Blue Cross and Blue Shield April 2021 Multi-Tier Basic Drug List
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A Comparison of Fluticasone Propionate, 1 Mg Daily, with Beclomethasone Dipropionate, 2 Mg Daily, in the Treatment of Severe Asthma
Copyright ©ERS Joumals Ltd 1993 Eur Respir J , 1993, 6, Sn-884 European Respiratory Joumal Printed in UK - all rights reserved ISSN 0903 - 1936 A comparison of fluticasone propionate, 1 mg daily, with beclomethasone dipropionate, 2 mg daily, in the treatment of severe asthma N.C. Bames*, G. Marone**, G.U. Di Maria***, S. Visser, I. Utama++, S.L. Payne+++, on behalf of an International Study Group A comparison of fluticasone propionate. 1 mg daily, with beclomethasone dipropionate, • The London Chest Hospital, London, 2 mg daily, in the treatment of severe asthma. N. C. Bames, G. Marone, G.U. Di Maria, UK. ** Servizio di Allergologia e S. Visser. l Utama, S.L Payne, on behalf of an International Study Group. @ERS Immunologia Clinica. I Clinica Medica Journals Ltd 1993. Universita, Napoli, Italy. *** lnstituto Malattie Respiratorie, Ospedale Tomaselli, ABSTRACT: We wanted w compare the efficacy and safety of fluticasone propi Catania, Sicily, Italy. onate, a new topically active inhaled corticosteroid, to that of high dose beclo + H.F. Verwoerd Hospital, Pretoria, South methasone dipropionate, in severe adult asthma. Africa. ++ St Laurentius Ziekenhius, 1 Patients currently receiving between 1.5-2.0 mg·day- of an inhaled corticoster CV Roermond, The Netherlands. +++ oid were treated for six weeks in a double-blind, randomized, parallel group study Glaxo Group Research Ltd, Greenford, with 1 mg·day-1 fluticasone propionate (n•82), or 2 mg·day·1 beclometbasone Middlesex, UK. dipropionate (n•72). Mean morning peak expirarory flow rates (PEFR) increased from 303 w 321 Correspondence: N.C. Bames l·min-1 with fluticasone propionate, and from 294 w 319 l·min·1 with beclometbasone The London Chest Hospital dipropionate. -
Flonase Sensimist Allergy Relief (Fluticasone Furoate)
Flonase® Sensimist™ Allergy Relief (fluticasone furoate) – Rx-to-OTC Approval • On February 8, 2017, GlaxoSmithKline Consumer Healthcare announced the launch of Flonase Sensimist Allergy Relief (fluticasone furoate) nasal spray, as an over the counter (OTC) treatment to temporarily relieve symptoms of hay fever or other upper respiratory allergies: nasal congestion; runny nose; sneezing; itchy nose; and itchy, watery eyes (in ages 12 years and older). — Flonase Sensimist Allergy Relief contains 27.5 mcg/spray of fluticasone furoate. — Flonase Sensimist Allergy Relief should not be used in children less than 2 years of age. • Previously, fluticasone furoate was only available by prescription as Veramyst®. Veramyst is no longer commercially available. • Fluticasone is also available OTC as brand (Flonase® Allergy Relief, Children’s Flonase® Allergy Relief) and generic products containing 50 mcg/spray of fluticasone propionate. — These products share the same indications as Flonase Sensimist Allergy Relief, but are not intended for children under 4 years of age. • Prescription fluticasone propionate nasal spray (50 mcg/spray) is available generically and indicated for the management of the nasal symptoms of perennial non-allergic rhinitis in adult and pediatric patients aged 4 years and older. • Warnings for Flonase Sensimist Allergy Relief state the following: — Do not use: in children under 2 years of age, to treat asthma, if there is an injury or surgery to the nose that is not fully healed, or if an allergic reaction to Flonase Sensimist Allergy Relief or any of its ingredients has occurred. — Ask a doctor prior to use if the patient has or had glaucoma or cataracts. -
Effects of Selexipag and Its Active Metabolite in Contrasting The
