The Salina Journal from Salina, Kansas on May 14, 1995 · Page 43
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The Salina Journal from Salina, Kansas · Page 43

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Salina, Kansas
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Sunday, May 14, 1995
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Page 43
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HISMANAL* Btkxt prescntta please consult complete prescribing «*»• natal a vmtii te Mowing Is a oriel summary MBCKnQttMtBBSUE HISMMUL cam m titrated lot the rtW ol Symplons urticaria. HSIMIUL sftoukl am be used is i p rn product for irnineolalereielolswilorK Patents snnM be adM not lo roost the Hose 'a an amp! to accelerate Die orart ol action Clinical statics Ion not been conducted lo enluale Ine dkdiwicss ol MSIUIW. hi ta cornnon cokl. CONCOMITMT MUNISTRATION V AS1EMZOLE WITH ERYIHWHIYCW IS COKIRAIWIWIED BEMUSE EOT- THHOMYCm IS KNOWN TO WPWfi THE CYTOCHHOHE P«0 EHZnC SVSTEU WHICH MSO WUBCES ASTEM- Z0£ UETHOJSU. 1HEK HAVE BEEN TWO REPORTS TO DATE Of SYNCOPE WITH TORSADES DE TONTES. REOUW ING HOSmAUZHIW. Ill FATBITS TAXING COUNW- TONS OF HSUUW. ID HO DAM WITH EMtHROMWW. IN EACH CASE THE OT INTERVALS WERE PROLONGED BEYOW 6SO MILLISECONDS AT THE TME Of THE EVBlT; ONE Mm ALSO RECEIVED KETOCONABKE AND THE OTHER WTHTAiSOHADKyPOKAlEMW. CWCMiHHT ADMINISTRATION OF ASTEIWOLE WITH KETOCONAHUE UaEIS IS COMRAMCATEO BECAUSE AVAILABLE HUMAN PHARUACORMETIC DATA INDICATE THAT ORAL KTOOJNAZDU SBKfCWir IWSITS THE METABOUSM OF ASTEMZOLE. KSU.TMG M EUVATEO PLASMA LEVELS Of ASTEMIZOIE AND DESUETHV- LASTEUCOLt DATA SUGGEST THAT CARDIOVASCULAR EVENTS AKASSOWTED WITH ELEVATION rjFASTMZOU ANMM ASTEMCOIE METABOLITE UVaS. RESULTING IN ELECTROCAROIOORAPMiOT PROLONGATION. CONCOMITANT ADHWISTRATKIN Of ASTEMI20LE WITH ITRACONAZOLE IS ALSO COHTRAINDICATEO BASED ON THE CHEMICAL RESEMBLANCE OF ITRACONAZOLE AND KETOCONAZOLE. IN WRO-DATA SUGGEST THAT ITRACONAZOLE HAS A LESS PRONOUNCED EFFECT ON THE BIOTRANSFORMATION SYSTEM RESPONSIBLE FOR THE METABOLISM OF ASTEMIZOIE COMPARED TO KETOCONAZOLE. ISte VMMMS mi MCNIKM: bug Heradigns.) HISMANAL is cttnMokd in patents wBi tnwn hyper- sensitjiity to istHTO* « any of me inactive inorefcrfe MMIT.Or .MOTHER orno- BBTH mime MATH. ORBAC LODGATDN, TORtHB DE HMB. AND OTHER V» TMCU1M MWTTMMS NAK BEEN OBtEMEO • Pjimnt EUKHMIECOMKIKO OUEI OF UTB0U. MHU IK WMlm * SUM EWITI MM OKI OF IE El OF UTEWIOU. TOMAMI DE NMTEt wmmpuiiMK van MMB.T ocoMB AT MNeitB DOKS M IM M »M W MMJM TKt IK REOMMMEIBMLT UK. MU tW SOT THAT THEKFA0TIAK AttWATEOWmi Elf UTKMOF Un LEWU, KWLTM M BBTNCNMSMmC OTFMUMHH. TKEK Mm HUE 1110 OCCUMB AT 11 W ONLY m * FM Mian m» nmi MMHM c* TUCCt ISK GONIMMttlTMNl HI MMtMMI BUM NMMI BOB.* «• Of TNE nTHTUl JMUMUC MMrVTKMM. --------- M lammantHuitnmxuiimaatv WllMlli|MIT1BrriD«CCBB«ETHEOWT BBMP" _._._. OFuiMnuwm giocmiueu TMun. mucoiuzou. n an- want* a ornnimum. its COHMMK- UTM«BMfUyTOM:PMlnaKT10M.