Adult: Available preparation:
Betamethasone 0.1% w/v and neomycin 0.5% w/v nasal drops
For steroid-responsive cases: Instil 2-3 drops into each nostril bid or tid.
Ophthalmic Ocular inflammation with existing bacterial infection
Adult: Available preparation:
Betamethasone 0.1% w/v and neomycin 0.5% w/v eye drops
For steroid-responsive cases: Instil 1 or 2 drops to each affected eye up to 6 times daily according to clinical response.
Otic/Aural Otitis externa
Adult: Available preparation:
Betamethasone 0.1% w/v and neomycin 0.5% w/v ear drops
For steroid-responsive cases where prophylactic antibiotic treatment is also required: Instil 2-3 drops into the ear 3-4 times daily. Dosage recommendations may vary among countries and individual products (refer to specific product guidelines).
Topical/Cutaneous Corticosteroid-responsive dermatoses with secondary infection
Adult: Available preparations:
Betamethasone 1 mg and neomycin 5 mg per g of cream
Betamethasone 1 mg and neomycin 5 mg per g of ointment
As cream or ointment: Apply a small quantity onto the affected area bid or tid, or as directed. Once improvement occurs, maintain by applying once daily or even less often. Treatment must not be continued for more than 7 days, unless instructed otherwise. Child: ≥2 years Same as adult dose. Limit treatment to 5 days.
Special Patient Group
Pharmacogenomics:
Neomycin
Current studies suggest, individuals with mitochondrial deoxyribonucleic acid (DNA) mutations in the 12S ribosomal ribonucleic acid (RNA), particularly the m.1555A>G mutation, are at an increased risk of aminoglycoside-associated ototoxicity including those who had aminoglycoside serum levels within the recommended range. The m.1555A>G mutation is the most common mutation and occurs in families with maternally transmitted deafness. Although mitochondrial mutations are rare, and penetrance is uncertain, genetic testing may be considered before starting recurrent or long-term treatment with aminoglycoside antibiotics, but testing must not delay urgently needed treatment.
Additionally, studies show that patients who carry the 1555G allele may have a greater risk of aminoglycoside-induced hearing loss as compared to those patients with 1555A allele, although other genetic and clinical factors may increase this risk.
Renal Impairment
Topical:
Dose reduction may be required.
Contraindications
Hypersensitivity. Topical: Acne vulgaris, perianal and genital pruritus, perioral dermatitis, rosacea, primary cutaneous viral infections (e.g. chickenpox, herpes simplex); primary infected skin lesions caused by fungi or bacteria, primary or secondary infections due to yeast, secondary infections due to Pseudomonas or Proteus species; otitis externa (when the ear drum is perforated). Children <2 years. Prolonged use over a large area or in large quantities in circumstances where significant systemic absorption may occur. Eye, nose, and ear drops: Viral, fungal, tuberculous or purulent conditions of the eye; fungal infections of ear or nose; presence of glaucoma or possible herpetic keratitis (e.g. dendritic ulcer); perforated tympanic membrane.
Special Precautions
Patient with psoriasis. Withdraw use when there is a spread of infection. Avoid prolonged application on the face. Eye, nose, and ear drops: Patient with known m.1555A>G mitochondrial mutations, disease-causing thinning of eye layers, family history of increased eye pressure or ototoxicity, previous eye or nose surgery. Renal impairment. Children. Pregnancy and lactation.
Adverse Reactions
Significant: Adrenal suppression with or without clinical features of Cushing's syndrome (particularly in children or during prolonged use), increased risk of contact sensitisation (extended or recurrent application), local hypersensitivity reaction, atrophic changes in the skin (e.g. thinning, striae, dilatation of superficial blood vessels), ototoxicity, nephrotoxicity; visual disturbance (ophthalmic); growth retardation (nasal). Rarely, generalised pustular psoriasis. Ear and labyrinth disorders: Burning or stinging of the ear (otic). Eye disorders: Ophthalmic: Corneal ulceration, increased intraocular pressure leading to optic nerve damage, reduced visual acuity, visual field defect, mydriasis, ptosis, glaucoma, epithelial punctate keratitis; posterior subcapsular cataracts (intensive or prolonged use). Gastrointestinal disorders: Nasal: Nausea, disturbance to sense of taste. Nervous system disorders: Nasal: Headache, lightheadedness. Respiratory, thoracic and mediastinal disorders: Nasal: Sneezing, epistaxis, rebound congestion, nasal irritation and dryness, bronchial asthma, perforation or ulceration of nasal septum, parosmia, anosmia. Skin and subcutaneous tissue disorders: Local skin burning, pruritus, allergic contact dermatitis, hypertrichosis, changes in pigmentation.
