Topical corticosteroid equivalency

A common mistake is to be too cautious about topical steroids. Some parents undertreat their children's eczema because of an unfounded fear of topical steroids. They may not apply the steroid as often as prescribed, or at the strength needed to clear the flare-up. This may actually lead to using more steroid in the long term, as the inflamed skin may never completely clear. So, you may end up applying a topical steroid on and off (perhaps every few days) for quite some time. The child may be distressed or uncomfortable for this period if the inflammation does not clear properly. A flare-up is more likely to clear fully if topical steroids are used correctly.

In summary, the three bioequivalence approaches that are currently consistently accepted by regulatory authorities are bioequivalence studies with clinical endpoints, in-vivo pharmacodynamic studies (in particular VCA for topical corticosteroid products), and waivers for topical solutions. Also, most require pharmacokinetic studies if there are safety concerns relating to systemic exposure. However, it is refreshing to see that the regulatory authorities are giving credence to alternative science-based methods for demonstration of bioequivalence, rather than insistence on clinical endpoint studies.

There is no evidence of safe and effective use of topical corticosteroids in pregnant mothers. Therefore, they should be used only if clearly needed. Long term use and large applications of topical corticosteroids may cause birth defects in the unborn. It is not known whether topical corticosteroids enter breast milk. Therefore, caution must be exercised before using it in nursing mothers. Topical corticosteroids should not be applied to the breasts of nursing mothers unless the mothers instructed to do so by the physician.

Cream, ointment, solution, gel, or lotion: Apply to affected area two to four times a day

Comments:
-Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions.
-If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy initiated.
-The safety and efficacy of drug use for longer than 4 weeks have not been established.

Use: Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses

Topical corticosteroid equivalency

topical corticosteroid equivalency

Cream, ointment, solution, gel, or lotion: Apply to affected area two to four times a day

Comments:
-Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions.
-If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy initiated.
-The safety and efficacy of drug use for longer than 4 weeks have not been established.

Use: Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses

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