Overview
Neomycin is a broad-spectrum aminoglycoside antibiotic drug that is derived from the metabolic products of Streptomyces fradiae. Neomycin is a complex comprised of three components, neomycin A, B, and C. Neomycin B, also known as framycetin, is the most active component of the complex and neomycin C is the isomer of neomycin B, making these two stereoisomers the active components of neomycin. Neomycin A, or neamine, is a moiety that conjoins two molecules of neomycin B and C together. Neomycin is active against both gram-positive and gram-negative organisms and mediates its pharmacological action by binding to bacterial ribosomes and inhibiting protein synthesis, which is crucial for the survival of bacteria. Neomycin sulfate is the most common form for pharmaceutical preparations; because the compound is a complex, the amount of neomycin in products is measured in units. Neomycin sulfate as monotherapy is available in an oral solution for adjunct use in the treatment of hepatic coma. It is also used in combination with polymyxin B sulfates and hydrocortisone in otic suspensions for use in the treatment of bacterial infections in the external auditory canal, including infections caused by medical procedures in the ear. Neomycin is also used in combination with polymyxin B sulfates and dexamethasone in ophthalmic preparations for use in the treatment of inflammatory conditions and infections in the eye. Neomycin is also available in over-the-counter topical products to prevent minor skin infections.
Indication
Oral neomycin sulfate is indicated as an adjunctive therapy in hepatic coma (portal-system encephalopathy) by reducing ammonia-forming bacteria in the intestinal tract. It is strongly recommended that oral neomycin is only used in infections that are proven or strongly suspected to be caused by susceptible bacteria to reduce the risk of the development of drug-resistant bacteria. Neomycin, in combination with polymyxin B sulfates and hydrocortisone in otic suspensions, is used in the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the antibiotics. This otic formulation is also used in the treatment of infections of mastoidectomy and fenestration cavities caused by organisms susceptible to the antibiotics. The ophthalmic solution containing neomycin in combination with polymyxin B sulfates and dexamethasone is used to treat steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists.
Associated Conditions
- Allergic Contact Dermatitis
- Allergic Skin Reaction
- Atopic Dermatitis
- Atopic Dermatitis (AD) of the external ear canal
- Bacterial diarrhoea
- Burns
- Carbuncle
- Contact Dermatitis
- Cradle Cap
- Dermatitis
- Diarrhea
- Discoid Lupus Erythematosus (DLE)
- Ear infection bacterial
- Ear infection bacterial caused by susceptible bacteria
- Gastrointestinal Tract Infections
- Hepatic coma
- Hidradenitis Suppurativa (HS)
- Hot Water Burns (Scalds)
- Impetigo
- Impetigo contagious
- Infantile Eczema
- Infected skin ulcer
- Infection of the outer ear caused by susceptible bacteria
- Infectious diarrhea
- Inflammatory Reaction caused by Acne
- Intertrigo
- Itching caused by Infection
- Lichen Planus (LP)
- Localized Infection caused by susceptible bacteria
- Nail infection
- Neurodermatitis
- Otitis Externa
- Postoperative Wound Infection
- Psoriasis Vulgaris (Plaque Psoriasis)
- Pustular Dermatosis
- Pustular acne
- Radiodermatitis
- Secondarily Infected Eczema
- Secondary Bacterial Infection
- Skin Burn
- Skin Infections
- Skin Irritation
- Skin Ulcer
- Solar erythema
- Wound Infections
- Abrasions
- Bacterial skin infections
- Blistering caused by Staphylococcus
- Erythematous eruptions
- Intertriginous erythema of the anogenital
- Ocular bacterial infections caused by susceptible bacteria
- Resistant to other corticosteroids Dermatosis
- Susceptible Bacterial Infections
