DOCSLIB.ORG

SENATE BILL No. 1237 No

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
SENATE BILL No. 1237 No SENATE BILL No. 1237 SENATE BILL No. 1237 March 26, 2008, Introduced by Senators SWITALSKI, GLEASON, ANDERSON, KAHN, PAPPAGEORGE, BIRKHOLZ and JACOBS and referred to the Committee on Health Policy. A bill to amend 1978 PA 368, entitled "Public health code," by amending section 7216 (MCL 333.7216), as amended by 1999 PA 42. THE PEOPLE OF THE STATE OF MICHIGAN ENACT: 1 Sec. 7216. (1) The following controlled substances are 2 included in schedule 3: 3 (a) Unless listed in another schedule, any material, 4 compound, mixture, or preparation containing any quantity of the 5 following substances having a potential for abuse associated with 6 a stimulant effect on the central nervous system, including their 7 salts, isomers, including optical, position, or geometric 8 isomers, and salts of the isomers if the existence of the salts, 9 isomers, and salts of isomers is possible within the specific SENATE BILL No. 1237 06180'07 KKR 2 1 chemical designation: 2 Benzphetamine Mediatric tabs 3 Chlorphentermine Mediatric liquid 4 Clortermine Phendimetrazine 5 Edrisal tabs Special formula 711 tabs 6 Genegesic caps Thora Dex No. 1 tab 7 Hovizyme tabs Thora Dex No. 2 tab 8 Mazindol 9 (b) Unless listed in another schedule, any material, 10 compound, mixture, or preparation containing any quantity of the 11 following substances having a potential for abuse associated with 12 a depressant effect on the central nervous system, including 13 their salts, isomers, including optical, position, or geometric 14 isomers, and salts of the isomers if the existence of the salts, 15 isomers, and salts of isomers is possible within the specific 16 chemical designation: 17 Chlorhexadol Phencyclidine 18 Glutethimide Sulfondiethylmethane 19 Lysergic acid Sulfonethylmethane 20 Lysergix acid amide Sulfonmethane 21 Methyprylon 22 (c) Nalorphine. 23 (d) Any substance that contains any quantity of a derivative 24 of barbituric acid, or any salt of a derivative of barbituric 25 acid, except those substances that are specifically listed in 26 other schedules. 06180'07 KKR 3 1 (e) A compound, mixture, or preparation containing 2 amobarbital, secobarbital, pentobarbital, or a salt of 3 amobarbital, secobarbital, or pentobarbital, and 1 or more other 4 active medicinal ingredients that are not listed in a schedule. 5 (f) A suppository dosage form containing amobarbital, 6 secobarbital, pentobarbital, or a salt of amobarbital, 7 secobarbital, or pentobarbital and approved by the food and drug 8 administration for marketing only as a suppository. 9 (g) Any material, compound, mixture, or preparation 10 containing limited quantities of any of the following narcotic 11 drugs or their salts: 12 (i) Not more than 1.8 grams of codeine, or any of its salts, 13 per 100 milliliters or not more than 90 milligrams per dosage 14 unit, with an equal or greater quantity of an isoquinoline 15 alkaloid of opium. 16 (ii) Not more than 1.8 grams of codeine, or any of its salts, 17 per 100 milliliters or not more than 90 milligrams per dosage 18 unit, with 1 or more active nonnarcotic ingredients in recognized 19 therapeutic amounts. 20 (iii) Not more than 300 milligrams of dihydrocodeinone, or any 21 of its salts, per 100 milliliters or not more than 15 milligrams 22 per dosage unit, with a fourfold or greater quantity of an 23 isoquinoline alkaloid of opium. 24 (iv) Not more than 300 milligrams of dihydrocodeinone, or any 25 of its salts, per 100 milliliters or not more than 15 milligrams 26 per dosage unit, with 1 or more active nonnarcotic ingredients in 27 recognized therapeutic amounts. 06180'07 KKR 4 1 (v) Not more than 1.8 grams of dihydrocodeine, or any of its 2 salts, per 100 milliliters or not more than 90 milligrams per 3 dosage unit, with 1 or more active nonnarcotic ingredients in 4 recognized therapeutic amounts. 