DOCSLIB.ORG

Newsletterno5 2013EC.Pdf

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Newsletterno5 2013EC.Pdf prepared in collaboration with the WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden TheThe aim aim of of the the Newsletter Newsletter is is to to No.No. 5, 3, 2013 2012 disseminatedisseminate information information on on the the safetysafety and and efficacy efficacy of of pharmaceuticalpharmaceutical products, products, based on communications received based onfrom communications our network of received "drug from our network of "drug information officers" and other TheThe WHO WHO Pharmaceuticals Pharmaceuticals Newsletter Newsletter provides provides you you wit withh informationsources such officers" as specialized and other sources such as specialized thethe latest latest information information on on the the safety safety of of medicines medicines a andnd bulletins and journals, as well as legallegal actions actions taken taken by by regulatory regulatory authorities authorities acros acrosss the the partnersbulletins in WHO. and journals, The information as well as partners in WHO. The information world.world. It It also also provides provides signals signals from from the the Uppsala Uppsala is produced in the form of résumés MonitoringMonitoring Centre's Centre's SIGNAL SIGNAL documents. document inis English,produced full in thetexts form of which of résumés may in English,be obtained full texts on request of which from: may be obtained on request from: Quality Assurance and Safety: The feature article in this issue gives you… Medicines, EMP-HSS, QualityWorld HealthAssurance Organization, and Safety: 1211 GenevaMedicines, 27, Switzerland, EMP-HSS, E-mail address: [email protected] World Health Organization, This Newsletter is also available on 1211 Genevaour Internet 27, Switzerland, website: http://www.who.int/medicineE-mail address: [email protected] Further information on adverse reactions may be obtained from the This Newsletter is also available on WHO Collaborating Centre for Internationalour Drug Internet Monitoring website: http://www.who.int/medicineBox 1051 s 751 40 Uppsala Tel: +46-18-65.60.60 Further Fax:information +46-18-65.60.80 on adverse reactionsE-mail: may [email protected] obtained from the Internet:WHO http://www.who-umc.org Collaborating Centre for International Drug Monitoring Box 1051 Contents Contents Regulatory matters Regulatory matters Safety of medicines Safety of medicines Signal Feature Feature © World Health Organization 2013 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permission to reproduce or translate WHO publications – whether for sale or for non-commercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; e- mail: [email protected]). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. Printed by the WHO Document Production Services, Geneva, Switzerland TAB LE OF CONTENTS Regulatory Matters Acetaminophen ............................................................................................ 4 Caffeine for apnoea of prematurity ................................................................. 4 Calcitonin medicines ..................................................................................... 4 Codeine ...................................................................................................... 5 Diclofenac ................................................................................................... 6 Ergot derivatives .......................................................................................... 6 Filgrastim and pegfilgrastim ........................................................................... 7 Flupirtine-containing medicines ...................................................................... 7 Intravenous iron-containing medicines ............................................................ 8 Ketoconazole, oral ........................................................................................ 8 Mefloquine Hydrochloride .............................................................................. 9 Meprobamate ............................................................................................. 10 Metoclopramide .......................................................................................... 10 Ondansetron for intravenous use ................................................................... 11 Retigabine .................................................................................................. 11 Sunitinib malate .......................................................................................... 11 Safety of medicines Nitrofurantoin ............................................................................................. 13 Panitumumab ............................................................................................. 13 Pazopanib hydrochloride............................................................................... 13 Rituximab .................................................................................................. 14 Vemurafenib ............................................................................................... 