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Steroids Topical Steroids, Topical Therapeutic Class Review (TCR) October 3, 2017 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]. October 2017 Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2004-2017 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, Pharm Div 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 Aqua 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; moderate to severe (Derma-Smoothe/FS®)7 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, Relief of inflammatory and pruritic manifestations of corticosteroid- (Synalar®)8 Medimetriks responsive dermatoses fluocinolone Solutech Relief of inflammatory and pruritic manifestations of corticosteroid- acetonide/Cetaphil® cleanser responsive dermatoses lotion** (Xilapak Kit)9 fluocinolone acetonide/urea* Solutech Relief of inflammatory and pruritic manifestations of corticosteroid- (NoxiPak Kit)10 responsive dermatoses hydrocortisone generic, Avidas, Relief of inflammatory and pruritic manifestations of corticosteroid- (Advanced Allergy Collection Arbor, BPI Labs, responsive dermatoses Kit, Ala-Cort®, Ala-Scalp®, Chattem Cons, Anti-Itch, Aqua Glycolic HC®, Crown Labs, CVS, Beta HC, Cortaid, Cortisone, Gentex/Marnel, Cortizone, Dermarest Insight, Merz, Eczema, Dermasorb™ HC, Mission, Ontos, Hydro Skin, MiCort™ HC, Person & Covey, Noble Formula HC, Nucort, Sebela, Reckitt Pediaderm™ HC, Scalacort®, Benck, Rite Aid Corp, Scalacort-DK® Kit, Scalpicin, Rugby, Valeant, Texacort®)11,12,13,14,15,16 Walgreens Medium Potency betamethasone dipropionate Promius Treatment of mild to moderate plaque psoriasis in patients 18 years (Sernivo™)17 of age or older betamethasone valerate generic, Prestium Relief of inflammatory and pruritic manifestations of corticosteroid- (Luxiq®)18 responsive dermatoses of the scalp betamethasone valerate19 generic Relief of inflammatory and pruritic manifestations of corticosteroid- responsive dermatoses *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 – October 2017 Page 2 | Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2004-2017 Magellan Rx Management. All Rights Reserved. FDA-Approved Indications (continued) Drug Manufacturer Indications Medium Potency (continued) clocortolone pivalate generic, Dr. Reddy, Relief of inflammatory and pruritic manifestations of corticosteroid- (Cloderm®)20 Promius responsive dermatoses fluocinolone acetonide generic, Relief of inflammatory and pruritic manifestations of corticosteroid- (Synalar®)21 Medimetriks responsive dermatoses flurandrenolide generic, Aqua Relief of inflammatory and pruritic manifestations of corticosteroid- (Cordran®)22,23 responsive dermatoses flurandrenolide Allergan Relief of inflammatory and pruritic manifestations of corticosteroid- (Cordran® Tape)24 responsive dermatoses fluticasone propionate generic, Sandoz Cream, Ointment: Relief of inflammatory and pruritic manifestations (Cutivate®)25 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, Valeant Treatment of mild to moderate atopic dermatitis in patients 3 (Locoid® / Lipocream)26 months to 18 years of age hydrocortisone probutate Pharmaderm/Sand Relief of inflammatory and pruritic manifestations of corticosteroid- (Pandel®)27 responsive dermatoses in patients 18 years of age and older hydrocortisone valerate28 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®)29 Sharpe & Dohme responsive dermatoses in patients 2 years of age or older prednicarbate generic, Valeant Relief of the inflammatory and pruritic manifestations of (Dermatop®)30 corticosteroid responsive dermatoses triamcinolone acetonide generic, Promius, Relief of inflammatory and pruritic manifestations of corticosteroid- (Dermasorb™ TA, Kenalog®, Ranbaxy/Sun, Crown responsive dermatoses Trianex™,Triderm®)31,32,33,34 Labs, Upsher-Smith triamcinolone generic, Genpak, Relief of inflammatory and pruritic manifestations of corticosteroid- acetonide/dimethicone International, responsive dermatoses (DermacinRx® Silapak, Nucare, Patchwerx, Dermawerx SDS, Nutria Rx, PureTek, Shoreline Sanadermrx, Sure Result Tac, Pak, Tri-Sila)35,36 triamcinolone acetonide/ Whyteman Labs dimethicone/ silicone (Whytederm TDPak, Whytederm Trilasil Pak)37 triamcinolone generic, PureTek acetonide/silicone (DermacinRx® Silazone™)38 triamcinolone generic, PureTek, acetonide/silicone Shoreline Pharma (Dermazone, Silazone-II™)39 Steroids, Topical Review – October 2017 Page 3 | Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2004-2017 Magellan Rx Management. All Rights Reserved. FDA-Approved Indications (continued) Drug Manufacturer Indications Medium Potency (continued) triamcinolone acetonide PureTek Relief of inflammatory and pruritic manifestations of corticosteroid- ointment/dimethicone (Ellzia responsive dermatoses Pak™)40 High Potency amcinonide41 generic Relief of inflammatory and pruritic manifestations of corticosteroid- betamethasone generic responsive dermatoses dipropionate42 Topicort topical spray: Only approved for treatment of plaque betamethasone dipropionate generic, Merck psoriasis in patients 18 years of age or older augmented lotion, cream (Diprolene, Diprolene® AF)43 desoximetasone (Topicort®, generic, Taro Topicort® topical spray)44,45 diflorasone diacetate cream generic (Apexicon E, Psorcon) 46 fluocinonide47 generic fluocinonide generic ,Valeant (Vanos™)48 halcinonide Ranbaxy/Sun (Halog®)49 triamcinolone acetonide generic, Crown Labs Triderm®)50,51,52,53 Very High Potency betamethasone dipropionate generic Relief of inflammatory and pruritic manifestations of corticosteroid- augmented gel, ointment responsive dermatoses (Diprolene AF54) clobetasol propionate generic, Galderma, Lotion: Relief of inflammatory and pruritic manifestations of (Clobex®, Clodan™ shampoo) Medimetrix corticosteroid-responsive dermatoses 55,56 Shampoo: Treatment of moderate to severe forms of scalp psoriasis Spray: Treatment of moderate to severe plaque psoriasis affecting up to 20% of body surface area clobetasol propionate generic, Sandoz, Cream, gel, ointment: Short-term treatment of inflammatory and (Cormax®, Valeant pruritic manifestations of corticosteroid-responsive dermatoses Temovate®)57,58 Solution: Short-term treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp diflorasone diacetate generic Relief of inflammatory and pruritic manifestations of corticosteroid- ointment59 responsive dermatoses clobetasol propionate generic, Prestium Short-term treatment of inflammatory and pruritic manifestations of (Olux®, Olux-E®)60 corticosteroid-responsive dermatoses of the scalp and short-term treatment of mild to moderate plaque psoriasis of non-scalp
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