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Drug Interactions due to Chelating Cations

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1. Diagnosis and therapy of genetic haemochromatosis

this phase of venesection FBC should be monitored weekly and SF Tsat moni- tored monthly. Homozygotes with normal iron indices and compound heterozygotes with minimal elevation of iron indices may be suitable for blood donation and annual monitoring of SF and Tsat. (1B) Iron depletion for patients who cannot tolerate venesection In rare circumstances, such as juvenile haemochromatosis or delayed diagnosis, it may be necessary to use iron chelation therapy to reverse cardiac damage. Physicians dealing (...) with the treatment of iron overload due to blood transfusion in patients with homozygous beta-thalassaemia have great expertise in dealing with heart failure and should be consulted. There is limited experience of using the oral iron chelator deferasirox (Exjade) in patients with C282Y homozygous GH and modest iron loading (median SF 645 lg/l). SF values were modestly reduced but signi?cant patient withdrawal from GI, renal and hepatic toxicities was observed (Phatak et al, 2010). Homozygotes without iron

2019 British Society of Gastroenterology

2. Guideline for the preparation of an Investigational Medicinal Product Dossier (IMPD)

. Eur JNuclMedMol ImagingDrug substance (synonyms: active pharmaceutical ingre- dient, API, active ingredient, medicinal substance) is any substance or mixture of substances intended to be used in themanufactureofadrug(medicinal)productandthat,when usedintheproductionofadrug,becomesanactiveingredient of the drug product. Such substances are intended to furnish pharmacologicalactivityorotherdirecteffectinthediagnosis, cure,mitigation,treatmentorpreventionofdiseaseortoaffect the structure and function (...) radiopharmaceutical prepara- tions, as the drug substance is indeed to be considered as that part of the formulation which carries or binds the radionuclide. In most cases, due to the peculiar nature and transient existence of the radionuclide as well as for radioprotection requirements, radiopharma- ceuticals are prepared following continuous processes, and the radioactive drug substances are not isolated, unlike during the preparation of typical non-radioactive pharmaceuticals. For this reason, during

2014 European Association of Nuclear Medicine

3. Management of Poisoning

Management of Poisoning Management of Poisoning MOH Clinical Practice Guidelines Dec/2011 Ministry of Health, Singapore College of Medicine Building 16 College Road Singapore 169854 TEL (65) 6325 9220 FAX (65) 6224 1677 WEB www.moh.gov.sg ISBN 978-981-08-9904-2 College of Family Physicians Singapore Singapore Medical Association Pharmaceutical Society of Singapore Society for Emergency Medicine in Singapore Toxicology Society (Singapore) Singapore Paediatric Society Chapter of Emergency (...) should be consulted (pg 55). GPP D Prolonged resuscitation should be attempted in drug-induced cardiac arrest (pg 55). Grade D, Level 3 C Titrated doses of naloxone, together with bag-valve-mask ventilation, should be administered for suspected opioid-induced coma, prior to intubation for respiratory insuf? ciency (pg 56). Grade C, Level 2+ D In bradycardia due to calcium channel or beta-blocker toxicity that is refractory to conventional vasopressor therapy, intravenous calcium, glucagon or insulin

2020 Ministry of Health, Singapore

4. Update of recommendations on first- and second-line antiretroviral regimens

35 low- and middle-income countries have started procurement; many are expecting to receive their first shipments of DTG- containing formulations from generic manufacturers. The risk of drugdrug interactions is low, but DTG cannot be used with certain anticonvulsants (such as phenytoin and phenobarbital) and should not be co-administered with cation-containing antacids (such as calcium and magnesium), laxatives and multivitamin supplements because of the risk of chelation resulting (...) with TB (4–6). These guidelines provide further reassurance of DTG as the preferred antiretroviral (ARV) drug in first- and second-line regimens due to the declining estimate of neural tube defect risk and observed efficacy. This reassurance comes at a time when pretreatment resistance to non-nucleoside reverse-transcriptase inhibitors (NNRTI) is increasing in low- and middle-income countries, creating demand for access to alternative non-NNRTI ARV drugs (7) (Box 1). Box 1. Recommendations: first

2019 World Health Organisation HIV Guidelines

5. Updated recommendations on first-line and second-line antiretroviral regimens and post-exposure prophylaxis and recommendations on early infant diagnosis of HIV