14 Signal Mirtazapine and Rhabdomyolysis ................................................................... 15 Roflumilast and Melaena .............................................................................. 18 Tapentadol and Delusion .............................................................................. 23 WHO Pharmaceuticals Newsletter No. 5, 2013 • 3 REGULATORY MATTERS with other drugs already citrate). All product doses Acetaminophen known to have such an should be prescribed as association, when assessing caffeine citrate, taking into patients with potentially drug- account the different strengths Association with risk of induced skin reactions. Any of the marketed products. serious skin reactions patient who develops a skin Caffeine (citrate) is authorised USA. The U.S. Food and Drug rash or reaction while using for treatment of apnoea of Administration (FDA) notified acetaminophen or any other premature newborns and may health-care professionals and pain reliever/fever reducer be given orally or patients that acetaminophen should stop the drug and seek intravenously. has been associated with a risk medical attention right away. of rare but serious skin Anyone who has experienced a There is no change to the reactions. Acetaminophen is a serious skin reaction with formulation of these products. common active ingredient to acetaminophen should not take The new packaging of Viridian treat pain and reduce fever; it the drug again and should Pharma products displaying is included in many contact their health-care the new name may not be prescription and over-the- professional to discuss immediately available. counter products. These skin alternative pain relievers/fever However, all packaging reactions, known as Stevens- reducers. (current and new) has dual Johnson Syndrome (SJS), toxic labelling, which clearly states The US FDA will require that a epidermal necrolysis (TEN), the strengths of both caffeine warning be added to the labels and acute generalized and caffeine citrate. of prescription drug products exanthematous pustulosis containing acetaminophen to (AGEP), can be fatal. These Doses specified when address the risk of serious skin reactions can occur with first- prescribing should always be reactions. The US FDA will also time use of acetaminophen or expressed as caffeine citrate request that manufacturers at any time while it is being because of a risk of confusion add a warning about serious taken. Other drugs used to and potential for dosing errors skin reactions to the product treat fever and pain/body (2 mg caffeine citrate is labels of OTC acetaminophen aches (e.g., non-steroidal anti- equivalent to 1 mg caffeine). drug products marketed under inflammatory drugs, or a new drug application and will Health-care professionals are NSAIDS, such as ibuprofen and encourage manufacturers of also advised that caffeine naproxen) also carry the risk drug products marketed under citrate is for use in neonatal of causing serious skin the OTC monograph do the intensive care units only, and reactions, which is already
Load more

Recommended publications
  • Medicines to Avoid Before Allergy Skin Testing
    Medicines to Avoid Before Allergy Skin Testing he American Academy of Otolaryngic Beta blockers are a risk factor for more serious and Allergy (AAOA) has developed this clinical treatment resistant anaphylaxis, making the use of beta care statement to assist healthcare providers blockers a relative contraindication to inhalant in determining which medicines patients skin testing. Tshould avoid prior to skin testing. These medicines are known to decrease or eliminate skin reactivity, causing a Treatment with omalizumab (anti-IgE antibody) can 20, 21 negative histamine control. Providers should have a suppress skin reactivity for up to six months. thorough understanding of the classes of medicines that Topical calcineurin inhibitors have a variable affect. could interfere with allergy testing. With proper patient Pimecrolimus22 did not affect histamine testing but counseling, the goal is to yield interpretable skin results tacrolimus12 did. without unnecessary medicine discontinuation. Herbal products have the potential to affect skin prick Antihistamines suppress the histamine response for testing. In the most comprehensive study,23 using a a variable period of time. In general, first-generation single–dose crossover study, it was felt that common antihistamines can be stopped for 72 hours, however, herbal products did not significantly affect the histamine several types including Cyproheptadine (Periactin) can skin response. However, complementary and other have active histamine suppression for up to 11 days. alternative medicines do sometimes have a significant Second-generation antihistamines also suppress testing histamine response24 and included butterbur, stinging for a variable length of time, up to 7 days. Astelin nettle, citrus unshiu powder, lycopus lucidus, spirulina, (Azelastine) nasal spray has been shown to suppress cellulose powder, traditional Chinese medicine, Indian 1, 2, 3, 4, 5, 6, 7 10 testing for up to 48 hours.
