DOCSLIB.ORG

36148 Federal Register / Vol

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text

Load more

36148 Federal Register / Vol. 85, No. 115 / Monday, June 15, 2020 / Rules and Regulations Sundstrand) model 54H60 propellers with a collection of information subject to the Administration (NARA). For information on blade having a serial number (S/N) below requirements of the Paperwork Reduction the availability of this material at NARA, S/N 813320. Act unless that collection of information email: [email protected], or go to: displays a currently valid OMB Control https://www.archives.gov/federal-register/cfr/ (d) Subject Number. The OMB Control Number for this ibr-locations.html. Joint Aircraft System Component (JASC) information collection is 2120–0056. Public Issued on June 3, 2020. Code 6111, Propeller Blade Section. reporting for this collection of information is estimated to be approximately 1 hour per Lance T. Gant, (e) Unsafe Condition response, including the time for reviewing Director, Compliance & Airworthiness This AD was prompted by the separation instructions, searching existing data sources, Division, Aircraft Certification Service. of a propeller blade that resulted in the loss gathering and maintaining the data needed, [FR Doc. 2020–12821 Filed 6–12–20; 8:45 am] of an airplane and 17 fatalities. The FAA is completing and reviewing the collection of BILLING CODE 4910–13–P issuing this AD to detect cracking in the information. All responses to this collection propeller blade taper bore. The unsafe of information are mandatory. Send condition, if not addressed, could result in comments regarding this burden estimate or failure of the propeller blade, blade any other aspect of this collection of DEPARTMENT OF JUSTICE separation, and loss of the airplane. information, including suggestions for reducing this burden to: Information Drug Enforcement Administration (f) Compliance Collection Clearance Officer, Federal Comply with this AD within the Aviation Administration, 10101 Hillwood 21 CFR Part 1308 compliance times specified, unless already Parkway, Fort Worth, TX 76177–1524. done. [Docket No. DEA–601] (j) Alternative Methods of Compliance (g) Required Actions (AMOCs) Schedules of Controlled Substances: (1) For affected propellers identified in (1) The Manager, Boston ACO Branch, Exempt Anabolic Steroid Products Planning Information, paragraph 1.E.(1), of FAA, has the authority to approve AMOCs Hamilton Sundstrand Corporation Alert for this AD, if requested using the procedures AGENCY: Drug Enforcement Service Bulletin (ASB) 54H60–61–A154, found in 14 CFR 39.19. In accordance with Administration, Department of Justice. dated August 26, 2019 (‘‘the ASB’’), perform 14 CFR 39.19, send your request to your ACTION: Order with opportunity for an eddy current inspection (ECI) of all blades principal inspector or local Flight Standards comment. installed on the propeller within one year or District Office, as appropriate. If sending 500 flight hours after the effective date of this information directly to the manager of the SUMMARY: The Drug Enforcement AD, whichever occurs first. certification office, send it to the attention of Administration is designating two (2) For affected propellers identified in the person identified in paragraph (k) of this pharmaceutical preparations containing Planning Information, paragraph 1.E.(2), of AD. esterified estrogens and the ASB, perform an ECI of all blades (2) Before using any approved AMOC, installed on the propeller within two years or methyltestosterone as exempt anabolic notify your appropriate principal inspector, steroid products under the Controlled 1,000 flight hours after the effective date of or lacking a principal inspector, the manager this AD, whichever occurs first. of the local flight standards district office/ Substances Act. (3) Perform the ECI of the affected certificate holding district office. DATES: This order is effective June 15, propeller blades using the Accomplishment 2020. Written comments must be Instructions, paragraph 3.C. of the ASB. (k) Related Information postmarked, and electronic comments (4) If any propeller blade fails any For more information about this AD, must be sent, on or before August 14, inspection required by this AD, based on the contact Maureen Maisttison, Aerospace 2020. criteria in paragraph 3.C. of the ASB, remove Engineer, Boston ACO Branch, FAA, 1200 the blade from service and replace with a District Avenue, Burlington, MA 01803; ADDRESSES: To ensure proper handling blade eligible for installation prior to the next phone: 781–238–7076; fax: 781–238–7199; of comments, please reference ‘‘Docket flight. email: [email protected]. No. DEA–601’’ on all electronic and (5) For all affected propellers, repeat the (l) Material Incorporated by Reference written correspondence, including any inspection