Second Edition Second Edition GUIDELINES for the TREATMENT of MALARIA
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Eurartesim, INN-Piperaquine & INN-Artenimol
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT Eurartesim 160 mg/20 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 160 mg piperaquine tetraphosphate (as the tetrahydrate; PQP) and 20 mg artenimol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). White oblong biconvex film-coated tablet (dimension 11.5x5.5mm / thickness 4.4mm) with a break-line and marked on one side with the letters “S” and “T”. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Eurartesim is indicated for the treatment of uncomplicated Plasmodium falciparum malaria in adults, adolescents, children and infants 6 months and over and weighing 5 kg or more. Consideration should be given to official guidance on the appropriate use of antimalarial medicinal products, including information on the prevalence of resistance to artenimol/piperaquine in the geographical region where the infection was acquired (see section 4.4). 4.2 Posology and method of administration Posology Eurartesim should be administered over three consecutive days for a total of three doses taken at the same time each day. 2 Dosing should be based on body weight as shown in the table below. Body weight Daily dose (mg) Tablet strength and number of tablets per dose (kg) PQP Artenimol 5 to <7 80 10 ½ x 160 mg / 20 mg tablet 7 to <13 160 20 1 x 160 mg / 20 mg tablet 13 to <24 320 40 1 x 320 mg / 40 mg tablet 24 to <36 640 80 2 x 320 mg / 40 mg tablets 36 to <75 960 120 3 x 320 mg / 40 mg tablets > 75* 1,280 160 4 x 320 mg / 40 mg tablets * see section 5.1 If a patient vomits within 30 minutes of taking Eurartesim, the whole dose should be re-administered; if a patient vomits within 30-60 minutes, half the dose should be re-administered. -
Taking Artemisinin to Clinical Anticancer Applications: Design, Synthesis and Characterization
Taking Artemisinin to Clinical Anticancer Applications: Design, Synthesis and Characterization of pH-responsive Artemisinin Dimer Derivatives in Lipid Nanoparticles Yitong Zhang A dissertation submitted in partial fulfillment of the requirements for the degree of Doctor of Philosophy University of Washington 2015 Reading Committee: Tomikazu Sasaki, Chair Rodney J.Y. Ho Champak Chatterjee Program Authorized to Offer Degree: Chemistry i ©Copyright 2015 Yitong Zhang ii University of Washington Abstract Taking Artemisinin to Clinical Anticancer Applications: Design, Synthesis and Characterization of pH-responsive Artemisinin Dimer Derivatives in Lipid Nanoparticles Yitong Zhang Chair of the Supervisory Committee: Professor Tomikazu Sasaki Chemistry iii Abstract Qinghaosu or Artemisinin is an active sesquiterpene lactone isolated from Artemisia annua L. The natural product and its derivatives are known as a first line treatment for malaria. Investigations have also reported that the compound exhibits anti-cancer activities both on cell lines and in animal models. The remarkably stable endoperoxide bridge under ambient conditions is believed to be responsible for the selectivity as well as potency against cells that are rich in iron content. Dimeric derivatives where two artemisinin units are covalently bonded through lactone carbon (C10) show superior efficacies against both malaria parasites and cancer cells. Artemisinin dimer succinate derivative demonstrates a 100-fold enhancement in potency, compared to the natural product, with IC50 values in the low micromolar range. This work focuses on the development of artemisinin dimer derivatives to facilitate their clinical development. Novel pH-responsive artemisinin dimers were synthesized to enhance the aqueous solubility of the pharmacophore motif. Compounds with promising potency against human breast cancer cell lines were selected for lipid and protein based nanoparticle formulations for delivery of the derivatives without the need of organic co-solvents into animal models. -
