DOCSLIB.ORG

Quinidine Assay Preservatives, and Stabilizers Precautions • for in Vitro Diagnostic Use

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Quinidine Assay Preservatives, and Stabilizers Precautions • for in Vitro Diagnostic Use 4 REAGENTS Reagents contain the following substances: Mouse monoclonal antibodies reactive to quinidine (1.35 µg/mL), glucose-6-phosphate (22 mM), nicotinamide adenine dinucleotide (18 mM), quinidine labeled with glucose-6-phosphate dehydrogenase (0.41 U/mL), 0.1% sodium azide, Tris buffer, Quinidine Assay preservatives, and stabilizers Precautions • For in vitro diagnostic use. July 2012 4Q052.2D_C • Contains nonsterile mouse monoclonal antibodies. • Assay components contain sodium azide, which may react with lead and copper plumbing to See shaded sections: form highly explosive metal azides. If waste is discarded down the drain, flush it with a large Updated information from August 2010 edition. volume of water to prevent azide buildup. • Do not use the kit after the expiration date. • This kit contains streptomycin sulfate. Please dispose of appropriately. • Turbid or yellow reagents may indicate contamination or degradation and must be discarded. Safety data sheets (MSDS/SDS) available on www.siemens.com/diagnostics Catalog Quantity/ Preparation of Reagents Number Product Description Volume The Emit® 2000 Quinidine Assay reagents are provided ready to use; no preparation is OSR4Q229 Emit® 2000 Quinidine Assay necessary. OSR4Q518 R1 (Antibody/Substrate Reagent 1) 2 x 23 mL Storage of Assay Components OSR4Q548 R2 (Enzyme Reagent 2) 2 x 13 mL • Improper storage of reagents can affect assay performance. • When not in use, store reagents upright at 2–8°C and with screw caps tightly closed. 4Q109UL Emit® 2000 Quinidine Calibrators* 1 x 5 mL†, 5 x 2 mL • Unopened reagents are stable until the expiration date printed on the label if stored upright at 2–8°C. *Required for calibrating the Emit ® 2000 Quinidine Assay. Sold separately. • Do not freeze reagents or expose them to temperatures above 32°C. †Additional negative calibrator is provided. Note: Reagents and calibrators are shipped ready to use in liquid form. 5 SPECIMEN COLLECTION AND PREPARATION Note: Reagents 1 and 2 are provided as a matched set. They should not be interchanged with components of kits with different lot numbers. • Each assay requires serum or plasma. Whole blood cannot be used. The anticoagulants The Emit® 2000 Quinidine Calibrators contain the following stated quinidine concentrations: heparin, citrate, oxalate, and EDTA have been tested and may be used with this assay. Some sample dilution may occur when samples are collected in tubes containing citrate Calibrator 0 0.5 1 2 4 8 anticoagulant. The amount of dilution and the possible need to correct for it should be considered when interpreting assay results for these samples. Quinidine (µg/mL) 0 0.5 1.0 2.0 4.0 8.0 • Sample volume is instrument-dependent. Refer to the appropriate Application Sheet for Quinidine (µmol/L) 0 1.5 3.1 6.2 12 25 specific volumes. • Store the serum or plasma refrigerated at 2–8°C. For transporting, maintain the sample temperature at 2–8°C. Samples can be stored refrigerated at 2–8°C for up to 7 days or stored 1 INTENDED USE frozen (-20°C) for up to 1 month. • Pharmacokinetic factors influence the correct time of sample collection after the last drug The Emit® 2000 Quinidine Assay is a homogeneous enzyme immunoassay intended for use in dose. These factors include dosage form, mode of administration, concomitant drug therapy, the quantitative analysis of quinidine in human serum or plasma. These reagents are packaged and biological variations affecting drug disposition.1–3 specifically for use on a variety of AU® Clinical Chemistry Systems. • Measure the steady-state serum concentration representing the trough level just before the next scheduled dose. 2 SUMMARY • Human serum or plasma samples should be handled and disposed of as if they were potentially infectious. Monitoring serum quinidine concentrations, along with careful clinical assessment, is the most effective means of achieving an optimum antiarrhythmic effect and reducing the risk of toxicity for the following reasons: 6 PROCEDURE • Serum quinidine concentrations correlate better with pharmacologic activity than does dosage.1,2 Materials Provided Emit® 2000 Quinidine Assay • The quinidine dosage required to control cardiac arrhythmias varies substantially in different Reagent 1 patients and in the same patient at different times. These variations