Cefixime in the treatment of bacterial infections: issues of effectiveness and safety

Release form and composition

The dosage form of Cefixime EXPRESS is dispersible tablets: biconvex, oval, with a dividing line on one side; the color of the tablets is yellow with a pink tint, with white and red inclusions; have a specific strawberry aroma (7 pcs each in blister packs, one package and instructions for medical use in a cardboard box; 21 pcs each in polypropylene bottles, sealed with high-density polyethylene caps with a capsule insert with silica gel and an outer ring that provides control first opening, in a cardboard box one bottle and instructions for use of Cefixime EXPRESS).

Composition for 1 dispersible tablet:

• active ingredient: cefixime – 400 mg (in the form of cefixime trihydrate – 447.7 mg);
• auxiliary components: microcrystalline cellulose (MCC) 102, colloidal silicon dioxide (Aerosil), low-substituted hydroxypropylcellulose (hyprolose), polyvinylpyrrolidone (povidone) K30, saccharin, magnesium stearate, sunset yellow dye (E110), strawberry flavoring*.

*Flavor composition: [maltodextrin, natural flavors, triacetin (E1518), gum arabic (E414), 1,2-propylene glycol (E1520), acetic acid (E260)] or [natural flavors, propylene glycol (E1520), ethanol].

Pharmacological properties

Pharmacodynamics

The active substance of Cefixime EXPRESS is a semisynthetic antibiotic of the third generation cephalosporin group - cefixime. It has a wide spectrum of antimicrobial bactericidal action, the mechanism of which is associated with inhibition of the synthesis of bacterial cell walls. Shows resistance to the action of beta-lactamases produced by the majority of both gram-positive and gram-negative bacteria.

The antimicrobial activity of cefixime has been confirmed by clinical observations and in vitro studies against Streptococcus pyogenes, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae, Proteus mirabilis.

In addition, in vitro it is active against gram-positive (Streptococcus agalactiae) and gram-negative (Citrobacter diversus, Citrobacter amalonaticus, Haemophilus parainfluenzae, Klebsiella oxytoca, Klebsiella pneumoniae, Pasteurella multocida, Proteus vulgaris, Providencia spp., Salmonella spp., Shigella spp.) bacteria.

Resistance to the drug is shown by: Enterococcus spp., Clostridium spp., Pseudomonas spp., Listeria monocytogenes, Staphylococcus spp. (including methicillin-resistant strains), Bacteroides fragilis and most strains of Enterobacter spp.

Pharmacokinetics

Main pharmacokinetic characteristics of cefixime:

• absorption: after oral administration, the bioavailability of the substance is 40–50%. Cmax (maximum concentration) in blood plasma is reached in adult patients after 3–4 hours and is 1.49–3.25 mcg/ml and 2.5–4.9 mcg/ml for 200 and 400 mg of cefixime, respectively. Food intake does not have a significant effect on bioavailability and absorption from the digestive tract;
• distribution: when taking the drug at a dose of 200 mg, Vd (volume of distribution) is 6.7 l, upon reaching equilibrium concentration it increases to 16.8 l. Cefixime binds to plasma proteins, mainly albumin, at a level of ~ 65%, the highest levels are observed in urine and bile. Penetrates the placental barrier, the concentration in the blood of the umbilical cord is from 1/6 to 1/2 of that in the maternal blood plasma; the substance is not detected in breast milk;
• metabolism and excretion: cefixime is not metabolized in the liver; from 50 to 55% of the dose taken unchanged is excreted in the urine within 24 hours; about 10% is excreted in bile. In adults and children, T1/2 (half-life) is 3–4 hours.

Pharmacokinetics of cefixime in special clinical situations:

• Impaired renal function: an increase in T1/2 can be expected, resulting in an increase in plasma concentration and a slowdown in renal elimination. In patients with CC (creatinine clearance) 30 ml/min after taking 400 mg of cefixime, T1/2 increases to 7–8 hours, Cmax in plasma is ~ 7.53 μg/ml, about 5.5% is excreted in urine over 24 hours substances;
• impaired liver function: in patients with liver cirrhosis, T1/2 increases to 6.4 hours, TCmax (time to reach Cmax) increases to 5.2 hours; at the same time, the proportion of the drug excreted by the kidneys becomes larger. Cmax and AUC (area under the pharmacokinetic concentration-time curve) do not change.

