View Board, Austin, Texas, As Well As the Ethics Com- Pendent Examiner in the Same Room with the Same Instru- Mittee of Eye Center and Research, Aseer, Saudi Arabia
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Brimonidine Tartrate; Brinzolamide
Contains Nonbinding Recommendations Draft Guidance on Brimonidine Tartrate ; Brinzolamide This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA, or the Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the Office of Generic Drugs. Active Ingredient: Brimonidine tartrate; Brinzolamide Dosage Form; Route: Suspension/drops; ophthalmic Strength: 0.2%; 1% Recommended Studies: One study Type of study: Bioequivalence (BE) study with clinical endpoint Design: Randomized (1:1), double-masked, parallel, two-arm, in vivo Strength: 0.2%; 1% Subjects: Males and females with chronic open angle glaucoma or ocular hypertension in both eyes. Additional comments: Specific recommendations are provided below. ______________________________________________________________________________ Analytes to measure (in appropriate biological fluid): Not applicable Bioequivalence based on (95% CI): Clinical endpoint Additional comments regarding the BE study with clinical endpoint: 1. The Office of Generic Drugs (OGD) recommends conducting a BE study with a clinical endpoint in the treatment of open angle glaucoma and ocular hypertension comparing the test product to the reference listed drug (RLD), each applied as one drop in both eyes three times daily at approximately 8:00 a.m., 4:00 p.m., and 10:00 p.m. for 42 days (6 weeks). 2. Inclusion criteria (the sponsor may add additional criteria): a. Male or nonpregnant females aged at least 18 years with chronic open angle glaucoma or ocular hypertension in both eyes b. -
Table 1. Glaucoma Medications: Mechanisms, Dosing and Precautions Brand Generic Mechanism of Action Dosage/Avg
OPTOMETRIC STUDY CENTER Table 1. Glaucoma Medications: Mechanisms, Dosing and Precautions Brand Generic Mechanism of Action Dosage/Avg. % Product Sizes Side Effects Warnings Reduction CHOLINERGIC AGENTS Direct Pilocarpine (generic) Pilocarpine 1%, 2%, 4% Increases trabecular outflow BID-QID/15-25% 15ml Headache, blurred vision, myopia, retinal detachment, bronchiole constriction, Angle closure, shortness of breath, retinal narrowing of angle detachment Indirect Phospholine Iodide (Pfizer) Echothiophate iodide 0.125% Increases trabecular outflow QD-BID/15-25% 5ml Same as above plus cataractogenic iris cysts in children, pupillary block, Same as above, plus avoid prior to any increased paralysis with succinylcholine general anesthetic procedure ALPHA-2 AGONISTS Alphagan P (Allergan) Brimonidine tartrate 0.1%, 0.15% with Purite Decreases aqueous production, increases BID-TID/up to 26% 5ml, 10ml, 15ml Dry mouth, hypotension, bradycardia, follicular conjunctivitis, ocular irritation, Monitor for shortness of breath, dizziness, preservative uveoscleral outflow pruritus, dermatitis, conjunctival blanching, eyelid retraction, mydriasis, drug ocular redness and itching, fatigue allergy Brimonidine tartrate Brimonidine tartrate 0.15%, 0.2% Same as above Same as above 5ml, 10ml Same as above Same as above (generic) Iopidine (Novartis) Apraclonidine 0.5% Decreases aqueous production BID-TID/up to 25% 5ml, 10ml Same as above but higher drug allergy (40%) Same as above BETA-BLOCKERS Non-selective Betagan (Allergan) Levobunolol 0.25%, 0.5% Decreases -
ALPHAGAN® 0.2% Safely and Effectively
NDA 20613/S-031 Page 4 HIGHLIGHTS OF PRESCRIBING INFORMATION ___________ ___________ ADVERSE REACTIONS Most common adverse reactions occurring in These highlights do not include all the information needed approximately 10 to 30% of patients receiving brimonidine to use ALPHAGAN® 0.2% safely and effectively. See full ophthalmic solution 0.2% included oral dryness, ocular prescribing information for ALPHAGAN® 0.2%. hyperemia, burning and stinging, headache, blurring, foreign body sensation, fatigue/drowsiness, conjunctival ALPHAGAN® (brimonidine tartrate ophthalmic solution) follicles, ocular allergic reactions, and ocular pruritus. (6.1) 0.2% For Topical Ophthalmic Use To report SUSPECTED ADVERSE REACTIONS, Initial U.S. Approval: 