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LGM-Pharma-Regulatory-1527671011
Pipeline Products List Specialty Portfolio Updated Q2 2018 Updated Q2 2018 See below list of newly approved API’s, samples are readily available for your R&D requirements: Inhalation Ophthalmic Transdermal Sublingual Abaloparatide Defibrotide Sodium Liraglutide Rituximab Abciximab Deforolimus Lixisenatide Rivastigmine Aclidinium Bromide Azelastine HCl Agomelatine Alprazolam Abemaciclib Delafloxacin Lumacaftor Rivastigmine Hydrogen Tartrate Beclomethasone Dipropionate Azithromycin Amlodipine Aripiprazole Acalabrutinib Denosumab Matuzumab Rizatriptan Benzoate Budesonide Besifloxacin HCl Apomorphine Eletriptan HBr Aclidinium Bromide Desmopressin Acetate Meloxicam Rocuronium Bromide Adalimumab Difluprednate Memantine Hydrochloride Rolapitant Flunisolide Bimatoprost Clonidine Epinephrine Aflibercept Dinoprost Tromethamine Micafungin Romidepsin Fluticasone Furoate Brimonidine Tartrate Dextromethorphan Ergotamine Tartrate Agomelatine Dolasetron Mesylate Mitomycin C Romosozumab Fluticasone Propionate Bromfenac Sodium Diclofenac Levocetrizine DiHCl Albiglutide Donepezil Hydrochloride Mometasone Furoate Rotigotine Formoterol Fumarate Cyclosporine Donepezil Meclizine Alectinib Dorzolamide Hydrochloride Montelukast Sodium Rucaparib Iloprost Dexamethasone Valerate Estradiol Melatonin Alemtuzumab Doxercalciferol Moxifloxacin Hydrochloride Sacubitril Alirocumab Doxorubicin Hydrochloride Mycophenolate Mofetil Salmeterol Xinafoate Indacaterol Maleate Difluprednate Fingolimod Meloxicam Amphotericin B Dulaglutide Naldemedine Secukinumab Levalbuterol Dorzolamide -
Contraception and Misconceptions
CONTRACEPTION AND MISCONCEPTIONS CONTRACEPTION IN WOMEN WITH MENTAL ILLNESS OVERVIEW Hormones and mood How mental illness impacts on contraceptive choice Ideal contraception Pro and cons of contraceptive methods in women with mental illness Hormonal contraception and mood ESTROGENS anti-inflammatory neuroprotective effects of estradiol modulation of the limbic processing memory of emotionally-relevant information. estradiol “beneficially” modulates pathways implicated in the pathophysiology of depression, including serotonin and norepinephrine pathways PROGESTROGENS Previously thought to be anxiogenic, depressogenic Breakdown products Depression – alpha hydroxy progestrogen breakdown products pro – inflammatory, anxiogenic HORMONES AND MOODS – COMPLEX INTERPLAY MENTAL ILLNESS AND CONTRACEPTIVE CHOICE Effect of mental illness on contraceptive choice Effect of contraceptive choice on mental illness Drug interactions EFFECT MENTAL ILLNESS ON CONTRACEPTIVE CHOICE Impulsive Poor planning Cognitive and problem judgement Poor adherence IMPULSIVITY COGNITION POOR JUDGEMENT LETS NOT FORGET SUBSTANCES…… TYPES OF CONTRACEPTION No method Non hormonal Condom/Femidom Diaphragm Non hormone containing IUCD (Copper T) Hormonal COC POP Mirena Evra Patch Nuva Ring Implant ORAL CONTRACEPTIVES POP – avoid Same time every day COC Pros Effective Reduction PMS – monophasic estrogen dominant pill eg Femodene, Yaz, Nordette Cons Drug interactions Pill burden Daily dose EVRA PATCH Weekly patch Transdermal system: 150 mcg/day -
ORTHO TRI-CYCLEN® TABLETS ORTHO-CYCLEN® TABLETS (Norgestimate/Ethinyl Estradiol)
PHYSICIANS' PACKAGE INSERT ORTHO TRI-CYCLEN® TABLETS ORTHO-CYCLEN® TABLETS (norgestimate/ethinyl estradiol) Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases. DESCRIPTION Each of the following products is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. ORTHO TRI-CYCLEN 21 Tablets and ORTHO TRI-CYCLEN 28 Tablets. Each white tablet contains 0.180 mg of the progestational compound, norgestimate (18,19-Dinor- 17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). Inactive ingredients include lactose, magnesium stearate, and pregelatinized starch. Each light blue tablet contains 0.215 mg of the progestational compound norgestimate (18,19- Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-,oxime,(17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). Inactive ingredients include FD & C Blue No. 2 Aluminum Lake, lactose, magnesium stearate, and pregelatinized starch. Each blue tablet contains 0.250 mg of the progestational compound norgestimate (18,19-Dinor-17- pregn-4-en-20-yn-3-one, 17-(acetyloxy)-13-ethyl-,oxime,(17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). Inactive ingredients include FD & C Blue No. 2 Aluminum Lake, lactose, magnesium stearate, and pregelatinized starch. -