required by paragraphs (g)(1) attachments. through (4) of this AD at intervals not (1) The Director of the Federal Register • Electronic comments: The Drug exceeding 3 years or 1,500 flight hours, approved the incorporation by reference whichever comes first, after the previous (IBR) of the service information listed in this Enforcement Administration (DEA) inspection. paragraph under 5 U.S.C. 552(a) and 1 CFR encourages that all comments be (6) Report the results of the ECI required part 51. submitted electronically through the by paragraphs (g)(1) through (5) of this AD in (2) You must use this service information Federal eRulemaking Portal which accordance with the Accomplishment as applicable to do the actions required by provides the ability to type short Instructions, paragraph 3.C.(6) of the ASB. this AD, unless the AD specifies otherwise. comments directly into the comment (i) Hamilton Sundstrand Corporation (h) Installation Prohibition field on the web page or attach a file for (Hamilton Sundstrand) Alert Service Bulletin lengthier comments. Please go to http:// After the effective date of this AD, do not 54H60–61–A154, dated August 26, 2019. www.regulations.gov and follow the install any Hamilton Sundstrand propeller (ii) [Reserved] blades having an S/N below 813320 on any (3) For Hamilton Sundstrand service online instructions at that site for propeller, unless the blade has first passed information identified in this AD, contact submitting comments. Upon completion the inspection required by this AD. After the Hamilton Sundstrand, 1 Hamilton Road, of your submission, you will receive a effective date of this AD, do not install any Windsor Locks, CT 06096–1010, United Comment Tracking Number for your propeller assemblies with affected propeller States; phone: (877) 808–7575; email: CRC@ comment. Please be aware that blades onto any aircraft unless the affected collins.com. submitted comments are not propeller blades have passed the inspection (4) You may view this service information instantaneously available for public required by paragraph (g) of this AD. at the FAA, Airworthiness Products Section, view on Regulations.gov. If you have Operational Safety Branch, 1200 District received a Comment Tracking Number, (i) Paperwork Reduction Act Burden Avenue, Burlington, MA 01803. For Statement information on the availability of this your comment has been successfully A federal agency may not conduct or material at the FAA, call 781–238–7759. submitted and there is no need to sponsor, and a person is not required to (5) You may view this service information resubmit the same comment. respond to, nor shall a person be subject to that is incorporated by reference at the • Paper comments: Paper comments a penalty for failure to comply with a National Archives and Records that duplicate electronic submissions VerDate Sep<11>2014 16:05 Jun 12, 2020 Jkt 250001 PO 00000 Frm 00006 Fmt 4700 Sfmt 4700 E:\FR\FM\15JNR1.SGM 15JNR1 jbell on DSKJLSW7X2PROD with RULES Federal Register / Vol. 85, No. 115 / Monday, June 15, 2020 / Rules and Regulations 36149 are not necessary. Should you wish to submission that is not identified as middle aged males,’’ ECI explained that mail a paper comment, in lieu of an directed above as confidential. ‘‘in combination with Esterified electronic comment, it should be sent An electronic copy of this document Estrogens, abuse of the substance would via regular or express mail to: Drug is available at http:// give counter effects of its intended use, Enforcement Administration, Attn: DEA www.regulations.gov for easy reference. causing a significant raise in the Federal Register Representative/ Legal Authority Estrogen level in males abusing the Regulatory Drafting and Policy Support product.’’ Id. Section, 8701 Morrissette Drive, Anabolic steroids are listed in Upon review of the application, DEA Springfield, Virginia 22152. schedule III of the Controlled accepted it for filing. On November 2, Substances Act (CSA). 21 U.S.C. 802(41) FOR FURTHER INFORMATION CONTACT: 2015, DEA provided a copy of ECI’s and 812(c), Schedule III(e). The CSA Scott A. Brinks, Regulatory Drafting and application to the Secretary of Health further provides that the Attorney Policy Support Section, Diversion and Human Services (HHS) and General may, by regulation, exempt requested an evaluation and a Control Division, Drug Enforcement from any or all CSA provisions any Administration; Mailing Address: 8701 recommendation. ‘‘compound, mixture, or preparation On September 30, 2019, the Assistant Morrissette Drive, Springfield, Virginia which contains any anabolic steroid, Secretary for Health (ASH) provided 22152; Telephone: (571) 362–3261. which is intended for administration to HHS’s evaluation and recommendation SUPPLEMENTARY
Recommended publications
  • MENEST ® Brand of Esterified Estrogens Tablets, USP

