Dermatologic topical corticosteroids Dermatologic topical corticosteroids

OTC Dermatologic Topical Corticosteroids Michael L. Koenig, Ph.D. Interdisciplinary Scientist Division of Over-the-Counter Drug Products Center for Drug Evaluation and Research

Overview ,[object Object],[object Object],[object Object]

Regulation of OTC Drugs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

OTC Monographs ,[object Object],[object Object],[object Object]

OTC Monographs ,[object Object],[object Object],[object Object],Advisory Review Panel

OTC Monographs ,[object Object],[object Object],[object Object],ANPR

OTC Monographs Comments ANPR TFM

OTC Monographs Comments Data TFM FM

Regulatory History of Hydrocortisone

Regulatory History of Hydrocortisone ,[object Object],[object Object],[object Object],[object Object],[object Object]

Regulatory History of Hydrocortisone ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Regulatory History of Hydrocortisone ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Regulatory History of Hydrocortisone ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Regulatory History of Hydrocortisone ,[object Object],[object Object],[object Object],[object Object]

Hydrocortisone Does Not Suppress HPA Axis * Hydrocortisone acetate 7 8 14 10 9 n Ellison et al., 2000 Lucky et al., 1997 Patel et al., 1995 Marten et al., 1980 Munro, 1979 Published Study 0.5 – 17.7 years 1 28 days 2.5 3 - 10 years 1 28 days 1 14 days 1* Duration of Treatment Hydrocortisone (%)

Current Labeling of Hydrocortisone

Monograph Labeling: Hydrocortisone Warnings External use only Do not use ■ for the treatment of diaper rash. Consult a doctor. ■ in the genital area if you have a vaginal discharge. Consult a doctor. ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Active ingredient Purpose Hydrocortisone (1%)…………………………………………....Anti-itch Drug Facts Drug Facts (continued) When using this product ■ avoid contact with the eyes ■ do not exceed the recommended daily dosage unless directed by a doctor ■ do not cover treated skin ■ do not use any other hydrocortisone product ■ do not put directly in rectum using fingers or any mechanical device Directions ■ adults and children 2 years of age and older: a pply to affected area not more than 3 to 4 times daily. ■ children under 2 years of age: Do not use. Consult a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Stop use and ask a doctor if ■ condition worsens ■ symptoms persist for more than 7 days or clear up and occur again within a few days ■ rectal bleeding occurs

Monograph Labeling: Hydrocortisone temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to: ■ eczema ■ poison ivy, oak, sumac ■ insect bites ■ soaps ■ detergents ■ cosmetics ■ jewelry ■ seborrheic dermatitis ■ psoriasis ■ and for external genital or anal itching Stop use and ask a doctor if ■ symptoms persist for more than 7 days or clear up and occur again within a few days ■ apply to affected area not more than 3 to 4 times daily. ■ children under 2 years of age: Do not use. Consult a doctor. Warnings External use only Do not use ■ for the treatment of diaper rash. Consult a doctor. ■ in the genital area if you have a vaginal discharge. Consult a doctor. ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Active ingredient Purpose Hydrocortisone (1%)…………………………………………....Anti-itch Drug Facts Drug Facts (continued) When using this product ■ avoid contact with the eyes ■ do not exceed the recommended daily dosage unless directed by a doctor ■ do not cover treated skin ■ do not use any other hydrocortisone product ■ do not put directly in rectum using fingers or any mechanical device Directions ■ adults and children 2 years of age and older: a pply to affected area not more than 3 to 4 times daily. ■ children under 2 years of age: Do not use. Consult a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Stop use and ask a doctor if ■ condition worsens ■ symptoms persist for more than 7 days or clear up and occur again within a few days ■ rectal bleeding occurs

temporarily relieves itching of minor skin irritations, inflammation and rashes… symptoms persist for more than 7 days or clear up and occur again within a few days ■ apply to affected area not more than 3 to 4 times daily ■ children under 2 years of age: do not use, ask a doctor

Dermatologic topical corticosteroids Dermatologic topical corticosteroids

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