Clinical Policy: Topical Agents: Corticosteroids
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(CD-P-PH/PHO) Report Classification/Justifica
COMMITTEE OF EXPERTS ON THE CLASSIFICATION OF MEDICINES AS REGARDS THEIR SUPPLY (CD-P-PH/PHO) Report classification/justification of medicines belonging to the ATC group D07A (Corticosteroids, Plain) Table of Contents Page INTRODUCTION 4 DISCLAIMER 6 GLOSSARY OF TERMS USED IN THIS DOCUMENT 7 ACTIVE SUBSTANCES Methylprednisolone (ATC: D07AA01) 8 Hydrocortisone (ATC: D07AA02) 9 Prednisolone (ATC: D07AA03) 11 Clobetasone (ATC: D07AB01) 13 Hydrocortisone butyrate (ATC: D07AB02) 16 Flumetasone (ATC: D07AB03) 18 Fluocortin (ATC: D07AB04) 21 Fluperolone (ATC: D07AB05) 22 Fluorometholone (ATC: D07AB06) 23 Fluprednidene (ATC: D07AB07) 24 Desonide (ATC: D07AB08) 25 Triamcinolone (ATC: D07AB09) 27 Alclometasone (ATC: D07AB10) 29 Hydrocortisone buteprate (ATC: D07AB11) 31 Dexamethasone (ATC: D07AB19) 32 Clocortolone (ATC: D07AB21) 34 Combinations of Corticosteroids (ATC: D07AB30) 35 Betamethasone (ATC: D07AC01) 36 Fluclorolone (ATC: D07AC02) 39 Desoximetasone (ATC: D07AC03) 40 Fluocinolone Acetonide (ATC: D07AC04) 43 Fluocortolone (ATC: D07AC05) 46 2 Diflucortolone (ATC: D07AC06) 47 Fludroxycortide (ATC: D07AC07) 50 Fluocinonide (ATC: D07AC08) 51 Budesonide (ATC: D07AC09) 54 Diflorasone (ATC: D07AC10) 55 Amcinonide (ATC: D07AC11) 56 Halometasone (ATC: D07AC12) 57 Mometasone (ATC: D07AC13) 58 Methylprednisolone Aceponate (ATC: D07AC14) 62 Beclometasone (ATC: D07AC15) 65 Hydrocortisone Aceponate (ATC: D07AC16) 68 Fluticasone (ATC: D07AC17) 69 Prednicarbate (ATC: D07AC18) 73 Difluprednate (ATC: D07AC19) 76 Ulobetasol (ATC: D07AC21) 77 Clobetasol (ATC: D07AD01) 78 Halcinonide (ATC: D07AD02) 81 LIST OF AUTHORS 82 3 INTRODUCTION The availability of medicines with or without a medical prescription has implications on patient safety, accessibility of medicines to patients and responsible management of healthcare expenditure. The decision on prescription status and related supply conditions is a core competency of national health authorities. -
Orange Book Cumulative Supplement 7 July 2006
CUMULATIVE SUPPLEMENT 07 July 2006 APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS 26th EDITION Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research Office of Generic Drugs 2006 Prepared By Office of Generic Drugs Center for Drug Evaluation and Research Food and Drug Administration APPROVED DRUG PRODUCTS with THERAPEUTIC EQUIVALENCE EVALUATIONS 26th EDITION Cumulative Supplement 07 July 2006 CONTENTS PAGE 1.0 INTRODUCTION ........................................................................................................................................ iii 1.1 How to use the Cumulative Supplement ........................................................................................... iii 1.2 Applicant Name Changes.................................................................................................................. iv 1.3 Availability of the Edition ................................................................................................................... vi 1.4 Report of Counts for the Prescription Drug Product List ................................................................... vi 1.5 Zocor (simvastatin) Patent Relisting.................................................................................................viii 1.6 Cumulative Supplement Legend ....................................................................................................... vi DRUG PRODUCT LISTS Prescription Drug Product List ...................................................................................................... -
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 -
)&F1y3x PHARMACEUTICAL APPENDIX to THE