Cefixime
International name of the medicinal substance:
Cefixime The list of drugs containing the active substance Cefixime is given after the description.
Pharmacological action:
III generation cephalosporin antibiotic for parenteral use.
Acts bactericidal (disturbs the synthesis of the cell wall of microorganisms). It has a wide spectrum of action, which includes various aerobic and anaerobic gram-positive and gram-negative microorganisms, incl. Pseudomonas aeruginosa. Resistant to beta-lactamases of both gram-positive and gram-negative microorganisms. Highly active against Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis (including strains producing beta-lactamases), Escherichia coli, Proteus mirabilis, Proteus vulgaris, Neisseria gonorrhoeae, Klebsiella pneumonia e, Klebsiella oxytoca, Pasteurella multocida, Providencia spp., Salmonella spp., Shigella spp., Citrobacter spp. (including Citrobacter diversus), Serratia marcescens. Pseudomonas spp., Acinetobacter spp., some strains of Streptococcus, Enterococcus spp. (methicillin-resistant strains), Listeria monocytogenes, Bacteroides fragilis, most strains of Staphylococcus, Enterobacter and Clostridium are resistant to cefixime. Pharmacokinetics:
When taken orally, bioavailability is 40-50%. Food increases the time of maximum absorption by 0.8 hours. TCmax is 2-6 hours for tablets and suspension 400 mg/5 ml and 2-5 hours for suspension 200 mg/5 ml. Cmax after oral administration of 100, 200 and 400 mg is 1-1.3, 2-3 and 3.5-4.4 mcg/ml, respectively. After taking the suspension, Cmax is 25-50% higher (due to the difference in bioavailability, it is not recommended to replace the suspension with tablets when treating otitis media). Cmax in urine after taking doses of 100, 200 and 400 mg is 73, 107 and 164 mcg/ml, respectively. High concentrations of the drug remain for a long time in blood serum, bile, and urine. T1/2 - 3-4 hours, in case of renal failure - 6.4-11.5 hours. Volume of distribution - 0.11 l/kg. Bonding with plasma proteins is 65-70%. Excreted unchanged by the kidneys - 50%, with bile - 10%.

Indications:
Bacterial infections of the upper and lower respiratory tract (pharyngitis, tonsillitis, sinusitis, acute bronchitis and exacerbation of chronic bronchitis), urinary tract (uncomplicated);
otitis media, uncomplicated gonorrhea of ​​the urethra and cervix. Contraindications:
Hypersensitivity, incl.
to penicillins, penicillamine, children's age (up to 6 months), lactation period. Side effects:
Allergic reactions: urticaria, skin hyperemia, skin itching, itching in the genital area, eosinophilia, fever, exudative erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome).
From the nervous system: headache, dizziness, tinnitus. From the genitourinary system: vaginitis. From the urinary system: impaired renal function, interstitial nephritis. From the digestive system: nausea, vomiting, stomatitis, diarrhea, abdominal pain, constipation, pseudomembranous colitis, dysbacteriosis, cholestasis; cholestatic jaundice. From the hematopoietic organs: pancytopenia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, aplastic anemia, hemolytic anemia, bleeding. Laboratory indicators: increased activity of liver transaminases and alkaline phosphatase, hyperbilirubinemia, increased urea nitrogen, hypercreatininemia, increased prothrombin time. Other: candidiasis, development of hypovitaminosis B, shortness of breath. Special instructions:
Patients with a history of allergic reactions to penicillins may have increased sensitivity to cephalosporin antibiotics.
During treatment, a false-positive direct Coombs reaction and a false-positive urine reaction to ketonuria and glucose are possible. Preparations containing the active substance Cefixime:
Zimax, Ixim Lupin, Pancef, Suprax, Suprax Solutab, Tsemidexor, Ceforal Solutab, Cefspan

The information provided in this section is intended for medical and pharmaceutical professionals and should not be used for self-medication. The information is provided for informational purposes only and cannot be considered official.

Contraindications

Absolute:

• chronic renal failure in children;
• the child's body weight is less than 25 kg;
• breastfeeding period;
• established hypersensitivity to antibacterial drugs of the cephalosporin or penicillin group;
• hypersensitivity to the active or auxiliary components in the composition of dispersible tablets.

Cefixime EXPRESS should be used with caution in case of renal failure, colitis (history), during pregnancy and in old age.

