Overview
Gentamicin is a bactericidal aminoglycoside that was discovered and isolated from Micromonospora purpurea in 1963. It is one of the most frequently prescribed aminoglycosides due to its spectrum of activity, low cost, and availability. Gentamicin is effective against both gram-positive and gram-negative organisms but is particularly useful for the treatment of severe gram-negative infections including those caused by Pseudomonas aeruginosa. There is the added benefit of synergy when gentamicin is co-administered with other antibacterials such as beta-lactams. This synergistic activity is not only important for the treatment of complex infections, but can also contribute to dose optimization and reduced adverse effects. Although gentamicin is well-established and may be used in a variety of clinical applications, it is also associated with severe adverse effects including nephrotoxicity and ototoxicity which may limit its use.
Indication
1.本品适用于敏感铜绿假单胞菌、变形杆菌（吲哚阳性和阴性）属、大肠埃希菌、克雷伯菌属、肠杆菌属、沙雷菌属、柠檬酸杆菌属以及葡萄球菌属（不包括耐甲氧西林菌株）所致的严重感染；临床上本品常与β内酰胺类或其他抗菌药物联合应用。本品与青霉素G（或氨苄西林）联合应用治疗肠球菌感染； 2.本品用于铜绿假单胞菌或葡萄球菌属所致的严重中枢神经系统感染（如脑膜炎、脑室炎）时，可同时用本品鞘内注射作为辅助治疗； 3.本品不适用于单纯性尿路感染初治，除非病原菌对其他毒性较低的抗菌药物不敏感，本品对链球菌属中多数菌种（尤其D组）、肺炎链球菌和厌氧菌（如拟杆菌属或梭状芽孢杆菌属）无效； 4.本品口服可用于肠道感染或结肠手术前准备，也可用本品肌注合并克林霉素或甲硝唑以减少结肠手术后感染率。 5.局部外用适用于治疗敏感细菌所致的外眼感染，如结膜炎、结膜炎、泪囊炎、睑缘炎、睑板腺炎等。
Associated Conditions
- Allergic Conjunctivitis (AC)
- Bacterial Conjunctivitis
- Bacterial Infections
- Bacterial Keratitis
- Bacterial Peritonitis
- Bacterial dacryocystitis
- Blepharoconjunctivitis
- Central Nervous System Infections
- Corneal infection
- Dermatitis infected
- Ecthyma
- Eczematous dermatitis infected
- Folliculitis
- Furunculosis
- Gram-negative enteric bacilli neonatal sepsis
- Impetigo contagious
- Inflammation
- Keratoconjunctivitis
- Meibomianitis
- Meningitis, Bacterial
- Ocular Inflammation
- Pustular Psoriasis (PP)
- Pustular acne
- Pyoderma Gangrenosum
- Seborrheic Dermatitis
- Septicemia gram-negative
- Skin Infections
- Skin and Subcutaneous Tissue Bacterial Infections
- Sycosis barbae
- Bacterial blepharitis
- Bacterial corneal ulcers
- Bacterial skin infections
- Complicated Respiratory tract infection bacterial
- Complicated Urinary Tract Infection caused by susceptible bacteria
- Corticosteroid-responsive dermatoses
- Ocular bacterial infections
- Severe Endocarditis enterococcal
- Severe Infection Pseudomonas aeruginosa
- Severe Staphylococcal infection
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/12/02 | Phase 4 | Not yet recruiting | University Hospital, Akershus | ||
2024/07/05 | Phase 3 | Suspended | |||
2024/04/26 | Phase 3 | Recruiting | |||
2024/04/12 | Phase 2 | Not yet recruiting | |||
2024/03/27 | Phase 4 | Recruiting | Women and Infants Hospital of Rhode Island | ||
2024/03/26 | Phase 4 | Recruiting | St. Joseph's Hospital and Medical Center, Phoenix | ||
