Ophthalmic Ocular inflammation with existing bacterial infection, Ocular inflammation with risk of bacterial infection
Adult: Available preparation:
Hydrocortisone 10 mg, neomycin 3.5 mg, and polymyxin B 10,000 units per mL of eye drop solution
Instil 1-2 drops into the affected eye(s) 3-4 hourly. May be given more frequently if necessary, depending on the severity of the condition.
Otic/Aural Otic infections, Otitis externa
Adult: Available preparations:
Hydrocortisone 10 mg, neomycin 3.5 mg, and polymyxin B 10,000 units per mL of ear drop suspension
Hydrocortisone 10 mg, neomycin 3,400 units, and polymyxin B 10,000 units per mL of ear drop solution
Instil 3-4 drops into the affected ear(s) 3-4 times daily. Alternatively, insert a gauze wick into the ear canal, keep it saturated with the solution for 24-48 hours. Max treatment duration: 10 consecutive days. Child: ≥3 years Instil 3 drops into the affected ear 3-4 times daily. Alternatively, insert a gauze wick into the ear canal, keep it saturated with the solution for 24-48 hours. Max treatment duration: 10 consecutive days.
Topical/Cutaneous Corticosteroid-responsive dermatoses with secondary infection
Adult: Available preparation:
Hydrocortisone 5 mg, neomycin 3.5 mg, and polymyxin B 10,000 units per g of cream
Apply a thin layer to affected area(s) 2-4 times daily. Elderly: Initiate at the lower end of the dosing range.
Special Patient Group
Pharmacogenomics:
Neomycin
Current evidence suggests that there is an increased risk of aminoglycoside-associated ototoxicity in patients with mitochondrial deoxyribonucleic acid (DNA) mutations in the 12S ribosomal ribonucleic acid (RNA) gene, particularly the m.1555A>G mutation, including patients with aminoglycoside serum levels within the recommended range. The estimated prevalence of this mutation in the general population is 0.2%. Some cases were also associated with a maternal history of deafness. Although mitochondrial mutations are rare, and penetrance is uncertain, genetic testing prior to initiation of recurrent or long-term treatment with aminoglycoside antibiotics may be considered but the testing should not delay urgently needed aminoglycoside treatment.
Furthermore, according to several studies, patients with mitochondrial mutations carrying the 1555G allele may have a greater risk of aminoglycoside-induced hearing loss, as compared to those with the 1555A allele. Other genetic and clinical factors may also influence the risk of aminoglycoside-induced hearing loss.
Renal Impairment
Otic/Aural
Dosage reduction may be necessary.
Contraindications
Hypersensitivity. Fungal, or viral infections (e.g. herpes simplex, vaccinia, and varicella) of the external auditory canal, ocular structures, and of the skin. Perforated tympanic membrane.
Special Precautions
Patient with glaucoma, or history of ocular herpes simplex. Renal impairment. Children and elderly. Pregnancy and lactation. Not intended for use over a wide area (topical) or for extended periods of time.
Adverse Reactions
Significant: Hypothalamic-pituitary-adrenal (HPA) axis suppression (particularly in younger children or in patients receiving high doses for prolonged periods); immunosuppression (e.g. secondary infection, fungal infection, prolonged viral infection, or limited response to vaccines); Kaposi sarcoma (prolonged treatment), neomycin sensitization (e.g. itching, reddening, oedema of the conjunctiva and eyelid, failure to heal); systemic effects (e.g. Cushing’s syndrome, hyperglycaemia, or glycosuria); ototoxicity (e.g. permanent sensorineural hearing loss due to cochlear damage); ocular effects (e.g. ocular hypertension and/or glaucoma, damage to the optic nerve, visual acuity and fields of vision defects, corneal and scleral thinning (leading to perforation), posterior subcapsular cataract formation, delayed healing or increased incidence of bleb formation following cataract surgery). Ear and labyrinth disorders: Rarely, stinging and burning sensation in the ears. Eye disorders: Eye irritation. Immune system disorders: Hypersensitivity. Skin and subcutaneous tissue disorders: Pruritus, skin irritation, burning sensation, xerosis, hypertrichosis, acneiform eruptions, folliculitis, skin hypopigmentation, allergic contact dermatitis, perioral dermatitis, maceration of the skin, striae, skin atrophy, and miliaria. Potentially Fatal: Rarely, anaphylaxis.
Monitor serum creatinine and BUN at baseline and periodically during chronic therapy. Perform eye examination (e.g. tonometry, slit-lamp exam) for changes in intraocular pressure and cataract formation, 2-3 weeks following onset of chronic therapy. Perform audiometry in symptomatic patients. Monitor for signs and symptoms of sensitization, skin atrophy, hypothalamic pituitary axis suppression and neurologic signs and symptoms of superinfection.