    MENEST ® Brand of Esterified Estrogens Tablets, USP

    PRESCRIBING INFORMATION MENEST ® brand of esterified estrogens tablets, USP WARNINGS 1. ESTROGENS HAVE BEEN REPORTED TO INCREASE THE RISK OF ENDOMETRIAL CARCINOMA. Three independent case control studies have shown an increased risk of endometrial cancer in postmenopausal women exposed to exogenous estrogens for prolonged periods.1–3 This risk was independent of the other known risk factors for endometrial cancer. These studies are further supported by the finding that incidence rates of endometrial cancer have increased sharply since 1969 in eight different areas of the United States with population-based cancer reporting systems, an increase which may be related to the rapidly expanding use of estrogens during the last decade.4 The three case control studies reported that the risk of endometrial cancer in estrogen users was about 4.5 to 13.9 times greater than in nonusers. The risk appears to depend on both duration of treatment1 and on estrogen dose.3 In view of these findings, when estrogens are used for the treatment of menopausal symptoms, the lowest dose that will control symptoms should be utilized and medication should be discontinued as soon as possible. When prolonged treatment is medically indicated, the patient should be reassessed on at least a semiannual basis to determine the need for continued therapy. Although the evidence must be considered preliminary, one study sug- gests that cyclic administration of low doses of estrogen may carry less risk than continuous administration3; it therefore appears prudent to utilize such a regimen. Close clinical surveillance of all women taking estrogens is important. In all cases of undiagnosed persistent or recurring abnormal vaginal bleeding, adequate diagnostic measures should be undertaken to rule out malignancy.
  • Hormonal Treatment Strategies Tailored to Non-Binary Transgender Individuals

    Hormonal Treatment Strategies Tailored to Non-Binary Transgender Individuals

    Journal of Clinical Medicine Review Hormonal Treatment Strategies Tailored to Non-Binary Transgender Individuals Carlotta Cocchetti 1, Jiska Ristori 1, Alessia Romani 1, Mario Maggi 2 and Alessandra Daphne Fisher 1,* 1 Andrology, Women’s Endocrinology and Gender Incongruence Unit, Florence University Hospital, 50139 Florence, Italy; [email protected] (C.C); jiska.ristori@unifi.it (J.R.); [email protected] (A.R.) 2 Department of Experimental, Clinical and Biomedical Sciences, Careggi University Hospital, 50139 Florence, Italy; [email protected]fi.it * Correspondence: fi[email protected] Received: 16 April 2020; Accepted: 18 May 2020; Published: 26 May 2020 Abstract: Introduction: To date no standardized hormonal treatment protocols for non-binary transgender individuals have been described in the literature and there is a lack of data regarding their efficacy and safety. Objectives: To suggest possible treatment strategies for non-binary transgender individuals with non-standardized requests and to emphasize the importance of a personalized clinical approach. Methods: A narrative review of pertinent literature on gender-affirming hormonal treatment in transgender persons was performed using PubMed. Results: New hormonal treatment regimens outside those reported in current guidelines should be considered for non-binary transgender individuals, in order to improve psychological well-being and quality of life. In the present review we suggested the use of hormonal and non-hormonal compounds, which—based on their mechanism of action—could be used in these cases depending on clients’ requests. Conclusion: Requests for an individualized hormonal treatment in non-binary transgender individuals represent a future challenge for professionals managing transgender health care. For each case, clinicians should balance the benefits and risks of a personalized non-standardized treatment, actively involving the person in decisions regarding hormonal treatment.
  • Estrogen Agents, Oral-Transdermal

