Pancef (Cefixim)

Alkaloid AD Skopje, Republic of North Macedonia

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$27 - $32
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Product Overview

Composition

Active substance:

cefixim (in the form of a trihydrate cefixim);

Excipients:

MKC;

pre-gelatinized starch;

calcium dihydrophosphate;

gelatin;

corn starch;

sodium lauryl sulfate;

magnesium stearate;

hypromellosis;

macrogol 4000;

titanium dioxide (E171)

Pharmacological action

Panzef is a broad spectrum antibacterial (bactericidal).

Pharmacodynamics

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

The mechanism of action is due to the suppression of the synthesis of the cell membrane of the causative agent. 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 that produce beta-lactamases), Escherichia coli, Citrobacter diversus), Serratia marcescens.

Pseudomonas spp., Acinetobacter spp, some strains Streptococcus, Enterococcus spp. (meticillium-resistant strains), Listeria monocytogenes, Bacteroides fragilis, most Staphylococcus, Enterobacter and Clostridium strains are resistant

Pharmacokinetics

Suction. After ingestion, the absorption of cefixim is 40-50% regardless of food intake; however, it was noted that Cmax in blood serum is achieved faster by 0.8 hours when taking the drug together with food. When taking the drug in the form of tablets at a dose of 400 mg Cmax in plasma is 3.5 μg/ml. Tmax - 2-6 hours.

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

Distribution. Plasma protein binding is 50-60%. Vd is 0.6-1.1 l/kg. High concentrations of the drug persist for a long time in blood serum, bile, urine.

Metabolism. There is no data on cefixim metabolites.

Withdignment. Cefixim is excreted mainly by the kidneys by glomerular filtration unchanged - 50%, with bile - 10%.

T1/2 in healthy volunteers is on average 3-4 hours, in some cases - up to 9 hours. Long-term T1/2 makes it possible to do a single dosing.

In case of kidney dysfunction in Cl creatinine 20-40 ml/min T1/2 increases and averages 6.4 hours, Cl creatinine 5-20 ml/min T1/2 increases and 11.5 hours.

Indications

Infectious and inflammatory diseases caused by cefixim-sensitive microorganisms:

  • upper respiratory tract infections (tonzillitis, pharyngitis, sinusitis);
  • middle otitis;
  • lower respiratory tract infections (bronchitis, tracheobronchiitis);
  • 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: old age, kidney failure, colitis (in history).

Side effects

Allergic reactions: hives, skin hyperemia, itching, genital itching, eosinophilia, fever, multiform exudative erythema (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 jade.

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

From the hematopoietic organs: pancitopenia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, aplastic anemia, hemolytic anemia, bleeding.

Laboratory indicators: increased activity of liver transaminases and SRF, hyperbilirubinemia, increased urea nitrogen, hypercreatinemia, increase in PV.

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

Interaction

Canal secretion blockers (allopurinol, diuretics, etc.) delay the elimination of kidney cefixim, which can lead to increased toxicity.

Cefixim reduces the prothrombin index, enhances the action of indirect anticoagulants.

Antacides containing magnesium or aluminum hydroxide slow down the absorption of the drug. Simultaneous use of cefixim and carbamazepine increases the concentration of the latter.

How to take, course of administration and dosage

Inside. For adults and children over 12 years of age with a body weight of more than 50 kg, the recommended daily dose is 400 mg (1 time per day or 200 mg 2 times a day). In case of uncomplicated gonorrhea - 400 mg once. The average duration of treatment is 7-10 days.

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

In case of kidney dysfunction, the dose is set depending on the clearance of creatinine in blood serum: in Cl creatinine 21-60 ml/min or in patients on hemodialysis, the daily dose should be reduced by 25%; in Cl creatinine 20 ml/min or less or in patients on peritoneal dialysis,

Overdose

Symptoms: strengthening the manifestations of the described side effects.

Treatment: stomach washing, symptomatic and supportive therapy.

Hemodialysis and peritoneal dialysis are ineffective.

Special instructions

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

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

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

Release form

tablets

Storage conditions

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

Shelf life

3 years

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