209627Orig1s000
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 209627Orig1s000 MULTI-DISCIPLINE REVIEW Summary Review Office Director Cross Discipline Team Leader Review Clinical Review Non-Clinical Review Statistical Review Clinical Pharmacology Review Reviewers of Multi-Disciplinary Review and Evaluation SECTIONS OFFICE/ AUTHORED/ ACKNOWLEDGED/ DISCIPLINE REVIEWER DIVISION APPROVED Mark Seggel, Ph.D. OPQ/ONDP/DNDP2 Authored: Section 4.2 Digitally signed by Mark R. Seggel -S CMC Lead DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Mark R. Signature: Mark R. Seggel -S Seggel -S, 0.9.2342.19200300.100.1.1=1300071539 Date: 2018.08.08 16:29:15 -04'00' Frederic Moulin, DVM, PhD OND/ODE3/DBRUP Authored: Section 5 Pharmacology/ Digitally signed by Frederic Moulin -S Toxicology DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, Reviewer Signature: Frederic Moulin -S 0.9.2342.19200300.100.1.1=2001708658, cn=Frederic Moulin -S Date: 2018.08.08 15:26:57 -04'00' Kimberly Hatfield, PhD OND/ODE3/DBRUP Approved: Section 5 Pharmacology/ Toxicology Digitally signed by Kimberly P. Hatfield -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, Team Leader Signature: Kimberly P. Hatfield -S 0.9.2342.19200300.100.1.1=1300387215, cn=Kimberly P. Hatfield -S Date: 2018.08.08 14:56:10 -04'00' Li Li, Ph.D. OCP/DCP3 Authored: Sections 6 and 17.3 Clinical Pharmacology Dig ta ly signed by Li Li S DN c=US o=U S Government ou=HHS ou=FDA ou=People Reviewer cn=Li Li S Signature: Li Li -S 0 9 2342 19200300 100 1 1=20005 08577 Date 2018 08 08 15 39 23 04'00' Doanh Tran, Ph.D. -
Estrogen and Progestin Hormone Doses in Combined Birth Control Pills
Estrogen and Progestin Hormone Doses in Combined Birth Control Pills Estrogen level Pill Brand Name Progestin Dose (mg) ethinyl estradiol (micrograms) 20 mcgm Alesse® levonorgestrel 0.10 Levlite® levonorgestrel 0.10 Loestrin 1/20® Fe norethindrone 1.00 acetate Mircette® desogestrel 0.15 Ortho Evra® norelgestromin 0.15 (patch) (norgestimate metabolite) phasic Estrostep® Fe norethindrone 1.0/1.0/1.0 20/30/35 mcgm acetate 30 mcgm Levlen® levonorgestrel 0.15 Levora® levonorgestrel 0.15 Nordette® levonorgestrel 0.15 Lo/Ovral® norgestrel 0.30 Desogen® desogestrel 0.15 Ortho-Cept® desogestrel 0.15 Loestrin® 1.5/30 norethindrone 1.50 acetate Yasmin® drospirenone 3.0 phasic Triphasil® levonorgestrel 0.05/0.075/0.125 30/40/30 mcgm Tri-Levlen® levonorgestrel 0.05/0.075/0.125 Trivora® levonorgestrel 0.05/0.075/0.125 35 mcgm Ortho-Cyclen® norgestimate 0.25 Ovcon-35® norethindrone 0.40 Brevicon® norethindrone 0.50 Modicon® norethindrone 0.50 Necon® norethindrone 1.00 Norethin® norethindrone 1.00 Norinyl® 1/35 norethindrone 1.00 Ortho-Novum® 1/35 norethindrone 1.00 Demulen® 1/35 ethynodiol diacetate 1.00 Zovia® 1/35E ethynodiol diacetate 1.00 phasic Ortho-Novum® norethindrone 0.50/1.00 35/35 mcgm 10/11 Jenest® norethindrone 0.50/1.00 phasic Ortho-Tri-Cyclen® norgestimate 0.15/0.215/0.25 35/35/35 mcgm Ortho-Novum® norethindrone 0.50/0.75/1.00 7/7/7 Tri-Norinyl® norethindrone 0.50/1.00/0.50 50 mcgm Necon® 1/50 norethindrone 1.00 Norinyl® 1/50 norethindrone 1.00 Ortho-Novum® 1/50 norethindrone 1.00 Ovcon-50® norethindrone 1.00 Ovral® norgestrel 0.50 Demulen® 1/50 ethynodiol diacetate 1.00 Zovia® 1/50E ethynodiol diacetate 1.00 Which pills have higher progestin side efects or cause more acne and hair growth? Each progestin has a diferent potency, milligram per milligram, in terms of progesterone efect to stop menstrual bleeding or androgen efect to stimulate acne and hair growth. -
Steroid Use in Prednisone Allergy Abby Shuck, Pharmd Candidate