Spectrum of action

The activity of drugs from the cephalosporin group gradually changes from generation to generation:

• Medicines of 1-2 generations are most effective against infection with gram-positive flora (staphylo- and streptococci, corynebacteria).
• For the 3rd and 5th generations of cephalosporins, there is already an increased activity against gram-negative bacteria (Enterobacter, Haemophilus influenzae, gonococcus, meningococcus, Klebsiella, Moraxella, Proteus) and anaerobes (peptococcus, peptostreptococcus, clostridia, bacteroides) along with high efficiency against gram-positive flora. In addition, ceftazidime and cefixime are harmful to Pseudomonas aeruginosa.
• 4th generation cephalosporins are different: their effect is maximum for gram-negative bacteria, while cefepime also has an antipseudomonas effect.

Antibiotics from the cephalosporin series are classified as β-lactam antibiotics. Each of their representatives has 7-ACC (7-aminocephalosporanic acid) in its structure and is characterized by higher resistance to the special bacterial enzyme β-lactamase. By preventing the synthesis of components of the cell wall of bacterial cells, cephalosporins realize their bactericidal effect, i.e. completely destroy microbial cells.

Cefixime EXPRESS, instructions for use: method and dosage

Cefixime EXPRESS dispersible tablets are intended for oral use. They can be swallowed with plenty of water, or diluted in water to form a suspension and drunk immediately after preparation. Eating does not affect the effectiveness of the antibacterial agent.

Recommended daily doses:

• children weighing from 25 to 50 kg: 1/2 tablet (200 mg) at a time;
• adults and children weighing more than 50 kg: 1 tablet (400 mg) at a time; You can take the daily dose in two doses, dividing the tablet according to risk.

The duration of therapy depends on the type of infection, the nature of the disease and the course of the infectious process. After the disappearance of symptoms of infection and/or fever, it is advisable to continue the use of Cefixime EXPRESS for at least 48–72 hours.

Duration of the therapeutic course depending on the disease:

• infections of the respiratory tract and ENT organs (ear, nose, throat): from 7 to 14 days;
• tonsillopharyngitis caused by Streptococcus pyogenes: at least 10 days;
• uncomplicated gonorrhea: once (at a dose of 400 mg);
• uncomplicated urinary tract infections in women: lower urinary tract – 3–7 days, upper urinary tract – 14 days;
• uncomplicated infections of the upper and lower urinary tract in men: from 7 to 14 days.

In case of impaired renal function, the dose of Cefixime EXPRESS is prescribed depending on the QC in the blood serum. For patients with CC 21–60 ml/min or on hemodialysis, it is recommended to use cefixime in other dosage forms, allowing the daily dose to be reduced by 25%. With CC ≤ 20 ml/min or in patients on peritoneal dialysis, the daily dose must be halved.

Cefixime in the treatment of bacterial infections: issues of effectiveness and safety