    Estrogen Agents, Oral-Transdermal

    GEORGIA MEDICAID FEE-FOR-SERVICE ESTROGEN AGENTS, ORAL - TRANSDERMAL PA SUMMARY Preferred Non-Preferred Oral Estrogens Estradiol generic n/a Menest (esterified estrogens) Premarin (estrogens, conjugated) Oral Estrogen/Progestin Combinations Angeliq (drospirenone/estradiol) Bijuva (estradiol/progesterone) Estradiol/norethindrone and all generics for Activella Norethindrone/ethinyl estradiol and all generics for Femhrt Low Dose 0.5/2.5 (norethindrone/ethinyl Femhrt Low Dose estradiol) Jinteli and all generics for Femhrt 1/5 (norethindrone/ethinyl estradiol) Prefest (estradiol/norgestimate) Premphase (conjugated estrogens/medroxyprogesterone) Prempro (conjugated estrogens/medroxyprogesterone) Topical Estrogens Alora (estradiol transdermal patch) Divigel (estradiol topical gel) Estradiol transdermal patch (generic Climara) Elestrin (estradiol topical gel) Evamist (estradiol topical spray solution) Estradiol transdermal patch (generic Vivelle-Dot) Menostar (estradiol transdermal patch) Minivelle (estradiol transdermal patch) Vivelle-Dot (estradiol transdermal patch) Topical Estrogens/Progestin Combination Climara Pro (estradiol/levonorgestrel transdermal patch) n/a Combipatch (estradiol/norethindrone transdermal patch) Oral Selective Estrogen Receptor Modulator (SERMs) Raloxifene generic Duavee (conjugated estrogens/bazedoxifene) Osphena (ospemifene) LENGTH OF AUTHORIZATION: 1 year PA CRITERIA: Bijuva ❖ Approvable for the treatment of moderate to severe vasomotor symptoms associated with menopause in women with an intact uterus who have experienced inadequate response, allergies, contraindications, drug-drug interactions or intolerable side effects to at least two preferred oral estrogen/progestin combination products. Revised 6/29/2020 Norethindrone/Ethinyl Estradiol and All Generics for Femhrt Low Dose ❖ Prescriber must submit a written letter of medical necessity stating the reasons at least two preferred oral estrogen/progestin combination products, one of which must be brand Femhrt Low Dose, are not appropriate for the member.
  • Part I Biopharmaceuticals

    Part I Biopharmaceuticals

    1 Part I Biopharmaceuticals Translational Medicine: Molecular Pharmacology and Drug Discovery First Edition. Edited by Robert A. Meyers. © 2018 Wiley-VCH Verlag GmbH & Co. KGaA. Published 2018 by Wiley-VCH Verlag GmbH & Co. KGaA. 3 1 Analogs and Antagonists of Male Sex Hormones Robert W. Brueggemeier The Ohio State University, Division of Medicinal Chemistry and Pharmacognosy, College of Pharmacy, Columbus, Ohio 43210, USA 1Introduction6 2 Historical 6 3 Endogenous Male Sex Hormones 7 3.1 Occurrence and Physiological Roles 7 3.2 Biosynthesis 8 3.3 Absorption and Distribution 12 3.4 Metabolism 13 3.4.1 Reductive Metabolism 14 3.4.2 Oxidative Metabolism 17 3.5 Mechanism of Action 19 4 Synthetic Androgens 24 4.1 Current Drugs on the Market 24 4.2 Therapeutic Uses and Bioassays 25 4.3 Structure–Activity Relationships for Steroidal Androgens 26 4.3.1 Early Modifications 26 4.3.2 Methylated Derivatives 26 4.3.3 Ester Derivatives 27 4.3.4 Halo Derivatives 27 4.3.5 Other Androgen Derivatives 28 4.3.6 Summary of Structure–Activity Relationships of Steroidal Androgens 28 4.4 Nonsteroidal Androgens, Selective Androgen Receptor Modulators (SARMs) 30 4.5 Absorption, Distribution, and Metabolism 31 4.6 Toxicities 32 Translational Medicine: Molecular Pharmacology and Drug Discovery First Edition. Edited by Robert A. Meyers. © 2018 Wiley-VCH Verlag GmbH & Co. KGaA. Published 2018 by Wiley-VCH Verlag GmbH & Co. KGaA. 4 Analogs and Antagonists of Male Sex Hormones 5 Anabolic Agents 32 5.1 Current Drugs on the Market 32 5.2 Therapeutic Uses and Bioassays
  • Anabolic Steroids

