Mometasone Powder Rationale for Inclusion In

Total Page:16

File Type:pdf, Size:1020Kb

Mometasone Powder Rationale for Inclusion In MOMETASONE POWDER RATIONALE FOR INCLUSION IN PA PROGRAM Background Mometasone is a corticosteroid demonstrating potent anti-inflammatory activity able to decrease inflammation through a mechanism of action that is not known. However, corticosteroids are thought to act by the induction of phospholipase A2, which leads to the inhibition of a common precursor for potent inflammatory mediators. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption (1). Mometasone is commercially available in the following dosage forms: topical cream, topical lotion, topical ointment, nasal spray and as a powder for inhalation. Regulatory Status FDA approved topical indication: Mometasone is a corticosteroid indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age and older (1). The safety and efficacy of mometasone have not been established in pediatric patients below 2 years of age (1). Summary Topical steroids have anti-inflammatory, antipruritic, and vasoconstrictive properties. Mometasone is FDA-approved for inflammatory and pruritic manifestations of corticosteroid- responsive dermatoses in patients 2 years of age and older. The safety and efficacy of mometasone have not been established in pediatric patients below 2 years of age (1). Mometasone is commercially available in the following dosage forms: topical cream, topical lotion, topical ointment, nasal spray and as powder for inhalation. Mometasone powder may be considered medically necessary in a topical formulation for patients 2 years of age or older for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Mometasone powder may be considered investigational in a topical formulation for patients Mometasone Powder FEP Clinical Rationale MOMETASONE POWDER under the age of 2 years, or in patients without a diagnosis of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Prior authorization is required to ensure the safe, clinically appropriate and cost effective use of mometasone powder while maintaining optimal therapeutic outcomes. References Elocon [package insert]. Whitehouse Station, NJ: Merck Sharp & Dohme Corp.; Revised April 2013. Mometasone Powder FEP Clinical Rationale .
Loading...
Loading...

—— Preview end. ——

Recommended publications
  • Using Rheology Measurement As a Potentially Predictive Tool for Solder Paste Transfer Efficiency and Print Volume Consistency
    USING RHEOLOGY MEASUREMENT AS A POTENTIALLY PREDICTIVE TOOL FOR SOLDER PASTE TRANSFER EFFICIENCY AND PRINT VOLUME CONSISTENCY Mitch Holtzer, Karen Tellefsen and Westin Bent Alpha Assembly Solutions South Plainfield, NJ, USA mitch.holtzer@alphaassembly.com ABSTRACT Commercially available solder pastes use an upper and Industry standards such as J-STD-005 and JIS Z 3284-1994 lower limit for viscosity. Generally, this viscosity is call for the use of viscosity measurement(s) as a quality measured at one shear rate, typically the shear associated assurance test method for solder paste. Almost all solder with a spiral viscometer rotating at 10 revolutions per paste produced and sold use a viscosity range at a single minute (RPM). If the powder contained in solder paste is shear rate as part of the pass fail criteria for shipment and dissolved by the acid activator in the solder paste flux, the customer acceptance respectively. viscosity of the solder paste will quickly increase. If the viscosity increases more than 20 to 30% above the upper As had been reported many times, an estimated 80% of the limit of the specification, poor printing results will be highly defects associated with the surface mount technology likely. The solder paste will not roll evenly over the stencil process involve defects created during the printing process. and apertures in the stencil will remain unfilled, causing Viscosity at a single shear rate could predict a fatal flaw in skips in the paste printing pattern. the printability of a solder paste sample. However, false positive single shear rate viscosity readings are not The purpose of the study was to determine if there is a unknown.
