Ixim Lupin, suspension 100 mg/5 ml, 25 g

Ixim Lupin is a III generation semi-synthetic cephalosporin antibiotic for oral administration of a broad spectrum. It acts bactericidally. The mechanism of action is due to inhibition of synthesis of the cell membrane of the pathogen. Cefixime is resistant to β-lactamases produced by most gram-positive and gram-negative bacteria.

In vitro cefixime is active against Gram-positive bacteria: Streptococcus agalactiae; Gram-negative bacteria: Haemophilus parainfluenzae, Proteus vulgaris, Klebsiella pneumoniae, Klebsiella oxytoca, Pasteurella multocida, Providencia spp, Salmonella spp., Shigella spp., Citrobacter amalonaticus, Citrobacter diversus, Serratia marcescens.

In vitro and in clinical practice cefixime is active against Gram-positive bacteria: Streptococcus pneumoniae, Streptococcus pyogenes; Gram-negative bacteria: Haemophilus influenzae, Moraxella (Branhamella) catarrhalis, Escherichia coli, Proteus mirabilis, Neisseria gonorrhoeae.

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

Pharmacokinetics

In oral administration the bioavailability of cefixime is 40-50% regardless of meals, but the Cmax of cefixime in serum is reached faster by 0.8 h when the drug is taken with food. Binding with plasma proteins, mainly with albumin, is 65%.

About 50% of dose is excreted unchanged in 24 hours with urine, about 10% of dose is excreted with bile. T1/2 depends on the dose and is 3-4 hours. In patients with kidney dysfunction in IQ from 20 to 40 ml/min the T1/2 is increased up to 6.4 hours, in IQ of 5-10 ml/min – up to 11.5 hours.

Indications

Infectious and inflammatory diseases caused by susceptible microorganisms: pharyngitis, tonsillitis, sinusitis, acute and chronic bronchitis, otitis media, uncomplicated urinary tract infections, uncomplicated gonorrhea.

Active ingredient

Composition

Active ingredient:

Cefixime F. USA (in trihydrate form) 120.39 mg;

Particularly excipients: xanthan gum; sodium benzoate; strawberry flavoring 052311 APO551; colloidal silicon dioxide (Aerosil 200); sucrose

How to take, the dosage

Ingestion.

In children over 12 years of age with a body weight of >50 kg and adults, the average daily dose is 400 mg once a day (or 200 mg twice a day).

In uncomplicated urinary tract and cervical gonorrhea, 400 mg once.

In children under 12 years of age, in a dose of 8 mg/kg once daily or 4 mg/kg twice daily (every 12 hours).

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

The average duration of treatment course is 7-10 days. In case of diseases caused by Sterthococcus pyogenes the course of treatment should be at least 10 days.

In case of renal dysfunction the dose is adjusted depending on serum creatinine Cl: in creatinine Cl 21-60 ml/min or in patients on hemodialysis the daily dose should be reduced by 25%; in creatinine Cl 20 ml/min or less or in patients on peritoneal dialysis the daily dose should be reduced by half.

How to prepare the suspension

The vial is inverted and the powder is shaken. About half (17 ml) of the required volume (34 ml) of boiled water cooled to room temperature is added to the vial with the drug, closed with a lid, shaken thoroughly until a homogeneous suspension is formed. Further add cooled boiled water to the mark (arrow) on the label, close the lid, shake thoroughly until a homogeneous suspension is formed. Allow to stand for 5 minutes.

The ready suspension should be well shaken before use.

Must be used no later than 14 days after preparation.

Contraindications

Hypersensitivity to cephalosporins and penicillins.

Side effects

Gastrointestinal system: dry mouth, anorexia, diarrhea, nausea, vomiting, abdominal pain, flatulence, transient increase in liver transaminases and alkaline phosphatase activity, hyperbilirubinemia, jaundice, GI candidiasis, dysbacteriosis; rarely – stomatitis, glossitis, pseudomembranous enterocolitis.

Hematopoietic system disorders: leukopenia, thrombocytopenia, neutropenia, hemolytic anemia.

CNS disorders: dizziness, headache.

Urinary system disorders: interstitial nephritis.

Allergic reactions: skin itching, urticaria, skin hyperemia, eosinophilia, fever.

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