Transition of Anticoagulants 2016
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Enoxaparin Sodium Solution for Injection, Manufacturer's Standard
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PrLOVENOX® Enoxaparin sodium solution for injection 30 mg in 0.3 mL solution (100 mg/mL), pre-filled syringes for subcutaneous or intravenous injection 40 mg in 0.4 mL solution (100 mg/mL), pre-filled syringes for subcutaneous or intravenous injection 60 mg in 0.6 mL solution (100 mg/mL), pre-filled syringes for subcutaneous or intravenous injection 80 mg in 0.8 mL solution (100 mg/mL), pre-filled syringes for subcutaneous or intravenous injection 100 mg in 1 mL solution (100 mg/mL), pre-filled syringes for subcutaneous or intravenous injection 300 mg in 3 mL solution (100 mg/mL), multidose vials for subcutaneous or intravenous injection PrLOVENOX® HP Enoxaparin sodium (High Potency) solution for injection 120 mg in 0.8 mL solution (150 mg/mL), pre-filled syringes for subcutaneous or intravenous injection 150 mg in 1 mL solution (150 mg/mL), pre-filled syringes for subcutaneous or intravenous injection Manufacturer’s standard Anticoagulant/Antithrombotic Agent ATC Code: B01AB05 Product Monograph – LOVENOX (enoxaparin) Page 1 of 113 sanofi-aventis Canada Inc. Date of Initial Approval: 2905 Place Louis-R.-Renaud February 9, 1993 Laval, Quebec H7V 0A3 Date of Revision September 7, 2021 Submission Control Number: 252514 s-a version 15.0 dated September 7, 2021 Product Monograph – LOVENOX (enoxaparin) Page 2 of 113 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. TABLE OF CONTENTS .............................................................................................................. -
Kengrexal, INN-Cangrelor Tetrasodium
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT Kengrexal 50 mg powder for concentrate for solution for injection/infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains cangrelor tetrasodium corresponding to 50 mg cangrelor. After reconstitution 1 mL of concentrate contains 10 mg cangrelor. After dilution 1 mL of solution contains 200 micrograms cangrelor. Excipient with known effect Each vial contains 52.2 mg sorbitol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for injection/infusion. White to off-white lyophilised powder. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Kengrexal, co-administered with acetylsalicylic acid (ASA), is indicated for the reduction of thrombotic cardiovascular events in adult patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) who have not received an oral P2Y12 inhibitor prior to the PCI procedure and in whom oral therapy with P2Y12 inhibitors is not feasible or desirable. 4.2 Posology and method of administration Kengrexal should be administered by a physician experienced in either acute coronary care or in coronary intervention procedures and is intended for specialised use in an acute and hospital setting. Posology The recommended dose of Kengrexal for patients undergoing PCI is a 30 micrograms/kg intravenous bolus followed immediately by 4 micrograms/kg/min intravenous infusion. The bolus and infusion should be initiated prior to the procedure and continued for at least two hours or for the duration of the procedure, whichever is longer. At the discretion of the physician, the infusion may be continued for a total duration of four hours, see section 5.1. -
Safety of Venous Thromboembolism Prophylaxis with Fondaparinux in Ischemic Stroke☆
Thrombosis Research 135 (2015) 249–254 Contents lists available at ScienceDirect Thrombosis Research journal homepage: www.elsevier.com/locate/thromres Regular Article Safety of venous thromboembolism prophylaxis with fondaparinux in ischemic stroke☆ C.T. Hackett a,d,1, R.S. Ramanathan a,1, K. Malhotra a,M.R.Quigleyb,c,K.M.Kellya,c,M.Tiana,J.Protetcha, C. Wong a,c,D.G.Wrighta,c,A.H.Tayala,c,⁎ a Department of Neurology and Allegheny General Hospital Comprehensive Stroke Center, University of South Carolina b Department of Neurosurgery and Allegheny General Hospital, University of South Carolina c Drexel University College of