Medicines That Adversely Affect Allergy Skin Testing
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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products in the 1990s, and the Orange Book makes the notation that the Clistin products were not discontinued or withdrawn for safety or efficacy reasons. -
Table S1: Sensitivity, Specificity, PPV, NPV, and F1 Score of NLP Vs. ICD for Identification of Symptoms for (A) Biome Developm
Table S1: Sensitivity, specificity, PPV, NPV, and F1 score of NLP vs. ICD for identification of symptoms for (A) BioMe development cohort; (B) BioMe validation cohort; (C) MIMIC-III; (D) 1 year of notes from patients in BioMe calculated using manual chart review. A) Fatigue Nausea and/or vomiting Anxiety Depression NLP (95% ICD (95% CI) P NLP (95% CI) ICD (95% CI) P NLP (95% CI) ICD (95% CI) P NLP (95% CI) ICD (95% CI) P CI) 0.99 (0.93- 0.59 (0.43- <0.00 0.25 (0.12- <0.00 <0.00 0.54 (0.33- Sensitivity 0.99 (0.9 – 1) 0.98 (0.88 -1) 0.3 (0.15-0.5) 0.85 (0.65-96) 0.02 1) 0.73) 1 0.42) 1 1 0.73) 0.57 (0.29- 0.9 (0.68- Specificity 0.89 (0.4-1) 0.75 (0.19-1) 0.68 0.97 (0.77-1) 0.03 0.98 (0.83-1) 0.22 0.81 (0.53-0.9) 0.96 (0.79-1) 0.06 0.82) 0.99) 0.99 (0.92- 0.86 (0.71- 0.94 (0.79- 0.79 (0.59- PPV 0.96 (0.82-1) 0.3 0.95 (0.66-1) 0.02 0.95 (0.66-1) 0.16 0.93 (0.68-1) 0.12 1) 0.95) 0.99) 0.92) 0.13 (0.03- <0.00 0.49 (0.33- <0.00 0.66 (0.48- NPV 0.89 (0.4-1) 0.007 0.94 (0.63-1) 0.34 (0.2-0.51) 0.97 (0.81-1) 0.86 (0.6-0.95) 0.04 0.35) 1 0.65) 1 0.81) <0.00 <0.00 <0.00 F1 Score 0.99 0.83 0.88 0.57 0.95 0.63 0.82 0.79 0.002 1 1 1 Itching Cramp Pain NLP (95% ICD (95% CI) P NLP (95% CI) ICD (95% CI) P NLP (95% CI) ICD (95% CI) P CI) 0.98 (0.86- 0.24 (0.09- <0.00 0.09 (0.01- <0.00 0.52 (0.37- <0.00 Sensitivity 0.98 (0.85-1) 0.99 (0.93-1) 1) 0.45) 1 0.29) 1 0.66) 1 0.89 (0.72- 0.5 (0.37- Specificity 0.96 (0.8-1) 0.98 (0.86-1) 0.68 0.98 (0.88-1) 0.18 0.5 (0-1) 1 0.98) 0.66) 0.88 (0.69- PPV 0.96 (0.8-1) 0.8 (0.54-1) 0.32 0.8 (0.16-1) 0.22 0.99 (0.93-1) 0.98 (0.87-1) NA* 0.97) 0.98 (0.85- 0.57 (0.41- <0.00 0.58 (0.43- <0.00 NPV 0.98 (0.86-1) 0.5 (0-1) 0.02 (0-0.08) NA* 1) 0.72) 1 0.72) 1 <0.00 <0.00 <0.00 F1 Score 0.97 0.56 0.91 0.28 0.99 0.68 1 1 1 *Denotes 95% confidence intervals and P values that could not be calculated due to insufficient cells in 2x2 tables. -
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. -
Intraocular Pressure Rise After Phacoemulsification Prophylactic
British Journal of Ophthalmology 1995; 79: 809-813 809 Intraocular pressure rise after phacoemulsification Br J Ophthalmol: first published as 10.1136/bjo.79.9.809 on 1 September 1995. Downloaded from with posterior chamber lens implantation: effect of prophylactic medication, wound closure, and surgeon's experience Thomas G Bomer, Wolf-Dietrich A Lagreze, Jens Funk Abstract pressure rises usually occur between 6 and 8 Aims-A prospective clinical trial was hours after surgery.6 carried out to evaluate the effect of Various antiglaucomatous agents have been prophylactic medication, the technique of used to prevent the intraocular pressure rise wound closure, and the surgeon's experi- after cataract extraction. Oral acetazolamide15 16 ence on the intraocular pressure rise after and topical timolol'6-19 lowered the pressure cataract extraction. rise in the early period after intracapsular and Methods-In 100 eyes, the intraocular extracapsular cataract extraction. Levobunolol pressure was measured before as well as proved to be superior to timolol 4-7 hours 2-4, 5-7, and 22-24 hours after phaco- after extracapsular cataract