    [Show full text]
  • Zhejiang Xianju Pharmaceutical Co. Ltd
    No.1, Xianyao Road, Xianju, Zhejiang, China, 317300 Xianju Pharma Outline Outline I. Brief Introduction II. Quality Unit III. Production System IV. EHS System I. Brief Introduction Xianju Pharma Zhejiang Xianju Pharmaceutical Co., Ltd. A professional manufacturer of steroids and hormone products with largest scale and maximum varieties in China. A state-designated manufacturer of contraceptive drugs in China. Company Milestones Jan 1972 Foundation of company May 1997 Incorporated into Zhejiang Medicine Co., Ltd Oct. 1999 Listed in Shanghai Stock Market Jun. 2000 Reorganized into Xianju Pharmaceutical Co., Ltd Dec. 2001 Reformed to Zhejiang Xianju Pharmaceutical Co., Ltd Jan. 2010 listed in Shenzhen Stock Market Location of Xianju There are six airports around Shanghai Xianju, which makes us easily accessible for our partners. Headquarter Hangzhou Located in Xianju, Taizhou City Ningbo Yangfu Site (FPPs) Located in Yangfu, Xianju, Taizhou Yiwu City 6.8km from headquarter Duqiao Site (APIs) Located in LinHai, TaiZhou City, 82.9km from headquarter Taizhou Wenzhou Yangfu Site (APIs) Under construction, finish at 2017 Company Organization General Manager Vice G.M for Vice G.M Vice G.M for Vice G.M for Vice G.M for Quality Director Sales for Market Administration Finance Technology Finance Dept Finance Dept Application Tech Dept Endineering Construction Domestic DrugRegistrationDept. Research& Development Dept. Marketing Dept. Marketing Quality Control Quality Domestic Trading Dept International TradeDep Quality Assurance For FPP Quality Assurance For API Regulatory AffairsDept Human Resource Dept Information Technology Dept Dept Enterprise Management Dept Affairs Administrative Taizhou Xianju Quality System Quality Xianju Taizhou . t G.M. Assistant EHS Dept Production Management Dept G.M.
    [Show full text]
  • This Fact Sheet Provides Information to Patients with Eczema and Their Carers. About Topical Corticosteroids How to Apply Topic
    This fact sheet provides information to patients with eczema and their carers. About topical corticosteroids You or your child’s doctor has prescribed a topical corticosteroid for the treatment of eczema. For treating eczema, corticosteroids are usually prepared in a cream or ointment and are applied topically (directly onto the skin). Topical corticosteroids work by reducing inflammation and helping to control an over-reactive response of the immune system at the site of eczema. They also tighten blood vessels, making less blood flow to the surface of the skin. Together, these effects help to manage the symptoms of eczema. There is a range of steroids that can be used to treat eczema, each with different strengths (potencies). On the next page, the potencies of some common steroids are shown, as well as the concentration that they are usually used in cream or ointment preparations. Using a moisturiser along with a steroid cream does not reduce the effect of the steroid. There are many misconceptions about the side effects of topical corticosteroids. However these treatments are very safe and patients are encouraged to follow the treatment regimen as advised by their doctor. How to apply topical corticosteroids How often should I apply? How much should I apply? Apply 1–2 times each day to the affected area Enough cream should be used so that the of skin according to your doctor’s instructions. entire affected area is covered. The cream can then be rubbed or massaged into the Once the steroid cream has been applied, inflamed skin. moisturisers can be used straight away if needed.