are due to differences Reagent 2 inabsorption and metabolism and to the influences of disease states and coadministered drugs.1–3 Materials Required But Not Provided • Quinidine is safe and effective only in a narrow range of serum concentrations.1–3 Emit® 2000 Quinidine Calibrators Multi-level commercial controls • The symptoms of serious quinidine toxicity can mimic those of an ineffectively controlled cardiac disorder.1 Calibration Methods historically used to monitor serum quinidine concentrations include spectroscopic assay, chromatographic assay, and immunoassay.1, 2, 4 Recalibrate whenever a new lot of reagents is used or as indicated by control results (see Quality Control, below). If a new set of reagents with the same lot number is used, validate the system by assaying controls. 3 METHODOLOGY Quality Control The Emit® 2000 Quinidine Assay is a homogeneous enzyme immunoassay technique used for 1. Validate the calibration by assaying multi-level controls. Commercial controls are available for the analysis of specific compounds in biological fluids.4,5 The assay is based on competition this purpose. Ensure that control results fall within acceptable limits as defined by your own between drug in the sample and drug labeled with the enzyme glucose-6-phosphate laboratory. Once the calibration is validated, run samples. dehydrogenase (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding 2. Follow government regulations or accreditation requirements for quality control frequency. to the antibody, so the drug concentration in the sample can be measured in terms of enzyme At least once each day of use, analyze two levels of Quality Control (QC) material with known activity. Active enzyme converts oxidized nicotinamide adenine dinucleotide (NAD) to NADH, Quinidine concentrations. Follow your laboratory internal QC procedures if the results resulting in an absorbance change that is measured spectrophotometrically. Endogenous serum obtained are outside acceptable limits. G6PDH does not interfere because the coenzyme functions only with the bacterial (Leuconostoc mesenteroides) enzyme employed in the assay. 3. Refer to the instrument operator’s manual for appropriate instrument checks. Diluting High Concentration Samples Comparative Analysis To estimate quinidine concentrations above the assay range, patient samples containing more In this study, samples from patients were analyzed on the TDx analyzer and on the AU600 Clinical than 8.0 µg/mL (25 µmol/L) quinidine may be diluted with one or two parts distilled or deionized Chemistry System. A summary of the results is as follows: water or Emit® 2000 Quinidine Calibrator 0. After diluting the sample, repeat the entire assay sequence and multiply the results by the dilution factor. Some analyzers dilute and retest high Table 3 — Comparative Analysis Results concentration samples automatically. See the analyzer User’s Guide or appropriate Application Sheet for instructions. Slope 1.02 Intercept -0.06 Evaluation and Interpretation of Results Mean TDx 2.85 • This assay uses Math Model No. 1. AU600 2.86 • The factors that can influence the relationship between quinidine serum or plasma concentrations and clinical response include the type and severity of arrhythmia, liver Correlation Coefficient 0.98 1–3 function, kidney function, general state of health, and use of other drugs. Number 53 • The concentration of quinidine in serum or plasma depends on the time of the last drug dose; mode of administration; concomitant drug therapy; sample condition; time of sample collection; and individual variations of absorption, distribution, biotransformation, and Specificity excretion. These parameters must be considered when interpreting results.1–3 The Emit® 2000 Quinidine Assay measures the total (protein-bound plus unbound) quinidine concentration in serum or plasma. In addition, dihydroquinidine (DHQ) makes a small, but • Results of this test should always be interpreted in conjunction with the patient’s medical measurable, contribution to the assayed value (see Section 8, Expected Values). history, clinical presentation and other findings. Compounds whose chemical structure or concurrent therapeutic use would suggest possible cross-reactivity have been tested. o-Desmethylquinidine (DMQ), a minor metabolite of quinidine, 7 LIMITATIONS OF THE PROCEDURE cross-reacts with this assay. The compounds listed in Table 4 do not interfere with the Emit® 2000 Quinidine Assay when o-Desmethylquinidine (DMQ), a minor metabolite of quinidine, cross-reacts with this assay (see tested in the presence of 2.0 µg/mL quinidine. Levels tested were at or above maximum Section 9, Specific Performance Characteristics, Specificity). physiological or pharmacological concentrations. Table 4 — Compounds That Do Not Interfere 8 EXPECTED VALUES Concentration Tested Concentration Tested Compound (µg/mL) Compound (µg/mL) The Emit® 2000 Quinidine Assay accurately quantitates quinidine concentrations in human serum or plasma containing 0.5–8.0 µg/mL (1.5–25 µmol/L) quinidine. Dihydroquinidine Structurally Related Compounds Structurally Unrelated Compounds 6,7 (DHQ), a constituent of pharmaceutical quinidine preparations, has antiarrhythmic activity