Cutolo et al. Arthritis Research & Therapy (2018) 20:77 https://doi.org/10.1186/s13075-018-1577-0 RESEARCH ARTICLE Open Access Effects of selexipag and its active metabolite in contrasting the profibrotic myofibroblast activity in cultured scleroderma skin fibroblasts Maurizio Cutolo1*, Barbara Ruaro1, Paola Montagna1, Renata Brizzolara1, Emanuela Stratta2, Amelia Chiara Trombetta1, Stefano Scabini2, Pier Paolo Tavilla3, Aurora Parodi3, Claudio Corallo4, Nicola Giordano4, Sabrina Paolino1, Carmen Pizzorni1, Alberto Sulli1, Vanessa Smith5 and Stefano Soldano1 Abstract Background: Myofibroblasts contribute to fibrosis through the overproduction of extracellular matrix (ECM) proteins, primarily type I collagen (COL-1) and fibronectin (FN), a process which is mediated in systemic sclerosis (SSc) by the activation of fibrogenic intracellular signaling transduction molecules, including extracellular signal-regulated kinases 1 and 2 (Erk1/2) and protein kinase B (Akt). Selexipag is a prostacyclin receptor agonist synthesized for the treatment of pulmonary arterial hypertension. The study investigated the possibility for selexipag and its active metabolite (ACT-333679) to downregulate the profibrotic activity in primary cultures of SSc fibroblasts/myofibroblasts and the fibrogenic signaling molecules involved. Methods: Fibroblasts from skin biopsies obtained with Ethics Committee (EC) approval from patients with SSc, after giving signed informed consent, were cultured until the 3rd culture passage and then either maintained in normal growth medium (untreated cells) or independently treated with different concentrations of selexipag (from 30 μMto 0.3 μM) or ACT-333679 (from 10 μMto0.1μM) for 48 h. Protein and gene expressions of α-smooth muscle actin (α-SMA), fibroblast specific protein-1 (S100A4), COL-1, and FN were investigated by western blotting and quantitative real-time PCR. -
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 -
Uncertainty Reigns in Error Disclosure Debate
74 Practice Trends S K I N & A L L E R G Y N E W S • August 2008 Uncertainty Reigns in Error Disclosure Debate B Y J A N E M . A N D E R S O N ington, Seattle, told attendees at the annual desire full disclosure of harmful errors, harmful to the patient,” Dr. Gallagher said. Contributing Writer meeting of the American College of Physi- while at the same time worrying that The University of Washington recently cians that physicians are unsure about what health care workers might hide them. In surveyed 4,000 physicians about commu- WA S H I N G T O N — Physicians generally to include when they disclose a medical er- disclosure, they want “an explicit state- nication with patients, colleagues, and believe that medical errors—especially ror. But he added that physicians are ac- ment that an error occurred,” details of health care institutions about errors. those that cause an adverse event—should tively debating the best way to proceed. what happened, and the implications for According to Dr. Gallagher, the survey be disclosed to patients, but there is dis- “Over the next 5 years, we’re going to see their health, he said. on error disclosure was sent to 2,000 physi- agreement about the level of detail that very exciting changes,” he said. “I think Physicians define errors more narrowly cians in Washington State and 2,000 Cana- should be provided, according to a physi- physicians as a profession will be leading than patients do. They agree in principle dian physicians. -
Connecticut Medicaid
ACNE AGENTS, TOPICAL ‡ ANGIOTENSIN MODULATOR COMBINATIONS ANTICONVULSANTS, CONT. CONNECTICUT MEDICAID (STEP THERAPY CATEGORY) AMLODIPINE / BENAZEPRIL (ORAL) LAMOTRIGINE CHEW DISPERS TAB (not ODT) (ORAL) (DX CODE REQUIRED - DIFFERIN, EPIDUO and RETIN-A) AMLODIPINE / OLMESARTAN (ORAL) LAMOTRIGINE TABLET (IR) (not ER) (ORAL) Preferred Drug List (PDL) ACNE MEDICATION LOTION (BENZOYL PEROXIDE) (TOPICAL)AMLODIPINE / VALSARTAN (ORAL) LEVETIRACETAM SOLUTION, IR TABLET (not ER) (ORAL) • The Connecticut Medicaid Preferred Drug List (PDL) is a BENZOYL PEROXIDE CREAM, WASH (not FOAM) (TOPICAL) OXCARBAZEPINE TABLET (ORAL) listing of prescription products selected by the BENZOYL PEROXIDE 5% and 10% GEL (OTC) (TOPICAL) ANTHELMINTICS PHENOBARBITAL ELIXIR, TABLET (ORAL) Pharmaceutical and Therapeutics Committee as efficacious, BENZOYL PEROXIDE 6% CLEANSER (OTC) (TOPICAL) ALBENDAZOLE TABLET (ORAL) PHENYTOIN CHEW TABLET, SUSPENSION (ORAL) safe and cost effective choices when prescribing for HUSKY CLINDAMYCIN PH 1% PLEGET (TOPICAL) BILTRICIDE TABLET (ORAL) PHENYTOIN SOD EXT CAPSULE (ORAL) A, HUSKY C, HUSKY D, Tuberculosis (TB) and Family CLINDAMYCIN PH 1% SOLUTION (not GEL or LOTION) (TOPICAL)IVERMECTIN TABLET (ORAL) PRIMIDONE (ORAL) Planning (FAMPL) clients. CLINDAMYCIN / BENZOYL PEROXIDE 1.2%-5% (DUAC) (TOPICAL) SABRIL 500 MG POWDER PACK (ORAL) • Preferred or Non-preferred status only applies to DIFFERIN 0.1% CREAM (TOPICAL) (not OTC GEL) (DX CODE REQ.) ANTI-ALLERGENS, ORAL SABRIL TABLET (ORAL) those medications that fall within the drug classes DIFFERIN -
FLONASE (Fluticasone Propionate) Nasal Spray Bacterial, Viral, Or Parasitic Infection; Ocular Herpes Simplex)
HIGHLIGHTS OF PRESCRIBING INFORMATION • Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, These highlights do not include all the information needed to use contact dermatitis, rash) have been reported after administration of FLONASE safely and effectively. See full prescribing information for FLONASE nasal spray. Discontinue FLONASE nasal spray if such FLONASE. reactions occur. (5.3) • Potential worsening of infections (e.g., existing tuberculosis; fungal, FLONASE (fluticasone propionate) nasal spray bacterial, viral, or parasitic infection; ocular herpes simplex). Use with Initial U.S. Approval: 1994 caution in patients with these infections. More serious or even fatal course --------------------------- RECENT MAJOR CHANGES --------------------------- of chickenpox or measles can occur in susceptible patients. (5.4) • Hypercorticism and adrenal suppression may occur with very high Warnings and Precautions, Glaucoma and Cataracts (5.2) 1/2019 dosages or at the regular dosage in susceptible individuals. If such --------------------------- INDICATIONS AND USAGE ---------------------------- changes occur, discontinue FLONASE nasal spray slowly. (5.5) FLONASE nasal spray is a corticosteroid indicated for the management of the • Monitor growth of pediatric patients. (5.7) nasal symptoms of perennial nonallergic rhinitis in adult and pediatric patients ------------------------------ ADVERSE REACTIONS ------------------------------ aged 4 years and older. (1) The most common adverse reactions (>3%) are headache, pharyngitis, ----------------------- DOSAGE AND ADMINISTRATION ----------------------- epistaxis, nasal burning/nasal irritation, nausea/vomiting, asthma symptoms, For intranasal use only. Recommended starting dosages: and cough. (6.1) • Adults: 2 sprays per nostril once daily (200 mcg per day). (2.1) To report SUSPECTED ADVERSE REACTIONS, contact • Adolescents and children aged 4 years and older: 1 spray per nostril once GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or daily (100 mcg per day). -
Effect of Prostanoids on Human Platelet Function: an Overview
International Journal of Molecular Sciences Review Effect of Prostanoids on Human Platelet Function: An Overview Steffen Braune, Jan-Heiner Küpper and Friedrich Jung * Institute of Biotechnology, Molecular Cell Biology, Brandenburg University of Technology, 01968 Senftenberg, Germany; steff[email protected] (S.B.); [email protected] (J.-H.K.) * Correspondence: [email protected] Received: 23 October 2020; Accepted: 23 November 2020; Published: 27 November 2020 Abstract: Prostanoids are bioactive lipid mediators and take part in many physiological and pathophysiological processes in practically every organ, tissue and cell, including the vascular, renal, gastrointestinal and reproductive systems. In this review, we focus on their influence on platelets, which are key elements in thrombosis and hemostasis. The function of platelets is influenced by mediators in the blood and the vascular wall. Activated platelets aggregate and release bioactive substances, thereby activating further neighbored platelets, which finally can lead to the formation of thrombi. Prostanoids regulate the function of blood platelets by both activating or inhibiting and so are