Bimaks 400mg 5 tablets

Composition and Dosage Form Coated tablets: 5 tablets per pack. 1 tab. Cefixime................................400 mg Coloring agent: Titanium dioxide. Clinical-Pharmacological Group Third-generation cephalosporin. See blog: Bimax — Antibiotic against respiratory infections Pharmacological Properties Cefixime is an orally administered, beta-lactamase-stable, third-generation cephalosporin with a broad spectrum and bactericidal action against many Gram-positive and Gram-negative microorganisms. Cefixime is effective in treating infections caused by many types of microorganisms, such as: Streptococcus, Neisseria gonorrhoeae, Branhamella catarrhalis, Escherichia coli, Klebsiella, Proteus, and Haemophilus influenzae. Its spectrum of action and MIC values are similar to other third-generation cephalosporins. The bactericidal action of Cefixime is due to the inhibition of cell wall synthesis. Cefixime is stable in the presence of beta-lactamase enzymes, and as a result, many strains resistant to penicillins and some cephalosporins due to the presence of beta-lactams may be susceptible to Cefixime. Cefixime is active in vitro against the following organisms: Gram-positive organisms: Streptococcus pyogenes, Streptococcus pneumonia, Streptococcus agalactiae. Gram-negative organisms: Haemophilus influenzae, Haemophilus parainfluenzae, Branhamella catarrhalis, Neisseria gonorrhoeae, Escherichia coli, Proteus mirabilis, Proteus vulgaris, other indole-positive Proteus species, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacteriaceae, Pasteurella multocida, Providencia species, Salmonella species, Shigella species, Citobacter amalonaticus, Citobacter diversus, Serratia marcescenes. Cefixime is inactive in vitro against the following organisms: Pseudomonas species, Streptococcus faecalis, Listeria monocytogenes, most Staphylococcus species (coagulase-positive and negative strains and methicillin-resistant strains), Enterobacter species, most Bacteroides fragilis strains, and Clostridium species. Pharmacokinetics After oral administration, food does not affect the absorption rate of Cefixime, and Cefixime is readily absorbed. Age does not affect the pharmacokinetics of Cefixime. With doses ranging from 200-2000 mg, there is a linear increase in peak serum concentration and area under the concentration-time curve. 3-4 hours after a single oral dose of 200 or 400 mg, the peak serum concentration was 2-4 mcg/mL and 3-5 mcg/mL, respectively. No accumulation of Cefixime in serum and urine has been confirmed after multiple doses. 50% of the absorbed dose is excreted unchanged in the urine within 24 hours. 10% of the dose is excreted in the bile. 65% of Cefixime is bound to serum proteins, and the serum half-life in healthy adults is 3-4 hours. In moderate renal impairment (creatinine clearance 20-40 mL/min) and some types of renal impairment (creatinine clearance 5-20 mL/min), the serum half-life is prolonged to 6.4 and 11.5 hours, respectively. Only a very small amount of Cefixime is excreted by hemodialysis or peritoneal dialysis. Cefixime is not metabolized in vivo. 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 in treating 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 impairment. 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 To prepare the oral suspension, shake the bottle several times to loosen the powder. Fill the bottle halfway with boiled and cooled water and then shake vigorously. After about 5 minutes, a homogeneous mass is obtained. Fill the bottle with water to the mark on the bottle (50 ml) and shake well again. Shake the bottle before use. Dosage in Renal Impairment: Bimax tablets can be taken in case of renal impairment. The usual dosage regimen is used in patients with a creatinine clearance of 60 mL/min or more. For clearance between 21 and 60 mL/min, 75% of the standard dose is taken at standard intervals. In patients with clearance <20 mL/min or in patients on continuous ambulatory peritoneal dialysis, 50% of the standard dose is used at standard intervals. A significant amount of the drug is not excreted from the body by either hemodialysis or peritoneal dialysis. Side Effects 400 mg Bimax coated tablets are generally well tolerated. Most adverse effects are moderate in severity. Gastrointestinal effects: Diarrhea is the most common, moderate to mild in severity, and rarely requires discontinuation of treatment. Nausea, abdominal pain, dyspepsia, vomiting, and abdominal distension are less common. Pseudomembranous colitis is rare. Central nervous system effects: Headache, dizziness. Hypersensitivity reactions: Skin rash, itching, urticaria, joint pain, and fever. These effects disappear upon discontinuation of therapy. Hematological effects and changes in laboratory test results: Thrombocytopenia, leukopenia, eosinophilia. These reactions are rare and reversible. Temporary changes in liver and kidney function tests are observed. In case of unexpected side effects, consult a doctor. Contraindications Cefixime is contraindicated in case of known allergy to cephalosporin antibiotics. Pregnancy and Lactation Category B drug. Animal studies have not shown teratogenic effects 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. Special Precautions Cefixime should be used with caution in case of previously identified hypersensitivity reactions to other drugs. Caution should be exercised in penicillin-sensitive patients due to cross-sensitivity between cephalosporins and penicillins. In case of allergic reactions, the drug should be discontinued and appropriate therapy initiated. Dose adjustment of 400 mg Bimax coated tablets should be made in patients with acute renal failure. Dose adjustment of Bimax suspension should be made in patients with acute renal failure. There is a possibility of the development of resistant organisms, which may lead to their overgrowth, especially with prolonged treatment. Treatment with broad-spectrum antibiotics, including Cefixime, can lead to changes in intestinal flora and overgrowth of Clostridia. Studies have shown that the toxin produced by Clostridium difficile is the primary cause of antibiotic-associated diarrhea, including pseudomembranous colitis. In case of severe diarrhea, treatment should be discontinued. Overdose Information on Cefixime overdose is insufficient. Adverse reactions observed in healthy patients after a single dose of up to 2 g of Cefixime do not differ from reactions observed in patients undergoing treatment with standard doses. Gastric lavage is indicated. There is no specific antidote. Cefixime is not significantly removed from circulation by either hemodialysis or peritoneal dialysis. Drug Interactions No interactions with other drugs have been reported. When taking Cefixime, a false positive reaction for glucose in the urine may occur when using copper sulfate-based tests, such as Benedict's solution, Fehling's solutions. The drug does not affect enzymatic glucose oxidase methods. Positive results have been observed in direct antiglobulin (Coombs) tests in patients taking other cephalosporins. It is likely that these results are due to interaction with Cefixime. Storage Conditions and Expiration Date Store the preparation at a temperature not exceeding 30°C, out of reach of children. Shelf life - 2 years. Diluted suspension is active for 14 days. Dispensing Conditions: The preparation is dispensed by prescription only.