Load more

Recommended publications
  • TAYSIDE PRESCRIBER Issue No
    TAYSIDE PRESCRIBER Issue No. 122 – May 2012 Produced by the NS Tayside Medicines Governance Unit in conjunction with Mental Health Citalopram & escitalopram:QT interval prolongation New maximum daily dose restrictions, contraindications, and warnings Information has been issued via Drug Safety Update, Volume 5, Issue 5, December 2011 and ‘Dear Healthcare Professional Letters’ for both citalopram and escitalopram regarding new restrictions on the maximum daily doses, contraindications, and warnings. This is as a result of an assessment of a QT study that revealed dose-dependent increase in the QT interval observed with ECG monitoring for both citalopram and escitalopram. Maximum licensed daily doses for citalopram and escitalopram Adults Adults > 65 years Adults with hepatic impairment Citalopram 40 mg 20 mg 20 mg Escitalopram (non-formulary) 20 mg 10 mg 10mg The guidance in NHS Tayside is: ⇒ to review all patients on high dose* citalopram or escitalopram with aim of reducing to new maximum licensed doses ( * above new maximum licensed daily doses as stated in the table above) ⇒ not to prescribe citalopram or escitalopram with other medication known to prolong the QT interval ⇒ not to prescribe citalopram and escitalopram in patients with known QT prolongation or congenital long QT syndrome ⇒ to consider alternative antidepressant in patients with cardiac disease ( e.g. patients with significant bradycardia; recent myocardial infarction or decompensated heart failure) See flow diagram on page 3 for further guidance and table below on medicines known to prolong the QT interval. Medicines known to increase plasma levels of citalopram or escitalopram, e.g. omeprazole & some antivirals may require dose reduction of citalopram or escitalopram and should be used with caution.
    [Show full text]
  • PRODUCT MONOGRAPH ELAVIL® Amitriptyline Hydrochloride Tablets
    PRODUCT MONOGRAPH ELAVIL® amitriptyline hydrochloride tablets USP 10, 25, 50 and 75 mg Antidepressant AA PHARMA INC. DATE OF PREPARATION: 1165 Creditstone Road Unit #1 August 29, 2018 Vaughan, ON L4K 4N7 Control No.: 217626 1 PRODUCT MONOGRAPH ELAVIL® amitriptyline hydrochloride tablets USP 10, 25, 50, 75 mg THERAPEUTIC CLASSIFICATION Antidepressant ACTIONS AND CLINICAL PHARMACOLOGY Amitriptyline hydrochloride is a tricyclic antidepressant with sedative properties. Its mechanism of action in man is not known. Amitriptyline inhibits the membrane pump mechanism responsible for the re-uptake of transmitter amines, such as norepinephrine and serotonin, thereby increasing their concentration at the synaptic clefts of the brain. Amitriptyline has pronounced anticholinergic properties and produces EKG changes and quinidine-like effects on the heart (See ADVERSE REACTIONS). It also lowers the convulsive threshold and causes alterations in EEG and sleep patterns. Orally administered amitriptyline is readily absorbed and rapidly metabolized. Steady-state plasma concentrations vary widely and this variation may be genetically determined. Amitriptyline is primarily excreted in the urine, mostly in the form of metabolites, with some excretion also occurring in the feces. INDICATIONS AND CLINICAL USE ELAVIL® (amitriptyline hydrochloride) is indicated in the drug management of depressive illness. ELAVIL® may be used in depressive illness of psychotic or endogenous nature and in selected patients with neurotic depression. Endogenous depression is more likely to be alleviated than are other depressive states. ELAVIL® ®, because of its sedative action, is also of value in alleviating the anxiety component of depression. As with other tricyclic antidepressants, ELAVIL® may precipitate hypomanic episodes in patients with bipolar depression. These drugs are not indicated in mild depressive states and depressive reactions.
