Conjugated Estrogens
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PRESCRIBING INFORMATION OGEN* (Estropipate) Tablets 0.75 Mg, 1.5
PRESCRIBING INFORMATION OGEN* (estropipate) Tablets 0.75 mg, 1.5 mg, 3.0 mg Estrogen Pfizer Canada Inc. Date of Revision: 17,300 Trans-Canada Highway 25 May 2009 Kirkland, Quebec, H9J 2M5 Control No. 120830 * TM Pharmacia Enterprises S.A. Pfizer Canada Inc., licensee © Pfizer Canada Inc., 2009 OGEN* (estropipate) Prescribing Information Page 1 of 27 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION.........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND PRECAUTIONS..................................................................................4 ADVERSE REACTIONS..................................................................................................11 CLINICAL TRIAL ADVERSE DRUG REACTIONS.....................................................13 DRUG INTERACTIONS ..................................................................................................13 DOSAGE AND ADMINISTRATION..............................................................................15 OVERDOSAGE ................................................................................................................16 ACTION AND CLINICAL PHARMACOLOGY ............................................................16 -
Clomifene Citrate(BANM, Rinnm) ⊗
2086 Sex Hormones and their Modulators Profasi; UK: Choragon; Ovitrelle; Pregnyl; USA: Chorex†; Choron; Gonic; who received the drug for a shorter period.6 No association be- 8. Werler MM, et al. Ovulation induction and risk of neural tube Novarel; Ovidrel; Pregnyl; Profasi; Venez.: Ovidrel; Pregnyl; Profasi†. tween gonadotrophin therapy and ovarian cancer was noted in defects. Lancet 1994; 344: 445–6. Multi-ingredient: Ger.: NeyNormin N (Revitorgan-Dilutionen N Nr this study. The conclusions of this study were only tentative, 9. Greenland S, Ackerman DL. Clomiphene citrate and neural tube 65)†; Mex.: Gonakor. defects: a pooled analysis of controlled epidemiologic studies since the numbers who developed ovarian cancer were small; it and recommendations for future studies. Fertil Steril 1995; 64: has been pointed out that a successfully achieved pregnancy may 936–41. reduce the risk of some other cancers, and that the risks and ben- 10. Whiteman D, et al. Reproductive factors, subfertility, and risk efits of the procedure are not easy to balance.7 A review8 of epi- of neural tube defects: a case-control study based on the Oxford Clomifene Citrate (BANM, rINNM) ⊗ Record Linkage Study Register. Am J Epidemiol 2000; 152: demiological and cohort studies concluded that clomifene was 823–8. Chloramiphene Citrate; Citrato de clomifeno; Clomifène, citrate not associated with any increase in the risk of ovarian cancer 11. Sørensen HT, et al. Use of clomifene during early pregnancy de; Clomifeni citras; Clomiphene Citrate (USAN); Klomifeenisi- when used for less than 12 cycles, but noted conflicting results, and risk of hypospadias: population based case-control study. -
Mass Spectrometry Analysis of Hormones in Water by Direct Injection
Application Note Environmental Mass Spectrometry Analysis of Hormones in Water by Direct Injection Using the Agilent 6470 Triple Quadrupole Mass Spectrometer Authors Abstract Imma Ferrer, E. Michael Thurman, and Some hormones are included in the Contaminant Candidate List CCL4 of the Jerry A. Zweigenbaum Environmental Protection Agency (EPA) to be assessed for regulation in drinking University of Colorado and water. These compounds are also of regulatory interest in the EU, China, and other Agilent Technologies, Inc. countries. Therefore, the environmental community often desires the analysis of these compounds in water samples. This Application Note describes the methodology used for the determination of eight hormones (17-α-ethinylestradiol, 17-β-estradiol, estriol, 4-androstene-3,17-dione, equilin, estrone, progesterone, and testosterone) in tap water using an Agilent 6470 triple quadrupole mass spectrometer. A direct injection method using 100 µL of water sample was carried out. This method saves time, reduces handling errors and analytical variability, and is sensitive enough to detect hormones in surface and drinking water at ng/L levels. Introduction Both positive and negative ion modes and stored at −18 °C. A mix of all were used, depending on the specific the hormones was prepared at a The presence of hormones in compound. We also used a novel concentration of 1 μg/mL. Serial dilutions environmental waters has always been mobile phase approach that included were prepared to obtain a calibration controversial because either none have ammonium fluoride to enhance the curve ranging from 1 to 500 ng/L. been detected, or very low traces have negative ion signal4. -
