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).
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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/10/30 | N/A | Active, not recruiting | Qianfoshan Hospital | ||
2023/10/23 | Phase 4 | Recruiting | Shanghai Pulmonary Hospital, Shanghai, China | ||
2023/08/29 | Phase 1 | Recruiting | |||
2022/06/23 | Phase 3 | Completed | |||
2022/04/06 | N/A | UNKNOWN | |||
2021/07/16 | Phase 3 | Active, not recruiting | |||
2021/05/04 | Phase 4 | Completed | |||
2020/09/23 | Phase 1 | Completed | Erik Allen Jensen | ||
2020/03/05 | Phase 4 | Completed | |||
2019/06/05 | Early Phase 1 | UNKNOWN | Sutphin Drugs |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Eugia US LLC | 55150-470 | INTRAVENOUS | 1.2 g in 30 mL | 10/26/2022 | |
| Fosun Pharma USA Inc | 72266-163 | INTRAVENOUS | 1.2 g in 30 mL | 1/10/2023 | |
| Gland Pharma Limited | 68083-241 | INTRAVENOUS | 40 mg in 1 mL | 2/27/2023 | |
| DirectRX | 61919-598 | OPHTHALMIC | 3 mg in 1 mL | 1/10/2024 | |
| Bausch & Lomb Incorporated | 24208-290 | OPHTHALMIC | 3 mg in 1 mL | 11/1/2023 | |
| NuCare Pharmaceuticasl,Inc. | 68071-2772 | OPHTHALMIC | 3 mg in 1 mL | 6/24/2022 | |
| H.J. Harkins Company, Inc. | 52959-108 | OPHTHALMIC | 3 mg in 1 mL | 2/13/2012 | |
| Aidarex Pharmaceuticals LLC | 33261-519 | OPHTHALMIC | 3 mg in 1 mL | 8/20/2018 | |
| Rebel Distributors Corp | 21695-416 | OPHTHALMIC | 3 mg in 1 mL | 8/25/2009 | |
| A-S Medication Solutions | 50090-3569 | OPHTHALMIC | 3.0 mg in 1 mL | 3/9/2012 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 2/18/2019 | ||
Authorised | 7/20/2011 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| TOBREX STERILE OPHTHALMIC OINTMENT 0.3% | SIN04722P | OINTMENT | 3 mg/g | 6/13/1990 | |
| TOBREX STERILE OPHTHALMIC SOLUTION 0.3% | SIN04451P | SOLUTION | 3 mg/ml | 5/22/1990 | |
| TOBRADEX STERILE OPHTHALMIC SUSPENSION | SIN04438P | SOLUTION | 0.3% | 5/21/1990 | |
| ZYLET® STERILE OPHTHALMIC SUSPENSION | SIN13647P | SUSPENSION, STERILE | 3mg/ ml | 5/4/2009 | |
| TOBRADEX OPHTHALMIC OINTMENT | SIN04309P | OINTMENT | 0.3% | 4/16/1990 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| TOBESON OPHTHALMIC SOLUTION 0.3/0.1% W/V | N/A | N/A | N/A | 9/2/2016 | |
| TOBREX OPHTHALMIC OINT 0.3% | N/A | N/A | N/A | 7/28/1983 | |
| TOBRADEX OPHTHALMIC SUSP | N/A | N/A | N/A | 4/2/1990 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| Hospira Tobramycin 40 mg/mL Injection 80 mg/2mL vial | 121463 | Medicine | A | 8/24/2005 | |
| TOBI tobramycin 300mg/5mL solution for inhalation ampoule | 73172 | Medicine | A | 2/18/2000 | |
| TOBRAMYCIN CH tobramycin 300 mg/5 mL inhalation solution ampoule | 241212 | Medicine | A | 4/13/2016 | |
| Pfizer (Australia) TOBRAMYCIN (as sulfate) PF 80 mg/2 mL injection ampoule | 10776 | Medicine | A | 7/9/1991 | |
| NEBCIN tobramycin 80mg/2mL (as sulfate)Injection vial | 77034 | Medicine | A | 6/27/2001 | |
| TOBREX tobramycin 3mg/mL eye drops bottle | 25365 | Medicine | A | 10/15/1991 | |
| MAPLE TOBRAMYCIN tobramycin 300mg/5mL solution for inhalation ampoules | 279354 | Medicine | A | 2/23/2018 | |
