Source: Registered Drug Product Database (NG) Revision Year: 2019 Publisher: Bliss GVS Pharma Ltd., 102, Hyde Park, Saki Vihar Road, Andheri (East), Mumbai - 400 072
Funbact A cream is contraindicated in patients with conditions such as rosacea, acne vulgaris, perioral dermatitis, perianal and genital pruritus, primary cutaneous viral infections, otitis externa and hypersensitivity to any component of the preparation.
Due to the known ototoxic and nephrotoxic potential of neomycin sulphate, use in large quantities or on large areas for prolonged periods of time is not recommended in circumstances where significant systemic absorption may occur.
Long-term continuous topical therapy should be avoided where possible, particularly in infants and children, as adrenal suppression, with or without clinical features of Cushing's syndrome, can occur even without occlusion. Bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressings, and the skin should be cleansed before a fresh dressing is applied.
Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses, development of tolerance, risk of generalised pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin. If used in psoriasis careful patient supervision is important. Extension of infection may occur due to the masking effect of the steroid. Following significant systemic absorption, aminoglycosides such as neomycin can cause irreversible ototoxicity; and neomycin has nephrotoxic potential. In renal impairment the plasma clearance of neomycin is reduced.
Following significant systemic absorption, neomycin sulphate can intensify and prolong the respiratory depressant effects of neuromuscular blocking agents.
There is little information to demonstrate the possible effect of topically applied betametasone, neomycin and clotrimazole in pregnancy and lactation. However, neomycin present in maternal blood can cross the placenta and may give rise to a theoretical risk of foetal toxicity, thus use of this medicinal product is not recommended in pregnancy or lactation.
None known.
Prolonged and intensive treatment with highly active corticosteroid preparations may cause local atrophic changes in the skin such as thinning, striae, and dilatation of the superficial blood vessels, particularly when occlusive dressings are used or when skin folds are involved.
In rare instances, treatment of psoriasis with corticosteroids (or its withdrawal) is thought to have provoked the pustular form of the disease.
There are reports of local skin burning, pruritus, pigmentation changes, allergic contact dermatitis and hypertrichosis with topical steroids.
None known.
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