5 (vi) Not more than 300 milligrams of ethylmorphine, or any of 6 its salts, per 100 milliliters or not more than 15 milligrams per 7 dosage unit, with 1 or more ingredients in recognized therapeutic 8 amounts. 9 (vii) Not more than 500 milligrams of opium per 100 10 milliliters or per 100 grams, or not more than 25 milligrams per 11 dosage unit, with 1 or more active nonnarcotic ingredients in 12 recognized therapeutic amounts. 13 (viii) Not more than 50 milligrams of morphine, or any of its 14 salts, per 100 milliliters or per 100 grams, with 1 or more 15 active nonnarcotic ingredients in recognized therapeutic amounts. 16 (h) Any material, compound, mixture, or preparation 17 containing any quantity of ketamine, a salt of ketamine, an 18 isomer of ketamine, or a salt of an isomer of ketamine. 19 (I) EXCEPT AS OTHERWISE PROVIDED IN THIS SECTION, ANABOLIC 20 STEROIDS. 21 (2) The administrator may promulgate rules to except a 22 compound, mixture, or preparation containing any stimulant or 23 depressant substance listed in subsection (1)(a) and (b) from the 24 application of all or any part of this article if the compound, 25 mixture, or preparation contains 1 or more active medicinal 26 ingredients not having a stimulant or depressant effect on the 27 central nervous system and if the admixtures are in combinations, 06180'07 KKR 5 1 quantity, proportion, or concentration that vitiate the potential 2 for abuse of the substances having a stimulant or depressant 3 effect on the central nervous system. 4 (3) AS USED IN THIS SECTION, "ANABOLIC STEROID" MEANS ANY 5 DRUG OR HORMONAL SUBSTANCE THAT IS CHEMICALLY AND 6 PHARMACOLOGICALLY RELATED TO TESTOSTERONE, OTHER THAN ESTROGENS, 7 PROGESTINS, AND CORTICOSTEROIDS, AND THAT PROMOTES MUSCLE GROWTH, 8 INCLUDING ANY SALT, ESTER, OR ISOMER OF A DRUG OR SUBSTANCE 9 LISTED IN THIS SUBSECTION, IF THAT SALT, ESTER, OR ISOMER 10 PROMOTES MUSCLE GROWTH. ANABOLIC STEROID INCLUDES ANY OF THE 11 FOLLOWING: 12 (A) BOLDENONE. 13 (B) CHLOROTESTOSTERONE (4-CHLOROTESTOSTERONE). 14 (C) CHORIONIC GONADOTROPIN. 15 (D) CLOSTEBOL. 16 (E) DEHYDROCHLORMETHYLTESTOSTERONE. 17 (F) DIHYDROTESTOSTERONE (4-DIHYDROTESTOSTERONE). 18 (G) DROSTANOLONE. 19 (H) ETHYLESTRENOL. 20 (I) FLUOXYMESTERONE. 21 (J) FORMEBOLONE. 22 (K) HUMAN GROWTH HORMONE. 23 (l) MESTEROLONE. 24 (M) METHANDIENONE. 25 (N) METHANDRANONE. 26 (O) METHANDRIOL. 27 (P) METHANDROSTENOLONE. 06180'07 KKR 6 1 (Q) METHENOLONE. 2 (R) METHYLTESTOSTERONE. 3 (S) MIBOLERONE. 4 (T) NANDROLONE. 5 (U) NORETHANDROLONE. 6 (V) OXANDROLONE. 7 (W) OXYMESTERONE. 8 (X) OXYMETHOLONE. 9 (Y) STANOLONE. 10 (Z) STANOZOLOL. 11 (AA) TESTOLACTONE. 12 (BB) TESTOSTERONE. 13 (CC) TESTOSTERONE CYPIONATE. 14 (DD) TESTOSTERONE ENANTHATE. 15 (EE) TESTOSTERONE PROPIONATE. 16 (FF) TRENBOLONE. 17 (4) THE FOLLOWING ANABOLIC STEROID PRODUCTS ARE EXCEPTED 18 FROM ALL SCHEDULES OF CONTROLLED SUBSTANCES: 19 (A) ANABOLIC STEROIDS THAT ARE EXPRESSLY INTENDED FOR 20 ADMINISTRATION THROUGH IMPLANTS TO CATTLE OR OTHER NONHUMAN 21 SPECIES AND THAT ARE APPROVED BY THE FEDERAL FOOD AND DRUG 22 ADMINISTRATION FOR SUCH USE. 23 (B) ESTERIFIED ESTROGENS 1.25 MILLIGRAMS AND METHYL 24 TESTOSTERONE 2.5 MILLIGRAM TABLETS. 25 (C) ESTERIFIED ESTROGENS 0.625 MILLIGRAMS AND METHYL 26 TESTOSTERONE 1.25 MILLIGRAM TABLETS. 27 (D) CONJUGATED ESTROGENS 1.25 MILLIGRAMS AND METHYL 06180'07 KKR 7 1 TESTOSTERONE 10 MILLIGRAM TABLETS. 2 (E) CONJUGATED ESTROGENS 0.625 MILLIGRAMS AND METHYL 3 TESTOSTERONE 5 MILLIGRAM TABLETS. 4 (F) TESTOSTERONE ENANTHATE 90 MILLIGRAM/MILLILITER AND 5 ESTRADIOL VALERATE 4 MILLIGRAM/MILLILITER INJECTION. 6 (G) TESTOSTERONE CYPIONATE 50 MILLIGRAM/MILLILITER AND 7 ESTRADIOL CYPIONATE 2 MILLIGRAM/MILLILITER INJECTION. 06180'07 Final Page KKR .
