Panzef® (Pancef®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceCefiximCefixim
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    • Dosage form: & nbspGranules for the preparation of a suspension for oral administration.
    Composition:
    60 ml of the suspension contain the active substance: cefixime (in the form of cefixime trihydrate) 1.207 g-1.351 g.

    100 ml of the suspension contain the active substance: cefixime (as cefixime trihydrate) 2,000 g-2.238 g

    Excipients: sucrose, xanthan gum, sodium benzoate, orange flavor.
    Description:
    Light yellow to yellow granules.

    Prepared suspension: White or white with a yellowish hue homogeneous suspension, with an orange smell.
    Pharmacotherapeutic group:Antibiotic-cephalosporin.
    ATX: & nbsp

    J.01.D.D.08   Cefixim

    Pharmacodynamics:
    Cefixim is a cephalosporin antibiotic III generation for ingestion with a pronounced antibacterial activity against most gram-positive andgram-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 agalactiae, 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 (CmOh) in the blood serum are achieved faster by 0.8 hours when taking the drug with food. TSmOh 2-6 hours for a suspension of 400 mg / 5 ml and 2-5 hours for a suspension of 200 mg / 5 ml. After taking suspension CmOh (in comparison with tablets) is higher by 25-50%. The maximum concentration in the blood plasma is reached in 2-6 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 serum, bile, urine.

    Metabolism

    There is no data on metabolites of cefixime.

    Excretion

    Cefixime is excreted mainly by the kidneys in an unchanged form of 50%, with bile-10%. Half-life in healthy volunteers averages 3-4 hours, in some cases up to 9 hours. A prolonged half-life period makes possible a single dosing.

    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 (pharyngitis, sinusitis);

    ■ otitis media;

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

    ■ urinary tract infections;

    ■ uncomplicated gonorrhea (urethra and cervix);

    ■ tonsillitis.
    Contraindications:Hypersensitivity to cephalosporins, incl. to penicillins, penicillamine. Children up to 6 months.
    Carefully:Elderly age, renal insufficiency, colitis (in the anamnesis).
    Pregnancy and lactation:The use of cefixime during pregnancy 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 1 time / soupsi 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 administered as a suspension in a dose of 8 mg / kg body weight 1 time / day or 4 mg / kg every 12 hours:

    Body weight (kg)

    Dose/cyr (graduated cap, ml)

    Dose/ cyr (mg)

    up to 6,0

    2.5

    50

    6,0 -12,5

    5

    100

    12,5-25,0

    10

    200

    25,0-37,5

    15

    300

    37,5- 50

    15-20

    300-400

    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. Due to the difference in bioavailability, the suspension is not recommended to be replaced with tablets. 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.

    Method of preparation 60 ml suspension for ingestion 100 mg / 5 ml.

    The suspension is prepared immediately before the first use.Vial shake several times. Using a measuring cap, add 40 ml of boiled water cooled to room temperature in 2 stages and shake vigorously after each addition until a homogeneous suspension forms. To dispense the finished suspension, a measuring cap should be used, which should be rinsed well with water after each use.

    Method of preparation 100 ml of suspension for ingestion 100 mg / 5 ml.

    The suspension is prepared immediately before the first use. Vial shake several times. With a cap, add 66 ml of boiled water cooled to room temperature in 2 stages and shake vigorously after each addition until a homogeneous suspension forms. To dispense the finished suspension, a measuring cap should be used, which should be rinsed well with water after each use.

    Before use, the prepared suspension should be shaken well.

    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; jaundice

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

    Laboratory indicators: increased activity of "hepatic" 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 maintenance therapy Hemodialysis and peritoneal dialysis are ineffective.

    Interaction:The tubular secretion blockers (including allopurinol, diuretics) delay the excretion of cefixil 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.
    Special instructions:The patient 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, prolonged use of cefixime can lead to the growth of Clostridium difficile, which is manifested by the development of severe diarrhea. In this case, it is especially important to consider the possibility of developing pseudomembranous colitis. During treatment, false-positive direct Coombs reaction and false-positive urine reaction to glucose, ketonuria are possible.
    Form release / dosage:

    Granules for the preparation of a suspension for oral administration of 100 mg / 5 ml.

    Packaging:

    For 60 ml of suspension

    Primary: 32 g granules for the preparation of 60 ml suspension for ingestion 100 mg / 5 ml in a bottle of dark glass with a screwed aluminum cover with a polyethylene liner and the control of the first opening.

    Secondary: Each bottle together with the instructions for use complete with a measuring cap is placed in a pack of cardboard.

    For 100 ml of suspension

    Primary: on 53 g granules for the preparation of 100 ml suspension for ingestion 100 mg / 5 ml in a bottle of dark glass with a screwed aluminum cover with a polyethylene liner and the control of the first opening.

    Secondary: Each bottle together with the instructions for use complete with a measuring cap is placed in a pack of cardboard.

    Storage conditions:
    List B.

    Granules for the preparation of suspension should be stored in a dark place at a temperature of 15 to 25 ° C.

    The prepared suspension should be stored in a dark place at a temperature of 15 to 25 ° C not more than 14 days.

    Keep out of the reach of children.
    Shelf life:3 years. Do not use after the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-009444/09
    Date of registration:24.11.2009
    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
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