extraction.20 Apra- emulsification and posterior chamber lens clonidine lowered the intraocular pressure rise implantation. Each of 25 patients received after uncomplicated phacoemulsification21 and either 1% topical apraclonidine, 0.5%/o extracapsular cataract extraction22 23 when topical levobunolol, 500 mg oral acetazo- given 30 minutes to 1 hour before surgery, lamide, or placebo. Forty four eyes were whereas immediate postoperative treatment operated with sclerocorneal sutureless with apraclonidine was ineffective.22 24 Miotics tunnel and 56 eyes with corneoscleral are frequently used to promote miosis and incision and suture. -
Intranasal Rhinitis Agents
Intranasal Rhinitis Agents Therapeutic Class Review (TCR) February 1, 2020 No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, digital scanning, or via any information storage or retrieval system without the express written consent of Magellan Rx Management. All requests for permission should be mailed to: Magellan Rx Management Attention: Legal Department 6950 Columbia Gateway Drive Columbia, Maryland 21046 The materials contained herein represent the opinions of the collective authors and editors and should not be construed to be the official representation of any professional organization or group, any state Pharmacy and Therapeutics committee, any state Medicaid Agency, or any other clinical committee. This material is not intended to be relied upon as medical advice for specific medical cases and nothing contained herein should be relied upon by any patient, medical professional or layperson seeking information about a specific course of treatment for a specific medical condition. All readers of this material are responsible for independently obtaining medical advice and guidance from their own physician and/or other medical professional in regard to the best course of treatment for their specific medical condition. This publication, inclusive of all forms contained herein, is intended to be educational in nature and is intended to be used for informational purposes only. Send comments and suggestions to [email protected]. -
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. -
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. -
Allergy Testing and History Form
Skin Testing Information and Consent 1. Skin Testing An allergy skin test is used to identify the substances that are causing your allergy symptoms. We will apply several extracts of common allergens to the skin and observe for a reaction. The reactions are then graded and confirmatory intradermal testing may be performed. This involves placing a small amount of extract under the skin of the upper arm. We then observe the reaction and record the results. On the day of testing please wear a short-sleeved shirt that can be pushed up comfortably to your shoulder. Allow 1-2 hours for your test session. You will need to stay on the premises during this time. Please do not bring children to your appointment. 2. Risks of Skin Testing Bleeding and infection may occur due to abrading of the skin. Any time the skin integrity is broken it puts on at risk for infection. However, this is a rare occurrence. The antigens used for testing are sterile and approved by the FDA. Occasionally, skin testing can trigger a severe allergic reaction requiring treatment with medications and/or treatment in the ER. Patients with asthma are at increased risk for triggering an asthma attack during testing. You should not undergo testing if you feel that you have allergy or asthma symptoms are currently under poor control. 3. Contraindications to Skin Testing Women who are pregnant or anyone who is currently taking Beta-Blockers, Tricyclic Anti-depressants or MAOI’s medications will NOT be skin tested. Please be sure to inform us of ALL your medications before the skin test is applied. -