Steroid Use in Prednisone Allergy Abby Shuck, PharmD candidate 2015 University of Findlay If a patient has an allergy to prednisone and methylprednisolone, what (if any) other corticosteroid can the patient use to avoid an allergic reaction? Corticosteroids very rarely cause allergic reactions in patients that receive them. Since corticosteroids are typically used to treat severe allergic reactions and anaphylaxis, it seems unlikely that these drugs could actually induce an allergic reaction of their own. However, between 0.5-5% of people have reported any sort of reaction to a corticosteroid that they have received.1 Corticosteroids can cause anything from minor skin irritations to full blown anaphylactic shock. Worsening of allergic symptoms during corticosteroid treatment may not always mean that the patient has failed treatment, although it may appear to be so.2,3 There are essentially four classes of corticosteroids: Class A, hydrocortisone-type, Class B, triamcinolone acetonide type, Class C, betamethasone type, and Class D, hydrocortisone-17-butyrate and clobetasone-17-butyrate type. Major* corticosteroids in Class A include cortisone, hydrocortisone, methylprednisolone, prednisolone, and prednisone. Major* corticosteroids in Class B include budesonide, fluocinolone, and triamcinolone. Major* corticosteroids in Class C include beclomethasone and dexamethasone. Finally, major* corticosteroids in Class D include betamethasone, fluticasone, and mometasone.4,5 Class D was later subdivided into Class D1 and D2 depending on the presence or 5,6 absence of a C16 methyl substitution and/or halogenation on C9 of the steroid B-ring. It is often hard to determine what exactly a patient is allergic to if they experience a reaction to a corticosteroid. -
Etats Rapides
List of European Pharmacopoeia Reference Standards Effective from 2015/12/24 Order Reference Standard Batch n° Quantity Sale Information Monograph Leaflet Storage Price Code per vial Unit Y0001756 Exemestane for system suitability 1 10 mg 1 2766 Yes +5°C ± 3°C 79 ! Y0001561 Abacavir sulfate 1 20 mg 1 2589 Yes +5°C ± 3°C 79 ! Y0001552 Abacavir for peak identification 1 10 mg 1 2589 Yes +5°C ± 3°C 79 ! Y0001551 Abacavir for system suitability 1 10 mg 1 2589 Yes +5°C ± 3°C 79 ! Y0000055 Acamprosate calcium - reference spectrum 1 n/a 1 1585 79 ! Y0000116 Acamprosate impurity A 1 50 mg 1 3-aminopropane-1-sulphonic acid 1585 Yes +5°C ± 3°C 79 ! Y0000500 Acarbose 3 100 mg 1 See leaflet ; Batch 2 is valid until 31 August 2015 2089 Yes +5°C ± 3°C 79 ! Y0000354 Acarbose for identification 1 10 mg 1 2089 Yes +5°C ± 3°C 79 ! Y0000427 Acarbose for peak identification 3 20 mg 1 Batch 2 is valid until 31 January 2015 2089 Yes +5°C ± 3°C 79 ! A0040000 Acebutolol hydrochloride 1 50 mg 1 0871 Yes +5°C ± 3°C 79 ! Y0000359 Acebutolol impurity B 2 10 mg 1 -[3-acetyl-4-[(2RS)-2-hydroxy-3-[(1-methylethyl)amino] propoxy]phenyl] 0871 Yes +5°C ± 3°C 79 ! acetamide (diacetolol) Y0000127 Acebutolol impurity C 1 20 mg 1 N-(3-acetyl-4-hydroxyphenyl)butanamide 0871 Yes +5°C ± 3°C 79 ! Y0000128 Acebutolol impurity I 2 0.004 mg 1 N-[3-acetyl-4-[(2RS)-3-(ethylamino)-2-hydroxypropoxy]phenyl] 0871 Yes +5°C ± 3°C 79 ! butanamide Y0000056 Aceclofenac - reference spectrum 1 n/a 1 1281 79 ! Y0000085 Aceclofenac impurity F 2 15 mg 1 benzyl[[[2-[(2,6-dichlorophenyl)amino]phenyl]acetyl]oxy]acetate -
Regulation of Ventral Tegmental Area Dopamine Neuron Activity by Feeding-Related Hypothalamic Neuropeptides