| TOBI PODHALER tobramycin 28 mg hard capsule for inhalation blister pack with Podhaler device | 182302 | Medicine | A | 3/6/2012 | |
| Pfizer (Australia) TOBRAMYCIN (as sulfate) 80 mg/2 mL injection BP ampoule | 101217 | Medicine | A | 5/4/2004 | |
| Hospira Tobramycin 40 mg/mL Injection 40 mg/1 mL vial | 121461 | Medicine | A | 8/24/2005 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| TOBRADEX | novartis pharmaceuticals canada inc | 00778907 | Suspension - Ophthalmic | 0.3 % / W/V | 12/31/1990 |
| TOBREXAN | novartis pharmaceuticals canada inc | 02261243 | Solution - Ophthalmic | 0.3 % / W/V | N/A |
| AJ-TOBRAMYCIN | agila jamp canada inc | 02384930 | Liquid - Intramuscular
,
Intravenous | 40 MG / ML | N/A |
| TOBRAMYCIN OPHTHALMIC SOLUTION USP 0.3% | bausch & lomb pharmaceuticals inc. | 02239148 | Liquid - Ophthalmic | 3 MG / ML | 9/1/1999 |
| NEBCIN INJ 1.2GM/30ML | eli lilly canada inc | 00608963 | Liquid - Intramuscular
,
Intravenous | 1.2 G / VIAL | 12/31/1986 |
| SANDOZ TOBRAMYCIN / DEXAMETHASONE | 02517825 | Suspension - Ophthalmic | 0.3 % / W/V | N/A | |
| TOBREX | novartis pharmaceuticals canada inc | 00513962 | Solution - Ophthalmic | 0.3 % / W/V | 12/31/1981 |
| APO-TOBRAMYCIN | 02245698 | Solution - Ophthalmic | 0.3 % | 9/18/2002 | |
| TOBRADEX | novartis pharmaceuticals canada inc | 00778915 | Ointment - Ophthalmic | 0.3 % / W/W | 12/31/1990 |
| PMS-TOBRAMYCIN 0.3% OPHTHALMIC SOLUTION | 02239577 | Liquid - Ophthalmic | 3 MG / ML | 2/18/1999 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| TOBREX 3 MG/ML COLIRIO EN SOLUCIÓN | Novartis Farmaceutica S.A. | 57594 | COLIRIO EN SOLUCIÓN | Medicamento Sujeto A Prescripción Médica | Commercialized |
| TOBRAMICINA ALTAN 300 MG/5 ML SOLUCION PARA INHALACION POR NEBULIZADOR | Altan Pharmaceuticals Sa | 84187 | SOLUCIÓN PARA INHALACIÓN POR NEBULIZADOR | Uso Hospitalario | Commercialized |
| TOBRAMICINA BRAUN 3 mg/ml SOLUCION PARA PERFUSION INTRAVENOSA | B Braun Medical S.A. | 64191 | SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized |
| TOBRABACT 3,0 mg/ml COLIRIO EN SOLUCION | Medicom Healthcare Ireland Limited | 64350 | COLIRIO EN SOLUCIÓN | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| TOBI 300 mg/5 ml SOLUCION PARA INHALACION POR NEBULIZADOR | 63689 | SOLUCIÓN PARA INHALACIÓN POR NEBULIZADOR | Uso Hospitalario | Not Commercialized | |
| TOBREXAN 3 MG/ML COLIRIO EN SOLUCIÓN | Novartis Farmaceutica S.A. | 66421 | COLIRIO EN SOLUCIÓN | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| TOBI PODHALER 28 mg POLVO PARA INHALACION (CAPSULA DURA) | 10652002 | POLVO PARA INHALACIÓN (CÁPSULA DURA) | Uso Hospitalario | Commercialized | |
| TOBRAMICINA SUN 300 MG/5 ML SOLUCION PARA INHALACION POR NEBULIZADOR | 82287 | SOLUCIÓN PARA INHALACIÓN POR NEBULIZADOR | Uso Hospitalario | Commercialized | |
| TOBREX UNGÜENTO OFTÁLMICO 3 MG/G POMADA OFTÁLMICA | Novartis Farmaceutica S.A. | 57593 | POMADA OFTÁLMICA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| TOBRADEX 1 MG/ML + 3 MG/ML COLIRIO EN SUSPENSIÓN | Novartis Farmaceutica S.A. | 61575 | COLIRIO EN SUSPENSIÓN | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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