2020 NY44 Formulary
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(12) Patent Application Publication (10) Pub. No.: US 2008/0317805 A1 Mckay Et Al
US 20080317805A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2008/0317805 A1 McKay et al. (43) Pub. Date: Dec. 25, 2008 (54) LOCALLY ADMINISTRATED LOW DOSES Publication Classification OF CORTICOSTEROIDS (51) Int. Cl. A6II 3/566 (2006.01) (76) Inventors: William F. McKay, Memphis, TN A6II 3/56 (2006.01) (US); John Myers Zanella, A6IR 9/00 (2006.01) Cordova, TN (US); Christopher M. A6IP 25/04 (2006.01) Hobot, Tonka Bay, MN (US) (52) U.S. Cl. .......... 424/422:514/169; 514/179; 514/180 (57) ABSTRACT Correspondence Address: This invention provides for using a locally delivered low dose Medtronic Spinal and Biologics of a corticosteroid to treat pain caused by any inflammatory Attn: Noreen Johnson - IP Legal Department disease including sciatica, herniated disc, Stenosis, mylopa 2600 Sofamor Danek Drive thy, low back pain, facet pain, osteoarthritis, rheumatoid Memphis, TN38132 (US) arthritis, osteolysis, tendonitis, carpal tunnel syndrome, or tarsal tunnel syndrome. More specifically, a locally delivered low dose of a corticosteroid can be released into the epidural (21) Appl. No.: 11/765,040 space, perineural space, or the foramenal space at or near the site of a patient's pain by a drug pump or a biodegradable drug (22) Filed: Jun. 19, 2007 depot. E Day 7 8 Day 14 El Day 21 3OO 2OO OO OO Control Dexamethasone DexamethasOne Dexamethasone Fuocinolone Fluocinolone Fuocinolone 2.0 ng/hr 1Ong/hr 50 ng/hr 0.0032ng/hr 0.016 ng/hr 0.08 ng/hr Patent Application Publication Dec. 25, 2008 Sheet 1 of 2 US 2008/0317805 A1 900 ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 80.0 - 7OO – 6OO - 5OO - E Day 7 EDay 14 40.0 - : El Day 21 2OO - OO = OO – Dexamethasone Dexamethasone Dexamethasone Fuocinolone Fluocinolone Fuocinolone 2.0 ng/hr 1Ong/hr 50 ng/hr O.OO32ng/hr O.016 ng/hr 0.08 nghr Patent Application Publication Dec. -
(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. -
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 -
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. -
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 -
Fluocinolone Acetonide Promotes the Proliferation and Mineralization Of
Basic Research—Biology Fluocinolone Acetonide Promotes the Proliferation and Mineralization of Dental Pulp Cells Zhongning Liu, DDS, MS,* Ting Jiang, DDS, PhD,* Yixiang Wang, DDS, MS,† and Xinzhi Wang, DDS, PhD* Abstract Introduction: The aim of this study was to investigate Key Words the role of the steroid fluocinolone acetonide on the Dental pulp cells, fluocinolone acetonide, mineralization, proliferation proliferation and mineralization of human dental pulp cells (DPCs). The potential effect of fluocinolone aceto- he recovery of injured dental pulp is still one of the unresolved clinical problems. nide on reparative dentin formation and the recovery TWhen unexpected pulp exploration occurs, the survival of vital pulp will be more of injured dental pulp were evaluated. Methods: The difficult. Because healthy and vital pulp can promise a better prognosis of the injured proliferative effect of fluocinolone acetonide on DPCs tooth, preserving the vitality of pulp tissue is of key importance for long-time tooth pres- was analyzed by cholecystokinin octapeptide assay ervation (1). The ideal dental pulp capping agent should not only induce the formation and flow cytometry. The mineralized effect of fluocino- of reparative dentin but also inhibit inflammatory processes. The widely used capping lone acetonide was investigated by the detection of agents (ie, calcium hydroxide and mineral trioxide aggregate) are mainly focused on mineralization-related biomarkers including alkaline the closure of the exposed pulp; however, they are short of the anti-inflammation effect. phosphatase (ALP), bone sialoprotein, and osteocalcin So far, there is no ideal dental pulp capping material for the repair of slightly inflam- by using ALP histochemical staining, ALP activity, immu- matory pulp cases. -
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 . -
Aspects of the Bioavailability of Topical Corticosteroid
- - ASPECTS OF THE BIOAVAILABILITY OF TOPICAL CORTICOSTEROID FORMULATIONS. A Thesis Submitted to RHOD ES UNIVERSITY in Partial Fulfilment of the Requirements for the Degree of MASTER OF SCIENCE by ASHLEY DENIS MAGNUS B.Pharm.(Rhodes) School of Pharmaceutical Sciences, Rhodes University, Grahamstown, South Africa. 6140 November 1978. - i - CONTENTS ABSTRACT iii ACKNOWLEDGEMENTS iv PREPARATIONS v STANDARDS vi INSTRUMENTA TION vii STRUCTURES viii 1. INTRODUCTION 1 1.1 BIOASSAYS USED TO ASSESS TOPICAL STEROID ACTIVITY 1 1. 2 TEE HUMAN VASOCONSTRICTOR ASSAY AS A MEASURE OF TOPICAL STEROID ACTIVITY 5 1 .2.1 Alcoholic Vasoconstrictor Studies 5 1.2.2 Studies of Vasoconstriction in Other Solvents 9 1.2.3 Studied of Vasoconstri ction in Formulated Products 10 1. 3 THE MECHANISM OF BLANCHING 1 6 1.4 THE SKIN AS A CORTICOSTEROID RESERVOIR 18 1. 5 TEE CORRELATION OF VASOCONSTRICTOR ACTIVITY WITE CLINICAL EFFICACY 19 1. 6 THE EFFECT OF EXTEMPORANEOUS DILUTION OF TOPICAL CORTICO- STEROID FORMULATIONS 20 1.6.1 Pharmaceutical Considerations 21 1.6.2 Bacteriological Consider ations 22 1.6.3 Biopharmaceutical Considerations 23 2. METHODS 24 2.1 TEE BLANCHING ASSAY 24 2.1 .1 Volunteers 24 2.1 . 2 Mode of Application 24 2 .1.3 Reading of Results 26 2.2 STATISTICAL EVALUATION 27 2 . 3 CALCULATION OF PERCENT TOTAL POSSIBLE SCORE (% TPS) 28 2.4 DETERMINATION OF AREA UNDER THE BLANCHING PROFILE 28 3. DISCUSSION 31 3 .1 TEE ASSESSMENT OF VARIABLES AFFECTING TEE BLANCHING ABILITY OF FORMULATED PRODUCTS 31 - ii - CONTENTS (continued)/ 3.1. 1 The Effect of the Amount of Formulated Product Applied to the Test Site 32 3.