Panzef - instructions for use, dose, side effects, contraindications

Excipients: microcrystalline cellulose, pregelatinized starch, calcium dihydrogen phosphate, gelatin, corn starch, sodium lauryl sulfate, magnesium stearate, hypromellose, macrogol 4000, titanium dioxide E 171.

Description:Oblong, biconvex tablets covered with a film coat of creamy white color, with a risk on one side.

Pharmacotherapeutic group:Antibiotic-cephalosporin.

ATX: & nbsp

J.01.D.D.08 Cefixim

Pharmacodynamics:

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

The mechanism of action is due to the 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 agaiactiae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis (including strains producing beta-lactamases), 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:

Suction

After oral administration, the intake of cefixime is 40-50%, regardless of food intake; However, it was noted that the maximum concentrations (Cmah) in plasma are achieved faster by 0.8 h when taking the drug with food. When taking the drug in the form of tablets at a dose of 400 mg CmThe concentration in plasma is 3.5 μg / ml. The maximum concentrations in the plasma are reached after 2 to 6 hours.

Distribution

Binding to plasma proteins is 50-60%. The volume of distribution is 0.6-1.1 l / kg.

High concentrations of the drug persist for a long time in blood plasma, bile, urine.

Excretion

Cefixime is excreted mainly by the kidneys by glomerular filtration. Half-life in healthy people is 3-4 hours.

If the renal function is impaired with the clearance of creatinine (CC) 20-40 ml / min, the half-life period increases and on the average is 6.4 h, with KK 5-20 ml / min -11.5 h.

Indications:

Infectious-inflammatory diseases caused by microorganisms sensitive to cefixime:

■ infections of the upper respiratory tract (tonsillitis, pharyngitis, sinusitis);

■ otitis media;

■ infection of the lower respiratory tract (bronchitis, tracheobronchitis);

■ urinary tract infections;

■ uncomplicated gonorrhea (urethra and cervix).

Contraindications:Hypersensitivity to cephalosporins and penicillins.

Children under 12 years.

Carefully:Elderly age, renal insufficiency, colitis (in the anamnesis).

Pregnancy and lactation:The use of cefixime during pregnancy and during lactation is possible only if the intended benefit to the mother exceeds the potential risk to the fetus. If necessary, the appointment in the lactation period should stop breastfeeding.

Dosing and Administration:

Inside. For adults and children over 12 years of age weighing more than 50 kg the recommended daily dose is 400 mg (once / once or 200 mg twice a day). With uncomplicated gonorrhea - 400 mg once. The average duration of treatment is 7-10 days.

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

If the renal function is impaired, the dose is set depending on the creatinine clearance in the blood serum: with creatinine clearance of 21-60 ml / min or in patients on hemodialysis, the daily dose should be reduced by 25%; with a creatinine clearance of 20 ml / min or less, or in patients on peritoneal dialysis, the daily dose should be reduced by a factor of 2.

Side effects:

Allergic reactions: urticaria, skin hyperemia, itching, itching in the genital area, eosinophilia, fever, multiforme exudative erythema (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's 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, dysbacteriosis, cholestasis; cholestatic jaundice.

From the hematopoiesis: pancytopenia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, aplastic anemia, hemolytic anemia, bleeding;

Laboratory indicators: increased activity of "liver" transaminases and alkaline phosphatase, hyperbilirubinemia, increased urea nitrogen, hypercreatininaemia, increased prothrombin time;

Other: Candidiasis, development of hypovitaminosis B, dyspnea.

Overdose:Symptoms: increased manifestations of the described side effects. Treatment: gastric lavage, symptomatic and supportive therapy. Hemodialysis and peritoneal dialysis are ineffective.

Interaction:

The tubular secretion blockers (allopurinol, diuretics, etc.) delay the excretion of cefixime by the kidneys, which can lead to an increase in toxicity.

Cefixim reduces the prothrombin index, increases the effect of indirect anticoagulants. Antacids containing magnesium or aluminum hydroxide, slow the absorption of the drug.With the simultaneous use of cefixime and carbamazepine, the concentration of the latter increases.

Special instructions:

Patients who had a history of allergic reactions to penicillins, may have increased sensitivity to cephalosporin antibiotics. In case of an allergic reaction, discontinue use of the drug and, if necessary, take appropriate measures.

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

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

Form release / dosage:Film-coated tablets 400 mg.

Packaging:

Primary: 5 or 6 tablets per blister perforated from aluminum foil and PVC / TE / PVDX film.

Secondary: 1 blister (6 tablets each), or 2 blisters (5 tablets each), along with instructions for use, are placed in a cardboard box.

Storage conditions:In a dark place at a temperature of 15 to 25 ° C. Keep out of reach of children.

Shelf life:3 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-001308/09

Date of registration:20.02.2009

The owner of the registration certificate:Alkaloid, JSCAlkaloid, JSC Macedonia

Manufacturer: & nbsp

ALKALOID, AD Macedonia

Representation: & nbspALKALOID, AOALKALOID, AO

Information update date: & nbsp14.01.2016

Illustrated instructions

Instructions

Panzef® (Pancef®)