CLASSIFICATION: Cephalosporin, Cefotaxime is semi-synthetic, broad-spectrum antibiotic belonging to third generation cephalosporins for parenteral administration. COMPOSITION: Each vial of Cefotaxime sodium for injection contains: Cefotaxime Sodium equivalent to Cefotaxime 1g. Each ampoule of Water for injection contains: Sterilized water 10ml. INDICATIONS: Cefotaxime is indicated in the treatment of following infections caused by susceptible micro-organisms. Urinary Tract Infections: Both complicated and uncomplicated caused by E.coli, P. mirabilis, P.vulgaris, and Klebsiella Spp. Uncomplicated Gonorrhoea (Cervical/Urethral and rectal) caused by Neisseria gonorrhoeae. Skin and Skin Structure Infections: by Staphylococci and/or Streptococcus pyogenes, Viridans group Streptococci, E.coli, Staphylococcus aureus, S.epidermidis, Enterobacter cloacea, Klebsiella oxytoca, K pneumoniae, Proteus mirabilis, etc Lower Respiratory Tract Infections: by Group A b haemolytic Streptococci, Hemophilous influenzae, H. parainfluenzae, Klebsiella pneumoniae, Streptococcus pneumoniae, Staphylococcus aureus, E.coli, Enterobacter aerogenes, Proteus mirabilis, or Serratia marscence. Pelvic Inflammatory Diseases: by Neisseria gonorrhoeae. Bacterial Septicaemia: by Staphylococcus aureus, Streptococcus pneumoniae, E.coli, H.influenzae, or Klebsiella pneumoriae. Bone and Joint Infections: by Staphylococcus aureus, Streptococcus pneumoniae, E.coli, Proteus vulgaris, Klebsiella pneumoniae, or Enterobacteriaceae. Intra-Abdominal Infections: by Klebsiella pneumoniae, Bacteroides fragilis, E.coli, Clostridium spp. Meningitis: by Hemophilous influenzae, N.meningitidis or Streptococcus pneumonoae. ADVERSE REACTIONS: The most common undesirable effects are Hypersensitivity reactions including Skin rashes. Uricaria, Eosinophilia, Fever, Reactions resembling Serum sickness, and anaphylaxis reactions. In Hematologic Category, there may be a positive response to the Coomb's Test although Hemolytic anaemia rarely occurs. Neutropenia and Thrombocytopenia. And prolongation of the prothrombin time has been occasionally reported. Nephrotoxicity has been reported with Cefotaxime sodium. Other adverse effects include BUN dlevation (in about 1.2% of the patients). Creatinine elevation (in less than 1.0% of the patients), and presence of casts in the urine (in less than 1.0% cases). Gastro intestinal effects include nausea, vomiting and diarrhoea. Pseudomembranous colitis is also reported very commonly. Hepatic problems include SGOT elevation (in about 3.2% of cases), SGPT elevation (3.3%), elevation in alkaline phosphatase and bilirubin. Genitourinary adverse effects include Moniliasis or Vaginitis (in less than 1.0% case). PRECAUTIONS: Sterile Cefotaxime should be given with caution in patients having sensitivity to penicillin. Antibacterial agents, including Sterile Cefotaxime, should be administered with caution to any patient who has demonstrated any type of allergy and hypersensitivity to and drug. Cefotaxime should be used with caution in patients with markedly impaired kidney functions. Should be used with caution in pregnant and/or lactating mothers as there are no controlled studies has been done to establish the complete safety of the drug use in these cases. DOSAGE AND ADMINISTRATION: Cefotaxime Sodium may be administered IM or IV after reconstitution as directed in the labeling. ADULT:1-2g given once a day or in equally divided doses twice a day, depending on type and severity of infections, For the treatment of uncomplicated gonorrhoea infections, a single IM dose of 1g is recommended. IN NEONATES, INFANTS, AND CHILDREN: Neonates:0-1 week of age 50mg/kg IV 12 hourly 1-4 weeks of age 50mg/kg IV 8 hourly Infants & Children:1month-12years 50-180mg/kg For body weight less than 50kg, IM or IV given in 4 to 6 equal doses. For body weight more than 50kg, the usual adult dosage should be used, the maximum daily dose should not exceed 12g. DRUG INTERACTIONS: Cefotaxime may be used with an aminoglycoside as synergy may occur against some Gram-negative organisms, but the drugs should be given separately. It has sometimes been used with another beta lactam to broaden the spectrum of activity. Cefotaxime has also been used with metronidazole in the treatment of mixed aerobic-anaerobic infections. As for many cephalosporins, probenecid reduces the renal clearance of cefotaxime, resulting in higher and prolonged plasma concentrations of cefotaxime and its desacetyl metabolite. STORAGE: Store in a protected environment below 25°C and avoid light. PRESENTATION: 50 vials of Cefotaxime Sodium per box. EXPIRY DATE: Three years.
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