Medicine, University of South Carolina d Department of Psychology, University of South Carolina article info abstract Article history: Introduction: Unfractionated heparin (UFH), low molecular weight heparin or fondaparinux are recommended Received 19 June 2014 for venous thromboembolism (VTE) prophylaxis in acutely ill medical patients. There are limited data on the Received in revised form 11 September 2014 safety of fondaparinux for VTE prophylaxis in ischemic stroke. We examined adverse event frequency in Accepted 4 November 2014 hospitalized patients with ischemic stroke who received VTE prophylaxis with fondaparinux versus UFH. Available online 13 December 2014 Materials and Methods: We performed a propensity score matched analysis on a retrospective cohort of 644 consecutive patients with acute ischemic stroke receiving fondaparinux (n = 322) or UFH (n = 322) for VTE prophylaxis. Patients who received intravenous tPA and continuous intravenous infusions of UFH were excluded. The primary outcome was major hemorrhage (intracranial or extracranial) and the secondary outcome was total hemorrhage (major and minor hemorrhage) during hospitalization. -
Product Monograph
PRODUCT MONOGRAPH PrFONDAPARINUX SODIUM INJECTION 2.5 mg/0.5 mL , 5.0 mg/0.4 mL, 7.5 mg/0.6 mL, and 10.0 mg/0.8 mL Sterile 2.5 mg/0.5 mL (5 mg/mL) 5.0 mg/0.4 mL (12.5 mg/mL) 7.5 mg/0.6 mL (12.5 mg/mL) 10.0 mg/0.8 mL (12.5 mg/mL) Synthetic Antithrombotic DIN Owner: Date of Preparation: Dr. Reddy’s Laboratories Limited July 20, 2012 Bachupally – 500 090 INDIA Date of Revision: November 3, 2014 Canadian Importer/Distributor: Innomar Strategies Inc. 3470 Superior Court- Oakville, Ontario L6L 0C4 CANADA Submission Control Number: 174569 1 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION........................................................................3 INDICATIONS AND CLINICAL USE..............................................................................3 CONTRAINDICATIONS...................................................................................................4 WARNINGS AND PRECAUTIONS..................................................................................4 ADVERSE REACTIONS....................................................................................................9 DRUG INTERACTIONS..................................................................................................22 DOSAGE AND ADMINISTRATION..............................................................................23 OVERDOSAGE................................................................................................................27 -
Rtpa) for the Treatment of Hepatic Veno-Occlusive Disease (VOD
Bone Marrow Transplantation, (1999) 23, 803–807 1999 Stockton Press All rights reserved 0268–3369/99 $12.00 http://www.stockton-press.co.uk/bmt Recombinant tissue plasminogen activator (rtPA) for the treatment of hepatic veno-occlusive disease (VOD) S Kulkarni1, M Rodriguez2, A Lafuente2, P Mateos2, J Mehta1, S Singhal1, R Saso3, D Tait4, JG Treleaven3 and RL Powles1 Departments of 1Medical Oncology, 3Haematology and 4Radiotherapy, Royal Marsden NHS Trust, Sutton, Surrey, UK; and 2Haematology Department, Hospital La Paz, Madrid, Spain Summary: clinical syndrome characterized by hyperbilirubinemia, hepatomegaly and fluid retention,2,3 and results from dam- Seventeen patients who developed hepatic veno-occlus- age to structures in zone 3 of the liver acinus.4 In patients ive disease (VOD) following hematopoietic stem cell who have undergone hematopoietic stem cell transplan- transplantation were treated with recombinant tissue tation, chemoradiotherapy-induced endothelial cell damage plasminogen activator (rtPA) with or without heparin. is likely to be responsible for the pathogenesis of vessel rtPA was started a median of 13 days post transplant obstruction.5 (range 4–35). All patients received rtPA at a dose of 10 Treatment of established VOD has primarily been sup- mg/day as a starting dose, and 12 patients also received portive and any specific measures have resulted in little heparin (1500 U bolus; then 100 U/kg/day as a continu- impact on outcome. Based on the available evidence for ous i.v. infusion). The median number of days of rtPA involvement of hemostatic mechanisms and cytokines in therapy was 2.5 (1–12). The median total serum biliru- the pathogenesis of VOD,6–8 anti-thrombotic and anti-cyto- bin level was 116 mmol/l (range 63–194) at the begin- kine agents have been assessed for their role in treatment. -
