Spectracef film-coated pills400mg N10
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Composition Cefditoren 400 mg (in the form of cefditorene pivoxil) Auxiliary substances: mannitol as needed (approximately 70 mg), sodium caseinate 200 mg, croscarmellose sodium 300 mg, sodium tripolyphosphate 8 mg, magnesium stearate 10 mg, Opadry white 55 mg (hypromellose 34.4 mg , titanium dioxide 17.2 mg, macrogol-400 3.4 mg), carnauba wax 0.01 mg, opacode ink blue (shellac IN IMS 74 OP 50.41%, butanol 24.35%, Aluminum varnish based on the dye of blue diamond FCF 11.25%, titanium dioxide 4.49%, propylene glycol 2.91%, isopropanol 4.65%, ammonia (concentrated solution 1.94%). Pharmacological action The mechanism of action of Cefditoren pivoxil, a semisynthetic beta-lactam antibiotic, is a prodrug of cefditoren (third generation cephalosporin). The mechanism of action of the drug is associated with inhibition of the synthesis of the bacterial wall due to its affinity with penicillin-binding proteins. Pharmacokinetic / pharmacodynamic features When administering the drug at a dose of 200 mg 2 times a day, his plasma levels above the minimum inhibitory concentration against 90% of the microorganisms (MPK90) for Moraxella catarrhalis, Haemophilus influenzae, Haemophilus parainfluenzae, Streptococcus pyogenes and sensitive to penicillin Streptococcus strains pneumoniae in for at least 50% of the time from the dosing interval. The purpose of cefditorene in a dose of 400 mg 2 times a day ensures that its concentration is maintained above the IPC for 51% of the dosing interval, which exceeds the BMD in relation to 50% of microorganisms (MPK50) for Streptococcus pneumoniae resistant to penicillin. Mechanisms of resistance Cefditoren as a third-generation cephalosporin has common resistance mechanisms for this group of antibiotics. Gram-positive microorganism resistance may be associated with changes in the penicillin-binding protein of Streptococcus pneumoniae and Streptococcus viridans, or the appearance of an additional penicillin-binding protein (PBP2a) in Staphylococcus spp. Cefditoren is resistant to most of the most common chromosomal and plasmid beta-lactamase gram-negative bacteria. However, like other cephalosporins, cefditoren is hydrolyzed by broad-spectrum beta-lactamases, mediated by plasmids. In addition, the cause of resistance can be the production of chromosomal beta-lactamase in mutant strains of Enterobacter spp., Citrobacter spp., Morganella spp. and Serratia spp. The mechanism of action of cefditoren is similar to other cephalosporin antibiotics and differs from the mechanism of action of other groups of antibiotics.In general, cross-resistance between cefditoren and other antibiotic groups was not observed. However, in rare cases, some mechanisms of action (for example, associated with the impermeability of the inner membrane or with the presence of a mechanism for the active removal of the antibiotic from the cell) may be similar for all groups of antibiotics. This causes a certain level of resistance to all antibiotics. Minimum inhibitory concentration (BMD) Recommended values of BMD for cefditoren, allowing to classify microorganisms with high, intermediate sensitivity and resistance: sensitive - & # 8804. 0.5 mcg / ml, with intermediate sensitivity -> 0.5 mcg / ml and <2 mcg / ml, resistant - & # 8805. 2 mcg / ml. Sensitivity The following provides information on the sensitivity spectrum of most microorganisms for approved indications for use. The prevalence of acquired resistance may vary depending on the geographic area, as well as in individual pathogens. For this reason, it is advisable to obtain information about the sensitivity of microorganisms in a particular region, especially when treating severe infections. In cases where the resistance of pathogens is in doubt, you can seek help from a specialist who will assess the feasibility of prescribing cefditoren in a specific clinical case. Typically, you can find the language of the world. Microorganisms: Clostridium perfringes, Peptostreptococcus spp., Microorganisms with initial cefditoren resistance. Aerobic gram-positive microorganisms: Enterococcus spp., Methicillin-resistant strains of Staphylococcus aureus. Aerobic gram-negative microorganisms: Acinetobacter baumanii, Pseudomonas aeruginosa. Anaerobic microorganisms: Bacteroides fragilis, Clostridium difficile, Other: Chlamydia spp., Mycoplasma spp., Legionella spp. 1- clinical efficacy has been shown for sensitive pathogens according to approved indications. 