Panzef gran.d/prepared suspension.d/orally 100mg/5ml(32g) 0

Antibacterial therapy is the main method of treating respiratory diseases of bacterial etiology. The choice of drug is determined by the type of microorganism and its sensitivity, the age of the patient, and the desired route of administration. In pediatric practice, the oral route of administration is preferable if there are no restrictions on the effectiveness of therapy and side effects of the drug. Due to their high efficiency and low toxicity, cephalosporins are one of the most popular groups of antibiotics in pediatrics. Based on their structure, spectrum of action and resistance to β-lactamases, cephalosporins are currently divided into 5 groups (Table 1) [1]:

Cephalosporins have gained wide popularity in the treatment of respiratory diseases, which is associated with a wide spectrum of action and the availability of drugs used for oral administration, incl. prolonged and with low toxicity. The use of antibiotics orally, especially long-acting forms, significantly reduces the risk of the spread of infectious diseases, reduces the burden on medical personnel and allows for wider use of drugs both in hospitals and in outpatient settings. It should be emphasized that oral antibacterial therapy as a starting treatment is most indicated for mild and moderate forms of the disease, incl. for diseases of the upper respiratory tract, uncomplicated acute pneumonia and exacerbations of chronic and recurrent inflammatory bronchopulmonary diseases.

Pancef belongs to the third generation of cephalosporins (Table 2) and has a number of advantages, which makes it the drug of choice for respiratory diseases. The drug has antibacterial and bactericidal effects based on the suppression of the synthesis of peptidoglycan, the main structural component of the bacterial cell wall. Resistant to β-lactamases. Active against many gram-positive and gram-negative microorganisms. In vitro and in clinical practice, cefixime is active against gram-positive bacteria: Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae; gram-negative bacteria: Haemophilus influenzae, Moraxella (Branhamella) catarrhalis, E.coli, Proteus mirabilis, N. Gonorrhoeae, Haemophilus parainfluenzae, Proteus vulgaris, Klebsiella pneumoniae, Klebsiella oxytoca, Pasteurella multocida, Providencia spp., Salmonella spp., Shigella spp., Citrobacter amalonaticus, Citrobacter diversus, Serratia marcescens.

Pseudomonas spp., Enterococcus (Streptococcus) serogroup D, Listeria monocytogenes and most strains of Staphylococcus spp. are resistant to cefixime. (including methicillin-resistant strains), Enterobacter spp., Bacteroides fragilis, Clostridium spp. [2, 3]. After oral administration, 40–50% of cefixime is absorbed (regardless of food intake), however, the time to maximum absorption when taken with food increases by approximately 0.8 hours. Serum Cmax is achieved within 2–6 hours. Serum protein binding is about 65%. About 50% is excreted unchanged in urine within 24 hours.

In animal studies, it was noted that cefixime is also excreted in bile (10%). Another important characteristic of the drug is its long (3–4 hours) half-life, which makes it possible to use it once a day [2, 3].

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 concentration in the bronchial mucosa, bronchial secretions and sputum is 35–40, 10–20 and 0–4%, respectively. 8.4 hours after taking cefixime, the accumulation of the drug in the lung tissue is within the therapeutic concentrations for significant pathogens of community-acquired pneumonia, which are Str. pneumoniae, H. influenzae [2–4].

Cefixime has a minimal inhibitory effect on the resident flora of the colon in children - the basis of colonization resistance as one of the components of the body’s general immunity [5]. For respiratory diseases in children, indications for the use of Pancef may include infectious and inflammatory diseases caused by microorganisms sensitive to the drug: pharyngitis, tonsillitis, sinusitis, acute and chronic bronchitis, otitis media, pneumonia, exacerbations of chronic lung diseases, in which the antibiotic may be included in complex therapy of the disease, incl. combination of antibiotics.

The effectiveness of cefixime has been studied in numerous clinical studies in our country and abroad. Domestic authors have demonstrated the high effectiveness of cefixime in the treatment of patients with various forms of sinusitis, incl. against the background of bronchial asthma [6, 7]. The frequency of positive results from cefixime therapy exceeded that of amoxicillin and cefazolin [8] and was comparable to that of amoxicillin-clavulanate [9]. In the treatment of acute and chronic forms of A-streptococcal tonsillitis with cefixime, high clinical efficacy rates 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.