2023/12/13 | Not Applicable | Recruiting | |||
2023/08/23 | Phase 2 | Withdrawn | |||
2023/08/04 | Phase 3 | Not yet recruiting | |||
2023/03/13 | Phase 3 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| A-S Medication Solutions | 50090-2333 | OPHTHALMIC | 3 mg in 1 mL | 1/16/2023 | |
| E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | 0168-0078 | TOPICAL | 1 mg in 1 g | 3/17/2010 | |
| Cosette Pharmaceuticals, Inc. | 0713-0682 | TOPICAL | 1 mg in 1 g | 11/23/2023 | |
| REMEDYREPACK INC. | 70518-3785 | OPHTHALMIC | 3 mg in 1 mL | 3/29/2024 | |
| Baxter Healthcare Corporation | 0338-0507 | INTRAVENOUS | 60 mg in 50 mL | 7/7/2016 | |
| Eugia US LLC | 55150-402 | INTRAMUSCULAR, INTRAVENOUS | 40 mg in 1 mL | 5/24/2021 | |
| Baxter Healthcare Corporation | 0338-0509 | INTRAVENOUS | 80 mg in 50 mL | 7/7/2016 | |
| Aidarex Pharmaceuticals LLC | 53217-229 | OPHTHALMIC | 3 mg in 1 mL | 2/20/2017 | |
| Asclemed USA, Inc. | 76420-254 | OPHTHALMIC | 3 mg in 1 mL | 7/19/2022 | |
| Asclemed USA, Inc. | 76420-137 | OPHTHALMIC | 3 mg in 1 mL | 3/4/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| BEPROGENT CREAM | SIN09020P | CREAM | 0.1% w/w | 11/28/1996 | |
| TRI-MICON CREAM | SIN10705P | CREAM | 0.1% w/w | 1/26/1999 | |
| B-TASONE-G CREAM | SIN04424P | CREAM | 0.3% w/w | 2/26/1990 | |
| ANTASONE CREAM | SIN02144P | CREAM | 1.214mg equiv to 1 mg | 6/25/1988 | |
| GENTRISONE CREAM | SIN04989P | CREAM | 1 mg/g | 8/3/1990 | |
| GENTAMICIN INJECTION 80 mg/2 ml | SIN09941P | INJECTION | 80 mg/2 ml | 8/19/1998 | |
| COMBIDERM CREAM | SIN05109P | CREAM | 0.1% | 10/8/1990 | |
| GARASENT INJECTION 80 mg/2 ml | SIN11085P | INJECTION | 80 mg/2 ml | 8/27/1999 | |
| MIRAMYCIN INJECTION 80 mg/2 ml | ATLANTIC LABORATORIES CORPN LTD | SIN01849P | INJECTION | 80 mg/2 ml | 6/17/1988 |
| GENTAMICIN INJECTION BP 80 mg/2 ml | SIN05260P | INJECTION | 80 mg/2 ml | 12/14/1990 |
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 |
|---|---|---|---|---|---|
| TRIDAZINE-FORTE CREAM | N/A | N/A | N/A | 9/28/2009 | |
| TOLNAFU CREAM | N/A | N/A | N/A | 3/16/2011 | |
| GENTRISONE CREAM | N/A | N/A | N/A | 11/13/1989 | |
| BETAGENT CREAM | N/A | N/A | N/A | 11/13/1989 | |
| JOYCELINE CREAM | N/A | N/A | N/A | 5/2/1994 | |
| GENBESON CREAM | N/A | N/A | N/A | 11/25/2010 | |
| BEGENZOLE CREAM | N/A | N/A | N/A | 2/26/2020 | |
| MYDERM CREAM | N/A | N/A | N/A | 2/14/2020 | |
| CLOZODERMA CREAM | N/A | N/A | N/A | 8/6/1990 | |
| DEXA-GENTAMICIN EYE OINTMENT | N/A | N/A | N/A | 4/12/2011 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| GENTAMICIN NORIDEM gentamicin (as sulfate) 80 mg/2 mL solution for injection ampoule | 391250 | Medicine | A | 7/10/2023 | |
| DBL GENTAMICIN 10mg/1mL(as sulfate) Injection | 16339 | Medicine | A | 10/8/1991 | |
