Performance Drug List - Standard Control for Clients ® with Advanced Control Specialty Formulary
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LANTUS® (Insulin Glargine [Rdna Origin] Injection)
Rev. March 2007 Rx Only LANTUS® (insulin glargine [rDNA origin] injection) LANTUS® must NOT be diluted or mixed with any other insulin or solution. DESCRIPTION LANTUS® (insulin glargine [rDNA origin] injection) is a sterile solution of insulin glargine for use as an injection. Insulin glargine is a recombinant human insulin analog that is a long-acting (up to 24-hour duration of action), parenteral blood-glucose-lowering agent. (See CLINICAL PHARMACOLOGY). LANTUS is produced by recombinant DNA technology utilizing a non- pathogenic laboratory strain of Escherichia coli (K12) as the production organism. Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Chemically, it is 21A- B B Gly-30 a-L-Arg-30 b-L-Arg-human insulin and has the empirical formula C267H404N72O78S6 and a molecular weight of 6063. It has the following structural formula: LANTUS consists of insulin glargine dissolved in a clear aqueous fluid. Each milliliter of LANTUS (insulin glargine injection) contains 100 IU (3.6378 mg) insulin glargine. Inactive ingredients for the 10 mL vial are 30 mcg zinc, 2.7 mg m-cresol, 20 mg glycerol 85%, 20 mcg polysorbate 20, and water for injection. Inactive ingredients for the 3 mL cartridge are 30 mcg zinc, 2.7 mg m-cresol, 20 mg glycerol 85%, and water for injection. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and sodium hydroxide. LANTUS has a pH of approximately 4. CLINICAL PHARMACOLOGY Mechanism of Action: The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism. -
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. -
Pre Feasibility Report for Manufacturing of Apis
Pre Feasibility Report For Manufacturing of APIs Cipla Limited Plot No. M12 & M14, Misc. Zone, Phase II, Sector III, Indore SEZ, Pithampur, District Dhar (M.P). - 454775 1 1. IDENTIFICATION OF PROJECT AND PROJECT PROPONENT: CIPLA Ltd is established in the year 1935 as a listed Public Limited Company. CIPLA is engaged in manufacturing of Bulk Drugs and Formulations of wide range of products in the form of tablets, injections, inhalers, capsules, ointment, powder, topical preparations, liquid, syrup drops, sprays, gels, suppositories etc. The company is having its registered office at Mumbai Central, Mumbai – 400 008. 80 years later, the company has become a front runner in the pharmaceutical industry, wielding the latest technology to combat disease and suffering in many ways, touching the lives of thousands the world over.The company’s products are manufactured in 25 state-of- art units. The company is having its manufacturing facilities at following locations: Locations Product Category Vikhroli- Mumbai R&D Virgonagar (Bangalore) Bulk Drugs and Formulations Bommasandra (Bangalore) Bulk Drug Patalganga Bulk Drugs and Formulations Kurkumbh Bulk Drugs and Formulations Goa Formulations Baddi Formulations Sikkim Formulations Indore Formulations The company is having well defined board of directors followed by managerial and technical team looking after entire operation. Management Council- 1. Mr. Umang Vohra - Managing Director and Global Chief Executive Officer 2. Mr. PrabirJha - Global Chief People Officer 3. Mr. KedarUpadhye - Global Chief Financial Officer 4. Dr. Ranjana Pathak - Global Head – Quality 5. Geena Malhotra - Global Head - Integrated Product Development 6. Mr. Raju Subramanyam – Global Head - Operations List of Key Executives- 1. -
Drug Information Center Highlights of FDA Activities
Drug Information Center Highlights of FDA Activities – 3/1/21 – 3/31/21 FDA Drug Safety Communications & Drug Information Updates: Ivermectin Should Not Be Used to Treat or Prevent COVID‐19: MedWatch Update 3/5/21 The FDA advised consumers against the use of ivermectin for the treatment or prevention of COVID‐19 following reports of patients requiring medical support and hospitalization after self‐medicating. Ivermectin has not been approved for this use and is not an anti‐viral drug. Health professionals are encouraged to report adverse events associated with ivermectin to MedWatch. COVID‐19 EUA FAERS Public Dashboard 3/15/21 The FDA launched an update to the FDA Adverse Event Reporting System (FAERS) Public Dashboard that provides weekly updates of adverse event reports submitted to FAERS for drugs and therapeutic biologics used under an Emergency Use Authorization (EUA) during the COVID‐19 public health emergency. Monoclonal Antibody Products for COVID‐19 – Fact Sheets Updated to Address Variants 3/18/21 The FDA authorized revised fact sheets for health care providers to include susceptibility of SARS‐CoV‐2 variants to each of the monoclonal antibody products available through EUA for the treatment of COVID‐19 (bamlanivimab, bamlanivimab and etesevimab, and casirivimab and imdevimab). Abuse and Misuse of the Nasal Decongestant Propylhexedrine Causes Serious Harm 3/25/21 The FDA warned that abuse and misuse of the nasal decongestant propylhexedrine, sold OTC in nasal decongestant inhalers, has been increasingly associated with cardiovascular and mental health problems. The FDA has recommended product design changes to support safe use, such as modifications to preclude tampering and limits on the content within the device. -
