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22-556Orig1s000
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 22-556Orig1s000 MEDICAL REVIEW(S) MEDICAL OFFICER REVIEW Division Of Pulmonary, Allergy, and Rheumatology Products, HFD-570 APPLICATION: NDA 22-556 TRADE NAME: Karbinal ER™ APPLICANT/SPONSOR: Tris Pharma USAN NAME: Carbinoxamine Extended-Release MEDICAL OFFICER: Peter Starke, MD Oral Suspension TEAM LEADER: Theresa Michele, MD CATEGORY: Antihistamine DATE: February 25, 2013 ROUTE: Oral SUBMISSIONS REVIEWED IN THIS DOCUMENT Document Date Submission Date Application/Doc Comments October 4, 2012 October 5, 2012 SD-17 Complete Response submission January 8, 2013 January 9, 2013 SD-20 Response to labeling (formatting) IR RELATED APPLICATIONS Date Application Comments REVIEW SUMMARY: This is clinical review of a Complete Response (CR) to a CR action taken by the Agency on October 7, 2011, for a 505(b)(2) application from Tris Pharma for Carbinoxamine Extended-Release (ER) Oral Suspension, equivalent to 4 mg of carbinoxamine maleate (CM) per 5 mL. The formulation is a sustained release formulation of carbinoxamine maleate suspended in a drug-polistirex resin complex. The proposed Trade Name is Karbinal ER. The application references both the currently available generic immediate-release Carbinoxamine Maleate 4 mg tablets (ANDA 40-442) and oral solution 4 mg/5 mL(ANDA 40-458), marketed under the brand name Palgic and manufactured by Milkart, Inc., and the no-longer-marketed immediate-release innovator products, Clistin 4 mg tablets (NDA 08-915) and 4 mg/5 mL elixir (NDA 08-955), previously marketed by McNeil. McNeil discontinued marketing the Clistin products in the 1990s, and the Orange Book makes the notation that the Clistin products were not discontinued or withdrawn for safety or efficacy reasons. -
FEXOFENADINE HYDROCHLORIDE 180 MG FILM-COATED TABLETS Fexofenadine Hydrochloride
ID1089 MRP _ UK Version: 07 Review Date: 19/02/2020 PACKAGE LEAFLET: INFORMATION FOR THE USER FEXOFENADINE HYDROCHLORIDE 120 MG FILM-COATED TABLETS FEXOFENADINE HYDROCHLORIDE 180 MG FILM-COATED TABLETS Fexofenadine hydrochloride Read all of this leaflet carefully before you start using 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 of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet, (see section 4). In this leaflet: 1. What Fexofenadine hydrochloride is and what it is used for 2. What you need to know before you take Fexofenadine hydrochloride 3. How to take Fexofenadine hydrochloride 4. Possible side effects of Fexofenadine hydrochloride 5. How to store Fexofenadine hydrochloride 6. Contents of the pack and other information 1. WHAT FEXOFENADINE HYDROCHLORIDE IS AND WHAT IT IS USED FOR FEXOFENADINE HYDROCHLORIDE Contains fexofenadine hydrochloride which is an antihistamine. Only Fexofenadine hydrochloride 120 mg tablets is used in adults and adolescents of 12 years and older to relieve the symptoms that occur with hay fever (seasonal allergic rhinitis) such as sneezing, itchy, running or blocked nose and itchy, red and watery eye). Fexofenadine hydrochloride 180 mg tablets is used in adults and adolescents of 12 years and older to relieve the symptoms that occur with long term allergic skin reactions( chronic idiopathic urticaria) such as itching, swelling and rashes 2. -
Fexofenadine Hydrochloride) Tablets
Rev. September 2005 ALLEGRA® (fexofenadine hydrochloride) Tablets DESCRIPTION Fexofenadine hydrochloride, the active ingredient of ALLEGRA, is a histamine H1-receptor antagonist with the chemical name (±)-4-[1 hydroxy-4-[4-(hydroxydiphenylmethyl)-1- piperidinyl]-butyl]-α, α-dimethyl benzeneacetic acid hydrochloride. It has the following chemical structure: The molecular weight is 538.13 and the empirical formula is C32H39NO4•HCl. Fexofenadine hydrochloride is a white to off-white crystalline powder. It is freely soluble in methanol and ethanol, slightly soluble in chloroform and water, and insoluble in hexane. Fexofenadine hydrochloride is a racemate and exists as a zwitterion in aqueous media at physiological pH. ALLEGRA is formulated as a tablet for oral administration. Each tablet contains 30, 60, or 180 mg fexofenadine hydrochloride (depending on the dosage strength) and the following excipients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The aqueous tablet film coating is made from hypromellose, iron oxide blends, polyethylene glycol, povidone, silicone dioxide, and titanium dioxide. CLINICAL PHARMACOLOGY Mechanism of Action Fexofenadine hydrochloride, the major active metabolite of terfenadine, is an antihistamine with selective peripheral H1-receptor antagonist activity. Both enantiomers of fexofenadine hydrochloride displayed approximately equipotent antihistaminic effects. Fexofenadine hydrochloride inhibited antigen-induced bronchospasm in sensitized guinea pigs and histamine -