    [Show full text]
  • Inline-Supplementary-Material-1.Pdf
    Appendix 1: STOPP/START criteria version 2 applied to the TRUST dataset Physiological system Criteria Criteria included Number (%) (The relevant () criteria for each participant were applied to the dataset and recorded in of Microsoft Office Excel ® (2013)) criteria included out of total criteria STOPP criteria Indication of medication A1. Any drug prescribed without an evidence-based clinical indication. X 1/3 (33.3) A2. Any drug prescribed beyond the recommended duration, where treatment duration is X well defined. A3. Any duplicate drug class prescription e.g. two concurrent NSAIDs, SSRIs, loop diuretics, ACE inhibitors, anticoagulants (optimisation of monotherapy within a single drug class should be observed prior to considering a new agent). Cardiovascular system B1. Digoxin for heart failure with preserved systolic ventricular function (no clear evidence X 7/13 (53.8) of benefit). B2. Verapamil or diltiazem with NYHA Class III or IV heart failure (may worsen heart failure). B3. Beta-blocker in combination with verapamil or diltiazem (risk of heart block). B4. Beta blocker with symptomatic bradycardia (< 50/min), type II heart block or complete heart block (risk of profound hypotension, asystole). B5. Amiodarone as first-line antiarrhythmic therapy in supraventricular tachyarrhythmias X (higher risk of side-effects than beta-blockers, digoxin, verapamil or diltiazem). B6. Loop diuretic as first-line treatment for hypertension (safer, more effective alternatives available). B7. Loop diuretic for dependent ankle oedema without clinical, biochemical evidence or radiological evidence of heart failure, liver failure, nephrotic syndrome or renal failure (leg elevation and /or compression hosiery usually more appropriate). B8. Thiazide diuretic with current significant hypokalaemia (i.e.
    [Show full text]
  • PDF Download
    CURRENT THERAPEUTIC RESEARCH VOL. 56, NO. 5, MAY 1995 EFFECTS OF CEREBRAL METABOLIC ENHANCERS ON BRAIN FUNCTION IN RODENTS KOICHIRO TAKAHASHI,l MINORU YAMAMOTO,’ MASANORI SUZUKI,’ YUKIKO OZAWA,’ TAKASHI YAMAGUCHI,l HIROFUMI ANDOH, AND KOUICHI ISHIKAWA2 ‘Department of Pharmacology, Clinical Pharmacology Research Laboratory, Yamunouchi Pharmaceutical Co. Ltd., and ‘Department of Pharmacology, School of Medicine, Nihon University, Tokyo, Japan AFWI’RACT The effects of cerebral metabolic enhancers (indeloxazine, bi- femelane, idebenone, and nicergoline) on reserpine-induced hypother- mia, the immobility period in forced swimming tests, and passive avoidance learning behavior were compared with the effects of ami- triptyline in rodents. Indeloxazine, bifemelane, and amitriptyline antagonized hypothermia in mice given reserpine. Indeloxaxine and amitriptyline decreased the immobility period in mice in the forced swimming test in a dose-dependent manner. The latency of step- through in the passive avoidance test in rats was prolonged by ad- ministration of indeloxazine but shortened by administration of amitriptyline. Neither idebenone nor nicergoline displayed any phar- macologic action in these tests. The results suggest that indeloxaxine possesses an antidepressant activity similar to that of amitriptyline but differs from amitriptyline in its anticholinergic properties and its ability to ameliorate impaired brain function such as that of learning behavior. In addition, indeloxazine exhibited broader effects on brain functions than either bifemelane, idebenone, or nicergoline. INTRODUCTION Cerebral metabolic enhancers (drugs that enhance energy metabolism) including brain glucose and ATP levels such as indeloxazine,1*2 bi- femelane, 3*4idebenone?6 and nicergoline,7>8 are currently used for the treatment of patients with various psychiatric symptoms. These symptoms include reduced spontaneity and emotional disturbance in patients with cerebral vascular disease.
    [Show full text]
  • Is Alcohol Use Related to High Cholesterol in Premenopausal
    Research iMedPub Journals Journal of Preventive Medicine 2018 http://www.imedpub.com/ Vol.3 No.1:3 ISSN 2572-5483 DOI: 10.21767/2572-5483.100024 Is Alcohol Use Related To High Cholesterol in Premenopausal Women Aged 40-51 Years Old? Sydnee Homeyer, Jessica L Hartos*, Holli Lueg, Jessica Moore and Patricia Stafford Department of Physician Assistant Studies, University of North Texas Health Science Center, USA *Corresponding author: Jessica L. Hartos, Department of Physician Assistant Studies, University of North Texas Health Science Center, USA, Tel: 817-735-2454; Fax: 817-735-2529; E-mail: [email protected] Received date: November 13, 2017; Accepted date: January 8, 2018; Publication date: January 15, 2018 Citation: Homeyer S, Hartos JL, Lueg H, Moore J, Stafford P, et al. (2018) Is Alcohol Use Related To High Cholesterol In Premenopausal Women Aged 40-51 Years Old? J Prev Med Vol.3 No.3: 3. Copyright: © 2018 Homeyer S, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution and reproduction in any medium, provided the original author and source are credited. Introduction Abstract Increased serum cholesterol levels is a major risk factor for coronary heart disease (CHD) [1], and over seventy-one million Purpose: Alcohol use and cholesterol are related in men and American adults have high cholesterol (27%) [2,3]. In American postmenopausal women but relations between alcohol use women, cholesterol levels have been shown to increase with and cholesterol are unclear for premenopausal women. The age, and nearly 1 in 2 American women has high or borderline purpose of this study was to determine whether alcohol use was related to cholesterol in women aged 40-51 years old.