Artemisinin Resistance: Current Status and Scenarios for Containment
REVIEWS Artemisinin resistance: current status and scenarios for containment Arjen M. Dondorp*‡, Shunmay Yeung*§, Lisa White*‡, Chea Nguon§, Nicholas P.J. Day*‡, Duong Socheat§|| and Lorenz von Seidlein*¶ Abstract | Artemisinin combination therapies are the first-line treatments for uncomplicated Plasmodium falciparum malaria in most malaria-endemic countries. Recently, partial artemisinin-resistant P. falciparum malaria has emerged on the Cambodia–Thailand border. Exposure of the parasite population to artemisinin monotherapies in subtherapeutic doses for over 30 years, and the availability of substandard artemisinins, have probably been the main driving force in the selection of the resistant phenotype in the region. A multifaceted containment programme has recently been launched, including early diagnosis and appropriate treatment, decreasing drug pressure, optimising vector control, targeting the mobile population, strengthening management and surveillance systems, and operational research. Mathematical modelling can be a useful tool to evaluate possible strategies for containment. Parenteral In nearly all countries in which malaria is endemic, antimalarial properties (artemisinin) was identified, and Administered by injection. artemisinin combination therapies (ACT) are now the several more potent derivatives were synthesized, includ- recommended first-line therapy for uncomplicated ing artesunate, artemether and dihydroartemisinin11 Plasmodium falciparum malaria, a policy endorsed by (FIG. 1). Artemisinin derivatives have an excellent safety the WHO1. This change in policy followed a period profile in the treatment of malaria, a rapid onset of action of increasing failure rates with chloroquine and later and are active against the broadest range of stages in the sulphadoxine–pyrimethamine treatment, which arose life cycle of Plasmodium spp. compared with other anti- from the development of resistant P. -
Despite Improvements, COVID-19'S Health Care Disruptions Persist
News & Analysis Global Health More Comprehensive Care Drug-Resistant Malaria Detected for Miscarriage Needed Worldwide in Africa Will Require Monitoring About 1 in 10 women will have a miscar- Evidence in Africa that the malaria parasite riage over a lifetime—a statistic that repre- Plasmodium falciparum has developed sents 23 million pregnancies lost annually, genetic variants that confer partial resis- or 44 per minute worldwide, according to tance to the antimalarial drug artemisinin is a series of articles in The Lancet. Despite a warning of potential treatment failure on the magnitude, the articles described mis- the horizon, a drug-resistance monitoring carriage as a misunderstood phenomenon study suggested. and called for more comprehensive care to Partial resistance to artemisinin, the cur- prevent and treat miscarriage. rent frontline treatment for malaria, first The 15% of pregnancies that end in a emerged in Cambodia in 2008 and has be- miscarriage can be attributed to risk fac- come common in Southeast Asia, the au- tors including age during pregnancy, smok- thors wrote. Artemisinin is a fast-acting drug ing, stress, air pollution, and exposure to that typically clears the parasite within 3 pesticides, 1 of the studies reported. For days. It’s usually combined with a longer- Miscarriage is a misunderstood phenomenon, repeated miscarriages, which affect about acting drug to kill any remaining parasites. according to a recent series of articles. 2% of women, another study indicated When artemisinin resistance emerged in that progesterone could increase live-birth Asia, resistance to the combination therapy rates and that levothyroxine may decrease soon followed. 2020 when half of essential services had the risk of miscarriage for women with The current study was part of routine been interrupted. -