    [Show full text]
  • COPD Agents Review – October 2020 Page 2 | Proprietary Information
    COPD Agents Therapeutic Class Review (TCR) October 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]. October 2020
    [Show full text]
  • (12) United States Patent (10) Patent No.: US 6,844,355 B2 Somberg Et Al
    USOO684.4355B2 (12) United States Patent (10) Patent No.: US 6,844,355 B2 Somberg et al. (45) Date of Patent: Jan. 18, 2005 (54) OPTICALLY ACTIVE ISOMERS OF QUININE Catterall, (1992) Physiol. Rev. 72(supp):S15-S48. AND QUINDINE AND THEIR RESPECTIVE Chan et al., (1991) J. Chromatogr. 571:291-297. BIOLOGICALACTION Chen et al., (1998) Nature 392:293–296. (75) Inventors: John C. Somberg, Lake Forest, IL Coplen et al., (1991) Circulation 84:527. (US); Vasant Ranade, Libertyville, IL Drabowicz et al., (1984) “Chemical Abstracts” Phosphorus (US) Sulfur 16:2676–270 (XP002165239). Engler et al., (1985) Helv. Chim. Acta. 68:789–800. (73) Assignee: Academic Pharmaceuticals, Inc., Lake Ficker et al., (1998) Circ. Res. 82:386–395. Bluff, IL (US) Gellens et al., (1992) Proc. Natl. Acad. Sci. 89:554–558. (*) Notice: Subject to any disclaimer, the term of this Gutzwiller et al., (1973) “Chemical Abstracts” Helv. Chim. patent is extended or adjusted under 35 Acta. 79:1494–1503 (XP002165238). U.S.C. 154(b) by 0 days. Hartmann et al. (1994) Circ. Res. 75:114-122. Karle I.L. et al., (1981) Proc. Natl. Acad. Sci. 78:5938–5941. (21) Appl. No.: 10/168,919 Karle, J.M. (1997) Antimicrob. Agents Chemother. (22) PCT Filed: Dec. 22, 2000 41:791-794. Kiehn et al. (1996) Circulation 94:2572–2579. (86) PCT No.: PCT/US00/352.13 Krafte et al., (1994) Europ. J. Pharma. 266:245-254. S371 (c)(1), Li et al. (1996) Circ. Res. 78:689-696. (2), (4) Date: Oct. 30, 2002 Sanguinetti et al., (1990) J.
    [Show full text]
  • PERPHENAZINE and AMITRIPTYLINE HYDROCHLORIDE- Perphenazine and Amitriptyline Hydrochloride Tablet, Film Coated Mylan Pharmaceuticals Inc
    PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE- perphenazine and amitriptyline hydrochloride tablet, film coated Mylan Pharmaceuticals Inc. ---------- WARNING Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug- treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Perphenazine and amitriptyline hydrochloride is not approved for the treatment of patients with dementia- related psychosis (see WARNINGS). Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of perphenazine and amitriptyline or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need.
