Package Leaflet: Information for the User
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Package Leaflet: Information for the Patient Desogestrel Rowex
Package leaflet: Information for the patient Desogestrel Rowex 75 microgram Film-coated tablets desogestrel Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What Desogestrel Rowex is and what it is used for 2. What you need to know before you take Desogestrel Rowex 4. Possible side effects 5. How to store Desogestrel Rowex 6. Contents of the pack and other information 1. What Desogestrel Rowex is and what it is used for Desogestrel Rowex used to prevent pregnancy. There are 2 main kinds of hormone contraceptive. - The combined pill, "The Pill", which contains 2 types of female sex hormone an oestrogen and a progestogen, - The progestogen-only pill, POP, which doesn't contain an oestrogen. Desogestrel Rowex is a progestogen-only-pill (POP). Desogestrel Rowex contains a small amount of one type of female sex hormone, the progestogen desogestrel. Most POPs work primarily by preventing the sperm cells from entering the womb but do not always prevent the egg cell from ripening, which is the main way that combined pills work. -
35 Cyproterone Acetate and Ethinyl Estradiol Tablets 2 Mg/0
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PrCYESTRA®-35 cyproterone acetate and ethinyl estradiol tablets 2 mg/0.035 mg THERAPEUTIC CLASSIFICATION Acne Therapy Paladin Labs Inc. Date of Preparation: 100 Alexis Nihon Blvd, Suite 600 January 17, 2019 St-Laurent, Quebec H4M 2P2 Version: 6.0 Control # 223341 _____________________________________________________________________________________________ CYESTRA-35 Product Monograph Page 1 of 48 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION ....................................................................... 3 SUMMARY PRODUCT INFORMATION ............................................................................................. 3 INDICATION AND CLINICAL USE ..................................................................................................... 3 CONTRAINDICATIONS ........................................................................................................................ 3 WARNINGS AND PRECAUTIONS ....................................................................................................... 4 ADVERSE REACTIONS ....................................................................................................................... 13 DRUG INTERACTIONS ....................................................................................................................... 16 DOSAGE AND ADMINISTRATION ................................................................................................ 20 OVERDOSAGE .................................................................................................................................... -
The Progestogen Only Pill
The Progestogen Only Pill Mini-pill or POP A service provided by page 2 of 8 How does the progestogen only pill (POP) work? The progestogen only pill mainly works by thickening the mucus you produce from your cervix. This makes it more difficult for sperm to get to the egg. It can also sometimes stop your ovaries from producing an egg (ovulation). How effective is the pill? The effectiveness of the pill depends on the woman taking it. At best it is over 98% effective (when no pills are missed). However failure rates can be much higher (9-15%) if women do not remember to take their pill properly. Missed pills can lead to pregnancy. Advantages of the POP • It doesn’t interfere with sex. • You can use it whilst you are breastfeeding. • It is useful if you cannot take oestrogen (the hormone contained in the combined oral contraceptive) • Can be used at any age even if you smoke and are over 35 years of age. • It may help with premenstrual symptoms and painful periods. page 3 of 8 Disadvantages of the POP • You have to remember to take your pill at the same time every day. • Your periods may become irregular or even stop altogether on the POP, this is not dangerous but if you miss a period you need to check that you are not pregnant by coming to clinic for a pregnancy test. • You may get some temporary side effects, such as spotty skin, breast tenderness and mood changes, though these should stop within a few months. -