1996 contact Allergan at 1-800-433-8871 or the FDA at 1 800-FDA-1088 or www.fda.gov/medwatch. _________ _________ INDICATIONS AND USAGE ___________ ____________ DRUG INTERACTIONS ALPHAGAN® 0.2% is an alpha adrenergic agonist indicated Antihypertensives/cardiac glycosides may lower blood for lowering intraocular pressure (IOP) in patients with open- pressure. (7.1) angle glaucoma or ocular hypertension. (1) ________ ________ Use with CNS depressants may result in an additive or DOSAGE AND ADMINISTRATION potentiating effect. (7.2) One drop in the affected eye(s), three times daily, Tricyclic antidepressants may potentially blunt the approximately 8 hours apart. (2) hypotensive effect of systemic clonidine. (7.3) _______ _______ DOSAGE FORMS AND STRENGTHS Monoamine oxidase inhibitors may result in increased Solution containing 2 mg/mL brimonidine tartrate. (3) hypotension. (7.4) _________ _____________ _______ ______ CONTRAINDICATIONS USE IN SPECIFIC POPULATIONS Neonates and infants (under the age of 2 years). (4.1) Use with caution in children > 2 years of age. -
New Medicines Committee Briefing March 2015 Simbrinza
New Medicines Committee Briefing March 2015 Simbrinza® (Brinzolamide 10mg + Brimonidine tartrate 2mg/ml) for treatment of elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension. Simbrinza® is to be reviewed for use within: Primary Care Secondary Care Summary: Simbrinza® is a combination of brinzolamide which is a carbonic anhydrase (CA-II) inhibitor and brimonidine which is an alpha-2 adrenergic agonist. Simbrinza® is licensed for the treatment of elevated IOP in adult patients with open-angle glaucoma or ocular hypertension whom failed on mono-therapy. Simbrinza® is administered twice daily in the affected eye(s). Simbrinza® is the first combination therapy which does not contain a beta-blocker. SMC has accepted Simbrinza® for use within NHS Scotland, as there is no significant additional cost associated with the combination product compared with its individual components. One trial indicated that fixed combination of Simbrinza® administered BD had a significantly greater IOP lowering effect compared to either brinzolamide 1% or brimonidine 0.2% alone and displayed a safety profile consistent with its individual components. Another trial noted Simbrinza® to be non-inferior to separate administration of brimonidine and brinzolamide less than 10 min apart to prevent wash out. 1 Formulary application: Opthamology department: Consultant submitting application: Mr Lynval Jones (Consultant Ophthalmologist, Glaucoma) Clinical Director supporting application: Gareth Rowland (Clinical Director of Specialised Surgery) Mr Jones has requested for Simbrinza® to be considered for inclusion in the North Staffordshire Joint Formulary for the treatment of elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension who have not responded to monotherapy. -
Pharmacology of Ophthalmologically Important Drugs James L
Henry Ford Hospital Medical Journal Volume 13 | Number 2 Article 8 6-1965 Pharmacology Of Ophthalmologically Important Drugs James L. Tucker Follow this and additional works at: https://scholarlycommons.henryford.com/hfhmedjournal Part of the Chemicals and Drugs Commons, Life Sciences Commons, Medical Specialties Commons, and the Public Health Commons Recommended Citation Tucker, James L. (1965) "Pharmacology Of Ophthalmologically Important Drugs," Henry Ford Hospital Medical Bulletin : Vol. 13 : No. 2 , 191-222. Available at: https://scholarlycommons.henryford.com/hfhmedjournal/vol13/iss2/8 This Article is brought to you for free and open access by Henry Ford Health System Scholarly Commons. It has been accepted for inclusion in Henry Ford Hospital Medical Journal by an authorized editor of Henry Ford Health System Scholarly Commons. For more information, please contact [email protected]. Henry Ford Hosp. Med. Bull. Vol. 13, June, 1965 PHARMACOLOGY OF OPHTHALMOLOGICALLY IMPORTANT DRUGS JAMES L. TUCKER, JR., M.D. DRUG THERAPY IN ophthalmology, like many specialties in medicine, encompasses the entire spectrum of pharmacology. This is true for any specialty that routinely involves the care of young and old patients, surgical and non-surgical problems, local eye disease (topical or subconjunctival drug administration), and systemic disease which must be treated in order to "cure" the "local" manifestations which frequently present in the eyes (uveitis, optic neurhis, etc.). Few authors (see bibliography) have attempted an introduction to drug therapy oriented specifically for the ophthalmologist. The new resident in ophthalmology often has a vague concept of the importance of this subject, and with that in mind this paper was prepared. -
