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Depo-Estradiol (Estradiol Cypionate) Injection
Market Applicability Market DC GA KY MD NJ NY WA Applicable X X X X X X NA Depo-Estradiol (estradiol cypionate) injection Override(s) Approval Duration Prior Authorization 1 year Medications Depo-Estradiol (estradiol cypionate) injection APPROVAL CRITERIA Requests for Depo-Estradiol (estradiol cypionate) injection may be approved when the following criteria are met: I. Individual is using to treat moderate to severe vasomotor symptoms associated with menopause; OR II. Individual has been diagnosed with hypoestrogenism due to hypogonadism; OR III. Individual has a diagnosis of gender dysphoria or gender identity disorder (WPATH 2012, Endocrine Society 2017) ; AND IV. Individual is 16 years of age or older; AND V. The goal of treatment is male-to-female gender reassignment. Requests for Depo-Estradiol (estradiol cypionate) injection may not be approved for any of the following: I. Individual has undiagnosed abnormal genital bleeding; OR II. Individual has known or suspected cancer of the breast; OR III. Individual has known or suspected estrogen-dependent neoplasia; OR IV. Individual has active deep vein thrombosis, pulmonary embolism or history of these conditions; OR V. Individual has active or recent (within the past year) arterial thromboembolic disease (such as stroke or myocardial infarction); OR VI. Individual has liver dysfunction or disease. PAGE 1 of 2 02/24/2020 New Program Date 02/24/2020 CRX-ALL-0519-20 This policy does not apply to health plans or member categories that do not have pharmacy benefits, nor does it apply to Medicare. Note that market specific restrictions or transition-of-care benefit limitations may apply. -
Contraception: Choosing the Right Method for You
Contraception: Choosing the Right Method for You Megan Sax, MD and James L. Whiteside, MD What’s available? Choosing a method of contraception can be overwhelming. The most commonly used methods of reversible contraception in the United States are: hormonal methods the intrauterine device (IUD) the implant barrier methods (e.g. male condom)1 Friends, family, and the Internet are full of stories of failed contraception or bad reactions and these stories can have a big influence that doesn’t always line up with the facts.2 However, knowing these facts is critical to figuring out what type will work best for you. Highly Effective Contraception The best place to start in choosing your contraception is to determine when, if ever, you are planning on starting a family. If you do not wish to become pregnant in the next year, a Long-Acting Reversible Contraceptive (LARC) device may be a good option. LARCs include an implant placed under the skin of the upper, inner arm (brand name Nexplanon) and the IUD. IUDs are placed inside the uterus (see Figure 1). They use copper (brand name ParaGard) or hormones (brand names: Mirena, Lilleta, Skyla, Kyleena) to stop a pregnancy from happening. LARCs are the most effective reversible form of contraception. Less than 1% of users experience unintended pregnancy during the first year of use.3 Currently, the implant Nexplanon is effective for 3 years. The hormonal IUD may be used for 3 to 5 years, depending on the brand. The copper IUD works for 10 years. These devices are inserted and removed by a medical care provider. -
Pms-ESTRADIOL VALERATE INJECTION
PRODUCT MONOGRAPH Prpms-ESTRADIOL VALERATE INJECTION Estradiol Valerate 10 mg/mL Estrogen PHARMASCIENCE INC. Date of Revision: 6111 Royalmount Avenue, Suite 100 June 30, 2009 Montreal, Quebec H4P 2T4 Control Number: 120632 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION……………………………...3 SUMMARY PRODUCT INFORMATION……………………………………….3 INDICATIONS AND CLINICAL USE…………………………………………...3 CONTRAINDICATIONS…………………………………………………………4 WARNINGS AND PRECAUTIONS…………………………………….……….5 ADVERSE REACTIONS………………………………………………………...13 DRUG INTERACTIONS………………………………………………………...15 DOSAGE AND ADMINISTRATION…………………………………………...17 OVERDOSAGE………………………………………………………………….19 ACTION AND CLINICAL PHARMACOLOGY……………………………….19 STORAGE AND STABILITY…………………………………………………...22 DOSAGE FORMS, COMPOSITION AND PACKAGING……………………..22 PART II: SCIENTIFIC INFORMATION…………………………………………….23 PHARMACEUTICAL INFORMATION………………………………………...23 CLINICAL TRIALS……………………………………………………………...24 DETAILED PHARMACOLOGY………………………………………………..24 REFERENCES…………………………………………………………………...25 PART III: CONSUMER INFORMATION……………………………………………………27 2 PRODUCT MONOGRAPH Prpms- ESTRADIOL VALERATE INJECTION (Estradiol Valerate) 10 mg/mL PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Dosage Form / Strength Clinically Relevant Nonmedicinal Administration Ingredients Intramuscular Injection / 10 mg/mL Sesame Oil For a complete listing see Dosage Forms, Composition and Packaging section. INDICATIONS AND CLINICAL USE pms-ESTRADIOL VALERATE INJECTION is indicated in the treatment of: I. amenorrhea (primary -