    [Show full text]
  • E the Effect of Topiramate on Weight Loss in Patients with Type 2 Diabetes
    E The effect of topiramate on weight loss in patients with type 2 diabetes RTICL Sedighe Moradi, Scott Reza Jafarian Kerman, Mina Mollabashi A Institute of Endocrinology and Metabolism (Hemmat Campus), Firoozgar Hospital, Tehran University of Medical Sciences, Tehran, Iran Background: Obesity has been associated with several co‑morbidities such as diabetes and increased mortality. In general, the use of medication promotes only a modest weight loss in the range of 2 to 10 kg, usually most effective during the first 6 months of therapy; however, studies have shown positive effects on other risk factors such as blood pressure and serum glucose levels, but there are fewer studies in patients with diabetes. The aim of this study was to assess the effect of topiramate on weight reduction patients with type 2 diabetes. Materials and Methods: This was a 32‑week randomized clinical trial study of 69 subjects during 2008‑2010. RIGINAL Patients, in two treatment groups were given topiramate (39 patients) and Placebo (30 patients) and were subjected to participation in a non‑pharmacologic lifestyle intervention program; which were randomly allocated in our two groups. The percentage change in body O weight and Body Mass Index (BMI) at the end of the study was the primary efficacy endpoint and secondary indicators were changes in blood pressure (BP), proportion of subjects who achieved 5% or 10% weight loss, changes in lipid profile (total cholesterol, low‑density lipoprotein cholesterol, high‑density lipoprotein cholesterol, triglycerides); and changes in glycosylated hemoglobin (HgA1c). Paired samples and independent samples t‑test was used for statistical analysis.
    [Show full text]
  • Local Product Document Pfizer Venezuela, S.A
    LOCAL PRODUCT DOCUMENT PFIZER VENEZUELA, S.A. 1. MEDICINAL PRODUCT BRAND NAME ® SERMION 2. CUALITATIVE AND CUANTITATIVE COMPOSITION Every coated tablet contains 10 and 30 mg of Nicergoline. 3. PHARMACEUTICAL FORM Coated tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. Cerebrovascular insufficiency of senile source. 2. Peripheral Vasodilator. 3. Treatment of Senile dementia from light to medium level of vascular type and Alzheimer. 4.2 DOSAGE 1. 30 mg/day and Cerebrovascular insufficiency of senile source. 2. 30 mg twice per day, as Peripheral Vasodilator and on treatment of Senile dementia from light to medium level of vascular type and Alzheimer. 4.3 CONTRAINDICATIONS Hypersensitivity to Nicergoline. 4.4 WARNINGS AND PRECAUTIONS Nicergoline, as other adrenergic blocking agents, may significantly reduce blood pressure (arterial hypotension) in some patients. Likewise, as other sympatholytic agents, it has been associated to different degrees of sexual impotence and libido reduction. Do not administer this product if pregnant, if pregnancy is suspected or during breast-feeding. 4.5 ADVERSE EFFECTS Drowsiness, cephalea, tiredness, constipation, pyrosis, vomiting, diarrhea, facial flushing, sexual impotence and libido reduction, uric acid and L.H increment. 5. PHARMACOLOGICAL PROPERTIES 5.1 Pharmacokinetics Properties A) Onset and Duration - Benign prostatic hypertrophy, intramuscular: 2 hours. - Two hours after a single 4-mg intramuscular injection, average peak and mean urinary flow rates increased by 50% and 77%, respectively. B) Drug Concentration Levels - ORAL: 1 to 1.5 hours. - Maximal blood levels are reached 1 to 1.5 hours after oral dosing. - The mean maximum plasma concentrations after daily administration of a 30-mg film-coated tablet and a 30-mg effervescent tablet solution are 88 ng/mL and 41 ng/mL, respectively).
