Pancef, 100 mg/5 ml 53 g

Pharmacological action – broad spectrum antibacterial (bactericidal).

Pharmacodynamics

Cefixime is a cephalosporin antibiotic of III generation for oral administration with strong antibacterial activity against most gram-positive and gram-negative microorganisms.

The mechanism of action is caused by inhibition of the synthesis of the cell membrane of the pathogen. It is 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). beta-lactamase-producing strains), Escherichia coli, Proteus mirabilis, Proteus vulgaris, Neisseria gonorrhoeae, Klebsiella pneumoniae, 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

Intake. After oral administration, absorption of cefixime is 40-50% regardless of meals; however, it has been noted that Cmax in blood serum is reached faster by 0.8 h when the drug is taken with food. When taking the drug in tablet form at a dose of 400 mg, Cmax in plasma is 3.5 mcg/ml. Tmax is 2-6 hours.

After taking the suspension, Cmax (compared to tablets) is 25-50% higher. Tmax is 2-6 h for 400 mg/5 ml suspension and 2-5 h for 200 mg/5 ml suspension. Tmax in plasma is also 2-6 hours.

Distribution. Binding to plasma proteins is 50-60%. Vd is 0.6-1.1 l/kg. High concentrations of the drug remain in blood serum, bile and urine for a long time.

Metabolism. There are no data on cefixime metabolites.

Elimation. Cefixime is excreted mainly by the kidneys by glomerular filtration in unchanged form – 50%, with bile – 10%.

The T1/2 in healthy volunteers is on average 3 to 4 h, in some cases up to 9 h. Long T1/2 makes possible single dosing.

In patients with impaired renal function in creatinine Cl 20-40 ml/min T1/2 is increased and on average 6.4 h, in creatinine Cl 5-20 ml/min T1/2 is 11.5 h.

Indications

Infectious and inflammatory diseases caused by cefixime-sensitive microorganisms:

– upper respiratory tract infections (tonsillitis, pharyngitis, sinusitis);

– middle otitis media;

– lower respiratory tract infections (bronchitis, tracheobronchitis);

– urinary tract infections;

– uncomplicated gonorrhea (urethra and cervix).

Active ingredient

Composition

100 ml of the suspension contain:

the active substance:

cefixime (in the form of cefixime trihydrate) 2.000 g-2.238 g

excipients: sucrose; xanthan gum; sodium benzoate; orange flavoring.

How to take, the dosage

Ingestion. For adults and children over 12 years of age with body weight over 50 kg, the recommended daily dose is 400 mg once daily or 200 mg twice daily.

In uncomplicated gonorrhea, 400 mg once daily.

In children aged 6 months to 12 years with a body weight less than 50 kg, the drug is given as a suspension in a dose of 8 mg/kg once daily or 4 mg/kg every 12 hours.

The average duration of treatment is 7-10 days.

Infections caused by Streptococcus pyogenes should be treated for at least 10 days. Because of the difference in bioavailability, the suspension is not recommended to be replaced with tablets.

In patients with impaired renal function the dose is adjusted according to serum creatinine clearance: in creatinine Cl 21-60 ml/min or in patients on hemodialysis the daily dose should be reduced by 25%; in creatinine Cl 20 ml/min or less or in patients on peritoneal dialysis the daily dose should be reduced by half.

Interaction

Blockers of tubular secretion (allopurinol, diuretics, etc.) delay renal excretion of cefixime, which may lead to increased toxicity.

Cefixime decreases the prothrombin index and increases the effect of indirect anticoagulants.

Antacids containing magnesium or aluminum hydroxide slow down absorption of the drug. Concomitant use of cefixime and carbamazepine increases the concentration of the latter.

Special Instructions

Patients with a history of allergic reactions to penicillins may have hypersensitivity to cephalosporin antibiotics. In case of allergic reactions the drug should be discontinued and, if necessary, appropriate measures should be taken.

As with other antibacterial drugs, prolonged use of cefixime may disrupt normal gut flora, which may lead to growth of Clostridium difficile and cause severe diarrhea and pseudomembranous colitis.

False positive direct Coombs reaction and false positive urine reaction for glucose, ketonuria are possible during treatment.

Contraindications

– hypersensitivity to cephalosporins, penicillins, penicillamine;

– childhood under 6 months (for suspension) and under 12 years (for tablets).

With caution: older age, renal failure, colitis (in anamnesis).

Side effects

Allergic reactions: urticaria, skin hyperemia, skin itching, genital itching, eosinophilia, fever, erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome).

Nervous system disorders: headache, dizziness, tinnitus.

Anxiety to the genitourinary system: vaginitis.

Urinary system disorders: interstitial nephritis.

In the digestive system: nausea, vomiting, stomatitis, diarrhea, abdominal pain, constipation, pseudomembranous enterocolitis, dysbacteriosis, cholestasis; cholestatic jaundice.

Hematopoietic organs: pancytopenia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, aplastic anemia, hemolytic anemia, bleeding.

Laboratory parameters: increased hepatic transaminases and alkaline phosphatase activity, hyperbilirubinemia, increased urea nitrogen, hypercreatininemia, increased PV.

Others: candidiasis, development of hypovitaminosis B, shortness of breath.

Overdose

Symptoms: intensification of the manifestations of the described side effects.

Treatment: gastric lavage, symptomatic and supportive therapy.

Hemodialysis and peritoneal dialysis are ineffective.

Pregnancy use

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