Georgia State University ScholarWorks @ Georgia State University Neuroscience Institute Dissertations Neuroscience Institute 8-7-2018 Regulation of Ventral Tegmental Area Dopamine Neuron Activity by Feeding-related Hypothalamic Neuropeptides Katherine MS West Georgia State University Follow this and additional works at: https://scholarworks.gsu.edu/neurosci_diss Recommended Citation West, Katherine MS, "Regulation of Ventral Tegmental Area Dopamine Neuron Activity by Feeding-related Hypothalamic Neuropeptides." Dissertation, Georgia State University, 2018. https://scholarworks.gsu.edu/neurosci_diss/36 This Dissertation is brought to you for free and open access by the Neuroscience Institute at ScholarWorks @ Georgia State University. It has been accepted for inclusion in Neuroscience Institute Dissertations by an authorized administrator of ScholarWorks @ Georgia State University. For more information, please contact [email protected]. REGULATION OF VENTRAL TEGMENTAL AREA DOPAMINE NEURON ACTIVITY BY FEEDING-RELATED HYPOTHALAMIC NEUROPEPTIDES by KATHERINE M. S. WEST Under the Direction of Aaron Roseberry, Ph.D. ABSTRACT The prevalence of obesity has doubled worldwide since the 1980s, and having a high body mass index contributes to more deaths worldwide than being underweight. Over the past 20 years, consumption of calorie-dense foods has increased, and this is considered one of the major causes of the rapid rise in obesity. Thus, understanding the neural control of food intake is important for the development of new and effective treatments of obesity. Two important brain regions that regulate food intake are the hypothalamus and the mesocorticolimbic dopamine system. The hypothalamus is essential for the homeostatic control of feeding and body weight, while the mesocorticolimbic dopamine system, also known as the reward system, is the primary circuit for reward and motivated behavior. -
U.S. Medical Eligibility Criteria for Contraceptive Use, 2016
Morbidity and Mortality Weekly Report Recommendations and Reports / Vol. 65 / No. 3 July 29, 2016 U.S. Medical Eligibility Criteria for Contraceptive Use, 2016 U.S. Department of Health and Human Services Centers for Disease Control and Prevention Recommendations and Reports CONTENTS Introduction ............................................................................................................1 Methods ....................................................................................................................2 How to Use This Document ...............................................................................3 Keeping Guidance Up to Date ..........................................................................5 References ................................................................................................................8 Abbreviations and Acronyms ............................................................................9 Appendix A: Summary of Changes from U.S. Medical Eligibility Criteria for Contraceptive Use, 2010 ...........................................................................10 Appendix B: Classifications for Intrauterine Devices ............................. 18 Appendix C: Classifications for Progestin-Only Contraceptives ........ 35 Appendix D: Classifications for Combined Hormonal Contraceptives .... 55 Appendix E: Classifications for Barrier Methods ..................................... 81 Appendix F: Classifications for Fertility Awareness–Based Methods ..... 88 Appendix G: Lactational -
Recommendations for Contraceptive Use, 2013 Adapted from the World Health Organization Selected Practice Recommendations for Contraceptive Use, 2Nd Edition
Morbidity and Mortality Weekly Report Early Release / Vol. 62 June 14, 2013 U.S. Selected Practice Recommendations for Contraceptive Use, 2013 Adapted from the World Health Organization Selected Practice Recommendations for Contraceptive Use, 2nd Edition Continuing Education Examination available at http://www.cdc.gov/mmwr/cme/conted.html. U.S. Department of Health and Human Services Centers for Disease Control and Prevention Early Release CONTENTS CONTENTS (Continued) Introduction ............................................................................................................1 Appendix A: Summary Chart of U.S. Medical Eligibility Criteria for Methods ....................................................................................................................2 Contraceptive Use, 2010 .................................................................................. 