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WELLBUTRIN SR Safely and Effectively
HIGHLIGHTS OF PRESCRIBING INFORMATION psychosis, hallucinations, paranoia, delusions, homicidal ideation, These highlights do not include all the information needed to use aggression, hostility, agitation, anxiety, and panic, as well as suicidal WELLBUTRIN SR safely and effectively. See full prescribing ideation, suicide attempt, and completed suicide. Observe patients information for WELLBUTRIN SR. attempting to quit smoking with bupropion for the occurrence of such symptoms and instruct them to discontinue bupropion and contact a WELLBUTRIN SR (bupropion hydrochloride) sustained-release tablets, healthcare provider if they experience such adverse events. (5.2) for oral use • Initial U.S. Approval: 1985 Seizure risk: The risk is dose-related. Can minimize risk by gradually increasing the dose and limiting daily dose to 400 mg. Discontinue if WARNING: SUICIDAL THOUGHTS AND BEHAVIORS seizure occurs. (4, 5.3, 7.3) See full prescribing information for complete boxed warning. • Hypertension: WELLBUTRIN SR can increase blood pressure. Monitor blood pressure before initiating treatment and periodically during • Increased risk of suicidal thinking and behavior in children, treatment. (5.4) adolescents and young adults taking antidepressants. (5.1) • Activation of mania/hypomania: Screen patients for bipolar disorder and • Monitor for worsening and emergence of suicidal thoughts and monitor for these symptoms. (5.5) behaviors. (5.1) • Psychosis and other neuropsychiatric reactions: Instruct patients to contact a healthcare professional if such reactions occur. (5.6) --------------------------- INDICATIONS AND USAGE ---------------------------- • Angle-closure glaucoma: Angle-closure glaucoma has occurred in WELLBUTRIN SR is an aminoketone antidepressant, indicated for the patients with untreated anatomically narrow angles treated with treatment of major depressive disorder (MDD). (1) antidepressants. -
Maturation and Development. Biological and Psychological Perspectives
J Neurol Neurosurg Psychiatry: first published as 10.1136/jnnp.46.4.375-b on 1 April 1983. Downloaded from Journal of Neurology, Neurosurgery, and Psychiatry 1983;46:375-376 definition by trained transcribers with an tumours in childhood. Book reviews interexaminer reliability of F = 0-81 fol- These volumes are much recommended Gilies de la Tourette Syndrome Volume 35 lowed by 2-way Anovas with blocking for to all neurosurgeons who wish to be of Advances in Neurology. Edited by subject pairs to compute F ratios for com- acquainted with the "state of play" in Arnold J Friedhoff and Thomas N Chase. paring the mean Z scores on each language paediatric neurosurgery. The editors are, (Pp 478; $58.90.) New York, Raven Press. function. This is incomprehensible as well however, very naive if they believe, as they 1982. as meaningless. It is impossible to find out suggest in their preface to volume 2, that it whether clonidine is really useful or not or may be "possible for paediatric This volume contains the proceedings of whether haloperidol does possess definite neurosurgeons throughout the entire world the 1981 New York symposium on advantages over other neuroleptics. to provide their knowledge and care to the Tourette syndrome. The 67 papers are This is the second major work on Gilles benefit of all children". At least 1000 mil- organised into 10 main sections, clinical de la Tourette's syndrome to appear in 4 lion of the world's population are provided and historical over-view, neuro-anatomy years, the first edited by the Shapiros, with very few neurosurgeons (for the and neuropathology, neurophysiology, Bruun, and Sweet. -
Concomitant Drugs Associated with Increased Mortality for MDMA Users Reported in a Drug Safety Surveillance Database Isaac V