ALTEPLASE: Class: Thrombolytic Agent (Fibrinolytic Agent
ALTEPLASE: Class: Thrombolytic Agent (Fibrinolytic Agent ). Indications: - Management of acute myocardial infarction for the lysis of thrombi in coronary arteries; management of acute ischemic stroke -Acute myocardial infarction (AMI): Chest pain ≥20 minutes, ≤12-24 hours; S-T elevation ≥0.1 mV in at least two ECG leads -Acute pulmonary embolism (APE): Age ≤75 years: Documented massive pulmonary embolism by pulmonary angiography or echocardiography or high probability lung scan with clinical shock . -Restoration of central venous catheter function *Unlabeled/Investigational :Acute peripheral arterial occlusive disease. Dosage: -Coronary artery thrombi: Front loading dose (weight-based): -Patients >67 kg: Total dose: 100 mg over 1.5 hours; infuse 15 mg over 1-2 minutes. Infuse 50 mg over 30 minutes. Infuse remaining 35 mg of alteplase over the next hour. Maximum total dose: 100 mg -Patients ≤67 kg: Infuse 15 mg I.V. bolus over 1-2 minutes, then infuse 0.75 mg/kg (not to exceed 50 mg) over next 30 minutes, followed by 0.5 mg/kg over next 60 minutes (not to exceed 35 mg) Maximum total dose: 100 mg. See “Notes.” Note: Concurrently, begin heparin 60 units/kg bolus (maximum: 4000 units) followed by continuous infusion of 12 units/kg/hour (maximum: 1000 units/hour) and adjust to aPTT target of 1.5-2 times the upper limit of control. Note: Thrombolytic should be administered within 30 minutes of hospital arrival. Administer concurrent aspirin, clopidogrel, and anticoagulant therapy (ie, unfractionated heparin, enoxaparin, or fondaparinux) with alteplase (O’Gara, 2013). -Acute massive or submassive pulmonary embolism: I.V. (Activase®): 100 mg over 2 hours; may be administered as a 10 mg bolus followed by 90 mg over 2 hours as was done in patients with submassive PE (Konstantinides, 2002). -
Heparin Induced Thrombocytopenia – Adult – Inpatient– Clinical Practice Guideline
Heparin Induced Thrombocytopenia – Adult – Inpatient– Clinical Practice Guideline Table of Contents EXECUTIVE SUMMARY ........................................................................................................... 2 SCOPE ...................................................................................................................................... 6 METHODOLOGY ...................................................................................................................... 6 DEFINITIONS (OPTIONAL): ..................................................................................................... 7 INTRODUCTION ....................................................................................................................... 7 RECOMMENDATIONS .............................................................................................................. 7 BENEFITS/HARMS OF IMPLEMENTATION ...........................................................................17 IMPLEMENTATION PLAN AND TOOLS ........................ERROR! BOOKMARK NOT DEFINED. REFERENCES .........................................................................................................................17 APPENDIX A ............................................................................................................................17 Note: Active Table of Contents Click to follow link CPG Contact for Changes: CPG Contact for Content: Name: Philip J Trapskin, PharmD,BCPS Name: Anne E. Rose, PharmD Phone Number: 263-1328 Phone Number: -
Anticoagulation Dosing Guideline for Adult COVID-19 Patients