Prescribing Information for High-Dose Fexofenadine in the Management of Urticaria in Adults
1 Prescribing information for high-dose fexofenadine in the management of urticaria in adults This prescribing information document outlines the prescribing responsibilities between the specialist and GP. GPs are invited to participate. If the GP feels that such prescribing is outside their area of expertise or have clinical concerns about the safe management of the drug in primary care, then he or she is under no obligation to do so. In such an event, clinical responsibility for the patient’s health remains with the specialist. If a specialist asks the GP to prescribe, the GP should reply to this request as soon as practicable. Consultant details GP details Patient details Name: Name: Name: Address: Address: NHS Number: Email: Email: Date of birth: Contact number: Contact number: Contact: Introduction Fexofenadine is a second generation non-sedating H1-antihistamine used in the treatment of allergic disorders. Fexofenadine is a pharmacologically active metabolite of terfenadine. Licensed indication: In adults and children 12 years and older, the licensed dose is 180mg daily for the relief of symptoms associated with chronic idiopathic urticaria. Unlicensed indication (the focus of this document): As advised by Europeani and British Association of Dermatologistsii guidelines, doses of antihistamines up to four times the recommended daily dose may be used in the treatment of urticaria. Adult dosage and administration The licensed maximum recommended daily dose is 180mg once daily taken before a meal. Doses of up to four times the daily recommended dose have been used in the treatment of severe urticaria (unlicensed indication)i Available as: 30mg, 120mg and 180mg tablets Specialist responsibilities Provide patient/carer with relevant written information on the unlicensed use of high-dose fexofenadine and possible side-effects. -
Guideline for Preoperative Medication Management
Guideline: Preoperative Medication Management Guideline for Preoperative Medication Management Purpose of Guideline: To provide guidance to physicians, advanced practice providers (APPs), pharmacists, and nurses regarding medication management in the preoperative setting. Background: Appropriate perioperative medication management is essential to ensure positive surgical outcomes and prevent medication misadventures.1 Results from a prospective analysis of 1,025 patients admitted to a general surgical unit concluded that patients on at least one medication for a chronic disease are 2.7 times more likely to experience surgical complications compared with those not taking any medications. As the aging population requires more medication use and the availability of various nonprescription medications continues to increase, so does the risk of polypharmacy and the need for perioperative medication guidance.2 There are no well-designed trials to support evidence-based recommendations for perioperative medication management; however, general principles and best practice approaches are available. General considerations for perioperative medication management include a thorough medication history, understanding of the medication pharmacokinetics and potential for withdrawal symptoms, understanding the risks associated with the surgical procedure and the risks of medication discontinuation based on the intended indication. Clinical judgement must be exercised, especially if medication pharmacokinetics are not predictable or there are significant risks associated with inappropriate medication withdrawal (eg, tolerance) or continuation (eg, postsurgical infection).2 Clinical Assessment: Prior to instructing the patient on preoperative medication management, completion of a thorough medication history is recommended – including all information on prescription medications, over-the-counter medications, “as needed” medications, vitamins, supplements, and herbal medications. Allergies should also be verified and documented. -
Antihistamines in the Treatment of Chronic Urticaria I Jáuregui,1 M Ferrer,2 J Montoro,3 I Dávila,4 J Bartra,5 a Del Cuvillo,6 J Mullol,7 J Sastre,8 a Valero5