    [Show full text]
  • Non-Antibiotics, Efflux Pumps and Drug Resistance of Gram-Negative Rods
    Polish Journal of Microbiology MINIREVIEW 2018, Vol. 67, No 2, 129–135 DOI: 10.21307/pjm-2018-017 Non-antibiotics, Efflux Pumps and Drug Resistance of Gram-negative Rods AGNIESZKA EWA LAUDY* Department of Pharmaceutical Microbiology, Medical University of Warsaw, Warsaw, Poland Submitted 24 March 2018, revised 29 March 2018, accepted 04 April 2018 Abstract Non-antibiotic medicinal products consist of drugs with diverse activity against bacteria. Many non-antibiotics demonstrate direct anti- bacterial activity against Gram-positive cocci. The activity observed against Gram-negative rods is much lower and non-antibiotics primarily from the following groups: non-steroidal anti-inflammatory drugs, cardiovascular and antidepressant medicinal products demonstrate this activity. It has been shown that the low activity of some non-antibiotics or the absence of activity against Gram-negative rods is related, among other things, to the extrusion of these compounds from bacterial cells by multi-drug resistance efflux pumps. Substrates for the resistance-nodulation-division efflux systems include the following non-antibiotics: salicylate, diclofenac, ibuprofen, mefenamic acid, naproxen, amitriptyline, alendronate sodium, nicergoline, and ticlopidine. In addition, interactions between non-antibiotics and multi-drug resistance efflux pumps have been observed. It has also been revealed that depending on the concentration, salicylate induces expression of multi-drug resistance efflux pumps in Escherichia coli, Salmonella enterica subsp. enterica serotype Typhimurium, and Burkholderia cenoce­ pacia. However, salicylate does not affect the expression of the resistance-nodulation-division efflux systems Stenotrophomonasin maltophilia and Acinetobacter baumannii. Most importantly, there were no effects of medicinal products containing some non-antibiotic active substances, except salicylate, as substrates of multi-drug resistance efflux pumps, on the induction of Gram-negative rod resistance to quinolones.
    [Show full text]
  • 4 Supplementary File
    Supplemental Material for High-throughput screening discovers anti-fibrotic properties of Haloperidol by hindering myofibroblast activation Michael Rehman1, Simone Vodret1, Luca Braga2, Corrado Guarnaccia3, Fulvio Celsi4, Giulia Rossetti5, Valentina Martinelli2, Tiziana Battini1, Carlin Long2, Kristina Vukusic1, Tea Kocijan1, Chiara Collesi2,6, Nadja Ring1, Natasa Skoko3, Mauro Giacca2,6, Giannino Del Sal7,8, Marco Confalonieri6, Marcello Raspa9, Alessandro Marcello10, Michael P. Myers11, Sergio Crovella3, Paolo Carloni5, Serena Zacchigna1,6 1Cardiovascular Biology, 2Molecular Medicine, 3Biotechnology Development, 10Molecular Virology, and 11Protein Networks Laboratories, International Centre for Genetic Engineering and Biotechnology (ICGEB), Padriciano, 34149, Trieste, Italy 4Institute for Maternal and Child Health, IRCCS "Burlo Garofolo", Trieste, Italy 5Computational Biomedicine Section, Institute of Advanced Simulation IAS-5 and Institute of Neuroscience and Medicine INM-9, Forschungszentrum Jülich GmbH, 52425, Jülich, Germany 6Department of Medical, Surgical and Health Sciences, University of Trieste, 34149 Trieste, Italy 7National Laboratory CIB, Area Science Park Padriciano, Trieste, 34149, Italy 8Department of Life Sciences, University of Trieste, Trieste, 34127, Italy 9Consiglio Nazionale delle Ricerche (IBCN), CNR-Campus International Development (EMMA- INFRAFRONTIER-IMPC), Rome, Italy This PDF file includes: Supplementary Methods Supplementary References Supplementary Figures with legends 1 – 18 Supplementary Tables with legends 1 – 5 Supplementary Movie legends 1, 2 Supplementary Methods Cell culture Primary murine fibroblasts were isolated from skin, lung, kidney and hearts of adult CD1, C57BL/6 or aSMA-RFP/COLL-EGFP mice (1) by mechanical and enzymatic tissue digestion. Briefly, tissue was chopped in small chunks that were digested using a mixture of enzymes (Miltenyi Biotec, 130- 098-305) for 1 hour at 37°C with mechanical dissociation followed by filtration through a 70 µm cell strainer and centrifugation.