    Anabolic Steroids

    epartment .D of .S Ju U s t ic U.S. Department of Justice e . n o Drug Enforcement Administration i t a r t is Office of Diversion Control D in Laws and penalties for anabolic r m ug d E t A steroid abuse (cont’d) nforcemen an individual’s first drug offense. The maximum www.dea.gov penalty for trafficking is five years in prison and a For more information: fine of $250,000 if this is the individual’s first felony drug offense. If this is the second felony drug offense, the maximum period of imprisonment and Please contact your nearest the maximum fine both double. The period of DEA office imprisonment and the amount of fine are enhanced Or if the offense involves the distribution of an anabolic Visit one of our Internet Websites: steroid and a masking agent or if the distribution is to an athlete. In addition, enhanced penalties exist www.DEAdiversion.usdoj.gov for any athletic coach who uses his/her position to Or influence an athlete to use an anabolic steroid. While www.dea.gov the above listed penalties are for federal offenses, individual states have also implemented fines and penalties for illegal use of anabolic steroids. The International Olympic Committee (IOC), National Collegiate Athletic Association (NCAA), and many professional sports leagues (e.g. Major League Baseball, National Basketball Association, National Football League , and National Hockey League) have banned the use of steroids by athletes, both because of their potential dangerous side effects and they give the user an unfair advantage.
  • Adverse Effects of Anabolic-Androgenic Steroids: a Literature Review

    Adverse Effects of Anabolic-Androgenic Steroids: a Literature Review

    healthcare Review Adverse Effects of Anabolic-Androgenic Steroids: A Literature Review Giuseppe Davide Albano 1,†, Francesco Amico 1,†, Giuseppe Cocimano 1, Aldo Liberto 1, Francesca Maglietta 2, Massimiliano Esposito 1, Giuseppe Li Rosi 3, Nunzio Di Nunno 4, Monica Salerno 1,‡ and Angelo Montana 1,*,‡ 1 Legal Medicine, Department of Medical, Surgical and Advanced Technologies, “G.F. Ingrassia”, University of Catania, 95123 Catania, Italy; [email protected] (G.D.A.); [email protected] (F.A.); [email protected] (G.C.); [email protected] (A.L.); [email protected] (M.E.); [email protected] (M.S.) 2 Department of Clinical and Experimental Medicine, University of Foggia, 71122 Foggia, Italy; [email protected] 3 Department of Law, Criminology, Magna Graecia University of Catanzaro, 88100 Catanzaro, Italy; [email protected] 4 Department of History, Society and Studies on Humanity, University of Salento, 73100 Lecce, Italy; [email protected] * Correspondence: [email protected]; Tel.: +39-095-3782153 † These authors contributed equally to this work. ‡ These authors share last authorship. Abstract: Anabolic-androgenic steroids (AASs) are a large group of molecules including endoge- nously produced androgens, such as testosterone, as well as synthetically manufactured derivatives. AAS use is widespread due to their ability to improve muscle growth for aesthetic purposes and athletes’ performance, minimizing androgenic effects. AAS use is very popular and 1–3% of US inhabitants have been estimated to be AAS users. However, AASs have side effects, involving all organs, tissues and body functions, especially long-term toxicity involving the cardiovascular system Citation: Albano, G.D.; Amico, F.; and the reproductive system, thereby, their abuse is considered a public health issue.
  • The Combined Cardiac Effect of the Anabolic Steroid, Nandrolone And