| M»Mit*aguaailWfmVKINUlB)iy IK LML, Hct uXtfUTHKOLEimraai WIN MWCMT KMIB mHMCTM B0U SOB- ttLVBEMMI. mtmuta.ieafuattnmiwiiiBt mtcan it tmHUVi'ncm. man m mm MCSMH Miamu WNU UM n WNBHIE OeKMINMIlM »IMtnBlT MB wnumuTEOMictL Ewiwnw. wcuMMe BfCnWIMMMPMC 1BIM ILNUlt FOd 01 ^»jiim)iii). MnwMcr rKCAUnM.IHOOUUMO UTIATMN.) Pjtenls know to low comMons kiding to OT id isMinle a teconmiikd ones. The elW ol Blenv o* ii pitenB via in receima WHB «*icli alter me OT nlenal a intaonn. Howevo. In vim ol jsracoie's bum poMal to OTpreloogjiion. II ii adraUe lo anit Us use ii Pilnnls rath Of piolongilion synkow 01 Him OT Mug mntaMns «nitli an itftatt lo prolong OT inuivals linctaling pnlucol. aim aMantiytmics. am« Wotiic na blocktn such as beonkl. and Wouctae). mtens »Bft eWroMe itaoroul*« sodi as tiyixtatena or hypomajoe- strnu. or hose Utog totto with pottntol lor mduonj elearoltleaDiwmttes. Rare cases ol ontmjscuto evenu Hm beeo obsenal in Mlaas «in hettic iWunctai. SntoiaK: naWoi ol tne |tonMojk»«ta ol asteninle in piSMts w» hipac lyslunoion Has Ml Been peilonwl. Since istenuole is emnsialy mtabotaed By teiw. At ust ol HSUUIAL in Caotm aiouM be own to Wimul aiCdiiilinergic (diying eltas) in pjuno wth lower aiway diseases. Caution staid be ued in pawns with cnMsis ot MBef lim Diseases. HISMANAL does not appear lo be cUyzaUe. CjUiM stauU also be used often treating patients «iti lent! impainHnL See CONTHAIOCATIONS Ml WARNINGS sectws to <b- n reoarAnQ potenbal dnjy interactions. i n bHimnii nun trim- CMitm dk ntaiole It cMnMoM. ((H CON- TMMUmNI art WAIHtS B01) Due to tin eternal emtoty ol fccoauolt, mtnmtuole. and rnnaiole iv. U teUconuile, cootomttj use ol Itese products «* asMBole Is not recommnU oilier miciolide inlittolics. including. Iroleandomytin. aclnramyon, and ctanrhrornyon, is not recommended fetomallealirraiett: PitMs uaip HrSMAIW.' (asleroMel sliould receive Ine lokuinQ mtoriiujjon and oistructras. AflUBUuines are pre~ snouU cc aduised t| lo adlvm to me reconmended dose, and 2) feat Die use ol eoesive doses may lead u serious cardmscular evens. Some patens appear to imase the dose ol HfSHIMl in an attempt lo accelerate the onset ol acton PATIENTS SHOULD BE ADVISED NOT TO 00 THIS and not to use HtSIWNAl' as a p r n product tor tamateu reW ol symptoms. Patents shout! be questioned atom *e n other prescription or om-Bwoufler n*Soti>n. and oe caaooned regarding tt poMal lor tWhreafci- ing arrhythmias nth conciurent use ol ketocomole. rtra- suit the physician Mm cmcumM ue d ofter rmam •nth aslmode. Patjenls should be matted atom pig- igncr or twatoi bdm sartng WSMANAL ftenpy. since *t drvg Hot! be used in pnjnancy 01 hraton at/ 'I t* paten*! benefit justfts the POMM risk to fetus w baby. (Set Pregnancy subsection.) In addrbn, patents shaft be inswdeito lake MSMANAL on an enny twach, m. at least 2 hoin afv a MIL No acttdaaltood should be Men lor al lent 1 how Mer dosiq. Patients slwuM also be MncM to on Ms megaton In t Ugh* closed rarSnu in a cod, *y pta. any tarn beat or dtrecl smljw. am) jwjyhjmchJdria .. Circtaognic poMaT has not been nvnkd in rats given 2SX the recommended human dose ot asMink tar 24 man. at in into given «to the recommended rwnan . ctnmabd ndange and Ames ksts ol OatOe raw M . lmpairmi«t oftirtill* us Ml observed in nde or loiale rats given Mte the recomnenderl lunn dost HniiiUfiilimirapiiC: Teratogeiw tftco «ere ml obsened in ms administered 200i ne recmnended hrmn oost « in rabbits grven 200* . ijlirjils adnwisletfd 