1x8 Tablets 16 Tablets 69 ml Dey Suspension Artemex-E (Artemether & Lumefantrine) Anti-malarial DESCRIPTION ArtemexL DS/Porte tables 8 dry suspension isa new treatment of mala, Tes the feed combination fof Aremetzer Mciyether derisive of Aersni) & Lamefanrine (luorine derivative belonging ‘tuioalcool eas) ‘CoMPosITION: “ArtemerL. DS Tablets: Ancmetber Sh Spee 40 mg Lametactrine Shr sec 0 me ‘Arremer Forte Tablets ESTERS coi ‘Aemethe Sth es. fom umetatrne Spc “0 me Arteperd DS Bry Suspension: Bach ml contains Artemithes Sch Specs ‘Dimefastine Sch Spec uinicay,reanacovocy. shames ann ‘ecemen Done be depen sol pre Laem ae Heng Ons cosh cet (op ene) ire we eueeemdocreet dimmers He «erg ndperen sci oft hr pi of nee eo oft seca ear cee ters Seo Hooter ct oe and Lamelatrine combination also deare ly chan over conventional Ethalirial PHARMACOKINETICS: Absorption AArremther is absorbed quickly with peak plasma ‘concentration caching in about hour er doing, tse spon of Henle arte tens lagtime of wp so 2 hours, with peak plasms ‘oncentition in about ot hours ster dosing. Pood enhauces the absorptioa of Artemethes & Lomefaatrine, The Plative bioavailability of [Eamelantrine incretes sixteen fld compared with jntake on emoty stomach. High iat coatent Is conducive for absorption. Food has aso been shows, to ncreate The absorption of Lumelatsoe inpatients ‘vith malaria, Usoally sm aeutaly il patients here 2 {endeney of consuming low ft die. Absorption of [Eumefsaerine under fasting conditions i ery poor Patients should therefore be encouraged to ake the iediction with anormal diet at sage as food exa be terse Disribation ‘Anemether and Lamefunrine ae both highly bound to human serum proteins in vitro @3A ‘and 9.9%, respectively. Artemetberis wel diabetes throbs the body with some aint for the brown tn and ‘drezal lind, while Lumelanrine has an atin for ‘dipes eod andolar tse ad 2 some exteat for the longs splees (doe to slow eliminscion from iymphod Uae) and bone warvow: Metaboion: “Arce hers aid and acon maize in iniman liver microvomes so the biclopaly active tap eetbelite ydeontenaaain (met lason), Freee hohe ye ann CPA k cimelnirng i be meabetecd by CXPIAY nun et microsomes were uccrsadaton of Lumelaeiae kes place drcaycaher he oxduve ovansiorsation, Howeren Lesetanense nbs the cytochrome cnzyine CVFADE Elna ' ‘Kreme is apdly cared ivom pls with an diminaton laf of abou 2 hous. Lumefaatine Saints very dow’ wi achntaton bale SeEe'Tips in Daven wah falaperun melanie Bemogeaghic drastic sucht ser al weight open have wo cliealyeeleant effets onthe Pirtacokireis of Artmeher fe eselstring glance Ascaris: hen ete aes bnchan fd urge due to. te rapid ood gain pat tetabolimn, but several metabolites (unidented) Ee been detected iy oth faces ae une INDICATIONS: ‘Aremethee/Lumsfacineindicared forthe estment of uncomplicated P. falciparum malaria including, tnultfdrag eesiuant strate of. laleiparun, Thit Combination is av elective ogaipt the blood sage Of P, viva bur not active agri. Sypnozoites, ‘gee Lelie ms the mali be resistant to other antimalarial drogs, “World Health Organization recommends ‘Artemetber! Limefantine ar fist line treatment for the acute uncomplicated P altparum malaria for both muleidrug fesistant areas 6 drug sensitive ‘CONTRAINDICATIONS: ‘Srtemetber sed bamelarine ae contraindicated in Aone with kypervensitiity to the active mubsaness fr any of the cripcets aces with # family hincory of congenial Eth aby ether ciel condton kop to polo the Qe interval such st gatiens wit a himory of Symptomatic cardiac archythmisy, patients with litalyselevsr badyearea or with ever earise sci, Lamy hstory of sudden death starbanoes gl cleareiyte balance, eg bypokalsemin or Concomitant use of drugs that are known vo be tpetbolized by cytohtotie enayme CYPIDS (eg ficsinde, metoprolol, mpramin, amitriptyline, clomipramine) Daves takiag droge tha: are known to prolong the ‘Qe interval suc Ss aniaeehyramics of ls TA Se selena septa afer en fsatsbioncs including some ages of the follow Slee macrolide oregon inion and {tiazole anfungal agents, certain noe sedating at