Load more

Recommended publications
  • 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
    [Show full text]
  • (12) United States Patent (10) Patent No.: US 6,284,263 B1 Place (45) Date of Patent: Sep
    USOO6284263B1 (12) United States Patent (10) Patent No.: US 6,284,263 B1 Place (45) Date of Patent: Sep. 4, 2001 (54) BUCCAL DRUG ADMINISTRATION IN THE 4,755,386 7/1988 Hsiao et al. TREATMENT OF FEMALE SEXUAL 4,764,378 8/1988 Keith et al.. DYSFUNCTION 4,877,774 10/1989 Pitha et al.. 5,135,752 8/1992 Snipes. 5,190,967 3/1993 Riley. (76) Inventor: Virgil A. Place, P.O. Box 44555-10 5,346,701 9/1994 Heiber et al. Ala Kahua, Kawaihae, HI (US) 96743 5,516,523 5/1996 Heiber et al. 5,543,154 8/1996 Rork et al. ........................ 424/133.1 (*) Notice: Subject to any disclaimer, the term of this 5,639,743 6/1997 Kaswan et al. patent is extended or adjusted under 35 6,180,682 1/2001 Place. U.S.C. 154(b) by 0 days. * cited by examiner (21) Appl. No.: 09/626,772 Primary Examiner Thurman K. Page ASSistant Examiner-Rachel M. Bennett (22) Filed: Jul. 27, 2000 (74) Attorney, Agent, or Firm-Dianne E. Reed; Reed & Related U.S. Application Data ASSciates (62) Division of application No. 09/237,713, filed on Jan. 26, (57) ABSTRACT 1999, now Pat. No. 6,117,446. A buccal dosage unit is provided for administering a com (51) Int. Cl. ............................. A61F 13/02; A61 K9/20; bination of Steroidal active agents to a female individual. A61K 47/30 The novel buccal drug delivery Systems may be used in (52) U.S. Cl. .......................... 424/435; 424/434; 424/464; female hormone replacement therapy, in female 514/772.3 contraception, to treat female Sexual dysfunction, and to treat or prevent a variety of conditions and disorders which (58) Field of Search ....................................
    [Show full text]
  • Steroids and Other Appearance and Performance Enhancing Drugs (Apeds) Research Report
    Research Report Revised Febrero 2018 Steroids and Other Appearance and Performance Enhancing Drugs (APEDs) Research Report Table of Contents Steroids and Other Appearance and Performance Enhancing Drugs (APEDs) Research Report Introduction What are the different types of APEDs? What is the history of anabolic steroid use? Who uses anabolic steroids? Why are anabolic steroids misused? How are anabolic steroids used? What are the side effects of anabolic steroid misuse? How does anabolic steroid misuse affect behavior? What are the risks of anabolic steroid use in teens? How do anabolic steroids work in the brain? Are anabolic steroids addictive? How are anabolic steroids tested in athletes? What can be done to prevent steroid misuse? What treatments are effective for anabolic steroid misuse? Where can I get further information about steroids? References Page 1 Steroids and Other Appearance and Performance Enhancing Drugs (APEDs) Research Report Esta publicación está disponible para su uso y puede ser reproducida, en su totalidad, sin pedir autorización al NIDA. Se agradece la citación de la fuente, de la siguiente manera: Fuente: Instituto Nacional sobre el Abuso de Drogas; Institutos Nacionales de la Salud; Departamento de Salud y Servicios Humanos de los Estados Unidos. Introduction Appearance and performance enhancing drugs (APEDs) are most often used by males to improve appearance by building muscle mass or to enhance athletic performance. Although they may directly and indirectly have effects on a user’s mood, they do not produce a euphoric high, which makes APEDs distinct from other drugs such as cocaine, heroin, and marijuana. However, users may develop a substance use disorder, defined as continued use despite adverse consequences.
