|Manufacturer:||X-Gen Pharmaceuticals, Inc.|
|Other Info:||To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tobramycin for Injection USP 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.|
Tobramycin for injection USP 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 pediatric patient and adult caused by P.
coli, and Klebsiella sppLower respiratory tract infections caused by P.
aeruginosa, Klebsiella spp, Enterobacter spp, Serratia spp, 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 spp, and Enterobacter sppSkin, bone, and skin structure infections caused by P.
aeruginosa, Proteus spp, E.
coli, Klebsiella spp, Enterobacter spp, and S.
aureusComplicated and recurrent urinary tract infections caused by P.
aeruginosa, Proteus spp (indole-positive and indole-negative), E.
coli, Klebsiella spp, Enterobacter spp, Serratia spp, S.
aureus, Providencia spp, and Citrobacter sppAminoglycosides, including tobramycin for injection USP, 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 for injection USP 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 for injection USP may be initiated before the results of susceptibility studies are obtained.
The decision to continue therapy with tobramycin for injection USP 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 for Injection USP 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.
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.
SeeWarnings box above.Serious allergic reactions including anaphylaxis and dermatologic reactions including exfoliative dermatitis, toxic epidermal necrolysis, erythema multiforme, and Stevens-Johnson Syndrome have been reported rarely in patients on tobramycin therapy.
Although rare, fatalities have been reported.(SeeCONTRAINDICATIONS).If an allergic reaction occurs, the drug should be discontinued and appropriate therapy instituted.