| B. BRAUN GENTAMICIN gentamicin (as sulfate) 360 mg/120 mL injection, intravenous infusion, bottle | 280495 | Medicine | A | 5/17/2019 | |
| B. BRAUN GENTAMICIN gentamicin (as sulfate) 240 mg/80 mL injection, intravenous infusion, bottle | 280507 | Medicine | A | 5/17/2019 | |
| DBL GENTAMICIN 80mg/2mL Injection BP | 47268 | Medicine | A | 1/31/1994 | |
| B. BRAUN GENTAMICIN gentamicin (as sulfate) 80 mg/80 mL injection, intravenous infusion, bottle | 280508 | Medicine | A | 5/17/2019 | |
| Hospira Gentamicin Injection BP 80 mg/2 mL vial | 34197 | Medicine | A | 12/2/1991 | |
| Gentamicin 80 mg/2 mL Injection BP | 278535 | Medicine | A | 8/1/2016 | |
| Pfizer (Australia) GENTAMICIN 80 mg/2 mL (as sulfate) injection BP ampoule | 11376 | Medicine | A | 8/13/1991 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| GARAMYCIN INJ 40MG/ML | schering-plough canada inc | 00223824 | Solution - Intravenous
,
Intramuscular | 40 MG / ML | 12/31/1966 |
| ODAN-GENTAMICIN | odan laboratories ltd | 00832162 | Solution - Ophthalmic | 5 MG / ML | 12/31/1991 |
| GENTRASUL LIQ 3MG/ML | bausch & lomb canada inc. | 00772429 | Drops - Ophthalmic | 3 MG / ML | 12/31/1988 |
| GARATEC OPHTHALMIC DPS 5MG/ML | technilab pharma inc. | 00880191 | Drops - Ophthalmic | 5 MG / ML | 12/31/1992 |
| ODAN-GENTAMICIN | odan laboratories ltd | 01989073 | Ointment - Ophthalmic | 5 MG / G | 12/31/1994 |
| OCUGRAM ONT 3MG/GM | herdt et charton inc. | 01987461 | Ointment - Topical
,
Ophthalmic | 3 MG / G | 12/31/1994 |
| GARAMYCIN INJ 10MG/ML PEDIATRIC | schering-plough canada inc | 00223832 | Solution - Intravenous
,
Intramuscular | 10 MG / ML | 12/31/1970 |
| GENTACIDIN OPH SOLN 3MG/ML | iolab pharmaceuticals | 00810282 | Drops - Ophthalmic | 3 MG / ML | 12/31/1991 |
| GARATEC OTIC DPS 5MG/ML | technilab pharma inc. | 00880205 | Drops - Otic | 5 MG / ML | 12/31/1992 |
| GENTACIDIN OPHTHALMIC SOLUTION 3MG/ML | 02133245 | Drops - Ophthalmic | 3 MG / ML | 12/31/1996 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| CELESTODERM 1 mg/g + 1 mg/g CREMA | Organon Salud S.L. | 42399 | CREMA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| DIPROGENTA 0,5 mg/g + 1 mg/g crema | Organon Salud S.L. | 53541 | CREMA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| CELESTODERM 1 MG/G + 1 MG/G CREMA | Organon N.V. | 4105707462008 | CREMA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| GENTAMICINA BRAUN 3 MG/ML SOLUCION PARA PERFUSION | B Braun Medical S.A. | 63854 | SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
| DIPROGENTA 0,5 MG/G + 1 MG/G CREMA | Organon Portugal Sociedade Unipessoal Lda. | 9454504IP3 | CREMA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| DIPROGENTA 0,5 MG/G + 1 MG/G CREMA | Organon Portugal Sociedade Unipessoal Lda. | 9454504IP2 | CREMA | 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. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.