NINDS Custom Collection II
ACACETIN ACEBUTOLOL HYDROCHLORIDE ACECLIDINE HYDROCHLORIDE ACEMETACIN ACETAMINOPHEN ACETAMINOSALOL ACETANILIDE ACETARSOL ACETAZOLAMIDE ACETOHYDROXAMIC ACID ACETRIAZOIC ACID ACETYL TYROSINE ETHYL ESTER ACETYLCARNITINE ACETYLCHOLINE ACETYLCYSTEINE ACETYLGLUCOSAMINE ACETYLGLUTAMIC ACID ACETYL-L-LEUCINE ACETYLPHENYLALANINE ACETYLSEROTONIN ACETYLTRYPTOPHAN ACEXAMIC ACID ACIVICIN ACLACINOMYCIN A1 ACONITINE ACRIFLAVINIUM HYDROCHLORIDE ACRISORCIN ACTINONIN ACYCLOVIR ADENOSINE PHOSPHATE ADENOSINE ADRENALINE BITARTRATE AESCULIN AJMALINE AKLAVINE HYDROCHLORIDE ALANYL-dl-LEUCINE ALANYL-dl-PHENYLALANINE ALAPROCLATE ALBENDAZOLE ALBUTEROL ALEXIDINE HYDROCHLORIDE ALLANTOIN ALLOPURINOL ALMOTRIPTAN ALOIN ALPRENOLOL ALTRETAMINE ALVERINE CITRATE AMANTADINE HYDROCHLORIDE AMBROXOL HYDROCHLORIDE AMCINONIDE AMIKACIN SULFATE AMILORIDE HYDROCHLORIDE 3-AMINOBENZAMIDE gamma-AMINOBUTYRIC ACID AMINOCAPROIC ACID N- (2-AMINOETHYL)-4-CHLOROBENZAMIDE (RO-16-6491) AMINOGLUTETHIMIDE AMINOHIPPURIC ACID AMINOHYDROXYBUTYRIC ACID AMINOLEVULINIC ACID HYDROCHLORIDE AMINOPHENAZONE 3-AMINOPROPANESULPHONIC ACID AMINOPYRIDINE 9-AMINO-1,2,3,4-TETRAHYDROACRIDINE HYDROCHLORIDE AMINOTHIAZOLE AMIODARONE HYDROCHLORIDE AMIPRILOSE AMITRIPTYLINE HYDROCHLORIDE AMLODIPINE BESYLATE AMODIAQUINE DIHYDROCHLORIDE AMOXEPINE AMOXICILLIN AMPICILLIN SODIUM AMPROLIUM AMRINONE AMYGDALIN ANABASAMINE HYDROCHLORIDE ANABASINE HYDROCHLORIDE ANCITABINE HYDROCHLORIDE ANDROSTERONE SODIUM SULFATE ANIRACETAM ANISINDIONE ANISODAMINE ANISOMYCIN ANTAZOLINE PHOSPHATE ANTHRALIN ANTIMYCIN A (A1 shown) ANTIPYRINE APHYLLIC -
Dihydropteroate Synthase Gene Mutations in Pneumocystis
Dihydropteroate Synthase Gene Mutations in Pneumocystis and Sulfa Resistance Laurence Huang,* Kristina Crothers,* Chiara Atzori,† Thomas Benfield,‡ Robert Miller,§ Meja Rabodonirina,¶ and Jannik Helweg-Larsen# Pneumocystis pneumonia (PCP) remains a major Patients who are not receiving regular medical care, as cause of illness and death in HIV-infected persons. Sulfa well as those who are not receiving or responding to anti- drugs, trimethoprim-sulfamethoxazole (TMP-SMX), and retroviral therapy or prophylaxis, are also at increased risk dapsone are mainstays of PCP treatment and prophylaxis. for PCP (2). PCP may also develop in other immunosup- While prophylaxis has reduced the incidence of PCP, its pressed populations, such as cancer patients and transplant use has raised concerns about development of resistant organisms. The inability to culture human Pneumocystis, recipients. Furthermore, PCP remains a leading cause of Pneumocystis jirovecii, in a standardized culture system death among critically ill patients, despite advances in prevents routine susceptibility testing and detection of drug treatment and management (3). resistance. In other microorganisms, sulfa drug resistance The first-line treatment and prophylaxis regimen for has resulted from specific point mutations in the dihy- PCP is trimethoprim-sulfamethoxazole (TMP-SMX) (4). dropteroate synthase (DHPS) gene. Similar mutations While prophylaxis has been shown to reduce the incidence have been observed in P. jirovecii. Studies have consistent- of PCP, the widespread and long-term use of TMP-SMX in ly demonstrated a significant association between the use HIV patients has raised concerns regarding the develop- of sulfa drugs for PCP prophylaxis and DHPS gene muta- ment of resistant organisms. Even short-term exposure to tions. -