Drug Interactions
Neomycin and polymyxin B: May enhance the respiratory depressant effects of neuromuscular blocking agents (e.g. tubocurarine, succinylcholine).
Action
Description: Mechanism of Action: Hydrocortisone is a corticosteroid with both glucocorticoid and mineralocorticoid activity. It reduces inflammation by suppression of polymorphonuclear leukocytes migration and reversal of increased capillary permeability.
Neomycin is an aminoglycoside. It inhibits bacterial protein synthesis by binding to 30S ribosomal subunits of susceptible bacteria.
Polymyxin B is a bactericidal active against most gram-negative bacilli. It binds to cell membrane phospholipids, increases permeability, disrupting the bacterial cytoplasmic membrane permitting leakage of intracellular constituents, essential to bacterial existence. Pharmacokinetics: Absorption: Hydrocortisone: Absorbed percutaneously; extent is dependent on several factors (e.g. epidermal integrity, formulation and the use of occlusive dressings).
Neomycin: Poorly absorbed percutaneously. Time to peak plasma concentration: 1-4 hours.
Polymyxin B: Not absorbed. Distribution: Hydrocortisone: Crosses the placenta. Plasma protein binding: >90%.
Neomycin: Distributes to tissues and concentrates in renal cortex. Plasma protein binding: 0-30%.
Polymyxin B: Widely distributed and extensively bound to cell membranes in the tissues. Plasma protein binding: Approx 60%. Metabolism: Hydrocortisone: Metabolised in the liver and body tissue. Excretion: Hydrocortisone: Via urine (mainly as glucoronides, and as unchanged drug [small amount]). Elimination half-life: Approx 100 minutes.
Neomycin: Via urine (30-50% of absorbed drug as unchanged drug). Elimination half-life: 2-3 hours.
Polymyxin B: Via urine (approx 60% as unchanged drug). Elimination half-life: 6 hours.
Chemical Structure
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)
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)
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)
S03CA04 - hydrocortisone and antiinfectives ; Belongs to the class of combinations of corticosteroids and antiinfectives used in ophthalmologic and otologic preparations.
References
Gao Z, Chen Y, Guan MX. Mitochondrial DNA Mutations Associated with Aminoglycoside-Induced Ototoxicity. Journal of Otology. 2017;12(1):1-8. doi: 10.1016/j.joto.2017.02.001. Accessed 27/08/2021Tian Nguyen, Anita Jeyakumar. Genetic Susceptibility to Aminoglycoside Ototoxicity. International Journal of Pediatric Otorhinolaryngology. 2019 Feb;120(1):15-19. doi: 10.1016/j.ijporl.2019.02.002. Accessed 27/08/2021. PMID: 30743189Aminoglycosides (Gentamicin, Amikacin, Tobramycin, and Neomycin): Increased Risk of Deafness in Patients with Mitochondrial Mutations. Medicines & Healthcare products Regulatory Agency. https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency. Accessed 27/08/2021.Anon. Hydrocortisone (Ophthalmic). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 13/08/2021.Anon. Hydrocortisone (Topical). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 13/08/2021.Anon. Neomycin, Polymyxin B, and Hydrocortisone (Ophthalmic). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 13/08/2021.Anon. Neomycin, Polymyxin B, and Hydrocortisone (Otic). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 13/08/2021.Anon. Neomycin, Polymyxin B, and Hydrocortisone (Topical). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 13/08/2021.Anon. Neomycin. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 13/08/2021.Anon. Polymyxin B. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 13/08/2021.Buckingham R (ed). Hydrocortisone. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 13/08/2021.Buckingham R (ed). Neomycin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 13/08/2021.Buckingham R (ed). Polymyxin B Sulfate. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 13/08/2021.Clinical Annotation for rs267606617 (MT-RNR1); Amikacin, Aminoglycoside Antibacterials, Gentamicin, Kanamycin, Neomycin, Streptomycin or Tobramycin; Ototoxicity. Pharmacogenomics Knowledgebase (PharmGKB). https://www.pharmgkb.org. Accessed 27/08/2021.Cortisporin Cream (Physicians Total Care, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 13/08/2021.Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension (Sandoz Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 13/08/2021.Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension (Preferred Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 13/08/2021.Neomycin; Polymyxin B; Hydrocortisone. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 13/08/2021.Otosporin Ear Drops (Phoenix Labs). MHRA. https://products.mhra.gov.uk. Accessed 13/08/2021.Pocin H Ear Drops (Duopharma Manufacturing). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 13/08/2021.
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