    [Show full text]
  • Pharmaceutical Appendix to the Tariff Schedule 2
    Harmonized Tariff Schedule of the United States (2007) (Rev. 2) Annotated for Statistical Reporting Purposes PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE Harmonized Tariff Schedule of the United States (2007) (Rev. 2) Annotated for Statistical Reporting Purposes PHARMACEUTICAL APPENDIX TO THE TARIFF SCHEDULE 2 Table 1. This table enumerates products described by International Non-proprietary Names (INN) which shall be entered free of duty under general note 13 to the tariff schedule. The Chemical Abstracts Service (CAS) registry numbers also set forth in this table are included to assist in the identification of the products concerned. For purposes of the tariff schedule, any references to a product enumerated in this table includes such product by whatever name known. ABACAVIR 136470-78-5 ACIDUM LIDADRONICUM 63132-38-7 ABAFUNGIN 129639-79-8 ACIDUM SALCAPROZICUM 183990-46-7 ABAMECTIN 65195-55-3 ACIDUM SALCLOBUZICUM 387825-03-8 ABANOQUIL 90402-40-7 ACIFRAN 72420-38-3 ABAPERIDONUM 183849-43-6 ACIPIMOX 51037-30-0 ABARELIX 183552-38-7 ACITAZANOLAST 114607-46-4 ABATACEPTUM 332348-12-6 ACITEMATE 101197-99-3 ABCIXIMAB 143653-53-6 ACITRETIN 55079-83-9 ABECARNIL 111841-85-1 ACIVICIN 42228-92-2 ABETIMUSUM 167362-48-3 ACLANTATE 39633-62-0 ABIRATERONE 154229-19-3 ACLARUBICIN 57576-44-0 ABITESARTAN 137882-98-5 ACLATONIUM NAPADISILATE 55077-30-0 ABLUKAST 96566-25-5 ACODAZOLE 79152-85-5 ABRINEURINUM 178535-93-8 ACOLBIFENUM 182167-02-8 ABUNIDAZOLE 91017-58-2 ACONIAZIDE 13410-86-1 ACADESINE 2627-69-2 ACOTIAMIDUM 185106-16-5 ACAMPROSATE 77337-76-9
    [Show full text]
  • Control Be Implemented. the First Large-Scale Systematic Olympic Games
    Br J Sports Med: first published as 10.1136/bjsm.11.4.162 on 1 December 1977. Downloaded from 162 Brit. J. Sports Med. - Vol. 1 1, No. 4, December 1977, pp. 162-169 RADIOIMMUNOASSAY OF ANABOLIC STEROIDS: AN EVALUATION OF THREE ANTISERA FOR THE DETECTION OF ANABOLIC STEROIDS IN BIOLOGICAL FLUIDS Robert DUGAL, Ph.D., Claire DUPUIS, Ph.D. and Michel J. BERTRAND, Ph.D. Centre de Recherches en Sciences de la Sante, Institut National de la Recherche Scientifique, Centre Hospitalier Louis-H. Lafontaine, Montrdal, Quebec, Canada ABSTRACT Recently developped radioimmunoassays (RIA) for the analysis of anabolic steroids and their metabolites in biological fluids were tested for cross-reactivity with other types of steroids. Results show that the degree of desirable cross-reactivity within the two classes of orally active anabolic steroids vary widely and that the antiserum for 19-Nortestosterone (the active principle of intramuscular, preparations) has a very high degree of undesirable cross- reactivity with components of oral contraceptives. Single and multiple dose studies in human volunteers demonstrate that the detection level and degree of retrospectivity are likewise variable but that the test easily detects most anabolic steroids during treatment. At the present time, the combination of the three antisera for the assay of a sample appears to be a relatively rapid and economic method for screening large numbers of samples in situations where doping control of anabolic steroids is required. The importance of utilizing physico-chemical means for identification of RIA potential positives is emphasized. INTRODUCTION (Sumner, 1974: Brooks et al, 1975) and identification procedures for a limited number of them have also been copyright.
