Topical Corticosteroids in Clinical Practice
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Clinical Policy: Topical Agents: Corticosteroids
Clinical Policy: Topical Agents: Corticosteroids Reference Number: OH.PHAR.PPA.92 Effective Date: 01/01/2020 Revision Log Last Review Date: Line of Business: Medicaid See Important Reminder at the end of this policy for important regulatory and legal information. Description TOPICAL AGENTS: CORTICOSTEROIDS – LOW POTENCY NO PA REQUIRED “PREFERRED” PA REQUIRED “NON- PREFERRED” DESONIDE cream, ointment (generic of Desowen®) ALCLOMETASONE cream, ointment (generic of FLUOCINOLONE ACETONIDE 0.01% cream, solution Aclovate®) (generic of Synalar®) CAPEX® shampoo (fluocinolone acetonide) FLUOCINOLONE body oil, scalp oil (generic of Derma- DESONATE®gel (desonide) Smoothe/ FS®) DESONIDE lotion (generic of Desowen®) HYDROCORTISONE cream, lotion, ointment HYDROCORTISONE ACETATE WITH ALOE gel HYDROCORTISONE WITH UREA cream (generic of Carmol HC®) PANDEL® cream (hydrocortisone probutate) PEDIADERM HC® kit TOPICAL AGENTS: CORTICOSTEROIDS – MEDIUM POTENCY NO PA REQUIRED “PREFERRED” PA REQUIRED “NON--PREFERRED” BETAMETHASONE DIPROPIONATE-CALCIPOTRIENE BETAMETHASONE DIPROPIONATE lotion (generic of Ointment Diprolene®) BETAMETHASONE VALERATE cream, lotion (generic of CLOCORTOLONE PIVALATE (generic of Cloderm®) Valisone®) CORDRAN® tape (flurandrenolide) FLUTICASONE PROPIONATE cream, ointment (generic of DESOXIMETASONE cream, gel, ointment (generic of Cutivate®) Topicort®) MOMETASONE FUROATE cream, ointment, solution FLUOCINOLONE ACETONIDE 0.025% cream, ointment (generic of Elocon®) (generic of Synalar®) PREDNICARBATE cream (generic of Dermatop®) FLUTICASONE -
Steroids Topical
Steroids, Topical Therapeutic Class Review (TCR) September 18, 2020 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]. September -
Triamcinolone Acetonide Cream USP, 0.025%, 0.1%, 0.5% for Dermatologic Use Only Not for Ophthalmic Use Rx Only
TRIAMCINOLONE ACETONIDE- triamcinolone acetonide cream Padagis Israel Pharmaceuticals Ltd ---------- Triamcinolone Acetonide Cream USP, 0.025%, 0.1%, 0.5% For Dermatologic Use Only Not For Ophthalmic Use Rx Only DESCRIPTION The topical corticosteroids constitute a class of primarily synthetic steroids used as anti- inflammatory and anti-pruritic agents. Triamcinolone acetonide is designated chemically as pregna-1,4-diene-3,20-dione,9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene) bis (oxy)]-,(11ß,16α)-. C24H31FO6, and M.W. of 434.51; CAS Reg. No. 76-25-5. Each gram of 0.025%, 0.1% and 0.5% Triamcinolone Acetonide Cream USP contains 0.25 mg, 1 mg, or 5 mg triamcinolone acetonide respectively, in a washable cream base of cetyl alcohol, cetyl esters wax, glycerin, glyceryl monostearate, isopropyl palmitate, polysorbate-60, propylene glycol, purified water, sorbic acid, and sorbitan monostearate. CLINICAL PHARMACOLOGY Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. Pharmacokinetics - The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. -
Summary of Product Characteristics
Health Products Regulatory Authority Summary of Product Characteristics 1 NAME OF THE MEDICINAL PRODUCT Audaval 0.1% Ointment 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One gram of ointment contains 1 mg of betamethasone (0.1% w/w) as valerate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Ointment Opaque ointment. 4 CLINICAL PARTICULARS 4.1 Therapeutic Indications Audaval preparations are indicated for the treatment of: eczema in children over 1 year elderly and adults; including atopic and discoid eczemas; prurigo nodularis; psoriasis (excluding widespread plaque psoriasis); neurodermatoses, including lichen simplex, lichen planus; seborrhoeic dermatitis; contact sensitivity reactions; discoid lupus erythematosus and they may be used as an adjunct to systemic steroid therapy in generalised erythroderma. In general, ointment preparations are particularly appropriate for dry, lichenified or scaly skin conditions whereas a cream preparation may be more suitable in the case of moist or weeping lesions. 