involved in hemostasis. Each prostanoid has a unique activity profile and, thus, a specific profile of action. This article reviews the effects of the following prostanoids: prostaglandin-D2 (PGD2), prostaglandin-E1, -E2 and E3 (PGE1, PGE2, PGE3), prostaglandin F2α (PGF2α), prostacyclin (PGI2) and thromboxane-A2 (TXA2) on platelet activation and aggregation via their respective receptors. Keywords: prostacyclin; thromboxane; prostaglandin; platelets 1. Introduction Hemostasis is a complex process that requires the interplay of multiple physiological pathways. Cellular and molecular mechanisms interact to stop bleedings of injured blood vessels or to seal denuded sub-endothelium with localized clot formation (Figure1). -
Nanosuspensions of Selexipag: Formulation, Characterization, and in Vitro Evaluation Rusul M
Iraqi J Pharm Sci, Vol.30(1) 2021 Selexipag nanosuspension DOI : https://doi.org/10.31351/vol30iss1pp144-153 Nanosuspensions of Selexipag: Formulation, Characterization, and in vitro Evaluation Rusul M. Alwan*,1 and Nawal A. Rajab** * Ministry of Health and Environment, Najaf Health Department, Najaf, Iraq. **Department of Pharmaceutics, College of Pharmacy, University of Baghdad, Baghdad, Iraq. Abstract Selexipag(SLP) is an orally selective long-acting prostacyclin receptor agonist indicated for pulmonary arterial hypertension treatment. It is practically insoluble in water (class II, according to BCS). This work aims to prepare and optimize Selexipag nanosuspensions (SLPNS) to enhance the saturation solubility and in vitro dissolution rate. The solvent antisolvent precipitation method was used for the production of NS, and the effect of formulation parameters (stabilizer type, drug: stabilizer ratio, and use of co-stabilizer) and process parameter (stirring speed) on the particle size (P.S) and polydispersity index (PDI) were studied. The result revealed that the P.S of all prepared SLPNS formulation was in the nanometer range, except for the formulas that stabilized by Poloxamer. The optimal SLPNS (F15), which is stabilized by Soluplus® (SLP: stabilizer ratio 1:2) and prepared at a stirring speed of 1000 rpm, showed the smallest P.S and appropriate PDI, which are 47 nm and 0.073. The formula F5 exhibits 136 folds, an increase in the saturation solubility, and an enhancement in the dissolution rate in phosphate buffer pH 6.8 (100% drug release during 60 min) compared to the pure drug. This result indicates that SLPNS is an efficient way for improving the saturation solubility and the dissolution rate of SLP. -
Utah Medicaid Pharmacy and Therapeutics Committee Drug
Utah Medicaid Pharmacy and Therapeutics Committee Drug Class Review Single Ingredient Nasal Corticosteroids Beclomethasone dipropionate (Qnasl) Beclomethasone dipropionate monohydrate (Beconase AQ) Budesonide (Rhinocort) Ciclesonide (Omnaris, Zetonna) Flunisolide (Generic) Fluticasone Furoate (Flonase Sensimist) Fluticasone Propionate (Flonase, Xhance) Mometasone Furoate (Nasonex) Triamcinolone Acetonide (Nasacort) AHFS Classification: 52.08.08 Corticosteroids (EENT) Final Report February 2018 Review prepared by: Valerie Gonzales, Pharm.D., Clinical Pharmacist Elena Martinez Alonso, B.Pharm., MSc MTSI, Medical Writer Vicki Frydrych, Pharm.D., Clinical Pharmacist Joanita Lake, B.Pharm., MSc EBHC (Oxon), Research Assistant Professor Joanne LaFleur, Pharm.D., MSPH, Associate Professor University of Utah College of Pharmacy University of Utah College of Pharmacy, Drug Regimen Review Center Copyright © 2018 by University of Utah College of Pharmacy Salt Lake City, Utah. All rights reserved Contents Abbreviations ................................................................................................................................................ 2 Executive Summary ....................................................................................................................................... 3 Introduction .................................................................................................................................................. 5 Table 1. Nasal corticosteroid products ............................................................................................. -