Chemical Compounds As Carcinogenic Agents Second Supplementary Report: Literature of 1938 and 1939 Biological Considerations
CHEMICAL COMPOUNDS AS CARCINOGENIC AGENTS SECONDSUPPLEMENTARY REPORT: LITERATURE OF 1938 AND 1939 J. W. COOK AND E. L. KENNAWAY (From the Royal Cancer Hospital (Free), London, and the University of Glasgow) BIOLOGICALCONSIDERATIONS (Continued from page 428, Jitly 1940) II. Action of Carcinogenic Compounds in Difierent Species and Tissues A number of reports of the action of carcinogenic compounds on human tis- sues have appeared. Klar (601) developed a nodule on the forearm after completion of a series of experiments with 3:4-benzpyrene. He applied a solution of the hydrocarbon (0.25 per cent in benzol) to the skin of mice with a paint brush and for at least part of the period wore rubber gloves. He also conducted experiments, of which no description is given, with the powdered hydrocarbon contained in a glass vessel. Three months after the completion of the experiments a small nodule appeared on the dorsum of the left forearm, This was excised in May 1938 and described by Professor Huckel as a “ so- called benign calcifying epithelioma.” The growth extended into the subcu- taneous fatty tissue; the connection with the superficial epithelium is not described nor is it evident in the two photomicrographs which illustrate the report. The author does not state his age. Gordonoff and Walthard (562) record the occurrence of a tumor in a labo- ratory assistant, aged forty-two, engaged in applying methylcholanthrene (0.3 per cent in benzol) to the skin of mice. The site was in the nasolabial fold, at a spot often touched by the patient when smoking. The microscopic ap- pearance was that of a “ still well delimited stage of an incipient squamous- cell sarcoma.” Cottini and Mazzone (479) deliberately applied 3 :4-benzpyrene ( 1 per cent in benzene) to the skin, generally of the arm or thigh, of 26 patients with various cutaneous diseases, usually daily for periods up to 120 days. -
The Reactivity of Human and Equine Estrogen Quinones Towards Purine Nucleosides
S S symmetry Article The Reactivity of Human and Equine Estrogen Quinones towards Purine Nucleosides Zsolt Benedek †, Peter Girnt † and Julianna Olah * Department of Inorganic and Analytical Chemistry, Budapest University of Technology and Economics, Szent Gellért tér 4, H-1111 Budapest, Hungary; [email protected] (Z.B.); [email protected] (P.G.) * Correspondence: [email protected] † These authors contributed equally to this work. Abstract: Conjugated estrogen medicines, which are produced from the urine of pregnant mares for the purpose of menopausal hormone replacement therapy (HRT), contain the sulfate conjugates of estrone, equilin, and equilenin in varying proportions. The latter three steroid sex hormones are highly similar in molecular structure as they only differ in the degree of unsaturation of the sterane ring “B”: the cyclohexene ring in estrone (which is naturally present in both humans and horses) is replaced by more symmetrical cyclohexadiene and benzene rings in the horse-specific (“equine”) hormones equilin and equilenin, respectively. Though the structure of ring “B” has only moderate influence on the estrogenic activity desired in HRT, it might still significantly affect the reactivity in potential carcinogenic pathways. In the present theoretical study, we focus on the interaction of estrogen orthoquinones, formed upon metabolic oxidation of estrogens in breast cells with purine nucleosides. This multistep process results in a purine base loss in the DNA chain (depurination) and the formation of a “depurinating adduct” from the quinone and the base. The point mutations induced in this manner are suggested to manifest in breast cancer development in the long run. -
Bazedoxifene–Conjugated Estrogens for Treating Endometriosis Endometriosis: Nina S
Endometriosis: Case Report Bazedoxifene–Conjugated Estrogens Teaching Points for Treating Endometriosis 1. The estrogen receptor (ER) is a definitive down- stream target in endometriosis. As an endometrial ER antagonist, bazedoxifene assures not only block- Valerie A. Flores, MD, ade of estrogen binding, but it also has the ability to Nina S. Stachenfeld, PhD, degrade the receptor. This unique property of baze- and Hugh S. Taylor, MD doxifene blocks estrogen action and makes it an attractive treatment option for endometriosis. 2. Conjugated estrogens paired with bazedoxifene do BACKGROUND: Endometriosis is a gynecologic disorder not require a progestin to block endometrial affecting 6–10% of reproductive-aged women. First-line growth, thus avoiding the side effects associated therapies are progestin-based regimens; however, failure with progestin-based regimens. 