Formulary Updates Effective January 1, 2021
Formulary Updates Effective January 1, 2021 Dear Valued Client, Please see the following lists of formulary updates that will apply to the HometownRx Formulary effective January 1 st , 2021. As the competition among clinically similar products increases, our formulary strategy enables us to prefer safe, proven medication alternatives and lower costs without negatively impacting member choice or access. Please note: Not all drugs listed may be covered under your prescription drug benefit. Certain drugs may have specific restrictions or special copay requirements depending on your plan. The formulary alternatives listed are examples of selected alternatives that are on the formulary. Other alternatives may be available. Members on a medication that will no longer be covered may want to talk to their healthcare providers about other options. Medications that do not have alternatives will be available at 100% member coinsurance . Preferred to Non -Preferred Tier Drug Disease State /Drug Class Preferred Alternatives ALREX Eye inflammation loteprednol (generic for LOTEMAX) APRISO 1 Gastrointestinal agent mesalamine (generic for APRISO) BEPREVE Eye allergies azelastine (generic for OPTIVAR) CIPRODEX 1 Ear inflammation ciprofloxacin-dexamethasone (generic for CIPRODEX) COLCRYS 1 Gout colchicine (generic for COLCRYS) FIRST -LANSOPRAZOLE Gastrointestinal agent Over-the-counter lansoprazole without a prescription FIRST -MOUTHWASH BLM Mouth inflammation lidocaine 2% viscous solution (XYLOCAINE) LOTEMAX 1 Eye inflammation loteprednol etabonate (generic -
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. -
WSAVA List of Essential Medicines for Cats and Dogs
The World Small Animal Veterinary Association (WSAVA) List of Essential Medicines for Cats and Dogs Version 1; January 20th, 2020 Members of the WSAVA Therapeutic Guidelines Group (TGG) Steagall PV, Pelligand L, Page SW, Bourgeois M, Weese S, Manigot G, Dublin D, Ferreira JP, Guardabassi L © 2020 WSAVA All Rights Reserved Contents Background ................................................................................................................................... 2 Definition ...................................................................................................................................... 2 Using the List of Essential Medicines ............................................................................................ 2 Criteria for selection of essential medicines ................................................................................. 3 Anaesthetic, analgesic, sedative and emergency drugs ............................................................... 4 Antimicrobial drugs ....................................................................................................................... 7 Antibacterial and antiprotozoal drugs ....................................................................................... 7 Systemic administration ........................................................................................................ 7 Topical administration ........................................................................................................... 9 Antifungal drugs ..................................................................................................................... -
Baqsimi, INN-Glucagon
17 October 2019 EMA/CHMP/602404/2019 Committee for Medicinal Products for Human Use (CHMP) Assessment report BAQSIMI International non-proprietary name: glucagon Procedure No. EMEA/H/C/003848/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union Table of contents 1. Background information on the procedure .............................................. 7 1.1. Submission of the dossier ...................................................................................... 7 1.2. Steps taken for the assessment of the product ......................................................... 8 2. Scientific discussion ................................................................................ 9 2.1. Problem statement ............................................................................................... 9 2.1.1. Disease or condition ........................................................................................... 9 2.1.2. Epidemiology .................................................................................................. 10 2.1.3. Biologic features, Aetiology and pathogenesis ..................................................... 10 2.1.4. Clinical presentation, diagnosis ......................................................................... -
Type 2 Diabetes Adult Outpatient Insulin Guidelines
