MedPath

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
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
Associated Therapies
-

Antibiotic Loaded Cement After TKA

Phase 3
Completed
Conditions
Total Knee Arthoplasty
Interventions
Procedure: total knee arthroplasty
Device: Antibiotic cement spacer
Drug: Tobramycin
Drug: Gentamicin
First Posted Date
2022-06-23
Last Posted Date
2024-04-30
Lead Sponsor
Rothman Institute Orthopaedics
Target Recruit Count
50
Registration Number
NCT05429671
Locations
🇺🇸

Rothman Orthopaedic Institute, Philadelphia, Pennsylvania, United States

Effect of Various Treatment Modalities on Dendritic Vial Ulcer

First Posted Date
2022-04-06
Last Posted Date
2022-04-06
Lead Sponsor
Sohag University
Target Recruit Count
40
Registration Number
NCT05313828
Locations
🇪🇬

Sohag University, Sohag, Egypt

Acute Application of Antibiotic Powder in Open Fracture Wounds

Phase 4
Completed
Conditions
Anti-Bacterial Agents
Extremity Fracture Lower
Extremity Fractures Upper
Fractures, Open
Wounds and Injuries--Infections
Fractures, Bone
Interventions
First Posted Date
2021-05-04
Last Posted Date
2024-02-05
Lead Sponsor
University of Colorado, Denver
Target Recruit Count
20
Registration Number
NCT04872400
Locations
🇺🇸

University of Colorado Anschutz, Aurora, Colorado, United States

🇺🇸

Denver Health and Hospital Authority, Denver, Colorado, United States

Tobramycin Administered at the Beginning of Dialysis

Phase 1
Completed
Conditions
Renal Dialysis
Renal Failure, Chronic
Interventions
First Posted Date
2019-04-05
Last Posted Date
2021-02-26
Lead Sponsor
Maisonneuve-Rosemont Hospital
Target Recruit Count
11
Registration Number
NCT03904836
Locations
🇨🇦

Maisonneuve-Rosemont Hospital, Montréal, Quebec, Canada

Locally Applied Antibiotics for Infection Prophylaxis in Treatment of Open Fractures

Phase 3
Terminated
Conditions
Fractures, Open
Interventions
First Posted Date
2018-10-15
Last Posted Date
2023-06-15
Lead Sponsor
University of Virginia
Target Recruit Count
11
Registration Number
NCT03705962
Locations
🇺🇸

University of Virginia Medical Center, Charlottesville, Virginia, United States

Topical Antibiotics in Chronic Rhinosinusitis

Phase 1
Completed
Conditions
Chronic Rhinosinusitis (Diagnosis)
Interventions
First Posted Date
2018-09-17
Last Posted Date
2022-04-20
Lead Sponsor
Mayo Clinic
Target Recruit Count
19
Registration Number
NCT03673956
Locations
🇺🇸

Mayo Clinic in Rochester, Rochester, Minnesota, United States

DPI-Tobra-Kind Cyclops® in Children With Cystic Fibrosis

Phase 1
Conditions
Cystic Fibrosis
Interventions
First Posted Date
2018-04-02
Last Posted Date
2021-10-01
Lead Sponsor
University Medical Center Groningen
Target Recruit Count
10
Registration Number
NCT03485456
Locations
🇳🇱

University Medical Center Groningen, Groningen, Netherlands

Study for Antibiotic Impregnated Calcium Sulfate Beads as Prophylaxis for Surgical Site Infection

Phase 4
Conditions
Surgical Site Infection
Interventions
Other: Standard of Care
Device: Stimulan Rapid Cure
Drug: Vancomycin
Drug: Tobramycin
First Posted Date
2017-10-12
Last Posted Date
2018-07-19
Lead Sponsor
McMaster University
Target Recruit Count
60
Registration Number
NCT03308253
Locations
🇨🇦

Hamilton General Hospital, Hamilton, Ontario, Canada

Evaluation of Short Antibiotic Combination Courses Followed by Aerosols in Cystic Fibrosis

Phase 3
Terminated
Conditions
Cystic Fibrosis
Interventions
First Posted Date
2017-02-28
Last Posted Date
2021-09-05
Lead Sponsor
University Hospital, Lille
Target Recruit Count
23
Registration Number
NCT03066453
Locations
🇫🇷

CRCM mixte - CH de Dunkerque, Dunkerque, France

🇫🇷

CRCM mixte - CHU de Caen Hôpital Côte de Nacre, Caen, France

🇫🇷

CRCM pédiatrique - CHU d'Amiens Hôpital Nord, Amiens, France

and more 4 locations

Efficacy Comparison of Two Kinds of Treatment in Treating Dry Eye Caused by Meibomian Gland Dysfunction

Not Applicable
Completed
Conditions
Dry Eye Syndrome
Interventions
First Posted Date
2016-11-08
Last Posted Date
2022-05-05
Lead Sponsor
Peking University Third Hospital
Target Recruit Count
20
Registration Number
NCT02958514
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