The Use of Central Nervous System Active Drugs During Pregnancy
Pharmaceuticals 2013, 6, 1221-1286; doi:10.3390/ph6101221 OPEN ACCESS pharmaceuticals ISSN 1424-8247 www.mdpi.com/journal/pharmaceuticals Review The Use of Central Nervous System Active Drugs During Pregnancy Bengt Källén 1,*, Natalia Borg 2 and Margareta Reis 3 1 Tornblad Institute, Lund University, Biskopsgatan 7, Lund SE-223 62, Sweden 2 Department of Statistics, Monitoring and Analyses, National Board of Health and Welfare, Stockholm SE-106 30, Sweden; E-Mail: [email protected] 3 Department of Medical and Health Sciences, Clinical Pharmacology, Linköping University, Linköping SE-581 85, Sweden; E-Mail: [email protected] * Author to whom correspondence should be addressed; E-Mail: [email protected]; Tel.: +46-46-222-7536, Fax: +46-46-222-4226. Received: 1 July 2013; in revised form: 10 September 2013 / Accepted: 25 September 2013 / Published: 10 October 2013 Abstract: CNS-active drugs are used relatively often during pregnancy. Use during early pregnancy may increase the risk of a congenital malformation; use during the later part of pregnancy may be associated with preterm birth, intrauterine growth disturbances and neonatal morbidity. There is also a possibility that drug exposure can affect brain development with long-term neuropsychological harm as a result. This paper summarizes the literature on such drugs used during pregnancy: opioids, anticonvulsants, drugs used for Parkinson’s disease, neuroleptics, sedatives and hypnotics, antidepressants, psychostimulants, and some other CNS-active drugs. In addition to an overview of the literature, data from the Swedish Medical Birth Register (1996–2011) are presented. The exposure data are either based on midwife interviews towards the end of the first trimester or on linkage with a prescribed drug register. -
Generic Drugs and Trade Name Equivalents: Alphabetized by Generic Name
GENERIC DRUGS AND TRADE NAME EQUIVALENTS: ALPHABETIZED BY GENERIC NAME Generic Trade Generic Trade Generic Trade acetaminophen Tylenol escitalopram Lexapro niacin, nicotinic acid Niaspan, Slo-Niacin acetaminophen-codeine Tylenol #3 estrogen Premarin nitroglycerin Nitro-bid acetazolamide Diamox eszopiclone Lunesta nystatin Mycostatin acyclovir Zovirax ethambutol Myambutol ofloxacin Ocuflox albuterol Proventil, Ventolin eye vitamin supplement Ocuvite PreserVision olopatadine Patanol alendronate Fosamax famciclovir Famvir omeprazole Prilosec allopurinol Zyloprim felodipine Plendil paraffin-mineral oil Lacri-Lube alprazolam Xanax fexofenadine Allegra paroxetine Paxil aminocaproic acid Amicar fexofenadine-pseudoephedrine Allegra-D pegaptanib Macugen amiodarone Cordarone finasteride Propecia, Proscar peginterferon alfa-2a Pegasys amitryptyline Elavil fluconazole Diflucan peginterferon alfa-2b PegIntron amlodipine Norvasc flunisolide AeroBid pemirolast potassium Alamast amoxicillin Amoxil, Dispermox fluorometholone FML phenytoin Dilantin amoxicillin-clavulanate Augmentin fluorouracil Efudex pilocarpine IsoptoCarpine, Pilocar apraclonidine Iopidine fluoxetine Prozac piroxicam Feldene AREDS formula PreserVision flutamide Eulexin polymyxin B-bacitracin Polysporin atenolol Tenormin fluticasone Flovent, Flonase polymyxin B-bacitracin-neomycin Neosporin (ointment) atorvastatin Lipitor folinic acid Folixor polymyxin B-neomycin-gramicidin Neosporin (suspension) azathioprine Imuran foscarnet Foscavir potassium chloride Micro-K, K-Dur, Klor-Com azelastine -
COMBIGAN® EYE DROPS (Brimonidine Tartrate 2.0 Mg Per Ml and Timolol (As Maleate) 5.0 Mg Per Ml)
