| Drug Name: | Tobramycin in Sodium Chloride |
| Manufacturer: | HOSPIRA, INC. |
| Other Info: | 60 mg Tobramycin in 50 mL80 mg Tobramycin in 50 mL or 100 mLFOR INTRAVENOUS INFUSION ONLYFlexible ContainerRx onlyTo reduce the development of drug-resistant bacteria and maintain the effectiveness of tobramycin and other antibacterial drugs, tobramycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. |
| Clinical Trials: | |
Tobramycin sulfate is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below:Septicemia in the neonate, child, and adult caused by P aeruginosa, E coli, and Klebsiella spLower respiratory tract infections caused by P aeruginosa, Klebsiella sp, Enterobacter sp, Serratia sp, E coli, and S aureus (penicillinase and non-penicillinase-producing strains)Serious central-nervous-system infections (meningitis) caused by susceptible organismsIntra-abdominal infections, including peritonitis, caused by E coli, Klebsiella sp, and Enterobacter spSkin, bone, and skin-structure infections caused by P aeruginosa, Proteus sp, E coli, Klebsiella sp, Enterobacter sp, and S aureusComplicated and recurrent urinary tract infections caused by P aeruginosa, Proteus sp (indole-positive and indole-negative), E coli, Klebsiella sp, Enterobacter sp, Serratia sp, S aureus, Providencia sp, and Citrobacter spAminoglycosides, including tobramycin sulfate, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are not susceptible to antibiotics having less potential toxicity.
Tobramycin sulfate may be considered in serious staphylococcal infections when penicillin or other potentially less toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgment indicate its use.Bacterial cultures should be obtained prior to and during treatment to isolate and identify etiologic organisms and to test their susceptibility to tobramycin.
If susceptibility tests show that the causative organisms are resistant to tobramycin, other appropriate therapy should be instituted.
In patients in whom a serious life-threatening gram-negative infection is suspected, including those in whom concurrent therapy with a penicillin or cephalosporin and an aminoglycoside may be indicated, treatment with tobramycin sulfate may be initiated before the results of susceptibility studies are obtained.
The decision to continue therapy with tobramycin should be based on the results of susceptibility studies, the severity of the infection, and the important additional concepts discussed in the WARNINGS box above.To reduce the development of drug-resistant bacteria and maintain the effectiveness of tobramycin and other antibacterial drugs, tobramycin 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 antimicrobial therapy.
In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.A hypersensitivity to any aminoglycoside is a contraindication to the use of tobramycin.
A history of hypersensitivity or serious toxic reactions to aminoglycosides may also contraindicate the use of any other aminoglycoside because of the known cross-sensitivity of patients to drugs in this class.