Antihistamines in the treatment of chronic urticaria I Jáuregui,1 M Ferrer,2 J Montoro,3 I Dávila,4 J Bartra,5 A del Cuvillo,6 J Mullol,7 J Sastre,8 A Valero5 1 Service of Allergy, Hospital de Basurto, Bilbao, Spain 2 Department of Allergology, Clínica Universitaria de Navarra, Pamplona, Spain 3 Allergy Unit, Hospital La Plana, Villarreal (Castellón), Spain 4 Service of Immunoallergy, Hospital Clínico, Salamanca, Spain 5 Allergy Unit, Service of Pneumology and Respiratory Allergy, Hospital Clínic (ICT), Barcelona, Spain 6 Clínica Dr. Lobatón, Cádiz, Spain 7 Rhinology Unit, ENT Service (ICEMEQ), Hospital Clínic, Barcelona, Spain 8 Service of Allergy, Fundación Jiménez Díaz, Madrid, Spain ■ Summary Chronic urticaria is highly prevalent in the general population, and while there are multiple treatments for the disorder, the results obtained are not completely satisfactory. The second-generation H1 antihistamines remain the symptomatic treatment option of choice. Depending on the different pharmacokinetics and H1 receptor affi nity of each drug substance, different concentrations in skin can be expected, together with different effi cacy in relation to the histamine-induced wheal inhibition test - though this does not necessarily have repercussions upon clinical response. The antiinfl ammatory properties of the H1 antihistamines could be of relevance in chronic urticaria, though it is not clear to what degree they infl uence the fi nal therapeutic result. Before moving on to another therapeutic level, the advisability of antihistamine dose escalation should be considered, involving increments even above those approved in the Summary of Product Characteristics. Physical urticaria, when manifesting isolatedly, tends to respond well to H1 antihistamines, with the exception of genuine solar urticaria and delayed pressure urticaria. -
Antihistamine Therapy in Allergic Rhinitis
CLINICAL REVIEW Antihistamine Therapy in Allergic Rhinitis Paul R. Tarnasky, MD, and Paul P. Van Arsdel, Jr, MD Seattle, Washington Allergic rhinitis is a common disorder that is associated with a high incidence of mor bidity and considerable costs. The symptoms of allergic rhinitis are primarily depen dent upon the tissue effects of histamine. Antihistamines are the mainstay of therapy for allergic rhinitis. Recently, a second generation of antihistamines has become available. These agents lack the adverse effect of sedation, which is commonly associated with older antihistamines. Current practice of antihistamine therapy in allergic rhinitis often involves random selection among the various agents. Based upon the available clinical trials, chlorpheniramine appears to be the most reasonable initial antihistaminic agent. A nonsedating antihis tamine should be used initially if a patient is involved in activities where drowsiness is dangerous. In this comprehensive review of allergic rhinitis and its treatment, the cur rent as well as future options in antihistamine pharmacotherapy are emphasized. J Fam Pract 1990; 30:71-80. llergic rhinitis is a common condition afflicting some defined by the period of exposure to those agents to which A where between 15 and 30 million people in the United a patient is sensitive. Allergens in seasonal allergic rhinitis States.1-3 The prevalence of disease among adolescents is consist of pollens from nonflowering plants such as trees, estimated to be 20% to 30%. Two thirds of the adult grasses, and weeds. These pollens generally create symp allergic rhinitis patients are under 30 years of age.4-6 Con toms in early spring, late spring through early summer, sequently, considerable costs are incurred in days lost and fall, respectively. -
Pre - PA Allowance Age 18 Years of Age Or Older Quantity 60 Grams Every 90 Days ______
