Pancef granules for suspension 100mg/5ml bottle 100ml

Mechanism of action

Semisynthetic cephalosporin III generation antibiotic for oral administration of a wide spectrum of action. Bactericidal effect. The mechanism of action is due to inhibition of the synthesis of the cell membrane of the pathogen. Cefixime is resistant to β-lactamase produced by most gram-positive and gram-negative bacteria.

In vitro cefixime 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 active against gram-positive bacteria: Streptococcus pneumoniae, Streptococcus pyogenes; Gram-negative bacteria: Haemophilus influenzae, Moraxella (Branhamella) catarrhalis, Escherichia coli, Proteus mirabilis, Neisseria gonorrhoeae.

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

Pharmacokinetics

When taken orally, the bioavailability of cefixime is 40-50% regardless of food intake, however C_max serum cefixime is reached by 0.8 h faster when taking the drug with food. Binding to plasma proteins, mainly albumin, is 65%. About 50% of the dose is excreted in the urine unchanged within 24 hours, about 10% of the dose is excreted in the bile. T_1/2 depends on the dose and is 3-4 hours. In patients with impaired renal function with CC from 20 to 40 ml / min T_1/2 increases to 6.4 h, with CC 5–10 ml / min - to 11.5 h.

Indications

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

Dosing regimen

For adults and children over 12 years old with a body weight of more than 50 kg, the daily dose is 400 mg (1 time / day or 200 mg 2 times / day). Duration of treatment is 7-10 days. With uncomplicated gonorrhea - 400 mg once.

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

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

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

Side effect

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

Hemic and lymphatic: leukopenia, thrombocytopenia, neutropenia, hemolytic anemia.

From the side of the central nervous system: dizziness, headache.

Urogenital: interstitial nephritis.

Allergic reactions: pruritus, urticaria, skin flushing, eosinophilia, fever.

Contraindications

Hypersensitivity to cephalosporins and penicillins.

Use during pregnancy and lactation

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

If necessary, use during lactation should stop breastfeeding.

Application for violations of kidney function

In cases 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 KK≤20 ml / min, the daily dose should be reduced by 2 times.

Use in children

Caution should be used in children under the age of 6 months.

Use in elderly patients

Caution should be used in elderly patients.

special instructions

It should be used with caution in elderly patients, patients with chronic renal failure or pseudomembranous colitis (in history), in children under 6 months.

With prolonged use, the normal intestinal microflora may be impaired, 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 reaction and a false-positive reaction of urine to glucose are possible.

Overdose

Tubular secretion blockers (allopurinol, diuretics) delay the excretion of cefixime by the kidneys, which can lead to increased toxicity.

Cefixime reduces the prothrombin index, enhances the effect of indirect anticoagulants.

Antacids containing Magnesium or aluminum hydroxide, slow down the absorption of cefixime.