This article describes the characteristics of one of the representatives of oral CS - cefixime and highlights its role in the treatment of various infections. Cefixime is a semi-synthetic CS of the third generation. The presence of an amino-thiazolyl group in the structure of the drug (Fig. 1) determines its high affinity for penicillin-binding proteins and, accordingly, high antibacterial activity, as well as stability to the hydrolytic action of β-lactamases. The vinyl group in position 3 of the molecule ensures good absorption of the drug when taken orally. The spectrum of antibacterial activity of cefixime and other oral CS is presented in Table 1. Of the gram-positive microorganisms, streptococci are most sensitive to cefixime (MIC for more than 90% of strains of S. pyogenes and S. agalactiae is <0.5 mg/l). Cefixime has superior antipneumococcal activity to ceftibuten. The high antihemophilic activity of cefixime is comparable to that of respiratory fluoroquinolones. Among enterobacteria, E. coli, Proteus spp., K. pneumoniae, including strains producing β-lactamases, are most sensitive to cefixime. The drug is practically inactive against S. aureus, enterococci, Ps. aeruginosa and anaerobes. Pharmacokinetics. When taking 400 mg of cefixime on an empty stomach, the bioavailability is 40–50%. The relationship between the complete absorption of cefixime and food intake has not been established. The combined use of cefixime and antacids containing magnesium or aluminum does not significantly affect the peak concentration of the drug in the blood or the area under the pharmacokinetic curve. Maximum serum concentrations are determined after 3–5 hours. The steady-state volume of distribution of cefixime is 16.8 l. The drug is determined in the tissues and fluids of the human body - palatine tonsils, mucous membrane of the maxillary sinus, secretions from the middle ear, bronchial mucosa, bronchogenic secretions, sputum. The binding of the drug to plasma proteins is 70%. Compared to other oral CAs, cefixime has the longest half-life (3.7 hours), which allows it to be prescribed once a day. The drug is excreted from the body mainly unchanged through the hepatobiliary system (60%) and the kidneys (40%). The drug content in urine is many times higher than the minimum inhibitory concentration for most pathogens of urinary tract infections. In case of renal failure, the half-life increases by 2–4 times, which requires dose adjustment [3]. Clinical studies The high effectiveness of cefixime, mainly in the treatment of infections of the ENT organs, respiratory and urinary tracts, has been demonstrated in clinical studies in both adults and children. Good results have been obtained in the treatment of patients with various forms of sinusitis with cefixime. In an open-label study that included 73 adult patients with acute sinusitis who received cefixime 400 mg once a day. within 10 days, the clinical and bacteriological effectiveness was 84% ​​[4]. In the work of American authors, these figures reached 90 and 86%, respectively [5]. Domestic authors have demonstrated the high effectiveness of cefixime in the treatment of patients with various forms of sinusitis, including those associated with bronchial asthma [6,7]. The frequency of positive results from cefixime therapy exceeded that of amoxicillin and cefazolin [6,8] and was comparable to that of amoxicillin-clavulanate [9]. As evidenced by the data of a large multicenter study performed in Germany, in the treatment of acute and chronic forms of A-streptococcal tonsillitis with cefixime, high rates of clinical effectiveness were noted in both children (98.8 and 96.2%) and adults (98 and 98. 4% respectively) [10]. In 4 comparative studies, the bacteriological effectiveness of cefixime was similar to that of penicillin and even exceeded it (Fig. 2). Currently, cefixime can be considered as an alternative to amoxicillin-clavulanate in the treatment of chronic recurrent forms of A-streptococcal tonsillitis, when the likelihood of production of β-lactamases by microbes - co-pathogens localized in the deep layers of the tonsils is very high. Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality among adults worldwide. Over the coming decades, the incidence of COPD is projected to increase as a result of the continued influence of risk factors and the aging population. Among the bacterial causative agents of exacerbations of COPD, the most frequently identified are H. influenzae (30–70%), S. pneumoniae (10–15%), and M. catarrhalis (8–13%). In persons over 65 years of age, in the presence of chronic concomitant diseases and severe bronchial obstruction (forced expiratory volume in 1 second - FEV1<50% of predicted), the role of enterobacteria increases (up to 30%) and, in the presence of bronchiectasis, - P aeruginosa. The new version of the GOLD (Global Initiative For Chronic Obstructive Lung Disease) working group report from 2011 emphasizes that the use of antibiotics for exacerbation of COPD reduces short-term mortality by 77%, treatment failure by 53%, and purulent sputum production by 44 %. Antibiotics should be prescribed to patients with exacerbation of COPD who have three main symptoms: increased shortness of breath, increased sputum volume and increased purulent character; or there are two main symptoms of the disease, one of which is an increase in the purulent nature of the sputum; or there is a need for assisted ventilation (invasive or non-invasive). Oral administration of drugs is preferable. The recommended duration of antibacterial therapy is usually 5–10 days. [15]. Based on the above, during exacerbation of uncomplicated COPD, the prescription of drugs that have, first of all, high activity against most potential pathogens is indicated, i.e. inhibitor of protected penicillins and oral cephalosporins of the third generation, including cefixime. Summary data of 8 comparative studies of the clinical and bacteriological effectiveness of cefixime and other antibiotics in patients with COPD, performed using a single design, are presented in Tables 2 and 3. In most other studies that included patients with COPD, the clinical effectiveness of cefixime ranged from 80 to 93% [17– 20]. As noted by domestic authors, the high activity of cefixime against pathogens exacerbating uncomplicated, and, with a certain etiology, complicated COPD, positions it among the drugs that provide not only a pronounced clinical effect, but also a long infection-free interval [21]. Urinary tract infections (UTIs) take second place in outpatient practice after respiratory tract infections in terms of the frequency of patient visits to medical institutions. According to the SONAR study, by the age of 18–20 years, 50.6% of women develop at least one episode of UTI per year, and with age, the prevalence of this nosological form increases [22]. In recent years, there has been a clear trend toward increasing resistance of the main