4.2 Posology and method of administration For topical use only. If no improvement is seen after two to four weeks, the diagnosis should be reconsidered and specialist referral may be necessary. Adults, adolescents and the elderly A small quantity of Audaval should be applied to the affected area one to three times daily as directed by physician until improvement occurs. It may then be possible to maintain improvement by applying once a day, or even less often, or by using the appropriate ready diluted (1 in 4) preparation, Audaval RD 0.025% Ointment. Allow adequate time for absorption after each application before applying an emollient. If no improvement is seen within two to four weeks, reassessment of the diagnosis, or referral, may be necessary. -
St John's Institute of Dermatology
St John’s Institute of Dermatology Topical steroids This leaflet explains more about topical steroids and how they are used to treat a variety of skin conditions. If you have any questions or concerns, please speak to a doctor or nurse caring for you. What are topical corticosteroids and how do they work? Topical corticosteroids are steroids that are applied onto the skin and are used to treat a variety of skin conditions. The type of steroid found in these medicines is similar to those produced naturally in the body and they work by reducing inflammation within the skin, making it less red and itchy. What are the different strengths of topical corticosteroids? Topical steroids come in a number of different strengths. It is therefore very important that you follow the advice of your doctor or specialist nurse and apply the correct strength of steroid to a given area of the body. The strengths of the most commonly prescribed topical steroids in the UK are listed in the table below. Table 1 - strengths of commonly prescribed topical steroids Strength Chemical name Common trade names Mild Hydrocortisone 0.5%, 1.0%, 2.5% Hydrocortisone Dioderm®, Efcortelan®, Mildison® Moderate Betamethasone valerate 0.025% Betnovate-RD® Clobetasone butyrate 0.05% Eumovate®, Clobavate® Fluocinolone acetonide 0.001% Synalar 1 in 4 dilution® Fluocortolone 0.25% Ultralanum Plain® Fludroxycortide 0.0125% Haelan® Tape Strong Betamethasone valerate 0.1% Betnovate® Diflucortolone valerate 0.1% Nerisone® Fluocinolone acetonide 0.025% Synalar® Fluticasone propionate 0.05% Cutivate® Hydrocortisone butyrate 0.1% Locoid® Mometasone furoate 0.1% Elocon® Very strong Clobetasol propionate 0.1% Dermovate®, Clarelux® Diflucortolone valerate 0.3% Nerisone Forte® 1 of 5 In adults, stronger steroids are generally used on the body and mild or moderate steroids are used on the face and skin folds (armpits, breast folds, groin and genitals). -
Clobetasol Propionate Lotion in the Treatment of Moderate to Severe Plaque-Type Psoriasis
THERAPEUTICS FOR THE CLINICIAN Clobetasol Propionate Lotion in the Treatment of Moderate to Severe Plaque-Type Psoriasis Jacques Decroix, MD; Henrik Pres, MD; Nicolaï Tsankov, MD; Michel Poncet, PhD; Stéphanie Arsonnaud Owing to its anti-inflammatory, antipruritic, soriasis is a lifelong condition, with onset vasoconstrictive, and immune-modulating prop- occurring at any time throughout life. It erties, clobetasol propionate is used to treat P affects men and women equally, and almost all psoriasis. This study was conducted to evaluate races in varying rates of frequency are affected. Pso- the efficacy, safety, and cosmetic acceptability riasis usually first appears between the