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Docetaxel with Prednisone Or Prednisolone for the Treatment of Prostate Cancer ISSN 1366-5278 Feedback Your Views About This Report
Health Technology Assessment Health Technology Health Technology Assessment 2007; Vol. 11: No. 2 2007; 11: No. 2 Vol. Docetaxel with prednisone or prednisolone for the treatment of prostate cancer A systematic review and economic model of the clinical effectiveness and cost-effectiveness of docetaxel in combination with prednisone or prednisolone for the treatment of hormone-refractory metastatic prostate cancer Feedback The HTA Programme and the authors would like to know R Collins, E Fenwick, R Trowman, R Perard, your views about this report. The Correspondence Page on the HTA website G Norman, K Light, A Birtle, S Palmer (http://www.hta.ac.uk) is a convenient way to publish and R Riemsma your comments. If you prefer, you can send your comments to the address below, telling us whether you would like us to transfer them to the website. We look forward to hearing from you. January 2007 The National Coordinating Centre for Health Technology Assessment, Mailpoint 728, Boldrewood, Health Technology Assessment University of Southampton, NHS R&D HTA Programme Southampton, SO16 7PX, UK. HTA Fax: +44 (0) 23 8059 5639 Email: [email protected] www.hta.ac.uk http://www.hta.ac.uk ISSN 1366-5278 HTA How to obtain copies of this and other HTA Programme reports. An electronic version of this publication, in Adobe Acrobat format, is available for downloading free of charge for personal use from the HTA website (http://www.hta.ac.uk). A fully searchable CD-ROM is also available (see below). Printed copies of HTA monographs cost £20 each (post and packing free in the UK) to both public and private sector purchasers from our Despatch Agents. -
Prednisolone Versus Dexamethasone for Croup: a Randomized Controlled Trial Colin M
Prednisolone Versus Dexamethasone for Croup: a Randomized Controlled Trial Colin M. Parker, MBChB, DCH, MRCPCH, FACEM,a,b Matthew N. Cooper, BCA, BSc, PhDc OBJECTIVES: The use of either prednisolone or low-dose dexamethasone in the treatment of abstract childhood croup lacks a rigorous evidence base despite widespread use. In this study, we compare dexamethasone at 0.6 mg/kg with both low-dose dexamethasone at 0.15 mg/kg and prednisolone at 1 mg/kg. METHODS: Prospective, double-blind, noninferiority randomized controlled trial based in 1 tertiary pediatric emergency department and 1 urban district emergency department in Perth, Western Australia. Inclusions were age .6 months, maximum weight 20 kg, contactable by telephone, and English-speaking caregivers. Exclusion criteria were known prednisolone or dexamethasone allergy, immunosuppressive disease or treatment, steroid therapy or enrollment in the study within the previous 14 days, and a high clinical suspicion of an alternative diagnosis. A total of 1252 participants were enrolled and randomly assigned to receive dexamethasone (0.6 mg/kg; n = 410), low-dose dexamethasone (0.15 mg/kg; n = 410), or prednisolone (1 mg/kg; n = 411). Primary outcome measures included Westley Croup Score 1-hour after treatment and unscheduled medical re-attendance during the 7 days after treatment. RESULTS: Mean Westley Croup Score at baseline was 1.4 for dexamethasone, 1.5 for low-dose dexamethasone, and 1.5 for prednisolone. Adjusted difference in scores at 1 hour, compared with dexamethasone, was 0.03 (95% confidence interval 20.09 to 0.15) for low-dose dexamethasone and 0.05 (95% confidence interval 20.07 to 0.17) for prednisolone. -
Penetration of Synthetic Corticosteroids Into Human Aqueous Humour
Eye (1990) 4, 526--530 Penetration of Synthetic Corticosteroids into Human Aqueous Humour C. N. 1. McGHEE,1.3 D. G. WATSON, 3 1. M. MIDGLEY, 3 M. 1. NOBLE, 2 G. N. DUTTON, z A. I. FERNl Glasgow Summary The penetration of prednisolone acetate (1%) and fluorometholone alcohol (0.1%) into human aqueous humour following topical application was determined using the very sensitive and specific technique of Gas Chromatography with Mass Spec trometry (GCMS). Prednisolone acetate afforded peak mean concentrations of 669.9 ng/ml within two hours and levels of 28.6 ng/ml in aqueous humour were detected almost 24 hours post application. The peak aqueous humour level of flu orometholone was S.lng/ml. The results are compared and contrasted with the absorption of dexamethasone alcohol (0.1%), betamethasone sodium phosphate (0.1 %) and prednisolone sodium phosphate (0.5%) into human aqueous humour. Topical corticosteroid preparations have been prednisolone acetate (1.0%) and fluorometh used widely in ophthalmology since the early alone alcohol (0.1 %) (preliminary results) 1960s and over the last 10 years the choice of into the aqueous humour of patients under preparations has become larger and more going elective cataract surgery. varied. Unfortunately, data on the intraocular penetration of these steroids in humans has SUbjects and Methods not paralleled the expansion in the number of Patients who were scheduled to undergo rou available preparations; indeed until recently, tine cataract surgery were recruited to the estimation of intraocular penetration has study and informed consent was obtained in been reliant upon extrapolation of data from all cases (n=88), Patients with corneal disease animal models (see Watson et ai., 1988, for or inflammatory ocular conditions which bibliography). -