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/12/24 | Early Phase 1 | Not yet recruiting | |||
2023/12/18 | Not Applicable | Completed | |||
2023/11/28 | Phase 4 | Recruiting | |||
2023/08/23 | Phase 2 | Not yet recruiting | |||
2023/03/22 | N/A | Recruiting | Uzsoki Hospital | ||
2022/10/25 | Phase 4 | Recruiting | |||
2021/01/28 | Phase 2 | Active, not recruiting | |||
2018/09/10 | Phase 4 | Recruiting | |||
2018/07/20 | Not Applicable | UNKNOWN | |||
2018/06/14 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| MWI | 13985-608 | OPHTHALMIC | 3.5 mg in 1 g | 3/23/2015 | |
| Aidarex Pharmaceuticals LLC | 33261-551 | OPHTHALMIC | 3.5 mg in 1 mL | 8/14/2018 | |
| Bausch & Lomb Incorporated | 24208-780 | OPHTHALMIC | 3.5 mg in 1 g | 6/30/2023 | |
| DIRECT RX | 61919-113 | OPHTHALMIC | 3.5 mg in 1 g | 1/21/2020 | |
| NuCare Pharmaceuticals,Inc. | 68071-4229 | AURICULAR (OTIC) | 3.5 mg in 1 mL | 6/16/2023 | |
| Physicians Total Care, Inc. | 54868-1070 | OPHTHALMIC | 3.5 mg in 1 mL | 6/1/2012 | |
| Trifecta Pharmaceuticals USA | 69396-061 | TOPICAL | 3.5 mg in 100 g | 5/12/2025 | |
| Padagis US LLC | 0574-4144 | OPHTHALMIC | 3.5 mg in 1 g | 11/9/2018 | |
| Medimetriks Pharmaceuticals | 43538-940 | TOPICAL | 3.5 mg in 1 g | 1/10/2023 | |
| Phoenix Pharmaceutical, Inc. | 57319-343 | OPHTHALMIC | 3.5 mg in 1 g | 9/30/2010 |
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 |
|---|---|---|---|---|---|
| NEO-BETASONE CREAM | SIN04129P | CREAM | 0.5% w/w | 3/28/1990 | |
| NEO-CORTISONE CREAM | SIN04113P | CREAM | 500 mg/100 g | 3/28/1990 | |
| PROCTOSEDYL SUPPOSITORY | SIN01717P | SUPPOSITORY | 10 mg | 6/8/1988 | |
| UNIFLEX-N CREAM | SIN01930P | CREAM | 0.5% w/w | 6/23/1988 | |
| MAXITROL STERILE OPHTHALMIC SUSPENSION | SIN04358P | SOLUTION | 3500 iu/ml | 5/2/1990 | |
| BANEOCIN POWDER | SIN00678P | POWDER | 5000 iu/g | 5/3/1988 | |
| POLYBAMYCIN OINT. | SIN04413P | OINTMENT | 3.5 mg/g | 5/3/1990 | |
| POLYDEXA EAR DROPS | SIN04945P | SOLUTION | 650000 iu/100 ml | 7/16/1990 | |
| POLYGYNAX VAGINAL CAPSULE | SIN07745P | CAPSULE | 35000 iu | 6/15/1994 | |
| DEXTRACIN EYE/EAR DROPS | SIN00959P | SOLUTION | 0.5% w/v | 5/10/1988 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Neomycin Sulfate Tablets | 国药准字H14021961 | 化学药品 | 片剂 | 4/20/2020 | |
| Neomycin Sulfate Tablets | 国药准字H31020916 | 化学药品 | 片剂 | 7/4/2024 | |
| Neomycin Sulfate Tablets | 国药准字H31020799 | 化学药品 | 片剂 | 5/12/2020 | |
| Neomycin Sulfate Tablets | 国药准字H61021913 | 化学药品 | 片剂 | 12/11/2020 | |
| Neomycin Sulfate Tablets | 国药准字H11020691 | 化学药品 | 片剂 | 11/20/2020 | |
| Neomycin Sulfate Tablets | 国药准字H44021092 | 化学药品 | 片剂 | 1/13/2020 | |
| Neomycin Sulfate Tablets | 国药准字H41021162 | 化学药品 | 片剂 | 7/15/2020 | |
| Neomycin Sulfate Tablets | 国药准字H32020292 | 化学药品 | 片剂 | 7/7/2020 | |
| unguentum neomycini sulftis | 国药准字H44024845 | 化学药品 | 软膏剂 | 1/6/2021 | |
| unguentum neomycini sulftis | 国药准字H31022262 | 化学药品 | 软膏剂 | 1/15/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| FORTIN CREAM | N/A | N/A | N/A | 2/23/2000 | |
| CINO-N CREAM | N/A | N/A | N/A | 3/5/1987 | |
| LONGAXON CREAM | N/A | N/A | N/A | 1/14/1997 | |
| MCKAY CREAM | N/A | N/A | N/A | 3/26/2003 | |
| BENZACIN CREAM | N/A | N/A | N/A | 8/23/1999 | |
| XYLOPAN CREAM | N/A | N/A | N/A | 3/11/1999 | |
| PROMAX CREAM | N/A | N/A | N/A | 12/29/2004 | |
| NIZOKOMP CREAM | N/A | N/A | N/A | 3/21/2003 | |
| UNI-CORT-N CREAM | N/A | N/A | N/A | 8/1/1995 | |
| RAPIDERM CREAM | N/A | N/A | N/A | 8/23/1999 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| Kenacomb Otic Ointment tube | 19201 | Medicine | A | 9/30/1991 | |
| OTOCOMB Otic ear drops bottle | 56477 | Medicine | A | 8/7/1996 | |
| Kenacomb Otic ear drops bottle | 19200 | Medicine | A | 9/30/1991 | |
| Kenacomb Ointment tube | 19197 | Medicine | A | 9/30/1991 | |
| OTOCOMB Otic ointment tube | 56460 | Medicine | A | 8/7/1996 |
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