Background 37 4.2 Supporting evidence 38 4.3 Implementation considerations 39 4.4 Research gaps 39 5. Early infant diagnosis 40 5.1 Background 40 5.2 Supporting evidence 40 5.3 Rationale for the recommendation 41 5.4 Implementation considerations 43 5.5 Research gaps 43 6. Plans for updating, dissemination and evaluation 44 References 45 Annexes 52 Annex 1. Methods for developing the guidelines 53 Annex 2. Drug toxicity and drugdrug interactions of ARV drugs 57 Annex 3. Dosages of ARV drugs 61 Annex 4 (...) feeding WHO/CDS/HIV/18.26 Web Annex D. Surveys of values and preferences WHO/CDS/HIV/18.27 Web Annex E. Recommendations for use of hormonal contraception for women living with HIV using antiretroviral therapy WHO/CDS/HIV/18.28 Web Annex F. Systematic review of which ART regimen to switch to when failing first-line treatment WHO/CDS/HIV/18.29 Web Annex G. Systematic review of the safety and efficacy of antiretroviral drugs for post-exposure prophylaxis WHO/CDS/HIV/18.30 Web Annex H. Indeterminate

2019 World Health Organisation HIV Guidelines

6. Safe provision of anaesthesia in magnetic resonance units

or the intervention. In addition, the magnetic ?eld strengths that are in routine use have increased, and more patients are now scanned with active implanted medical devices such as neurostimulators, pacemakers and drug pumps, which adds to the challenges for the anaesthetic team. The combination of a continuous strong magnetic ?eld, reduced patient access and a site frequently remote from the operating theatre suite means that these cases are complex; clearly established guidelines and risk management processes (...) in patients with a pacemaker or de?brillator. New England Journal of Medicine 2017; 376: 755–64. 14. Zikria JF, Machnicki S, Rhim E, Bhatti T, Graham RE. MRI of patients with cardiac pacemakers: a review of the medical literature. American Journal of Roentgenology 2011; 196: 390–401. 15. Kanal E, Barkovich AJ, Bell C, et al. ACR guidance document for safe MR practices. American Journal of Roentgenology 2007;188:1447–74. 16. Shellock FG, Wilson SF, Mauge CP. Magnetically programmable shunt valve: MRI at 3

2019 Association of Anaesthetists of GB and Ireland

7. Trientine tetrahydrochloride (Cuprior) - Hepatolenticular Degeneration

intolerant of D-Penicillamine therapy. Cuprior was designated as an orphan medicinal product EU/3/15/1471 on 19 March 2015. Cuprior was designated as an orphan medicinal product in the following indication: Treatment of Wilson’s disease. The ground of the ODD at the time of designation was the lack of availability of the Reference Medicinal Product in the EU, resulting in an unmet medical need for the patients in the community. Following the CHMP positive opinion on this marketing authorisation (...) of the dose found in rat urine. In vivo and in vitro investigations into the mechanism of renal excretion of trientine indicated a specific, active excretion system for trientine. Trientine is not recognised by the H+/organic cation transporter, but a Na+/spermine antiporter on the renal brush-border membrane contributes to the secretion of trientine in the renal proximal tubule, but does not recognise the trientine-copper complex. The effect of drug interactions on urinary excretion of trientine in rat

2017 European Medicines Agency - EPARs

8. 2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease

Atherosclerosis in Other Arterial Beds (Coronary, Carotid, and Renal Arteries)? ? ? ? ? ? e740 5? Medical Therapy for the Patient With PAD ? ? ? ? ? ? ? ? e740 5?1? Antiplatelet Agents: Recommendations? ? ? ? ? ? e741 5?2? Statin Agents: Recommendation ? ? ? ? ? ? ? ? ? ? e742 5?3? Antihypertensive Agents: Recommendations ??? e742 5?4? Smoking Cessation: Recommendations ? ? ? ? ? e743 5?5? Glycemic Control: Recommendations ? ? ? ? ? ? ? e743 5?6? Oral Anticoagulation: Recommendations? ? ? ? ? e744 5?7 (...) ? Cilostazol: Recommendation ? ? ? ? ? ? ? ? ? ? ? ? ? e744 5?8? Pentoxifylline: Recommendation ? ? ? ? ? ? ? ? ? ? ? e745 5?9? Chelation Therapy: Recommendation ? ? ? ? ? ? ? e745 5?10? Homocysteine Lowering: Recommendation??? e745 5?11? Influenza Vaccination: Recommendation ? ? ? ? e745 6? Structured Exercise Therapy: Recommendations ? ? ? e745 7? Minimizing Tissue Loss in Patients With PAD: Recommendations ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? e747 8? Revascularization for Claudication

