Injection Manufacturer/Distributor: Square Pharmaceuticals Ltd. Generic Name:Cefotaxime 500mg Injection
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Cefotaxime is indicated for the treatment of the following infections either before the infecting organism has been identified or when caused by bacteria of established sensitivity:
Respiratory Tract Infections: Acute or chronic bronchitis, bacterial pneumonia, infected bronchiectasis, lung abscess and postoperative chest infections
Urinary Tract Infections: Acute and chronic pyelonephritis, cystitis and asymptomatic bacteriuria
Soft-tissue Infection: Cellulitis, peritonitis and wound
infections
Bone and Joint Infections: Osteomyelitis, septic arthritis
Obstetric and gynaecological infections: Pelvic inflammatory disease Gonorrhoea particularly when penicillin has failed or is unsuitable
Other Bacterial Infections: Meningitis and other sensitive infections suitable for parenteral antibiotic therapy
Septicaema: Septicemia is a serious bloodstream infection. It’s also known as bacteremia, or blood poisoning. Septicemia occurs when a bacterial infection elsewhere in the body, such as in the lungs or skin, enters the bloodstream. This is dangerous because the bacteria and their toxins can be carried through the bloodstream to your entire body.
Prophylaxis: The administration of Cefotaxime prophylactically may reduce the incidence of certain post operative infections in patients undergoing surgical procedures that are classified as contaminated or potentially contaminated or in clean operation where infection would have serious effects.
Pharmacology
Cefotaxime binds to one or more penicillin binding proteins (PBPs), which block the last transpeptidation step of peptidoglycan production in the bacterial cell wall, halting biosynthesis and resulting in bacterial cell death. Cefotaxime is a bactericidal 3rd generation parenteral cephalosporin antibiotic with a broad spectrum of activity. Cefotaxime is particularly effective against gram-negative bacteria that are susceptible to or resistant to first-generation or second-generation cephalosporins. In terms of activity against gram-positive bacteria, it is similar to other cephalosporins.
Adults: The recommended dosage for mild to moderate infections is 1 gm every 12 hourly. However, dosage may be varied according to the severity of infection, sensitivity of causative organisms and condition of the patient. In severe infections dosage may be increased up to 12 gm daily given in 3 or 4 divided doses. For infections caused by sensitive Pseudomonas spp. daily doses of greater than 6 gm will usually be required
Children: The usual dosage range is 100-150 mg/kg/day in 2 to 4 divided doses. However, in very severe infections doses of up to 200 mg/kg/day may be required.
Neonates: The recommended dosage is 50 mg/kg/day in 2 to 4 divided doses. In severe infections 150-200 mg/kg/day, in divided doses, have been given.
Dosage in gonorrhoea: 500 mg as a single dose.
Ceftibuten's pharmacokinetic profile is unaffected by theophylline or antacid. Ceftibuten's Cmax and AUC are increased by ranitidine.
Cefotaxime is contraindicated in patients who have shown hypersensitivity to cefotaxime or the cephalosporin group of antibiotics.
Cefotaxime has been linked to a small number of adverse effects, all of which have been moderate and temporary. Candidaemia, rashes, fever, transitory increases in hepatic transaminase and/or alkaline phosphatase, and diarrhoea have all been recorded as side effects. Pseudomembranous colitis, like all cephalosporins, can occur infrequently during treatment. If this happens, the medicine should be stopped and a special treatment plan should be implemented. Changes in renal function have been reported seldom with high doses of Cefotaxime, like with other cephalosporins. The use of large doses of cephalosporins, especially in patients with renal failure, can cause encephalopathy. There have been reports of hypersensitivity reactions.
Although no harmful effects on the developing foetus have been shown in animal investigations, the safety of Cefotaxime in human pregnancy has not been demonstrated. As a result, Cefotaxime should not be used during pregnancy, particularly during the first trimester, unless the projected benefit is carefully weighed against the potential dangers. Cefotaxime is a drug that is excreted in milk.
Cefotaxime should be used with caution in people who have had gastrointestinal disorders, especially colitis. Because typical doses of Cefotaxime can result in high and sustained antibiotic concentrations in patients with temporary or permanent reductions in urine output due to renal insufficiency, the total daily dosage should be lowered when Cefotaxime is given to such individuals. The dosage should be determined by the severity of the illness, the degree of renal impairment, and the susceptibility of the pathogenic organism. There is no clinical evidence that modifying Cefotaxime dosage in patients with even severe renal impairment is necessary.
Third generation Cephalosporins
Store at a temperature below 25°C, away from light and moisture. Suspension: After reconstitution, the suspension can be stored at 2° to 8°C for 14 days. Keep out of children's reach.
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