a history of seizures, vascular diseases and organic brain damage, due to the risk of developing adverse reactions from the central nervous system, the drug should be prescribed only for health reasons.

If severe and prolonged diarrhea occurs during or after treatment, the diagnosis of pseudomembranous colitis should be excluded, which requires immediate discontinuation of the drug and the appointment of appropriate treatment.

If pain appears in the tendons or when the first signs of tenosynovitis appear, treatment should be stopped.

During treatment, peripheral blood patterns should be monitored.

During treatment, you should refrain from engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

Treatment: induction of vomiting, gastric lavage. Symptomatic, supportive therapy (including adequate hydration of the body). There is no specific antidote.

Side effects Tsifran st 500mg+600mg 10 pcs. film-coated tablets

From the digestive system: decreased appetite, dry oral mucosa, “metallic” taste in the mouth, nausea, vomiting, diarrhea, abdominal pain, flatulence, cholestatic jaundice (especially in patients with previous liver diseases), hepatitis, hepatonecrosis.

From the central nervous system and peripheral nervous system: headache, dizziness, fatigue, impaired coordination of movements (including locomotor ataxia), dysarthria, peripheral neuropathy, rarely - convulsions, weakness, tremor, insomnia, increased intracranial pressure, confusion. , depression, hallucinations, as well as other manifestations of psychotic reactions, migraine, thrombosis of cerebral arteries.

From the senses: disturbances of taste and smell, visual impairment (diplopia, changes in color vision), tinnitus, hearing loss.

From the cardiovascular system: tachycardia, arrhythmia, decreased blood pressure, fainting.

From the hematopoietic organs: leukopenia, granulocytopenia, anemia (including hemolytic), thrombocytopenia, leukocytosis, thrombocytosis.

From the urinary system: hematuria, crystalluria (with an alkaline reaction of urine and decreased diuresis), glomerulonephritis, dysuria, polyuria, urinary retention, decreased nitrogen excretory function of the kidneys, interstitial nephritis.

Allergic reactions: skin itching, urticaria, skin rash, drug fever, petechiae, swelling of the face or larynx, shortness of breath, eosinophilia, photosensitivity, vasculitis, erythema nodosum, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome).

From the laboratory parameters: hypoprothrombinemia, increased activity of liver transminases and alkaline phosphatase, hypercreatininemia, hyperbilirubinemia, hyperglycemia.

Other: arthralgia, arthritis, tenosynovitis, tendon ruptures, asthenia, myalgia, superinfections (candidiasis, pseudomembranous colitis), flushing of the face, increased sweating.

Drug interactions

Tinidazole.

Enhances the effect of indirect anticoagulants (to reduce the risk of bleeding, the dose is reduced by 50%) and the effect of ethanol (disulfiram-like reactions).

Compatible with sulfonamides and antibiotics (aminoglycosides, erythromycin, rifampicin, cephalosporins).

Not recommended for use with ethionamide.

Phenobarbital speeds up metabolism.

Ciprofloxacin.

Due to a decrease in the activity of microsomal oxidation processes in hepatocytes, it increases the concentration and lengthens T1/2 of theophylline (and other xanthines, including caffeine), oral hypoglycemic drugs, indirect anticoagulants, and helps reduce the prothrombin index.

When combined with other antimicrobial drugs (beta-lactam antibiotics, aminoglycosides, clindamycin, metronidazole), synergism is usually observed.

Enhances the nephrotoxic effect of cyclosprorine, there is an increase in serum creatinine, in such patients it is necessary to monitor this indicator 2 times a week.

Oral administration together with iron-containing drugs, sucralfate and antacid drugs containing magnesium, calcium, 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.

NSAIDs (excluding acetylsalicylic acid) increase the risk of seizures.

Didanosine reduces the absorption of ciprofloxacin due to the formation of complexes with the magnesium and aluminum ions contained in didanosine.

Metoclopramide accelerates absorption, which leads to a decrease in the time to reach Cmax.

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

Tsifran ST

Tsifran ST (tinidazole + ciprofloxacin) is a combined antibacterial drug. Used for the treatment of combined aerobic and anaerobic invasions, as well as bacterial invasions of the gastrointestinal tract (chronic inflammation of the sinuses, abscess pneumonia, pyothorax, infections that develop when the anatomical barriers of the gastrointestinal tract are violated, gynecological infections, infections after surgical interventions, purulent-necrotic process in the bone tissue, dermatological infections, oral infections, amoebic and/or bacterial diarrhea and dysentery). Anaerobes - clostridia, bacteroides, peptococci and peptostreptococci - are sensitive to tinidazole. In most cases, in the presence of an anaerobic infection, aerobes are also present in the lesion, therefore, to increase efficiency, an antibacterial drug effective against aerobes is added. In Cifran ST, this is ciprofloxacin, sensitivity to which is shown by such aerobes as Escherichia coli, Klebsiella, Salmonella, Yersinia, Shigella, Haemophilus influenzae, Neisseria, mycoplasma, Vibrio cholerae, staphylococcus, streptococcus, chlamydia, mycoplasma, legionella, mycobacterium tuberculosis. Tinidazole and ciprofloxacin are rapidly absorbed from the digestive tract. Maximum concentrations of both substances are observed 1-2 hours after administration. The half-life of tinidazole is 12-14 hours. The drug has good penetrating ability.