)&f1y3X PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE )&f1y3X PHARMACEUTICAL APPENDIX TO THE TARIFF SCHEDULE 3 Table 1. This table enumerates products described by International Non-proprietary Names (INN) which shall be entered free of duty under general note 13 to the tariff schedule. The Chemical Abstracts Service (CAS) registry numbers also set forth in this table are included to assist in the identification of the products concerned. For purposes of the tariff schedule, any references to a product enumerated in this table includes such product by whatever name known. Product CAS No. Product CAS No. ABAMECTIN 65195-55-3 ACTODIGIN 36983-69-4 ABANOQUIL 90402-40-7 ADAFENOXATE 82168-26-1 ABCIXIMAB 143653-53-6 ADAMEXINE 54785-02-3 ABECARNIL 111841-85-1 ADAPALENE 106685-40-9 ABITESARTAN 137882-98-5 ADAPROLOL 101479-70-3 ABLUKAST 96566-25-5 ADATANSERIN 127266-56-2 ABUNIDAZOLE 91017-58-2 ADEFOVIR 106941-25-7 ACADESINE 2627-69-2 ADELMIDROL 1675-66-7 ACAMPROSATE 77337-76-9 ADEMETIONINE 17176-17-9 ACAPRAZINE 55485-20-6 ADENOSINE PHOSPHATE 61-19-8 ACARBOSE 56180-94-0 ADIBENDAN 100510-33-6 ACEBROCHOL 514-50-1 ADICILLIN 525-94-0 ACEBURIC ACID 26976-72-7 ADIMOLOL 78459-19-5 ACEBUTOLOL 37517-30-9 ADINAZOLAM 37115-32-5 ACECAINIDE 32795-44-1 ADIPHENINE 64-95-9 ACECARBROMAL 77-66-7 ADIPIODONE 606-17-7 ACECLIDINE 827-61-2 ADITEREN 56066-19-4 ACECLOFENAC 89796-99-6 ADITOPRIM 56066-63-8 ACEDAPSONE 77-46-3 ADOSOPINE 88124-26-9 ACEDIASULFONE SODIUM 127-60-6 ADOZELESIN 110314-48-2 ACEDOBEN 556-08-1 ADRAFINIL 63547-13-7 ACEFLURANOL 80595-73-9 ADRENALONE -
Psorcon®(Diflorasone Diacetate Cream, USP)
PSORCON- diflorasone diacetate cream Taro Pharmaceuticals U.S.A., Inc. ---------- psorcon® (diflorasone diacetate cream, USP) 0.05% Rx only For External Use Only - Not for Ophthalmic Use. DESCRIPTION PSORCON® (diflorasone diacetate cream USP), 0.05% contains the active compound diflorasone diacetate, a synthetic corticosteroid for topical dermatological use. Chemically, diflorasone diacetate is 6α, 9α-difluoro-11β,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione 17,21 diacetate, with the empirical formula C26H32F2O7, a molecular weight of 494.5, and the following structural formula: Each gram of PSORCON® (diflorasone diacetate cream USP), 0.05% contains 0.5 mg diflorasone diacetate in a cream base consisting of butylated hydroxytoluene, cetyl alcohol, citric acid, glyceryl stearate/PEG 100 stearate, isopropyl myristate, lanolin alcohol, mineral oil, monobasic sodium phosphate, polyoxyl 40 stearate, polysorbate 60, propylene glycol, purified water, sorbitan monostearate and vegetable oil. CLINICAL PHARMACOLOGY Like other topical corticosteroids, diflorasone diacetate has anti-inflammatory, anti-pruritic, and vasoconstrictive actions. The mechanism of the anti-inflammatory activity of the topical corticosteroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Occlusive dressings with hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. -
Medication List
Medication List Walgreens Plus™ members receive discounts on thousands of generic and brand-name medications included on this Medication List, which is divided into two sections, “Value Priced” Medications and “Discounted” Medications*. The price for a medication identified as “Value-Priced” is listed below: Get savings up to 85% off Cash Prices • 30-day-supply drugs cost $5 (tier 1), $10 (tier 2) or $15 (tier 3) on Atorvastatin (generic Lipitor) and • 90-day-supply drugs cost $10 (tier 1), $20 (tier 2) or $30 (tier 3) Rosuvastatin (generic Crestor) †† The Discounted Medications section lists the discounts offered to Walgreens Plus members on other generic and brand-name medications not included in the Value-Priced Medication section. The price for a medication is based on its tier and whether it is a 30-day or 90-day supply†. There may be an additional cost for quanities greater than those listed. This discount prescription pricing applies only to Walgreen Plus members on prescriptions purchased in select Walgreens stores that are not billed to insurance and/or used in combination with other health or pharmacy benefit programs. For further details, see your pharmacist or Walgreens.com/Plus. VALUE GENERICS NAPROXEN 250MG TAB 2 60 180 Antifungal NAPROXEN 500MG TAB 2 60 180 Quantity NAPROXEN 375MG TAB 2 60 180 Drug Name Tier 30 90 NAPROXEN DR 500MG TAB 3 60 180 FLUCONAZOLE 150MG TAB 2 1 3 TERBINAFINE 250MG TAB 2 30 90 Asthma Quantity Antiviral Drug Name Tier 30 90 Quantity ALBUTEROL 0.083% INH SOLN 25X3ML 2 75 225 Drug Name Tier 30 90 AMINOPHYLLINE -