    [Show full text]
  • Nuedexta) National Drug Monograph May 2013 VA Pharmacy Benefits Management Services, Medical Advisory Panel, and VISN Pharmacist Executives
    Dextromethorphan/ Quinidine Monograph Dextromethorphan Hydrobromide and Quinidine Sulfate (Nuedexta) National Drug Monograph May 2013 VA Pharmacy Benefits Management Services, Medical Advisory Panel, and VISN Pharmacist Executives The purpose of VA PBM Services drug monographs is to provide a comprehensive drug review for making formulary decisions. These documents will be updated when new clinical data warrant additional formulary discussion. Documents will be placed in the Archive section when the information is deemed to be no longer current. Executive Summary: Current therapy for pseudobulbar affect (PBA) typically utilizes non-pharmacologic coping strategies such as relaxation and distraction techniques. The off-label use of selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs) and dopaminergic agents has found limited success in treating PBA exacerbations. Dextromethorphan/quinidine (Nuedexta) is a combination of two existing generic formulary options; however quinidine is not available in an appropriate strength or in a liquid formulation (200mg, 300mg capsules only). Low dose quinidine inhibits the rapid metabolism of dextromethorphan, therefore increasing the bioavailability of dextromethorphan, resulting in effective plasma levels. In a double-blind, placebo-controlled study, the combination of dextromethorphan (20 or 30 mg) and low dose quinidine (10 mg) [STAR trial] significantly reduced the frequency of pseudobulbar affect episodes vs. placebo over the course of 12 weeks of treatment (p < 0.0001). Patients in the dextromethorphan/quinidine 20 mg/10 mg group reported a mean weekly episode reduction of 82% from baseline vs. a reduction of 47% in the placebo group (p = 0.001). Mean Center for Neurological Study-Lability Scale (CNS-LS) scores decreased by 8.2 points for both dextromethorphan/quinidine dosage groups vs.
    [Show full text]
  • Trimbow, INN-Beclometasone Dipropionate, Formoterol Fumarate
    ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT Trimbow 87 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each delivered dose (the dose leaving the mouthpiece) contains 87 micrograms of beclometasone dipropionate, 5 micrograms of formoterol fumarate dihydrate and 9 micrograms of glycopyrronium (as 11 micrograms glycopyrronium bromide). Each metered dose (the dose leaving the valve) contains 100 micrograms of beclometasone dipropionate, 6 micrograms of formoterol fumarate dihydrate and 10 micrograms of glycopyrronium (as 12.5 micrograms glycopyrronium bromide). Excipient with known effect Trimbow contains 8.856 mg ethanol per actuation. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Pressurised inhalation, solution (pressurised inhalation). Colourless to yellowish liquid solution. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications COPD Maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or a combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist (for effects on symptoms control and prevention of exacerbations see section 5.1). Asthma Maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and medium dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year. 4.2 Posology and method of administration Posology Adults The recommended dose is two inhalations twice daily. The maximum dose is two inhalations twice daily. Patients should be advised to take Trimbow every day even when asymptomatic.
    [Show full text]
  • ANTIDEPRESSANTS in USE in CLINICAL PRACTICE Mark Agius1 & Hannah Bonnici2 1Clare College, University of Cambridge, Cambridge, UK 2Hospital Pharmacy St
    Psychiatria Danubina, 2017; Vol. 29, Suppl. 3, pp 667-671 Conference paper © Medicinska naklada - Zagreb, Croatia ANTIDEPRESSANTS IN USE IN CLINICAL PRACTICE Mark Agius1 & Hannah Bonnici2 1Clare College, University of Cambridge, Cambridge, UK 2Hospital Pharmacy St. James Hospital Malta, Malta SUMMARY The object of this paper, rather than producing new information, is to produce a useful vademecum for doctors prescribing antidepressants, with the information useful for their being prescribed. Antidepressants need to be seen as part of a package of treatment for the patient with depression which also includes psychological treatments and social interventions. Here the main Antidepressant groups, including the Selective Serotonin uptake inhibiters, the tricyclics and other classes are described, together with their mode of action, side effects, dosages. Usually antidepressants should be prescribed for six months to treat a patient with depression. The efficacy of anti-depressants is similar between classes, despite their different mechanisms of action. The choice is therefore based on the side-effects to be avoided. There is no one ideal drug capable of exerting its therapeutic effects without any adverse effects. Increasing knowledge of what exactly causes depression will enable researchers not only to create more effective antidepressants rationally but also to understand the limitations of existing drugs. Key words: antidepressants – depression - psychological therapies - social therapies * * * * * Introduction Monoamine oxidase (MAO) inhibitors í Non-selective Monoamine Oxidase Inhibitors Depression may be defined as a mood disorder that í Selective Monoamine Oxidase Type A inhibitors negatively and persistently affects the way a person feels, thinks and acts. Common signs include low mood, Atypical Anti-Depressants and other classes changes in appetite and sleep patterns and loss of inte- rest in activities that were once enjoyable.