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 [11]. In an open, non-comparative study, the authors [12] assessed the effectiveness of cefixime in 30 children (age 1 year 5 months – 11 years) suffering from acute otitis media (AOM), incl. in 28 – with purulent discharge from the ear. The drug was used orally in the form of a suspension in 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 for 40 children [13]. Treatment 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% [14]. When comparing cefixime and amoxicillin, the effectiveness of treatment of AOM did not differ significantly.

At the same time, amoxicillin showed greater activity in pneumococcal etiology, and cefixime - in the disease caused by H. influenzae.

Numerous single-arm and comparative clinical studies have assessed the effectiveness of cefixime in the treatment of lower respiratory tract infections. These studies mainly concerned adult patients and showed the effectiveness of the drug in chronic obstructive pulmonary disease, acute and chronic bronchitis, and pneumonia [15–17]. The effectiveness of the drug is associated with the fact that it acts on the main respiratory pathogens involved in the bacterial process in lung diseases. The minimum threshold concentration of 50/90 cefixime against pneumococcus in Russia was 0.25–0.5 μg/ml, which falls within the sensitivity range of <1 μg/ml [18]. High activity of cefixime against Haemophilus spp. (including in relation to ampicillin-resistant and β-lactamase-producing strains) is not lost over time (unlike other β-lactams). This is due to the effective overcoming of common resistance mechanisms and a high degree of affinity for penicillin-binding proteins. The capabilities of cefixime are evidenced by studies of clinical strains of H. influenzae from 11 European countries, which showed that in terms of antihemophilic activity, cefixime is not inferior to respiratory fluoroquinolones, 32 times higher than that of cefuroxime and 128 times higher than that of cefaclor [18].

In addition to assessing clinical effectiveness, various modes of use of the drug were studied. A controlled study examined the effectiveness of two regimens of cefixime: 5-day (400 mg/day) and 1-day, also 400 mg/day in 222 patients with exacerbation of chronic bronchitis. A successful clinical response was obtained from 91% of patients in the first group, and from 89% in the second. The bacteriological effect was similar in both groups. The number of adverse reactions in the second group was higher [19].

In pediatric practice, cefixime is used for acute and chronic lung diseases. A study was conducted of the effectiveness and safety of cefixime for 61 children aged 3–15 years with exacerbations of recurrent bronchitis (15 children), chronic inflammatory bronchopulmonary diseases (46 children), which developed as a result of an unfavorable outcome of acute pneumonia with the formation of chronic bronchitis based on pneumosclerosis, bronchial deformation and bronchiectasis, as well as against the background of congenital malformations of the bronchi and lungs. All children during the period of exacerbation of the bronchopulmonary process received, along with antibiotics, complex therapy, including mucolytic, mucoregulatory and bronchospasmolytic drugs according to indications, kinesitherapy. Clinical effectiveness was detected in 54 of 61 (88.6%) patients. It is characterized by an improvement in general condition (on average on the 4th day); reduction of cough (on the 3rd–4th day); a decrease in the amount of sputum produced (on the 3rd–5th day); improvement of the rheological properties of sputum (on the 5th–6th day); a decrease in physical changes in the lungs and their prevalence (on the 4th day); improvement of functional indicators (forced expiratory volume in 1 second, forced expiration of the vital capacity of the lungs, decrease in flows at the level of 25 and 75% of the exhaled lung volume) on the 12th day; normalization of hematological changes on days 6–10.

The clinical effectiveness of the drug was confirmed by the results of bacteriological studies. Eradication of microbes from sputum or bronchial secretions by the 6–7th day of treatment was observed when H. influenzae was inoculated - in 94% of patients; when seeding B. catarrhalis - in all patients; when sown with S. pneumoniae – in 74.4% of patients [20]. Similar data on the effectiveness of cefixime (albeit on a smaller sample of 13 outpatients) are provided by another Russian author [4]. Complete recovery (protracted bronchitis, acute pneumonia) occurred in 77% of patients by the 7th day of treatment and not a single patient required an additional course of antibiotics. Side effects (nausea, vomiting, loose stool) were observed in one patient, but by that time the pneumonia had resolved and no new antibiotic was required.

