January 2021 Table of Drugs
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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. -
Regulatory News
WHO Drug Information Vol. 28, No. 4, 2014 Regulatory news Ebola curative – transfusions of whole blood or blood plasma from recovered patients Update on treatments and vaccines have been scheduled to be conducted in Liberia, in line with WHO technical The Ebola crisis has prompted an guidelines (4). unprecedented cooperation between regulators In September the European Medicines to support WHO and to advise on possible Agency (EMA) established an expert pathways for the development, evaluation and group to review available information approval of medicines to fight Ebola. Progress on Ebola experimental treatments – towards provision of treatments and vaccines is excluding convalescent therapies – and summarized below. invited developers to submit their data (5). In August 2014, a WHO-convened panel Vaccines had agreed unanimously that is ethically On 29–30 September, 70 experts acceptable to use of experimental attended a WHO-convened consultation medicines and vaccines under the on Ebola vaccines. They took stock of the exceptional circumstances of the Ebola many ongoing efforts to rapidly evaluate epidemic (1). In early September, WHO the safety and efficacy of Ebola vaccines convened a consultation on potential for deployment as soon as possible to Ebola therapies and vaccines (2). The critical frontline workers and ultimately to importance of supportive care and populations at risk in mass vaccination community response was stressed in this campaigns. Two candidate vaccines have and subsequent discussions. clinical-grade vials available for safety trials. (6) Treatments In October, WHO convened industry In September, more than 200 experts leaders and key partners to discuss trials from around the world met at WHO and production of Ebola vaccine (7). -
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. -
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. -
Aqueous Clear Solutions of Fluocinolone Acetonide for Treatment
(19) & (11) EP 2 366 408 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: of the grant of the patent: A61K 47/10 (2006.01) A61K 47/12 (2006.01) 18.07.2012 Bulletin 2012/29 A61K 47/14 (2006.01) A61K 47/32 (2006.01) A61K 47/38 (2006.01) A61K 9/00 (2006.01) (2006.01) (21) Application number: 10155005.1 A61K 31/58 (22) Date of filing: 01.03.2010 (54) Aqueous clear solutions of fluocinolone acetonide for treatment of otic inflammation Wässrige klare Lösungen aus Fluocinolon-Acetonid zur Behandlung von Ohrentzündungen Solutions claires aqueuses d’acétonide de fluocinolone pour le traitement de l’inflammation otique (84) Designated Contracting States: • Izquierdo Torres, Francisca AT BE BG CH CY CZ DE DK EE ES FI FR GB GR E-08950 HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL Esplugues de LLobregat - Barcelona (ES) PT RO SE SI SK SM TR (74) Representative: ABG Patentes, S.L. (43) Date of publication of application: Avenida de Burgos, 16D 21.09.2011 Bulletin 2011/38 Edificio Euromor 28036 Madrid (ES) (73) Proprietor: Laboratorios SALVAT, S.A. 08950 Esplugues de Llobregat, Barcelona (ES) (56) References cited: EP-A1- 0 995 435 DE-A1- 2 515 594 (72) Inventors: GB-A- 1 013 180 GB-A- 1 133 800 • Ruiz i Pol, Jaume GB-A- 1 411 432 US-A1- 2009 325 938 E-08950, US-A1- 2010 036 000 Esplugues de LLobregat-Barcelona (ES) Note: Within nine months of the publication of the mention of the grant of the European patent in the European Patent Bulletin, any person may give notice to the European Patent Office of opposition to that patent, in accordance with the Implementing Regulations. -
Ehealth DSI [Ehdsi V2.2.2-OR] Ehealth DSI – Master Value Set
MTC eHealth DSI [eHDSI v2.2.2-OR] eHealth DSI – Master Value Set Catalogue Responsible : eHDSI Solution Provider PublishDate : Wed Nov 08 16:16:10 CET 2017 © eHealth DSI eHDSI Solution Provider v2.2.2-OR Wed Nov 08 16:16:10 CET 2017 Page 1 of 490 MTC Table of Contents epSOSActiveIngredient 4 epSOSAdministrativeGender 148 epSOSAdverseEventType 149 epSOSAllergenNoDrugs 150 epSOSBloodGroup 155 epSOSBloodPressure 156 epSOSCodeNoMedication 157 epSOSCodeProb 158 epSOSConfidentiality 159 epSOSCountry 160 epSOSDisplayLabel 167 epSOSDocumentCode 170 epSOSDoseForm 171 epSOSHealthcareProfessionalRoles 184 epSOSIllnessesandDisorders 186 epSOSLanguage 448 epSOSMedicalDevices 458 epSOSNullFavor 461 epSOSPackage 462 © eHealth DSI eHDSI Solution Provider v2.2.2-OR Wed Nov 08 16:16:10 CET 2017 Page 2 of 490 MTC epSOSPersonalRelationship 464 epSOSPregnancyInformation 466 epSOSProcedures 467 epSOSReactionAllergy 470 epSOSResolutionOutcome 472 epSOSRoleClass 473 epSOSRouteofAdministration 474 epSOSSections 477 epSOSSeverity 478 epSOSSocialHistory 479 epSOSStatusCode 480 epSOSSubstitutionCode 481 epSOSTelecomAddress 482 epSOSTimingEvent 483 epSOSUnits 484 epSOSUnknownInformation 487 epSOSVaccine 488 © eHealth DSI eHDSI Solution Provider v2.2.2-OR Wed Nov 08 16:16:10 CET 2017 Page 3 of 490 MTC epSOSActiveIngredient epSOSActiveIngredient Value Set ID 1.3.6.1.4.1.12559.11.10.1.3.1.42.24 TRANSLATIONS Code System ID Code System Version Concept Code Description (FSN) 2.16.840.1.113883.6.73 2017-01 A ALIMENTARY TRACT AND METABOLISM 2.16.840.1.113883.6.73 2017-01 -
Afamelanotide 16Mg Implant (SCENESSE) for Generalised Vitiligo – First Line in Combination with Narrow-Band Ultraviolet B Light (NB-UVB)