Patient Counseling Information
Topical: Avoid smoking or going near naked flames after application due to the risk of severe burns. Wash fabrics (e.g. clothing, bedding, dressings) that has been in contact with this drug to reduce product build-up. Eye drops: This drug may cause transient blurred vision, if affected, do not drive or operate machinery. Remove contact lenses before administration and for a time following use.
Monitoring Parameters
Monitor growth in children.
Drug Interactions
Betamethasone: May increase the risk of systemic side effects with CYP3A4 inhibitors (e.g. ritonavir, itraconazole, cobicistat-containing products).
Neomycin: May enhance and prolong the respiratory depressant effects of neuromuscular blocking agents.
Action
Description: Mechanism of Action: Betamethasone, a topical corticosteroid, has anti-inflammatory, antiallergic, and antipruritic activity. It produces its anti-inflammatory effect via multiple mechanisms to inhibit late phase allergic reactions including reduction of the density of mast cells, chemotaxis and activation of eosinophils, cytokine production, and inhibition of arachidonic acid metabolism.
Neomycin, a broad-spectrum aminoglycoside antibacterial, is effective against majority of bacteria commonly associated with skin infections. It acts by binding to 30S ribosomal subunits thus interfering with the bacterial protein synthesis. Pharmacokinetics: Absorption: Betamethasone: May be absorbed from normal intact skin.
Neomycin: Absorbed from wounds and inflamed skin. Distribution: Betamethasone: Crosses the placenta (topical).
Neomycin: Distributed to tissues and concentrated in renal cortex. Metabolism: Betamethasone: Metabolised mainly by the liver. Excretion: Via the kidneys.
Neomycin: Half-life: 2-3 hours.
Chemical Structure
Betamethasone Source: National Center for Biotechnology Information. PubChem Database. Betamethasone, CID=9782, https://pubchem.ncbi.nlm.nih.gov/compound/Betamethasone (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)
Storage
Cream or ointment: Store below 30°C. Eye, nose, and ear drops: Store below 25°C. Protect from light and heat.
S01CA05 - betamethasone and antiinfectives ; Belongs to the class of corticosteroids in combination with antiinfectives. Used in the treatment of eye diseases. D07CC01 - betamethasone and antibiotics ; Belongs to the class of potent (group III) corticosteroids, in combination with antibiotics. Used in the treatment of dermatological diseases. S03CA06 - betamethasone and antiinfectives ; Belongs to the class of combinations of corticosteroids and antiinfectives used in ophthalmologic and otologic preparations.
References
Estivill X, Govea N, Barceló A et al. Familial Progressive Sensorineural Deafness Is Mainly Due to the mtDNA A1555G Mutation and Is Enhanced by Treatment with Aminoglycosides. The American Journal of Human Genetics. 1998;62(1):27-35. doi: 10.1086/301676. Accessed 02/07/2021Gao 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 02/07/2021Göpel W, Berkowski S, Preuss M et al. Mitochondrial mutation m.1555A>G as a risk factor for failed newborn hearing screening in a large cohort of preterm infants. BMC Pediatrics. 2014;14(1):210. doi: 10.1186/1471-2431-14-210. Accessed 02/07/2021Aminoglycosides (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 02/07/2021.Anon. Betamethasone (Topical). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 13/07/2021.Anon. Betamethasone and Neomycin. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 01/07/2021.Anon. Neomycin. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 13/07/2021.Betacin Eye/Ear Drops (Duopharma [M] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 01/07/2021.Betamethasone Valerate/Neomycin Sulphate 1 mg/5 mg/g Cream (Chemidex Pharma Limited). MHRA. https://products.mhra.gov.uk. Accessed 01/07/2021.Betamethasone Valerate/Neomycin Sulphate 1 mg/5 mg/g Ointment (Chemidex Pharma Limited). MHRA. https://products.mhra.gov.uk. Accessed 01/07/2021.Betnesol-N Eye, Ear and Nose Drops (RPH Pharmaceuticals, AB). MHRA. https://products.mhra.gov.uk. Accessed 01/07/2021.Betnovate-N Cream (GlaxoSmithKline Pharmaceutical Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 01/07/2021.Betnovate-N Cream (GlaxoSmithKline Sdn. Bhd.). MIMS Malaysia. http://www.mims.com/malaysia. Accessed 01/07/2021.Buckingham R (ed). Betamethasone. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/07/2021.Buckingham R (ed). Neomycin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/07/2021.Clinical Annotation for rs267606617 (MT-RNR1); Amikacin, Aminoglycoside Antibacterials, Gentamicin, Kanamycin, Neomycin, Streptomycin or Tobramycin; Ototoxicity. Pharmacogenomics Knowledgebase (PharmGKB). https://www.pharmgkb.org. Accessed 02/07/2021.Joint Formulary Committee. Betamethasone with Neomycin. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/07/2021.
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