2 - some strains with high resistance to penicillin may have a reduced sensitivity to cefditoren. Strains resistant to cefotaxime and ceftriaxone should not be considered as sensitive to cefditoren.Gram-negative microorganisms that contain chromosomal beta-lactamases, such as Citrobacter freundii, Enterobacter aerogenes, Enterobacter cloacae, Morganella morganii, Serratia marcescens, should be regarded as resistant to cefditoren, despite their apparent susceptibility in vitro. Dosing and Administration Inside. Tablets should be swallowed whole, drinking plenty of water, preferably after a meal. The recommended dose depends on the severity of the infection, the initial state of the patient and the potential infectious agents. Adults and children over 12 years old Acute pharyngotonsillitis, acute sinusitis and uncomplicated infections of the skin and subcutaneous fat: 200 mg every 12 hours for 10 days. Exacerbation of chronic bronchitis: 200 mg every 12 hours for 5 days. Community-acquired pneumonia: 200 mg every 12 hours for 14 days. In severe cases, a dose of 400 mg is recommended every 12 hours for 14 days. Elderly patients For elderly patients, with the exception of cases of severe abnormal liver function and / or kidney, dose adjustment is not required. Renal impairment In patients with mild renal impairment, dose adjustment is not required. In patients with moderately severe renal failure (creatinine clearance 30-50 ml / min), the recommended dose should not exceed 200 mg twice a day. In patients with severe renal insufficiency (creatinine clearance less than 30 ml / min), the maximum daily dose should not exceed 200 mg. In patients on hemodialysis, the recommended dose has not been established. Liver dysfunction In patients with mild or moderate hepatic dysfunction, dose adjustment is not required (classes A or B by Child-Pugh). In severe hepatic impairment (Child-Pugh class C), no data are available for prescribing the recommended dose. Precautions During the period of treatment may worsen psoriasis. With pheochromocytoma, propranolol can be used only after taking an alpha blocker. After a long course of treatment, propranolol should be discontinued gradually, under the supervision of a physician. Against the background of treatment with propranolol, IV administration of verapamil, diltiazem should be avoided. A few days before anesthesia, you must stop taking propranolol or pick up a remedy for anesthesia with minimal negative inotropic effects.Influence on the ability to drive vehicles and control mechanisms In patients whose activities require increased attention, the question of the use of propranolol on an outpatient basis should be addressed only after evaluating the individual response of the patient. Side Effects The adverse events presented below are listed depending on the anatomical and physiological classification and frequency of occurrence. The frequency of occurrence is determined as follows: very often (& # 8805 .1 / 10), often (& # 8805 .1 / 100 and <1/10), infrequently (& # 8805 .1 / 1000 and <1/100), rarely (& # 8805 .1 / 10 000 and <1/1 000), very rarely (<1/10 000, including individual cases). Metabolism and nutrition: rarely - anorexia. On the part of the nervous system: often - a headache. rarely - nervousness, dizziness, insomnia, drowsiness, sleep disorders. From the organ of vision: very rarely - photosensitivity. On the part of the ENT organs: very rarely - pharyngitis, rhinitis, sinusitis, ringing in the ears. On the part of the respiratory system, organs of the chest and mediastinum: very rarely - bronchospasm. On the part of the gastrointestinal tract: very often - diarrhea. often - nausea, abdominal pain, dyspepsia. rarely - constipation, flatulence, vomiting, oral candidiasis, belching, pseudomembranous colitis, dryness of the oral