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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
-

Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis

Phase 4
Completed
Conditions
Conjunctivitis
Interventions
First Posted Date
2008-06-25
Last Posted Date
2015-03-24
Lead Sponsor
Bausch & Lomb Incorporated
Target Recruit Count
137
Registration Number
NCT00705159
Locations
🇺🇸

Pediatric Ophthalmology of Erie, Erie, Pennsylvania, United States

Pharmacokinetic Evaluation of an 8 -Week Treatment With Inhaled Tobramycin

Phase 3
Completed
Conditions
Pseudomonas Infections
Interventions
First Posted Date
2008-03-12
Last Posted Date
2017-02-24
Lead Sponsor
Novartis
Target Recruit Count
50
Registration Number
NCT00634192
Locations
🇩🇪

Novartis Investigator Site, Munich, Germany

🇩🇪

Novartis Investigator site, Halle/Saale, Germany

TOBRADEX Ophthalmic Suspension Versus Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension

Phase 3
Completed
Conditions
Ocular Inflammation Associated With Blepharaconjunctivitis
Interventions
First Posted Date
2007-12-19
Last Posted Date
2010-03-02
Lead Sponsor
Alcon Research
Target Recruit Count
221
Registration Number
NCT00576251
Locations
🇺🇸

Houston, Houston, Texas, United States

Tobramycin Administered by eFlow Rapid Nebulizer: Pharmacokinetic Study

Phase 1
Completed
Conditions
Cystic Fibrosis
First Posted Date
2007-01-11
Last Posted Date
2007-01-11
Lead Sponsor
Novartis
Target Recruit Count
20
Registration Number
NCT00420836

Tobramycin Inhalation Solution Administered by eFlow Rapid Nebulizer: Scintigraphy Study

Phase 1
Completed
Conditions
Cystic Fibrosis
First Posted Date
2006-11-15
Last Posted Date
2007-05-07
Lead Sponsor
Novartis
Target Recruit Count
12
Registration Number
NCT00399945

Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Tobramycin for Bacterial Conjunctivitis (C-01-401-004)

Phase 3
Completed
Conditions
Bacterial Conjunctivitis
Interventions
First Posted Date
2005-03-15
Last Posted Date
2013-12-16
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
743
Registration Number
NCT00105469
Locations
🇺🇸

Alan Shuster, MD, Jupiter, Florida, United States

🇺🇸

Children's Eye Physicians, Littleton, Colorado, United States

🇺🇸

Pasco Eye Institute, New Port Richey, Florida, United States

and more 22 locations

Phase III Randomized Study of the Inhalation of Tobramycin in Patients With Cystic Fibrosis

Phase 3
Completed
Conditions
Cystic Fibrosis
Bacterial Infection
First Posted Date
2000-02-25
Last Posted Date
2015-03-25
Lead Sponsor
FDA Office of Orphan Products Development
Target Recruit Count
200
Registration Number
NCT00004829
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