2017 American Heart Association

9. Dutrebis - lamivudine / raltegravir potassium

image GC Gas chromatography HAART Highly active antiretroviral therapy HDPE High density polyethylene HIV Human Immunodeficiency Virus HPLC High Performance Liquid Chromatography ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use IR Infrared Medicinal product no longer authorised EMA/154027/2015 Page 5/72 IsTI Integrase strand transfer inhibitor KF Karl Fischer titration LAM Lamivudine NIR Near Infrared Spectroscopy NMR Nuclear (...) , and P260, one each for the US, EU, and Canada, respectively, using locally-sourced lamivudine), one FMI food effect study (P254), and one drug-drug interaction study (P214). Medicinal product no longer authorised EMA/154027/2015 Page 20/72 GCP The Clinical trials were performed in accordance with GCP as claimed by the applicant. The applicant has provided a statement to the effect that clinical trials conducted outside the community were carried out in accordance with the ethical standards of Directive

2015 European Medicines Agency - EPARs

10. Measurement of Reactive Oxygen Species, Reactive Nitrogen Species, and Redox-Dependent Signaling in the Cardiovascular System

or RNS accumulation. Despite extensive data implicating oxidative stress in animal models of cardiovascular disease and dysfunction, there is still no conclusive evidence that ROS/RNS are fundamentally involved in the pathogenesis of cardiovascular disease in humans, and there is a paucity of convincing evidence that antioxidants are effective therapies in cardiovascular medicine. Yet the belief remains that oxidative stress contributes to many cardiovascular pathologies. Putative reasons (...) biomarkers have been used to study human oxidative stress, many of these assays are used inappropriately or without due experimental diligence, resulting in potential inaccuracies and artifacts, as well as much confusion in the literature. Moreover, the cardiovascular researcher who is a novice in the field of free radical biology may be overwhelmed in choosing from the many tools and methods currently available to measure ROS, RNS, and oxidative stress. Objectives The purpose of this scientific

2016 American Heart Association

11. Current Diagnostic and Treatment Strategies for Specific Dilated Cardiomyopathies: A Scientific Statement From the American Heart Association Full Text available with Trip Pro

hypertension usually precedes the development of HF with anti–vascular en- dothelial growth factor medications; it is also generally acknowledged that if blood pressure is well controlled with antihypertensive drugs, the risk of HF is low with anti–vascular endothelial growth factor therapy. Several other newer classes of medications for the treatment of cancer are in development; at this time, there are not enough data to clearly implicate them as causing cardiomyopathy, but with expanded clinical use (...) there is truly a difference in re- sponse to treatment according to pathogenesis of HF. Currently, it is accepted that guideline-directed medical and device therapies, including implantable cardioverter- defibrillator (ICD) and cardiac resynchronization therapy (CRT) for HF, are beneficial in DCM. 1 DIAGNoSTIC AND TrEATMENT STrATEGIES for SpECIfIC C ArDIoMyop AThIES In the following sections, diagnostic and treatment strat- egies for specific cardiomyopathies such as cardiac amyloidosis, cardiotoxins

2016 American Heart Association

12. Lower Extremity Peripheral Artery Disease: Guideline on the Management of Patients With

to demonstrate that screening all patients with PAD for asymptomatic atherosclerosis in other arterial beds improves clinical outcome. Intensive treatment of risk factors through GDMT is the principle method for preventing adverse cardiovascular ischemic events from asymptomatic dis- ease in other arterial beds. 5. MEDICAL THERAPY FOR THE PATIENT WITH PAD Patients with PAD should receive a comprehensive program of GDMT, including structured exercise and lifestyle modi?cation, to reduce cardiovascular (...) 5.8. Pentoxifylline: Recommendation .. e92 5.9. Chelation Therapy: Recommendation .. e92 5.10. Homocysteine Lowering: Recommendation .. .. e92 5.11. In?uenza Vaccination: Recommendation .. e93 6.STRUCTURED EXERCISE THERAPY: RECOMMENDATIONS e93 7.MINIMIZING TISSUE LOSS IN PATIENTS WITH PAD: RECOMMENDATIONS .. e95 8.REVASCULARIZATION FOR CLAUDICATION e96 8.1. Revascularization for Claudication: Recommendation ... .. e96 8.1.1. Endovascular Revascularization for Claudication: Recommendations ... e97