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 effectiveness was observed in 100 and 94% of children, respectively [23]. The possibility of using cefixime in children with uncomplicated community-acquired pneumonia at a dose of 8 mg/kg/day in 1–2 doses for children over 6 months and at a dose of 200–400 mg 1–2 times a day for body weight above 25 kg has been noted [21, 22 ]. In general, cefixime is well tolerated. As a rule, adverse reactions did not require discontinuation of treatment or hospitalization. The most common side effects were related to the digestive system (diarrhea, change in stool consistency). The possibility of headache and dizziness, as well as changes in the hematopoietic system are reported: eosinophilia, leukopenia, thrombocytopenia, neutropenia, hemolytic anemia. Among others, allergic reactions (skin rash) are distinguished. The incidence of adverse reactions requiring treatment discontinuation was estimated to range from <1% (Europe) to 7.7% (USA, Canada)[10, 16].

Thus, Pancef (cefixime), a third-generation cephalosporin antibiotic for oral administration, has a wide spectrum of antimicrobial activity (including pathogens that produce β-lactamases) and favorable pharmacokinetic characteristics. Pancef is considered as the drug of choice for the treatment of infections of the ENT organs and respiratory tract (pneumonia, bronchitis, exacerbation of chronic lung diseases). The drug is well tolerated and easy to use, especially in an outpatient setting.

PANCEF (granules)

The stool is very soft, the phlegm has begun to come off, but... My eldest son brings snot and a red throat from kindergarten!
This is tough, comrades(((Well, on the 3rd day the temperature of 38.5 is exactly right. For two days we bring down the temperature, the cough worsens again, the throat turns red and the decision is made to start an antibiotic (although I really hoped to do without it, because... Only in December the child received a good dose of antibiotics.) Well, we got to the most important thing))) The choice fell on Pancef. Nothing personal, I just had this drug at home, bought it a long time ago and had no use for it. The summary at first glance is not simple, but everything is quite simple: How to dilute: I have a preparation for preparing 60 ml of suspension (there are large packages for preparing 100 ml). I take boiled water at room temperature and add 20 ml to the bottle, shake for a long, long time, take another 20 ml of water, add and shake again))) and it’s ready. Store at room temperature, but not higher than 25 degrees and no more than 2 weeks. Unfortunately, the suspension is not stored for long, so even if there is something left after treatment, you will have to throw it away, regardless of the price.

How and how much to take: 5 ml of diluted suspension contains 100 mg of the active substance (cephexime), children are prescribed 8 mg per kilogram of weight. My child weighs 13 kg, i.e. 13*8=104 mg of cephexime he should receive per day. This is just 5 ml of suspension. The dose can be divided into 2 times (every 12 hours), or it can be taken once.

I give it once a day, more often I can forget)) 30 minutes before meals I give Acipol, we eat and 30 minutes after the meal I give Pancef. In principle, you can take an antibiotic whenever you want, but I like this regimen better, there are fewer side effects and Acipol already has time to work.

Today is only the second day of the appointment, I wrote it right away so as not to forget, I’ll add it later. 1st day of admission: in the evening I gave Pancef and paracetamol, slept well (but last night it was just terrible, I woke up every hour, cried, then it took a long time to bring down the temperature). Day 2: I woke up in the morning without a fever, the whole day was also normal, the wet cough returned again, not yet the same as it was after physio, but much better. No runny nose, red throat. I gave Pancef for lunch. Day 3: Slept terribly, woke up, cried, it’s not clear why. Maybe for the weather. Didn't cough at night. We went to the doctor, there is no wheezing, breathing has become softer, the throat is red only on the back wall, there is no runny nose. During the day he rarely coughs, the cough is wet. They told us to do inhalations and drainage for 3 days to remove sputum. I don’t see any side effects from Pancef yet. Day 4: We slept well, I feel good, my throat is already normal, I treat it 2 times a day, there are no side effects from the antibiotic yet. Day 5: Coughs rarely, maximum 5 times throughout the day. Let's inhale and get treatment. Day 6: the cough became wet, but a side effect appeared - the stool became softer, and by the evening I completely crap myself, I got up to go to the toilet 3 times at night. Day 7: Today is the last day of taking the antibiotic Pancef. The cough has become much milder, we have seen an immunologist again, and we will continue treatment. Well, now treat the intestines in addition.