A New Robust Technique for Testing of Glucocorticosteroids in Dogs and Horses Terry E
Iowa State University Capstones, Theses and Retrospective Theses and Dissertations Dissertations 2007 A new robust technique for testing of glucocorticosteroids in dogs and horses Terry E. Webster Iowa State University Follow this and additional works at: https://lib.dr.iastate.edu/rtd Part of the Veterinary Toxicology and Pharmacology Commons Recommended Citation Webster, Terry E., "A new robust technique for testing of glucocorticosteroids in dogs and horses" (2007). Retrospective Theses and Dissertations. 15029. https://lib.dr.iastate.edu/rtd/15029 This Thesis is brought to you for free and open access by the Iowa State University Capstones, Theses and Dissertations at Iowa State University Digital Repository. It has been accepted for inclusion in Retrospective Theses and Dissertations by an authorized administrator of Iowa State University Digital Repository. For more information, please contact [email protected]. A new robust technique for testing of glucocorticosteroids in dogs and horses by Terry E. Webster A thesis submitted to the graduate faculty in partial fulfillment of the requirements for the degree of MASTER OF SCIENCE Major: Toxicology Program o f Study Committee: Walter G. Hyde, Major Professor Steve Ensley Thomas Isenhart Iowa State University Ames, Iowa 2007 Copyright © Terry Edward Webster, 2007. All rights reserved UMI Number: 1446027 Copyright 2007 by Webster, Terry E. All rights reserved. UMI Microform 1446027 Copyright 2007 by ProQuest Information and Learning Company. All rights reserved. This microform edition is protected against unauthorized copying under Title 17, United States Code. ProQuest Information and Learning Company 300 North Zeeb Road P.O. Box 1346 Ann Arbor, MI 48106-1346 ii DEDICATION I want to dedicate this project to my wife, Jackie, and my children, Shauna, Luke and Jake for their patience and understanding without which this project would not have been possible. -
Steroid Use in Prednisone Allergy Abby Shuck, Pharmd Candidate
Steroid Use in Prednisone Allergy Abby Shuck, PharmD candidate 2015 University of Findlay If a patient has an allergy to prednisone and methylprednisolone, what (if any) other corticosteroid can the patient use to avoid an allergic reaction? Corticosteroids very rarely cause allergic reactions in patients that receive them. Since corticosteroids are typically used to treat severe allergic reactions and anaphylaxis, it seems unlikely that these drugs could actually induce an allergic reaction of their own. However, between 0.5-5% of people have reported any sort of reaction to a corticosteroid that they have received.1 Corticosteroids can cause anything from minor skin irritations to full blown anaphylactic shock. Worsening of allergic symptoms during corticosteroid treatment may not always mean that the patient has failed treatment, although it may appear to be so.2,3 There are essentially four classes of corticosteroids: Class A, hydrocortisone-type, Class B, triamcinolone acetonide type, Class C, betamethasone type, and Class D, hydrocortisone-17-butyrate and clobetasone-17-butyrate type. Major* corticosteroids in Class A include cortisone, hydrocortisone, methylprednisolone, prednisolone, and prednisone. Major* corticosteroids in Class B include budesonide, fluocinolone, and triamcinolone. Major* corticosteroids in Class C include beclomethasone and dexamethasone. Finally, major* corticosteroids in Class D include betamethasone, fluticasone, and mometasone.4,5 Class D was later subdivided into Class D1 and D2 depending on the presence or 5,6 absence of a C16 methyl substitution and/or halogenation on C9 of the steroid B-ring. It is often hard to determine what exactly a patient is allergic to if they experience a reaction to a corticosteroid. -
