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CASODEX (Bicalutamide)
HIGHLIGHTS OF PRESCRIBING INFORMATION • Gynecomastia and breast pain have been reported during treatment with These highlights do not include all the information needed to use CASODEX 150 mg when used as a single agent. (5.3) CASODEX® safely and effectively. See full prescribing information for • CASODEX is used in combination with an LHRH agonist. LHRH CASODEX. agonists have been shown to cause a reduction in glucose tolerance in CASODEX® (bicalutamide) tablet, for oral use males. Consideration should be given to monitoring blood glucose in Initial U.S. Approval: 1995 patients receiving CASODEX in combination with LHRH agonists. (5.4) -------------------------- RECENT MAJOR CHANGES -------------------------- • Monitoring Prostate Specific Antigen (PSA) is recommended. Evaluate Warnings and Precautions (5.2) 10/2017 for clinical progression if PSA increases. (5.5) --------------------------- INDICATIONS AND USAGE -------------------------- ------------------------------ ADVERSE REACTIONS ----------------------------- • CASODEX 50 mg is an androgen receptor inhibitor indicated for use in Adverse reactions that occurred in more than 10% of patients receiving combination therapy with a luteinizing hormone-releasing hormone CASODEX plus an LHRH-A were: hot flashes, pain (including general, back, (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of pelvic and abdominal), asthenia, constipation, infection, nausea, peripheral the prostate. (1) edema, dyspnea, diarrhea, hematuria, nocturia, and anemia. (6.1) • CASODEX 150 mg daily is not approved for use alone or with other treatments. (1) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca Pharmaceuticals LP at 1-800-236-9933 or FDA at 1-800-FDA-1088 or ---------------------- DOSAGE AND ADMINISTRATION ---------------------- www.fda.gov/medwatch The recommended dose for CASODEX therapy in combination with an LHRH analog is one 50 mg tablet once daily (morning or evening). -
Triclosan Disrupts Thyroid Hormones: Mode-Of-Action, Developmental Susceptibility, and Determination of Human Relevance
Triclosan Disrupts Thyroid Hormones: Mode-of-Action, Developmental Susceptibility, and Determination of Human Relevance Katie Beth Paul “A dissertation submitted to the faculty of the University of North Carolina at Chapel Hill in partial fulfillment of the requirements for the degree of Doctor of Philosophy in the Curriculum of Toxicology.” Chapel Hill 2011 Approved by: Kim L. R. Brouwer, Pharm.D., Ph.D. Kevin M. Crofton, Ph.D. Michael J. DeVito, Ph.D. Philip C. Smith, Ph.D James A. Swenberg, D.V.M., Ph.D. ©2011 Katie Beth Paul ALL RIGHTS RESERVED ii Abstract Katie Beth Paul Triclosan Disrupts Thyroid Hormones: Mode-of-Action, Developmental Susceptibility, and Determination of Human Relevance (Under the direction of Kevin M. Crofton, Ph.D.) Preliminary study demonstrated that triclosan (TCS), a bacteriostat in myriad consumer products, decreases serum thyroxine (T4) in rats. Adverse neurodevelopmental consequences result from thyroid hormone (TH) disruption; therefore determination of whether TCS disrupts THs during development, its mode-of-action (MOA), and the human relevance is critical. This research tested the hypothesis that TCS disrupts THs via activation of pregnane X and constitutive androstane receptors (PXR, CAR), mediating Phase I-II enzyme and hepatic transporter expression and protein changes, thereby increasing catabolism and elimination of THs, resulting in decreased TH concentrations. For Aim One, the hypothesized MOA was assessed using weanling female Long-Evans rats orally exposed to TCS (0-1000 mg/kg/day) for four days. Serum T4 decreased 35% at 300 mg/kg/day. Activity and expression of markers of Phase I (Cyp2b, Cyp3a1) and Phase II (Ugt1a1, Sult1c1) metabolism were moderately induced, consistent with PXR and/or CAR activation and increased hepatic catabolism. -
Gynecomastia-Like Hyperplasia of Female Breast