    [Show full text]
  • Orally Inhaled & Nasal Drug Products
    ORALLY INHALED & NASAL DRUG PRODUCTS: INNOVATIONS FROM MAJOR DELIVERY SYSTEM DEVELOPERS www.ondrugdelivery.com 00349_GF_OnDrugDelivery349_GF_OnDrugDelivery PulmonaryPulmonary NasalNasal NovemberNovember 2010.indd2010.indd 1 330/11/100/11/10 111:32:331:32:33 “Orally Inhaled & Nasal Drug Products: Innovations from Major Delivery CONTENTS System Developers” This edition is one in the ONdrugDelivery series of pub- Innovation in Drug Delivery by Inhalation lications from Frederick Furness Publishing. Each issue focuses on a specific topic within the field of drug deliv- Andrea Leone-Bay, Vice-President, Pharmaceutical ery, and is supported by industry leaders in that field. Development, Dr Robert Baughman, Vice-President, Clinical Pharmacology & Bioanalytics, Mr Chad EDITORIAL CALENDAR 2011: Smutney, Senior Director, Device Technology, February: Prefilled Syringes Mr Joseph Kocinsky, Senior Vice-President, March: Oral Drug Delivery & Advanced Excipients Pharmaceutical Technology Development April: Pulmonary & Nasal Drug Delivery (OINDP) MannKind Corporation 4-7 May: Injectable Drug Delivery (Devices Focus) June: Injectable Drug Delivery (Formulations Focus) Current Innovations in Dry Powder Inhalers September: Prefilled Syringes Richard Sitz, Technical Manager, DPI Technology October: Oral Drug Delivery Platform Leader November: Pulmonary & Nasal Drug Delivery (OINDP) 3M Drug Delivery Systems 10-12 December: Delivering Biologics (Proteins, Peptides & Nucleotides) Pulmonary Delivery & Dry-Powder Inhalers: SUBSCRIPTIONS: Advances in Hard-Capsule
    [Show full text]
  • An Introduction to Fast Dissolving Oral Thin Film Drug Delivery Systems: a Review
    Muthadi Radhika Reddy /J. Pharm. Sci. & Res. Vol. 12(7), 2020, 925-940 An Introduction to Fast Dissolving Oral Thin Film Drug Delivery Systems: A Review Muthadi Radhika Reddy1* 1School of pharmacy, Gurunanak Institute of Technical Campus, Hyderabad, Telangana, India and Department of Pharmacy, Gandhi Institute of Technology and Management University, Vizag, Andhra Pradesh, India INTRODUCTION 2. Useful in situations where rapid onset of action Fast dissolving drug delivery systems were first developed required such as in motion sickness, allergic attack, in the late 1970s as an alternative to conventional dosage coughing or asthma forms. These systems consist of solid dosage forms that 3. Has wide range of applications in pharmaceuticals, Rx disintegrate and dissolve quickly in the oral cavity without Prescriptions and OTC medications for treating pain, the need of water [1]. Fast dissolving drug delivery cough/cold, gastro-esophageal reflux disease,erectile systems include orally disintegrating tablets (ODTs) and dysfunction, sleep disorders, dietary supplements, etc oral thin films (OTFs). The Centre for Drug Evaluation [4] and Research (CDER) defines ODTs as,“a solid dosage 4. No water is required for the administration and hence form containing medicinal substances which disintegrates suitable during travelling rapidly, usually within a matter of seconds, when placed 5. Some drugs are absorbed from the mouth, pharynx upon the tongue” [2]. USFDA defines OTFs as, “a thin, and esophagus as the saliva passes down into the flexible, non-friable polymeric film strip containing one or stomach, enhancing bioavailability of drugs more dispersed active pharmaceutical ingredients which is 6. May offer improved bioavailability for poorly water intended to be placed on the tongue for rapid soluble drugs by offering large surface area as it disintegration or dissolution in the saliva prior to disintegrates and dissolves rapidly swallowing for delivery into the gastrointestinal tract” [3].
    [Show full text]
  • Superior Nuclear Receptor Selectivity and Therapeutic Index of Methylprednisolone Aceponate Versus Mometasone Furoate
    DOI:10.1111/j.1600-0625.2007.00597.x www.blackwellpublishing.com/EXD Original Article Superior nuclear receptor selectivity and therapeutic index of methylprednisolone aceponate versus mometasone furoate Parham Mirshahpanah1, Wolf-Dietrich Do¨ cke2, Udo Merbold2, Khusru Asadullah2, Lars Ro¨se2, Heike Scha¨ cke2 and Thomas M. Zollner1 1Research Business Area Dermatology, Berlex Biosciences, Richmond, CA, USA; 2Corporate Research Area Inflammation, Bayer Schering Pharma, Berlin, Germany Correspondence: Thomas M. Zollner, TRG Inflammation, Bayer Schering Pharma, Berlin, Germany, Tel.: +1 510 669 4272, e-mail: Thomas.Zollner@bayerhealthcare.com Accepted for publication 18 June 2007 Abstract: Although introduced more than 50 years ago, topical a relevant rodent model in vivo. We demonstrate that glucocorticoids are still the first line therapy for many methylprednisolone aceponate displays higher specificity in inflammatory skin disorders such as atopic eczema, contact nuclear receptor binding compared with mometasone furoate. dermatitis and many others. Recently, significant improvements Methylprednisolone aceponate was also markedly superior in have been made to optimize the ratio of desired to unwanted terms of minimizing induction of skin atrophy or telangiectasias effects. While with early compounds such as triamcinolone, when compared with mometasone furoate. Based on these topical side effects such as skin atrophy and telangiectasias can be observations, methylprednisolone aceponate is expected to have a observed rather frequently, newer drugs such as methyl- greater therapeutic index as compared with mometasone furoate, prednisolone aceponate or mometasone furoate have a at least in the test systems used here. The degree to which this significantly improved therapeutic index. The present study observation may translate into a clinical setting requires compared these two modern topical glucocorticoids, which confirmation.
