1 INDICATIONS AND USAGE Tobramycin for Injection, is an aminoglycoside antibacterial indicated for the treatment of serious bacterial infections caused by susceptible isolates of the designated bacteria in the diseases listed below ( 1.1 ): Septicemia in the pediatric patient and adults caused by P.

aeruginosa , E.

coli , and Klebsiella species (spp).

Lower respiratory tract infections caused by P.

aeruginosa, Klebsiella spp, Enterobacter spp, Serratia spp, E.

coli, and S.

aureus Serious central nervous system infections (meningitis) caused by susceptible organisms.

Intra-abdominal infections, including peritonitis, caused by E.

coli, Klebsiella spp., and Enterobacter spp.

Skin, bone, and skin structure infections caused by P.

aeruginosa, Proteus spp, E.

coli, Klebsiella spp., Enterobacter spp., and S.

aureus.

Complicated 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 spp.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tobramycin for Injection and other antibacterial drugs, Tobramycin for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria ( 1.2 ).

1.1 Septicemia Tobramycin for Injection is indicated for the treatment of septicemia caused by susceptible isolates of P.

aeruginosa, E.

coli, and Klebsiella spp., in adult and pediatric patients.

1.2 Lower Respiratory Tract Infections Tobramycin for Injection is indicated for the treatment of lower respiratory tract infections caused by susceptible isolates of P.

aeruginosa, Klebsiella spp., Enterobacter spp., Serratia spp., E.

coli, and S.

aureus in adult and pediatric patients.

1.3 Central Nervous System Infections (Meningitis) Tobramycin for Injection is indicated for the treatment of bacterial meningitis caused by susceptible bacteria in adult and pediatric patients.

1.4 Intra-abdominal Infections Tobramycin for Injection is indicated for the treatment of intra-abdominal infections, including peritonitis, caused by susceptible isolates of E.

coli, Klebsiella spp., and Enterobacter spp.

in adult and pediatric patients.

1.5 Skin and Skin Structure Infections Tobramycin for Injection is indicated for the treatment of skin and skin structure infections caused by susceptible isolates of P.

aeruginosa, Proteus spp., E.

coli, Klebsiella spp., Enterobacter spp., and S.

aureus in adult and pediatric patients.

1.6 Bone Infections Tobramycin for Injection is indicated for the treatment of bone infections caused by susceptible isolates of P.

aeruginosa, Proteus spp., E.

coli, Klebsiella spp., Enterobacter spp., and S.

aureus in adult and pediatric patients 1.7 Complicated and Recurrent Urinary Tract Infections Tobramycin for Injection is indicated for the treatment of complicated urinary tract infections caused by susceptible isolates of P.

aeruginosa, Proteus spp., (indole-positive and indole-negative), E.

coli, Klebsiella spp., Enterobacter spp., Serratia spp., S.

aureus, Providencia spp., and Citrobacter spp.

in adult and pediatric patients 1.8 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tobramycin for Injection and other antibacterial drugs, Tobramycin for 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.

6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: Nephrotoxicity [see Boxed Warning and Warnings and Precautions ( 5.1 )] Ototoxicity [see Boxed Warning and Warnings and Precautions ( 5.2 )] Embryo-Fetal Toxicity [see Boxed Warning and Warnings and Precautions ( 5.3 )] Allergic Reactions [see Warnings and Precautions ( 5.4 )] Neuromuscular Blockade [see Warnings and Precautions ( 5.5 )] The following adverse reactions associated with the use of Tobramycin for Injection were identified in clinical studies or postmarketing reports.

Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and Lymphatic System Disorders: anemia, granulocytopenia, leukopenia, leukocytosis, eosinophilia and thrombocytopenia Ear and Labyrinth Disorders: Tinnitus, hearing loss, vertigo Gastrointestinal Disorders: nausea, vomiting, diarrhea General Disorders and Administration Site Conditions: fever, lethargy, pain at the injection site Immune system disorders: Anaphylaxis, hypersensitivity reactions Laboratory Investigations: elevated blood urea nitrogen, elevated serum creatinine, hyponatremia, hypokalemia, hypomagnesemia, hypocalcemia, hypophosphatemia, urinary casts, increased serum transaminases (AST, ALT); increased serum LDH and bilirubin Nervous System Disorders: headache, numbness, paresthesia, muscle twitching, convulsions, mental confusion, and disorientation Skin and Subcutaneous Tissue Disorders: rash, itching, urticaria Most common adverse reactions are ototoxicity and nephrotoxicity.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.