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

Alkaloid AD Skopje, Republic of Northern Macedonia

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Product Overview

Structure

Active substance:

cefixime (as cefixime trihydrate);

 

Excipients:

 sucrose;

xanthan gum;

sodium benzoate;

orange flavor

pharmachologic effect

Panceph is a broad-spectrum antibacterial (bactericidal).

Pharmacodynamics

Cefixime is a third-generation cephalosporin antibiotic for oral administration 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. Resistant to beta-lactamases of both gram-positive and gram-negative microorganisms.

It is highly active against Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis (including strains producing beta-lactamases), Escherichia coli, Proteusella gibelis bacteria, 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 of the strains of Staphylococcus, Enterobacter and Clostridium are resistant to cefixime.

Pharmacokinetics

Suction. After oral administration, the absorption of cefixime is 40-50%, regardless of food intake; however, it was noted that C max  in serum is reached faster by 0.8 hours when taking the drug with food. When taking the drug in the form of tablets at a dose of 400 mg, C max   in plasma is 3.5 μg / ml. T max  - 2-6 hours

After taking the suspension, C max  (compared with tablets) is 25–50% higher. T max  - 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%. V d  is 0.6-1.1 l / kg. High concentrations of the drug persist for a long time in blood serum, bile, and urine.

Metabolism. There is no data on the metabolites of cefixime.

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

T 1/2  in healthy volunteers averages 3-4 hours, in some cases up to 9 hours. A long T 1/2  makes a single dose possible.

In case of impaired renal function with Cl creatinine, 20–40 ml / min T 1/2  increases and averages 6.4 hours, with Cl creatinine 5–20 ml / min T 1/2  - 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's age up to 6 months (for suspension) and up to 12 years (for tablets).

With caution: old age, renal failure, colitis (history).

Side effects

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

From the nervous system: 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 hemopoietic organs: pancytopenia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, aplastic anemia, hemolytic anemia, bleeding.

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

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

Interaction

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

How to take, course of administration and dosage

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

With uncomplicated gonorrhea - 400 mg once.

For children aged 6 months to 12 years, body weight less than 50 kg, the drug is prescribed in the form of a suspension in 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 therapy.

Hemodialysis and peritoneal dialysis are ineffective.

Special instructions

Patients with a history of allergic reactions to penicillins may be hypersensitive to cephalosporin antibiotics. In case of an allergic reaction, it is necessary to stop the use of the drug and, if necessary, take appropriate measures.

As with other antibacterial drugs, prolonged use of cefixime may disturb the normal intestinal microflora, which can lead to the growth of Clostridium difficile and 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.

Release form

Granules for oral suspension

Storage conditions

In the dark place at a temperature of 15–25 ° C

Shelf life

3 years

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