Download Article (PDF)
Use of astemizole in a large group practice TIMOTHY J. CRAIG, DO MARK GREENWALD, MD VANESSA KAUFFMANN JILL CRAIG, MS Astemizole was released in 1988. Shortly after the release of astemizole and terfe In late 1992, a new warning label was added nadine, it became evident that both were associat in response to reports of syncope and death ed with prolonged QT intervals and arrhythmias, from arrhythmia. Records of patients given new mainly torsades de pointes. Because of this associ prescriptions for astemizole were reviewed ation, the Food and Drug Administration (FDA) and to assess compliance with the warnings in a the manufacturers provided a warning letter to large multispecialty practice. The indication physicians in 1992.1 For astemizole, the warning was appropriate in 89% of cases. Excessive stated: (1) That arrhythmias have usually occurred doses were used in 4% of cases. Two percent when the dose of 10 mg/d (the recommended dose) of prescriptions were given to patients with was exceeded. Exceeding this dose and the use of contraindications. Only two complications loading doses should be avoided. (2) Serum levels were documented. Despite carrying a drug of astemizole may be elevated by ketoconazole, ery warning, astemizole continues to be used thromycin;, and itraconazole. These drugs should inappropriately and is a medicolegal concern. not be used together. (3) Presyncope and syncope Education and drug evaluations can be used may precede fatal arrhythmias and calls for dis to enhance compliance and decrease the risk continuing astemizole. (4) The drug should be avoid associated with the use of astemizole. ed in patients with significant liver disease. -
Loratadine and Cetirizine
86 ЗАРУБІЖНИЙ ДОСВІД Anne K Ellis1,2,4,*, Yifei Zhu3, Lisa M Steacy2, Terry Walker2, James H Day1,2 1Division of Allergy & Immunology, Department of Medicine, Queen’s University, Kingston, ON, Canada 2Allergy Research Unit, Kingston General Hospital, Kingston, ON, Canada 3Life Sciences, Queen’s University, Kingston, ON, Canada 4Mailing Address: Doran 1, Division of Allergy, Kingston General Hospital, 76 Stuart Street, Kingston, ON K7L 2V7, Canada *Corresponding author. Mailing Address: Doran 1, Division of Allergy, Kingston General Hospital, 76 Stuart Street, Kingston, ON K7L 2V7, Canada A four-way, double-blind, randomized, placebo controlled study to determine the efficacy and speed of azelastine nasal spray, versus loratadine, and cetirizine in adult subjects with allergen-induced seasonal allergic rhinitis Key words: allergic rhinitis, azelastine, environmental exposure unit, onset of action, cetirizine, loratadine. Introduction inter-study variations when assessing the efficacy and onset of Seasonal allergic rhinitis (SAR) is an inflammatory disease action of various drugs to treat SAR; therefore, this study was characterized by multiple symptoms including sneezing, conducted in the highly controlled environment of the rhinnorhea, nasal congestion, nasal and nasopharyngeal itch- Environmental Exposure Unit (EEU). The EEU is a well- ing, and has associated ocular symptoms such as itchy, watery validated and internationally recognized controlled allergen and red/burning eyes [1]. Oral antihistamines are often the challenge facility located in Kingston, ON Canada [14–16]. first line treatment administered for SAR [2]. However, as The EEU allows for large groups of clinical trial participants SAR symptoms result from an interaction between inhaled to be simultaneously exposed to controlled levels of airborne allergens and IgE antibodies on mast cells located in the allergens such as ragweed or grass pollen. -