Case Report Annals of Infertility & Reproductive Endocrinology Published: 25 May, 2018 Gynecomastia-Like Hyperplasia of Female Breast Haitham A Torky1*, Anwar A El-Shenawy2 and Ahmed N Eesa3 1Department of Obstetrics-Gynecology, As-Salam International Hospital, Egypt 2Department of Surgical Oncology, As-Salam International Hospital, Egypt 3Department of Pathology, As-Salam International Hospital, Egypt Abstract Introduction: Gynecomastia is defined as abnormal enlargement in the male breast; however, histo-pathologic abnormalities may theoretically occur in female breasts. Case: A 37 years old woman para 2 presented with a right painless breast lump. Bilateral mammographic study revealed right upper quadrant breast mass BIRADS 4b. Wide local excision of the mass pathology revealed fibrocystic disease with focal gynecomastoid hyperplasia. Conclusion: Gynecomastia-like hyperplasia of female breast is a rare entity that resembles malignant lesions clinically and radiological and is only distinguished by careful pathological examination. Keywords: Breast mass; Surgery; Female gynecomastia Introduction Gynecomastia is defined as abnormal enlargement in the male breast; however, the histo- pathologic abnormalities may theoretically occur in female breasts [1]. Rosen [2] was the first to describe the term “gynecomastia-like hyperplasia” as an extremely rare proliferative lesion of the female breast which cannot be distinguished from florid gynecomastia. The aim of the current case is to report one of the rare breast lesions, which is gynecomastia-like hyperplasia in female breast. Case Presentation A 37 years old woman para 2 presented with a right painless breast lump, which was accidentally OPEN ACCESS discovered 3 months ago and of stationary course. There was no history of trauma, constitutional symptoms or nipple discharge. -
Pharmaceuticals and Endocrine Active Chemicals in Minnesota Lakes
Pharmaceuticals and Endocrine Active Chemicals in Minnesota Lakes May 2013 Authors Mark Ferrey Contributors/acknowledgements The MPCA is reducing printing and mailing costs This report contains the results of a study that by using the Internet to distribute reports and characterizes the presence of unregulated information to wider audience. Visit our website contaminants in Minnesota’s lakes. The study for more information. was made possible through funding by the MPCA reports are printed on 100 percent post- Minnesota Clean Water Fund and by funding by consumer recycled content paper manufactured the U.S. Environmental Protection Agency without chlorine or chlorine derivatives. (EPA), which facilitated the sampling of lakes for this study. The Minnesota Pollution Control Agency (MPCA) thanks the following for assistance and advice in designing and carrying out this study: Steve Heiskary, Pam Anderson, Dereck Richter, Lee Engel, Amy Garcia, Will Long, Jesse Anderson, Ben Larson, and Kelly O’Hara for the long hours of sampling for this study. Cynthia Tomey, Kirsten Anderson, and Richard Grace of Axys Analytical Labs for the expert help in developing the list of analytes for this study and logistics to make it a success. Minnesota Pollution Control Agency 520 Lafayette Road North | Saint Paul, MN 55155-4194 | www.pca.state.mn.us | 651-296-6300 Toll free 800-657-3864 | TTY 651-282-5332 This report is available in alternative formats upon request, and online at www.pca.state.mn.us. Document number: tdr-g1-16 Contents Contents ........................................................................................................................................... -
Effect of Antimicrobial Triclosan on Reproductive System of Male
A tica nal eu yt c ic a a m A r a c t h a P Ibtisham et al., Pharm Anal Acta 2016, 7:11 Pharmaceutica Analytica Acta DOI: 10.4172/2153-2435.1000516 ISSN: 2153-2435 Review Article Open Access Effect of Antimicrobial Triclosan on Reproductive System of Male Rat Fahar Ibtisham, Aamir Nawab, Yi Zhao, Guanghui Li, Mei Xiao and Lilong An* Agricultural Collage, Guangdong Ocean University, Zhanjiang, Guangdong, China *Corresponding author; Lilong An, Agricultural Collage, Guangdong Ocean University, Haida Road, Mazhang District, Zhanjiang 524088, Guangdong, China, Tel: +86-759-2383247; E-mail: [email protected] Received date: October 31, 2016; Accepted date: November 26, 2016; Published date: November 28, 2016 Copyright: © 2016 Ibtisham F, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Abstract Triclosan (5-chloro-2-(2,4-dichlorophenoxy)phenol: TCS) is a synthetic, broad-spectrum antibacterial agent used in broad range of household and personal care products including hand soap, toothpaste, and deodorants. Recently, concerns have been raised over TCS’s potential for endocrine and reproductive disruption. This review contains the information about deleterious toxic effects of TCS on reproductive system of male rat and the possible mechanism. The literature findings showed that TCS deadly affects the reproductive profile of male rats. According to literature TCS depress the testicular function of male rat including spermatogenesis and steroidogenesis by decreasing the androgen production. 3-hydroxysteroid dehydrogenase (3β-HSD) and 17β-hydroxysteroid dehydrogenase (17β- HSD) are two critical enzymes in the steroidogenesis pathway, while according to findings TCS treated rats had lowered concentration of androgen. -