08/19/2018 on BhDMf5ePHKbH4TTImqenVGLGjjqParD6K7Nl5tTGGFqgjMmLRmuIlIgbkUbgVXoQ by http://journals.lww.com/greenjournal from Downloaded rates are high, often requiring alternative hormonal agents, each with unfavorable side effects. Bazedoxifene with con- ’ 1 Downloaded that can have a significant effect on patients lives. jugated estrogens is approved for treatment of menopausal Treatment consists of agents that induce atrophy of symptoms, and use in animal studies has demonstrated from regression of endometriotic lesions. As such, it represents endometriotic lesions. There is tremendous need for http://journals.lww.com/greenjournal a potential treatment option for endometriosis. therapies that are effective, have favorable side effect profiles, and can be used long term in women with CASE: A patient with stage III endometriosis referred for symptomatic endometriosis, especially for those not management of dysmenorrhea and cyclic pelvic pain was treated with 20 mg bazedoxifene and 0.45 mg conjugated responding to progestin-based regimens. -
Materializing Estrogen and Regulation Under Canada's Food and Drugs Act, 1939-1953 Lara Jessie Tessaro
Osgoode Hall Law School of York University Osgoode Digital Commons LLM Theses Theses and Dissertations 8-27-2018 Toxic Enactments: Materializing Estrogen and Regulation Under Canada's Food and Drugs Act, 1939-1953 Lara Jessie Tessaro Follow this and additional works at: https://digitalcommons.osgoode.yorku.ca/llm Part of the Legal History Commons TOXIC ENACTMENTS: MATERIALIZING ESTROGEN AND REGULATION UNDER CANADA’S FOOD AND DRUGS ACT, 1939-1953 LARA TESSARO A THESIS SUBMITTED TO THE FACULTY OF GRADUATE STUDIES IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE DEGREE OF MASTER OF LAWS GRADUATE PROGRAM IN LAW OSGOODE HALL LAW SCHOOL, YORK UNIVERSITY TORONTO, ONTARIO August 2018 © Lara Tessaro, 2018 ABSTRACT The study describes how estrogen was standardized in Canada, in the 1940s and early 1950s, under the Food and Drugs Act. Contributing to interdisciplinary conversations, it provides an empirical case of how regulatory practices enact material realities. Using archival material, the study describes how estrogen was achieved, in part, through heterogeneous practices of the Canadian Committee on Pharmacopoeial Standards, National Health, and government solicitors. These regulators disagreed on whether, how, and by whom estrogens should be standardized. Rather than resolve these disagreements, Canada enacted multiple regulations purporting to standardize estrogen, and government solicitors practiced “techniques of validating” to render the regulations as lawful. I argue that these regulatory enactments materialized estrogen as a potent, unpredictable, and multiple object. Further, I show how estrogen spawned novel regulatory techniques in Canada, particularly the use of consumer product labels. In this way, estrogen catalyzed an early example of risk regulation in Canada. -
Full Text Pdf
Eastern Biologist No. 4 2015 Protective Effects of Conjugated Equine Estrogens and 17-β Estradiol on Oxidatively Stressed Astrocytes Whitley E. Grimes and Kathleen S. Hughes The Eastern Biologist . ♦ A peer-reviewed journal that publishes original articles focused on the many diverse disciplines of biological research, except for the natural history science disciplines (ISSN 2165-6657 [online]). ♦ Subject areas - The journal welcomes manuscripts based on original research and observations, as well as research summaries and general interest articles. Subject areas include, but are not limited to, biochemistry, biotechnology, cell biology, developmental biology, genetics and genomics, immunology, microbiology, molecular evolution, neurobiology, parasitology, physiology, toxicology, as well as scientific pedagogy. ♦ Offers article-by-article online publication for prompt distribution to a global audience ♦ Offers authors the option of publishing large files such as data tables, audio and video clips, and even PowerPoint presentations as online supplemental files. ♦ Special issues - The Eastern Biologist welcomes proposals for special issues that are based on conference proceedings or on a series of invitational articles. Special issue editors can rely on the publisher’s years of experiences in efficiently handling most details relating to the publication of special issues. ♦ Indexing - As is the case with Eagle Hill's other journals, the Eastern Biologist is expected to be fully indexed in Elsevier, Thomson Reuters, Proquest, EBSCO, Google Scholar, and other databases. ♦ The journal staff is pleased to discuss ideas for manuscripts and to assist during all stages of manuscript preparation. The journal has a mandatory page charge to help defray a portion of the costs of publishing the manuscript. -
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. -