mucosa, taste perversion. very rarely - aphthous stomatitis. On the part of the liver and biliary tract: rarely - a violation of liver function. From the skin and subcutaneous fat: rare: rash, itching, urticaria. From the musculoskeletal system and connective tissue: very rarely - myalgia. On the part of the genitourinary system: often: candidal vaginitis. rarely - vaginitis, whiter. Other: rarely - fever, asthenia, generalized pain, excessive sweating. From the laboratory parameters: sometimes - leukopenia, thrombocytosis, increasing the concentration of alanine aminotransferase (ALT). rarely - an increase in blood clotting time, hyperglycemia, hypokalemia, bilirubinemia, increased concentrations of aspartate aminotransferase (ACT), alkaline phosphatase, albuminuria. In addition, isolated cases of eosinophilia, thrombocytopenia, a decrease in thromboplastin time, thrombocytopathy, an increase in the concentration of lactate dehydrogenase (LDH), hypoproteinemia and an increase in the concentration of creatinine are described. There have also been individual reports of the following adverse events.From the side of blood-forming organs: hemolytic anemia, lymphadenopathy. From a water and electrolytic exchange: dehydration. On the part of the psyche: dementia, depersonalization, emotional lability, euphoria, hallucinations, thought disorder, increased libido, collapse. The nervous system: amnesia, impaired coordination, muscle hypertonus, meningitis, tremor. On the part of the organ of vision: impaired vision, disorders of the organ of vision, pain in the eyes, blepharitis. Since the cardiovascular system: atrial fibrillation, heart failure, tachycardia, ventricular premature beats, postural hypotension. On the part of the gastrointestinal tract: hemorrhagic colitis, ulcerative colitis, gastrointestinal bleeding, glossitis, hiccups, discoloration of the tongue. On the part of the urinary system: dysuria, pain in the kidneys, nephritis, nocturia, polyuria, urinary incontinence, urinary tract infection. On the part of the urogenital system: pain in the mammary glands, menstrual disorders, metrorrhagia, erectile dysfunction. Others: unpleasant body odor, chills. The following adverse reactions were not recorded as adverse events after cefditorine, but they are characteristic of cephalosporins Allergic reactions: allergic reactions, including Stevens-Johnson syndrome, erythema multiforme, serum sickness, toxic epidermal necrolysis. On the part of the urinary system: renal dysfunction, toxic nephropathy. On the part of the liver and biliary tract: cholestasis. From the side of blood-forming organs: aplastic anemia. Specific guidance When developing a hypersensitivity reaction, treatment should be discontinued, and the patient should be prescribed the necessary treatment. As with the use of other broad-spectrum antibiotics, treatment with cefditorenom can lead to excessive growth of resistant microflora. For this reason, monitoring patients receiving this drug is recommended, especially in the case of long-term treatment. In patients with severe renal failure, it is recommended to periodically monitor renal function. During the course of treatment with cephalosporins, prothrombin activity may decrease.For this reason, in patients at risk (with renal or hepatic insufficiency or in the case of prior administration of anticoagulants), monitoring of prothrombin time is necessary. The development of diarrhea during or after treatment, especially with its severe, persistent nature and the presence of blood impurities, may indicate pseudomembranous colitis. In mild cases of diarrhea, it is enough to discontinue the drug; in more severe cases, antibiotic therapy, to which Clostridium difficile is sensitive, and the appointment of infusion therapy is indicated. Like other cephalosporins, cefditoren can lead to a false-positive result of a direct Coombs test, the detection of glucose in the urine using a copper recovery test, but not using an enzyme test. Because of the high risk of a false-negative result of the ferricyanide glucose test in plasma or blood, it is recommended that, during treatment with cefditorenum, glucose oxidase or glucose