Dosage/Direction for Use
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.
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.
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).
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.
Renal impairment: Dose reduction may be required.
Special Populations: 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.
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.
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. Patient Counselling 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.
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.
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.
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.
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.
Nasal: Eye, nose, and ear drops: Store below 25°C. Protect from light and heat. Ophthalmic: Eye, nose, and ear drops: Store below 25°C. Protect from light and heat. Otic/Aural: Eye, nose, and ear drops: Store below 25°C. Protect from light and heat. Topical/Cutaneous: Cream or ointment: Store below 30°C.
S01BA06 - betamethasone ; Belongs to the class of corticosteroids. Used in the treatment of inflammation of the eye.
C05AA05 - betamethasone ; Belongs to the class of products containing corticosteroids for topical use. Used in the treatment of hemorrhoids and anal fissures.
A01AB08 - neomycin ; Belongs to the class of local antiinfective and antiseptic preparations. Used in the treatment of diseases of the mouth.
S03AA01 - neomycin ; Belongs to the class of antiinfectives used in ophthalmologic and otologic preparations.
H02AB01 - betamethasone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.
R02AB01 - neomycin ; Belongs to the class of antibiotics used in throat preparations.
S01CB04 - betamethasone ; Belongs to the class of corticosteroids/antiinfectives/mydriatics combinations. Used in the treatment of eye diseases.
D07XC01 - betamethasone ; Belongs to the class of potent (group III) corticosteroids in other combinations. Used in the treatment of dermatological diseases.
J01GB05 - neomycin ; Belongs to the class of other aminoglycosides. Used in the systemic treatment of infections.
R03BA04 - betamethasone ; Belongs to the class of other inhalants used in the treatment of obstructive airway diseases, glucocorticoids.
D07AC01 - betamethasone ; Belongs to the class of potent (group III) corticosteroids. Used in the treatment of dermatological diseases.
A07AA01 - neomycin ; Belongs to the class of antibiotics. Used in the treatment of intestinal infections.
B05CA09 - neomycin ; Belongs to the class of antiinfectives used as irrigating solutions.
D06AX04 - neomycin ; Belongs to the class of other topical antibiotics used in the treatment of dermatological diseases.
S02AA07 - neomycin ; Belongs to the class of antiinfectives used in the treatment of ear infections.
S01AA03 - neomycin ; Belongs to the class of antibiotics. Used in the treatment of eye infections.
A07EA04 - betamethasone ; Belongs to the class of corticosteroids acting locally. Used in the treatment of intestinal inflammation.
R01AD06 - betamethasone ; Belongs to the class of topical corticosteroids used for prophylaxis and treatment of allergic rhinitis.
S02BA07 - betamethasone ; Belongs to the class of corticosteroids used in the treatment of inflammation of the ear.
S03BA03 - betamethasone ; Belongs to the class of corticosteroids used in ophthalmologic and otologic preparations.