Supporting Information a Analysed Substances
Electronic Supplementary Material (ESI) for Analyst. This journal is © The Royal Society of Chemistry 2020 List of contents: Tab. A1 Detailed list and classification of analysed substances. Tab. A2 List of selected MS/MS parameters for the analytes. Tab. A1 Detailed list and classification of analysed substances. drug of therapeutic doping agent analytical standard substance abuse drug (WADA class)* supplier (+\-)-amphetamine ✓ ✓ S6 stimulants LGC (+\-)-methamphetamine ✓ S6 stimulants LGC (+\-)-3,4-methylenedioxymethamphetamine (MDMA) ✓ S6 stimulants LGC methylhexanamine (4-methylhexan-2-amine, DMAA) S6 stimulants Sigma cocaine ✓ ✓ S6 stimulants LGC methylphenidate ✓ ✓ S6 stimulants LGC nikethamide (N,N-diethylnicotinamide) ✓ S6 stimulants Aldrich strychnine S6 stimulants Sigma (-)-Δ9-tetrahydrocannabinol (THC) ✓ ✓ S8 cannabinoids LGC (-)-11-nor-9-carboxy-Δ9-tetrahydrocannabinol (THC-COOH) S8 cannabinoids LGC morphine ✓ ✓ S7 narcotics LGC heroin (diacetylmorphine) ✓ ✓ S7 narcotics LGC hydrocodone ✓ ✓ Cerillant® oxycodone ✓ ✓ S7 narcotics LGC (+\-)-methadone ✓ ✓ S7 narcotics Cerillant® buprenorphine ✓ ✓ S7 narcotics Cerillant® fentanyl ✓ ✓ S7 narcotics LGC ketamine ✓ ✓ LGC phencyclidine (PCP) ✓ S0 non-approved substances LGC lysergic acid diethylamide (LSD) ✓ S0 non-approved substances LGC psilocybin ✓ S0 non-approved substances Cerillant® alprazolam ✓ ✓ LGC clonazepam ✓ ✓ Cerillant® flunitrazepam ✓ ✓ LGC zolpidem ✓ ✓ LGC VETRANAL™ boldenone (Δ1-testosterone / 1-dehydrotestosterone) ✓ S1 anabolic agents (Sigma-Aldrich) -
Medication Instructions for Allergy Patients
MEDICATION INSTRUCTIONS FOR ALLERGY PATIENTS Drugs which contain antihistamine or have antihistaminic effects can result in negative reactions to skin testing. As a result, it may not be possible to properly interpret skin test results, and testing may have to be repeated at a later date. While this list is extensive, it is NOT all inclusive (particularly of the various brand names). Discontinue ALL antihistamines including the following medications seven (7) days prior to skin testing (unless longer time specified): Antihistamines – Generic name (Brand name(s)): Cetirizine (Zyrtec, Zyrtec-D) Hydroxyzine (Vistaril, Atarax) Desloratadine (Clarinex) Levocetirizine (Xyzal) Fexofenadine (Allegra, Allegra-D) Loratadine (Claritin, Claritin-D, Alavert) Diphenhydramine (Aleve PM, Benadryl, Bayer P.M., Benylin, Contac P.M., Doans P.M, Excedrin PM, Legatrin P.M.. Nytol, Tylenol Nighttime, Unisom, Zzzquil) Chlorpheniramine (Aller-Chlor, Allerest, Alka Seltzer Plus, Chlor-Trimeton, Comtrex, Contac, Co-Pyronil, Coricidin, CTM, Deconamine, Dristan, Dura-tap, Naldecon, Ornade Spansules, Rondec, Sinutab, Teldrin, Triaminic, Triaminicin, Tylenol Allergy) Azatadine (Optimine, Trinalin) Doxylamine (Nyquil) Brompheniramine (Bromfed, Dimetane, Dimetapp) Meclizine (Antivert) Carbinoxamine (Clistin, Rondec) Pheniramine Clemastine (Tavist) Phenyltoloxamine (Nadecon) Cyclizine (Marezine) Promethazine (Phenergan) Cyprohepatidine (Periactin) (9 days) Pyrilamine (Mepyramine) Dexbrompheniramine (Drixoral) Quinacrine (Atabrine) Dexchlorpheniramine (Extendryl, Polaramine)