Let's summarize: the antibiotic Pancef in our case turned out to be very effective, the temperature was eliminated the next day, there was no wheezing in the lungs on the third day. It is taken calmly and has a pleasant orange taste. The disadvantages include the presence of side effects and the inability to store drug residues.

Well, instructions, just in case:

Panzef film-coated tablets 400 mg 6 pcs. in Voronezh

Film-coated tablets

Inside.

For adults and children over 12 years of age weighing more than 50 kg, the recommended daily dose is 400 mg (once a day or 200 mg 2 times a day). For uncomplicated gonorrhea - 400 mg once. The average duration of treatment is 7–10 days.

For infections caused by Streptococcus pyogenes

, the course of treatment should be at least 10 days.

In case of impaired renal function, the dose is set depending on the creatinine clearance in the blood serum: with creatinine Cl 21–60 ml/min or in patients on hemodialysis, the daily dose should be reduced by 25%; when Cl creatinine is 20 ml/min or less or in patients on peritoneal dialysis, the daily dose should be reduced by 2 times.

Oral suspension

Inside.

For adults and children over 12 years of age, weighing more than 50 kg, the recommended daily dose is 400 mg 1 time / day or 200 mg 2 times a day.

For uncomplicated gonorrhea - 400 mg once.

For children aged 6 months to 12 years, weighing less than 50 kg, the drug is prescribed as a suspension at a dose of 8 mg/kg once a day or 4 mg/kg every 12 hours.

The average duration of treatment is 7–10 days.

For infections caused by Streptococcus pyogenes

, the course of treatment should be at least 10 days. Due to differences in bioavailability, it is not recommended to replace the suspension with tablets.

In case of impaired renal function, the dose is set depending on the creatinine clearance in the blood serum: with creatinine Cl 21–60 ml/min or in patients on hemodialysis, the daily dose should be reduced by 25%; when Cl creatinine is 20 ml/min or less or in patients on peritoneal dialysis, the daily dose should be reduced by 2 times.

Method of preparation of 60 ml of suspension for oral administration 100 mg/5 ml.

The suspension is prepared immediately before the first use. Shake the bottle several times. Using a measuring cap, add 40 ml of boiled water cooled to room temperature in 2 stages and shake vigorously after each addition until a homogeneous suspension is formed.

Method of preparation of 100 ml of suspension for oral administration 100 mg/5 ml.

The suspension is prepared immediately before the first use. Shake the bottle several times. Using a measuring cap, add 66 ml of boiled water cooled to room temperature in 2 stages and shake vigorously after each addition until a homogeneous suspension is formed.

To dose the finished suspension, use a measuring cap, which should be rinsed well with water after each use.

The prepared suspension should be shaken well before use.

Panzef gran.d/prepared suspension.d/orally 100mg/5ml(32g) 0

Registration Certificate Holder

ALKALOID (Macedonia)

Dosage form

Medicine – Pancef® (Pancef)

Description

Granules for the preparation of a suspension for oral administration
5 ml of ready-made suspension.
cefixime 100 mg

32 g - dark glass bottles (1) complete with measuring cap - cardboard packs. 53 g - dark glass bottles (1) complete with measuring cap - cardboard packs. 32 g - dark glass bottles (40) complete with measuring cap - cardboard boxes. 53 g - dark glass bottles (40) complete with measuring cap - cardboard boxes.

Indications

Infectious and inflammatory diseases caused by sensitive microorganisms: pharyngitis, tonsillitis, sinusitis, acute and chronic bronchitis, otitis media, uncomplicated urinary tract infections, uncomplicated gonorrhea.