Hormonal Treatment Strategies Tailored to Non-Binary Transgender Individuals
Journal of Clinical Medicine Review Hormonal Treatment Strategies Tailored to Non-Binary Transgender Individuals Carlotta Cocchetti 1, Jiska Ristori 1, Alessia Romani 1, Mario Maggi 2 and Alessandra Daphne Fisher 1,* 1 Andrology, Women’s Endocrinology and Gender Incongruence Unit, Florence University Hospital, 50139 Florence, Italy; [email protected] (C.C); jiska.ristori@unifi.it (J.R.); [email protected] (A.R.) 2 Department of Experimental, Clinical and Biomedical Sciences, Careggi University Hospital, 50139 Florence, Italy; [email protected]fi.it * Correspondence: fi[email protected] Received: 16 April 2020; Accepted: 18 May 2020; Published: 26 May 2020 Abstract: Introduction: To date no standardized hormonal treatment protocols for non-binary transgender individuals have been described in the literature and there is a lack of data regarding their efficacy and safety. Objectives: To suggest possible treatment strategies for non-binary transgender individuals with non-standardized requests and to emphasize the importance of a personalized clinical approach. Methods: A narrative review of pertinent literature on gender-affirming hormonal treatment in transgender persons was performed using PubMed. Results: New hormonal treatment regimens outside those reported in current guidelines should be considered for non-binary transgender individuals, in order to improve psychological well-being and quality of life. In the present review we suggested the use of hormonal and non-hormonal compounds, which—based on their mechanism of action—could be used in these cases depending on clients’ requests. Conclusion: Requests for an individualized hormonal treatment in non-binary transgender individuals represent a future challenge for professionals managing transgender health care. For each case, clinicians should balance the benefits and risks of a personalized non-standardized treatment, actively involving the person in decisions regarding hormonal treatment. -
Comparing the Effects of Combined Oral Contraceptives Containing Progestins with Low Androgenic and Antiandrogenic Activities on the Hypothalamic-Pituitary-Gonadal Axis In
JMIR RESEARCH PROTOCOLS Amiri et al Review Comparing the Effects of Combined Oral Contraceptives Containing Progestins With Low Androgenic and Antiandrogenic Activities on the Hypothalamic-Pituitary-Gonadal Axis in Patients With Polycystic Ovary Syndrome: Systematic Review and Meta-Analysis Mina Amiri1,2, PhD, Postdoc; Fahimeh Ramezani Tehrani2, MD; Fatemeh Nahidi3, PhD; Ali Kabir4, MD, MPH, PhD; Fereidoun Azizi5, MD 1Students Research Committee, School of Nursing and Midwifery, Department of Midwifery and Reproductive Health, Shahid Beheshti University of Medical Sciences, Tehran, Islamic Republic Of Iran 2Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Islamic Republic Of Iran 3School of Nursing and Midwifery, Department of Midwifery and Reproductive Health, Shahid Beheshti University of Medical Sciences, Tehran, Islamic Republic Of Iran 4Minimally Invasive Surgery Research Center, Iran University of Medical Sciences, Tehran, Islamic Republic Of Iran 5Endocrine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Islamic Republic Of Iran Corresponding Author: Fahimeh Ramezani Tehrani, MD Reproductive Endocrinology Research Center Research Institute for Endocrine Sciences Shahid Beheshti University of Medical Sciences 24 Parvaneh Yaman Street, Velenjak, PO Box 19395-4763 Tehran, 1985717413 Islamic Republic Of Iran Phone: 98 21 22432500 Email: [email protected] Abstract Background: Different products of combined oral contraceptives (COCs) can improve clinical and biochemical findings in patients with polycystic ovary syndrome (PCOS) through suppression of the hypothalamic-pituitary-gonadal (HPG) axis. Objective: This systematic review and meta-analysis aimed to compare the effects of COCs containing progestins with low androgenic and antiandrogenic activities on the HPG axis in patients with PCOS. -
