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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
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
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A Study to Access Safety and Efficacy of Nebulized Tobramycin in Patients With Bronchiectasis

Phase 4
Conditions
Bronchiectasis
Interventions
Drug: Tobramycin
Drug: Saline
First Posted Date
2012-09-03
Last Posted Date
2012-12-05
Lead Sponsor
Shandong University
Target Recruit Count
120
Registration Number
NCT01677403
Locations
🇨🇳

Shandong University, Jinan, Shandong, China

Tobramycin 300 mg Once-a-day (o.d.) Aerosol in Adults With Cystic Fibrosis

Phase 4
Completed
Conditions
Cystic Fibrosis
Interventions
First Posted Date
2012-05-31
Last Posted Date
2012-07-24
Lead Sponsor
University of Milan
Target Recruit Count
10
Registration Number
NCT01608555
Locations
🇮🇹

IRCCS Ospedale Maggiore Policlinico via F. Sforza 35, Milan, Italy

Comparison of 2 Treatment Regimens for Eradication of P Aeruginosa Infection in Children With Cystic Fibrosis

Phase 4
Completed
Conditions
Cystic Fibrosis
Interventions
First Posted Date
2011-07-22
Last Posted Date
2011-08-04
Lead Sponsor
Universitaire Ziekenhuizen KU Leuven
Target Recruit Count
61
Registration Number
NCT01400750
Locations
🇧🇪

Department of pediatrics, CF center Uuiversity Hospital Leuven, Leuven, Belgium

Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus® /Pulmoaid® in Patients With Cystic Fibrosis

Phase 1
Conditions
Cystic Fibrosis
Interventions
First Posted Date
2011-04-18
Last Posted Date
2011-04-18
Lead Sponsor
Erempharma
Target Recruit Count
36
Registration Number
NCT01337219
Locations
🇫🇷

Centre de Ressource et de Compétence Mucoviscidose Pédiatrique Centre de Référence Mucoviscidose, Lyon, France

Effectiveness Comparison Between the Drugs TOBRACORT® and TOBRADEX® in Reducing the Signs and Symptoms of Acute Bacterial Conjunctivitis

Phase 3
Conditions
Acute Bacterial Conjunctivitis
Interventions
Drug: Tobracort
Drug: Tobradex
First Posted Date
2010-10-25
Last Posted Date
2010-10-25
Lead Sponsor
Azidus Brasil
Target Recruit Count
70
Registration Number
NCT01227915
Locations
🇧🇷

LAL Clínica Pesquisa e Desenvolvimento Ltda, Valinhos, São Paulo, Brazil

Clinical Efficacy and Safety of T1225 Versus Tobramycin 0.3 % Eye Drops in the Treatment of Purulent Bacterial Conjunctivitis of Children.

Phase 3
Completed
Conditions
Purulent Bacterial Conjunctivitis
Interventions
Drug: T1225
Drug: Tobramycin
First Posted Date
2010-07-02
Last Posted Date
2014-10-29
Lead Sponsor
Laboratoires Thea
Target Recruit Count
286
Registration Number
NCT01155999

A Single Arm 48-Week Follow-on Safety Study to a Core Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI®

Phase 3
Completed
Conditions
Cystic Fibrosis
First Posted Date
2010-04-27
Last Posted Date
2020-07-31
Lead Sponsor
Chiesi Farmaceutici S.p.A.
Target Recruit Count
209
Registration Number
NCT01111383
Locations
🇵🇱

I Oddzial Chorob Dzieciecych, Wojewodzki Specjalistyczny Szpital Dzieciecy, Kielce, Poland

🇵🇱

Dzieciecy Szpital Kliniczny Akademii Medycznej, Klinika Chorob Pluc I Reumatologii, Lublin, Poland

🇵🇱

Klinika Pneumonologii i Mukowiscydozy, Instytut Gruzlicy i Chorob Pluc w Rabce Zdroj, Rabka Zdroj, Poland

and more 17 locations

Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years

Phase 3
Completed
Conditions
Treatment of Early Pulmonary Infections With P. Aeruginosa in Cystic Fibrosis Patients
Interventions
Drug: TOBI
Drug: Placebo
First Posted Date
2010-03-08
Last Posted Date
2016-07-15
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
50
Registration Number
NCT01082367
Locations
🇨🇭

Novartis Investigative Site, Zürich, Switzerland

Duration of Antibiotics in Infective Exacerbations of Cystic Fibrosis

Phase 4
Conditions
Cystic Fibrosis
Interventions
First Posted Date
2010-01-08
Last Posted Date
2010-04-13
Lead Sponsor
Imperial College London
Target Recruit Count
240
Registration Number
NCT01044719
Locations
🇬🇧

Department of Cystic Fibrosis, Royal Brompton Hospital, London, United Kingdom

Comparison of Antibiotics for Pseudomonas in Early CF

Phase 1
Completed
Conditions
Cystic Fibrosis
Interventions
First Posted Date
2009-01-15
Last Posted Date
2011-04-18
Lead Sponsor
University of North Carolina, Chapel Hill
Target Recruit Count
21
Registration Number
NCT00823238
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