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International Nonproprietary Name (Active Substance): cefixime Clinical-Pharmacological Group: Antibacterial agents → Beta-lactam antibiotics (penicillins and cephalosporins) → Cephalosporins → Third-generation cephalosporins Manufacturer: PharmaVision Country of Manufacture: Turkey Dosage Form: 400mg film-coated tablet №5 Dispensing Regime: Group II (dispensed with prescription form N3) ATC Classification Code: J01DD08 Composition and Dosage Form Film-coated tablets: 5 pcs. in a pack 1 tab. cefixime................................400 mg Coloring agent: titanium dioxide. Suspension: 50 ml in a bottle 5 ml cefixime...................................100 mg Excipients: sodium benzoate as a preservative, raspberry essence as a flavoring agent, and sugar as a sweetener. Clinical-Pharmacological Group Third-generation cephalosporin. Indications Cefixime is indicated for the treatment of the following infections caused by susceptible microorganisms: Respiratory tract infections: tonsillitis, pharyngitis, otitis media, sinusitis, acute pneumonia, acute and chronic bronchitis. Urinary tract infections: acute cystitis, urethritis, pyelonephritis. Cefixime is effective for the treatment of infections caused by the following organisms: Streptococcus pneumoniae, Streptococcus pyogenes, E. coli, P. mirabilis, H. influenzae (beta-lactamase positive and negative), B. catarrhalis (beta-lactamase positive and negative). Cefixime has a high degree of stability against beta-lactamase. Dosage Regimen Bimax is an oral antibiotic and food does not affect the absorption rate of cefixime. Adults and children over 12 years of age: The usual dose is 400 mg per day, taken as a single dose or 200 mg every 12 hours. For the treatment of uncomplicated urinary tract infections, a dose of 200 mg is used. Dosage in elderly patients: The dose recommended for adults is used. Dose adjustment is required in patients with renal insufficiency. Dosage in children: For children under 2 years of age, the recommended dose is 8 mg/kg/day, taken as a single daily dose or divided into two doses, every 12 hours. For children from 2 years of age, the following dosage regimen is recommended: 2-4 years: 5 ml/day; 5-8 years: 10 ml/day; 9-12 years: 15 ml/day. For children weighing over 50 kg or children from 12 years of age, the adult dose is recommended. The safety and efficacy of cefixime in children under 6 months of age have not been established. Instructions for Reconstitution of Powder for Oral Suspension The bottle should be shaken several times to loosen the powder. The bottle should be half-filled with boiled and cooled water and then shaken vigorously. After about 5 minutes, a homogeneous mass is obtained. The bottle should be filled with water to the mark on the bottle (50 ml) and shaken well again. The bottle should be shaken before use. Dosage in Renal Insufficiency: Bimax tablets can be taken in case of renal insufficiency. The usual dosage regimen is used in patients with creatinine clearance of 60 ml/min or more. For clearance between 21 and 60 ml, 75% of the standard dose is taken at standard intervals. In patients with clearance A significant amount of the drug is not eliminated from the body by either hemodialysis or peritoneal dialysis. Contraindications Cefixime is contraindicated in case of established allergy to antibiotics of the cephalosporin group. Pregnancy and Lactation Category B drug. In animal studies, no teratogenic effects were observed with high doses of cefixime. There are no adequate and controlled studies, and therefore, cefixime is used during pregnancy and lactation only when clearly indicated. Storage Conditions and Expiry Date The preparation should be stored at a temperature not exceeding 30°C, out of reach of children.