SLINDA® (DROSPIRENONE 4 Mg) TABLETS
SLINDA® (DROSPIRENONE 4 mg) TABLETS AUSTRALIAN PRODUCT INFORMATION AUSTRALIAN PRODUCT 4.2 Dose And Method Of INFORMATION Administration SLINDA® (DROSPIRENONE) TABLETS Dose How to take SLINDA 1. NAME OF THE MEDICINE One tablet is to be taken daily for 28 Drospirenone consecutive days; one white active tablet daily during the first 24 days and one green inactive tablet 2. QUALITATIVE daily during the 4 following days. Tablets must be taken every day, at about AND QUANTITATIVE the same time of the day, so that the COMPOSITION interval between two tablets is always 24 hours. Tablets should be taken in White active film-coated tablets: the order shown on the blister. Stickers Each tablet contains 4 mg of marked with the 7 days of the week are drospirenone. provided. The patient should choose the sticker that starts with the day they Green placebo film-coated tablets: begin taking the tablets and stick it on The tablet does not contain active the blister. substances. The first tablet of the treatment should Excipient(s) with known effect: be taken on the first day of menstrual Each white active film-coated tablet bleeding. Thereafter tablet taking contains 17.5 mg of lactose. is continuous. A subsequent pack is started immediately after finishing the Each green placebo film-coated tablet previous pack, without a break in daily contains 55.5 mg of lactose monohydrate. tablet intake. For the full list of excipients, see section How to start SLINDA 6.1 List of Excipients. No preceding hormonal contraceptive use (in the past month) Tablet-taking has to start on day 1 of the 3. -
Desogestrel-Only Pill (Cerazette)
J Fam Plann Reprod Health Care: first published as 10.1783/147118903101197593 on 1 July 2003. Downloaded from Faculty of Family Planning and Reproductive Health Care Clinical Effectiveness Unit A unit funded by the FFPRHC and supported by the University of Aberdeen and SPCERH to provide guidance on evidence-based practice New Product Review (April 2003) Desogestrel-only Pill (Cerazette) Journal of Family Planning and Reproductive Health Care 2003; 29(3): 162–164 Evidence from a randomised trial has shown that a 75 mg (microgrammes) desogestrel pill inhibits ovulation in 97% of cycles. Thus, on theoretical grounds, we would expect the desogestrel pill to be more effective than existing progestogen- only pills (POPs). However, Pearl indices from clinical trials comparing it to a levonorgestrel POP were not significantly different. Therefore an evidence-based recommendation cannot be made that the desogestrel pill is different from other POPs in terms of efficacy, nor that it is similar to combined oral contraception (COC) in this respect. An evidence-based recommendation can be made that the desogestrel-only pill is similar to other POPs in terms of side effects and acceptability. The desogestrel-only pill is not recommended as an alternative to COC in routine practice, but provides a useful alternative for women who require oestrogen-free contraception. In clinical trials: l Ovulation was inhibited in 97% of cycles at 7 and 12 months after initiation. l The Pearl index was 0.41 per 100 woman-years, which was not significantly different from a levonorgestrel-only pill. However, the trial providing these data was too small to detect a clinically important difference. -
Dose Response Effect of Cyclical Medroxyprogesterone on Blood Pressure in Postmenopausal Women