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. -
Summary of Product Characteristics
Prednisolone, DK/H/2488/001-006, March 2021 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT /…/ 2.5 mg tablets /…/ 5 mg tablets /…/ 10 mg tablets /…/ 20 mg tablets /…/ 25 mg tablets /…/ 30 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.5 mg prednisolone. Each tablet contains 5 mg prednisolone. Each tablet contains 10 mg prednisolone. Each tablet contains 20 mg prednisolone. Each tablet contains 25 mg prednisolone. Each tablet contains 30 mg prednisolone. Excipient with known effect: Each 2.5 mg tablet contains 89.2 mg of lactose monohydrate Each 5 mg tablet contains 87.2 mg of lactose monohydrate Each 10 mg tablet contains 81.7 mg of lactose monohydrate Each 20 mg tablet contains 163.4 mg of lactose monohydrate Each 25 mg tablet contains 159.4 mg of lactose monohydrate Each 30 mg tablet contains 153.4 mg of lactose monohydrate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets 2.5mg tablet Yellow, 7mm, round, flat, tablet, with a score line on one side, imprinted with “A610” on one side and “2.5” on the other. 5mg tablet White, 7mm, round, flat, tablet, with a score line on one side, imprinted with “A620” on one side and “5” on the other. 10mg tablet Red, 7mm, round, flat, tablet, with a score line on one side, imprinted with “A630” on one side and “10” on the other. 20mg tablet Red, 9mm, round, flat, tablet, with a score line on one side, imprinted with “A640” on one side and “20” on the other. -
Pharmacokinetics of Ophthalmic Corticosteroids
British Journal ofOphthalmology 1992; 76: 681-684 681 MINI REVIEW Br J Ophthalmol: first published as 10.1136/bjo.76.11.681 on 1 November 1992. Downloaded from Pharmacokinetics of ophthalmic corticosteroids Corticosteroids have been used by ophthalmologists with an identical vehicle, the aqueous humour concentrations of increasing frequency over the past 30 years, with the these steroids are almost identical.'9 None the less it is concomitant development of a diverse range of drop, essential when considering such empirical data, to recall that ointment, subconjunctival, and oral preparations. Though the systemic anti-inflammatory effect of both betamethasone the clinical benefits and side effects of such corticosteroid and dexamethasone is five to seven times that of predniso- preparations have been well documented, their basic lone.39"' The local anti-inflammatory potency of ocular pharmacokinetics in the human eye have yet to be fully steroids has yet to be fully investigated and whilst early work established. Indeed most of our pharmacokinetic knowledge suggested that prednisolone acetate 1% had the greatest anti- of these drugs has been elucidated by extrapolation of data inflammatory effect in experimental keratitis,'7 later studies obtained from rabbit experiments.1-26 These results can be demonstrated that fluorometholone acetate in a 1% formu- significantly disparate from human data because of the lation was equally efficacious in the same model.26 However, thinner rabbit cornea, lower rabbit blink rate, effect of prednisolone -
Ophthalmic Steroids Reference Number: OH.PHAR.PPA.100 Effective Date: 01/01/2021 Revision Log Last Review Date: 11.20 Line of Business: Medicaid
Clinical Policy: Ophthalmic Agents: Ophthalmic Steroids Reference Number: OH.PHAR.PPA.100 Effective Date: 01/01/2021 Revision Log Last Review Date: 11.20 Line of Business: Medicaid See Important Reminder at the end of this policy for important regulatory and legal information. Description Ophthalmic Agents: Ophthalmic Steroids NO PA REQUIRED “PREFERRED” PA REQUIRED “NON-PREFERRED” DEXAMETHASONE SODIUM PHOSPHATE ALREX® (loteprednol etabonate) DUREZOL® (difluprednate) FLAREX® (fluorometholone acetate) FLUOROMETHOLONE INVELTYS® (loteprednol etabonate) FML FORTE® (fluorometholone) LOTEMAX® (loteprednol etabonate) FML S.O.P. ® (fluorometholone) LOTEMAX® SM (loteprednol etabonate) PRED MILD® (prednisolone acetate) LOTEPREDNOL PREDNISOLONE ACETATE MAXIDEX® (dexamethasone sodium phosphate) PREDNISOLONE SODIUM PHOSPHATE FDA approved indication(s) Alrex is indicated for: • Temporary relief of the signs and symptoms of seasonal allergic conjunctivitis Durezol is indicated for: • Treatment of postoperative ocular pain and postoperative ocular inflammation • Treatment of endogenous anterior uveitis Flarex, fluorometholone, FML Forte, and FML S.O.P are indicated for: • Treatment of corticosteroid-responsive ophthalmic disorders including allergic conjunctivitis, ocular burns or trauma due to corneal injury resulting from chemical, thermal or penetration trauma, giant papillary conjunctivitis (GPC), keratitis, postoperative ocular inflammation, vernal keratoconjunctivitis, and chronic anterior uveitis Inveltys is indicated for: • Treatment of postoperative -
