Preparation
Torped 250 mg IV/IM injection: Each vial contains Cefotaxime USP 250 mg as Cefotaxime Sodium. Each ampoule contains a solvent of 5 ml Water for Injection BP.
Torped 500 mg IV/IM injection: Each vial contains Cefotaxime USP 500 mg as Cefotaxime Sodium. Each ampoule contains a solvent of 10 ml Water for Injection BP.
Torped 1 gm IV/IM injection: Each vial contains Cefotaxime USP 1 gm as Cefotaxime Sodium. Each ampoule contains a solvent of 10 ml Water for Injection BP
Official Specification
Third Generation Cephalosporin Antibiotic
Indication
Torped (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 such as acute or chronic bronchitis, bacterial pneumonia, infected bronchiectasis, lung abscess and postoperative chest infections.
Urinary Tract Infections such as acute and chronic pyelonephritis, cystitis and asymptomatic bacteriuria.
Soft-tissue Infections such as cellulitis, peritonitis and wound infections.
Bone and Joint Infections such as osteomyelitis, septic arthritis.
Obstetric and gynaecological infections such as pelvic inflammatory disease.
Gonorrhoea particularly when penicillin has failed or is unsuitable.
Septicaemia
Other Bacterial Infections Meningitis and other sensitive infections suitable for parenteral antibiotic therapy.
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.
Contraindication
Torped (Cefotaxime) is contraindicated in patients who have shown hypersensitivity to cefotaxime or the cephalosporin group of antibiotics.
Dosage & Administration
Adults
The recommended dosage for mild to moderate infections is 1g 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 g daily given in 3 or 4 divided doses. For infections caused by sensitive Pseudomonas spp. daily doses of greater than 6 g 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
A single injection of 1 g may be administered intramuscularly or intravenously.
Dosage in renal impairment
Because of extra-renal elimination, it is only necessary to reduce the dosage of Cefotaxime in severe renal failure (GFR<5 ml/min = serum creatinine approximately 751 micromol/litre). After an initial loading dose of 1 g, daily dose should be halved without change in the frequency of dosing. In all other patients, dosage may require further adjustment according to the course of infection and the general condition of the patient.
route - IM - 250 mg 2 ml, 500 mg 2 ml, 1 gm 3 ml
route - IV - 250 mg 2-5 ml, 500 mg 2-10 ml, 1 gm 4-10 ml
Side Effect
Adverse reactions to Cefotaxime have occurred relatively infrequently and have generally been mild and transient. Effects reported include candidiasis, rashes, fever, transient rises in liver transaminase and/or alkaline phosphatase and diarrhoea. As with all cephalosporins, pseudomembranous colitis may rarely occur during treatment. If this occurs the drug should be stopped and specific treatment instituted.
As with other cephalosporins, changes in renal function have been rarely observed with high doses of Cefotaxime. Administration of high doses of cephalosporins particularly in patients with renal insufficiency may result in encephalopathy.
Hypersensitivity reactions have been reported, these include skin rashes, drug fever and very rarely anaphylaxis.
Precaution
Torped (Cefotaxime) should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. Because high and prolonged antibiotic concentrations can occur from usual doses in patients with transient or persistent reduction of urinary output because of renal insufficiency, the total daily dosage should be reduced when Cefotaxime is administered to such patients. Continued dosage should be determined by degree of renal impairment, severity of infection, and susceptibility of the causative organism. There is no clinical evidence supporting the necessity of changing the dosage of Cefotaxime in patients with even profound renal dysfunction.
Although studies in animals have not shown any adverse effect on the developing fetus, the safety of Cefotaxime in human pregnancy has not been established. Consequently, Cefotaxime should not be administered during pregnancy especially during first trimester, without carefully weighing the expected benefit against possible risks. Cefotaxime is excreted in the milk.
Drug Interaction
Increased nephrotoxicity has been reported following concomitant administration of cephalosporins and aminoglycoside antibiotics.
Presentation
Torped (Cefotaxime) is supplied as a sterile crystalline powder in glass vials.
Torped (Cefotaxime) 250 mg IV/IM injection: Pack of 1 vial contains Cefotaxime USP 250 mg as Cefotaxime Sodium accompanied by a solvent ampoule of 5 ml water for injection BP & a 5 ml disposable syringe with a baby needle.
Torped (Cefotaxime) 500 mg IV/IM injection: Pack of 1 vial contains Cefotaxime USP 500 mg as Cefotaxime Sodium accompanied by a solvent ampoule of 10 ml water for injection BP & a 10 ml disposable syringe.
Torped (Cefotaxime) 1 gm IV/IM injection: Pack of 1 vial contains Cefotaxime USP 1 gm as Cefotaxime Sodium accompanied by a solvent ampoule of 10 ml water for injection BP & a 10 ml disposable syringe.