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Neomycin sulphate PH. EUR. is an aminoglycoside antibiotic. It is a mixture of sulfate salts of substances produced by the growth of the bacterium Streptomyces fradiae, the main components being neomycin B and its stereoisomer neomycin C.[2] The substance is authorised as a medicine in the United Kingdom, where it is supplied as Neomycin 500mg Tablets by Amdipharm UK Limited.[1]
Neomycin sulphate PH. EUR. is an aminoglycoside antibiotic, a class of medicines that kill or stop the growth of bacteria. Chemically, it is a mixture of sulfate salts produced by the growth of Streptomyces fradiae, with neomycin B and neomycin C as the main components.[2] It contains not less than 600 International Units of neomycin per milligram, calculated with reference to the dried substance.[2] The substance is classified under the Anatomical Therapeutic Chemical (ATC) code A07AA01 as neomycin.[1] In the United Kingdom, neomycin sulphate is an authorised medicine, supplied as 500 mg tablets by Amdipharm UK Limited.[1] Other names include Neomycin 500mg Tablets.[1] In hospital formularies, neomycin sulphate also appears in combination products for the skin, eye and ear, such as creams, ointments and ear drops containing corticosteroids or other antibacterials.[3]
Neomycin sulphate is an aminoglycoside antibiotic. Aminoglycosides work by binding to bacterial ribosomes, the parts of the bacterial cell that make proteins, and this disrupts protein production and leads to bacterial cell death. The World Health Organization monograph describes neomycin sulfate as an antiinfective drug.[2] Neomycin is active against certain bacteria in the gut, which is why it is used to reduce the number of bacteria in the digestive tract before colorectal surgery. The NHS Mid Yorkshire formulary lists neomycin sulphate tablets for gastroenterology and surgical prophylaxis after colorectal surgery.[4]
In the registered clinical trial, neomycin sulphate is given as a tablet taken by mouth. The trial uses Neomycin 500mg Tablets at a dose of 1 gram, given orally together with erythromycin tablets.[1] The pharmaceutical form recorded in the trial is a tablet, and the route of administration is oral.[1] In clinical practice, neomycin sulphate is also available in other forms. The Chesterfield Royal Hospital formulary lists neomycin sulphate in topical preparations for the skin, eye and ear, including creams, ointments and ear drops, often in combination with corticosteroids such as betamethasone, prednisolone or fluocinolone.[3] The Tayside Area Formulary lists Neomycin Sulphate 0.5% cream (Neomycin cream BPC) as a non-formulary topical preparation.[5]
One clinical trial is registered for neomycin sulphate in the EU Clinical Trials Information System. The trial, known as the SELDDEC Trial, is a Phase 2 randomised controlled trial with a planned enrolment of 322 participants.[1] It is currently authorised, meaning it has received regulatory approval to proceed but has not yet reported results.[1]
The trial enrols adults undergoing elective colorectal surgery. The study tests whether preoperative oral antibiotics, given in the absence of mechanical bowel preparation, reduce the incidence of surgical site infection.[1] Participants receive either neomycin 500 mg tablets plus erythromycin 250 mg tablets, both given as a 1 gram oral dose, or a comparison treatment.[1]
The primary outcome of the SELDDEC Trial is the incidence of surgical site infection after elective colorectal surgery.[1] The trial is interventional, meaning participants receive a treatment and are followed over time to see whether the rate of wound infections differs between groups.[1]
The sources provided do not include detailed side effect information for neomycin sulphate. The World Health Organization monograph describes the chemical and physical properties of the substance but does not list adverse effects.[2] The NHS formulary entries describe where neomycin sulphate is used but do not provide side effect data.[4][5][3]
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