2016 American College of Cardiology

13. The 2016 International Society for Heart Lung Transplantation listing criteria for heart transplantation: A 10-year update

comment on cardiac resynchro- nization therapy (CRT) devices. Recommendation:ThepresenceofaCRTdevicedoes not alter the current peak volume of oxygen consump- tion (VO 2 ) cutoff recommendations (Class I, Level of Evidence: B). Evidence from the Comparison of Medical Therapy, Pacing, and De?brillation in Heart Failure (COMPANION) trial has shown that despite improvements in New York Heart Association Functional Classi?cation or 6-minute walk test distance, CRT did not have an effect (...) a minority among all HT recipients, the proportion ofpatientswithRCMreceivingHThassteadilyincreased,from 0.7% in the early 1990s to 2.2% in the early 2000s. 45 As opposed to heart failure secondary to DCM, no medicalordevicetherapyhasproventoimproveoutcomein patients with RCM. In addition, symptomatic therapy is often poorly effective because RCM patients are prone to digoxin toxicity, hypotension occurs frequently with vaso- dilators, and diuretic medications often result in prerenal azotemia due

2016 International Society for Heart and Lung Transplantation

14. Pediatric Pulmonary Hypertension: ATS/AHA Clinical Practice Guidelines

of new drug therapies, long-term outcomes for children with severe PAH remain poor. As in adult PAH, IPAH in pediatric patients can be devastating and often contributes to poor out- comes. 1 Unfortunately, whereas the adult PAH literature is a robust with several treatment guidelines, few studies specifi- cally address the safety and efficacy of therapies in children, and there are no treatment guidelines. Indeed, most studies of potential PAH therapeutics have focused on adults and, because (...) , evaluation, and therapies for PH in diverse settings. This approach included an extensive search performed by medical librarians with experience in perform- ing literature searches for previous guidelines task forces (Rosalind Dudden and her staff at the National Jewish Center, Denver, CO). Comprehensive literature reviews were per- formed with PubMed and Ovid Medline and made available through a common task force Web site. Standard search terms such as pulmonary hypertension and pediatric pulmonary

2015 American Thoracic Society

15. Pediatric Pulmonary Hypertension Full Text available with Trip Pro

LFTs required due to risk for hepatotoxicity HCG and pregnancy test required monthly Incidence of AST/ALT elevation is less in children compared with adults Fluid retention Teratogenicity Male infertility May decrease sildenafil level COR I LOE B Data have been published on efficacy in Eisenmenger PH 2 Forms of birth control required Drug interaction with sildenafil ERA Ambrisentan (a highly selective ET A antagonist) Dose range: 5–10 mg orally daily Use in pediatric patients 150 ng·kg -1 ·min -1 (...) to qualify as PH (Table 1). PH and related PVD cause significant morbidity and mor - tality in diverse childhood diseases. Despite the availability of new drug therapies, long-term outcomes for children with severe PAH remain poor. As in adult PAH, IPAH in pediatric patients can be devastating and often contributes to poor out- comes. 1 Unfortunately, whereas the adult PAH literature is a robust with several treatment guidelines, few studies specifi- cally address the safety and efficacy of therapies

2015 American Heart Association

16. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer

regarding the initial management of thyroid cancer include those relating to screening for thyroid cancer, staging and risk assessment, surgical management, radioiodine remnant ablation and therapy, and thyrotropin suppression therapy using levothyroxine. Recommendations related to long-term management 1 University of Colorado School of Medicine, Aurora, Colorado. 2 Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts. 3 The Mayo Clinic, Rochester, Minnesota. 4 Boston Medical (...) Center, Boston, Massachusetts. 5 Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania. 6 University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. 7 The University of Siena, Siena, Italy. 8 Massachusetts Eye and Ear In?rmary, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts. 9 University Health Network, University of Toronto, Toronto, Ontario, Canada. 10 Institute Gustave Roussy and University Paris Sud, Villejuif, France. 11 Oregon