    [Show full text]
  • The Inhaled Steroid Ciclesonide Blocks SARS-Cov-2 RNA Replication by Targeting Viral
    bioRxiv preprint doi: https://doi.org/10.1101/2020.08.22.258459; this version posted August 24, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder. All rights reserved. No reuse allowed without permission. 1 The inhaled steroid ciclesonide blocks SARS-CoV-2 RNA replication by targeting viral 2 replication-transcription complex in culture cells 3 4 Shutoku Matsuyamaa#, Miyuki Kawasea, Naganori Naoa, Kazuya Shiratoa, Makoto Ujikeb, Wataru 5 Kamitanic, Masayuki Shimojimad, and Shuetsu Fukushid 6 7 aDepartment of Virology III, National Institute of Infectious Diseases, Tokyo, Japan 8 bFaculty of Veterinary Medicine, Nippon Veterinary and Life Science University, Tokyo, Japan 9 cDepartment of Infectious Diseases and Host Defense, Gunma University Graduate School of 10 Medicine, Gunma, Japan 11 dDepartment of Virology I, National Institute of Infectious Diseases, Tokyo, Japan. 12 13 Running Head: Ciclesonide blocks SARS-CoV-2 replication 14 15 #Address correspondence to Shutoku Matsuyama, matuyama@nih.go.jp 16 17 Word count: Abstract 149, Text 3,016 bioRxiv preprint doi: https://doi.org/10.1101/2020.08.22.258459; this version posted August 24, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder. All rights reserved. No reuse allowed without permission. 18 Abstract 19 We screened steroid compounds to obtain a drug expected to block host inflammatory responses and 20 MERS-CoV replication. Ciclesonide, an inhaled corticosteroid, suppressed replication of MERS-CoV 21 and other coronaviruses, including SARS-CoV-2, the cause of COVID-19, in cultured cells. The 22 effective concentration (EC90) of ciclesonide for SARS-CoV-2 in differentiated human bronchial 23 tracheal epithelial cells was 0.55 μM.
    [Show full text]
  • SODIUM POLYSTYRENE SULFONATE, USP Cation-Exchange Resin
    Kayexalate® SODIUM POLYSTYRENE SULFONATE, USP Cation-Exchange Resin DESCRIPTION Kayexalate, brand of sodium polystyrene sulfonate is a benzene, diethenyl-polymer, with ethenylbenzene, sulfonated, sodium salt and has the following structural formula: The drug is a cream to light brown finely ground, powdered form of sodium polystyrene sulfonate, a cation-exchange resin prepared in the sodium phase with an in vitro exchange capacity of approximately 3.1 mEq (in vivo approximately 1 mEq) of potassium per gram. The sodium content is approximately 100 mg (4.1 mEq) per gram of the drug. It can be administered orally or in an enema. CLINICAL PHARMACOLOGY As the resin passes along the intestine or is retained in the colon after administration by enema, the sodium ions are partially released and are replaced by potassium ions. For the most part, this action occurs in the large intestine, which excretes potassium ions to a greater degree than does the small intestine. The efficiency of this process is limited and unpredictably variable. It commonly approximates the order of 33 percent but the range is so large that definitive indices of electrolyte balance must be clearly monitored. Metabolic data are unavailable. INDICATION AND USAGE Kayexalate is indicated for the treatment of hyperkalemia. CONTRAINDICATIONS Kayexalate is contraindicated in the following conditions: patients with hypokalemia, patients with a history of hypersensitivity to polystyrene sulfonate resins, obstructive bowel disease, neonates with reduced gut motility (postoperatively or drug induced) and oral administration in neonates (see PRECAUTIONS). WARNINGS Intestinal Necrosis: Cases of intestinal necrosis, which may be fatal, and other serious gastrointestinal adverse events (bleeding, ischemic colitis, perforation) have been reported in association with Kayexalate use.