Anticoagulation Dosing Guideline for Adult COVID-19 Patients Enoxaparin is the preferred first line anticoagulant for patients diagnosed with COVID-19. The incidence of HIT with enoxaparin is less than 1%. VTE Prophylaxis: VTE prophylaxis will be considered for COVID-19 patients who are low risk. Low risk COVID-19 patient 1. Not receiving mechanical ventilation 2. D-Dimer < 6 mg/L 3. ESRD on iHD without clotting Kidney Function BMI (kg/m2) Dosing of Enoxaparin Concern for HIT or LMWH Failure CrCL ≥ 30 mL/min 18.5-39.9 30mg SUBQ Q12H Consult Hematology 40-49.9 40mg SUBQ Q12H ≥ 50 60mg SUBQ Q12H CrCL < 30 mL/min 18.5-39.9 30mg SUBQ Q24H Consult Hematology OR ≥ 40 40mg SUBQ Q24H ESRD/AKI on RRT Special Population: < 18.5 (or weight < 50kg) Heparin 2500 SUBQ Q8H Consult Hematology *Contraindications: Platelets < 25 K/uL or Fibrinogen < 50 mg/dL or active bleeding Therapeutic anticoagulation Therapeutic anticoagulation will be considered for COVID-19 patients who are considered high risk or diagnosed with an acute VTE. High risk COVID-19 patient (for all hospitalized patients): Receiving mechanical ventilation AND D-dimer > 6 mg/L OR Acute kidney injury (Scr increase 0.3 mg/dL above baseline) +/- CVVHD/AVVHD/SLED or IHD with clotting Anti-Xa level goals for enoxaparin therapy (when indicated): 1. Therapeutic peak LMWH level (Drawn 4 hours after 3rd dose): 0.6-1 anti-Xa units/mL 2. Therapeutic trough LMWH level (Drawn 1 hour prior to 3rd dose): < 0.5 anti-Xa units/mL Kidney Function BMI Dosing of Enoxaparin Concern for HIT or (kg/m2) LMWH -
LOW MOLECULAR WEIGHT HEPARIN and FONDAPARINUX Zachary Stacy and Sara K
4 Chapter LOW MOLECULAR WEIGHT HEPARIN AND FONDAPARINUX Zachary Stacy and Sara K. Richter INTRODUCTION The low molecular weight heparins (LMWHs) and the synthetic pentasaccharide, fondaparinux, offer several advantages over unfractionated heparin (UFH). Enoxa- parin and dalteparin were approved in the United States in 1993 and 1994, respec- tively, followed by fondaparinux in 2001. Tinzaparin was approved and available in 2000, but was subsequently withdrawn from the market in 2011. These injectables have been traditionally used as prophylaxis for venous thromboembolism or as a bridge therapy to therapeutic oral anticoagulation. Based on their relative ease of dosing and monitoring, these agents frequently replace UFH in many clinical situations. This chapter will focus on those agents currently available in the United States, including enoxaparin, dalteparin, and fondaparinux. PHARMACOLOGY AND PHARMACOKINETICS1-9 Traditionally, unfractionated heparin was the parenteral anticoagulant used in the inpatient setting. Active unfractionated heparin compounds are composed of an inconsistent number of sugars, each ending in a specific pentasaccharide sequence. Using a consistent and shorter sequence of sugars improved the variability in the anticoagulant effect, giving rise to fractioned LMWH products. Mechanism of Action • LMWHs and fondaparinux are indirect inhibitors of clotting factors requiring antithrom- bin to exert an anticoagulant effect (Figure 4-1). • A specific pentasaccharide sequence binds to antithrombin to potentiate its activity. • LMWHs inhibit both Factor Xa and IIa (thrombin) activity. • Fondaparinux selectively inhibits only Factor Xa. • Refer to Tables 4-1 and 4-2 for comparison of the specific clotting factors inhibited. 65 66 Anticoagulation Therapy AT AT AT X a AT Thro mbin UFH AT AT X a AT Thro mbin LMWH Xa AT AT AT Throm bin Fondaparinux FIGURE 4-1. -
Transition of Anticoagulants 2019
Transition of Anticoagulants 2019 Van Hellerslia, PharmD, BCPS, CACP, Brand Generic Clinical Assistant Professor of Pharmacy Practice, Angiomax bivalirudin Temple University School of Pharmacy, Philadelphia, PA Arixtra fondaparinux Bevyxxa betrixaban Pallav Mehta, MD, Assistant Professor of Medicine, Coumadin warfarin Division of Hematology/Oncology, Eliquis apixaban MD Anderson Cancer Center at Cooper, Camden, NJ Fragmin dalteparin Lovenox enoxaparin Reviewer: Kelly Rudd, PharmD, BCPS, CACP, Pradaxa dabigatran Clinical Specialist, Anticoagulation, Bassett Medical Center, Savaysa edoxaban Cooperstown, NY Xarelto rivaroxaban From To Action Apixaban