Identification of Methyl Triclosan and Halogenated Analogues
SCIENCE OF THE TOTAL ENVIRONMENT 407 (2009) 2102– 2114 available at www.sciencedirect.com www.elsevier.com/locate/scitotenv Identification of methyl triclosan and halogenated analogues in male common carp (Cyprinus carpio) from Las Vegas Bay and semipermeable membrane devices from Las Vegas Wash, Nevada Thomas J. Leikera,1, Sonja R. Abneya, Steven L. Goodbredb, Michael R. Rosenc,⁎ aUS Geological Survey, Box 25046, MS 407, Denver, CO 80225-0046, USA bUS Geological Survey, California State University, Modoc Hall, 3020 State University Drive East, Suite 3005, Sacramento, CA 95819-6129, USA cUS Geological Survey, 2730 North Deer Run Road, Carson City NV, 89701, USA ARTICLE DATA ABSTRACT Article history: Methyl triclosan and four halogenated analogues have been identified in extracts of individual Received 22 August 2008 whole-body male carp (Cyprinus carpio) tissue that were collected from Las Vegas Bay, Nevada, Received in revised form and Semipermeable Membrane Devices (SPMD) that were deployed in Las Vegas Wash, Nevada. 3 November 2008 Methyl triclosan is believed to be the microbially methylated product of the antibacterial agent Accepted 9 November 2008 triclosan (2, 4, 4'-trichloro-4-hydroxydiphenyl ether, Chemical Abstract Service Registry Number Available online 2 December 2008 3380-34-5, Irgasan DP300). The presence of methyl triclosan and four halogenated analogues was confirmed in SPMD extracts by comparing low- and high-resolution mass spectral data and Keywords: Kovats retention indices of methyl triclosan with commercially obtained triclosan that was Triclosan derivatized to the methyl ether with ethereal diazomethane. The four halogenated analogues of Methyl triclosan methyltriclosandetectedinbothwhole-body tissue and SPMD extracts were tentatively Common carp identified by high resolution mass spectrometry. -
Conjugate and Prodrug Strategies As Targeted Delivery Vectors for Antibiotics † † ‡ Ana V
Review Cite This: ACS Infect. Dis. XXXX, XXX, XXX−XXX pubs.acs.org/journal/aidcbc Signed, Sealed, Delivered: Conjugate and Prodrug Strategies as Targeted Delivery Vectors for Antibiotics † † ‡ Ana V. Cheng and William M. Wuest*, , † Department of Chemistry, Emory University, 1515 Dickey Drive, Atlanta, Georgia 30322, United States ‡ Emory Antibiotic Resistance Center, Emory School of Medicine, 201 Dowman Drive, Atlanta, Georgia 30322, United States ABSTRACT: Innate and developed resistance mechanisms of bacteria to antibiotics are obstacles in the design of novel drugs. However, antibacterial prodrugs and conjugates have shown promise in circumventing resistance and tolerance mechanisms via directed delivery of antibiotics to the site of infection or to specific species or strains of bacteria. The selective targeting and increased permeability and accumu- lation of these prodrugs not only improves efficacy over unmodified drugs but also reduces off-target effects, toxicity, and development of resistance. Herein, we discuss some of these methods, including sideromycins, antibody-directed prodrugs, cell penetrating peptide conjugates, and codrugs. KEYWORDS: oligopeptide, sideromycin, antibody−antibiotic conjugate, cell penetrating peptide, dendrimer, transferrin inding new and innovative methods to treat bacterial F infections comes with many inherent challenges in addition to those presented by the evolution of resistance mechanisms. The ideal antibiotic is nontoxic to host cells, permeates bacterial cells easily, and accumulates at the site of infection at high concentrations. Narrow spectrum drugs are also advantageous, as they can limit resistance development and leave the host commensal microbiome undisturbed.1 However, various resistance mechanisms make pathogenic infections difficult to eradicate: Many bacteria respond to antibiotic pressure by decreasing expression of active transporters and porins2 and 3,4 Downloaded via EMORY UNIV on April 18, 2019 at 12:34:17 (UTC). -
Severe Gynaecomastia Associated with Spironolactone Treatment in A