uropathogen, E. coli, to antibiotics. Thus, a study carried out in a Moscow population of patients with acute community-acquired UTIs showed high levels of E. coli resistance to ampicillin (43.5%), ampicillin-sulbactam (28.5%), co-trimoxazole (31%), nalidix acid (21%) and fluoroquinolones – ciprofloxacin (15.5%) and levofloxacin (15%) [23]. In another multicenter study (Moscow, St. Petersburg, Rostov-on-Don), which included 105 patients with acute cystitis, the rates of antibiotic resistance of community-acquired E. coli strains were as follows: ciprofloxacin - 14.9%, amoxicillin-clavulanate - 19.1% , co-trimoxazole – 23.4%, cefazolin – 34.6%, ampicillin – 46.7% [24]. Consequently, the list of oral antibiotics that retain activity against major uropathogens and have acceptable pharmacokinetics is quite limited. This group should primarily include third-generation oral CS, including cefixime. In the work of V.V. Rafalsky et al. [25] demonstrated high activity of cefixime against strains of uropathogenic E. coli compared to ciprofloxacin. The frequency of susceptible strains was 98.9 and 88.9%, respectively. At the same time, the MIC90 against E. coli for cefixime turned out to be significantly lower than for ciprofloxacin - 0.5 mg/ml and 6.4 mg/ml, respectively. The authors conclude that cefixime can be considered as one of the drugs of choice for the treatment of community-acquired UTIs. V.V. Galkin et al. A prospective randomized clinical and economic study of the effectiveness of 5-day courses of therapy with cefixime and ciprofloxacin was performed in 104 patients with acute uncomplicated cystitis (UC). Eradication of uropathogens at the 2nd visit (8th day) was observed in 95.9, 55.6 and 71.4% of cases in patients from group 1 (cefixime), group 2a (ciprofloxacin 250 mg twice a day .) and group 2b (ciprofloxacin 500 mg twice a day), respectively. The value of the efficiency-cost coefficient for these groups was 3229.2, 7280.6 and 4111.5 rubles. respectively. Thus, a short course of cefixime is more preferable in terms of cost-effectiveness compared to other indicated regimens [26]. In a non-comparative pilot study that included 154 women with acute uncomplicated cystitis, the clinical effectiveness of cefixime (200 mg twice a day) was 98.9%, and the bacteriological effectiveness was 97.9% [27]. In another similar study (92 patients), these parameters were similar – 98 and 93%, respectively [28]. In comparative studies (Table 4), the effectiveness of cefixime was comparable to the effectiveness of other antibacterial drugs in the treatment of complicated UTIs. Thus, in a double-blind study, 528 patients were divided into 3 groups depending on the treatment regimen (cefixime 400 mg once a day, cefixime 200 mg twice a day, co-trimoxazole 480 mg twice a day. ). The course of treatment was 5–9 days. As a result of therapy, eradication of uropathogens was achieved in 100, 97 and 98% of cases, respectively [29]. In the work of German authors, which included 80 women (age 18–35 years) with uncomplicated UTIs, as a result of a single dose of cefixime (400 mg), ofloxacin (200 mg), co-trimoxazole (960 mg) or placebo, bacteriological cure was achieved in 89. 4; 89.4; 84.2 and 26.3% of cases, respectively [30]. A double-blind, multicenter study compared the effectiveness of cefixime and amoxicillin in 565 patients with uncomplicated UTIs. The clinical effectiveness of cefixime was noted in 90% of cases, amoxicillin - in 83%, bacteriological eradication - in 92 and 84%, respectively [31]. The study, performed in Taiwan, included 45 patients with complicated UTIs. Group 1 (23 people, average age 71.3 years) received ceftibuten at a dose of 400 mg/day, group 2 (22 people, average age 62.8 years) received cefixime 400 mg/day. The duration of therapy ranged from 10 to 14 days. Indicators of clinical (78.3 and 77.3%) and bacteriological (52.2 and 63.3%) effectiveness did not differ significantly [32]. The possibility of using cefixime as a second (oral) component during stepwise antibiotic therapy, mainly in the treatment of UTIs, should be considered one of the undoubted advantages of the drug. In a study by French authors [33], which included 95 patients with severe upper urinary tract infections, the effectiveness of two therapeutic regimens was compared: a) ceftriaxone 2 g/day. intravenously for 4 days, then 1 g/day. intramuscularly or intravenously for 11 days; b) ceftriaxone 2 g/day. intravenously for 4 days. followed by switching to cefixime 400 mg/day. once for 11 days. Clinical recovery at the end of treatment was observed in 47 of 48 patients treated with ceftriaxone and in 44 of 47 patients treated with stepwise therapy including cefixime. When examined after 10–84 days. after completion of treatment, clinical and bacteriological recovery was observed in 81 and 74.3% of patients, respectively. A prospective randomized study performed in Spain included 144 women aged 18–75 years who suffered from acute uncomplicated pyelonephritis. Group 1 (72 patients) received treatment with ceftriaxone at a dose of 1 g/day. 72 patients of group 2, after the initial administration of ceftriaxone 1 g intravenously, continued treatment with cefixime at a dose of 400 mg/day. At the end of therapy, clinical cure was observed in 91 and 92% of patients, respectively, and bacteriological cure in all patients [34]. According to the BEST multicenter study, UTIs are one of the most common infections in pregnant women, accounting for 39.9% of the total structure of infectious diseases in these individuals [37]. The most acceptable group of antibiotics for the treatment of UTIs in pregnant women are β-lactams, of which third-generation CS (cefixime, cefotaxime, ceftriaxone) exhibit the greatest activity against the main uropathogens. When treating UTIs in pregnant women on an outpatient basis, preference is given to oral forms. In a hospital setting, it is rational to use stepwise therapy (first ceftriaxone/cefotaxime intravenously, then cefixime/inhibitor-protected aminopenicillins orally) [38]. A study of the effectiveness and tolerability of cefixime for pyelonephritis in pregnant women included a separate study of this drug in hospitalized patients (in comparison with cefotaxime) and those undergoing outpatient treatment. Hospitalized pregnant women with moderate pyelonephritis were randomized into 2 groups of 15 people each: group 1 received cefixime 400 mg orally 1 time per day, group 2 received cefotaxime intramuscularly 1 g 2 times per day. The course of treatment was 12 days. The effectiveness of the therapy was equal in both groups – 93.3%. Cost minimization analysis showed that cefixime, with equal and high clinical efficacy and safety, has clear economic advantages compared to cefotaxime in the treatment of pyelonephritis in hospitalized pregnant women. High clinical and bacteriological effectiveness of cefixime has been shown when prescribed at a dose of 400 mg/day. within 6 