Journal of Human Hypertension (2001) 15, 313–321 2001 Nature Publishing Group All rights reserved 0950-9240/01 $15.00 www.nature.com/jhh ORIGINAL ARTICLE Dose response effect of cyclical medroxyprogesterone on blood pressure in postmenopausal women PJ Harvey1, D Molloy2, J Upton2 and LM Wing1 Departments of 1Clinical Pharmacology and 2Medicine, Flinders University of South Australia, Bedford Park, Adelaide, South Australia, Australia 5042 Objective: This study was designed to compare with mean values of weeks 3 and 4 of each phase used for placebo the dose-response effect of cyclical doses of analysis. Ambulatory BP was performed in the final the C21 progestogen, medroxyprogesterone acetate week of each phase. (MPA) on blood pressure (BP) when administered to Results: Compared with the placebo phase, end of normotensive postmenopausal women receiving a fixed phase clinic BP was unchanged by any of the proges- mid-range daily dose of conjugated equine oestrogen togen treatments. There was a dose-dependent (CEE). decrease in ambulatory daytime diastolic and mean Materials and methods: Twenty normotensive post- arterial BP with the progestogen treatments compared menopausal women (median age 53 years) participated with placebo (P Ͻ 0.05). in the study which used a double-blind crossover Conclusion: In a regimen of postmenopausal hormone design. There were four randomised treatment phases, replacement therapy with a fixed mid-range daily dose each of 4 weeks duration. The four blinded treatments of CEE combined with a cyclical regimen of a C21 pro- were MPA 2.5 mg, MPA 5 mg, MPA 10 mg and matching gestogen spanning the current clinical dose range, the placebo, taken for the last 14 days of each 28 day treat- progestogen has either no effect or a small dose-depen- ment cycle. -
Connecticut Medicaid
ACNE AGENTS, TOPICAL ‡ ANGIOTENSIN MODULATOR COMBINATIONS ANTICONVULSANTS, CONT. CONNECTICUT MEDICAID (STEP THERAPY CATEGORY) AMLODIPINE / BENAZEPRIL (ORAL) LAMOTRIGINE CHEW DISPERS TAB (not ODT) (ORAL) (DX CODE REQUIRED - DIFFERIN, EPIDUO and RETIN-A) AMLODIPINE / OLMESARTAN (ORAL) LAMOTRIGINE TABLET (IR) (not ER) (ORAL) Preferred Drug List (PDL) ACNE MEDICATION LOTION (BENZOYL PEROXIDE) (TOPICAL)AMLODIPINE / VALSARTAN (ORAL) LEVETIRACETAM SOLUTION, IR TABLET (not ER) (ORAL) • The Connecticut Medicaid Preferred Drug List (PDL) is a BENZOYL PEROXIDE CREAM, WASH (not FOAM) (TOPICAL) OXCARBAZEPINE TABLET (ORAL) listing of prescription products selected by the BENZOYL PEROXIDE 5% and 10% GEL (OTC) (TOPICAL) ANTHELMINTICS PHENOBARBITAL ELIXIR, TABLET (ORAL) Pharmaceutical and Therapeutics Committee as efficacious, BENZOYL PEROXIDE 6% CLEANSER (OTC) (TOPICAL) ALBENDAZOLE TABLET (ORAL) PHENYTOIN CHEW TABLET, SUSPENSION (ORAL) safe and cost effective choices when prescribing for HUSKY CLINDAMYCIN PH 1% PLEGET (TOPICAL) BILTRICIDE TABLET (ORAL) PHENYTOIN SOD EXT CAPSULE (ORAL) A, HUSKY C, HUSKY D, Tuberculosis (TB) and Family CLINDAMYCIN PH 1% SOLUTION (not GEL or LOTION) (TOPICAL)IVERMECTIN TABLET (ORAL) PRIMIDONE (ORAL) Planning (FAMPL) clients. CLINDAMYCIN / BENZOYL PEROXIDE 1.2%-5% (DUAC) (TOPICAL) SABRIL 500 MG POWDER PACK (ORAL) • Preferred or Non-preferred status only applies to DIFFERIN 0.1% CREAM (TOPICAL) (not OTC GEL) (DX CODE REQ.) ANTI-ALLERGENS, ORAL SABRIL TABLET (ORAL) those medications that fall within the drug classes DIFFERIN -
Combined Estrogen–Progestogen Menopausal Therapy
COMBINED ESTROGEN–PROGESTOGEN MENOPAUSAL THERAPY Combined estrogen–progestogen menopausal therapy was considered by previous IARC Working Groups in 1998 and 2005 (IARC, 1999, 2007). Since that time, new data have become available, these have been incorporated into the Monograph, and taken into consideration in the present evaluation. 