    [Show full text]
  • Medication Use for the Risk Reduction of Primary Breast Cancer in Women: a Systematic Review for the U.S
    Evidence Synthesis Number 180 Medication Use for the Risk Reduction of Primary Breast Cancer in Women: A Systematic Review for the U.S. Preventive Services Task Force Prepared for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 5600 Fishers Lane Rockville, MD 20857 www.ahrq.gov Contract No. HHSA-290-2015-00009-I, Task Order No. 7 Prepared by: Pacific Northwest Evidence-Based Practice Center Oregon Health & Science University Mail Code: BICC 3181 SW Sam Jackson Park Road Portland, OR 97239 www.ohsu.edu/epc Investigators: Heidi D. Nelson, MD, MPH Rongwei Fu, PhD Bernadette Zakher, MBBS Marian McDonagh, PharmD Miranda Pappas, MA L.B. Miller, BA Lucy Stillman, BS AHRQ Publication No. 19-05249-EF-1 January 2019 This report is based on research conducted by the Pacific Northwest Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (HHSA-290-2015-00009-I, Task Order No. 7). The findings and conclusions in this document are those of the authors, who are responsible for its contents, and do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services. The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment.
    [Show full text]
  • Controlled Substances Listed in This Section from Schedule VI
    Page 1 of 15 ARTICLE II Schedule I (a) Schedule I shall consist of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated, listed in this section. Each drug or substance has been assigned the DEA Controlled Substances Code Number set forth opposite it. (b) Opiates: (Narcotic Drugs) Unless specifically excepted or unless listed in another schedule, any of the following opiates, including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, whenever the existence of such isomers, esters, ethers, salts is possible within the specific chemical designation (for purposes of paragraph (b)(34) only, the term isomer includes the optical and geometric isomers): (1) Acetyl-alpha-methylfentanyl(N-[1-[1-methyl-2- phenethyl)-4-piperidinyl]-N-phenylacetamide) ----- 9815-(2-86) (2) Acetylmethadol ----------------------------------- 9601* (3) Allylprodine ------------------------------------- 9602* (4) Alphacetylmethadol (except Levo-alphacetylmethadol (LAAM)------------------------------- 9603* (5) Alphameprodine ----------------------------------- 9604* (6) Alphamethadol ------------------------------------ 9605* (7) Alpha-methylfentanyl (N-[1-(alpha-methyl-beta-phenyl) ethyl-4-piperidyl]propronanilide; 1-(1-methyl- 2-phenylethyl)-4(N-propanilido)piperidine) ------- 9814-(6-82) (8) Alpha-methylthiofentanyl(N-[1-methyl-2-(2thienyl) ethyl-4-piperidinyl]-N-phenylpropanamide) -------- 9832-(2-86) (9) Benzethidine ------------------------------------- 9606* (10)
    [Show full text]
  • Other Data Relevant to an Evaluation of Carcinogenicity and Its Mechanisms
    COMBINED ESTROGEN−PROGESTOGEN CONTRACEPTIVES 143 4. Other Data Relevant to an Evaluation of Carcinogenicity and its Mechanisms 4.1 Absorption, distribution, metabolism and excretion in humans The metabolism and disposition of various formulations of oral contraceptives used in humans differ. After entering the small intestine, estrogenic and progestogenic compounds in combined oral contraceptives undergo metabolism by bacterial enzymes and enzymes in the intestinal mucosa to varying extents. The mixture of metabolized and unmetabolized compounds then undergoes intestinal absorption, and thus enters the portal vein blood, which perfuses the liver. In the liver, the compounds can be metabolized extensively, which leads to variations in the amount of active drug. A fraction of the absorbed dose of ethinyl- estradiol and some progestogens is also excreted in the bile during its first transit through the liver. Although some of these compounds are partially reabsorbed via the enterohepatic circulation, a fraction may also be excreted in this ‘first pass’, which reduces overall bio- availability. Since steroids penetrate normal skin easily, various systems have also been developed that deliver estrogens and progestogens parenterally, e.g. transdermal patches, nasal sprays, subcutaneous implants, vaginal rings and intrauterine devices (Fanchin et al., 1997; Dezarnaulds & Fraser, 2002; Meirik et al., 2003; Sarkar, 2003; Wildemeersch et al., 2003; Sturdee et al., 2004). These different modes of administration have been described previously (IARC, 1999). In general, all parenteral routes avoid loss of the drug by hepatic first-pass metabolism and minimally affect hepatic protein metabolism. The absorption rates of orally administered estrogens and progestogens are usually rapid; peak serum values are observed between 0.5 and 4 h after intake.
