Last reviewed 2026-04-20 · How we verify

Tobi (tobramycin)

At a glance

Approved indications

• Allergic conjunctivitis
• Anterior uveitis
• Bacterial conjunctivitis
• Bacterial infection due to Klebsiella pneumoniae
• Bacterial infection due to Serratia
• Bacterial meningitis
• Bacterial peritonitis
• Bacterial septicemia
• Bacterial urinary infection
• Blepharoconjunctivitis
• Citrobacter Complicated UTI
• Complicated Proteus UTI
• Complicated UTI with Pseudomonas Aeruginosa
• Complicated Urinary Tract Infections
• Corneal abrasion
• Dacryocystitis
• E. Coli Osteomyelitis
• E. Coli Peritonitis
• Enterobacter Osteomyelitis
• Enterobacter Pneumonia

Boxed warnings

• WARNINGS Patients treated with Tobramycin Injection and other aminoglycosides should be under close clinical observation, because these drugs have an inherent potential for causing ototoxicity and nephrotoxicity. Neurotoxicity, manifested as both auditory and vestibular ototoxicity, can occur. The auditory changes are irreversible, are usually bilateral, and may be partial or total. Eighth-nerve impairment and nephrotoxicity may develop, primarily in patients having pre-existing renal damage and in those with normal renal function to whom aminoglycosides are administered for longer periods or in higher doses than those recommended. Other manifestations of neurotoxicity may include numbness, skin tingling, muscle twitching, and convulsions. The risk of aminoglycoside-induced hearing loss increases with the degree of exposure to either high peak or high trough serum concentrations. Patients who develop cochlear damage may not have symptoms during therapy to warn them of eighth-nerve toxicity, and partial or total irreversible bilateral deafness may continue to develop after the drug has been discontinued. Rarely, nephrotoxicity may not become apparent until the first few days after cessation of therapy. Aminoglycoside-induced nephrotoxicity usually is reversible. Renal and eighth-nerve function should be closely monitored in patients with known or suspected renal impairment and also in those whose renal function is initially normal but who develop signs of renal dysfunction during therapy. Peak and trough serum concentrations of aminoglycosides should be monitored periodically during therapy to assure adequate levels and to avoid potentially toxic levels. Prolonged serum concentrations above 12 mcg/mL should be avoided. Rising trough levels (above 2 mcg/mL) may indicate tissue accumulation. Such accumulation, excessive peak concentrations, advanced age, and cumulative dose may contribute to ototoxicity and nephrotoxicity (see PRECAUTIONS ). Urine should be examined for decreased specific gravity and increased excretion of protein, cells, and casts. Blood urea nitrogen, serum creatinine, and creatinine clearance should be measured periodically. When feasible, it is recommended that serial audiograms be obtained in patients old enough to be tested, particularly high-risk patients. Evidence of impairment of renal, vestibular, or auditory function requires discontinuation of the drug or dosage adjustment. Tobramycin should be used with caution in premature and neonatal infants because of their renal immaturity and the resulting prolongation of serum half-life of the drug. Concurrent and sequential use of other neurotoxic and/or nephrotoxic antibiotics, particularly other aminoglycosides (e.g., amikacin, streptomycin, neomycin, kanamycin, gentamicin, and paromomycin), cephaloridine, viomycin, polymyxin B, colistin, cisplatin, and vancomycin, should be avoided. Other factors that may increase patient risk are advanced age and dehydration. Aminoglycosides should not be given concurrently with potent diuretics, such as ethacrynic acid and furosemide. Some diuretics themselves cause ototoxicity, and intravenously administered diuretics enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue. Aminoglycosides can cause fetal harm when administered to a pregnant woman (see PRECAUTIONS ).

Common side effects

• Hearing loss
• Dizziness
• Vertigo
• Tinnitus
• Roaring in the ears
• Rising BUN
• Rising serum creatinine
• Oliguria
• Cylindruria
• Increased proteinuria
• Nausea
• Vomiting

Serious adverse events

• Ototoxicity
• Nephrotoxicity
• Granulocytopenia
• Thrombocytopenia
• Anemia
• Exfoliative dermatitis
• Mental confusion
• Disorientation
• Leukopenia
• Leukocytosis

Key clinical trials

• NCT00004829 (Phase 3)
• A Randomized, Blinded, Parallel Group, Multi-center Dose-finding Study, to Assess the Efficacy, Safety and Tolerability of Different Doses of Tobramycin Inhalation Powder in Patients With Non-Cystic F (Phase 2)
• NCT01102244 (Phase 3)
• Relative Efficacy of Loteprednol (Lotemax®) vs. Loteprednol/Tobramycin (Zylet®) in Treatment of Chronic Ocular Surface Inflammation Associated With Meibomian Gland Dysfunction (MGD)/Posterior Blephari (Phase 4)
• Bioequivalence and Safety Study of Vantobra and TOBI Nebulizer Solutions in Healthy Subjects (Phase 1)
• A Multi-center, Human Factors Engineering (HFE) Usability Study in Cystic Fibrosis Patients to Validate the Approved Instructions for Use (IFU) of TOBI® Podhaler™ (Tobramycin Inhalation Powder) Using (Phase 4)
• Combined Dry Powder Tobramycin and Nebulized Colistin Inhalation in CF Patients (Phase 3)
• An 8 Week Open-label Interventional Multicenter Study to Evaluate the Lung Clearance Index as Endpoint for Clinical Trials in Cystic Fibrosis Patients ≥ 6 Years of Age, Chronically Infected With Pseud (Phase 4)

Patents

Primary sources

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