hexokinase methods are used to determine glucose concentration in the blood or plasma. The combination of cephalosporins with aminoglycosides and / or loop diuretics, especially in patients with impaired renal function, may increase the risk of nephrotoxicity. Spectraceph contains approximately 13.1 mg (for pills with a dosage of 200 mg) and 26.2 mg (for pills with a dosage of 400 mg) of sodium in each dose, which must be considered when prescribing the drug to patients on a diet low in sodium. Effects on the ability to drive vehicles and control mechanisms No effect of cefditoren pivoxil on the ability to drive and / or other mechanisms was reported. At the same time, it should be borne in mind that taking the drug Spectracef may be accompanied by such undesirable phenomena as vomiting, headache. Use in pregnancy and lactation Pregnancy Clinical data on the use of cefditoren pivoxil in pregnant women have not been obtained. And although animal studies have not shown embryotoxic or teratogenic effects of the drug, Spectracene should not be used during pregnancy unless the expected benefit to the mother outweighs the potential risk to the fetus. Lactation period Data on the penetration of cefditoren in breast milk is not enough. Therefore, when using the drug Spectracef breastfeeding should be discontinued.Type: Medicinal product Amount in a package, pcs: 10 Expiry date: 24 months Active ingredient: Cefditoren Administration route: Oral Vacation schedule: Prescription Release form: Prescription Storage conditions: In a dry place, In a place protected from sun Keep out of reach of children Maximum storage temperature, ° С: 30 Pharmacological group: J01DD16 Cefditoren Minimum age: 12 years
Active ingredients
Release form
Pills
Composition
Cefditoren 400 mg (in the form of cefditorene pivoxil) Excipients: mannitol as needed (approximately 70 mg), sodium caseinate 200 mg, croscarmellose sodium 300 mg, sodium tripolyphosphate 8 mg, magnesium stearate 10 mg, Opadry white 55 mg (hypromellose 34.4 mg, titanium dioxide 17.2 mg, macrogol-400 3.4 mg), carnauba wax 0.01 mg, ink Opacode blue (shellac IN IMS 74 OP 50.41%, butanol 24.35%, Aluminum varnish based on the dye diamond blue FCF 11.25%, titanium dioxide 4.49%, propylene glycol 2.91%, isopropanol 4.65%, ammonia solution concentrated 1.94%).
Pharmacological effect
The mechanism of action of Cefditoren pivoxil, a semisynthetic beta-lactam antibiotic, is a prodrug of cefditoren (a third-generation cephalosporin). The mechanism of action of the drug is associated with inhibition of the synthesis of the bacterial wall due to its affinity with penicillin-binding proteins. Pharmacokinetic / pharmacodynamic features When administering the drug at a dose of 200 mg 2 times a day, his plasma levels above the minimum inhibitory concentration against 90% of the microorganisms (MPK90) for Moraxella catarrhalis, Haemophilus influenzae, Haemophilus parainfluenzae, Streptococcus pyogenes and sensitive to penicillin Streptococcus strains pneumoniae in for at least 50% of the time from the dosing interval. The purpose of cefditorene in a dose of 400 mg 2 times a day ensures that its concentration is maintained above the IPC for 51% of the dosing interval, which exceeds the BMD in relation to 50% of microorganisms (MPK50) for Streptococcus pneumoniae resistant to penicillin. Mechanisms of resistance Cefditoren as a third-generation cephalosporin has common resistance mechanisms for this group of antibiotics. Gram-positive microorganism resistance may be associated with changes in the penicillin-binding protein of Streptococcus pneumoniae and Streptococcus viridans, or the appearance of an additional penicillin-binding protein (PBP2a) in Staphylococcus spp. Cefditoren is resistant to most of the most common chromosomal and plasmid beta-lactamase gram-negative bacteria.However, like other cephalosporins, cefditoren is hydrolyzed by broad-spectrum beta-lactamases, mediated by plasmids. In addition, the cause of resistance can be the production of chromosomal beta-lactamase in mutant strains of Enterobacter spp., Citrobacter spp., Morganella spp. and Serratia spp. The mechanism of action of cefditoren is