DOXEPIN CREAM 5% (Prudoxin, Zonalon) Pre - PA Allowance Age 18 years of age or older Quantity 60 grams every 90 days _______________________________________________________________ Prior-Approval Requirements Age 18 years of age or older Diagnosis Patient must have the following: Moderate pruritus, due to atopic dermatitis (eczema) or lichen simplex chronicus AND the following: 1. Inadequate response, intolerance or contraindication to ONE medication in EACH of the following categories: a. Topical antihistamine (see Appendix I) b. High potency topical corticosteroid (see Appendix II) 2. Physician agrees to taper patient’s dose to the FDA recommended dose, and after tapered will only use for short-term pruritus relief (up to 8 days) a. Patients using over 60 grams of topical doxepin in 90 days be required to taper to 60 grams topical doxepin within 90 days Prior - Approval Limits Quantity 180 grams for 90 days Duration 3 months ___________________________________________________________________ Prior – Approval Renewal Requirements None (see appendix below) Doxepin 5% cream FEP Clinical Rationale DOXEPIN CREAM 5% (Prudoxin, Zonalon) APPENDIX I Drug Dosage Form Diphenhydramine Cream Phenyltoloxamine Lotion/ Cream Tripelennamine Cream Phendiamine Cream APPENDIX II Relative Potency of Selected Topical Corticosteroid Drug ProductsDosage Form Strength I. Very high potency Augmented betamethasone Ointment, Gel 0.05% dipropionate Clobetasol propionate Cream, Ointment 0.05% Diflorasone diacetate Ointment 0.05% Halobetasol propionate Cream, Ointment 0.05% II. High potency Amcinonide Cream, Lotion, 0.1% Augmented betamethasone Cream,Ointment Lotion 0.05% dipropionate Betamethasone Cream, Ointment 0.05% Betamethasonedipropionate valerate Ointment 0.1% Desoximetasone Cream, Ointment 0.25% Gel 0.05% Diflorasone diacetate Cream, Ointment 0.05% (emollient base) Fluocinonide Cream, Ointment, Gel 0.05% Halcinonide Cream, Ointment 0.1% Triamcinolone acetonide Cream, Ointment 0.5% III. -
Drugs Affectin the Autonomic Nervous System
Fundamentals of Medical Pharmacology Paterson Public Schools Written by Néstor Collazo, Ph.D. Jonathan Hodges, M.D. Tatiana Mikhaelovsky, M.D. for Health and Related Professions (H.A.R.P.) Academy March 2007 Course Description This fourth year course is designed to give students in the Health and Related Professions (H.A.R.P.) Academy a general and coherent explanation of the science of pharmacology in terms of its basic concepts and principles. Students will learn the properties and interactions between chemical agents (drugs) and living organisms for the rational and safe use of drugs in the control, prevention, and therapy of human disease. The emphasis will be on the fundamental concepts as they apply to the actions of most prototype drugs. In order to exemplify important underlying principles, many of the agents in current use will be singled out for fuller discussion. The course will include the following topics: ¾ The History of Pharmacology ¾ Terminology Used in Pharmacology ¾ Drug Action on Living Organisms ¾ Principles of Pharmacokinetics ¾ Dose-Response Relationships ¾ Time-Response Relationships ¾ Human Variability: Factors that will modify effects of drugs on individuals ¾ Effects of Drugs Attributable to Varying Modes of Administration ¾ Drug Toxicity ¾ Pharmacologic Aspects of Drug Abuse and Drug Dependence Pre-requisites Students must have completed successfully the following courses: Biology, Chemistry, Anatomy and Physiology, Algebra I and II Credits: 5 credits Basic Principles of Drug Action Introduction to Pharmacology a. Basic Mechanisms of Drug Actions b. Dose-response relationships c. Drug absorption d. Biotransformation of Drugs e. Pharmacokinetics f. Factors Affecting Drug Distribution g. Drug Allergy and Pharmacogenetics h. -
![With [3H]Mepyramine (Trieyclic Antidepressants/Antihistamine/Neurotransmitter/Amitriptyline) VINH TAN TRAN, RAYMOND S](https://docslib.b-cdn.net/cover/2862/with-3h-mepyramine-trieyclic-antidepressants-antihistamine-neurotransmitter-amitriptyline-vinh-tan-tran-raymond-s-1512862.webp)
With [3H]Mepyramine (Trieyclic Antidepressants/Antihistamine/Neurotransmitter/Amitriptyline) VINH TAN TRAN, RAYMOND S
Proc. Nati. Acad. Sci. USA Vol. 75, No. 12, pp. 6290-6294,, December 1978 Neurobiology Histamine H1 receptors identified in mammalian brain membranes with [3H]mepyramine (trieyclic antidepressants/antihistamine/neurotransmitter/amitriptyline) VINH TAN TRAN, RAYMOND S. L. CHANG, AND SOLOMON H. SNYDER* Departments of Pharmacology and Experimental Therapeutics, and Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland 21205 Communicated by Julius Axelrod, August 30,1978 ABSTRACT The antihistamine [3H mepyramine binds to Male Sprague-Dawley rats (150-200 g) were killed by cer- HI histamine receptors in mammalian brain membranes. vical dislocation, their brains were rapidly removed and ho- Potencies of H1 antihistamines at the binding sites correlate mogenized with a Polytron for 30 min (setting 5) in 30 vol of with their pharmacological antihistamine effects in the guinea pig ileum. Specific [3Himepyramine binding is saturable with ice-cold Na/K