Diabetes Coalition of California TYPE 2 DIABETES ADULT OUTPATIENT INSULIN GUIDELINES GENERAL RECOMMENDATIONS Start insulin if A1C and glucose levels are above goal despite optimal use of other diabetes 6,7,8 medications. (Consider insulin as initial therapy if A1C very high, such as > 10.0%) 6,7,8 Start with BASAL INSULIN for most patients 1,6 Consider the following goals ADA A1C Goals: A1C < 7.0 for most patients A1C > 7.0 (consider 7.0-7.9) for higher risk patients 1. History of severe hypoglycemia 2. Multiple co-morbid conditions 3. Long standing diabetes 4. Limited life expectancy 5. Advanced complications or 6. Difficult to control despite use of insulin ADA Glucose Goals*: Fasting and premeal glucose < 130 Peak post-meal glucose (1-2 hours after meal) < 180 Difference between premeal and post-meal glucose < 50 *for higher risk patients individualize glucose goals in order to avoid hypoglycemia BASAL INSULIN Intermediate-acting: NPH Note: NPH insulin has elevated risk of hypoglycemia so use with extra caution6,8,15,17,25,32 Long-acting: Glargine (Lantus®) Detemir (Levemir®) 6,7,8 Basal insulin is best starting insulin choice for most patients (if fasting glucose above goal). 6,7 8 Start one of the intermediate-acting or long-acting insulins listed above. Start insulin at night. When starting basal insulin: Continue secretagogues. Continue metformin. 7,8,20,29 Note: if NPH causes nocturnal hypoglycemia, consider switching NPH to long-acting insulin. 17,25,32 STARTING DOSE: Start dose: 10 units6,7,8,11,12,13,14,16,19,20,21,22,25 Consider using a lower starting dose (such as 0.1 units/kg/day32) especially if 17,19 patient is thin or has a fasting glucose only minimally above goal. -
Pharmacokinetic/Pharmacodynamic Modelling-Based Translational Approach Applied to the Anticancer Drug Gemcitabine in Advanced Pancreatic and Ovarian Cancer”
Departamento de Farmacia y Tecnología Farmacéutica Facultad de Farmacia y Nutrición UNIVERSIDAD DE NAVARRA “Pharmacokinetic/Pharmacodynamic Modelling-Based Translational Approach applied to the Anticancer Drug Gemcitabine in Advanced Pancreatic and Ovarian Cancer” María García-Cremades Mira Pamplona, 2017 Departamento de Farmacia y Tecnología Farmacéutica Facultad de Farmacia y Nutrición UNIVERSIDAD DE NAVARRA TESIS DOCTORAL “Pharmacokinetic/Pharmacodynamic Modelling-Based Translational Approach applied to the Anticancer Drug Gemcitabine in Advanced Pancreatic and Ovarian Cancer” Trabajo presentado por María García-Cremades Mira para obtener el Grado de Doctor Fdo. María García-Cremades Mira Pamplona, 2017 UNIVERSIDAD DE NAVARRA FACULTAD DE FARMACIA Y NUTRICIÓN Departamento de Farmacia y Tecnología Farmacéutica D. JOSÉ IGNACIO FERNÁNDEZ DE TROCÓNIZ FERNÁNDEZ, Doctor en Farmacia y Catedrático del Departamento de Farmacia y Tecnología Farmacéutica. Certifica: Que el presente trabajo, titulado “Pharmacokinetic/pharmacodynamic modelling-based translational approach applied to the anticancer drug gemcitabine in advanced pancreatic and ovarian cancer”, presentado por DÑA. MARÍA GARCÍA-CREMADES MIRA para optar al grado de Doctor en Farmacia, ha sido realizado bajo su dirección en los Departamentos de Farmacia y Tecnología Farmacéutica. Considerando finalizado el trabajo autorizan su presentación a fin de que pueda ser juzgado y calificado por el Tribunal correspondiente. Y para que así conste, firma la presente: Fdo.: Dr. José Ignacio F Trocóniz Pamplona, 2017 “El mundo es de los que hacen de cada momento una gran aventura” AGRADECIMIENTOS Quisiera comenzar expresando mi agradecimiento a la Universidad de Navarra y al Departamentos de Farmacia y Tecnología Farmacéutica por haberme posibilitado la realización de esta tesis doctoral. Al Dr. Iñaki Trocóniz me gustaría agradecerle la confianza y motivación que desde el primer día me ha dado. -
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 ............................................................................................. -
Drug Class Review Nasal Corticosteroids
Drug Class Review Nasal Corticosteroids Final Report Update 1 June 2008 The Agency for Healthcare Research and Quality has not yet seen or approved this report The purpose of this report is to make available information regarding the comparative effectiveness and safety profiles of different drugs within pharmaceutical classes. Reports are not usage guidelines, nor should they be read as an endorsement of, or recommendation for, any particular drug, use or approach. Oregon Health & Science University does not recommend or endorse any guideline or recommendation developed by users of these reports. Dana Selover, MD Tracy Dana, MLS Colleen Smith, PharmD Kim Peterson, MS Oregon Evidence-based Practice Center Oregon Health & Science University Mark Helfand, MD, MPH, Director Marian McDonagh, PharmD, Principal Investigator, Drug Effectiveness Review Project Copyright © 2008 by Oregon Health & Science University Portland, Oregon 97239. All rights reserved. Final Report Update 1 Drug Effectiveness Review Project TABLE OF CONTENTS INTRODUCTION ..........................................................................................................................5 Scope and Key Questions .......................................................................................................................7 METHODS ....................................................................................................................................9 Literature Search .....................................................................................................................................9