ages of 15 of clobetasol propionate lotion compared with and 30 years and may occur anywhere on the body. its vehicle and with clobetasol propionate Psoriasis is an inherited condition; however, cream in the treatment of moderate to severe both genetic and environmental factors play an plaque-type psoriasis. important role in its onset and course. The condi- A total of 222 patients were treated. After tion has a considerable impact on quality of life, 4 weeks of treatment, clobetasol propionate with patients complaining about the messiness of lotion was more efficient than vehicle lotion and the topical agents used to treat the condition and of equivalent efficacy as clobetasol propionate the profound psychological impact of the treat- cream. Cosmetic acceptability was significantly ments and the condition.1-5 better with clobetasol propionate lotion than with Clobetasol propionate is known for its anti- clobetasol propionate cream. Clobetasol propi- inflammatory, antipruritic, vasoconstrictive, and onate lotion was efficient, safe, and well toler- immune-modulating properties and is currently ated and offers a significantly higher cosmetic used in the treatment of certain hyperproliferative advantage in the treatment of moderate to or inflammatory dermatoses, including psoriasis severe plaque-type psoriasis compared with and atopic dermatitis. -
Different Strategies for Using Topical Corticosteroids in People with Eczema (Protocol)
Cochrane Database of Systematic Reviews Different strategies for using topical corticosteroids in people with eczema (Protocol) Chalmers JR, Axon E, Harvey J, Santer M, Ridd MJ, Lawton S, Langan S, Roberts A, Ahmed A, Muller I, Long CM, Panda S, Chernyshov P, Carter B, Williams HC, Thomas KS Chalmers JR, Axon E, Harvey J, Santer M, Ridd MJ, Lawton S, Langan S, Roberts A, Ahmed A, Muller I, Long CM, Panda S, Chernyshov P, Carter B, Williams HC, Thomas KS. Different strategies for using topical corticosteroids in people with eczema. Cochrane Database of Systematic Reviews 2019, Issue 6. Art. No.: CD013356. DOI: 10.1002/14651858.CD013356. www.cochranelibrary.com Different strategies for using topical corticosteroids in people with eczema (Protocol) Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. TABLE OF CONTENTS HEADER....................................... 1 ABSTRACT ...................................... 1 BACKGROUND .................................... 1 OBJECTIVES ..................................... 4 METHODS ...................................... 4 ACKNOWLEDGEMENTS . 8 REFERENCES ..................................... 9 APPENDICES ..................................... 12 CONTRIBUTIONSOFAUTHORS . 13 DECLARATIONSOFINTEREST . 14 SOURCESOFSUPPORT . 15 Different strategies for using topical corticosteroids in people with eczema (Protocol) i Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. [Intervention Protocol] Different strategies for using topical corticosteroids in -
April 1, 2019
BUREAU FOR MEDICAL SERVICES EFFECTIVE WEST VIRGINIA MEDICAID PREFERRED DRUG LIST WITH PRIOR AUTHORIZATION CRITERIA 04/01/2019 This is not an all-inclusive list of available covered drugs and includes only Version 2019.2e managed categories. Refer to cover page for complete list of rules governing this PDL. Prior authorization for a non-preferred agent in any class will be given only if there has been a trial of the preferred brand/generic equivalent or preferred formulation of the active ingredient, at a therapeutic dose, that resulted in a partial response with a documented intolerance. Prior authorization of a non-preferred isomer, pro-drug, or metabolite will be considered with a trial of a preferred parent drug of the same chemical entity, at a therapeutic dose, that resulted in a partial response with documented intolerance