    [Show full text]
  • Dietary Supplements Compendium Volume 1
    2015 Dietary Supplements Compendium DSC Volume 1 General Notices and Requirements USP–NF General Chapters USP–NF Dietary Supplement Monographs USP–NF Excipient Monographs FCC General Provisions FCC Monographs FCC Identity Standards FCC Appendices Reagents, Indicators, and Solutions Reference Tables DSC217M_DSCVol1_Title_2015-01_V3.indd 1 2/2/15 12:18 PM 2 Notice and Warning Concerning U.S. Patent or Trademark Rights The inclusion in the USP Dietary Supplements Compendium of a monograph on any dietary supplement in respect to which patent or trademark rights may exist shall not be deemed, and is not intended as, a grant of, or authority to exercise, any right or privilege protected by such patent or trademark. All such rights and privileges are vested in the patent or trademark owner, and no other person may exercise the same without express permission, authority, or license secured from such patent or trademark owner. Concerning Use of the USP Dietary Supplements Compendium Attention is called to the fact that USP Dietary Supplements Compendium text is fully copyrighted. Authors and others wishing to use portions of the text should request permission to do so from the Legal Department of the United States Pharmacopeial Convention. Copyright © 2015 The United States Pharmacopeial Convention ISBN: 978-1-936424-41-2 12601 Twinbrook Parkway, Rockville, MD 20852 All rights reserved. DSC Contents iii Contents USP Dietary Supplements Compendium Volume 1 Volume 2 Members . v. Preface . v Mission and Preface . 1 Dietary Supplements Admission Evaluations . 1. General Notices and Requirements . 9 USP Dietary Supplement Verification Program . .205 USP–NF General Chapters . 25 Dietary Supplements Regulatory USP–NF Dietary Supplement Monographs .
    [Show full text]
  • 021879Orig1s000
    CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 021879Orig1s000 OTHER REVIEW(S) 505(b)(2) ASSESSMENT Application Information NDA # 021879 NDA Supplement #: S- N/A Efficacy Supplement Type SE- N/A Proprietary Name: Nuedexta Established/Proper Name: (dextromethorphan/quinidine) Dosage Form: Capsules Strengths: dextromethorphan 20mg with quinidine 10 mg Applicant: Avanir Pharmaceuticals, Inc. Date of Receipt: April 30, 2010 PDUFA Goal Date: October 30, 2010 Action Goal Date (if different): Proposed Indication(s): indicated for the treatment of pseudobulbar affect (PBA) secondary to either amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS) GENERAL INFORMATION 1) Is this application for a recombinant or biologically-derived product and/or protein or peptide product OR is the applicant relying on a recombinant or biologically-derived product and/or protein or peptide product to support approval of the proposed product? YES NO If “YES “contact the (b)(2) review staff in the Immediate Office, Office of New Drugs. ReferenceVersion ID: 2857112 March 2009 page 1 INFORMATION PROVIDED VIA RELIANCE (LISTED DRUG OR LITERATURE) 2) List the information essential to the approval of the proposed drug that is provided by reliance on our previous finding of safety and efficacy for a listed drug or by reliance on published literature. (If not clearly identified by the applicant, this information can usually be derived from annotated labeling.) Source of information* (e.g., Information provided (e.g., published literature, name of pharmacokinetic data, or specific referenced product) sections of labeling) quinidine sulfate nonclinical safety literature nonclinical safety *each source of information should be listed on separate rows 3) Reliance on information regarding another product (whether a previously approved product or from published literature) must be scientifically appropriate.