Argatroban/ Wait 12 hours after last dose of apixaban to initiate parenteral anticoagulant. In cases of Bivalirudin/ high bleeding risk, consider omitting initial bolus when transitioning to heparin infusion. Enoxaparin/ Dalteparin/ Fondaparinux/ Heparin Apixaban Warfarin When going from apixaban to warfarin, consider the use of parenteral anticoagulation as a bridge (eg, start heparin infusion or therapeutic enoxaparin AND warfarin 12 hours after last dose of apixaban and discontinue parenteral anticoagulant when INR is therapeutic). Apixaban affects INR so that initial INR measurements during the transition may not be useful for determining the appropriate dose of warfarin. Apixaban Betrixaban, Wait 12 hours from last dose of apixaban to initiate betrixaban, dabigatran, edoxaban, or Dabigatran, rivaroxaban. Edoxaban, or Rivaroxaban Argatroban Apixaban, Start apixaban, betrixaban, dabigatran, -
(Dipotassium Salt) and Heparin on the Estimation of Packed Cell Volume
J Clin Pathol: first published as 10.1136/jcp.19.2.196 on 1 March 1966. Downloaded from J. clin. Path. (1966), 19, 196 Effect of ethylene-diamine-tetra-acetic acid (dipotassium salt) and heparin on the estimation of packed cell volume C. A. PENNOCK AND K. W. JONES From the Department of Haematology, Gibson Laboratories, Radcliffe Infirmary, Oxford SYNOPSIS The effect of varying concentrations of ethylene-diamine-tetra-acetic acid (E.D.T.A.) (dipotassium salt) and heparin on the estimation of packed cell volume has been studied using a microhaematocrit method. Varying concentrations of E.D.T.A. can produce serious errors in estimation of packed cell volume (P.C.V.) and reliable results are only obtained within the range of 1 to 2 mg./ml. Heparin is a more suitable anticoagulant for this investigation as varying the con- centration has little effect. Storage with either anticoagulant at suitable concentrations for 24 hours at room temperature has little influence on the results. The estimation ofthe packed cell volume (P.C.V.) is bottles are often returned to this laboratory contain- regarded as a reliable investigation in the diagnosis ing less than the recommended amount of blood.copyright. of anaemia, and errors in the estimation of mean Ethylene-diamine-tetra-acetic acid is known to corpuscular haemoglobin concentration (M.C.H.C.) cause distortion and shrinkage of red cells and are thought to be due more often to errors in the to affect the estimation of P.C.V. by conventional estimation of haemoglobin than of the P.C.V. -
Estonian Statistics on Medicines 2016 1/41
Estonian Statistics on Medicines 2016 ATC code ATC group / Active substance (rout of admin.) Quantity sold Unit DDD Unit DDD/1000/ day A ALIMENTARY TRACT AND METABOLISM 167,8985 A01 STOMATOLOGICAL PREPARATIONS 0,0738 A01A STOMATOLOGICAL PREPARATIONS 0,0738 A01AB Antiinfectives and antiseptics for local oral treatment 0,0738 A01AB09 Miconazole (O) 7088 g 0,2 g 0,0738 A01AB12 Hexetidine (O) 1951200 ml A01AB81 Neomycin+ Benzocaine (dental) 30200 pieces A01AB82 Demeclocycline+ Triamcinolone (dental) 680 g A01AC Corticosteroids for local oral treatment A01AC81 Dexamethasone+ Thymol (dental) 3094 ml A01AD Other agents for local oral treatment A01AD80 Lidocaine+ Cetylpyridinium chloride (gingival) 227150 g A01AD81 Lidocaine+ Cetrimide (O) 30900 g A01AD82 Choline salicylate (O) 864720 pieces A01AD83 Lidocaine+ Chamomille extract (O) 370080 g A01AD90 Lidocaine+ Paraformaldehyde (dental) 405 g A02 DRUGS FOR ACID RELATED DISORDERS 47,1312 A02A ANTACIDS 1,0133 Combinations and complexes of aluminium, calcium and A02AD 1,0133 magnesium compounds A02AD81 Aluminium hydroxide+ Magnesium hydroxide (O) 811120 pieces 10 pieces 0,1689 A02AD81 Aluminium hydroxide+ Magnesium hydroxide (O) 3101974 ml 50 ml 0,1292 A02AD83 Calcium carbonate+ Magnesium carbonate (O) 3434232 pieces 10 pieces 0,7152 DRUGS FOR PEPTIC ULCER AND GASTRO- A02B 46,1179 OESOPHAGEAL REFLUX DISEASE (GORD) A02BA H2-receptor antagonists 2,3855 A02BA02 Ranitidine (O) 340327,5 g 0,3 g 2,3624 A02BA02 Ranitidine (P) 3318,25 g 0,3 g 0,0230 A02BC Proton pump inhibitors 43,7324 A02BC01 Omeprazole