similar to other cephalosporin antibiotics and differs from the mechanism of action of other groups of antibiotics. In general, cross-resistance between cefditoren and other antibiotic groups was not observed. However, in rare cases, some mechanisms of action (for example, associated with the impermeability of the inner membrane or with the presence of a mechanism for the active removal of the antibiotic from the cell) may be similar for all groups of antibiotics. This causes a certain level of resistance to all antibiotics. Minimum inhibitory concentration (BMD) Recommended values of BMD for cefditoren, allowing to classify microorganisms with high, intermediate sensitivity and resistance: sensitive - & # 8804. 0.5 mcg / ml, with intermediate sensitivity -> 0.5 mcg / ml and <2 mcg / ml, resistant - & # 8805. 2 mcg / ml. Sensitivity The following provides information on the sensitivity spectrum of most microorganisms for approved indications for use. The prevalence of acquired resistance may vary depending on the geographic area, as well as in individual pathogens. For this reason, it is advisable to obtain information about the sensitivity of microorganisms in a particular region, especially when treating severe infections. In cases where the resistance of pathogens is in doubt, you can seek help from a specialist who will assess the feasibility of prescribing cefditoren in a specific clinical case. Typically, you can find the language of the world. Microorganisms: Clostridium perfringes, Peptostreptococcus spp., Microorganisms with initial cefditoren resistance. Aerobic gram-positive microorganisms: Enterococcus spp., Methicillin-resistant strains of Staphylococcus aureus. Aerobic gram-negative microorganisms: Acinetobacter baumanii, Pseudomonas aeruginosa.Anaerobic microorganisms: Bacteroides fragilis, Clostridium difficile, Other: Chlamydia spp., Mycoplasma spp., Legionella spp. 1- clinical efficacy has been shown for sensitive pathogens according to approved indications. 2 - some strains with high resistance to penicillin may have a reduced sensitivity to cefditoren. Strains resistant to cefotaxime and ceftriaxone should not be considered as sensitive to cefditoren. Gram-negative microorganisms that contain chromosomal beta-lactamases, such as Citrobacter freundii, Enterobacter aerogenes, Enterobacter cloacae, Morganella morganii, Serratia marcescens, should be regarded as resistant to cefditoren, despite their apparent susceptibility in vitro.
Indications
Treatment of infections caused by microorganisms sensitive to cefditoren: - infections of the upper respiratory tract: acute tonsillopharyngitis, acute sinusitis. - lower respiratory tract infections: exacerbation of chronic bronchitis, community-acquired pneumonia. - uncomplicated infections of the skin and subcutaneous fatty tissue: phlegmon, infected skin wounds, abscess, folliculitis, impetigo and furunculosis.
Contraindications
- hypersensitivity to cefditoren, other cephalosporins or any other component of the drug. - severe allergic reactions to penicillins and other beta-lactam antibacterial drugs. - hepatic failure class C on Child-Pugh. - patients on hemodialysis. - hypersensitivity reactions to protein casein in history. - primary carnitine deficiency. - children's age up to 12 years. - simultaneous use of cefditorene pivoxil and histamine H2 receptor blockers. With care: patients with hypersensitivity to other beta-lactam antibiotics due to the possibility of the development of cross-allergic reactions. simultaneous use with aminoglycosides and diuretics (furosemide). patients with pathology of the gastrointestinal tract (including history of colitis).
Use during pregnancy and lactation
Pregnancy Clinical data on the use of cefditoren pivoxil in pregnant women are not available. And although animal studies have not shown embryotoxic or teratogenic effects of the drug, Spectracene should not be used during pregnancy unless the expected benefit to the mother outweighs the potential risk to the fetus. Lactation period Data on the penetration of cefditoren in breast milk is not enough. Therefore, when using the drug Spectracef breastfeeding should be discontinued.