COMBIGAN® EYE DROPS (brimonidine tartrate 2.0 mg per mL and timolol (as maleate) 5.0 mg per mL) Consumer Medicine Information What is in this leaflet aware of this gradual loss of sight. any of the ingredients listed at Sometimes even normal eye the end of this leaflet, some This leaflet answers some common pressure is associated with damage symptoms of an allergic reaction questions about COMBIGAN® eye to the back of the eye. include skin rash, itching, drops. It does not contain all the There are usually no symptoms of shortness of breath or swelling available information. It does not glaucoma. The only way of of the face, lips or tongue, which take the place of talking to your knowing that you have glaucoma is may cause difficulty in doctor or pharmacist. to have your eye pressure, optic swallowing or breathing All medicines have risks and nerve and visual field checked by an • you are taking monoamine benefits. Your doctor has weighed eye specialist or optometrist. If oxidase antidepressant the risks of you using glaucoma is not treated it can lead medication COMBIGAN® eye drops against to serious problems, including total • you have bronchospasm, the benefits they expect it will have blindness. In fact, untreated bronchial asthma or have a for you. glaucoma is one of the most history of bronchial asthma or common causes of blindness. other lung disease If you have any concerns about using this medicine, ask your doctor COMBIGAN® eye drops lower the • you have a severe or unstable or or pharmacist. pressure in the eye by decreasing uncontrolled heart condition Keep this leaflet with the the fluid produced and helping the • the seal around the cap is broken medicine. -
Physiotherapy Study Guide in Progress 1-Lectures Lecture: 1
KING ABDULAZIZ UNIVERSITY Faculty of Medicine PHYSIOTHERAPY Study Guide 1 Physiotherapy study guide in progress Table of content Physiotherapy ......................................................................................................................... 1 Study Guide ........................................................................................................................... 1 Table of content ..................................................................................................................... 2 Course Description and Organization .................................................................................... 3 Major Course Objectives ....................................................................................................... 4 STUDY STRATEGIES AND CLASS PARTICIPATION EXPECTATIONS .................... 5 Instructional Methods .............................................................................................................. 5 Instructional Materials And Resources .................................................................................... 5 Assessment ............................................................................................................................... 6 In this Course your performance will be assessed according to the following: ............ 6 Students support ....................................................................................................................... 8 Male Section: Men Medical Complex .................................................................................... -
Marrakesh Agreement Establishing the World Trade Organization
No. 31874 Multilateral Marrakesh Agreement establishing the World Trade Organ ization (with final act, annexes and protocol). Concluded at Marrakesh on 15 April 1994 Authentic texts: English, French and Spanish. Registered by the Director-General of the World Trade Organization, acting on behalf of the Parties, on 1 June 1995. Multilat ral Accord de Marrakech instituant l©Organisation mondiale du commerce (avec acte final, annexes et protocole). Conclu Marrakech le 15 avril 1994 Textes authentiques : anglais, français et espagnol. Enregistré par le Directeur général de l'Organisation mondiale du com merce, agissant au nom des Parties, le 1er juin 1995. Vol. 1867, 1-31874 4_________United Nations — Treaty Series • Nations Unies — Recueil des Traités 1995 Table of contents Table des matières Indice [Volume 1867] FINAL ACT EMBODYING THE RESULTS OF THE URUGUAY ROUND OF MULTILATERAL TRADE