    [Show full text]
  • 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).
    [Show full text]
  • Direct-Write Fabrication of Pb(Nb,Zr,Ti)O3 Devices: Influence of Paste Rheology on Print Morphology and Component Properties
    journal J. Am. Ceram. Soc., 84 [11] 2462–68 (2001) Direct-Write Fabrication of Pb(Nb,Zr,Ti)O3 Devices: Influence of Paste Rheology on Print Morphology and Component Properties Sherry L. Morissette*,† and Jennifer A. Lewis* Department of Materials Science and Engineering, University of Illinois, Urbana, Illinois 61801 Paul G. Clem,* Joseph Cesarano III,* and Duane B. Dimos* Sandia National Laboratories, Albuquerque, New Mexico 87185 Lead niobium zirconate titanate (PNZT) pastes with tailored required before deposition of additional layers, this direct-write rheological properties have been developed for direct-write approach yields significant advantages over the conventional fabrication of thick-film capacitor elements in highly inte- method for producing multilayer devices, such as those based on grated, multifunctional electroceramic devices. Such pastes lamination of tape-cast layers with screen-printed elements, in- exhibited pseudoplastic behavior with a low shear apparent cluding the ability to modify patterned designs on-line during .viscosity of roughly 1 ؋ 106 cP. On aging, the degree of shear printing and to incorporate multiple materials in individual layers thinning and the low shear apparent viscosity decreased. The rheological requirements of thick film pastes for micropen Pastes prepared from as-received powders attained printable, printing and screen printing are nearly identical.7–9,11–17 Hence, -steady-state viscosities of ϳ2 ؋ 105 cP after 50 days of aging. commercially available screen printing pastes (e.g., silver–palla In contrast, pastes prepared from dispersant-coated powders dium conductor, ruthenium oxide resistor, and dielectric pastes) showed no measurable rheological changes after 1 day of can be readily utilized in this direct-write approach.
    [Show full text]
  • 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
    [Show full text]
  • Long Term Use of Mometasone Furoate
    Long Term Use Of Mometasone Furoate insuredBiosystematic Rickey Calhoun still ensured ban unexpectedly.his engraving unfavorably.Concretionary and beatific Marlo lives, but Vail shoddily mud her braving. Concealed and Can be inserted into the mometasone furoate nasal sprays include coughing scores How fact Is Saline Nasal Spray Good For daily Opening. Sniffing out dementia with a slight smell test Medical News Today. P224 Efficacy so long-term safety of QMF149 indacaterol. Elocon scalp lotion mometasone furoate NetDoctor. Spread of treatment with primary nasal sprays have few minutes after each side. For ah is in the terms and epidermal barrier should you use of each nostril one time or your symptoms. What to long term. Flonase And Ventolin. Maintenance Therapy With Mometasone Furoate 01. Mometasone Topical Uses Side Effects Interactions Pictures. In case we discern to way the effects of patient example of antimicrobial mouthwashes and nasal sprays on patient deaths and. You have read and do we set up long term steroid nasal corticosteroids, including all times a stinky cab or groin area. Mometasone is unlikely to dispel any lasting harmful effects if you acquaint the. Also some medications like blood pressure medicine could affect your sense of happy Cancer treatments may perhaps affect it Illness polyps chronic sinus infections or a deviated septum might cause smelling issues too. Selected Safety Information Merck Connect. Is there better safe and effective way to wean patients off long-term. Furoate monohydrate Nasal Spray 50 meg FOR INTRANASAL USE. Make sure you could be hazardous in combination with corticosteroids, ask a long periods as fluticasone furoate to check with immunosuppression and how does.
    [Show full text]