Etats Rapides
List of European Pharmacopoeia Reference Standards Effective from 2015/12/24 Order Reference Standard Batch n° Quantity Sale Information Monograph Leaflet Storage Price Code per vial Unit Y0001756 Exemestane for system suitability 1 10 mg 1 2766 Yes +5°C ± 3°C 79 ! Y0001561 Abacavir sulfate 1 20 mg 1 2589 Yes +5°C ± 3°C 79 ! Y0001552 Abacavir for peak identification 1 10 mg 1 2589 Yes +5°C ± 3°C 79 ! Y0001551 Abacavir for system suitability 1 10 mg 1 2589 Yes +5°C ± 3°C 79 ! Y0000055 Acamprosate calcium - reference spectrum 1 n/a 1 1585 79 ! Y0000116 Acamprosate impurity A 1 50 mg 1 3-aminopropane-1-sulphonic acid 1585 Yes +5°C ± 3°C 79 ! Y0000500 Acarbose 3 100 mg 1 See leaflet ; Batch 2 is valid until 31 August 2015 2089 Yes +5°C ± 3°C 79 ! Y0000354 Acarbose for identification 1 10 mg 1 2089 Yes +5°C ± 3°C 79 ! Y0000427 Acarbose for peak identification 3 20 mg 1 Batch 2 is valid until 31 January 2015 2089 Yes +5°C ± 3°C 79 ! A0040000 Acebutolol hydrochloride 1 50 mg 1 0871 Yes +5°C ± 3°C 79 ! Y0000359 Acebutolol impurity B 2 10 mg 1 -[3-acetyl-4-[(2RS)-2-hydroxy-3-[(1-methylethyl)amino] propoxy]phenyl] 0871 Yes +5°C ± 3°C 79 ! acetamide (diacetolol) Y0000127 Acebutolol impurity C 1 20 mg 1 N-(3-acetyl-4-hydroxyphenyl)butanamide 0871 Yes +5°C ± 3°C 79 ! Y0000128 Acebutolol impurity I 2 0.004 mg 1 N-[3-acetyl-4-[(2RS)-3-(ethylamino)-2-hydroxypropoxy]phenyl] 0871 Yes +5°C ± 3°C 79 ! butanamide Y0000056 Aceclofenac - reference spectrum 1 n/a 1 1281 79 ! Y0000085 Aceclofenac impurity F 2 15 mg 1 benzyl[[[2-[(2,6-dichlorophenyl)amino]phenyl]acetyl]oxy]acetate -
120.Clobetasol Propionate and [email protected]
IAJPS 2017, 4 (10), 3779-3786 Harikishor Barange et al ISSN 2349-7750 CODEN (USA): IAJPBB ISSN: 2349-7750 INDO AMERICAN JOURNAL OF PHARMACEUTICALSCIENCES Available online at: http://www.iajps.com Research Article DEVELOPMENT OF ANALYTICAL METHOD AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF CLOBETASOL PROPIONATE AND KETOCONAZOLE IN PHARMACEUTICAL CREAM FORMULATION BY RP-HPLC METHOD Harikishor Barange*, Suhail Asghar and Pooja Gour Unijules Life Sciences Ltd., B - 35, 36 MIDC Area Kalmeshwar Nagpur – 441501, Maharashtra, India. E-mail of Corresponding author: [email protected]. Abstract: A simple, accurate rapid and precise has been developed and validated for simultaneous estimation of Clobetasol Propionate and Ketoconazole in Pharmaceutical Cream Formulation by RP-HPLC Method. The successful estimation was carried out of the drug product is developed on the ODS Qualisil Column C18 (250 mm x 4.6 mm, 5μm or equivalent) at ambient temperature using Methanol: Acetonitrile: Phosphate buffer (50:20:30 v/v/v) as mobile phase composition. The flow rate was adjusted to 1.5mL/minute and the absorption maxima were observed on UV detector at 254 nm. Retention Time for Clobetasole Propionate 11.1±0.1min and Ketoconazole 12.2±0.1min. The linearity was obtained in the concentration range of 6-14µg/mL and 120-280µg/mL for Clobetasole Propionate and Ketoconazole respectively. Mean percentage recoveries were 99.16% for Clobetasole Propionate and 99.17% for Ketoconazole. The LOD of Clobetasole Propionate and Ketoconazole were found to be 0.7μg/mL and 2.0μg/mL whereas the LOQ was 3.0μg/mL and 10.0μg/mL respectively. Percentage relative standard deviation of percent assay values for replicate sample preparation was 0.28% for Clobetasole Propionate and 0.47% for Ketoconazole. -