Estradiol-17Β Pharmacokinetics and Histological Assessment Of
animals Article Estradiol-17β Pharmacokinetics and Histological Assessment of the Ovaries and Uterine Horns following Intramuscular Administration of Estradiol Cypionate in Feral Cats Timothy H. Hyndman 1,* , Kelly L. Algar 1, Andrew P. Woodward 2, Flaminia Coiacetto 1 , Jordan O. Hampton 1,2 , Donald Nickels 3, Neil Hamilton 4, Anne Barnes 1 and David Algar 4 1 School of Veterinary Medicine, Murdoch University, Murdoch 6150, Australia; [email protected] (K.L.A.); [email protected] (F.C.); [email protected] (J.O.H.); [email protected] (A.B.) 2 Faculty of Veterinary and Agricultural Sciences, University of Melbourne, Melbourne 3030, Australia; [email protected] 3 Lancelin Veterinary Hospital, Lancelin 6044, Australia; [email protected] 4 Department of Biodiversity, Conservation and Attractions, Locked Bag 104, Bentley Delivery Centre 6983, Australia; [email protected] (N.H.); [email protected] (D.A.) * Correspondence: [email protected] Received: 7 September 2020; Accepted: 17 September 2020; Published: 21 September 2020 Simple Summary: Feral cats (Felis catus) have a devastating impact on Australian native fauna. Several programs exist to control their numbers through lethal removal, using tools such as baiting with toxins. Adult male cats are especially difficult to control. We hypothesized that one way to capture these male cats is to lure them using female cats. As female cats are seasonal breeders, a method is needed to artificially induce reproductive (estrous) behavior so that they could be used for this purpose year-round (i.e., regardless of season). -
Drug and Chemical Reference Guideline
WISCONSIN DEPARTMENT OF AGRICULTURE, TRADE AND CONSUMER PROTECTION DIVISION OF FOOD AND RECREATIONAL SAFETY TITLE: Drug and Chemical Reference Guideline Document #: Replaces: New Revision Date: 1/21/2020 Page 1 of 6 General Guidelines: These drugs and substances are not to be used or • Drugs and administration equipment stored to not stored on dairy farms. These drugs are not eligible for contaminate milk or milk contact surfaces ELU privileges by veterinarians. • Non-lactating drugs separated from lactating drugs • Chloramphenicol using separate shelves or cabinets • Clenbuterol • Drugs properly labeled (see label requirements • Colloidal Silver below) • Diethylstilbestrol (DES) • Locked drug cabinets must be made accessible for • Dimethysulfoxide (DMSO) inspection • Dimetridazole • Drugs for animal species other than cattle must not • Dipyrone (Novine, No Pain) be stored in dairy facility • Estradiol Cypionate (ECP) • All bottles or packages in case lots properly labeled • Fluoroquinolones (sarafloxacin-Saraflox, orbafloxacin-Orbox, danofloxacin mesylate-A 180) Drug Labeling Requirements: • Furazolidone, Nitrofurazone, other Nitrofurans OTC Drugs: (over the counter) • Glycopeptides (vancomycin) • Name of Drug • Iononphores (Lasalocid) permitted for non-lactating • Active ingredients • Ipronidazole • Directions for use • Metronidazole and other Nitroimidazoles • Withholding/withdrawal or discard time for meat or • Phenylbutazone, “bute” (prohibited in dairy animals milk (even if zero) 20 months of age or older - no ELU allowed.) • Name -
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, -
F.8 Ethinylestradiol-Etonogestrel.Pdf
General Items 1. Summary statement of the proposal for inclusion, change or deletion. Here within, please find the evidence to support the inclusion Ethinylestradiol/Etonogestrel Vaginal Ring in the World Health Organization’s Essential Medicines List (EML). Unintended pregnancy is regarded as a serious public health issue both in developed and developing countries and has received growing research and policy attention during last few decades (1). It is a major global concern due to its association with adverse physical, mental, social and economic outcomes. Developing countries account for approximately 99% of the global maternal deaths in 2015, with sub-Saharan Africa alone accounting for roughly 66% (2). Even though the incidence of unintended pregnancy has declined globally in the past decade, the rate of unintended pregnancy remains high, particularly in developing regions. (3) Regarding the use of contraceptive vaginal rings, updated bibliography (4,5,6) states that contraceptive vaginal rings (CVR) offer an effective contraceptive option, expanding the available choices of hormonal contraception. Ethinylestradiol/Etonogestrel Vaginal Ring is a