It is excreted mainly in urine and in small quantities in feces. The presence of food contents in the gastrointestinal tract slows down the absorption of ciprofloxacin. Half-life is 3.5-4.5 hours. Cifran ST is not used in persons with individual intolerance to tinidazole and/or ciprofloxacin, as well as any other fluoroquinolone or imidazole antibiotics, or organic lesions of the nervous system. In pediatrics, Tsifran ST is not used. It is not recommended to use the drug in pregnant women and nursing mothers. The optimal time to take the drug is after meals. The structure of the tablet does not imply its breaking, chewing or any other violation of integrity. The tablet should be taken with a sufficient amount of water so that it can easily reach the site of absorption. The frequency of taking the drug is twice a day. The number of tablets per dose is determined by the dose of the drug: 2 tablets (for a dose of 250/300 mg) and 1 tablet (for a dose of 500/600 mg). During the drug course, it is recommended to avoid prolonged exposure to the sun in order to avoid phototoxicity reactions (if any develop, it is necessary to immediately interrupt pharmacotherapy). It is strictly not recommended to combine Tsifran ST with alcohol consumption, because ethanol in combination with tinidazole can provoke gastrointestinal spasms and dyspeptic reactions in the form of nausea and vomiting. During the course of medication, it is recommended to periodically do blood tests.

Tsifran od tab p/o film prolong. 500 mg 10 pcs

Pharmacological group:

Antimicrobial agent - fluoroquinolone.
Pharmacodynamics:
The bactericidal effect of fluoroquinolones is due to inhibition of the bacterial enzyme topoisomerase II (DNA gyrase). Topoisomerase II is required for normal bacterial DNA replication. This ATP-dependent process, in the absence of topoisomerase II, leads to uncontrolled replication of damaged DNA, and, consequently, to disruption of the synthesis of normal proteins in the bacterial cell. Ciprofloxacin has pronounced in vitro activity against a wide range of gram-negative and gram-positive bacteria. Ciprofloxacin acts on both reproducing and dormant microorganisms. As revealed by in vitro studies and use in clinical studies, ciprofloxacin is active against most strains of microorganisms: gram-positive (Bacillus anthracis, Enterococcus faecalis (most strains are relatively sensitive), Lysteria monocytogenes, Staphylococcus epidermidis, Staphylococcus saprophyticus). Staphylococcus aureus (methicillin-sensitive and penicillinase-producing strains, partially methicillin-resistant strains), Streptococcus pneumoniae, Streptococcus pyogenes; aerobic gram-negative (Campylobacter jejuni, Citrobacter diversus, Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluehzae, Klebsiella pneumoniae, Moraxella catarrhalis, Morganella morganii, Neisseria gonorrhoeae, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Pseudomonas aeruginosa, Salmonella typhi , Serratia marcescens, Shigella boydii, Shigella dysenteriae, Shigella flexneri, Shigella sonnei). In vitro studies showed ciprofloxacin at a minimum inhibitory concentration (MIC) of 90%) for the strains of the following microorganisms, but the clinical significance of these data is still being determined. Aerobic gram-positive: Staphylococcus haemolyticus, Staphylococcus hominis, Streptococcus pneumoniae. Aerobic gram-negative: Acinetobacter lwoffii, Aeromonas hydrophilia, Edwardsiella tarda, Klebsiella oxytoca, Legionella pneumophila, Salmonella enteritidis, Vibrio cholerae, Vibrio parahaemolyticus, Vibrio vulnificus, Yersinia enterocolitica. Other microorganisms: Mycobacterium tuberculosis (relatively sensitive). 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:

Pharmacokinetics: absorption: after oral administration, ciprofloxacin is rapidly absorbed from the gastrointestinal tract. Cifran® OD tablets provide a long-lasting, uniform release of ciprofloxacin, and the drug is taken only once a day. One dose of Cifran® OD 500 mg and Cifran® OD 1000 mg are able to maintain the required concentration of ciprofloxacin, which in other cases is provided by double use of conventional ciprofloxacin 250 mg or 500 mg, respectively: distribution: after administration of a single dose, maximum plasma concentrations (Cmax) are achieved in for 6 hours and are 1.3±0.4 μg/ml and 2.4±0.7 μg/ml for Cifran® OD 500 mg and Cifran® OD 1000 mg, respectively. The corresponding values of the area under the pharmacokinetic curve (AUC0-t) are 83±2.1 and 18.9±4.6 mcg*ml/h. Plasma protein binding ranges from 20% to 40%. Ciprofloxacin penetrates well into tissues and fluids of the body: lungs, skin, adipose tissue, muscles, cartilage and bone tissue, prostate gland, saliva, secretions of the mucous membrane of the nasal cavity and bronchi, sperm, lymph, peritoneal fluid and prostate secretions. Metabolism: ciprofloxacin is partially metabolized in the liver. Excretion: about 50% of the dose taken orally is excreted by the kidneys unchanged and about 15% in the form of active metabolites. Approximately 20-35% of the dose taken is excreted in the intestines. The half-life (T1/2) of Cifran® OD is about 6.5-7.5 hours. T1/2 can be prolonged with severe renal failure and in elderly people. Special patient groups

In case of impaired renal function: In patients with slightly impaired renal function, the half-life of ciprofloxacin may be slightly increased. In this case, it is necessary to correct the dosage regimen (See “Method of administration and dosage”). In case of impaired liver function: In preliminary studies in patients with stable liver cirrhosis, no significant changes in the pharmacokinetics of ciprofloxacin were noted. However, studies on the kinetics of ciprofloxacin in patients with acute liver failure have not been conducted.