    The Combined Cardiac Effect of the Anabolic Steroid, Nandrolone And

    ù1. v -¿. rlc) 77.- *n*hi.rnool oowol,ù*o ffi"/fu -lo *rn*(o fii'o fio¿o¿¿, /v&"ùún lonno **al cooaiæe';¿vfl"- oã. Benjamin D. Phillis, B.Sc. (Hons) Phatmacology Depattment of Clinical & Experimental Pharmacology Ftome Rd. , Medical School Noth Adelaide Univetsity ADEIAIDE SA 5OOO û.)r.'-*hr/7enveltîù Foremost, I would like to thank my two supervisors for the direction that they have given this ptojecr. To Rod, for his unfailing troubleshooting abiJity and to Jenny fot her advice and ability to add scientific rigour' Many thanks to Michael Adams for his technical assistance and especially fot performing the surgery for the ischaemia-reperfusion projects and for his willingness to work late nights and public holidays. Lastly I would like to thank my v¡ife for her extreme patience during the tumult of the last 5 years. Her love, suppoït, patience and undetstanding have been invaluable in this endeavout. Beniamin D. Phillis Octobet,2005 ADE,I-AIDE ii T*(¿t of Ao,t",tù DECI.ARATION I ACKNOWLEDGEMENTS il TABLE OF CONTENTS UI ABBREVIATIONS x ABSTRACT )ilr CÉIAPTER t-l Inttoduction 1-1 1.1 Background 1,-1, 1.2What ate anabolic stetoids? 7-1 1,3 General pharmacology of Anabolic steroids t-2 '1,-2 1.3.1 Genomic effects of anabolic steroids 1.3.2 Non-genomic effects of anabolic steroids 1-3 1.4 Clinical use of AS 1.-4 1.5 Patterns of AS abuse 1.-4 1.5.1 Steroid abuse by athletes 1.-+ 1.5.2 Stetoid abuse by sedentary teenagers r-6 1.5.3 Prevalence of abuse 1-6 1.5.4 Abuse ptevalence in Australia 1.-9 1.6 Cardiotoxicity of anabolic steroids r-9 1.6.1 Reduced cotonary flow 1.-1.1, 1,.6.2 Dtect myocatdial eff ects 1-1 5 1.6.3 Hypertension 1-21 1.7 Difficulties associated with anabolic steroid research 1.-24 1-25 1.8 The polydrug abuse Phenomenon 1.9 The pharmacology of cocaine 1-26 1.10 Pteparations 1-28 1-29 1.11 Metabolism lll 1-30 1.
  • Steroidal Estrogens

    Steroidal Estrogens

    FINAL Report on Carcinogens Background Document for Steroidal Estrogens December 13 - 14, 2000 Meeting of the NTP Board of Scientific Counselors Report on Carcinogens Subcommittee Prepared for the: U.S. Department of Health and Human Services Public Health Service National Toxicology Program Research Triangle Park, NC 27709 Prepared by: Technology Planning and Management Corporation Canterbury Hall, Suite 310 4815 Emperor Blvd Durham, NC 27703 Contract Number N01-ES-85421 Dec. 2000 RoC Background Document for Steroidal Estrogens Do not quote or cite Criteria for Listing Agents, Substances or Mixtures in the Report on Carcinogens U.S. Department of Health and Human Services National Toxicology Program Known to be Human Carcinogens: There is sufficient evidence of carcinogenicity from studies in humans, which indicates a causal relationship between exposure to the agent, substance or mixture and human cancer. Reasonably Anticipated to be Human Carcinogens: There is limited evidence of carcinogenicity from studies in humans which indicates that causal interpretation is credible but that alternative explanations such as chance, bias or confounding factors could not adequately be excluded; or There is sufficient evidence of carcinogenicity from studies in experimental animals which indicates there is an increased incidence of malignant and/or a combination of malignant and benign tumors: (1) in multiple species, or at multiple tissue sites, or (2) by multiple routes of exposure, or (3) to an unusual degree with regard to incidence, site or type of tumor or age at onset; or There is less than sufficient evidence of carcinogenicity in humans or laboratory animals, however; the agent, substance or mixture belongs to a well defined, structurally-related class of substances whose members are listed in a previous Report on Carcinogens as either a known to be human carcinogen, or reasonably anticipated to be human carcinogen or there is convincing relevant information that the agent acts through mechanisms indicating it would likely cause cancer in humans.
  • Appendix E: Hormonal Replacement Therapy Regimens E