47 How To Use This Document ...............................................................................3 Appendix B: When To Start Using Specific Contraceptive Summary of Changes from WHO SPR ............................................................4 Methods .............................................................................................................. 55 Contraceptive Method Choice .........................................................................4 Appendix C: Examinations and Tests Needed Before Initiation of Maintaining Updated Guidance ......................................................................4 Contraceptive Methods -
OHIO STATE BOARD of PHARMACY 77 South High Street, Room 1702; Columbus, OH 43215-6126 -Equal Opportunity Employer and Service Provider
OHIO STATE BOARD OF PHARMACY 77 South High Street, Room 1702; Columbus, OH 43215-6126 -Equal Opportunity Employer and Service Provider- TEL: 614/466-4143 E-MAIL: [email protected] FAX: 614/752-4836 TTY/TDD: Use the Ohio Relay Service: 1-800/750-0750 www.pharmacy.ohio.gov ORDER OF THE STATE BOARD OF PHARMACY (Docket No. D-031110-034) In The Matter Of: CHRISTOPHER KIEL, R.Ph. 8260 Cyrus Lane Sagamore Hills, Ohio 44067 (R.Ph. No. 03-1-12367) INTRODUCTION THE MATTER OF CHRISTOPHER KIEL CAME FOR HEARING ON MAY 4, 2004, BEFORE THE FOLLOWING MEMBERS OF THE BOARD: ROBERT P. GIACALONE, R.Ph. (presiding); DIANE C. ADELMAN, R.Ph.; GREGORY BRAYLOCK, R.Ph.; SUZANNE R. EASTMAN, R.Ph.; ELIZABETH I. GREGG, R.Ph.; LAWRENCE J. KOST, R.Ph.; NATHAN S. LIPSYC, R.Ph.; DOROTHY S. TEATER, PUBLIC MEMBER; AND JAMES E. TURNER, R.Ph. CHRISTOPHER KIEL WAS REPRESENTED BY JOSEPH W. DIEMERT, JR. AND DIANE A. CALTA AND THE STATE OF OHIO WAS REPRESENTED BY SALLY ANN STEUK, ASSISTANT ATTORNEY GENERAL. SUMMARY OF EVIDENCE State’s Witnesses 1. Joann Predina, R.Ph., Ohio State Board of Pharmacy 2. Frederick Lochner, U.S. Food and Drug Administration (FDA) Respondent's Witnesses 1. Christopher Kiel, R.Ph., Respondent State's Exhibits 1K. Copy of Notice of Opportunity For Hearing letter [11-10-03] 1A-1K-E. Procedurals 1K-F. Copy of Amendment Notice [03-03-04] 1G-1K-K. Procedurals 2. Copy of Ohio State Board of Pharmacy Compliance Bulletin 93-002 [09-15-93] 2A. -
G Protein-Coupled Receptors
S.P.H. Alexander et al. The Concise Guide to PHARMACOLOGY 2015/16: G protein-coupled receptors. British Journal of Pharmacology (2015) 172, 5744–5869 THE CONCISE GUIDE TO PHARMACOLOGY 2015/16: G protein-coupled receptors Stephen PH Alexander1, Anthony P Davenport2, Eamonn Kelly3, Neil Marrion3, John A Peters4, Helen E Benson5, Elena Faccenda5, Adam J Pawson5, Joanna L Sharman5, Christopher Southan5, Jamie A Davies5 and CGTP Collaborators 1School of Biomedical Sciences, University of Nottingham Medical School, Nottingham, NG7 2UH, UK, 2Clinical Pharmacology Unit, University of Cambridge, Cambridge, CB2 0QQ, UK, 3School of Physiology and Pharmacology, University of Bristol, Bristol, BS8 1TD, UK, 4Neuroscience Division, Medical Education Institute, Ninewells Hospital and Medical School, University of Dundee, Dundee, DD1 9SY, UK, 5Centre for Integrative Physiology, University of Edinburgh, Edinburgh, EH8 9XD, UK Abstract The Concise Guide to PHARMACOLOGY 2015/16 provides concise overviews of the key properties of over 1750 human drug targets with their pharmacology, plus links to an open access knowledgebase of drug targets and their ligands (www.guidetopharmacology.org), which provides more detailed views of target and ligand properties. The full contents can be found at http://onlinelibrary.wiley.com/doi/ 10.1111/bph.13348/full. G protein-coupled receptors are one of the eight major pharmacological targets into which the Guide is divided, with the others being: ligand-gated ion channels, voltage-gated ion channels, other ion channels, nuclear hormone receptors, catalytic receptors, enzymes and transporters. These are presented with nomenclature guidance and summary information on the best available pharmacological tools, alongside key references and suggestions for further reading.