Betnovate-N Special Precautions

Hypersensitivity: Betnovate-N cream should be used with caution in patients with a history of local hypersensitivity to betamethasone, neomycin or to any of the excipients of Betnovate-N cream. Local hypersensitivity reactions (see Adverse Reactions) may resemble symptoms of the condition under treatment.
Pseudomembranous colitis: Cases of mild to life-threatening pseudomembranous colitis have been reported in patients using antibiotics. Therefore, it is important to consider this diagnosis in patients developing diarrhoea during or after treatment with antibiotics. This is less likely to occur in the case of topical use of the medicinal product; however, if the patient has severe, persistent diarrhoea or experiences abdominal pain, the treatment should be discontinued immediately and the patient should undergo further diagnostic work-up.
Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression: Long-term treatment with Betnovate-N cream should be avoided where possible, particularly in children, due to the risk of reversible suppression of the HPA axis function and the occurrence of symptoms of Cushing's syndrome resulting from increased corticosteroid absorption. If these symptoms develop, the medicinal product should be discontinued gradually, or less potent corticosteroid should be used. Abrupt treatment withdrawal may result in glucocorticosteroid insufficiency (see Adverse Reactions).
Risk factors for increased corticosteroidal systemic effects are: High potency and formulation of topical steroid; Long-term exposure; Application to a large surface area of the body; Use on occluded areas of skin (e.g. on intertriginous areas or under occlusive dressings or nappies - in small children, nappies may act as an occlusive dressing); Increased hydration of the stratum corneum; Use on thin skin areas, e.g. the face; Use on broken skin or other conditions where the skin barrier may be impaired.
Psoriasis: Topical corticosteroids may have negative effects in psoriasis due to the risk of tolerance to the medicinal product, the risk of lesion worsening resulting from so-called rebounds once the product is discontinued, the risk of generalized pustular psoriasis, the risk of local or systemic toxicity associated with impaired barrier function of the skin (see Adverse Reactions), and the risk of local or systemic adverse reactions of corticosteroids, resulting from excessive absorption of the medicinal product through damaged skin.
The use of Betnovate-N cream in the treatment of psoriasis should be supervised by a doctor.
Medicinal product dilution: Antimicrobial medicinal products should not be diluted.
Hypersensitivity at the administration site: Prolonged or frequent use of Betnovate-N cream may increase the risk of skin hypersensitivity at the application site.
Ototoxicity and nephrotoxicity: Due to systemic absorption, aminoglycoside antibiotics, such as neomycin, may cause irreversible ototoxicity. Neomycin may have nephrotoxic effects (see Contraindications).
Renal impairment: In patients with renal impairment, the serum clearance of neomycin is decreased (see Dosage & Administration).
Application to the face: The face, more than other areas of the body, may exhibit atrophic changes after treatment with topical corticosteroids. This must be taken into consideration, particularly when treating psoriasis, lupus and severe eczema.
Application to the eyelids: Ensure that the product does not come into contact with the eyes and mucous membranes. Avoid applying the product to the eyelids as cataract and glaucoma may develop if the product enters conjunctival sac.
Visual disturbance: Visual disturbance may occur with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinophathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Infections: Skin infection may persist due to the masking effect of the corticosteroid. In case of secondary infection of inflammatory lesions treated with Betnovate-N cream, the corticosteroid should be discontinued and an agent with general antimicrobial properties should be administered.
Risk of bacterial infections under occlusive dressing: Bacterial infection is encouraged by the warm, moist conditions within skin folds or caused by occlusive dressings.
When the medicinal product is used under occlusive dressings, the skin should be cleansed before a dressing is applied as bacterial infection is encouraged by the warm, moist conditions caused by occlusive dressings.
Leg ulcers: Topical corticosteroids are sometimes used to treat the dermatitis around chronic leg ulcers. However, this use may be associated with a higher incidence of local hypersensitivity reactions and an increased risk of local infection.
If the patient develops irritation or hypersensitivity reactions, the medicinal product should be discontinued.
Due to the content of cetostearyl alcohol, the medicinal product may cause a local skin reaction (e.g. contact dermatitis).
Due to the content of chlorocresol, the medicinal product may cause allergic reactions.
Effects on ability to drive and use machines: No effects have been demonstrated.
Use in Children: In comparison with adults, children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects. Long-term corticosteroid therapy should be avoided in children younger than 12 years due to the risk of HPA axis suppression.