Version 10 February 2012
CMDh/223/2005 February 2014 Public Assessment Report Scientific discussion Zoreeda 25 Mikrogramm/125 Mikrogramm pro Dosis - Druckgasinhalation, Suspension Zoreeda 25 Mikrogramm/250 Mikrogramm pro Dosis - Druckgasinhalation, Suspension Fluticasone propionate, Salmeterol xinafoate Date: 11.05.2015 This module reflects the scientific discussion for the approval of Salmeterol plus Fluticason Propionat momaja 25 Mikrogramm/250 Mikrogramm Druckgasinhalator, Suspension and Salmeterol plus Fluticason-propionat momaja 25 Mikrogramm/125 Mikrogramm Druckgasinhalator, Suspension. The procedure was finalised at 04.08.2014. For information on changes after this date please refer to the module ‘Update’. 1/26 I. INTRODUCTION Based on the review of the quality, safety and efficacy data, the Member States have granted a marketing authorisation for Zoreeda 25 Mikrogramm/125 Mikrogramm pro Dosis - Druckgasinhalation, Suspension and Zoreeda 25 Mikrogramm/250 Mikrogramm pro Dosis - Druckgasinhalation, from Cipla Europe NV. The product is indicated in the regular treatment of asthma where use of a combination product (long-acting beta-2-agonist and inhaled corticosteroid) is appropriate: - patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short acting beta-2-agonist or - patients already adequately controlled on both inhaled corticosteroids and long-acting beta-2-agonist. A comprehensive description of the indications and posology is given in the SmPC. The marketing authorisation has been granted pursuant to Article 10(3)of Directive 2001/83/EC. Fluticasone propionate is a glucocorticoid anti-asthmatic inhalant (anti-inflammatory). Salmeterol xinafoate is a selective beta-2-adrenoceptor agonist (bronchodilator). II. QUALITY ASPECTS II.1 Introduction Salmeterol xinafoate and fluticasone propionate pressurised inhalation suspension comprises an aluminium canister with a suitable metering valve and a plastic actuator with dose indicator and fitted with dustcap in pouch with a silica gel bag. -
Formulation and Optimization of Lyophilized Selexipag Nanocrystals to Improve the Saturation Solubility and Dissolution Rate
Sys Rev Pharm 2020;11(11):596-605 A multifaceted review journal in the field of pharmacy Formulation and Optimization of Lyophilized Selexipag Nanocrystals to Improve the Saturation Solubility and Dissolution Rate Rusul M. Alwana*, Nawal A. Rajab, Areej W. Alhagiesac a* b Ministry of Health and Environment, Najaf health department, Najaf, Iraq. c Department of Pharmaceutics, College of Pharmacy, University of Baghdad, Baghdad, Iraq * Department of Pharmaceutics, College of Pharmacy, University of Kufa, Najaf, Iraq Corresponding author Email: [email protected] Phone number: 07831480928 Abstract Selexipag is first in class orally active, selective non- Keywords: Selexipag, Nanocrystal, nanosuspension, prostanoid prostacyclin receptor agonist with a long half- Selexipag nanocrystals. life. It has low oral bioavailability due to a poor dissolution rate, which is considered a rate-limiting step for drug absorption. Nanocrystals (NCs) formulation is an attractive approach for enhancing the poorly soluble drug's saturation solubility and dissolution rate. They offer the advantages of crystalline state, high drug loading capacity, and simple preparation method. This study aims to prepare and characterize Selexipag NCs, filled in hard gelatin capsule in attempt to improve its solubility and dissolution rate. The effect of stabilizer type and preparation methods on the NC particle size and polydispersity index were evaluated to select the most stable formula. The results revealed that the formula (F7) prepared by the solvent antisolvent precipitation with the ultrasonication method (which contain SLX: Soluplus® at a ratio of 1:2) has the smallest mean particle size (38.5 nm) and appropriate polydispersity index (0.12); hence it was selected as the optimal formula.