or a previous trial and therapy failure, at a therapeutic dose, with a preferred drug of a different chemical entity indicated to treat the submitted diagnosis. (The required trial may be overridden when documented evidence is provided that the use of these preferred agent(s) would be medically contraindicated.) Unless otherwise specified, the listing of a particular brand or generic name includes all legend forms of that drug. OTC drugs are not covered unless specified. PA criteria for non-preferred agents apply in addition to general Drug Utilization Review policy that is in effect for the entire pharmacy program, including, but not limited to, appropriate dosing, duplication of therapy, etc. The use of pharmaceutical samples will not be considered when evaluating the members’ medical condition or prior prescription history for drugs that require prior authorization. -
Choosing Topical Corticosteroids JONATHAN D
Choosing Topical Corticosteroids JONATHAN D. FERENCE, PharmD, Nesbitt College of Pharmacy and Nursing, Wilkes University, Wilkes-Barre, Pennsylvania ALLEN R. LAST, MD, MPH, Racine Family Medicine Residency Program, Medical College of Wisconsin, Racine, Wisconsin Topical corticosteroids are one of the oldest and most useful treatments for dermatologic conditions. There are many topical steroids available, and they differ in potency and formulation. Successful treatment depends on an accurate diagnosis and consideration of the steroid’s delivery vehicle, potency, frequency of application, duration of treatment, and side effects. Although use of topical steroids is common, evidence of effectiveness exists only for select condi- tions, such as psoriasis, vitiligo, eczema, atopic dermatitis, phimosis, acute radiation dermatitis, and lichen sclero- sus. Evidence is limited for use in melasma, chronic idiopathic urticaria, and alopecia areata. (Am Fam Physician. 2009;79(2):135-140. Copyright © 2009 American Academy of Family Physicians.) opical steroids are available in a Indications variety of potencies and prepara- An accurate diagnosis is essential when tions. Physicians should become selecting a steroid. A skin scraping and familiar with one or two agents in potassium hydroxide test can clarify whether T each category of potency to safely and effec- a steroid or an antifungal is an appropriate tively treat steroid-responsive skin condi- choice, because steroids can exacerbate a tions. When prescribing topical steroids, fungal infection. Topical corticosteroids are it is important to consider the diagnosis effective for conditions that are character- as well as steroid potency, delivery vehicle, ized by hyperproliferation, inflammation, frequency of administration, duration of and immunologic involvement. They can treatment, and side effects. -
LGC Standards Pharmacopoeial Reference Standards 2014
LL CTS INKSP RODUTO A L P ITH W WEBSHO LGC Standards Pharmacopoeial reference standards 2014 FOR STANDARDS WITH CofA SEE OUR CATALOGUE: PHARMACEUTICAL IMPURITIES AND PRIMARY REFERENCE STANDARDS LGC Quality – ISO Guide 34 • GMP/GLP • ISO 9001 • ISO/IEC 17025 • ISO/IEC 17043 Pharmaceutical impurities Code Product CAS No. CS Price Unit Adiphenine Hydrochloride O LGC Standards N O MM1172.00 Adiphenine Hydrochloride 50-42-0 A 250mg HCl Pharmaceutical impurities and Adrenaline Tartrate OH H OH O OH primary reference standardsMM0614.00 2014 N OH Adrenaline Tartrate 51-42-3 A 500mg OH OH O OH OH H MM0614.02 L-Adrenaline 51-43-4 A 500mg OH N OH Imp. C (EP) as Hydrochloride: 1-(3,4-Di- O H OH MM0614.13 hydroxyphenyl)-2-(methylamino)ethanone 62-13-5 A 100mg N HCl Hydrochloride (Adrenalone Hydrochloride) OH (1R)-1-(3,4-Dihydroxyphenyl)-2- OH O S O MM0614.01 methylaminoethanesulphonic Acid H 78995-75-2 A 100mg OH N (Adrenaline -Sulphonate) OH Alanine NH2 MM0566.00 Alanine 56-41-7 A 500mg OH O Imp. A (Pharmeuropa): (2 S)-2-Aminobutanedioic Acid O NH 2 MM0567.00 OH (Aspartic Acid) 56-84-8 A 500mg OH O Albendazole O H MM0382.00 Albendazole N O 54965-21-8 A 500mg N H S N Imp. A (EP): 5-(Propylsulphanyl)-1H- H MM0382.01 N 80983-36-4 A 100mg NH2 benzimidazol-2-amine S N O H Imp. B (EP): Methyl [5-Propylsulphinyl)- N O MM0382.02 N 54029-12-8 A 100mg H 1H-benzimidazol-2-yl]carbamate S N O O H Imp. -
