Gentamicin

To reduce the development of drug-resistant bacteria and maintain the effectiveness of gentamicin injection and other antibacterial drugs, gentamicin injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. …

• Gentamicin injection may be given IM or IV
• The patient’s pretreatment body weight should be obtained for calculation of correct dosage
• The dosage of aminoglycosides in obese patients should be based on an estimate of the lean body mass
• It is desirable to limit the duration of treatment with aminoglycosides to short term
• Patients with Normal Renal Function
• Adults The recommended dosage of gentamicin injection for patients with serious infections and normal renal function is 3 mg/kg/day, administered in three equal doses every eight hours (Table 1)
• For patients with life-threatening infections, dosages up to 5 mg/kg/day may be administered in three or four equal doses
• This dosage should be reduced to 3 mg/kg/day as soon as clinically indicated (Table 1)
• 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 after IM injection) is expected to be in the range of 4 to 6 mcg/mL
• When monitoring peak concentrations after IM or IV administration, 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. …

• Patients should be counseled that antibacterial drugs including gentamicin injection should only be used to treat bacterial infections
• They do not treat viral infections (e.g., the common cold)
• When gentamicin injection is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. …

• Hypersensitivity to gentamicin is a contraindication to its use
• A history of hypersensitivity or serious toxic reactions to other aminoglycosides may contraindicate use of gentamicin because of the known cross-sensitivity of patients to drugs in this class

(See BOXED WARNINGS .) Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people. Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycoside antibiotics cross the placenta, and there have been several reports of total irreversible bilateral congenital deafness in children whose mothers received streptomycin during pregnancy. …

To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Nephrotoxicity Adverse renal effects, as demonstrated by the presence of casts, cells or protein in the urine or by rising BUN, NPN, serum creatinine or oliguria, have been reported. They occur more frequently in patients with a history of renal impairment (especially if dialysis is required) and in patients treated for longer periods or with larger doses than recommended. …

Pregnancy See WARNINGS section.

In the event of overdosage or toxic reactions, hemodialysis may aid in the removal of gentamicin from the blood, especially if renal function is, or becomes, compromised. The rate of removal of gentamicin is considerably lower by peritoneal dialysis than it is by hemodialysis.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.