    [Show full text]
  • TESLAC (Testolactone Tablets, USP) Is Available for Oral Administration As Tablets Providing 50 Mg Testolactone Per Tablet
    ® TESLAC Rx only (testolactone tablets, USP) DESCRIPTION TESLAC (testolactone tablets, USP) is available for oral administration as tablets providing 50 mg testolactone per tablet. Testolactone is a synthetic antineoplastic agent that is structurally distinct from the androgen steroid nucleus in possessing a six-membered lactone ring in place of the usual five-membered carbocyclic D-ring. Testolactone is chemically designated as 13- hydroxy-3-oxo-13,17-secoandrosta-1,4-dien-17-oic acid δ-lactone. Graphic formula: C19H24O3 MW300.40 CAS-968-93-4 Inactive ingredients: calcium stearate, cornstarch, gelatin, and lactose. Testolactone is a white, odorless, crystalline solid, soluble in ethanol and slightly soluble in water. CLINICAL PHARMACOLOGY Although the precise mechanism by which testolactone produces its clinical antineoplastic effects has not been established, its principal action is reported to be inhibition of steroid aromatase activity and consequent reduction in estrone synthesis from adrenal androstenedione, the major source of estrogen in postmenopausal women. Based on in vitro studies, the aromatase inhibition may be noncompetitive and irreversible. This phenomenon may account for the persistence of testolactone’s effect on estrogen synthesis after drug withdrawal. 1 Despite some similarity to testosterone, testolactone has no in vivo androgenic effect. No other hormonal effects have been reported in clinical studies in patients receiving testolactone. In one study, testolactone administered orally (1000 mg/day) was reported to increase renal tubular reabsorption of calcium but to have no effect on serum calcium concentration. The mechanism of the hypocalciuric effect is unknown. No clinical effects in humans of testolactone on adrenal function have been reported; however, one study noted an increase in urinary excretion of 17-ketosteroids in most of the patients treated with 150 mg/day orally.
    [Show full text]
  • AHFS Therapeutic
    AHFS Therapeutic AHFS Therapeutic Class Description HICL HICL Description Program Edit Criteria 1 Edit Criteria 2 Edit Criteria 3 Edit Criteria 4 Edit Criteria 5 Class 240408 CARDIOTONIC AGENTS 000004 DIGOXIN PACE MAX DAILY UNITS : 0.667000 240408 CARDIOTONIC AGENTS 000004 DIGOXIN PACE MAX DAILY UNITS : 0.750000 240408 CARDIOTONIC AGENTS 000004 DIGOXIN PACE MAX DAILY UNITS : 1.500000 240408 CARDIOTONIC AGENTS 000004 DIGOXIN PACE MAX DAILY UNITS : 2.000000 240408 CARDIOTONIC AGENTS 000004 DIGOXIN PACE MAX DAILY UNITS : 2.500000 240408 CARDIOTONIC AGENTS 000004 DIGOXIN PACE MAX DAILY UNITS : 3.000000 240408 CARDIOTONIC AGENTS 000004 DIGOXIN PACE MAX DAILY UNITS : 3.750000 240408 CARDIOTONIC AGENTS 000004 DIGOXIN PACE MAX DAILY UNITS : 6.000000 240408 CARDIOTONIC AGENTS 000004 DIGOXIN PACE MAX DAILY UNITS : 7.500000 240408 CARDIOTONIC AGENTS 000004 DIGOXIN PACE Medical Exception Required 282032 RESPIRATORY AND CNS STIMULANTS 000007 CAFFEINE/DEXTROSE PACE Cannnot co‐administer inhaled Insulin and Asthma/COPD/Smoking Cessation agents 282032 RESPIRATORY AND CNS STIMULANTS 000008 CAFFEINE/MULTIVITAMIN PACE Cannnot co‐administer inhaled Insulin and Asthma/COPD/Smoking Cessation agents 282032 RESPIRATORY AND CNS STIMULANTS 000009 CAFFEINE/ETHYL ALCOHOL PACE Cannnot co‐administer inhaled Insulin and Asthma/COPD/Smoking Cessation agents 282032 RESPIRATORY AND CNS STIMULANTS 000010 CAFFEINE/SODIUM BENZOATE PACE Cannnot co‐administer inhaled Insulin and Asthma/COPD/Smoking Cessation agents 282032 RESPIRATORY AND CNS STIMULANTS 000011 CAFFEINE CITRATE