NEGOTIATIONS ACTE FINAL REPRENANT LES RESULTATS DES NEGOCIATIONS COMMERCIALES MULTILATERALES DU CYCLE D©URUGUAY ACTA FINAL EN QUE SE INCORPOR N LOS RESULTADOS DE LA RONDA URUGUAY DE NEGOCIACIONES COMERCIALES MULTILATERALES SIGNATURES - SIGNATURES - FIRMAS MINISTERIAL DECISIONS, DECLARATIONS AND UNDERSTANDING DECISIONS, DECLARATIONS ET MEMORANDUM D©ACCORD MINISTERIELS DECISIONES, DECLARACIONES Y ENTEND MIENTO MINISTERIALES MARRAKESH AGREEMENT ESTABLISHING THE WORLD TRADE ORGANIZATION ACCORD DE MARRAKECH INSTITUANT L©ORGANISATION MONDIALE DU COMMERCE ACUERDO DE MARRAKECH POR EL QUE SE ESTABLECE LA ORGANIZACI N MUND1AL DEL COMERCIO ANNEX 1 ANNEXE 1 ANEXO 1 ANNEX -
Safety and Efficacy of SIMBRINZA BID As an Adjunctive to DUOTRAV
Alcon - Business Use Only Protocol - Clinical Effective Date: 10-Apr-2017 Document: TDOC-0051572 Version: 2.0; Most-Recent; Effective; CURRENT Status: Effective Page 1 of 71 a Novartis company Short Title Safety and Efficacy of SIMBRINZA BID as an Adjunctive to DUOTRAV Long Title Safety and Efficacy with Twice Daily Brinzolamide 1% / Brimonidine 0.2% (SIMBRINZA) as an Adjunctive Therapy to Travoprost 0.004% / Timolol 0.5% (DUOTRAV) Protocol Number: GLJ576-P001/ NCT02730871 Study Phase: 4 Sponsor Name and Alcon Research, Ltd. Address: 6201 South Freeway Fort Worth, Texas 76134-2099 Investigational Product: SIMBRINZA Brinzolamide 1% (10 mg/mL)/Brimonidine 0.2% (2 mg/mL) eye drops suspension US IND# / EudraCT 2016-000176-20 Indication Studied: Ocular Hypertension Open Angle Glaucoma Printed By: Print Date: Alcon - Business Use Only Protocol - Clinical Effective Date: 10-Apr-2017 Document: TDOC-0051572 Version: 2.0; Most-Recent; Effective; CURRENT Status: Effective Page 2 of 71 Investigator Agreement: I have read the clinical study described herein, recognize its confidentiality, and agree to conduct the described trial in compliance with Good Clinical Practices (GCP), the ethical principles contained within the Declaration of Helsinki, this protocol, and all applicable regulatory requirements. Additionally, I will comply with all procedures for data recording and reporting, will permit monitoring, auditing, and inspection of my research center, and will retain all records until notified by the Sponsor. Principal Investigator: Signature Date Name: Address: Printed By: Print Date: Alcon - Business Use Only Protocol - Clinical Effective Date: 10-Apr-2017 Document: TDOC-0051572 Version: 2.0; Most-Recent; Effective; CURRENT Status: Effective Page 3 of 71 1 SYNOPSIS Sponsor: Alcon Research, Ltd. -
Implications of Dopamine D3 Receptor for Glaucoma: In-Silico and In-Vivo Studies
International PhD Program in Neuropharmacology XXVI Cycle Implications of dopamine D3 receptor for glaucoma: in-silico and in-vivo studies PhD thesis Chiara Bianca Maria Platania Coordinator: Prof. Salvatore Salomone Tutor: Prof. Claudio Bucolo Department of Clinical and Molecular Biomedicine Section of Pharmacology and Biochemistry. University of Catania - Medical School December 2013 Copyright ©: Chiara B. M. Platania - December 2013 2 TABLE OF CONTENTS ACKNOWLEDGEMENTS............................................................................ 4 LIST OF ABBREVIATIONS ........................................................................ 5 ABSTRACT ................................................................................................... 7 GLAUCOMA ................................................................................................ 9 Aqueous humor dynamics .................................................................. 10 Pharmacological treatments of glaucoma............................................ 12 Pharmacological perspectives in treatment of glaucoma ..................... 14 Animal models of glaucoma ............................................................... 18 G PROTEIN COUPLED RECEPTORS ....................................................... 21 GPCRs functions and structure ........................................................... 22 Molecular modeling of GPCRs ........................................................... 25 D2-like receptors ...............................................................................