Betno N^®

Betno N cream is a preparation of Betamethasone Valerate and Neomycin Sulfate. Betamethasone Valerate is a potent topical corticosteroid. Topical corticosteroids have anti-inflammatory, antipruritic and vasoconstrictive actions. Neomycin Sulfate is a broad-spectrum bactericidal antibiotic effective against the majority of bacteria commonly associated with skin infections.

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Betno N cream is indicated for the treatment of atopic dermatitis, nummular dermatitis (discoid eczema), prurigo nodularis, psoriasis (excluding widespread plaque psoriasis), lichen simplex chronicus (neurodermatitis) and lichen planus, seborrhoeic dermatitis, irritant or allergic contact dermatitis, insect bite reactions, miliaria (prickly heat), anal and genital intertrigo and otitis externa.

Route of administration: Betno N cream is for topical use only.

Adults and adolescents
Apply thinly and gently rub in using only enough to cover the entire affected area once or twice daily for up to seven days, then change to another corticosteroid preparation not containing neomycin sulfate if further treatment is required. Allow adequate time for absorption after each application before applying an emollient.
Children aged 2 years and above
This cream is suitable for use in children (2 years and above) at the same dose as adults. Children are more likely to develop local and systemic side effects of topical corticosteroids and in general, require shorter courses and less potent agents than adult.

Use in pregnancy

Use of this cream is not recommended in pregnancy and lactation.

Use in children and adolescents
Safety and effectiveness has not been established in children less than 2 years of age.

Manifestations of hypercortisolism (Cushing’s syndrome) and reversible hypothalamic-pituitary-adrenal (HPA) axis suppression can occur. On that case, the drug should be withdrawn gradually by reducing the frequency of application. Careful supervision is important if this cream is used in psoriasis. Following significant systemic absorption, aminoglycosides such as neomycin can cause irreversible ototoxicity. Extension of infection may occur due to the masking effect of the steroid. Dose should be reduced in patients with reduced renal function.

Most common side effects are pruritus and local skin burning or pain of skin. Other side effects include allergic contact dermatitis, erythema, rash, urticaria, pustular psoriasis, skin dryness and pigmentation changes.

This cream is contraindicated to patients with known hypersensitivity to betamethasone, neomycin or any other components of this cream. The cream should not be used in rosacea, acne vulgaris, perioral dermatitis, pruritus without inflammation, perianal and genital pruritus, primary cutaneous viral infections, primary infected skin lesions caused by infection with fungi or bacteria, primary or secondary infections due to yeasts, secondary infections due to Pseudomonas or Proteus species and otitis externa when the ear drum is perforated, because of the risk of ototoxicity.

Drug interaction with medication: 

Co-administered drugs that can inhibit CYP3A4 (e.g. ritonavir, itraconazole) have been shown to inhibit the metabolism of corticosteroids leading to increased systemic exposure. Following significant systemic absorption, neomycin sulfate can intensify and prolong the respiratory depressant effects of neuromuscular blocking agents. Possibility of cumulative toxicity should be considered when neomycin sulfate is applied topically in combination with systemic aminoglycoside therapy.

In the case of chronic overdose or misuse, the features of hypercortisolism may occur. Topical corticosteroids should be withdrawn gradually by reducing the frequency of application or by substituting a less potent corticosteroid.

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Each gram cream contains Betamethasone 1 mg as Betamethasone Valerate BP and Neomycin Sulfate BP 5 mg.

Storage
Store in a cool (below 25ºC) and dry place protected from light. Keep away from the reach of children.

Packing
Betno® N cream: Tube of 15 g.