2015 Pediatric Endocrine Society

17. Guidelines for the treatment of malaria. Third edition

Assessment, Development and Evaluation (GRADE) for assessing the quality of evidence 145 Annex 5 | Pharmacology of antimalarial drugs 205 Annex 6 | T reatment o f Plasmodium vivax, P. ovale, P. malariae and P. knowlesi infections 285 Annex 7 | Resistance to antimalarial medicines 299Glossary Artemisinin-based combination therapy (ACT). A combination of an artemisinin derivative with a longer-acting antimalarial that has a different mode of action. Asexual cycle. The life cycle of the malaria parasite (...) randomized trials or in extensive deployment. 4 | Treatment of uncomplicated Plasmodium falciparum malaria 40 Guidelines for the treatment of malaria 3 RD EDITION4.4 | RECURRENT FALCIPARUM MALARIA Recurrence of P. falciparum malaria can result from re-infection or recrudescence (treatment failure). Treatment failure may result from drug resistance or inadequate exposure to the drug due to sub-optimal dosing, poor adherence, vomiting, unusual pharmacokinetics in an individual or substandard medicines

2015 World Health Organisation Guidelines

18. Vitekta - elvitegravir

and COBI. GS-US-216-0120 and -0122 evaluated the effect of acid-reducing agents on EVG and EVG/COBI. QUAD STR GS-US-236-0106 evaluated the drug-drug interaction of the QUAD STR and hormonal contraceptives. Special Populations EVG and COBI GS-US-183-0133 evaluated the PK of EVG/COBI in subjects with moderate hepatic impairment. GS-US-216-0124 evaluated the PK of EVG/COBI in subjects with varying degrees of renal impairment. Medicinal product no longer authorised Assessment report EMA/701401/2013 Page 24 (...) and with the PIs proposed for co- administration In addition, results of A Phase 1 Study Evaluating the Drug Interaction Potential Between Once-Daily Cobicistat-Boosted Elvitegravir and Methadone or Buprenorphine/Naloxone (GS-US-216-0125) were provided. Medicinal product no longer authorised Assessment report EMA/701401/2013 Page 25/97 Table 4. Tabular Summary of Phase 2 and 3 Clinical Studies Study Number Study Objective(s) Design Study and Control Drug Regimens Duration of Treatment Number of Subjects

2013 European Medicines Agency - EPARs

19. Stribild - elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil

, suppression of HIV RNA to 10%) human metabolites. The intended pharmacokinetic drug interaction of inhibition of the CYP3A dependent metabolism of EVG by COBI has been studied extensively in vitro and in humans in vivo. In the rat, following co-administration with COBI at 30 mg/kg/day, exposures to EVG (AUC) were increased in males (when compared to that observed when EVG was administered alone) on Day 1. The effect was less pronounced in females due to the lower contribution of CYP3A to EVG metabolism (...) . Non-clinical and clinical data suggest that COBI is a relatively selective inhibitor and has a low potential to be an inducer in man. The metabolites of COBI are weaker inhibitors of CYP3A compared to COBI and due to their low systemic concentrations should not contribute to the primary pharmacodynamic effect of CYP3A inhibition. Neither FTC nor TDF interact with drug metabolizing enzymes as substrates, inhibitors, Assessment report EMA/332263/2013 Page 23/147 or inducers and that suggests

2013 European Medicines Agency - EPARs

20. Acute and Chronic Heart Failure

& Rehabilitation (EACPR), European Association of Echocardiography (EAE), European Heart Rhythm Association (EHRA), European Association of Percutaneous Cardiovascular Interventions (EAPCI) Working Groups: Acute Cardiac Care, Cardiovascular Pharmacology and Drug Therapy, Cardiovascular Surgery, Grown-up Congenital Heart Disease, Hypertension and the Heart, Myocardial and Pericardial Diseases, Pulmonary Circulation and Right Ventricular Function, Thrombosis, Valvular Heart Disease Councils: Cardiovascular (...) /526884 by guest on 02 April 2019CHA 2 DS 2 -VASc Cardiac failure, Hypertension, Age =75 (Doubled), Diabetes, Stroke (Doubled)-Vascular disease, Age 65–74 and Sex category (Female) CHARM Candesartan in Heart Failure: Assessment of Re- duction in Mortality and Morbidity CIBIS II Cardiac Insuf?ciency Bisoprolol Study II CMR cardiac magnetic resonance COMET Carvedilol or Metoprolol European Trial COMPANION Comparison of Medical Therapy, Pacing, and De- ?brillation in Heart Failure CONSENSUS Cooperative

2012 European Society of Cardiology

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