www.nature.com/scientificreports OPEN Concomitant drugs associated with increased mortality for MDMA users reported in a drug safety surveillance database Isaac V. Cohen1, Tigran Makunts2,3, Ruben Abagyan2* & Kelan Thomas4 3,4-Methylenedioxymethamphetamine (MDMA) is currently being evaluated by the Food and Drug Administration (FDA) for the treatment of post-traumatic stress disorder (PTSD). If MDMA is FDA-approved it will be important to understand what medications may pose a risk of drug– drug interactions. The goal of this study was to evaluate the risks due to MDMA ingestion alone or in combination with other common medications and drugs of abuse using the FDA drug safety surveillance data. To date, nearly one thousand reports of MDMA use have been reported to the FDA. The majority of these reports include covariates such as co-ingested substances and demographic parameters. Univariate and multivariate logistic regression was employed to uncover the contributing factors to the reported risk of death among MDMA users. Several drug classes (MDMA metabolites or analogs, anesthetics, muscle relaxants, amphetamines and stimulants, benzodiazepines, ethanol, opioids), four antidepressants (bupropion, sertraline, venlafaxine and citalopram) and olanzapine demonstrated increased odds ratios for the reported risk of death. Future drug–drug interaction clinical trials should evaluate if any of the other drug–drug interactions described in our results actually pose a risk of morbidity or mortality in controlled medical settings. 3,4-Methylenedioxymethamphetamine (MDMA) is currently being evaluated by the Food and Drug Adminis- tration (FDA) for the treatment of posttraumatic stress disorder (PTSD). During the past two decades, “ecstasy” was illegally distributed and is purported to contain MDMA, but because the market is unregulated this “ecstasy” may actually contain adulterants or no MDMA at all1. -
(12) Patent Application Publication (10) Pub. No.: US 2012/0190743 A1 Bain Et Al
US 2012O190743A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2012/0190743 A1 Bain et al. (43) Pub. Date: Jul. 26, 2012 (54) COMPOUNDS FOR TREATING DISORDERS Publication Classification OR DISEASES ASSOCATED WITH (51) Int. Cl NEUROKININ 2 RECEPTORACTIVITY A6II 3L/23 (2006.01) (75) Inventors: Jerald Bain, Toronto (CA); Joel CD7C 69/30 (2006.01) Sadavoy, Toronto (CA); Hao Chen, 39t. ii; C Columbia, MD (US); Xiaoyu Shen, ( .01) Columbia, MD (US) A6IPI/00 (2006.01) s A6IP 29/00 (2006.01) (73) Assignee: UNITED PARAGON A6IP II/00 (2006.01) ASSOCIATES INC., Guelph, ON A6IPI3/10 (2006.01) (CA) A6IP 5/00 (2006.01) A6IP 25/00 (2006.01) (21) Appl. No.: 13/394,067 A6IP 25/30 (2006.01) A6IP5/00 (2006.01) (22) PCT Filed: Sep. 7, 2010 A6IP3/00 (2006.01) CI2N 5/071 (2010.01) (86). PCT No.: PCT/US 10/48OO6 CD7C 69/33 (2006.01) S371 (c)(1) (52) U.S. Cl. .......................... 514/552; 554/227; 435/375 (2), (4) Date: Apr. 12, 2012 (57) ABSTRACT Related U.S. Application Data Compounds, pharmaceutical compositions and methods of (60) Provisional application No. 61/240,014, filed on Sep. treating a disorder or disease associated with neurokinin 2 4, 2009. (NK) receptor activity. Patent Application Publication Jul. 26, 2012 Sheet 1 of 12 US 2012/O190743 A1 LU 1750 15OO 1250 OOO 750 500 250 O O 20 3O 40 min SampleName: EM2OO617 Patent Application Publication Jul. 26, 2012 Sheet 2 of 12 US 2012/O190743 A1 kixto CFUgan <tro CFUgan FIG.2 Patent Application Publication Jul. -
Guaiana, G., Barbui, C., Caldwell, DM, Davies, SJC, Furukawa, TA
View metadata, citation and similar papers at core.ac.uk brought to you by CORE provided by Explore Bristol Research Guaiana, G., Barbui, C., Caldwell, D. M., Davies, S. J. C., Furukawa, T. A., Imai, H., ... Cipriani, A. (2017). Antidepressants, benzodiazepines and azapirones for panic disorder in adults: a network meta-analysis. Cochrane Database of Systematic Reviews, 2017(7), [CD012729]. https://doi.org/10.1002/14651858.CD012729 Publisher's PDF, also known as Version of record Link to published version (if available): 10.1002/14651858.CD012729 Link to publication record in Explore Bristol Research PDF-document This is the final published version of the article (version of record). It first appeared online via Cochrane Library at https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD012729/full . Please refer to any applicable terms of use of the publisher. University of Bristol - Explore