December Horizon Scanning Research & 2016 Intelligence Centre Afamelanotide 16mg Implant (SCENESSE) for generalised vitiligo – first line in combination with narrow-band ultraviolet B light (NB-UVB) NIHR HSRIC ID: 6667 Lay summary Afamelanotide is a new drug to treat generalised vitiligo. Vitiligo is a long-term condition where white patches develop on the skin, because of a lack of pigment in the skin. This condition may cause significant psychological distress. Afamelanotide is administered as an implant once every 28 days with NB-UVB light therapy administered 2-3 times per week. If licensed, afamelanotide may offer an additional treatment option for patients with this condition. This briefing is based on information available at the time of research and a limited literature search. It is not intended to be a definitive statement on the safety, efficacy or effectiveness of the health technology covered and should not be used for commercial purposes or commissioning without additional information. This briefing presents independent research funded by the National Institute for Health Research (NIHR). The views expressed are those of the author and not necessarily those of the NHS, the NIHR or the Department of Health. Horizon Scanning Research & Intelligence Centre University of Birmingham [email protected] www.hsric.nihr.ac.uk @OfficialNHSC TARGET GROUP • Generalised vitiligo: adults; stable or slowly progressing; with 10-50% of total body surface involvement – first line; in combination with narrow-band ultraviolet B light (NB- UVB). TECHNOLOGY DESCRIPTION Afamelanotide (SCENESSE; [Nle4,D-Phe7]-alpha-MSH; CUV-1647; EPT-1647; melanotan I; melanotan) is a structural analogue of endogenous alpha-melanocyte-stimulating hormone (α-MSH), which is formulated as a bioresorbable implant. -
2020 NY44 Formulary
2020 NY44/ Pharmacy Benefit Dimensions Drug Formulary This Drug Formulary represents the list of drugs and their appropriate copayment tiers for members of the NY44 Health Benefits Plan Trust. Note: If you are reading a printed version of this drug formulary, content may have been updated since it was last printed. For the most up-to-date information, please visit www.pbdrx.com. Drug Formulary Introduction Generic drugs appear in lower case. Brand name drugs are capitalized. This formulary lists all covered Tier 1 and Tier 2 drugs, but only lists representative products in Tier 3. Formulary/preferred generic drugs and select Over the Counter (OTC) and select Brand Name drugs listed on the Formulary are assigned to copay Tier 1. The formulary follows a “Mandatory Generic” policy which means that in most instances, once a generic product is available for which there are no bioequivalence concerns, the branded product is assigned to Copay Tier 3, and the generic product is assigned to Copay Tier 1. Certain non- preferred generic drugs may also be covered in the 3rd tier when efficacy, safety or cost factors suggest that better alternatives exist on the formulary. Not all tier 3 non-preferred drugs are listed in the formulary. For members with a 3 tier plan, most drugs not listed may be obtained, but the member will be responsible for their third tier copayment. Pharmacy Benefit Dimensions reserves the right to modify the copay tier of a particular drug as necessary. For example, the copay tier of a brand drug will be raised from Tier 2 to Tier 3 when a generic drug becomes available (the generic drug will be placed in copay Tier 1). -
Contact Dermatitis to Medications and Skin Products
Clinical Reviews in Allergy & Immunology (2019) 56:41–59 https://doi.org/10.1007/s12016-018-8705-0 Contact Dermatitis to Medications and Skin Products Henry L. Nguyen1 & James A. Yiannias2 Published online: 25 August 2018 # Springer Science+Business Media, LLC, part of Springer Nature 2018 Abstract Consumer products and topical medications today contain many allergens that can cause a reaction on the skin known as allergic contact dermatitis. This review looks at various allergens in these products and reports current allergic contact dermatitis incidence and trends in North America, Europe, and Asia. First, medication contact allergy to corticosteroids will be discussed along with its five structural classes (A, B, C, D1, D2) and their steroid test compounds (tixocortol-21-pivalate, triamcinolone acetonide, budesonide, clobetasol-17-propionate, hydrocortisone-17-butyrate). Cross-reactivities between the steroid classes will also be examined. Next, estrogen and testosterone transdermal therapeutic systems, local anesthetic (benzocaine, lidocaine, pramoxine, dyclonine) antihistamines (piperazine, ethanolamine, propylamine, phenothiazine, piperidine, and pyrrolidine), top- ical antibiotics (neomycin, spectinomycin, bacitracin, mupirocin), and sunscreen are evaluated for their potential to cause contact dermatitis and cross-reactivities. Finally, we examine the ingredients in the excipients of these products, such as the formaldehyde releasers (quaternium-15, 2-bromo-2-nitropropane-1,3 diol, diazolidinyl urea, imidazolidinyl urea, DMDM hydantoin), the non- formaldehyde releasers (isothiazolinones, parabens, methyldibromo glutaronitrile, iodopropynyl butylcarbamate, and thimero- sal), fragrance mixes, and Myroxylon pereirae (Balsam of Peru) for contact allergy incidence and prevalence. Furthermore, strategies, recommendations, and two online tools (SkinSAFE and the Contact Allergen Management Program) on how to avoid these allergens in commercial skin care products will be discussed at the end.