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
-

IV Colistin for Pulmonary Exacerbations: Improving Safety and Efficacy

Phase 4
Completed
Conditions
Cystic Fibrosis
Interventions
First Posted Date
2016-09-29
Last Posted Date
2023-04-21
Lead Sponsor
National Jewish Health
Target Recruit Count
51
Registration Number
NCT02918409
Locations
🇺🇸

National Jewish Health, Denver, Colorado, United States

Two Trabecular Micro-bypass Stents & Postoperative Travoprost to Treat Glaucoma Subjects on Two Hypotensive Agents

Phase 4
Completed
Conditions
Open-angle Glaucoma
Interventions
Procedure: Implantation of two iStent inject micro-bypass stents
Drug: Topical travoprost
Device: Two iStent inject micro-bypass stents
Drug: Tobramycin
Drug: Dexamethasone
First Posted Date
2016-08-22
Last Posted Date
2022-09-07
Lead Sponsor
Glaukos Corporation
Target Recruit Count
53
Registration Number
NCT02873806
Locations
🇦🇲

S.V. Malayan's Ophtalmology Centre, Yerevan, Armenia

Cystic Fibrosis Microbiome-determined Antibiotic Therapy Trial in Exacerbations: Results Stratified

Not Applicable
Completed
Conditions
Cystic Fibrosis
Interventions
First Posted Date
2015-08-18
Last Posted Date
2022-06-02
Lead Sponsor
University College Cork
Target Recruit Count
223
Registration Number
NCT02526004
Locations
🇮🇪

University College Cork, Cork, Ireland

Antibiotic Nephrotoxicity in Adult Patients With Cystic Fibrosis

Not Applicable
Conditions
Cystic Fibrosis
Interventions
First Posted Date
2015-07-03
Last Posted Date
2015-07-03
Lead Sponsor
The Leeds Teaching Hospitals NHS Trust
Registration Number
NCT02489955
Locations
🇬🇧

Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom

Once Daily Aminoglycoside Pharmacokinetics and Optimal Dosing in the Burn Population: A Prospective Study

Phase 1
Completed
Conditions
Burns
Infection
Interventions
First Posted Date
2014-10-21
Last Posted Date
2015-12-14
Lead Sponsor
Sandra Walker
Target Recruit Count
10
Registration Number
NCT02269969
Locations
🇨🇦

Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Patients Infected With Burkholderia Cepacia Complex

Phase 1
Completed
Conditions
Burkholderia Cepacia Infection
Cystic Fibrosis
Interventions
First Posted Date
2014-08-08
Last Posted Date
2020-11-04
Lead Sponsor
Unity Health Toronto
Target Recruit Count
10
Registration Number
NCT02212587
Locations
🇨🇦

St. Michael's Hospital, Toronto, Ontario, Canada

🇨🇦

Hospital for Sick Children, Toronto, Ontario, Canada

Pharmacokinetic and Pharmacoscintigraphic Comparison of TobrAir® 6.0 With TOBI® and TOBI® Podhaler™

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2014-08-04
Last Posted Date
2017-04-10
Lead Sponsor
Pharmaero ApS
Target Recruit Count
12
Registration Number
NCT02207426
Locations
🇬🇧

Quotient Clinical, Nottingham, United Kingdom

Efficacy & Tolerability of Tobramycin Podhaler in Bronchiectasis Patients With Chronic Pseudomonas Aeruginosa Infection

Not Applicable
Conditions
Bronchiectasis With Chronic Infection With Pseudomonas Aeruginosa
Interventions
First Posted Date
2014-04-02
Last Posted Date
2014-04-02
Lead Sponsor
Rabin Medical Center
Target Recruit Count
40
Registration Number
NCT02102152
Locations
🇮🇱

Pulmonary Institute, Rabin Medical Center, Beilinson Campus, Petach Tikva, Israel

Pharmacokinetic Evaluation and Tolerability of Dry Powder Tobramycin by a Novel Device in Patients With Non Cystic Fibrosis Bronchiectasis

Phase 1
Completed
Conditions
Bronchiectasis
Interventions
First Posted Date
2014-01-14
Last Posted Date
2014-12-16
Lead Sponsor
University Medical Center Groningen
Target Recruit Count
8
Registration Number
NCT02035488
Locations
🇳🇱

University Medical Center Groningen, Groningen, Netherlands

Tobramycin Exposure From Active Calcium Sulfate Bone Graft Substitute

Completed
Conditions
Orthopedic Operations
Interventions
First Posted Date
2013-09-10
Last Posted Date
2013-09-11
Lead Sponsor
University of Lausanne Hospitals
Target Recruit Count
12
Registration Number
NCT01938417
© Copyright 2025. All Rights Reserved by MedPath