Contraindications for use

Hypersensitivity to cephalosporins and penicillins.

pharmachologic effect

Semisynthetic cephalosporin antibiotic of the third generation for oral administration with a broad spectrum of action. Acts bactericidal. The mechanism of action is due to inhibition of the synthesis of the pathogen's cell membrane. Cefixime is resistant to the action of β-lactamases produced by most gram-positive and gram-negative bacteria.

In vitro, cefixime is active against gram-positive bacteria:

Streptococcus agalactiae;
gram-negative bacteria:
Haemophilus parainfluenzae, Proteus vulgaris, Klebsiella pneumoniae, Klebsiella oxytoca, Pasteurella multocida, Providencia spp., Salmonella spp., Shigella spp., Citrobacter amalonaticus, Citrobacter diversus, Serratia marcescens.
In vitro and in clinical practice, cefixime is active against gram-positive bacteria:
Streptococcus pneumoniae, Streptococcus pyogenes;
gram-negative bacteria:
Haemophilus influenzae, Moraxella (Branhamella) catarrhalis, Escherichia coli, Proteus mirabilis, Neisseria gonorrhoeae.

Resistant to cefixime

Pseudomonas spp., Enterococcus (Streptococcus) serogroup D, Listeria monocytogenes, most Staphylococcus spp. (including methicillin-resistant strains), Enterobacter spp., Bacteroides fragilis, Clostridium spp.

Dosage regimen

For adults and children over 12 years of age weighing more than 50 kg, the daily dose is 400 mg (1 time/day or 200 mg 2 times/day). The duration of treatment is 7-10 days. For uncomplicated gonorrhea - 400 mg once.

Children under 12 years of age - 8 mg/kg body weight 1 time/day or 4 mg/kg every 12 hours.

For infections caused by Streptococcus pyogenes, the course of treatment should be at least 10 days.

In case of impaired renal function (with CC from 21 to 60 ml/min) or in patients on hemodialysis, the daily dose should be reduced by 25%.

With CC≤20 ml/min or in patients on peritoneal dialysis, the daily dose should be reduced by 2 times.

Side effect

From the digestive system:

dry mouth, anorexia, diarrhea, nausea, vomiting, abdominal pain, flatulence, transient increase in the activity of liver transaminases and alkaline phosphatase, hyperbilirubinemia, jaundice, gastrointestinal candidiasis, dysbacteriosis; rarely - stomatitis, glossitis, pseudomembranous enterocolitis.

From the hematopoietic system:

leukopenia, thrombocytopenia, neutropenia, hemolytic anemia.

From the side of the central nervous system:

dizziness, headache.
From the urinary system:
interstitial nephritis.

Allergic reactions:

itching, urticaria, skin hyperemia, eosinophilia, fever.

special instructions

Use with caution in elderly patients, patients with chronic renal failure or pseudomembranous colitis (history), and in children under 6 months of age.

With long-term use, normal intestinal microflora may be disrupted, which can lead to the growth of Clostridium difficile and cause the development of severe diarrhea and pseudomembranous colitis.

In patients with a history of allergic reactions to penicillins, manifestations of hypersensitivity to cephalosporin antibiotics are possible.

During treatment, a positive direct Coombs test and a false positive urine test for glucose are possible.

Use during pregnancy and breastfeeding

Restrictions during pregnancy - With caution. Restrictions when breastfeeding - Contraindicated.

Use during pregnancy is possible only when the expected benefit to the mother outweighs the potential risk to the fetus.

If necessary, use during lactation should stop breastfeeding.

Use for renal impairment

Restrictions in case of impaired renal function - With caution. In case of impaired renal function (with CC from 21 to 60 ml/min) or in patients on hemodialysis, the daily dose should be reduced by 25%. With CC≤20 ml/min, the daily dose should be reduced by 2 times.

Use in elderly patients

Restrictions for elderly patients - Use with caution.

Use with caution in elderly patients.

Use in children

Restrictions for children - With caution.

Use with caution in children under 6 months of age.