Clobetasol Propionate Topical Solution USP, 0.05%
CLOBETASOL PROPIONATE- clobetasol propionate solution Taro Pharmaceuticals U.S.A., Inc. ---------- Clobetasol Propionate Topical Solution USP, 0.05% Rx only FOR TOPICAL DERMATOLOGIC USE ONLY – NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE. DESCRIPTION Clobetasol Propionate Topical Solution USP, 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11β,16β)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1- oxopropoxy)pregna-1,4-diene-3,20-dione and it has the following structural formula: Clobetasol propionate has the molecular formula C25H32ClFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate topical solution contains clobetasol propionate 0.5 mg/g in a base composed of carbomer 934P, isopropyl alcohol (39.3%), purified water, and sodium hydroxide. CLINICAL PHARMACOLOGY The corticosteroids are a class of compounds comprising steroid hormones secreted by the adrenal cortex and their synthetic analogs. In pharmacologic doses, corticosteroids are used primarily for their anti-inflammatory and/or immunosuppressive effects. Topical corticosteroids such as clobetasol propionate are effective in the treatment of corticosteroid-responsive dermatoses primarily because of their anti-inflammatory, antipruritic, and vasoconstrictive actions. However, while the physiologic, pharmacologic, and clinical effects of the corticosteroids are well known, the exact mechanisms of their actions in each disease are uncertain. Clobetasol propionate, a corticosteroid, has been shown to have topical (dermatologic) and systemic pharmacologic and metabolic effects characteristic of this class of drugs. -
And Their Covered Alternatives for the Premier and Premier Plus Pharmacy Plans 2020 Formulary Exclusions Drug List
Covered and non-covered drugs Drugs not covered — and their covered alternatives for the Premier and Premier Plus pharmacy plans 2020 Formulary Exclusions Drug List 05.03.925.1O (7/20) Formulary Exclusions Drug List effective July 1, 2020 Key Premier and Premier Plus pharmacy plans UPPERCASE Brand-name medicine lowercase italics Generic medicine Category Not covered Covered alternatives Analgesics acetaminophen/caffeine/dihydrocodeine acetaminophen/caffeine/dihydrocodeine cap tab 325-30-16 mg 320.5-30-16mg (generic TREZIX) ALLZITAL (butalbital/acetaminophen) butalbital/acetaminophen 50-325mg bupap butalbital/acetaminophen 50-300mg ANAPROX DS** (naproxen) Generic oral nonsteroidal anti-inflammatory drug FENORTHO* (fenoprofen calcium) FLECTOR PATCH (diclofenac epolamine) INDOCIN SUPP* (indomethacin) INDOCIN SUSP* (indomethacin) ketoprofen 25mg capsules ketoprofen er MOBIC** (meloxicam) NAPRELAN* (naproxen sodium) SPRIX (ketorolac trometh nasal spray) TIVORBEX (indomethacin) VIVLODEX (meloxicam) VOLTAREN** (diclofenac) ZIPSOR (diclofenac potassium) ZORVOLEX (diclofenac) CONZIP* (tramadol ER capsules) tramadol immediate-release or extended-release tablets (generic ULTRAM, ULTRAM ER) DEXPAK 6 DAY** (dexamethasone) dexamethasone tab therapy pack DEXPAK 10 DAY** (dexamethasone) DEXPAK 13** (dexamethasone) TAPERDEX 6 DAY (dexamethasone) LAZANDA (fentanyl citrate nasal spray) fentanyl citrate lozenge (generic ACTIQ) SUBSYS (fentanyl sublingual spray) LIDODERM** (lidocaine) lidocaine patch 5% NALOCET oxycodone-acetaminophen (generic PERCOCET) PERCOCET**