    [Show full text]
  • Cerebral Histamine H1 Receptor Binding Potential Measured With
    Cerebral Histamine H1 Receptor Binding Potential Measured with PET Under a Test Dose of Olopatadine, an Antihistamine, Is Reduced After Repeated Administration of Olopatadine Michio Senda1, Nobuo Kubo2, Kazuhiko Adachi3, Yasuhiko Ikari1,4, Keiichi Matsumoto1, Keiji Shimizu1, and Hideyuki Tominaga1 1Division of Molecular Imaging, Institute of Biomedical Research and Innovation, Kobe, Japan; 2Department of Otorhinolaryngology, Kansai Medical University, Osaka, Japan; 3Department of Mechanical Engineering, Kobe University, Kobe, Japan; and 4Micron, Inc., Kobe, Japan Some antihistamine drugs that are used for rhinitis and pollinosis have a sedative effect as they enter the brain and block the H1 Antihistamines are widely used as a medication for receptor, potentially causing serious accidents. Receptor occu- common allergic disorders such as seasonal pollinosis, pancy has been measured with PET under single-dose adminis- tration in humans to classify antihistamines as more sedating or chronic rhinitis, and urticaria. Some antihistamine drugs as less sedating (or nonsedating). In this study, the effect of re- have a sedative side effect as they enter the brain and block peated administration of olopatadine, an antihistamine, on the histamine H1 receptor, potentially causing traffic accidents cerebral H1 receptor was measured with PET. Methods: A total and other serious events, but the sedative effect is difficult to of 17 young men with rhinitis underwent dynamic brain PET with evaluate because of a large variation in neuropsychological 11 C-doxepin at baseline, under an initial single dose of 5 mg of measures and subjective symptoms. Measurement of cere- olopatadine (acute scan), and under another 5-mg dose after re- 11 peated administration of olopatadine at 10 mg/d for 4 wk (chronic bral histamine H1 receptor occupancy using PET with C- doxepin under a single administration of antihistamines has scan).
    [Show full text]
  • MEDICATIONS to AVOID PRIOR to ALLERGY SKIN TESTING Allergy
    MEDICATIONS TO AVOID PRIOR TO ALLERGY SKIN TESTING Allergy testing requires the ‘histamine response’ in order to be accurate and reliable. There are many types of antihistamines. Antihistamines are found in many different medicines, either as a single drug or mixed with a combination of chemicals. Please review all medicines you take (including Over-The-Counter) in order to make your allergy testing appointment most efficient and accurate. Generic names are in all lower case, trade names Capitalized. Oral antihistamines to be stopped 3 (THREE) days prior to your appointment: - brompheniramine (Actifed, Atrohist, Dimetapp, Drixoral) - cetirizine (Zyrtec, Zyrtec D) - chlopheniramine (Chlortrimeton, Deconamine, Kronofed A, Novafed A, Rynatan, Tussinex) - clemastine (Tavist, Antihist) - cyproheptadine (Periactin) - diphenhydramine (Benadryl, Allernix, Nytol) - doxylamine (Bendectin, Nyquil) - hydroxyzine (Atarax, Marax, Vistaril) - levocetirizine (Xyzal) - promethazine (Phenergan) Oral antihistamines to be stopped 7 (SEVEN) days prior to your appointment: - desloratadine (Clarinex) - fexofenadine (Allegra, Allegra D) - loratadine (Claritin, Claritin D, Alavert) Nose spray and eye drop antihistamines to stop 5 (FIVE) days prior to your appointment: - azelastine (Astelin, Astepro, Dymista, Optivar) - bepotastine (Bepreve) - ketotifen (Zaditor, Alaway) - olapatadine (Pataday, Patanase) - pheniramine (Visine A, Naphcon A) – OK to stop for 2 days Antacid medications (different type of antihistamine) to stop 3 (THREE) days prior to your appointment: - cimetidine (Tagamet) - famotidine (Pepcid) - ranitidine (Zantac) Note: Antihistamines are found in many over the counter medications, including Tylenol Allergy, Actifed Cold and Allergy, Alka-Seltzer Plus Cold with Cough Formula, and many others. Make sure you read and check the ingredients carefully and stop those containing antihistamines at least 3 (THREE) days prior to the appointment.
