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Steroids, Topical Therapeutic Class Review Steroids, Topical Therapeutic Class Review (TCR) May 14, 2019 No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, digital scanning, or via any information storage or retrieval system without the express written consent of Magellan Rx Management. All requests for permission should be mailed to: Magellan Rx Management Attention: Legal Department 6950 Columbia Gateway Drive Columbia, Maryland 21046 The materials contained herein represent the opinions of the collective authors and editors and should not be construed to be the official representation of any professional organization or group, any state Pharmacy and Therapeutics committee, any state Medicaid Agency, or any other clinical committee. This material is not intended to be relied upon as medical advice for specific medical cases and nothing contained herein should be relied upon by any patient, medical professional or layperson seeking information about a specific course of treatment for a specific medical condition. All readers of this material are responsible for independently obtaining medical advice and guidance from their own physician and/or other medical professional in regard to the best course of treatment for their specific medical condition. This publication, inclusive of all forms contained herein, is intended to be educational in nature and is intended to be used for informational purposes only. Send comments and suggestions to [email protected]. May 2019 Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2004–2019 Magellan Rx Management. All Rights Reserved. FDA-APPROVED INDICATIONS Drug Manufacturer Indications Low Potency alclometasone dipropionate1 generic Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses desonide (Desonate)2 Bayer Treatment of mild to moderate atopic dermatitis in patients 3 months of age and older desonide (Desowen®)3 generic, Galderma Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses desonide (Tridesilon™)4 Encore Dermatology Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses desonide (Verdeso™)5 Almirall Treatment of mild to moderate atopic dermatitis fluocinolone acetonide Galderma Treatment of seborrheic dermatitis of the scalp (Capex® Shampoo)6 fluocinolone acetonide generic, Royal Body oil: treatment of atopic dermatitis in adults; (Derma-Smoothe/FS®)7 moderate to severe atopic dermatitis in patients 3 months and older for up to 4 weeks Scalp oil: treatment of psoriasis of the scalp in adult patients fluocinolone acetonide generic, Medimetriks Relief of inflammatory and pruritic manifestations of (Synalar®, Synalar TS)8,9 corticosteroid-responsive dermatoses fluocinolone acetonide/Cetaphil® Solutech Relief of inflammatory and pruritic manifestations of cleanser lotion** corticosteroid-responsive dermatoses (Xilapak Kit)10 fluocinolone acetonide/ urea* Solutech Relief of inflammatory and pruritic manifestations of (NoxiPak Kit)11 corticosteroid-responsive dermatoses hydrocortisone generic, Avidas, Relief of inflammatory and pruritic manifestations of (Advanced Allergy Collection Kit, Ala- BPI Labs, Chain Drug, corticosteroid-responsive dermatoses Cort®, Ala-Scalp®, Aquanil, Anti-Itch, Chattem Cons, Crown Aqua Glycolic HC® Kit, Beta HC, Labs, CVS, Equaline, Cortaid, Cortisone, Cortizone, Insight, Kroger, Merz, Dermarest Eczema, Dermasorb™ HC Mission, Ontos, Complete Kit, GS Anti-Itch, MiCort™ Perrigo/Goodsen, Person HC, Noble Formula HC, QC Anti-Itch, & Covey, Pharmaceutical Scalacort®, Scalacort-DK® Kit, Scalp Specialties, Publix, Sebela, Relief, Scalpicin, Soothing Care, Reckitt Benck, Rite Aid Texacort®, Vanicream) 12, 13, 14, 15, 16 Corp, Target, Valeant/Bausch, Walgreens hydrocortisone/aloe vera (Cortisone- generic, CVS, Chain Drug, For the temporary relief of itching associated with 10, Cortisone Plus Aloe, Nucort, QC Chattem Cons, minor skin irritations, inflammation and rashes due to Anti-Itch with Aloe, SM Gentex/Marnel, Sunmark eczema, insect bites, poison ivy, poison oak, poison Hydrocortisone-Aloe, SM sumac, soaps, detergents, cosmetics, jewelry, Hydrocortisone Plus)17,18,19 seborrheic dermatitis, psoriasis, and external anal/genital itching. *Urea 20% cream is co-packaged with fluocinolone acetonide 0.01% as part of the NoxiPak Kit. It is used as a keratolytic. **Cetaphil cleanser lotion is co-packaged with fluocinolone acetonide 0.01% as part of the Xilapak Kit. It is used as a cleanser. Steroids, Topical Review – May 2019 Page 2 | Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2004–2019 Magellan Rx Management. All Rights Reserved. FDA-Approved Indications (continued) Drug