New Aspects of Human Trichinellosis: the Impact of New Trichinella Species F Bruschi, K D Murrell
15 REVIEW Postgrad Med J: first published as 10.1136/pmj.78.915.15 on 1 January 2002. Downloaded from New aspects of human trichinellosis: the impact of new Trichinella species F Bruschi, K D Murrell ............................................................................................................................. Postgrad Med J 2002;78:15–22 Trichinellosis is a re-emerging zoonosis and more on anti-inflammatory drugs and antihelminthics clinical awareness is needed. In particular, the such as mebendazole and albendazole; the use of these drugs is now aided by greater clinical description of new Trichinella species such as T papuae experience with trichinellosis associated with the and T murrelli and the occurrence of human cases increased number of outbreaks. caused by T pseudospiralis, until very recently thought to The description of new Trichinella species, such as T murrelli and T papuae, as well as the occur only in animals, requires changes in our handling occurrence of outbreaks caused by species not of clinical trichinellosis, because existing knowledge is previously recognised as infective for humans, based mostly on cases due to classical T spiralis such as T pseudospiralis, now render the clinical picture of trichinellosis potentially more compli- infection. The aim of the present review is to integrate cated. Clinicians and particularly infectious dis- the experiences derived from different outbreaks around ease specialists should consider the issues dis- the world, caused by different Trichinella species, in cussed in this review when making a diagnosis and choosing treatment. order to provide a more comprehensive approach to diagnosis and treatment. SYSTEMATICS .......................................................................... Trichinellosis results from infection by a parasitic nematode belonging to the genus trichinella. -
Drug Name Plate Number Well Location % Inhibition, Screen Axitinib 1 1 20 Gefitinib (ZD1839) 1 2 70 Sorafenib Tosylate 1 3 21 Cr
Drug Name Plate Number Well Location % Inhibition, Screen Axitinib 1 1 20 Gefitinib (ZD1839) 1 2 70 Sorafenib Tosylate 1 3 21 Crizotinib (PF-02341066) 1 4 55 Docetaxel 1 5 98 Anastrozole 1 6 25 Cladribine 1 7 23 Methotrexate 1 8 -187 Letrozole 1 9 65 Entecavir Hydrate 1 10 48 Roxadustat (FG-4592) 1 11 19 Imatinib Mesylate (STI571) 1 12 0 Sunitinib Malate 1 13 34 Vismodegib (GDC-0449) 1 14 64 Paclitaxel 1 15 89 Aprepitant 1 16 94 Decitabine 1 17 -79 Bendamustine HCl 1 18 19 Temozolomide 1 19 -111 Nepafenac 1 20 24 Nintedanib (BIBF 1120) 1 21 -43 Lapatinib (GW-572016) Ditosylate 1 22 88 Temsirolimus (CCI-779, NSC 683864) 1 23 96 Belinostat (PXD101) 1 24 46 Capecitabine 1 25 19 Bicalutamide 1 26 83 Dutasteride 1 27 68 Epirubicin HCl 1 28 -59 Tamoxifen 1 29 30 Rufinamide 1 30 96 Afatinib (BIBW2992) 1 31 -54 Lenalidomide (CC-5013) 1 32 19 Vorinostat (SAHA, MK0683) 1 33 38 Rucaparib (AG-014699,PF-01367338) phosphate1 34 14 Lenvatinib (E7080) 1 35 80 Fulvestrant 1 36 76 Melatonin 1 37 15 Etoposide 1 38 -69 Vincristine sulfate 1 39 61 Posaconazole 1 40 97 Bortezomib (PS-341) 1 41 71 Panobinostat (LBH589) 1 42 41 Entinostat (MS-275) 1 43 26 Cabozantinib (XL184, BMS-907351) 1 44 79 Valproic acid sodium salt (Sodium valproate) 1 45 7 Raltitrexed 1 46 39 Bisoprolol fumarate 1 47 -23 Raloxifene HCl 1 48 97 Agomelatine 1 49 35 Prasugrel 1 50 -24 Bosutinib (SKI-606) 1 51 85 Nilotinib (AMN-107) 1 52 99 Enzastaurin (LY317615) 1 53 -12 Everolimus (RAD001) 1 54 94 Regorafenib (BAY 73-4506) 1 55 24 Thalidomide 1 56 40 Tivozanib (AV-951) 1 57 86 Fludarabine -
Cyclosporiasis: an Update