Journal of Pre-Clinical and Clinical Research, 2015, Vol 9, No 1, 92-95 www.jpccr.eu CASE REPORT Severe gynaecomastia associated with spironolactone treatment in a patient with decompensated alcoholic liver cirrhosis – Case report Katarzyna Schab1, Andrzej Prystupa2, Dominika Mulawka3, Paulina Mulawka3 1 1st Military Teaching Hospital and Polyclinic, Lublin, Poland 2 Department of Internal Medicine, Medical University, Lublin, Poland 3 Cardinal Stefan Wyszyński District Specialist Hospital, Lublin, Poland Schab K, Prystupa A, Mulawka D, Mulawka P. Severe gynaecomastia associated with spironolactone treatment in a patient with decompensated alcoholic liver cirrhosis – Case report. J Pre-Clin Clin Res. 2015; 9(1): 92–95. doi: 10.5604/18982395.1157586 Abstract Gynaecomastia is uni- or bilateral breast enlargement in males associated with benign hyperplasia of the glandular, fibrous and adipose tissue resulting from oestrogen-androgen imbalance. Asymptomatic gynaecomastia is a common finding in healthy male adults and does not have to be treated, while symptomatic gynaecomastia might be the symptoma of many pathological conditions and requires meticulous diagnosis and therapeutic management. The commonest causes of gynaecomastia in the Polish population include liver cirrhosis and drugs used to treat its complications. The current study presents the case of severe painless gynaecomastia in a patient with decompensated alcoholic liver cirrhosis, treated with spironolactone because of ascites. Breast enlargement assessed a IIb according to the Simon’s Scale or III according to the Cordova-Moschella classification, developed slowly over the two-year period of low-dose spironolactone therapy The course and dynamics of disease are described and the main mechanisms leading to its development discussed. -
Gynecomastia — a Difficult Diagnostic Problem Ginekomastia — Trudny Problem Diagnostyczny
SZKOLENIE PODYPLOMOWE/POSTGRADUATE EDUCATION Endokrynologia Polska/Polish Journal of Endocrinology Tom/Volume 62; Numer/Number 2/2011 ISSN 0423–104X Gynecomastia — a difficult diagnostic problem Ginekomastia — trudny problem diagnostyczny Marek Derkacz1, Iwona Chmiel-Perzyńska2, Andrzej Nowakowski1 1Department of Endocrinology, Medical University, Lublin, Poland 2Department of Family Medicine, Medical University, Lublin, Poland Abstract Gynecomastia is a benign, abnormal, growth of the male breast gland which can occur unilaterally or bilaterally, resulting from a prolife- ration of glandular, fibrous and adipose tissue. Gynecomastia is characterised by the presence of soft, 2–4 cm in diameter, usually discus- shaped enlargement of tissues under the nipple. It is estimated that this pathology occurs in 32–65% of men over the age of 17. Gynecoma- stia is a psychosocial problem and may lead to a perceived lowering of quality of life. The main cause of gynecomastia is a loss of equilibrium between oestrogens and androgens. Increased sensitivity for oestrogens of the breast gland, or local factors (e.g. an excessive synthesis of oestrogens in breast tissues or changes in oestrogen and androgen receptors) may cause gynecomastia. Also, prolactin, thyroxine, cortisol, human chorionic gonadotropin, leptin and receptors for human chorionic gonadotropin, prolactin and luteinizing hormone localised in tissues of the male breast may participate in the etiopathogenesis of gyneco- mastia. Usually three types of gynecomastia are distinguished: physiological, idiopathic and pathological gynecomastia. The latter is the consequ- ence of relative or absolute excess of oestrogens. In this paper, frequent as well as casuistic causes of gynecomastia will be described. A diagnosis of gynecomastia is usually possible after a palpation examination. -
Evaluation of the Symptomatic Male Breast
Revised 2018 American College of Radiology ACR Appropriateness Criteria® Evaluation of the Symptomatic Male Breast Variant 1: Male patient of any age with symptoms of gynecomastia and physical examination consistent with gynecomastia or pseudogynecomastia. Initial imaging. Procedure Appropriateness Category Relative Radiation Level Mammography diagnostic Usually Not Appropriate ☢☢ Digital breast tomosynthesis diagnostic Usually Not Appropriate ☢☢ US breast Usually Not Appropriate O MRI breast without and with IV contrast Usually Not Appropriate O MRI breast without IV contrast Usually Not Appropriate O Variant 2: Male younger than 25 years of age with indeterminate palpable breast mass. Initial imaging. Procedure Appropriateness Category Relative Radiation Level US breast Usually Appropriate O Mammography diagnostic May Be Appropriate ☢☢ Digital breast tomosynthesis diagnostic May Be Appropriate ☢☢ MRI breast without and with IV contrast Usually Not Appropriate O MRI breast without IV contrast Usually Not Appropriate O Variant 3: Male 25 years of age or older with indeterminate palpable breast mass. Initial imaging. Procedure Appropriateness