    Appendix E: Hormonal Replacement Therapy Regimens E

    Appendix E: Hormonal Replacement Therapy Regimens E he proportion of post-menopausal women 14 days and a three-day drug-free period) or in who use hormone replacement therapy continuous combination with estrogen. These (HRT) has increased in the United States progestin/estrogen therapies (PERTs) alter the during the last two decades (13). While benefit-risk profile of HRT. Tuse of HRT has increased, the average dose and In the United States, conjugated equine estro- duration of use of postmenopausal estrogens has gen (CEE) (Premarin, Wyeth-Ayerst) is the most decreased until recently (64). This is due in part to commonly used form of estrogen for HRT.1,2 the discovery that the cancer-causing effects of There are a number of other estrogens used for postmenopausal estrogen are related to its dose HRT.3 Table E-1 lists the estrogens either ap- and duration. proved for osteoporosis by the Food and Drug Ad- This appendix describes the range of choice re- ministration or accepted for this use by a garding the dose, routes of administration, and committee of the United States Pharmacopoeia. In combinations of hormones currently in use or un- addition to the estrogens listed in the table, the es- der study as treatment for postmenopausal HRT. trogens quinestrol (Estrovis tablets, Parke-Davis) This appendix also describes the appropriate fol- and chlorotrianisene (TACE capsules, Marion low-up of women on HRT. Finally, this appendix Merrel Dow) are approved by the FDA for treat- describes how dosing regimens may affect com- ment of menopausal symptoms (61). pliance with HRT and describes other factors that affect HRT compliance.
  • PHARMACY TIMES by IEHP PHARMACEUTICAL SERVICES DEPARTMENT February 11, 2013

    PHARMACY TIMES by IEHP PHARMACEUTICAL SERVICES DEPARTMENT February 11, 2013

    PHARMACY TIMES BY IEHP PHARMACEUTICAL SERVICES DEPARTMENT February 11, 2013 The Centers for Medicare and Medicaid Services (CMS) developed performance and quality measures to help Medicare beneficiaries make informed decisions regarding health and prescription drug plans. As part of this effort, CMS adopted measures for High Risk Medication (HRM) endorsed by the Pharmacy Quality Alliance (PQA) and the National Quality Forum (NQF). The HRM was developed using existing HEDIS measurement “Drugs to be avoided in the elderly”. The HRM rate analyzes the percentage of Medicare Part D beneficiaries 65 years or older who have received prescriptions for drugs with a high risk of serious side effects in the elderly. In order to advance patient safety, IEHP will be identifying members over 65 and currently on one of the medications identified in Table 1. Providers will be receiving a list of these members from IEHP on an ongoing basis. IEHP asks providers to review their member’s current drug regimen and safety risk and make any appropriate changes when applicable. Table 1: Medications identified by CMS to be high risk in the elderly: Drug Class Drug Safety Concerns IEHP Formulary Alternative(s) Acetylcholinesterase Donepezil (in patients Orthostatic hypotension or Memantine Inhibitor with syncope) bradycardia Amphetamines Dextroamphetamine CNS stimulation Weight Control: Diet Lisdextroamphetamine & lifestyle Diethylpropion modification Methylphenidate Phentermine Depression: mirtazapine, trazodone Analgesic Pentazocine Confusion, hallucination, Mild Pain: (includes Meperidine delirium, fall, fracture APAP combination Tramadol Lowers seizure threshold medications) Aspirin > 325 mg/day GI bleeding/peptic ulcer, edema Mod-Severe Pain Diflunisal may worsen heart failure Norco Etodolac Vicodin Fenoprofen Percocet Ketoprofen Morphine Meclofenamate Mefenamic acid Nabumetone 303 E.
  • Hepatotoxic and Cardiotoxic Effects of Testosterone Enanthate Abuse on Adult Male Albino Rats

