Standard dosage: Adults and children over twelve years: The usual dosage is 1-2 g of TRAXONE Inj. administered once daily (every 24 hours). In severe cases or in infections caused by moderately sensitive organisms, the dosage may be raised to 4 g, administered once daily.
Neonates, Infants and Children up to 12 years: The following dosage schedules are recommended for once daily administration: Infants and Children (3 weeks up to 12 years): A daily dose of 20-80 mg/kg body weight. For Children with body weights of 50 kg or more, the usual adult dosage should be used, doses of 50 mg/kg body weight or more should be administered as a slow IV infusion over at least 30 min.
Neonates (up to 2 weeks): A daily dose of 20-50 mg/kg body weight, not to exceed 50 mg/kg, on account of the immaturity of the infant's enzyme systems. It is not necessary to differentiate between premature and infants born at term.
Elderly Patients: The dosages recommended for adults require no modification in the case of geriatric patients.
Duration of Therapy: The duration of therapy varies according to the course of the disease. As with antibiotic therapy in general, administration of TRAXONE Inj. should be continued for a minimum of 48-72 hours after the patient has become afebrile or evidence of bacterial eradication has been obtained.
Combination therapy: Synergy between TRAXONE Inj. and aminoglycosides has been demonstrated with many gram negative bacilli under experimental conditions. Although enhanced activity of such combinations is not always predictable, it should be considered in severe, life-threatening infections due to organisms, eg Pseudomonas aeruginosa. Because of physical incompatibility, the 2 drugs must be administered separately at the recommended dosages.
Special Dosage Instructions: Meningitis: In bacterial meningitis in infants and children, treatment begins with doses of 100 mg/kg (not to exceed 4 g) once daily. As soon as the causative organism has been identified and its sensitivity determined, the dosage can be reduced accordingly. The best results have been found with the following duration of therapy: See Table 4.
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Gonorrhea: For the treatment of gonorrhea (penicillinase-producing and nonpenicillinase-producing strains), a single 250 mg I.M. dose is recommended.
Preoperative Prophylaxis: To prevent postoperative infection in contaminated or potentially contaminated surgery, the recommended approach, depending on the risk of infection, is a single 1 to 2 g dose of TRAXONE Inj. administered 30-90 min prior to surgery. In colorectal surgery, concurrent (but separate) administration of TRAXONE Inj. and 5-nitroimidazole eg ornidazole, has proven effective.
Impaired Renal and Hepatic Function: In patients with impaired renal function, there is no need to reduce the dosage of TRAXONE Inj. provided that hepatic function is intact. Only in cases of preterminal renal failure (creatinine clearance <10 ml/min) should the TRAXONE Inj. dosage not exceed 2 g daily. In patients with liver damage, there is no need for the dosage to be reduced provided that renal function is intact. In cases of severe concomitant renal and hepatic dysfunction, the plasma concentrations of TRAXONE Inj. should be determined at regular intervals. In patients undergoing dialysis, no additional supplementary dosing is required following the dialysis. Serum concentrations should be monitored, however, to determine whether dosage adjustments are necessary, since the elimination rate in these patients may be reduced.