Polymyxin B + Neomycin + Hydrocortisone


Generic Medicine Info
Indications and Dosage
Otic/Aural
Otitis externa
Adult: Available preparation
Polymyxin B 10,000 units/mL, neomycin 3,400 units/mL and hydrocortisone 10 mg/mL
Instill 3 drops into affected ear(s) 3-4 times daily. Alternatively, insert a gauze wick into the canal and keep it saturated with the solution for 24-48 hours. Discontinue if there is no clinical improvement after 7 days.
Child: ≥3 years Same as adult dose.
Renal Impairment
Dosage reduction may be necessary.
Incompatibility
Polymyxin B: Inactivated by strong acids and alkalis.
Contraindications
Hypersensitivity to polymyxin B, neomycin and hydrocortisone and other aminoglycosides. Perforated tympanic membrane, untreated viral, fungal and tubercular infections. Children <3 years.
Special Precautions
Patient with conditions where significant systemic absorption may occur, venous stasis eczema and ulceration, pre- and post-operative period. Prolonged use. Children. Pregnancy and lactation.
Adverse Reactions
Significant: Irreversible ototoxicity (e.g. deafness), nephrotoxicity, neurotoxicity, neomycin sensitisation (e.g. itching, reddening, oedema, failure to heal), immunosuppression, Kaposi sarcoma, and suppression of the pituitary-adrenal (HPA) axis after systemic absorption.
Ear and labyrinth disorders: Stinging, burning sensation in ears.
Potentially Fatal: Pseudomembranous colitis.
Ophth/Otic/Topical: C
Drug Interactions
Neomycin and polymyxin may increase risk of respiratory depression with neuromuscular blocking agents.
Action
Description: Polymyxin B is a bactericidal active against a wide range of gram negative bacilli. It binds to acid phospholipids in the bacterial cytoplasmic membrane, thereby altering permeability and disrupting the osmotic barrier leading to cell death.
Neomycin, an aminoglycoside, is a bactericidal active against a wide range of gram positive and gram negative bacteria. It interferes with bacterial protein synthesis by binding to 30S ribosomal subunits.
Hydrocortisone is a corticosteroid with both glucocorticoid and weak mineralocorticoid activity.  It reduces inflammatory response by suppression of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability.
Pharmacokinetics:
Absorption: Hydrocortisone: Absorbed through the skin particularly denuded areas.
Distribution: Polymyxin B: Widely distributed and extensively bound to cell membranes in the tissues. Plasma protein binding: Approx 60%.
Neomycin: Distributed to tissues, concentrated in renal cortex.
Hydrocortisone: Crosses placenta. Plasma-protein binding: >90%.
Metabolism: Hydrocortisone: Metabolised in the liver and tissues.
Excretion: Polymyxin B: Via urine. Elimination half-life: Approx 6 hour.
Neomycin: Via urine. Elimination half-life: 2-3 hour.
Hydrocortisone: Mainly via urine (mostly as conjugated glucuronide), with small amounts as unchanged drug. Plasma elimination half-life: Approx 100 minutes.
Chemical Structure

Chemical Structure Image
Polymyxin B

Source: National Center for Biotechnology Information. PubChem Database. Polymyxin b, CID=49800004, https://pubchem.ncbi.nlm.nih.gov/compound/Polymyxin-b (accessed on Jan. 21, 2020)


Chemical Structure Image
Neomycin

Source: National Center for Biotechnology Information. PubChem Database. Neomycin, CID=8378, https://pubchem.ncbi.nlm.nih.gov/compound/Neomycin (accessed on Jan. 21, 2020)


Chemical Structure Image
Hydrocortisone

Source: National Center for Biotechnology Information. PubChem Database. Hydrocortisone, CID=5754, https://pubchem.ncbi.nlm.nih.gov/compound/Hydrocortisone (accessed on Jan. 21, 2020)

Storage
Store below 25°C. Protect from light.
References
Anon. Hydrocortisone (Topical). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 23/01/2018.

Anon. Neomycin, Polymyxin B, and Hydrocortisone (Otic). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 22/01/2018.

Anon. Neomycin. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 23/01/2018.

Anon. Polymyxin B. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 23/01/2018.

Buckingham R (ed). Hydrocortisone. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/12/2017.

Buckingham R (ed). Neomycin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/12/2017.

Buckingham R (ed). Polymyxin B Sulfate. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/12/2017.

Joint Formulary Committee. Hydrocortisone with Neomycin and Polymyxin B Sulfate. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/12/2017.

Otosporin Ear Drops (Phoenix Labs). MHRA. https://products.mhra.gov.uk/. Accessed 01/12/2017.

Disclaimer: This information is independently developed by MIMS based on Polymyxin B + Neomycin + Hydrocortisone from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 MIMS. All rights reserved. Powered by MIMS.com
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