Dosage and administration
Inside Tablets should be swallowed whole, drinking plenty of water, preferably after a meal. The recommended dose depends on the severity of the infection, the initial state of the patient and the potential infectious agents. Adults and children over 12 years old Acute pharyngotonsillitis, acute sinusitis and uncomplicated infections of the skin and subcutaneous fat: 200 mg every 12 hours for 10 days. Exacerbation of chronic bronchitis: 200 mg every 12 hours for 5 days. Community-acquired pneumonia: 200 mg every 12 hours for 14 days. In severe cases, a dose of 400 mg is recommended every 12 hours for 14 days. Elderly patients For elderly patients, with the exception of cases of severe abnormal liver function and / or kidney, dose adjustment is not required. Renal impairment In patients with mild renal impairment, dose adjustment is not required. In patients with moderately severe renal failure (creatinine clearance 30-50 ml / min), the recommended dose should not exceed 200 mg twice a day. In patients with severe renal insufficiency (creatinine clearance less than 30 ml / min), the maximum daily dose should not exceed 200 mg. In patients on hemodialysis, the recommended dose has not been established. Liver dysfunction In patients with mild or moderate hepatic dysfunction, dose adjustment is not required (classes A or B by Child-Pugh). In severe hepatic impairment (Child-Pugh class C), no data are available for prescribing the recommended dose.
Side effects
The adverse events presented below are listed depending on the anatomical and physiological classification and frequency of occurrence. The frequency of occurrence is determined as follows: very often (& # 8805 .1 / 10), often (& # 8805 .1 / 100 and <1/10), infrequently (& # 8805 .1 / 1000 and <1/100), rarely (& # 8805 .1 / 10 000 and <1/1 000), very rarely (<1/10 000, including individual cases). Metabolism and nutrition: rarely - anorexia. On the part of the nervous system: often - a headache. rarely - nervousness, dizziness, insomnia, drowsiness, sleep disorders. From the organ of vision: very rarely - photosensitivity. On the part of the ENT organs: very rarely - pharyngitis, rhinitis, sinusitis, ringing in the ears. On the part of the respiratory system, organs of the chest and mediastinum: very rarely - bronchospasm.On the part of the gastrointestinal tract: very often - diarrhea. often - nausea, abdominal pain, dyspepsia. rarely - constipation, flatulence, vomiting, oral candidiasis, belching, pseudomembranous colitis, dryness of the oral mucosa, taste perversion. very rarely - aphthous stomatitis. On the part of the liver and biliary tract: rarely - a violation of liver function. From the skin and subcutaneous fat: rare: rash, itching, urticaria. From the musculoskeletal system and connective tissue: very rarely - myalgia. On the part of the genitourinary system: often: candidal vaginitis. rarely - vaginitis, whiter. Other: rarely - fever, asthenia, generalized pain, excessive sweating. From the laboratory parameters: sometimes - leukopenia, thrombocytosis, increasing the concentration of alanine aminotransferase (ALT). rarely - an increase in blood clotting time, hyperglycemia, hypokalemia, bilirubinemia, increased concentrations of aspartate aminotransferase (ACT), alkaline phosphatase, albuminuria. In addition, isolated cases of eosinophilia, thrombocytopenia, a decrease in thromboplastin time, thrombocytopathy, an increase in the concentration of lactate dehydrogenase (LDH), hypoproteinemia and an increase in the concentration of creatinine are described. There have also been individual reports of the following adverse events. From the side of blood-forming organs: hemolytic anemia, lymphadenopathy. From a water and electrolytic exchange: dehydration. On the part of the psyche: dementia, depersonalization, emotional lability, euphoria, hallucinations, thought disorder, increased libido, collapse. The nervous system: amnesia, impaired coordination, muscle hypertonus, meningitis, tremor. On the part of the organ of vision: impaired vision, disorders of the organ of vision, pain in the eyes, blepharitis. Since the cardiovascular system: atrial fibrillation, heart failure, tachycardia, ventricular premature beats, postural hypotension. On the part of the gastrointestinal tract: hemorrhagic colitis, ulcerative colitis, gastrointestinal bleeding, glossitis, hiccups, discoloration of the tongue. On the part of the urinary system: dysuria, pain in the kidneys, nephritis, nocturia, polyuria, urinary incontinence, urinary tract infection.On the part of the urogenital system: pain in the mammary glands, menstrual disorders, metrorrhagia, erectile dysfunction. Others: unpleasant body odor, chills. The following adverse reactions were not recorded as adverse events after cefditorine, but they are characteristic of cephalosporins Allergic reactions: allergic reactions, including Stevens-Johnson syndrome, erythema multiforme, serum sickness, toxic epidermal necrolysis. On the part of the urinary system: renal dysfunction, toxic nephropathy. On the part of the liver and biliary tract: cholestasis. From the side of blood-forming organs: aplastic anemia.
