Ixim Lupine (Ixime Lupine)

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: & nbspPowder for the preparation of a suspension for oral administration.
    Composition:Each 5 ml of the suspension contains:
    active substance: cefixime F. USA (in the form of trihydrate) 120.39 mg, equivalent to anhydrous cefixime 100 mg. Excipients: xanthan gum 10.00 mg, sodium benzoate 10.00 mg, strawberry flavor 052311 AP0551 25.00 mg, silicon dioxide colloid (Aerosil 200) 25.00 mg, sucrose 2309.61 mg.
    Description:
    Powder: From almost white to pale yellow powder.

    Finished suspension: From almost white to yellow suspension with a characteristic fruity odor.
    Pharmacotherapeutic group:Antibiotic-cephalosporin.
    ATX: & nbsp

    J.01.D.D.08   Cefixim

    Pharmacodynamics:Semisynthetic cephalosporin antibiotic III generation for oral administration.It acts bactericidal (it breaks the synthesis of the cell wall of microorganisms). Has a wide spectrum of antimicrobial action, which includes various aerobic and anaerobic Gram-positive and Gram-negative microorganisms, incl. Pseudomonas aeruginosa. It is resistant to beta-lactamases of both gram-positive and gram-negative microorganisms.

    Highly active against gram-positive: Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae; Gram-negative: Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis (including strains producing beta-lactamases), Escherichia coli, Proteus mirabilis, Proteus vulgaris, Neisseria gonorrhoeae (including penicillinase-producing strains), Klebsiella pneumoniae, Klebsiella oxytoca, Pasteurella multocida, Providencia sppSalmonella spp., Shigella spp., Citrobacter spp. (incl. Citrobacter diversus, Citrobacter amalonaticus), Serratia marcescens.

    TO cefixime are stable Pseudomonas spp ,, Enterococcus spp. (Streptococcus) serogroup D, Listeria monocytogenes, Bacteroides fragilis, most strains Staphylococcus (including methicillin-resistant strains), Enterobacter spp., Clostridium spp.

    Pharmacokinetics:

    Bioavailability of the drug when ingested - 40-50%. Admission together with food increases the time of maximum absorption by 0.8 hours. The maximum concentration (CmOh) in the serum after oral administration of the suspension in a dose of 100, 200 and 400 mg is 1-1.3, respectively; 1-4.5 and 1.9-7.7 μg / ml. Time to reach the maximum concentration (TCmOh) - 2-6 h for a suspension in a dose of 400 mg / 5 ml and 2-5 h for a suspension of 200 mg / 5 ml. The maximum concentration (CmOh) in the urine after taking in doses of 100, 200 and 400 mg - 73, 107 and 164 μg / ml, respectively.High concentrations of the drug persist for a long time in serum, bile, urine. The half-life (T1/2) is 3-4 hours, with renal insufficiency increases to 6.4-11.5 hours. The volume of distribution is 0.11 l / kg. The connection with plasma proteins is 65-70%. It is excreted by the kidneys in unchanged form - 50%, with bile - 10%. Due to the difference in bioavailability, it is not recommended to replace the suspension with tablets in the treatment of otitis media.

    Indications:
    Infectious and inflammatory diseases caused by microorganisms sensitive to the preparation:

    - upper and lower respiratory tract (pharyngitis, tonsillitis, sinusitis, acute bronchitis and exacerbation of chronic bronchitis),

    - otitis media,

    - urinary tract infections (uncomplicated),

    - uncomplicated gonorrhea of ​​the urethra and cervix.
    Contraindications:Hypersensitivity, incl. to penicillins, penicillamine, children's age (up to 6 months).
    Carefully:Elderly age, renal insufficiency, colitis (in the anamnesis).
    Pregnancy and lactation:In pregnancy, the use of the drug is only possible if the intended benefit to the mother exceeds the potential risk to the fetus.If necessary, use during lactation should stop breastfeeding.
    Dosing and Administration:

    Inside.

    For children over 12 years of age with a body weight of more than 50 kg and adults the average daily dose is 400 mg 1 once in day or 200 mg 2 times a day).

    With uncomplicated gonorrhea urethra and cervix - 400 mg once.

    Children under the age of 12 years prescribe a dose of 8 mg / kg once a day or 4 mg / kg 2 times a day (every 12 hours).

    For children aged 5-11 years the daily dose of the suspension is 6-10 ml, at the age of 2-4 years - 5 ml, at the age of 6 months to 1 year - 2.5-4 ml.