1. Exposure Data 1.1.2 Progestogens (a) Chlormadinone acetate Combined estrogen–progestogen meno- Chem. Abstr. Serv. Reg. No.: 302-22-7 pausal therapy involves the co-administration Chem. Abstr. Name: 17-(Acetyloxy)-6-chlo- of an estrogen and a progestogen to peri- or ropregna-4,6-diene-3,20-dione menopausal women. The use of estrogens with IUPAC Systematic Name: 6-Chloro-17-hy- progestogens has been recommended to prevent droxypregna-4,6-diene-3,20-dione, acetate the estrogen-associated risk of endometrial Synonyms: 17α-Acetoxy-6-chloro-4,6- cancer. Evidence from the Women’s Health pregnadiene-3,20-dione; 6-chloro-Δ6-17- Initiative (WHI) of adverse effects from the use acetoxyprogesterone; 6-chloro-Δ6-[17α] of a continuous combined estrogen–progestogen acetoxyprogesterone has affected prescribing. Patterns of exposure Structural and molecular formulae, and relative are also changing rapidly as the use of hormonal molecular mass therapy declines, the indications are restricted, O CH and the duration of the therapy is reduced (IARC, 3 C 2007). CH3 CH3 O C 1.1 Identification of the agents CH3 H O 1.1.1 Estrogens HH For Estrogens, see the Monograph on O Estrogen-only Menopausal Therapy in this Cl volume. C23H29ClO4 Relative molecular mass: 404.9 249 IARC MONOGRAPHS – 100A (b) Cyproterone acetate Structural and molecular formulae, and relative Chem. -
Coordinating Investigator
Public Disclosure Synopsis Page 1 of 6 KF4248/05 12 July 2016 Confidential TITLE OF TRIAL: Safety of the oral monophasic contraceptive GRT4248 (0.02 mg ethinylestradiol/2 mg chlormadinone acetate) in comparison to 0.02 mg ethinylestradiol/0.15 mg desogestrel given for 6 medication cycles SPONSOR/COMPANY: Grünenthal GmbH, 52099 Aachen, Germany COORDINATING Milano, Italy INVESTIGATOR: TRIAL CENTER(S): Thirty-three centers in total: 11 in Germany, 4 in Spain, 5 in France, 6 in Italy, 2 in Portugal, 5 in Russia PUBLICATION Not applicable (REFERENCE): TRIAL PERIOD (YEARS): First subject enrolled: 08 NOV 2005 Last subject completed: 16 AUG 2006 Data-base lock 24 OCT 2006 PHASE OF DEVELOPMENT: Phase III OBJECTIVES: To determine the safety of 0.02 mg ethinylestradiol/2 mg chlormadinone acetate, given for 24 days each 28-day cycle in comparison to 0.02 mg ethinylestradiol/0.15 mg desogestrel given for 21 days each 28-day cycle. Each investigational medicinal product (IMP) was to be taken for 6 cycles. METHODOLOGY: Randomized, multicenter, double-blind, desogestrel-controlled, parallel group, multiple administration, Phase III trial NUMBER OF SUBJECTS: Subjects were allocated by randomization to two medication groups, one receiving 0.02 mg ethinylestradiol/2 mg chlormadinone acetate (the GRT4248 group) and one receiving 0.02 mg ethinylestradiol/0.15 mg desogestrel (the EE/DSG group). The planned and actual sizes of the two groups were: Grünenthal Public Disclosure Synopsis Page 2 of 6 Confidential KF4248/05 12 July 2016 Evaluated Medication Randomized -
Guidance on Bioequivalence Studies for Reproductive Health Medicines
Medicines Guidance Document 23 October 2019 Guidance on Bioequivalence Studies for Reproductive Health Medicines CONTENTS 1. Introduction........................................................................................................................................................... 2 2. Which products require a bioequivalence study? ................................................................................................ 3 3. Design and conduct of bioequivalence studies .................................................................................................... 4 3.1 Basic principles in the demonstration of bioequivalence ............................................................................... 4 3.2 Good clinical practice ..................................................................................................................................... 4 3.3 Contract research organizations .................................................................................................................... 5 3.4 Study design .................................................................................................................................................. 5 3.5 Comparator product ....................................................................................................................................... 6 3.6 Generic product .............................................................................................................................................. 6 3.7 Study subjects