non-biodegradable, flexible, transparent with an outer diameter of 54 mm and a cross-sectional diameter of 4 mm. It contains 11.7 mg etonogestrel and 2.7 mg ethinyl estradiol. When placed in the vagina, each ring releases on average 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol over a three-week period of use. Ethinylestradiol/Etonogestrel Vaginal Ring is intended for women of fertile age. The safety and efficacy have been established in women aged 18 to 40 years. The main advantages of CVRs are their effectiveness (similar or slightly better than the pill), ease of use without the need of remembering a daily routine, user ability to control initiation and discontinuation, nearly constant release rate allowing for lower doses, greater bioavailability and good cycle control with the combined ring, in comparison with oral contraceptives. -
Estradiol Cypionate: Summary Report
Estradiol Cypionate: Summary Report Item Type Report Authors Yuen, Melissa V.; Gianturco, Stephanie L.; Pavlech, Laura L.; Storm, Kathena D.; Yoon, SeJeong; Mattingly, Ashlee N. Publication Date 2019-12 Keywords Estradiol cypionate; Compounding; Food, Drug, and Cosmetic Act, Section 503B; Food and Drug Administration; Outsourcing facility; Drug compounding; Legislation, Drug; United States Food and Drug Administration Rights Attribution-NoDerivatives 4.0 International Download date 27/09/2021 15:15:19 Item License http://creativecommons.org/licenses/by-nd/4.0/ Link to Item http://hdl.handle.net/10713/12106 Summary Report Estradiol cypionate Prepared for: Food and Drug Administration Clinical use of bulk drug substances nominated for inclusion on the 503B Bulks List Grant number: 2U01FD005946 Prepared by: University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) University of Maryland School of Pharmacy December 2019 This report was supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award (U01FD005946) totaling $2,342,364, with 100 percent funded by the FDA/HHS. The contents are those of the authors and do not necessarily represent the official views of, nor an endorsement by, the FDA/HHS or the U.S. Government. 1 Table of Contents REVIEW OF NOMINATIONS ................................................................................................... 4 METHODOLOGY ................................................................................................................... -
Gender-Affirming Hormone Therapy
GENDER-AFFIRMING HORMONE THERAPY Julie Thompson, PA-C Medical Director of Trans Health, Fenway Health March 2020 fenwayhealth.org GOALS AND OBJECTIVES 1. Review process of initiating hormone therapy through the informed consent model 2. Provide an overview of masculinizing and feminizing hormone therapy 3. Review realistic expectations and benefits of hormone therapy vs their associated risks 4. Discuss recommendations for monitoring fenwayhealth.org PROTOCOLS AND STANDARDS OF CARE fenwayhealth.org WPATH STANDARDS OF CARE, 2011 The criteria for hormone therapy are as follows: 1. Well-documented, persistent (at least 6mo) gender dysphoria 2. Capacity to make a fully informed decision and to consent for treatment 3. Age of majority in a given country 4. If significant medical or mental health concerns are present, they must be reasonably well controlled fenwayhealth.org INFORMED CONSENT MODEL ▪ Requires healthcare provider to ▪ Effectively communicate benefits, risks and alternatives of treatment to patient ▪ Assess that the patient is able to understand and consent to the treatment ▪ Informed consent model does not preclude mental health care! ▪ Recognizes that prescribing decision ultimately rests with clinical judgment of provider working together with the patient ▪ Recognizes patient autonomy and empowers self-agency ▪ Decreases barriers to medically necessary care fenwayhealth.org INITIAL VISITS ▪ Review history of gender experience and patient’s goals ▪ Document prior hormone use ▪ Assess appropriateness for gender affirming medical -
OTS-8120.6 Chapter 246-886
AMENDATORY SECTION (Amending WSR 15-13-086, filed 6/15/15, effective 7/16/15) WAC 246-887-020 Uniform Controlled Substances Act. (1) ((Con- sistent with the concept of uniformity where possible with the federal regulations for controlled substances (21 C.F.R.), the federal regula- tions are specifically made applicable to registrants in this state by virtue of RCW 69.50.306. Although those regulations are automatically applicable to registrants in this state,)) The pharmacy quality assur- ance commission (commission) ((is nevertheless adopting as its own regulations the existing regulations of the federal government pub- lished in)) adopts Title 21 of the Code of Federal Regulations ((re- vised as of April 1, 1991, and