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Neomycin

Generic Name
Neomycin
Brand Names
Casporyn HC, Cortisporin, Cortisporin-TC, Dioptrol, Diosporin, Diphen, Maxitrol, Neo-polycin, Neo-polycin HC, Neo-synalar, Neosporin Ointment, Neosporin Plus Maximum Strength, Neosporin Plus Maximum Strength Cream, Neosporin Solution, Procomycin, Statrol, Triple Antibiotic, Viaderm Kc
Drug Type
Small Molecule
CAS Number
1404-04-2
Unique Ingredient Identifier
I16QD7X297

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.

Background

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
2018/03/26
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
2013/12/05
Phase 1
Completed

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
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
STAT RX LLC USA
16590-167
OPHTHALMIC
3.5 mg in 1 mL
6/9/2010

EMA Drug Approvals

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Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Neomycin Sulfate Eye Drops
国药准字H31021571
化学药品
滴眼剂
3/17/2020
Neomycin Sulfate Eye Drops
国药准字H37022792
化学药品
眼用制剂
4/15/2021
Neomycin Sulfate Eye Drops
国药准字H20184011
化学药品
眼用制剂
11/24/2022
Neomycin Sulfate Eye Drops
国药准字H34021972
化学药品
眼用制剂
7/9/2020
Neomycin Sulfate Eye Drops
国药准字H42020655
化学药品
眼用制剂(滴眼剂)
8/5/2020
Neomycin Sulfate Eye Drops
国药准字H19994001
化学药品
眼用制剂
3/5/2020

PPB Drug Approvals

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TGA Drug Approvals

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ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.
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