Rapid Glucocorticoid Receptor-Mediated Inhibition of Hypothalamic–Pituitary–Adrenal Ultradian Activity in Healthy Males
6106 • The Journal of Neuroscience, April 28, 2010 • 30(17):6106–6115 Behavioral/Systems/Cognitive Rapid Glucocorticoid Receptor-Mediated Inhibition of Hypothalamic–Pituitary–Adrenal Ultradian Activity in Healthy Males Georgina M. Russell,1 David E. Henley,1,2 Jack Leendertz,1 Jennie A. Douthwaite,1 Susan A. Wood,1 Adam Stevens,3 Wolfram W. Woltersdorf,4 Bernard W. M. M. Peeters,5 Ge S. F. Ruigt,5 Anne White,3 Johannes D. Veldhuis,6 and Stafford L. Lightman1 1Henry Wellcome Laboratories for Integrative Neurosciences and Endocrinology, University of Bristol, Bristol BS1 3NY, United Kingdom, 2Faculty of Medicine, Dentistry and Health Sciences, University of Western Australia, Crawley 6009, Western Australia, Australia, 3Endocrine Sciences Research Group, Manchester Academic Health Sciences Center, University of Manchester, Manchester M13 9PT, United Kingdom, 4University Hospitals Bristol National Health Science Foundation Trust, Department of Laboratory Medicine, Bristol BS2 8HW, United Kingdom, 5Schering-Plough, 5340BH Oss, The Netherlands, and 6Endocrine Research Unit, Mayo Clinic College of Medicine, Rochester, Minnesota 55905 A complex dynamic ultradian rhythm underlies the hypothalamic–pituitary–adrenal (HPA) circadian rhythm. We have investigated in normal human male subjects the importance, site of action, and receptor-mediated processes involved in rapid basal corticosteroid feedback and its interaction with corticotrophin releasing hormone (CRH) drive. Pro-opiomelanocortin (POMC), ACTH, and cortisol were measured every 10 min from healthy males during the awakening period or late afternoon using an automated blood sampling system. Mathematical modeling into discrete pulses of activity revealed that intravenous infusion of the synthetic mixed glucocorticoid/ mineralocorticoid agonist prednisolone produced rapid inhibition of ACTH and cortisol pulsatility within 30 min in the morning and afternoon. -
Cyproterone Acetate and the Risk of Hepatic Toxicity CONFIDENTIAL
Cyproterone acetate and the risk of hepatic toxicity CONFIDENTIAL Medicines Adverse Reactions Committee Meeting date 5 December 2019 Agenda item 3.2.3 Title Cyproterone acetate and the risk of hepatic toxicity Medsafe Pharmacovigilance Submitted by Paper type For advice Team Active constituent Medicines Sponsors Cyproterone Procur tablets Douglas Pharmaceuticals Limited Siterone tablets REX Medical Ltd Funding Siterone 50 mg and 100 mg are funded Previous MARC Cyproterone use as a contraceptive has been discussed previously at the meetings following meeting: − 171st Meeting — 14 September 2017 Risks of severe depression, anxiety and suicidal ideation with hormonal contraceptives . Prescriber Update There have been articles regarding the risk of VTE when cyproterone is used as a contraceptive. Schedule Prescription medicine Usage data See section 2.4 Advice sought The Committee is asked to advise whether: − The data sheets for cyproterone tablets should be updated regarding the risk of hepatic toxicity. − This topic requires further communication other than MARC’s Remarks in Prescriber Update. Medicines Adverse Reactions Committee: 5 December 2019 Page 1 of 19 Cyproterone acetate and the risk of hepatic toxicity CONFIDENTIAL Table of Contents Medicines Adverse Reactions Committee .............................................................................................. 1 1.0 PURPOSE .................................................................................................................................. 3 2.0 BACKGROUND ........................................................................................................................ -
Steroids (PDF)
