Pancef, 100mg/5ml suspension, 60ml/32g

Composition

Active ingredient:

cefixime (in the form of cefixime trihydrate);

Auxiliary substances:

sucrose;

xanthan gum;

sodium benzoate;

orange flavor

Pharmacological action

Pantsef – broad-spectrum antibacterial (bactericidal).

Pharmacodynamics

Cefixime is a third-generation cephalosporin antibiotic for oral use with pronounced antibacterial activity against most gram-positive and gram-negative microorganisms.

The mechanism of action is due to 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 in relation to Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis (including strains, beta-lactamase-producing), 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 Streptococcus, Enterococcus spp. (methicillin-resistant strains), Listeria monocytogenes, Bacteroides fragilis, most strains Staphylococcus, Enterobacter, and Clostridium are resistant to cefixime.

Pharmacokinetics

Suction. After oral use, the absorption of cefixime is 40-50% regardless of food intake; however, it was noted that_cmax in blood serum is reached faster by 0.8 hours when taking the drug with food. When taking the drug in tablet form at a dose of 400 mg, the_cmax in plasma is 3.5 mcg / ml. T_max — 2-6 hours.

After taking the suspension, cmax (compared to tablets) is 25-50% higher. T_max is 2-6 hours for a suspension of 400 mg/5 ml and 2-5 hours for a suspension of 200 mg/5 ml. T_max in blood 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 persist for a long time in the blood serum, bile, and urine.

Metabolism. There are no data on cefixime metabolites.

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

T_1/2 in healthy volunteers is on average 3-4 hours, in some cases-up to 9 hours. Prolonged T_1/2 makes a single dosage possible.

When renal function is impaired, T 1/2 increases with a creatinine clearance of 20-40 ml/min and averages 6.4 hours, while T 1/2 increases with a creatinine clearance of 5-20 ml/min and 11.5 hours.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to cefixime:

• upper respiratory tract infections (tonsillitis, pharyngitis, sinusitis);
• otitis media;
• lower respiratory tract infections (bronchitis, tracheobronchitis);
• urinary tract infections;
• uncomplicated gonorrhea (urethra and cervix).

Contraindications

• hypersensitivity to cephalosporins, penicillins, penicillamine;
• children under 6 months of age (for suspension) and up to 12 years (for tablets).

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

Side effects

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

Nervous system disorders:  headache, dizziness, tinnitus.

From the genitourinary system:  vaginitis.

From the urinary system:  interstitial nephritis.

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

From the side of hematopoietic organs:  pancytopenia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, aplastic anemia, hemolytic anemia, bleeding.

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

Other services:  candidiasis, development of hypovitaminosis B, shortness of breath.

Interaction

Tubular secretion blockers (allopurinol, diuretics, etc. ) delay the elimination 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 the drug. Concomitant use of cefixime and carbamazepine increases the concentration of the latter.

How to take, course of use and dosage

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 twice a day.

With uncomplicated gonorrhea-400 mg once.

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.

Overdose

Symptoms:  increased manifestations of the described side effects.

Treatment:  gastric lavage, symptomatic and supportive care.

Hemodialysis and peritoneal dialysis are ineffective.

Special instructions

Patients who have had a history of allergic reactions to penicillins may be hypersensitive to cephalosporin antibiotics. If an allergic reaction occurs, stop using the drug and, if necessary, take appropriate measures.

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

During treatment, a false positive direct Coombs reaction and a false positive urine reaction to glucose, ketonuria are possible.

Form of production

Pellets for preparation of oral suspension

Storage conditions

In a dark place, at a temperature of 15-25 °C

Shelf life

3 years

Active ingredient

Cefixime

Conditions of release from pharmacies

By prescription

Dosage form

suspension for oral use

Description

Children as prescribed by a doctor

Indications

Tonsillitis, Bronchitis, Urinary Tract Infections, Pharyngitis, Sore Throat, Sinusitis, Otitis