Category Relative Radiation Level Mammography diagnostic Usually Appropriate ☢☢ Digital breast tomosynthesis diagnostic Usually Appropriate ☢☢ US breast May Be Appropriate O MRI breast without and with IV contrast Usually Not Appropriate O MRI breast without IV contrast Usually Not Appropriate O Variant 4: Male 25 years of age or older with indeterminate palpable breast mass. Mammography or digital breast tomosynthesis indeterminate or suspicious. Procedure Appropriateness Category Relative Radiation Level US breast Usually Appropriate O MRI breast without and with IV contrast Usually Not Appropriate O MRI breast without IV contrast Usually Not Appropriate O ACR Appropriateness Criteria® 1 Evaluation of the Symptomatic Male Breast Variant 5: Male of any age with physical examination suspicious for breast cancer (suspicious palpable breast mass, axillary adenopathy, nipple discharge, or nipple retraction). -
Findings of Gynecomastia That Developed in Follow-Up Secondary
Interesting Image Mol Imaging Radionucl Ther 2020;29:82-84 DOI:10.4274/mirt.galenos.2019.50490 Findings of Gynecomastia That Developed in Follow-up Secondary to Bicalutamide Treatment on Bone Scan Kemik Sintigrafisinde Bicalutamide Tedavisine Sekonder Takipte Gelişen Jinekomasti Bulguları Kemal Ünal1, Nahide Gökçora2 1Acıbadem University, Department of Nuclear Medicine, İstanbul, Turkey 2Gazi University, Department of Nuclear Medicine, Ankara, Turkey Abstract Prostate cancer is a common neoplastic disease especially in elder patients. Metastatic prostate disease has low five-year survival rate. Bicalutamide is an androgen receptor antagonist that acts as an inhibitor by competizing androgen receptors in the target tissue and used as a treatment option in prostate cancer. Bone scan was performed on a 79-year-old male with prostate cancer in our department. Blood pool images showed bilateral hyperemia in the breast regions which was not present on the previous scan one year ago. On physical examination, there was bilateral painful gynecomastia. It was learned that the patient was given Bicalutamide therapy after the first bone scan. Blood pool images may detect this side effect and should be evaluated with physical examination in case of clinical doubt. Keywords: Bicalutamide, gynecomastia, bone scan, prostate cancer Öz Prostat kanseri, ileri yaşlarda görülme sıklığı artan ve uzak metastazı olan hastalarda 5 yıllık sağkalım oranı önemli ölçüde düşük seyreden bir neoplazidir. Bicalutamide, prostat kanserli hastalarda kullanılan ve hedef dokudaki androjen reseptörleri ile kompetisyona girerek inhibitör etki gösteren bir ilaçtır. Prostat kanseri nedeniyle takip edilen 79 yaşındaki erkek hastaya bölümümüzde kemik sintigrafisi çekildi. Kan havuzu görüntülerinde bir yıl önceki incelemesinde gözlenmeyen, her iki meme bölgesinde hiperemi gelişimi görüldü. -
The 5 Stupidest Chemicals That Shouldn't Be in Your House (PDF)
MARCH 2013 NRDC faCT SHEET FS:13-03-A The 5 Stupidest Chemicals That Shouldn’t be in Your House As you begin the annual spring cleaning purge, make sure that you aren’t leaving behind a house filled with toxic chemicals that can harm you, your family, and your pets. Get rid of the chemicals that harm more than they help. 1. ANTIBACTERIAL PRODUCTS 2. TOXIC FLAME RETARDANTS Soaps, cosmetics, cleansers, lotions, toothpaste and other Furniture foam is saturated with flame retardant chemicals products may carry an “antibacterial” label, but you are really that not only don’t stop furniture fires, but also make fires paying extra for unnecessary additives like triclosan and its more toxic by forming deadly gases and soot, the real killers chemical cousin triclocarban—which may be doing more in most fires. What’s worse, flame retardant chemicals are harm than good. Triclosan is found in over 80 percent of linked to real and measurable health impacts, including Americans’ bodies and exposure has been linked to allergies, lower IQs and decreased attention spans for children exposed impaired reproduction, hormone disruption, and weakened in the womb, male infertility, male birth defects, and early muscles. The U.S. Food and Drug Administration (FDA) puberty in girls. A recent study in animals linked flame admitted that triclosan is no more effective at preventing retardants to autism and obesity. illness than regular soap. Widespread use—in everything Americans carry much higher levels of flame retardants from cutting boards, yoga mats, bedding, soaps and gels— in their bodies than anyone else in the world, due in large could also be promoting drug-resistant bacteria.