all references made therein to the di- rector or the secretary shall have reference to the commission, and)). The following sections ((are not applicable)) do not apply: Section ((1301.11-.13, section 1301.31, section 1301.43-.57)) 1301.13, section 1301.33, section 1301.35-.46, section 1303, section ((1308.41-.48)) 1308.41-.45, and section 1316.31-.67. ((The following specific rules shall take precedence over the federal rules adopted herein by refer- ence, and therefore any inconsistencies shall be resolved in favor of the following specific rules.)) Any inconsistencies between Title 21 of the Code of Federal Regulations sections 1300 through 1321 and chapter 246-887 WAC should be resolved in favor of chapter 246-887 WAC. Further, nothing in these rules applies to the production, pro- cessing, distribution, or possession of marijuana as authorized and regulated by the Washington state liquor and cannabis board. -
Profiles of Circulating Estradiol-17Β After Different Estrogen Treatments in Lactating Dairy Cows
Anim. Reprod., v.2, n.4, p.224-232, Oct./Dec. 2005 Profiles of circulating estradiol-17β after different estrogen treatments in lactating dairy cows A.H. Souza1, A.P. Cunha1, D.Z. Caraviello1, M.C. Wiltbank1,2 1Department of Dairy Science, 1675 Observatory Drive, University of Wisconsin, Madison, WI, USA 53706 Abstract Washburn et al., 2002). One of the physiological aspects that may affect reproductive efficiency in The objective of this study was to characterize lactating dairy cows is the elevated metabolism of the circulating concentrations of estradiol-17β (E-17β) estradiol-17β (E-17β; Sangsritavong et al., 2002). This after treatment with different types or doses of estrogens high E-17β metabolism appears to be due to the in the absence (Experiment 1) or presence (Experiment 2) elevated liver blood flow that is coincident with of a dominant follicle in lactating cows. In Experiment 1, elevated dry matter intake in lactating dairy cows cows (n = 12) had all follicles > 5 mm removed by (Sangsritavong et al., 2002). High rates of E-17β ultrasound-guided follicular aspiration every 12 h metabolism result in reduced circulating E-17β throughout the blood sampling period. Estrogen concentrations in lactating cows compared to non- treatments started 48 h after the first follicular aspiration. lactating cows (Sartori et al., 2002a; 2004) and in Treatments were: no treatment, E-17β (0.5 mg), or lactating cows with high milk production compared to estradiol benzoate (EB, 0.5 mg). Seven days after the cows with low production (Lopez et al., 2004; 2005). end of the first trial, cows were then re-randomized to Since E-17β is involved in many aspects of reproductive receive: no treatment, E-17β (1.0 mg), EB (1.0 mg), or physiology, this reduction in circulating E-17β could estradiol cypionate (ECP, 1.0 mg). -
1 Effects Ethinyl Estradiol Ethinyl Estradiol & Its Effects On
1 Effects Ethinyl Estradiol Ethinyl Estradiol & Its Effects on Cardiovascular Health Mary Eilert Lourdes University Spring 2019 BIO 490 Section A Dr. Anjali Gray 2 Effects Ethinyl Estradiol ABSTRACT Combined hormonal birth control regulates the menstrual cycle in women by manipulating the hormonal level. Combined hormonal contraception utilizes progestin and Ethinyl estradiol, which are synthetics of progesterone and estrogen. These synthetic hormones help regulate ovulation in women and in turn menstruation. Venous thromboembolism (VTE), stroke, and myocardial infarction are all risk factors when taking combined hormonal contraception due to the chemical composition of Ethinyl estradiol. Ethinyl estradiol’s binding mechanism to an estrogen receptor causes clots and therefore a risk for cardiovascular disease. The dosage of Ethinyl estradiol is related to an increased risk for VTE, stroke, and myocardial infarction. Due to the increased threat to cardiovascular health, physicians should screen patient health history carefully when prescribing combined hormonal birth control. Analyzing the risk Ethinyl estradiol poses to cardiovascular health in women can be used to determine if combined hormonal birth control is the ideal choice for contraception. 3 Effects Ethinyl Estradiol INTRODUCTION Birth control, a contraceptive, is frequently prescribed to women of varying ages throughout the United States. Birth control can be used for its primary use as a contraceptive or prescribed as a means of lessening symptoms of reproductive diseases, such as endometriosis. Birth control comes in various forms and methods. Intrauterine devices (IUDs) and birth control implants are forms which are implanted into the women and rely on the release of hormones to regulate the menstrual cycle (Planned Parenthood).