    [Show full text]
  • DBL™ Promethazine Hydrochloride Injection BP
    DBL™ Promethazine Hydrochloride Injection BP 1. NAME OF THE MEDICINE Promethazine hydrochloride 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of the solution contains 25.0 mg promethazine hydrochloride, 0.10 mg disodium edetate, 1.30 microlitre glacial acetic acid, 27.2 mg sodium acetate and 1.32 mg sodium metabisulfite in water for injections. Excipient(s) with known effect Sodium metabisulfite For the full list of excipients, see section 6.1 List of Excipients. 3. PHARMACEUTICAL FORM Solution for injection. DBL™ Promethazine Hydrochloride Injection BP is a clear, colourless solution of pH 5.0 to 6.0. 4. CLINICAL PARTICULARS 4.1 Therapeutic Indications DBL™ Promethazine Hydrochloride Injection BP is indicated for the following conditions: Treatment of allergic reactions such as: uncomplicated allergic conditions of the immediate type, e.g., pruritus, urticaria and angioedema, when oral therapy is impossible or contraindicated. Treatment and prevention of vomiting including: motion sickness; drug induced nausea; prevention and control of nausea and vomiting associated with certain types of anaesthesia and surgery, such as procedures with a high incidence of post-operative vomiting (e.g., gynaecological surgery, strabismus or middle ear surgery, and electroconvulsive therapy); in patients with a past history of motion sickness or post- operative vomiting; and in patients in whom avoidance of vomiting is crucial (e.g., neurosurgery and eye surgery). Page 1 of 10 Promethazine has sedative effects and it is also used in: pre-operative, post-operative and obstetric (during labour) sedation. 4.2 Dose and Method of Administration Dosage Allergic conditions Adults: 25 mg to 50 mg by deep intramuscular injection or slow intravenous injection; may be repeated within two hours if necessary.
    [Show full text]
  • IEHP Dualchoice Cal Mediconnect Formulary Maintenance Drug List
    IEHP DualChoice Cal MediConnect (Medicare-Medicaid Plan) Formulary Maintenance Drug List The following formulary medications may be approvable up to a three-month supply. Certain medications on this list may require prior approval from the plan based on existing criteria before being covered. For coverage information please see our formulary located on our website. BRAND GENERIC STREGTH DOSAGE FORM ABACAVIR ABACAVIR SULFATE 300 MG TABLET ABACAVIR ABACAVIR SULFATE 20 MG/ML SOLUTION TRIUMEQ ABACAVIR SULFATE/DOLUTEGRAVIR 600-50-300 TABLET SODIUM/LAMIVUDINE ABACAVIR-LAMIVUDINE ABACAVIR SULFATE/LAMIVUDINE 600-300MG TABLET ABACAVIR-LAMIVUDINE- ABACAVIR SULFATE/LAMIVUDINE/ZIDOVUDINE 150-300 MG TABLET ZIDOVUDINE TYMLOS ABALOPARATIDE 80MCG/DOSE PEN INJCTR ORENCIA ABATACEPT 125 MG/ML SYRINGE ORENCIA CLICKJECT ABATACEPT 125 MG/ML AUTO INJCT ORENCIA ABATACEPT 50MG/0.4ML SYRINGE ORENCIA ABATACEPT 87.5MG/0.7 SYRINGE VERZENIO ABEMACICLIB 50 MG TABLET VERZENIO ABEMACICLIB 100 MG TABLET VERZENIO ABEMACICLIB 150 MG TABLET VERZENIO ABEMACICLIB 200 MG TABLET ABIRATERONE ACETATE ABIRATERONE ACETATE 500 MG TABLET ABIRATERONE ACETATE ABIRATERONE ACETATE 250 MG TABLET YONSA ABIRATERONE ACETATE, SUBMICRONIZED 125 MG TABLET CALQUENCE ACALABRUTINIB 100 MG CAPSULE ACAMPROSATE CALCIUM ACAMPROSATE CALCIUM 333 MG TABLET DR ACARBOSE ACARBOSE 25 MG TABLET ACARBOSE ACARBOSE 50 MG TABLET ACARBOSE ACARBOSE 100 MG TABLET ACEBUTOLOL HCL ACEBUTOLOL HCL 200 MG CAPSULE ACEBUTOLOL HCL ACEBUTOLOL HCL 400 MG CAPSULE ACETAZOLAMIDE ER ACETAZOLAMIDE 500 MG CAPSULE ER ACETAZOLAMIDE
    [Show full text]