Bristol Research General rights This document is made available in accordance with publisher policies. Please cite only the published version using the reference above. Full terms of use are available: http://www.bristol.ac.uk/pure/about/ebr-terms Cochrane Database of Systematic Reviews Antidepressants, benzodiazepines and azapirones for panic disorder in adults: a network meta-analysis (Protocol) Guaiana G, Barbui C, Caldwell DM, Davies SJC, Furukawa TA, Imai H, Koesters M, Tajika A, Bighelli I, Pompoli A, Cipriani A Guaiana G, Barbui C, Caldwell DM, Davies SJC, Furukawa TA, Imai H, Koesters M, Tajika A, Bighelli I, Pompoli A, Cipriani A. Antidepressants, benzodiazepines and azapirones for panic disorder in adults: a network meta-analysis. Cochrane Database of Systematic Reviews 2017, Issue 7. -
Strategies for Managing Sexual Dysfunction Induced by Antidepressant Medication
King’s Research Portal DOI: 10.1002/14651858.CD003382.pub3 Document Version Publisher's PDF, also known as Version of record Link to publication record in King's Research Portal Citation for published version (APA): Taylor, M. J., Rudkin, L., Bullemor-Day, P., Lubin, J., Chukwujekwu, C., & Hawton, K. (2013). Strategies for managing sexual dysfunction induced by antidepressant medication. Cochrane Database of Systematic Reviews, (5). https://doi.org/10.1002/14651858.CD003382.pub3 Citing this paper Please note that where the full-text provided on King's Research Portal is the Author Accepted Manuscript or Post-Print version this may differ from the final Published version. If citing, it is advised that you check and use the publisher's definitive version for pagination, volume/issue, and date of publication details. And where the final published version is provided on the Research Portal, if citing you are again advised to check the publisher's website for any subsequent corrections. General rights Copyright and moral rights for the publications made accessible in the Research Portal are retained by the authors and/or other copyright owners and it is a condition of accessing publications that users recognize and abide by the legal requirements associated with these rights. •Users may download and print one copy of any publication from the Research Portal for the purpose of private study or research. •You may not further distribute the material or use it for any profit-making activity or commercial gain •You may freely distribute the URL identifying the publication in the Research Portal Take down policy If you believe that this document breaches copyright please contact [email protected] providing details, and we will remove access to the work immediately and investigate your claim. -
(12) Patent Application Publication (10) Pub. No.: US 2006/0110428A1 De Juan Et Al
US 200601 10428A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2006/0110428A1 de Juan et al. (43) Pub. Date: May 25, 2006 (54) METHODS AND DEVICES FOR THE Publication Classification TREATMENT OF OCULAR CONDITIONS (51) Int. Cl. (76) Inventors: Eugene de Juan, LaCanada, CA (US); A6F 2/00 (2006.01) Signe E. Varner, Los Angeles, CA (52) U.S. Cl. .............................................................. 424/427 (US); Laurie R. Lawin, New Brighton, MN (US) (57) ABSTRACT Correspondence Address: Featured is a method for instilling one or more bioactive SCOTT PRIBNOW agents into ocular tissue within an eye of a patient for the Kagan Binder, PLLC treatment of an ocular condition, the method comprising Suite 200 concurrently using at least two of the following bioactive 221 Main Street North agent delivery methods (A)-(C): Stillwater, MN 55082 (US) (A) implanting a Sustained release delivery device com (21) Appl. No.: 11/175,850 prising one or more bioactive agents in a posterior region of the eye so that it delivers the one or more (22) Filed: Jul. 5, 2005 bioactive agents into the vitreous humor of the eye; (B) instilling (e.g., injecting or implanting) one or more Related U.S. Application Data bioactive agents Subretinally; and (60) Provisional application No. 60/585,236, filed on Jul. (C) instilling (e.g., injecting or delivering by ocular ion 2, 2004. Provisional application No. 60/669,701, filed tophoresis) one or more bioactive agents into the Vit on Apr. 8, 2005. reous humor of the eye. Patent Application Publication May 25, 2006 Sheet 1 of 22 US 2006/0110428A1 R 2 2 C.6 Fig. -