Cyclosporiasis: An Update Cirle Alcantara Warren, MD Corresponding author Epidemiology Cirle Alcantara Warren, MD Cyclosporiasis has been reported in three epidemiologic Center for Global Health, Division of Infectious Diseases and settings: sporadic cases among local residents in an International Health, University of Virginia School of Medicine, MR4 Building, Room 3134, Lane Road, Charlottesville, VA 22908, USA. endemic area, travelers to or expatriates in an endemic E-mail: [email protected] area, and food- or water-borne outbreaks in a nonendemic Current Infectious Disease Reports 2009, 11:108–112 area. In tropical and subtropical countries (especially Current Medicine Group LLC ISSN 1523-3847 Haiti, Guatemala, Peru, and Nepal) where C. cayetanen- Copyright © 2009 by Current Medicine Group LLC sis infection is endemic, attack rates appear higher in the nonimmune population (ie, travelers, expatriates, and immunocompromised individuals). Cyclosporiasis was a Cyclosporiasis is a food- and water-borne infection leading cause of persistent diarrhea among travelers to that affects healthy and immunocompromised indi- Nepal in spring and summer and continues to be reported viduals. Awareness of the disease has increased, and among travelers in Latin America and Southeast Asia outbreaks continue to be reported among vulnera- [8–10]. Almost half (14/29) the investigated Dutch attend- ble hosts and now among local residents in endemic ees of a scientifi c meeting of microbiologists held in 2001 areas. Advances in molecular techniques have in Indonesia had C. cayetanensis in stool, confi rmed by improved identifi cation of infection, but detecting microscopy and/or polymerase chain reaction (PCR), and food and water contamination remains diffi cult. -
The Safety and Effectiveness of Single Dose Primaquine As a P
Malaria Policy Advisory Committee Meeting 11-13 September 2012, WHO HQ Session 5 WHO Evidence Review Group: The Safety and Effectiveness of Single Dose Primaquine as a P. falciparum gametocytocide Pullman Hotel, Bangkok, Thailand, 13-15 August 2012 Meeting Report Background Deployed since the early 1950s primaquine is the most Glossary: widely used 8-aminoquinoline antimalarial drug. It has been used extensively in the radical treatment of P. vivax G6PD: Glucose-6-phosphate dehydrogenase and P. ovale malaria, and as a single dose G6PDd: G6PD deficient gametocytocide in falciparum malaria. The main limitation to its use has been haemolytic toxicity. The 8- AHA: Acute haemolytic anaemia aminoquinoline antimalarials produce dose dependent acute haemolytic anaemia (AHA) in individuals who have ACT: Artemisinin combination treatment G6PD deficiency, an inherited X-linked abnormality. The MDA: Mass drug administration prevalence of the underlying allelic genes for G6PD deficiency varies typically between 5 and 32.5 % in POC: Point of care malaria endemic areas of Asia and Africa. Use of primaquine as a gametocytocide has great potential to reduce the transmission of falciparum malaria in low transmission settings, and in particular to help contain the spread of artemisinin resistant falciparum malaria in SouthEast Asia. The World Health Organisation currently recommends addition of primaquine 0.75 mg base/kg (adult dose 45 mg) to treatment regimens for P. falciparum malaria in areas of low transmission, particularly in areas where artemisinin resistant falciparum malaria is a threat, “when the risk for G6PD deficiency is considered low or testing for deficiency is available”. Unfortunately there is often uncertainty about the prevalence and severity of G6PD deficiency, and testing for it is usually not available in these areas. -
A Suitable RNA Preparation Methodology for Whole Transcriptome Shotgun Sequencing Harvested from Plasmodium Vivax‑Infected Patients Catarina Bourgard1, Stefanie C