phosphate buffer (50 mM, pH 7.5), and the a dissociation constant of about 4 nM in both equilibrium and suspension was centrifuged (50,000 X g for 10 min). The pellet kinetic experiments and a density of 10pmolper gram ofwhole was resuspended in the same volume of fresh buffer and cen- brain. Some tricyclic antidepressants are potent inhibitors of trifuged, and the final pellet was resuspended in the original secific [3Hmepamine binding. Regional variations of volume of ice-cold buffer by Polytron homogenization. Calf [3Hjmepyramine ing do not correlate with variations in brains were obtained from a local abattoir within 2 hr after the endogeneous histamine and histidine decarboxylase activity. death of the animals and transferred to the laboratory in ice- Histamine is a neurotransmitter candidate in mammalian brain cold saline. -
A Study of Effect of a Single Dose of Second Generation Antihistaminics on Cognitive and Psychomotor Function in Healthy Human Volunteers
International Journal of Basic & Clinical Pharmacology Saxena K et al. Int J Basic Clin Pharmacol. 2020 Dec;9(12):1836-1843 http:// www.ijbcp.com pISSN 2319-2003 | eISSN 2279-0780 DOI: https://dx.doi.org/10.18203/2319-2003.ijbcp20205120 Original Research Article A study of effect of a single dose of second generation antihistaminics on cognitive and psychomotor function in healthy human volunteers Kirti Saxena*, Sachendra K. Srivastava, Chaitali Mehta Department of Pharmacology, Surat Municipal Institute of Medical Education and Research, Surat, Gujarat, India Received: 26 September 2020 Revised: 01 November 2020 Accepted: 02 November 2020 *Correspondence: Dr. Kirti Saxena, Email: [email protected] Copyright: © the author(s), publisher and licensee Medip Academy. This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. ABSTRACT Background: Objective of the study was to assess whether second generation antihistaminic alter psychomotor and cognitive function in comparison with promethazine (marked sedation; altered psychomotor and cognitive impairment). Methods: It was a single blind prospective study. Seventy five healthy human volunteers were registered, divided in five groups. These groups have received placebo, promethazine 25 mg, cetirizine 10 mg, fexofenadine 120 mg and loratadine 10 mg. Cognitive and psychomotor functions were assessed pretreatment and 60 minutes after single dose of drug(post treatment)by using a battery of standard tests (e.g. PST-Perceptual speed test, BVRT-Benton visual retention test,SSS- Stanford Sleepiness Scale, FTT-Finger tapping test etc.). -
The Effects of Albuterol and Chronic Antidepressants on Intracranial Self-Stimulation Reward Thresholds
University of Rhode Island DigitalCommons@URI Open Access Dissertations 1989 THE EFFECTS OF ALBUTEROL AND CHRONIC ANTIDEPRESSANTS ON INTRACRANIAL SELF-STIMULATION REWARD THRESHOLDS Robert Louis Dufresne University of Rhode Island Follow this and additional works at: https://digitalcommons.uri.edu/oa_diss Recommended Citation Dufresne, Robert Louis, "THE EFFECTS OF ALBUTEROL AND CHRONIC ANTIDEPRESSANTS ON INTRACRANIAL SELF-STIMULATION REWARD THRESHOLDS" (1989). Open Access Dissertations. Paper 146. https://digitalcommons.uri.edu/oa_diss/146 This Dissertation is brought to you for free and open access by DigitalCommons@URI. It has been accepted for inclusion in Open Access Dissertations by an authorized administrator of DigitalCommons@URI. For more information, please contact [email protected]. THE EFFECTS OF ALBUTEROL AND CHRONIC ANTIDEPRESSANTS ON INTRACRANIAL SELF-STIMULATION REWARD THRESHOLDS BY ROBERT LOUIS DUFRESNE A DISSERTATION SUBMITTED IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE DEGREE OF OOCTOR OF PHILOSOPHY IN PHARMACOLOGY AND TOXICOLOGY UNIVERSITY OF RHODE ISLAND 1989 DOCTOR OF PIDLOSOPHY DISSERTATION CF ROBERTLOUISDUFRESNE Approved: Dissertation Committee UNIVERSITY OF RHODE ISLAND 1989 Abstract Male Sprague Dawley rats implanted with bipolar stainless steel electrodes aimed at the medial forebrain bundle at the level of the hypothalamus were trained to self administer a rewarding current on a 20:10 DRP operant schedule. A procedure based on the psychophysical method of limits was used to determine the threshold of self administration for this stimulus. The effects of the B2-agonist albuterol (salbutamol) on threshold, rearing, and motor activity were examined prior to and after a 19 day period of daily administration of either desipramine 10 mg/kg, fluoxetine 10 mg/kg, or saline.