(19) United States (12) Patent Application Publication (10) Pub
US 20130289061A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2013/0289061 A1 Bhide et al. (43) Pub. Date: Oct. 31, 2013 (54) METHODS AND COMPOSITIONS TO Publication Classi?cation PREVENT ADDICTION (51) Int. Cl. (71) Applicant: The General Hospital Corporation, A61K 31/485 (2006-01) Boston’ MA (Us) A61K 31/4458 (2006.01) (52) U.S. Cl. (72) Inventors: Pradeep G. Bhide; Peabody, MA (US); CPC """"" " A61K31/485 (201301); ‘4161223011? Jmm‘“ Zhu’ Ansm’ MA. (Us); USPC ......... .. 514/282; 514/317; 514/654; 514/618; Thomas J. Spencer; Carhsle; MA (US); 514/279 Joseph Biederman; Brookline; MA (Us) (57) ABSTRACT Disclosed herein is a method of reducing or preventing the development of aversion to a CNS stimulant in a subject (21) App1_ NO_; 13/924,815 comprising; administering a therapeutic amount of the neu rological stimulant and administering an antagonist of the kappa opioid receptor; to thereby reduce or prevent the devel - . opment of aversion to the CNS stimulant in the subject. Also (22) Flled' Jun‘ 24’ 2013 disclosed is a method of reducing or preventing the develop ment of addiction to a CNS stimulant in a subj ect; comprising; _ _ administering the CNS stimulant and administering a mu Related U‘s‘ Apphcatlon Data opioid receptor antagonist to thereby reduce or prevent the (63) Continuation of application NO 13/389,959, ?led on development of addiction to the CNS stimulant in the subject. Apt 27’ 2012’ ?led as application NO_ PCT/US2010/ Also disclosed are pharmaceutical compositions comprising 045486 on Aug' 13 2010' a central nervous system stimulant and an opioid receptor ’ antagonist. -
Protocol/Amendment No.: 252-10 a Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Pembrolizumab (MK-3475) in Combin
Product: MK-3475 (SCH 900475), INCB024360 1 Protocol/Amendment No.: 252-10 (INCB 24360-301-10) / NCT02752074 THIS PROTOCOL AMENDMENT AND ALL OF THE INFORMATION RELATING TO IT ARE CONFIDENTIAL AND PROPRIETARY PROPERTY OF MERCK SHARP & DOHME CORP., A SUBSIDIARY OF MERCK & CO., INC., WHITEHOUSE STATION, NJ, U.S.A. This study is co-funded by Incyte and MSD. Execution of Trial: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. One Merck Drive P.O. Box 100 Whitehouse Station, New Jersey, 08889-0100, U.S.A. Protocol-specific Contact information can be found in the Investigator Trial File Binder (or equivalent). Global Sponsor of the Study: Incyte Corporation (Referenced herein as Sponsor) 1801 Augustine Cut-Off Wilmington, Delaware, 19803, U.S.A TITLE: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Pembrolizumab (MK- 3475) in Combination With Epacadostat or Placebo in Subjects with Unresectable or Metastatic Melanoma (KEYNOTE-252 / ECHO-301) IND NUMBER: 121,704 EudraCT NUMBER: 2015-004991-31 MK-3475-252-10 (INCB 24360-301-10) Final Protocol 18-May-2018 Confidential 04XN7M Product: MK-3475 (SCH 900475), INCB024360 2 Protocol/Amendment No.: 252-10 (INCB 24360-301-10) TABLE OF CONTENTS SUMMARY OF CHANGES.................................................................................................14 1.0 TRIAL SUMMARY...................................................................................................29 2.0 TRIAL DESIGN.........................................................................................................30 -
)&F1y3x PHARMACEUTICAL APPENDIX to THE