    [Show full text]
  • Kava Kava Extract Is Available from Ashland Chemical Co., Mini Star International, Inc., and QBI (Quality Botanical Ingredients, Inc.)
    SUMMARY OF DATA FOR CHEMICAL SELECTION Kava Kava 9000-38-8; 84696-40-2 November 1998 TABLE OF CONTENTS Basis for Nomination Chemical Identification Production Information Use Pattern Human Exposure Regulatory Status Evidence for Possible Carcinogenic Activity Human Data Animal Data Metabolism Other Biological Effects Structure-Activity Relationships References BASIS OF NOMINATION TO THE CSWG Kava kava is brought to the attention of the CSWG because it is a rapidly growing, highly used dietary supplement introduced into the mainstream U.S. market relatively recently. Through this use, millions of consumers using antianxiety preparations are potentially exposed to kava kava. A traditional beverage of various Pacific Basin countries, kava clearly has psychoactive properties. The effects of its long-term consumption have not been documented adequately; preliminary studies suggest possibly serious organ system effects. The potential carcinogenicity of kava and its principal constituents are unknown. INPUT FROM GOVERNMENT AGENCIES/INDUSTRY The U.S. Pharmacopeia is in the process of reviewing kava kava. No decision on preparation of a monograph has been made. SELECTION STATUS ACTION BY CSWG: 12/14/98 Studies requested: - Toxicological evaluation, to include studies of reproductive toxicity and neurotoxicity - Genotoxicity Priority: High Rationale/Remarks: - Significant human exposure - Leading dietary supplement with rapidly growing use - Concern that kava has been promoted as a substitute for ritilin in children - Test extract standardized to 30 percent kavalactones - NCI is conducting studies in Salmonella typhimurium CHEMICAL IDENTIFICATION CAS Registry Number: 9000-38-8 Kava-kava resin (8CI) Chemical Abstract Service Name: 84696-40-2 CAS Registry Number: Pepper (Piper), P. methysticum, ext. Chemical Abstract Service Name: Extract of kava; kava extract; Piper Synonyms and Trade Names: methisticum extract Description: The tropical shrub Piper methysticum is widely cultivated in the South Pacific.
    [Show full text]
  • Low-Dose Doxepin for Treatment of Pruritus in Patients on Hemodialysis
    DIALYSIS Low-Dose Doxepin for Treatment of Pruritus in Patients on Hemodialysis Fatemeh Pour-Reza-Gholi,1 Alireza Nasrollahi,2 Ahmad Firouzan,1 Ensieh Nasli Esfahani,1 Farhat Farrokhi3 1Department of Nephrology, Introduction. Pruritus is one of the frequent discomforting Shaheed Labbafinejad complications in patients with end-stage renal disease. We Medical Center & Urology and prospectively evaluated the effectiveness of doxepin, an H1-receptor Nephrology Research Center, antagonist of histamine, in patients with pruritus resistant to Shaheed Beheshti Medical University, Tehran, Iran conventional treatment. 2Department of Nephrology, Materials and Methods. A randomized controlled trial with a Shohada-e-Tajrish Hospital, crossover design was performed on 24 patients in whom other Shaheed Beheshti Medical etiologic factors of pruritus had been ruled out. They were assigned University, Tehran, Iran into 2 groups and received either placebo or oral doxepin, 10 mg, 3Urology and Nephrology Research Center, Shaheed twice a day for 1 week. After a 1-week washout period, the 2 groups Beheshti Medical University, were treated conversely. Subjective outcome was determined by Tehran, Iran asking the patients described their pruritus as completely improved, relatively improved, or remained unchanged/worsened. Keywords. pruritus, doxepin, Results. Complete resolution of pruritus was reported in end-stage renal disease, 14 patients (58.3%) with doxepin and 2 (8.3%) with placebo dialysis (P < .001). Relative improvement was observed in 7 (29.2%) and 4 (16.7%), respectively. Overall, the improving effect of doxepin on Original Paper pruritus was seen in 87.5% of the patients. Twelve patients (50.0%) complained of drowsiness that alleviated in all cases after 2 days in average.
    [Show full text]