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Tobramycin

Generic Name
Tobramycin
Brand Names
Bethkis, Kitabis, Tobi, Tobi Podhaler Weekly Kit, Tobradex, Tobrex, Zylet, Tobi Podhaler, Vantobra (previously Tobramycin PARI)
Drug Type
Small Molecule
Chemical Formula
C18H37N5O9
CAS Number
32986-56-4
Unique Ingredient Identifier
VZ8RRZ51VK

Overview

Aminoglycosides, many of which are derived directly from Streptomyces spp., are concentration-dependent bactericidal antibiotics with a broad spectrum of activity against Gram-positive and Gram-negative organisms. Inhaled tobramycin is notable for its use in treating chronic Pseudomonas aeruginosa infections in cystic fibrosis patients, as P. aeruginosa is notoriously inherently resistant to many antibiotics. However, tobramycin can also be administered intravenously and topically to treat a variety of infections caused by susceptible bacteria. Its use is limited in some cases by characteristic toxicities such as nephrotoxicity and ototoxicity, yet it remains a valuable option in the face of growing resistance to front-line antibiotics such as β-lactams and cephalosporins. Tobramycin was approved by the FDA in 1975 and is currently available in a variety of forms for administration by inhalation, injection, and external application to the eye (ophthalmic).

Background

Aminoglycosides, many of which are derived directly from Streptomyces spp., are concentration-dependent bactericidal antibiotics with a broad spectrum of activity against Gram-positive and Gram-negative organisms. Inhaled tobramycin is notable for its use in treating chronic Pseudomonas aeruginosa infections in cystic fibrosis patients, as P. aeruginosa is notoriously inherently resistant to many antibiotics. However, tobramycin can also be administered intravenously and topically to treat a variety of infections caused by susceptible bacteria. Its use is limited in some cases by characteristic toxicities such as nephrotoxicity and ototoxicity, yet it remains a valuable option in the face of growing resistance to front-line antibiotics such as β-lactams and cephalosporins. Tobramycin was approved by the FDA in 1975 and is currently available in a variety of forms for administration by inhalation, injection, and external application to the eye (ophthalmic).

Indication

Inhaled tobramycin is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa, but is not recommended in patients under six years of age, those with forced expiratory volume in 1 second (FEV) <25 or >80% predicted, or in those with Burkholderia cepacia. Tobramycin applied topically to the eyes is indicated for the treatment of external eye (and adjoining structure) infections by susceptible bacteria. Tobramycin injection is indicated in adult and pediatric patients for the treatment of serious bacterial infections, including septicemia (caused by P. aeruginosa, Escherichia coli, and Klebsiella spp.), lower respiratory tract infections (caused by P. aeruginosa, Klebsiella spp., Enterobacter spp., Serratia spp., E. coli, and Staphylococcus aureus, both penicillinase and non-penicillinase-producing strains), 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., Serratia spp. and S. aureus), and complicated and recurrent urinary tract infections (caused by P. aeruginosa, Proteus spp., E. coli, Klebsiella spp., Enterobacter spp., Serratia spp., S. aureus, Providencia spp., and Citrobacter spp.). Aminoglycosides, including tobramycin, should generally not be used in uncomplicated urinary tract infections or staphylococcal infections unless less toxic antibiotics cannot be used and the bacteria in question are known to be sensitive to aminoglycosides. As with all antibiotics, tobramycin use should be limited to cases where bacterial infections are known or strongly suspected to be caused by sensitive organisms, and the possible emergence of resistance should be monitored closely.

Associated Conditions

  • Bacterial Peritonitis
  • Bone Infection
  • Cystic fibrosis, Pseudomonas aeruginosa infection
  • Eye Infections
  • Inflammation of the External Auditory Canal
  • Intraabdominal Infections
  • Lower respiratory tract infection bacterial
  • Meningitis, Bacterial
  • Ocular Inflammation
  • Septicemia gram-negative
  • Skin and Subcutaneous Tissue Bacterial Infections
  • Corticosteroid-responsive Disorder of the Ophthalmic
  • Ear infection-not otherwise specified caused by susceptible bacteria
  • Ocular bacterial infections
  • Recurrent Complicated Urinary Tract Infection
  • Steroid-responsive inflammation

Clinical Trials

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Title
Posted
Study ID
Phase
Status
Sponsor
2017/02/28
Phase 3
Terminated
University Hospital, Lille
2016/11/08
Not Applicable
Completed
2016/09/29
Phase 4
Completed
2016/09/05
Phase 3
Terminated
Virginie ESCABASSE
2016/08/22
Phase 4
Completed
2016/02/09
Phase 4
Completed
2016/01/15
Phase 2
Completed
Medical Center Alkmaar
2015/09/23
Not Applicable
Completed
2015/08/19
Not Applicable
Completed
2015/08/18
Not Applicable
Completed

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
FOSUN PHARMA USA INC
72266-196
OPHTHALMIC
3 mg in 1 mL
9/16/2021
Medsource Pharmaceuticals
45865-427
OPHTHALMIC
3 mg in 1 mL
7/27/2018
Novartis Pharmaceuticals Corporation
0078-0813
OPHTHALMIC
3 mg in 1 g
6/4/2021
Proficient Rx LP
63187-973
OPHTHALMIC
3 mg in 1 mL
12/1/2018
NuCare Pharmaceuticals,Inc.
68071-4537
OPHTHALMIC
3 mg in 1 mL
2/19/2021
Pari Respiratory Equipment, Inc.
24492-850
RESPIRATORY (INHALATION)
300 mg in 5 mL
11/30/2019
A-S Medication Solutions
50090-1135
OPHTHALMIC
3 mg in 1 mL
5/29/2018
Baxter Healthcare Corporation
36000-244
INTRAVENOUS, INTRAMUSCULAR
40 mg in 1 mL
3/15/2023
Teva Pharmaceuticals USA, Inc.
0093-3750
RESPIRATORY (INHALATION)
300 mg in 4 mL
10/27/2023
Bausch & Lomb Incorporated
24208-295
OPHTHALMIC
3 mg in 1 mL
8/31/2023

EMA Drug Approvals

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Status
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No EMA approvals found for this drug.

HSA Drug Approvals

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NMPA Drug Approvals

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Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Tobramycin Sulfate Injection
国药准字H31022096
化学药品
注射剂
7/17/2020
Tobramycin Sulfate Injection
国药准字H51021966
化学药品
注射剂
4/19/2021
Tobramycin Sulfate Injection
国药准字H13022770
化学药品
注射剂
10/23/2020
Tobramycin Sulfate Injection
国药准字H44023824
化学药品
注射剂
3/10/2020
Tobramycin Sulfate Injection
国药准字H23022195
化学药品
注射剂
4/26/2021
Tobramycin Sulfate Injection
国药准字H42020037
化学药品
注射剂
9/10/2020
Tobramycin Sulfate Injection
国药准字H44024006
化学药品
注射剂
3/4/2021
Tobramycin Sulfate Injection
国药准字H35020015
化学药品
注射剂
11/23/2023
Tobramycin Sulfate Injection
国药准字H61022094
化学药品
注射剂
10/25/2022
Tobramycin Sulfate Injection
国药准字H42021691
化学药品
注射剂
6/10/2020

PPB Drug Approvals

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No PPB approvals found for this drug.

TGA Drug Approvals

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