Pharmacy J-Code Billing/Topical Corticosteroid
Pharmacy Services (800) 522-0114, option 4 October 14, 2019 RE: Pharmacy J-Code Billing, Topical Corticosteroid Update Dear SoonerCare Provider, The purpose of this fax is to provide reminders regarding pharmacy J-code (HCPCS) billing and updates regarding coverage of topical corticosteroids (TCS). Pharmacies cannot process HCPCS codes for reimbursement through SoonerCare. Pharmacies may submit claims for drug products with a National Drug Code (NDC) for reimbursement via a pharmacy claim. Claims for medications billed by a pharmacy on a CMS1500 for HCPCS codes or J-codes will not process through the SoonerCare claims systems. Effective November 12, 2019, the following changes will apply for the TCS medications category: . Temovate® (clobetasol propionate 0.05% ointment) will move from Tier-3 to Tier-1. Prior authorization will no longer be required. Diprosone® (betamethasone dipropionate 0.05% ointment) and Trianex® (triamcinolone acetonide 0.05% ointment) will move from Tier-1 to Tier-2. Apexicon® (diflorasone diacetate 0.05% cream and ointment) and Apexicon E® (diflorasone diacetate/emollient 0.05% cream) will move from Tier-2 to Tier-3. Current users will not be “grandfathered”. All members receiving these medications will require that a manual prior authorization be submitted by their prescriber. Specific prior authorization criteria and Tier charts for TCS medications can be downloaded from www.okhca.org/pa, then clicking “Topical”. If a member requires any of the above medications, prior authorization requests can be submitted for consideration to SoonerCare Pharmacy Services. Prior authorization request forms can be found online at www.okhca.org/rxforms (PHARM-04). Thank you for the services you provide to Oklahomans insured by SoonerCare! SoonerCare Pharmacy Services • Pharmacy Management Consultants • PO Box 26901; ORI W-4403• Oklahoma City, Oklahoma 73126-0901 • Phone: (800) 522-0114, option 4 • Fax: (800) 224-4014 . -
A List of Medications That May Lower Your Patients' Costs
A list of medications that may lower your patients’ costs INTRODUCTION Catamaran utilizes a Pharmacy and Therapeutics Committee (P & T Committee), made up of practicing physicians, pharmacists, and nurses to help ensure that our formulary is medically sound and that it supports patient health. This committee reviews and evaluates medications on the formulary based on safety and efficacy to help maintain clinical integrity in all therapeutic categories. FORMULARY DESIGN There are numerous formulary designs that can be used by a pharmacy benefits administrator. Catamaran has chosen a formulary structure which is open and incentive based. Open Formulary: features co‐payments for medications that are preferred and non‐ preferred brands, plus lower co‐payments for generic drugs. Incentive Based: features different co‐payments for medications that are on or off the formulary. In this type of formulary, the patient cost structure may be two‐tier, three‐ tier, or four‐tier design. USING THIS FORMULARY REFERENCE GUIDE TO HELP CONTAIN COSTS Many benefit sponsors use the Catamaran formulary to help manage the overall cost of providing prescription drug benefits. This formulary offers a wide range of medications from which to choose. We realize that this formulary reference guide may not include every drug from every manufacturer. However, choosing a preferred drug when it is appropriate can provide access to the necessary medications to stay healthy, at a cost that is more affordable. KNOWING HOW THE FORMULARY INFORMATION IS ORGANIZED The following formulary reference guide is designed so that generic products are listed first in each drug category. The preferred brand name products are listed next, and non‐preferred brand products are listed last.