    The average duration of treatment is 7-10 days. In diseases caused by Streptococcus pyogenes, treatment should be at least 10 days. In case of impaired renal function the dose is set depending on the creatinine clearance (CC) in the blood serum: with a CC of 21-60 ml / min or in patients on hemodialysis, the daily dose should be reduced by 25%; with SC 20 ml / min or less, or in patients on peritoneal dialysis, the daily dose should be reduced by a factor of 2.

    A method of preparing a suspension. Turn the vial and shake the powder. Approximately half (17 ml) of the required volume (34 ml) of chilled toroom temperature of boiled water, cover with a lid, shake thoroughly until a homogeneous suspension forms. Then add the cooled boiled water to the mark (arrow) indicated on the label, cover it with a lid, shake it thoroughly until a homogeneous suspension forms. Allow to stand for 5 minutes.

    Before use, the prepared suspension is shaken well. Use at least 14 days after preparation.

    Side effects:

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

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

    From the nervous system: headache, dizziness, tinnitus.

    From the genitourinary system: vaginitis, candidamycosis, itching in the genital area

    bodies.

    From the urinary system: renal dysfunction, interstitial nephritis.

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

    From the laboratory indicators: eosinophilia, increased activity of "hepatic" transaminases and alkaline phosphatase, hyperbilirubinemia, increased urea nitrogen, hypercreatininaemia, increased prothrombin time.

    Other: development of hypovitaminosis B, dyspnea.

    Overdose:
    Symptoms: increased risk of adverse reactions.
    Treatment: because there is no specific antidote, gastric lavage is shown, symptomatic and supportive therapy, including the use of glucocorticosteroids, infusion therapy, and artificial ventilation. The procedure of peritoneal and hemodialysis does not significantly affect the concentration of cefixime in the blood plasma, respectively, hemo- or peritoneal dialysis is not effective.
    Interaction:Cefixim reduces the prothrombin index, increases the effect of indirect anticoagulants. Increases the level of carbamazepine in the blood serum. Blockers of tubular secretion (incl. allopurinol, diuretics) delay the excretion of cefixil by the kidneys, which can lead to an increase in toxicity.Antacids containing magnesium or aluminum hydroxide, slow the absorption of the drug.
    Special instructions:Patients who had a history of allergic reactions to penicillins, may have increased sensitivity to cephalosporin antibiotics. During treatment, a false-positive direct Coombs reaction and a false positive urine reaction to glucose and ketone bodies are possible. False positive urine reaction to ketone bodies can be observed with nitroprusside tests, but not with nitroferricyanide tests. False positive urine reaction to glucose during therapy can be observed when using solutions of Benedict or Fehling. It is preferable to carry out tests based on an enzymatic reaction using glucose oxidase.
    Effect on the ability to drive transp. cf. and fur:The drug does not affect driving by car and employment of other potentially dangerous activities requiring increased concentration of attention and speed of psychomotor reactions.
    Form release / dosage:
    Powder for the preparation of suspension for ingestion 100 mg / 5 ml.


    Packaging:
    Primary packaging:
    Powder 25 g to prepare 50 ml of the suspension is placed in a bottle of high-density polyethylene and a gasket of
    Laminated aluminum foil with the inscription "LUPIN".
    A label with an arrow indicating the level of water added is pasted onto the vial.

    Secondary packaging:

    1. The vials are sealed with a screw cap made of polypropylene with a protective lock from the children. On the cover in English indicate: "CLOSE TIGHTLY" (ie close tightly), "TO OPEN" (ie open), "PUSH DOWN AND UNSCREW" (ie, press and unscrew). The lid of the vial is closed with a measuring polyethylene cup. One bottle is placed in a cardboard box together with instructions for use.

    2. The vials are sealed with a screw cap made of polypropylene with a protective lock from the children. On the cover in English indicate: "CLOSE TIGHTLY" (ie close tightly), "TO OPEN" (ie open), "PUSH DOWN AND UNSCREW" (ie, press and unscrew). One bottle is placed in a cardboard box together with instructions for use.
    Storage conditions:
    In a dry place at a temperature not exceeding 25 ° C. Keep out of the reach of children.
    Shelf life:
    2 years (powder).

    14 days (ready suspension).

    Do not use after the expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-005238/09
    Date of registration:30.06.2009
    The owner of the registration certificate:Lupine Co., Ltd.Lupine Co., Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspLUPIN LIMITEDLUPIN LIMITED
    Information update date: & nbsp14.01.2016
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