special instructions
The adverse events presented below are listed depending on the anatomical and physiological classification and frequency of occurrence. The frequency of occurrence is determined as follows: very often (& # 8805 .1 / 10), often (& # 8805 .1 / 100 and <1/10), infrequently (& # 8805 .1 / 1000 and <1/100), rarely (& # 8805 .1 / 10 000 and <1/1 000), very rarely (<1/10 000, including individual cases). Metabolism and nutrition: rarely - anorexia. On the part of the nervous system: often - a headache. rarely - nervousness, dizziness, insomnia, drowsiness, sleep disorders. From the organ of vision: very rarely - photosensitivity. On the part of the ENT organs: very rarely - pharyngitis, rhinitis, sinusitis, ringing in the ears. On the part of the respiratory system, organs of the chest and mediastinum: very rarely - bronchospasm. On the part of the gastrointestinal tract: very often - diarrhea. often - nausea, abdominal pain, dyspepsia. rarely - constipation, flatulence, vomiting, oral candidiasis, belching, pseudomembranous colitis, dryness of the oral mucosa, taste perversion. very rarely - aphthous stomatitis. On the part of the liver and biliary tract: rarely - a violation of liver function. From the skin and subcutaneous fat: rare: rash, itching, urticaria. From the musculoskeletal system and connective tissue: very rarely - myalgia. On the part of the genitourinary system: often: candidal vaginitis. rarely - vaginitis, whiter. Other: rarely - fever, asthenia, generalized pain, excessive sweating. From the laboratory parameters: sometimes - leukopenia, thrombocytosis, increasing the concentration of alanine aminotransferase (ALT). rarely - an increase in blood clotting time, hyperglycemia, hypokalemia, bilirubinemia, increased concentrations of aspartate aminotransferase (ACT), alkaline phosphatase, albuminuria.In addition, isolated cases of eosinophilia, thrombocytopenia, a decrease in thromboplastin time, thrombocytopathy, an increase in the concentration of lactate dehydrogenase (LDH), hypoproteinemia and an increase in the concentration of creatinine are described. There have also been individual reports of the following adverse events. From the side of blood-forming organs: hemolytic anemia, lymphadenopathy. From a water and electrolytic exchange: dehydration. On the part of the psyche: dementia, depersonalization, emotional lability, euphoria, hallucinations, thought disorder, increased libido, collapse. The nervous system: amnesia, impaired coordination, muscle hypertonus, meningitis, tremor. On the part of the organ of vision: impaired vision, disorders of the organ of vision, pain in the eyes, blepharitis. Since the cardiovascular system: atrial fibrillation, heart failure, tachycardia, ventricular premature beats, postural hypotension. On the part of the gastrointestinal tract: hemorrhagic colitis, ulcerative colitis, gastrointestinal bleeding, glossitis, hiccups, discoloration of the tongue. On the part of the urinary system: dysuria, pain in the kidneys, nephritis, nocturia, polyuria, urinary incontinence, urinary tract infection. On the part of the urogenital system: pain in the mammary glands, menstrual disorders, metrorrhagia, erectile dysfunction. Others: unpleasant body odor, chills. The following adverse reactions were not recorded as adverse events after cefditorine, but they are characteristic of cephalosporins Allergic reactions: allergic reactions, including Stevens-Johnson syndrome, erythema multiforme, serum sickness, toxic epidermal necrolysis. On the part of the urinary system: renal dysfunction, toxic nephropathy. On the part of the liver and biliary tract: cholestasis. From the side of blood-forming organs: aplastic anemia.