Adults: The recommended dosage of Gentamicin Sulfate in 0.9% Sodium Chloride Injection for patients with serious infections and normal renal function is 3 mg/kg/day administered in three equal doses every eight hours (Table 3).

For patients with life-threatening infections, dosages up to 5 mg/kg/day may be administered in three or four equal doses. The dosage should be reduced to 3 mg/kg/day as soon as clinically indicated (Table 3).

It is desirable to measure both peak and trough serum concentrations of gentamicin to determine the adequacy and safety of the dosage. When such measurements are feasible, they should be carried out periodically during therapy to assure adequate but not excessive drug levels. For example, the peak concentration (at 30 to 60 minutes following cessation of infusion) is expected to be in the range of 4 to 6 mcg/mL. When monitoring peak concentrations, dosage should be adjusted so that prolonged levels above 12 mcg/mL are avoided. When monitoring trough concentrations (just prior to the next dose), dosage should be adjusted so that levels above 2 mcg/mL are avoided. Determination of the adequacy of a serum level for a particular patient must take into consideration the susceptibility of the causative organism, the severity of the infection, and the status of the patient’s host-defense mechanisms.

In patients with extensive burns, altered pharmacokinetics may result in reduced serum concentrations of aminoglycosides. In such patients treated with gentamicin, measurement of serum concentrations is recommended as a basis for dosage adjustment.

Children: 6 to 7.5 mg/kg/day (2 to 2.5 mg/kg administered every eight hours).

Infants and Neonates: 7.5 mg/kg/day (2.5 mg/kg administered every eight hours).

Premature or Full-Term Neonates One Week of Age or Less: 5 mg/kg/day (2.5 mg/kg administered every 12 hours).

NOTE: For further information concerning the use of gentamicin in infants and children, see Pediatric Gentamicin Sulfate Injection product information.

The usual duration of treatment for all patients is seven to ten days. In difficult and complicated infections, a longer course of therapy may be necessary. In such cases monitoring of renal, auditory, and vestibular functions is recommended, since toxicity is more apt to occur with treatment extended for more than ten days. Dosage should be reduced if clinically indicated.

For Intravenous Administration

The intravenous administration of gentamicin may be particularly useful for treating patients with bacterial septicemia or those in shock. It may also be the preferred route of administration for some patients with congestive heart failure, hematologic disorders, severe burns, or those with reduced muscle mass. For intermittent intravenous administration in adults, a single dose of Gentamicin Sulfate in 0.9% Sodium Chloride Injection may be administered according to individual patient requirements from the appropriate premixed container. The solution may be infused over a period of one-half to two hours.

Gentamicin Sulfate Injection should not be physically premixed with other drugs, but should be administered separately in accordance with the recommended route of administration and dosage schedule.