www.nature.com/scientificreports OPEN A suitable RNA preparation methodology for whole transcriptome shotgun sequencing harvested from Plasmodium vivax‑infected patients Catarina Bourgard1, Stefanie C. P. Lopes2,3, Marcus V. G. Lacerda2,3, Letusa Albrecht1,4* & Fabio T. M. Costa1* Plasmodium vivax is a world‑threatening human malaria parasite, whose biology remains elusive. The unavailability of in vitro culture, and the difculties in getting a high number of pure parasites makes RNA isolation in quantity and quality a challenge. Here, a methodological outline for RNA‑ seq from P. vivax isolates with low parasitemia is presented, combining parasite maturation and enrichment with efcient RNA extraction, yielding ~ 100 pg.µL−1 of RNA, suitable for SMART‑Seq Ultra‑Low Input RNA library and Illumina sequencing. Unbiased coding transcriptome of ~ 4 M reads was achieved for four patient isolates with ~ 51% of transcripts mapped to the P. vivax P01 reference genome, presenting heterogeneous profles of expression among individual isolates. Amongst the most transcribed genes in all isolates, a parasite‑staged mixed repertoire of conserved parasite metabolic, membrane and exported proteins was observed. Still, a quarter of transcribed genes remain functionally uncharacterized. In parallel, a P. falciparum Brazilian isolate was also analyzed and 57% of its transcripts mapped against IT genome. Comparison of transcriptomes of the two species revealed a common trophozoite‑staged expression profle, with several homologous genes being expressed. Collectively, these results will positively impact vivax research improving knowledge of P. vivax biology. Plasmodium vivax is the most prevalent malaria parasite outside Sub-Saharan Africa, causing the most geographi- cally widespread type of malaria, placing millions of people at risk of infection 1. -
Evolution of Plasmodium Falciparum Drug Resistance: Implications for the Development and Containment of Artemisinin Resistance
Jpn. J. Infect. Dis., 65, 465-475, 2012 Invited Review Evolution of Plasmodium falciparum drug resistance: implications for the development and containment of artemisinin resistance Toshihiro Mita1,2* and Kazuyuki Tanabe3,4 1Department of Molecular and Cellular Parasitology, Juntendo University School of Medicine, Tokyo 113-8421; 2Department of International Affairs and Tropical Medicine, Tokyo Women's Medical University, Tokyo 162-8666; and 3Laboratory of Malariology and 4Department of Molecular Protozoology, Research Institute for Microbial Diseases, Osaka University, Osaka 565-0871, Japan (Received March 15, 2012) CONTENTS: 1. Introduction 5. Artemisinin combination therapies (ACTs) and 2. Life cycle of P. falciparum resistance to artemisinins 3. Mechanisms of P. falciparum resistance to conven- 5–1. Artemisinin derivatives tional antimalarial drugs 5–2. ACTs 3–1. Chloroquine 5–3. Resistance and reduced susceptibility to arte- 3–2. Pyrimethamine and sulfadoxine misinins 4. Geographical spread of resistance to conventional 6. The Thailand-Cambodia border and the contain- antimalarial drugs ment of artemisinin resistance 4–1. Chloroquine 6–1. Thailand-Cambodia border: epicenter of drug 4–2. Pyrimethamine resistance 4–3. Sulfadoxine 6–2. Resistance and the Greater Mekong 6–3. Implications for the containment of artemisi- nin resistance 7. Concluding remarks SUMMARY: Malaria is a protozoan disease transmitted by the bite of the Anopheles mosquito. Among five species that can infect humans, Plasmodium falciparum is responsible for the most severe human malaria. Resistance of P. falciparum to chloroquine and pyrimethamine/sulfadoxine, conventionally used antimalarial drugs, is already widely distributed in many endemic areas. As a result, artemisinin- based combination therapies have been rapidly and widely adopted as first-line antimalarial treatments since the mid-2000s.