Hypersensitivity: BETNOVATE-N should be used with caution in patients with a history of local hypersensitivity to betamethasone, neomycin or to any of the excipients in the preparation. Local hypersensitivity reactions (see Adverse Reactions) may resemble symptoms of the condition under treatment.
Pseudomembranous colitis: Pseudomembranous colitis has been reported with the use of antibiotics and may range in severity from mild to life-threatening. Therefore, it is important to consider its diagnosis in patients who develop diarrhoea during or after antibiotic use. Although this is less likely to occur with topically applied BETNOVATE-N. If prolonged or significant diarrhoea occurs or the patient experiences abdominal cramps, treatment should be discontinued immediately and the patients investigated further.
Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression: Manifestations of hypercortisolism (Cushing's syndrome) and reversible hypothalamic-pituitary-adrenal (HPA) axis suppression can occur in some individuals as a result of increased systemic absorption of topical corticosteroids. If either of the above are observed, withdraw the drug gradually by reducing the frequency of application, or by substituting a less potent corticosteroid. Abrupt withdrawal of treatment may result in glucocorticosteroid insufficiency (see Adverse Reactions).
Risk factors for increased corticosteroidal systemic effects are: Potency and formulation of topical corticosteroid; Duration of exposure; Application to a large surface area; Use on occluded areas of skin (e.g. on intertriginous areas or under occlusive dressings (napkins may act as an occlusive dressing); Increasing hydration of the stratum corneum; Use on thin skin areas such as the face; Use on broken skin or other conditions where the skin barrier may be impaired.
Visual disturbances: Visual disturbance has been reported by patients using systemic and / or topical corticosteroids. If a patient has blurred vision or other visual disturbances, consider evaluation of possible causes which may include cataract, glaucoma or central serous chorioretinopathy.
Dilution: Products which contain antimicrobial agents should not be diluted.
Contact sensitisation: Extended or recurrent application of BETNOVATE-N may increase the risk of contact sensitisation.
Ototoxicity and nephrotoxicity: Following significant systemic absorption, aminoglycosides such as neomycin can cause irreversible ototoxicity. Neomycin has nephrotoxic potential.
Renal impairment: In renal impairment the plasma clearance of neomycin is reduced (see Dosage & Administration).
Application to the face: Prolonged application to the face is undesirable as this area is more susceptible to atrophic changes.
Application to the eyelids: If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as cataract and glaucoma might result from repeated exposure.
Infection: Extension of infection may occur due to the masking effect of the steroid. Any spread of infection requires withdrawal of topical corticosteroid therapy and administration of appropriate systemic antimicrobial therapy.
Infection risk with occlusion: Bacterial infection is encouraged by the warm, moist conditions within skin folds or induced by occlusive dressings. When using occlusive dressings, the skin should be cleansed before a fresh dressing is applied.
Chronic leg ulcers: Topical corticosteroids are sometimes used to treat the dermatitis around chronic leg ulcers. However, this use may be associated with a higher occurrence of local hypersensitivity reactions and an increased risk of local infection.
Effects on Ability to Drive and Use Machines: There have been no studies to investigate the effect of BETNOVATE-N on driving performance or the ability to operate machinery. A detrimental effect on such activities would not be anticipated from the adverse reaction profile of topical BETNOVATE-N.
Use in children: In comparison with adults, children and infants may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects. This is because children have an immature skin barrier and a greater surface area to body weight ratio compared with adults.
In children under 12 years of age, long-term continuous topical corticosteroid therapy should be avoided where possible, as adrenal suppression can occur.