    [Show full text]
  • Testotoxicosis: Gonadotrophin - Independent Male Sexual Precocity
    Postgrad Med J: first published as 10.1136/pgmj.68.797.225 on 1 March 1992. Downloaded from Postgrad Med J (1992) 68, 225 - 228 i) The Fellowship of Postgraduate Medicine, 1992 Testotoxicosis: gonadotrophin - independent male sexual precocity ArifAbdul Aziz, S.M.W. Jafri and Naeem Ul Haque Department ofMedicine, The Aga Khan University Hospital, Stadium Road, PO Box 3500, Karachi 74800, Pakistan Summary: In this era of rapidly developing investigational tools and pharmacology, the patho- physiology of precocious puberty is becoming well defined. What was previously thought to be a form of gonadotrophin releasing hormone (GNRH)-dependent central precocious puberty is now classified as GNRH-independent familial testotoxicosis. We present two such cases and review the clinical features, pathophysiology and treatment of testotoxicosis. Introduction Sexual precocity is defined as the appearance of medications during pregnancy. He was noted to physical signs of puberty before 8 years of age in have a rather large penis at 6 weeks of age when he females or 9 years of age in males. The clinical was circumcised. At the age of 6-9 months pubic disorders that induce sexual precocity can be hairs were noted. At age 2 years his height was by copyright. classified as gonadotrophin releasing hormone 99.7 cm and weight was approximately 15 kg both (GNRH) dependent or GNRH independent.' being above 97th percentile. He had a bone age of Male sexual precocity first described as a form of 6.4 years. He had stage IV genital development, central precocious puberty has recently been char- Stage IV pubic hair and testicular volume of 8 ml acterized as a familial intratesticular disorder.2'3 (Figures 1 and 2).
    [Show full text]
  • Lääkealan Turvallisuus- Ja Kehittämiskeskuksen Päätös
    Lääkealan turvallisuus- ja kehittämiskeskuksen päätös N:o xxxx lääkeluettelosta Annettu Helsingissä xx päivänä maaliskuuta 2016 ————— Lääkealan turvallisuus- ja kehittämiskeskus on 10 päivänä huhtikuuta 1987 annetun lääke- lain (395/1987) 83 §:n nojalla päättänyt vahvistaa seuraavan lääkeluettelon: 1 § Lääkeaineet ovat valmisteessa suolamuodossa Luettelon tarkoitus teknisen käsiteltävyyden vuoksi. Lääkeaine ja sen suolamuoto ovat biologisesti samanarvoisia. Tämä päätös sisältää luettelon Suomessa lääk- Liitteen 1 A aineet ovat lääkeaineanalogeja ja keellisessä käytössä olevista aineista ja rohdoksis- prohormoneja. Kaikki liitteen 1 A aineet rinnaste- ta. Lääkeluettelo laaditaan ottaen huomioon lää- taan aina vaikutuksen perusteella ainoastaan lää- kelain 3 ja 5 §:n säännökset. kemääräyksellä toimitettaviin lääkkeisiin. Lääkkeellä tarkoitetaan valmistetta tai ainetta, jonka tarkoituksena on sisäisesti tai ulkoisesti 2 § käytettynä parantaa, lievittää tai ehkäistä sairautta Lääkkeitä ovat tai sen oireita ihmisessä tai eläimessä. Lääkkeeksi 1) tämän päätöksen liitteessä 1 luetellut aineet, katsotaan myös sisäisesti tai ulkoisesti käytettävä niiden suolat ja esterit; aine tai aineiden yhdistelmä, jota voidaan käyttää 2) rikoslain 44 luvun 16 §:n 1 momentissa tar- ihmisen tai eläimen elintoimintojen palauttami- koitetuista dopingaineista annetussa valtioneuvos- seksi, korjaamiseksi tai muuttamiseksi farmako- ton asetuksessa kulloinkin luetellut dopingaineet; logisen, immunologisen tai metabolisen vaikutuk- ja sen avulla taikka terveydentilan
    [Show full text]