    Hepatotoxic and Cardiotoxic Effects of Testosterone Enanthate Abuse on Adult Male Albino Rats

    Al-Azhar Med. J.( Medicine). Vol. 50(2), April, 2021, 1335 - 1348 DOI: 10.12816/amj.2021.158480 https://amj.journals.ekb.eg/article_158480.html HEPATOTOXIC AND CARDIOTOXIC EFFECTS OF TESTOSTERONE ENANTHATE ABUSE ON ADULT MALE ALBINO RATS By Mohamed Abd El-Aziz El-Gendy, Fouad Helmy El-Dabbah, Ashraf Ibrahim Hassan and Naser Abd El-Naby Awad* Departments of Forensic Medicine & Clinical Toxicology and Pathology*, Al-Azhar Faculty of Medicine, Egypt E-mail: [email protected] ABSTRACT Background: Anabolic androgenic steroids (AASs) represent a group of synthetic derivatives of testosterone created to maximize anabolic effects and minimize the androgenic ones. Athletes use anabolic androgenic steroids (AAS) to enhance performance regardless of the health risk they may impact in some persons. Objective: To study the histopathological and biochemical changes that could occur on liver and cardiac muscle after administration of doping dose (supraphysiological dose) of testosterone enanthate (one of AAS). Materials and Methods: One hundred (100) male albino rats were included in the present study and divided into six groups. Group (1a); negative control group, Group (1b) positive control group treated with therapeutic dose of testosterone Enanthate (10 mg /Kg body weight intramuscular / I.M weekly for 12 weeks), group (2) was treated with doping dose of testosterone enanthate (60 mg /Kg body weight/ I.M for 4 weeks), group (3) was treated with treated with doping dose of testosterone enanthate (60 mg /Kg body weight / I.M weekly for 8 weeks), group (4) treated with doping dose of testosterone enanthate (60 mg /Kg body weight / I.M weekly for 12 weeks), group (5a) treated with doping dose of testosterone enanthate (60 mg /Kg body weight/ I.M/ weekly for 12 weeks followed by 2 weeks of treatment discontinuation) , group (5b) treated with doping dose of testosterone enanthate (60 mg /Kg body weight/ I.M weekly for 12 weeks followed by 4 weeks of treatment discontinuation).
  • Sex Steriods

    Sex Steriods

    Sex Steroids Endo, Energy and Repro 2017-2018 SEX STEROIDS David Mangelsdorf, Ph.D., Office: ND9.120, Phone: 55957 Email: [email protected] LEARNING OBJECTIVES: This section covers the mechanism of action and therapeutic uses of sex steroids. At the end of this lecture you should be able to: • Summarize the biosynthesis and mechanism of actions of androgens, estrogens, and progestins. • Identify the different therapeutic uses of sex steroid-based drugs (including HRT and birth control) and their mechanism of action. • Interpret the parallel and contrasting uses of these drugs in men vs. women; contrast the use of these drugs in cancer versus non-cancer indications. • Identify the basic structural features and the general pharmacological differences (including mechanisms of action, side effects, etc.) between estrogenic, progestinic, and androgenic drugs. • Describe the different treatment options for endocrine-related disorders of sex steroids. • In a given postmenopausal patient, identify risk factors for the use of HRT, list the types of drugs available and identify when they should be used. • Interpret the phase relationships between different OCP preparations and why they exist. • Recognize the use of non-pharmacological options for contraception. I. INTRODUCTION A. The sex steroids are the effector arm of the hypothalamic-pituitary-gonadal axis (see lecture on “Hypothalamic Pituitary Axes”). B. Sex steroids are some of the most widely used drugs pharmaceutically, particularly in birth control. 1. This is an oddity in pharmacology and medicine, in that the drug is given to healthy normal individuals. 2. Because the drug is used on a healthy person, it has to be under more stringent control to avoid potential side effects.