)&f1y3X PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE )&f1y3X PHARMACEUTICAL APPENDIX TO THE TARIFF SCHEDULE 3 Table 1. This table enumerates products described by International Non-proprietary Names (INN) which shall be entered free of duty under general note 13 to the tariff schedule. The Chemical Abstracts Service (CAS) registry numbers also set forth in this table are included to assist in the identification of the products concerned. For purposes of the tariff schedule, any references to a product enumerated in this table includes such product by whatever name known. Product CAS No. Product CAS No. ABAMECTIN 65195-55-3 ACTODIGIN 36983-69-4 ABANOQUIL 90402-40-7 ADAFENOXATE 82168-26-1 ABCIXIMAB 143653-53-6 ADAMEXINE 54785-02-3 ABECARNIL 111841-85-1 ADAPALENE 106685-40-9 ABITESARTAN 137882-98-5 ADAPROLOL 101479-70-3 ABLUKAST 96566-25-5 ADATANSERIN 127266-56-2 ABUNIDAZOLE 91017-58-2 ADEFOVIR 106941-25-7 ACADESINE 2627-69-2 ADELMIDROL 1675-66-7 ACAMPROSATE 77337-76-9 ADEMETIONINE 17176-17-9 ACAPRAZINE 55485-20-6 ADENOSINE PHOSPHATE 61-19-8 ACARBOSE 56180-94-0 ADIBENDAN 100510-33-6 ACEBROCHOL 514-50-1 ADICILLIN 525-94-0 ACEBURIC ACID 26976-72-7 ADIMOLOL 78459-19-5 ACEBUTOLOL 37517-30-9 ADINAZOLAM 37115-32-5 ACECAINIDE 32795-44-1 ADIPHENINE 64-95-9 ACECARBROMAL 77-66-7 ADIPIODONE 606-17-7 ACECLIDINE 827-61-2 ADITEREN 56066-19-4 ACECLOFENAC 89796-99-6 ADITOPRIM 56066-63-8 ACEDAPSONE 77-46-3 ADOSOPINE 88124-26-9 ACEDIASULFONE SODIUM 127-60-6 ADOZELESIN 110314-48-2 ACEDOBEN 556-08-1 ADRAFINIL 63547-13-7 ACEFLURANOL 80595-73-9 ADRENALONE -
Treatment of Social Phobia with Antidepressants
Antidepressants for Social Phobia Treatment of Social Phobia With Antidepressants Franklin R. Schneier, M.D. This article reviews evidence for the utility of antidepressant medications in the treatment of social phobia. Monoamine oxidase inhibitors (MAOIs) were the first antidepressants shown to be effective © Copyrightfor social phobia, but 2001dietary restrictions Physicians and a relatively Postgraduate high rate of adverse effects Press, often relegate Inc. MAOIs to use after other treatments have been found ineffective. Reversible inhibitors of monoamine oxidase (RIMAs) hold promise as safer alternatives to MAOIs, but RIMAs may be less effective and are currently unavailable in the United States. Selective serotonin reuptake inhibitors (SSRIs), of which paroxetine has been the best studied in social phobia to date, have recently emerged as a first- line treatment for the generalized subtype of social phobia. The SSRIs are well tolerated and consis- tently have been shown to be efficacious in controlled trials. (J Clin Psychiatry 2001;62[suppl 1]:43–48) arly evidence that antidepressantsOne might personal have utility copy maypressant be printed treatment of other anxiety disorders, such as panic E in the treatment of social phobia emerged in the disorder and obsessive-compulsive disorder. In particular, 1970s when studies found efficacy for monoamine oxidase the high rate of comorbidity of anxiety disorders with de- inhibitors (MAOIs) in patient samples that included both pression3 makes treatment with antidepressants an efficient -
(12) United States Patent (10) Patent No.: US 6,264,917 B1 Klaveness Et Al
USOO6264,917B1 (12) United States Patent (10) Patent No.: US 6,264,917 B1 Klaveness et al. (45) Date of Patent: Jul. 24, 2001 (54) TARGETED ULTRASOUND CONTRAST 5,733,572 3/1998 Unger et al.. AGENTS 5,780,010 7/1998 Lanza et al. 5,846,517 12/1998 Unger .................................. 424/9.52 (75) Inventors: Jo Klaveness; Pál Rongved; Dagfinn 5,849,727 12/1998 Porter et al. ......................... 514/156 Lovhaug, all of Oslo (NO) 5,910,300 6/1999 Tournier et al. .................... 424/9.34 FOREIGN PATENT DOCUMENTS (73) Assignee: Nycomed Imaging AS, Oslo (NO) 2 145 SOS 4/1994 (CA). (*) Notice: Subject to any disclaimer, the term of this 19 626 530 1/1998 (DE). patent is extended or adjusted under 35 O 727 225 8/1996 (EP). U.S.C. 154(b) by 0 days. WO91/15244 10/1991 (WO). WO 93/20802 10/1993 (WO). WO 94/07539 4/1994 (WO). (21) Appl. No.: 08/958,993 WO 94/28873 12/1994 (WO). WO 94/28874 12/1994 (WO). (22) Filed: Oct. 28, 1997 WO95/03356 2/1995 (WO). WO95/03357 2/1995 (WO). Related U.S. Application Data WO95/07072 3/1995 (WO). (60) Provisional application No. 60/049.264, filed on Jun. 7, WO95/15118 6/1995 (WO). 1997, provisional application No. 60/049,265, filed on Jun. WO 96/39149 12/1996 (WO). 7, 1997, and provisional application No. 60/049.268, filed WO 96/40277 12/1996 (WO). on Jun. 7, 1997. WO 96/40285 12/1996 (WO). (30) Foreign Application Priority Data WO 96/41647 12/1996 (WO).