Ancmutier & Lemeantine tact hese Tor ya, or for treating severe mala, alin al malar, or mare wih pulmonary oedems fr veal fale es abo nor iadeted for aad bas nat viva F malariae of Pov DOSAGE AND ADMINISTRATION: acients with see malaria ate frequently averte 19 food. The dose may be encouraged resme normal ating a» soon a food ean be foleraed nace tis Improves absorption of Aremeher Lamefancne Inthe event of vornsing within T hour of sdministration a repeat dese should be taken ‘ES regimen shoul be given} dap tora tsstment ‘ire dows a theme of inal diagnose & then at 8 Be Desege according to body seigh: Artinee 2omg/ 126mg Tablet Sew Kee tae BLD for 3 aye Anemos DS 42 mg/240mg Tablets: ‘aus € over 35 Kqr? bles BLD for 3 days, 25K in 38Kg. 1s ables BD for 3 15 gto 24 Kg tablet BLD for 3 days AremexL Forte 80 mg/482mg Tablets: ‘A 03 Rp lee BED Tor ap ‘Take the tablet after meal with water or ill (preleratly al). Fo smal Oulton crush the rile fod, ber before giving withTake compete course of medicine otherwise ifection ‘Artemex-L DS Dry S spension: ‘Once daly for 3 days Body Weight (RD Dosage 57a Taal 15-95 Sat iin Tt Beis el IITA Deal 75-9 Wal (Or as dracted by the physician ADVERSE REACTIONS: Antemether/Lamelantrize combination is well tolerated by children Many ofthe reported events ie due to dseae rather than co drug. Common Adverse events feported wich arcemether and intel combos taal beatae, ines, sleep dsordse, abdominal psn, anorexia’ arth vomiting, nnbses, palpitation, cough, arthralgia, tnyalgar peor, rash, asthenia and atique Snokete, ivclastaiy muscle comtatias, fre other adveryeeflects with artemether and iumelanting combination. Rar adver ven included Iypersensiany PRECAUTIONS: Use with cxstion in patiemss with severe hepatie ot make Should becluelymonsora asthe nx of renaecesce inay be erewer fees on ability o dive and use machines: Driving and use of machinery snot commended duo 1k of denen ao aue/ ten USE IN PREGNANCY & LACTATION: Pregnancy: There is no adequate data from the use of Artemether/Lamslanirine in pregnant. women ‘Aremethner/Lametantsnetresttent should only be toasideved if the expected beneit to the mother buweigh the sk to he fous acttion ‘Artemether/Lumetantrine excrete nto breast mile 1n Showld not be taken by Breastfeeding women DRUG INTERACTIONS: Meflogun: The pretesiment with mellogs tlle on plana concentrations of tenet Srencthar chy deoaremiaiin DHA) tobe ist salient round 3408) reduction levels {Canae and AUC) of melamine, possibly due tolower absorpeion secondary to ancora ‘Ketease inthe bie prosacion: Such patents sho theretore be encouraged to ext st dosing ier to Sotmpesae forthe deciegie in bow. witine ine done cased a ane prodongation Tike Qe mere which conden wih ts own farcitoxity. Thi elle saligity ut significa eater when quinine infused see semether an Femetanrine combination. Thus, price adminiteaton af aremethes and lrslarine combination appears fo enhance the mherent risk of QTeprolongaton Roel gan on enn Newrolepties and Tricyclic anti-depressants: Corininsracon of atemett tn uterine (Ge: nevtoleptics and tricyclic antidepres) Is fonirnindcsted OVERDOSAGE: nar of eopecte overdongy eympterstic sd uppontive therapy shovld be ven appropriate EGE ind bood possum level shouldbe montored PROCEDURE TO PREPARE SUSPENSION. ‘To make 60 ml suspension add some boiled cooled sraterto the powder and shake mel coil at power E dispersed. Shea towly ad moce water upco the ‘nat onthe bate and aake wel pan DIRECTIONS: Store is cool and dry place. 4 Prosse from bea light and moisrue. © Keepall medicines out of te reach of chidcen, DIRECTIONS FOR SUSPENSION: Keep bottle ighly closed when not use. © esp prepared suspension below 25 PRESENTATION: Angmexd.DS tablets ae availble in awa lier Peck ol (1x8) abies, ‘Riemer Fores are raise in alos blior Kren Ds 3 Me ia HDPE ‘laste bole with mesruring cup. [Per siaseatnaennene ae wae outa uythat BLL omg if (RAD bela el AE Teer Sfing Le hark come sBuiye Lie ABesohCins Aiba dont Kime Ginn end Lo whi BA ee aie lee Bsc iP ee Pilg Lit 2). The Schazo0 Pharmaceutical Cote Seis he comes