Pp375-430-Annex 1.Qxd
ANNEX 1 CHEMICAL AND PHYSICAL DATA ON COMPOUNDS USED IN COMBINED ESTROGEN–PROGESTOGEN CONTRACEPTIVES AND HORMONAL MENOPAUSAL THERAPY Annex 1 describes the chemical and physical data, technical products, trends in produc- tion by region and uses of estrogens and progestogens in combined estrogen–progestogen contraceptives and hormonal menopausal therapy. Estrogens and progestogens are listed separately in alphabetical order. Trade names for these compounds alone and in combination are given in Annexes 2–4. Sales are listed according to the regions designated by WHO. These are: Africa: Algeria, Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Congo, Côte d'Ivoire, Democratic Republic of the Congo, Equatorial Guinea, Eritrea, Ethiopia, Gabon, Gambia, Ghana, Guinea, Guinea-Bissau, Kenya, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mauritius, Mozambique, Namibia, Niger, Nigeria, Rwanda, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, South Africa, Swaziland, Togo, Uganda, United Republic of Tanzania, Zambia and Zimbabwe America (North): Canada, Central America (Antigua and Barbuda, Bahamas, Barbados, Belize, Costa Rica, Cuba, Dominica, El Salvador, Grenada, Guatemala, Haiti, Honduras, Jamaica, Mexico, Nicaragua, Panama, Puerto Rico, Saint Kitts and Nevis, Saint Lucia, Saint Vincent and the Grenadines, Suriname, Trinidad and Tobago), United States of America America (South): Argentina, Bolivia, Brazil, Chile, Colombia, Dominican Republic, Ecuador, Guyana, Paraguay, -
AMS the Role of Serms After Menopause
Information Sheet The Role of SERMs after Menopause SERMs is the shorthand term for a class of drug called selective oestrogen receptor modulators. These compounds are also referred to as oestrogen agonist/antagonists. They are a versatile group of drugs that can be used to treat a number of conditions associated with aging such as osteoporosis and hormone responsive cancers, and also infertility. Different kinds of SERMS • Naturally occurring SERMs include plant-derived oestrogens or phyto-oestrogens that are sometimes used to treat symptoms of menopause. • Clomiphene citrate is an early SERM which is used to induce ovulation in women desiring pregnancy. • Tamoxifen is another SERM which is taken to reduce the risk of recurrent breast cancer and to prevent the development of breast cancer in women at increased risk of breast cancer. It acts as an anti-oestrogen to reduce oestrogen stimulation in the breast but as an oestrogen agonist in other parts of the body. It improves bone density but increases the risk of endometrial cancer and also of deep vein thrombosis (DVT). In women who have had breast cancer this risk is outweighed by the benefits of reduction in risk of recurrent breast cancer. • Newer SERMs are being developed to make use of the positive effects of oestrogen such as preventing osteoporosis, treating genital atrophy (vaginal dryness), reducing cardiovascular risk and preventing breast cancer, These agents aim to minimise the negative effects of the older agents. Raloxifene,is already available in both Australia and New Zealand. Bazedoxifene and ospemifene are available in the USA and in some parts of Europe. -
Conjugated Estrogens Sustained Release Tablets) 0.3 Mg, 0.625 Mg, and 1.25 Mg
PRODUCT MONOGRAPH PrPREMARIN® (conjugated estrogens sustained release tablets) 0.3 mg, 0.625 mg, and 1.25 mg ESTROGENIC HORMONES ® Wyeth Canada Date of Revision: Pfizer Canada Inc., Licensee December 1, 2014 17,300 Trans-Canada Highway Kirkland, Quebec H9J 2M5 Submission Control No: 177429 PREMARIN (conjugated estrogens sustained release tablets) Page 1 of 46 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ...........................................................................3 INDICATIONS AND CLINICAL USE ................................................................................3 CONTRAINDICATIONS ......................................................................................................4 WARNINGS AND PRECAUTIONS ....................................................................................4 ADVERSE REACTIONS ....................................................................................................14 DRUG INTERACTIONS ....................................................................................................20 DOSAGE AND ADMINISTRATION ................................................................................23 OVERDOSAGE ...................................................................................................................25 ACTION AND CLINICAL PHARMACOLOGY ...............................................................25 STORAGE AND STABILITY ............................................................................................28