days. on an outpatient basis in pregnant women with uncomplicated pyelonephritis and mild manifestations of intoxication. Therefore, the use of cefixime for the treatment of UTIs in pregnant women is justified, but in this case, more careful medical monitoring of the patient’s condition is necessary [40]. In accordance with the recommendations of the US Centers for Disease Control and Prevention (CDC), cefixime is considered as an alternative agent in the treatment of acute uncomplicated urogenital or rectal gonorrhea, as well as a 2nd step agent in stepwise therapy for disseminated gonorrhea [41,42]. When a single dose of cefixime (400 mg orally) or ceftriaxone (125 mg intramuscularly) was administered to 161 pregnant women with gonococcal endocervicitis, cure was achieved in 96 and 95% of cases, respectively [43]. Oral CS and, in particular, cefixime, have attracted increasing attention from pediatricians in recent years. A wide spectrum of antimicrobial activity, good pharmacokinetics and prolonged action make it advisable to use these drugs in various regimens for the most common diseases encountered in pediatric practice, both in outpatient and inpatient settings [44]. In an open non-comparative study performed by domestic authors [45], the effectiveness of cefixime was assessed in 30 children (age 1 year 5 months - 11 years) suffering from acute otitis media (AOM), including 28 with purulent discharge from the ear . The drug was administered orally in the form of a suspension at an age-specific dosage for 6–7 days. in combination with local treatment. In 83.3% of cases, significant improvement was observed. A side effect (allergic reaction) was recorded in only 1 child. In another study by Russian authors, cefixime was more effective than cefazolin in the treatment of AOM in 40 children [46]. Therapy with cefixime and cefaclor in 63 sick children with AOM led to recovery in 97 and 78% of cases, respectively, and eradication of the pathogen in 94 and 68% [47]. When comparing cefixime and amoxicillin, the effectiveness of treatment of AOM was practically the same (Fig. 3). At the same time, amoxicillin showed greater activity in pneumococcal etiology, and cefixime - in the disease caused by H. influenzae. Domestic researchers studied the effectiveness and safety of cefixime in 61 children aged 3–15 years with exacerbation of chronic inflammatory diseases of the lower respiratory tract, including congenital malformations of the bronchi and lungs. Clinical effectiveness was stated in 88.8% of cases. The rates of bacteriological eradication depending on the isolated pathogen were as follows: H. influenzae – 94%, B. catarrhalis – 100%, S. pneumoniae – 74.4% [52]. A controlled randomized trial performed in Israel included 62 children with community-acquired segmental/lobar pneumonia. After an initial 2-day parenteral administration of ceftriaxone, patients were transferred to oral cefixime (29 patients) or amoxicillin-clavulanate (33 patients) for 8 days. Clinical efficiency was noted in 100 and 94% of children, respectively [53]. Local microbiological monitoring of pyelonephritis pathogens in children showed that in most cases, the allocated uropatogens showed high sensitivity to the III generation CS, including cefixim. Given the results obtained, this drug was included in the recommendations for empirical antibacterial therapy of pyelonephritis in children [54]. The high efficiency of cefixim was demonstrated both in monotherapy and as an oral component of step antibacterial therapy after the starting 3 -day treatment of ceftriaxone in a multicenter randomized study that included 306 children aged 1 month. Up to 2 years with the IMP, which were leaking with feverish syndrome. The sterility of urine was achieved after 25 and 24 hours from the beginning of treatment, respectively. After 6 months. After the treatment is completed, the clinical and microbiological symptoms of relapse were observed in 5.3 and 8.5% of cases, respectively [55]. In the Khranov review, an analysis of 23 studies is presented, including 3407 sick children with acute pyelonephritis. The effectiveness of both oral antibiotic therapy and a stepped treatment regimen for these patients are shown [56]. The effectiveness of the cefixim with intestinal infections is noted. In the treatment of 77 children with acute microbiologically verified shigellosis, 38 patients received cefixims at a dose of 8 mg/kg/day. 39 - co -trimoxazole 10-50 mg/kg/day. On 5 days. Therapy with the graphics of the clinical recovery, improvement or absence of the effect was noted, respectively, in 89, 8 and 3% of patients, in the treatment of comparison - in 25, 44 and 31% of patients; Elimation of the pathogen for 3 days. It was observed respectively in 78 and 38% of patients [57]. Undoubtedly, an important property of the cephyximum, which ensures the high compliance of patients and, therefore, the effectiveness of therapy, is the possibility of taking 1 p./Day. This fact is of fundamental importance, since, according to the results of a study performed by Romir, each second patient in Russia does not comply with a schedule for taking antibiotics. As a result of a survey of 1575, people over the age of 18, it turned out that only 45% of them observe recommendations for taking drugs throughout the course, 51% - until a certain point, 3% do not observe the administration regime at all. At the same time, 19% of the respondents refer to an uncomfortable reception schedule, 16% of patients would prefer an antibiotic with one technique for the entire course of treatment. In general, 62% of patients made their choice in favor of antibiotics with a single intake scheme [58]. Other authors testify to a decrease in compliance with the increase in the dying of the antibiotic [59,60]. Unwanted reactions. In general, the tolerance of the chamberlain is good. The frequency of unwanted reactions (HP) is presented in table 5. As a rule, the HP was not low, did not require the cessation of treatment or hospitalization. Most often, the development of HP was associated with the digestive system (diarrhea, a change in the consistency of the stool, etc.). Among other HP, skin rash, headache, dizziness, etc. are distinguished (Table 6). The frequency of HP, requiring the cessation of treatment, was estimated from <1% (Europe) to 7.7% (USA, Canada) [67]. Thus, the T -Cyfixim of the III generation for oral administration has a wide range of antimicrobial activity (including pathogens producing β -lactamase) and favorable pharmacokinetic characteristics. The drug is considered as a means of choosing for the treatment of uncomplicated IMPs (including pregnant women and children) in outpatient practice, as well as an alternative tool in the treatment of infections of ENT organs, respiratory tract (in particular COPD) and uncomplicated gonorrhea. The drug is distinguished by good tolerance and ease of use, especially in clinical conditions.