Manufacturer Indications Medium Potency betamethasone dipropionate generic Relief of inflammatory and pruritic manifestations of corticosteroid- cream, lotion20,21 responsive dermatoses in patients 13 years and older betamethasone dipropionate Promius Treatment of mild to moderate plaque psoriasis in patients 18 years (Sernivo™)22 of age or older betamethasone valerate generic, Mylan, Relief of inflammatory and pruritic manifestations of corticosteroid- (Luxiq®)23 responsive dermatoses of the scalp betamethasone valerate24 generic Relief of inflammatory and pruritic manifestations of corticosteroid- responsive dermatoses clocortolone pivalate Dr. Reddy*, Relief of inflammatory and pruritic manifestations of corticosteroid- (Cloderm®)25 Promius responsive dermatoses fluocinolone acetonide generic, Relief of inflammatory and pruritic manifestations of corticosteroid- (Synalar®)26 Medimetriks responsive dermatoses flurandrenolide generic, Aqua, Relief of inflammatory and pruritic manifestations of corticosteroid- (Cordran®, Nolix™)27,28,29,30 Artesa responsive dermatoses flurandrenolide Allergan Relief of inflammatory and pruritic manifestations of corticosteroid- (Cordran® Tape)31 responsive dermatoses fluticasone propionate generic, Sandoz Cream, Ointment: Relief of inflammatory and pruritic manifestations (Cutivate®)32,33,34 of corticosteroid-responsive dermatoses and atopic dermatitis Lotion: Relief of the inflammatory and pruritic manifestations of atopic dermatitis in patients 3 months of age and older hydrocortisone butyrate generic, Treatment of mild to moderate atopic dermatitis in patients 3 (Locoid® / Lipocream)35 Valeant/Bausch months to 18 years of age hydrocortisone probutate Pharmaderm/Sand Relief of inflammatory and pruritic manifestations of corticosteroid- (Pandel®)36 responsive dermatoses in patients 18 years of age and older hydrocortisone valerate37 generic Relief of inflammatory and pruritic manifestations of corticosteroid- responsive dermatoses in adult patients mometasone furoate generic, Merck Relief of inflammatory and pruritic manifestations of corticosteroid- (Elocon®)38 Sharpe & Dohme responsive dermatoses in patients 2 years of age or older prednicarbate generic, Relief of the inflammatory and pruritic manifestations of (Dermatop®)39 Valeant/Bausch corticosteroid responsive dermatoses triamcinolone acetonide generic, Promius, Relief of inflammatory and pruritic manifestations of corticosteroid- (Dermasorb™ TA, Kenalog®, Ranbaxy/Sun, responsive dermatoses Trianex™,Triderm®)40,41,42,43 Crown Labs, Upsher-Smith *Available as authorized generic (AG). Steroids, Topical Review – May 2019 Page 3 | Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2004–2019 Magellan Rx Management. All Rights Reserved. FDA-Approved Indications (continued) Drug Manufacturer Indications Medium Potency (continued) triamcinolone generic, Genpak, Relief of inflammatory and pruritic manifestations of acetonide/dimethicone International, Nucare, corticosteroid-responsive dermatoses (DermacinRx® Silapak, Patchwerx, PureTek, Dermawerx SDS, Nutria Rx, Shoreline Sanadermrx, Sure Result Tac, Pak, Tri-Sila) 44, 45 triamcinolone acetonide/ Whyteman Labs dimethicone/silicone (Whytederm TDPak, Whytederm Trilasil Pak)46 triamcinolone generic, PureTek acetonide/silicone (DermacinRx® Silazone™)47 triamcinolone generic, PureTek acetonide/silicone (Dermazone, Silazone-II™)48, 49 triamcinolone Shoreline acetonide/silicone (Silalite Pak™)50 triamcinolone acetonide PureTek Relief of inflammatory and pruritic manifestations of ointment/dimethicone corticosteroid-responsive dermatoses (Ellzia Pak™)51 High Potency amcinonide52 generic Relief of inflammatory and pruritic manifestations of betamethasone dipropionate generic corticosteroid-responsive dermatoses in patients 13 years and ointment53 older betamethasone dipropionate generic, Merck augmented cream (Diprolene® AF)54 clobetasol propionate Encore/Promius Treatment of moderate to severe plaque psoriasis in patients 18 (Impoyz™)55 years of age and older desoximetasone (Topicort®, generic, Taro Relief of inflammatory and pruritic manifestations of Topicort® topical spray)56,57 corticosteroid-responsive dermatoses diflorasone diacetate cream Sandoz, Taro (Apexicon® E, Psorcon®) 58,59 Topicort topical spray: Only approved for treatment of plaque psoriasis in patients 18 years of age or older fluocinonide60 generic fluocinonide generic ,Valeant (Vanos™)61 halcinonide Ranbaxy/Sun (Halog®)62 triamcinolone acetonide generic, Crown Labs (Triderm®)63,64,65,66 Steroids, Topical Review – May 2019 Page 4 | Proprietary Information. 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