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
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2018/06/14 | Phase 4 | Completed | |||
2018/03/26 | Phase 2 | Completed | |||
2017/02/03 | Early Phase 1 | UNKNOWN | |||
2016/06/07 | Phase 1 | Completed | |||
2016/05/06 | Phase 2 | Completed | |||
2016/04/07 | Phase 2 | Terminated | |||
2015/11/13 | N/A | Completed | Maimónides Biomedical Research Institute of Córdoba | ||
2015/06/16 | Phase 2 | UNKNOWN | Stephen Harbarth | ||
2014/06/20 | Phase 4 | Completed | Noah Rosenberg, MD | ||
2014/06/03 | Not Applicable | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Phoenix Pharmaceutical, Inc. | 57319-343 | OPHTHALMIC | 3.5 mg in 1 g | 9/30/2010 | |
| Sandoz Inc | 61314-631 | OPHTHALMIC | 3.5 mg in 1 g | 7/20/2011 | |
| Butler Animal Health Supply | 11695-1406 | OPHTHALMIC | 3.5 mg in 1 g | 10/5/2010 | |
| Proficient Rx LP | 63187-270 | AURICULAR (OTIC) | 3.5 mg in 1 mL | 1/1/2021 | |
| REMEDYREPACK INC. | 70518-0763 | AURICULAR (OTIC) | 3.5 mg in 1 mL | 2/13/2024 | |
| MWI | 13985-607 | OPHTHALMIC | 3.5 mg in 1 g | 3/23/2015 | |
| Casper Pharma LLC | 70199-011 | AURICULAR (OTIC) | 3.5 mg in 1 mL | 10/13/2022 | |
| Alcon Laboratories, Inc. | 0998-0630 | OPHTHALMIC | 3.5 mg in 1 mL | 12/18/2017 | |
| Physicians Total Care, Inc. | 54868-6122 | OPHTHALMIC | 3.5 mg in 1 g | 5/17/2010 | |
| Rebel Distributors Corp | 21695-438 | AURICULAR (OTIC) | 3.5 mg in 1 mL | 10/9/2008 |
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
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| No HSA approvals found for this drug. | |||||
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| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| LAMEBA CREAM | N/A | N/A | N/A | 3/21/2000 | |
| POLYSTATIN CREAM | N/A | N/A | N/A | 5/30/2001 | |
| FLUODERMA CREAM | N/A | N/A | N/A | 2/1/1996 | |
| GAMMACIN CREAM | N/A | N/A | N/A | 3/21/2003 | |
| EUMODERM CREAM | N/A | N/A | N/A | 1/16/1991 | |
| NATISON CREAM | N/A | N/A | N/A | 2/15/2008 | |
| CORAL CREAM | N/A | N/A | N/A | 1/28/2010 | |
| WEPPERS CREAM | N/A | N/A | N/A | 12/10/2005 | |
| DIPRODERM CREAM | N/A | N/A | N/A | 1/30/2003 | |
| BETACO CREAM | N/A | N/A | N/A | 6/9/1994 |
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| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
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Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| NEO-CORTEF 0.5% OINTMENT | 00194891 | Ointment - Topical | 0.5 % | 12/31/1954 | |
| NEODECADRON EYE EAR SOLN 0.1% | merck frosst canada & cie, merck frosst canada & co. | 00140732 | Liquid - Ophthalmic
,
Otic | 5 MG / ML | 12/31/1959 |
| ODAN-TROL | odan laboratories ltd | 00626597 | Suspension - Ophthalmic | 3.5 MG / ML | 12/31/1992 |
| CICATRIN POWDER | 00666173 | Powder - Topical | 3300 UNIT / G | 12/31/1987 | |
| DIOPTROL OINTMENT | steri-med pharma inc. | 02023849 | Ointment - Ophthalmic | 3.5 MG / G | 12/31/1994 |
| MYCIFRADIN SULFATE ORAL SOLUTION | pharmacia & upjohn inc | 00030805 | Solution - Oral | 125 MG / 5 ML | 12/31/1957 |
| ODAN-SPOR-HC | odan laboratories ltd | 00626600 | Suspension - Otic | 3.5 MG / ML | 12/31/1992 |
| AMINODERM POUDRE | desbergers ltée, division of technilab inc. | 00086649 | Powder - Topical | 5 MG / G | 12/31/1968 |
| NEO-CORTEF 1% OINTMENT | 00194913 | Ointment - Topical | 0.5 % | 12/31/1954 | |
| NEO-MEDROL | 00194867 | Cream - Topical | 5 MG / G | 12/31/1960 |
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