INFORMATION SHEET STEROIDS (CORTICOSTEROIDS) INTRODUCTION If you’ve started or are considering treatment with steroids, you’re not alone. Steroids, also called corticosteroids, are a common medicine for Crohn’s and Colitis, with 4 out of 5 people with the conditions taking them at some point. Our information can support you to make an informed decision about treatment that’s right for you. It looks at: • how steroids work Once your IBD is under control • what you can expect from treatment (with steroids) life quickly • possible side effects • stopping or changing treatment returns to normal. You realise how much the steroids can help you to get your life back. CONTENTS Other names for this medicine ............................................................................................. 2 Why you’ve been offered steroids ....................................................................................... 2 Barry, age 41 How steroids work ................................................................................................................... 3 living with Crohn’s Colitis How effective steroids are in Crohn’s and Colitis ............................................................ 3 Budesonide: Why it’s different from other steroids ....................................................... 3 How long steroids take to work ........................................................................................... 3 How to take steroids .............................................................................................................. -
Pharmacologic Characteristics of Corticosteroids 대한신경집중치료학회
REVIEW J Neurocrit Care 2017;10(2):53-59 https://doi.org/10.18700/jnc.170035 eISSN 2508-1349 Pharmacologic Characteristics of Corticosteroids 대한신경집중치료학회 Sophie Samuel, PharmD1, Thuy Nguyen, PharmD1, H. Alex Choi, MD2 1Department of Pharmacy, Memorial Hermann Texas Medical Center, Houston, TX; 2Department of Neurosurgery and Neurology, The University of Texas Medical School at Houston, Houston, TX, USA Corticosteroids (CSs) are used frequently in the neurocritical care unit mainly for their anti- Received December 7, 2017 inflammatory and immunosuppressive effects. Despite their broad use, limited evidence Revised December 7, 2017 exists for their efficacy in diseases confronted in the neurocritical care setting. There are Accepted December 17, 2017 considerable safety concerns associated with administering these drugs and should be limited Corresponding Author: to specific conditions in which their benefits outweigh the risks. The application of CSs in H. Alex Choi, MD neurologic diseases, range from traumatic head and spinal cord injuries to central nervous Department of Pharmacy, Memorial system infections. Based on animal studies, it is speculated that the benefit of CSs therapy Hermann Texas Medical Center, 6411 in brain and spinal cord, include neuroprotection from free radicals, specifically when given Fannin Street, Houston, TX 77030, at a higher supraphysiologic doses. Regardless of these advantages and promising results in USA animal studies, clinical trials have failed to show a significant benefit of CSs administration Tel: +1-713-500-6128 on neurologic outcomes or mortality in patients with head and acute spinal injuries. This Fax: +1-713-500-0665 article reviews various chemical structures between natural and synthetic steroids, discuss its E-mail: [email protected] pharmacokinetic and pharmacodynamic profiles, and describe their use in clinical practice. -
PREDNISOLONE (As Free Alcohol)
The European Agency for the Evaluation of Medicinal Products Veterinary Medicines and Information Technology Unit EMEA/MRL/629/99-FINAL July 1999 COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS PREDNISOLONE (as free alcohol) SUMMARY REPORT 1. Prednisolone is a synthetic glucocorticosteroid. In veterinary medicine, prednisolone (as the free alcohol) is included as an ingredient in a number of antibiotic preparations, which are indicated for intramammary administration for the treatment of bovine mastitis. The usual dose corresponds to 10 mg prednisolone per infected quarter. Treatment may be repeated at 12-hour intervals for a maximum of 3 treatments. Prednisolone is also used in human medicine, as the free alcohol and as various 21-ester derivatives, including the acetate, hexanoate, pivolate, sulfobenzoate, succinate and phosphate. 2. The pharmacological activity of prednisolone lasts longer than that of hydrocortisone but less than that of the longer-acting glucocorticoids such as dexamethasone. The gluconeogenic potency of prednisolone is equivalent to 400% of that of hydrocortisone but only around 13% of that of dexamethasone. It has very limited mineralocorticoid activity. Inhibitory concentration (IC)50 values were determined for a number of pharmacodynamic parameters in humans. The lowest IC50 value was obtained for cortisol suppression: 10.26 ± 3.83 ng/ml, corresponding to a dose of around 2160 µg/day. A special study was carried out in which groups of Wistar rats were given oral doses of prednisolone in the range 10 to 100 µg/kg bw. The rats were killed 2, 3 or 4 hours after dosing and liver samples were taken for determination of tyrosine aminotransferase activity.