Dermatologic topical corticosteroids

Rating : Rate It:
 
 
hindreen    on Dec 10, 2011 Says :

thanks
mogha    on Jun 29, 2011 Says :

thanksalot
Post a comment
    Post Comment on Twitter
Comments:  



  Notes
 
 
Slide 1 : OTC Dermatologic Topical Corticosteroids Michael L. Koenig, Ph.D. Interdisciplinary Scientist Division of Over-the-Counter Drug Products Center for Drug Evaluation and Research
Slide 2 : Overview Regulation of OTC Drugs Regulatory History of Hydrocortisone Current Labeling of Hydrocortisone
Slide 3 : Regulation of OTC Drugs NDA (New Drug Application) Drug product-specific Confidential Monograph Active ingredient-specific Public
Slide 4 : OTC Monographs OTC Drug Review initiated in 1972 > 200,000 OTC drug products 700 active ingredients in 26 therapeutic categories
Slide 5 : OTC Monographs Category I: GRASE (Generally Recognized as Safe and Effective) Category II: not GRASE Category III: cannot determine if safe and effective Advisory Review Panel
Slide 6 : OTC Monographs Category I: GRASE Category II: not GRASE Category III: cannot determine if safe and effective ANPR
Slide 7 : OTC Monographs ANPR TFM Comments
Slide 8 : OTC Monographs TFM Comments Data FM
Slide 9 : Regulatory History of Hydrocortisone
Slide 10 : Regulatory History of Hydrocortisone Introduced as Rx drug (1952) Rx-to-OTC switch rejected (1957) Failure to show safety for self-medication More testing on absorption through the skin Included with other active ingredients in review of external analgesics (1973-1978)
Slide 11 : Regulatory History of Hydrocortisone ANPR (1979) Lack of adverse local effects Striae Telangiectasia Pustular eruptions and crusting
Slide 12 : Regulatory History of Hydrocortisone ANPR (1979) Lack of systemic effects Percutaneous absorption Eosinophil count Urinary levels of 17-hydroxysteroids and 17-ketosteroids Blood glucose levels Serum sodium Plasma cortisol ? in response to insulin
Slide 13 : Regulatory History of Hydrocortisone No HPA Axis Suppression Munro and Clift, Br. J. Dermatol., 1973 (TAB 5) 40 patients with eczema, psoriasis Long term treatment (95% > 10 months) Corticosteroid combinations 10 included 1% hydrocortisone acetate 10/10: normal insulin stress response
Slide 14 : Regulatory History of Hydrocortisone Serious Adverse Events (1952-1973) 1960: Temporary growth retardation in 5.5 year old 1% hydrocortisone for 16 months 1962: Temporary growth retardation in infant 1% hydrocortisone twice daily for 6 months (total body) 1966: Rapid gain in body weight in 3-week old 0.25% hydrocortisone three times daily for 8.5 days 2100 mg/m2 body surface area
Slide 15 : Regulatory History of Hydrocortisone Panel Recommendations 0.25 – 0.5% hydrocortisone GRASE Recommended labeling: Indication – temporary relief of minor skin irritations, itching, and rashes due to eczema, dermatitis… Warnings Stop use if condition worsens or lasts > 7 days Do not use on children under 2 years of age Directions – Apply to affected area not more than 3 to 4 times daily
Slide 16 : Regulatory History of Hydrocortisone TFM (1983) FDA position Agreed 0.25 – 0.5% hydrocortisone GRASE Some labeling modifications Temporary relief of itching associated with minor skin irritations and rashes due to… Stop use if condition worsens or lasts > 7 days or if symptoms clear up and occur again within a few days
Slide 17 : Regulatory History of Hydrocortisone Amended TFM (1990) Citizen Petition requested increase in dosage strength to 1% Data and literature review 0.25 – 1.0% hydrocortisone GRASE Additional labeling modifications Do not use any other hydrocortisone product for the treatment of diaper rash
Slide 18 : Regulatory History of Hydrocortisone FM (20??) Pending Manufacturers generally comply with TFM and amended TFM Continuing review of data
Slide 19 : Hydrocortisone Does Not Suppress HPA Axis * Hydrocortisone acetate
Slide 20 : Current Labeling of Hydrocortisone
Slide 21 : Monograph Labeling: Hydrocortisone
Slide 22 : 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.
Slide 23 : 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

 


Related  Most Viewed

More By User

Flag as inappropriate

Free Medical Powerpoint Templates
Add as Friend flintoff     4 Years ago.

Category: Dermatology
Tags:
Embed:
2791 Views, 1 favourite
PowerPoint Slide Presentation on





Featured | Myworld | Browse | Patients | Popular | Latest | Tags | Conferences | Contact | Feedback | About Us | FAQ | RSS

Powerpoint Templates

Animated Powerpoint Templates | Business Powerpoint Templates | Education PPT |Mac PPT | Medical Powerpoint Templates |Powerpoint Maps | Technology PPT

copyright © www.SlideWorld.org