Ixime Lupin powder 100mg/5ml 25gr 50ml

Ixime Lupin instruction

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Dosage form, composition

powder for suspension for oral administration
Each 5 ml of suspension contains:

Active substance

Cefixim F. USA (in the form of trihydrate) 120.39 mg, equivalent to anhydrous Cefixim 100 mg.

Excipients

xanthan gum, sodium benzoate, strawberry flavor 052311 АР0551, silicon dioxide colloid (Aerosil 200), sucrose.

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 code J01DD08

PHARMACOLOGICAL PROPERTIES OF IXIM LUPIN

Pharmacodynamics

Semisynthetic cephopposporin 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 spp. Salmonella spp., Shigella spp ,, Citrobacter spp. (including Citrobacter diversus, Citrobacter amalonaticus), Serratia marcescens.
To Cefixim, Pseudomonas spp., Enterococcus spp. (Streptococcus) serogroup D, Listeria monocytogenes, Bacteroides fragilis, most strains of Staphylococcus (including methicillin-resistant strains), Enterobacter spp., Clostridium spp.

Pharmacokinetics

Bioavailability of Ixime Lupin when ingested - 40-50%. Admission together with food increases the time of maximum absorption by 0.8 hours. The maximum concentration (Cmax) in the serum after oral administration of the suspension at a dose of 100, 200 and 400 mg is 1-1.3, respectively; 1-4.5 and 1.9-7.7 μg / ml. The time to reach the maximum concentration (TCmax) is 2-6 h for suspensions at a dose of 400 mg / 5 ml and 2-5 h for a suspension of 200 ~ mg / 5 ml. The maximum concentration (Сmаx) 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 period (T1) is 3-4 hours, with renal failure 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 FOR USE

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 OF IXIM LUPIN

Hypersensitivity, incl. to penicillins, penicillamine, children's age (up to 6 months).

CAREFULLY

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

PREGNANCY AND PERIOD OF LACTATION

In pregnancy, the use of the drug is possible only in cases where the intended use for the mother exceeds the potential risk to the fetus. If necessary, use during lactation should stop breastfeeding.

METHOD OF USE AND DOSES

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 once a day (or 200 mg twice a day).
With uncomplicated gonorrhea of ​​the urethra and cervix - 400 mg once.
Children under the age of 12 years are prescribed at 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, 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 (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 boiled water cooled to room temperature is added to the vial with the preparation, covered with a lid, shaken carefully until a homogeneous suspension is formed. 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 Ixime Lupin, 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, noise in the ears.
From the genitourinary system: vaginitis, candidamycosis, itching in the genital area.
On the part of the urinary system: a violation of kidney function, interstitial nephritis.
From the hematopoiesis: pancytopenia, leukopenia, neutropenia, thrombocytopenia, agranulocytosis, aplastic anemia, hemolytic anemia, bleeding.
On the part of laboratory indicators: eosinophilia, increased activity of "liver" transaminases and alkaline phosphatase, hyperbilirubinemia, increased urea nitrogen, hypercreatininemia, 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 Cefixim in the blood plasma, respectively, hemo- or peritoneal dialysis is not effective.

INTERACTION WITH OTHER DRUGS

Cefixim reduces the prothrombin index, increases the effect of indirect anticoagulants. Increases the level of carbamazepine in the blood serum. Blockers of tubular secretion (including allopurinol, diuretics) delay the excretion of cefixin 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.

Form of issue

Powder for suspension for oral administration, 100 mg / 5 ml. Powder 25 g to prepare 50 ml of suspension is placed in a bottle of high-density polyethylene with a lid of polypropylene, with a protective lock from children, and a lining of laminated aluminum foil with the inscription "LUPIN". On the cover in English indicate: "CLOSE TIGHTLY" (ie close tightly), "TO OPEN" (ie open), "PUSH DOWN AND UNSCREW" (ie, press and unscrew). A label with an arrow indicating the level of water added is pasted onto the vial. One bottle is placed in a cardboard box together with instructions for use.

Shelf life

2 years (powder).
14 days (ready suspension).
Do not use after the expiry date printed on the package.

Storage conditions

In a dry place at a temperature of no higher than 25 ° C.
Keep out of the reach of children.

Conditions of leave from pharmacies

You don't need a prescription to buy Ixime Lupin.