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Side effects

Side effects from systems and organs recorded when taking Cefixime EXPRESS [incidence scale: very common (> 10%); often (1–10%); uncommon (0.1–1%); rarely (0.01–0.1%); extremely rare (≤ 0.01%)]:

• blood system and hematopoietic organs: extremely rarely - agranulocytosis, transient leukopenia, pancytopenia, thrombocytopenia, eosinophilia, isolated episodes of blood coagulation disorders were noted; with unknown frequency - hemolytic anemia;
• immune system: rarely - hypersensitivity reactions (rash, urticaria, itching, erythema multiforme); extremely rarely - toxic epidermal necrolysis (Lyell's syndrome), reactions associated with hypersensitivity, such as drug fever, Stevens-Johnson syndrome, serum-like syndrome, hemolytic anemia, interstitial nephritis, anaphylactic shock; in some patients, drug rash syndrome with eosinophilia and systemic reactions was observed;
• nervous system: infrequently - dizziness, headache, dysphoria, anxiety;
• respiratory system: with unknown frequency – dyspnea;
• gastrointestinal tract: often - digestive disorders, abdominal pain, nausea, vomiting, diarrhea; extremely rarely - pseudomembranous colitis;
• hepatobiliary system: rarely - increased activity of liver transaminases and alkaline phosphatase, increased bilirubin levels in the blood; extremely rarely – cholestatic jaundice, hepatitis;
• genitourinary system: extremely rarely - hematuria, a slight increase in serum creatinine and urea concentrations, acute renal failure accompanied by tubulointerstitial nephritis.

Common representatives

Of the numerous list of cephalosporins, the most frequently used at the moment are representatives of the 3rd generation, namely ceftriaxone, ceftibuten, cefditoren. This is due to their wide spectrum of action and relatively low cost. In addition, the last two drugs are available in oral form, which is very convenient for patients to take.

It may seem that cephalosporins, available in tablet form, are rarely used drugs. This is not true: such drugs are applicable even for severe infections of various organs, when other antibiotics do not have the desired effect.

It is advisable to compare the most common representatives according to a number of important criteria:

Speed ​​of effect (time of maximum concentration in blood):

Microbial spectrum of action:

Resistant strains of bacteria:

Side effects:

Use in pregnant and lactating patients:

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special instructions

It is reliably known that there are cross-allergic reactions of cefixime with penicillins, so a careful assessment of the patient’s medical history is necessary before starting treatment. If a hypersensitivity reaction develops, the use of Cefixime EXPRESS should be stopped immediately. If a patient is diagnosed with toxic epidermal necrolysis (Lyell's syndrome), Stevens-Johnson syndrome, drug rash syndrome with eosinophilia and systemic manifestations, in addition to stopping cefixime, he requires appropriate therapy. To relieve anaphylactic shock, administration of epinephrine (adrenaline), antihistamines and systemic glucocorticosteroids is indicated.

Long-term treatment with cefixime disrupts the normal intestinal microflora, which can result in excessive proliferation of the bacterium Clostridium difficile and the appearance of difficile-associated pseudomembranous colitis. If mild antibiotic-associated diarrhea is diagnosed, it is usually sufficient to stop using Cefixime EXPRESS. During more severe disorders, corrective therapy is recommended, for example, oral vancomycin at a dose of 250 mg 4 times a day. In pseudomembranous colitis, the use of antidiarrheal drugs that inhibit gastrointestinal motility is contraindicated.

Cefixime, like other cephalosporins, can cause the development of acute renal failure and tubulointerstitial nephritis. For these diseases, the course is interrupted and appropriate supportive treatment is prescribed.

The simultaneous use of cefixime with aminoglycosides, colistimethate sodium, polymyxin B, loop diuretics (furosemide, ethacrynic acid) in high doses is carried out under the control of renal function.

During long-term use of Cefixime EXPRESS, it is necessary to monitor hematopoietic function.

Only water should be used to dissolve dispersible tablets to form a suspension.

Cefixime can distort the results of laboratory tests, for example, giving a false-positive response to the direct Coombs test and a false-positive urine test for glucose with some rapid diagnostic test systems.

Impact on the ability to drive vehicles and complex mechanisms

A study of the effect of cefixime on a person’s ability to drive vehicles and complex machinery has not been conducted. It is necessary to take into account the side effect profile of Cefixime EXPRESS (for example, dizziness) and during therapy, use caution when performing potentially hazardous types of work.

Drug interactions

Medicines that reduce tubular secretion in the kidneys, for example, probenecid, etc., slow down the renal elimination of cefixime, increasing the risk of overdose.

Cefixime lowers the prothrombin index and potentiates the effectiveness of indirect anticoagulants.

The simultaneous use of cefixime and carbamazepine causes an increase in the plasma concentration of the latter. If it is necessary to prescribe them together, the patient is provided with drug monitoring.

Reviews of Cefixime EXPRESS

There are currently no patient reviews of Cefixime EXPRESS.

Experts highly appreciate cefixime. In Russian national recommendations, it is presented as a first-choice drug for the treatment of exacerbations of genitourinary system infections. Including the use of full course doses for the treatment of pregnant women. The favorable safety profile is especially noted (approved for use in pregnant women, as well as children and adolescents under 18 years of age, the only limitation is body weight less than 25 kg). Unlike other antibiotics, cefixime does not cause side effects from the cardiovascular and musculoskeletal systems.