20h the leuurninded ntinian dose. EratKyoott dleds accomoaned by maternal Umof; wre observed at lOfti Bit fecommemM human dose In rats. EntryoWcity or mumjl toiiciy us not observed in ells or rabbits admnstered 5fe the recommnded Hunan d»se. There an no adeouate and mil oggMled studies ii pregninl wmea HISMAHAL should be used durim pngnancy only i the potential oene» iusHes tie poieniial rnli to fee lefts. MetjtoMes my remain ii the body l» as king as 4 morts alter the end ol dosing. otojUttd on ttt Bass ol 6 tmes fte terminal ban-Mi II is not bom «*e«er this dnjg is ncreled to ruron nA. Because certain drugs are Icrowi to be tented in numn nut. caufcn skoddbe euicised «nen HISMAIUlis Horn- Outi lo a nursing woman. HISMANAL is Mtrettd in the Sakly an) eltacy in chBrcn inkf 1 1 years ot age IBS not ts (to. For Worraiw ngardn cardanscular a caidiac arrest, vertncubr nrhyltimas). TRAWnCATIONS and WARNltisS BOX. . recognition ol severe arrhythmias has been preceded by episodes ol syncope. SM&ly, m cases ol hypotension. oaWons. and ctomess have also been reported, vritn HtSUANAL UM, whch ttuy rrtict ondttctttd vtntricuUr arrhythmia. The reported mutates ol adverse reactors isled in the MMg OUt n derived torn moled clinical states in adults. In these studies the usual nuMenanct dose ol HISMANAL was 10 mg once daily. AWWEBFJT (MHI (MM) (MM) Fitgu AMtteinease WeigMiraeasf towosnm 7.1 67 U 39 16 2.1 25 U 1.4 Fjt.Fjr.tal, I* IkM MlWhdry 52 Phaiytojtt 1.7 Conjmctvtt U U 9i 1.6 1.4 a? 17 Zl 2.0 \2 II U U 210 M 11.1 cm u OJ 0.7 7.9 03 0.7 Adverse readion Wormalion has been ottamo) nan more Ban 7S» patents in al clinical trials. Weight gain las been reported » 3.6% ol astemWe treated paliems involved in connoted studies, win an average treatment duration ol 53 oays. ta 46 ol me 59 pilroa k» otum actual mght gain data vas avatable. the average «tg«t gain <as 3 i tg. Less fntjeUr/ ommnj advene uperiences reported in clinical Irals or spontaneously from marketing uptnence with HISMANU. includf angwdema. asymptomatic Irver eruyme elevations, bronchospasm. depression, edema. .. saBdMty.pnrtBS.ini ash, Mtrkding experiences include isolated cases ol convulsions. A causal relationship aim HISMANAL has not beeo estabtshed. OVERMSACE In the even! ol overdwge. supportive measures Inckdng gastric ravage and ernesis should be employed. Supwva*, curdosesdHISMANAL can cause death, ante arrest OT protonoalion. Unites de poMes. and other ventricular armymias. These events can afco occu, athough rarely, al doses (20-30 mo| dose lo Ine recommended dose 110 •aWkllStt WAWrMS BOX and DOSAGE AND AOMIN- tSTRATIoil) Scans and syncope have afeo been rtporred Mh oventae and nay be assoatednttacarta: evert Overdose tanents autt be caieUy mritnd as toog as the OT Merval is cntoged or armyWnis are present In some cases. His has been up lo SB dayi In overdose cases in vfich ventricular arrhythmias are associated widi ugreft- cant QT proronuliori. treabnenl w* imantiyttraj knwn lo piolong OT niervals is not reommendtd. HISUAIIAL does not appear to be doable. Oral LOso values to HISUAIIAL urn 2052 mjAn » mice and 3154 nttg ii rats, to ranyal rats. Ine rrtlfto «os 90S mgig it mats and 1235 mg/ig in lerraks. Revised Uarcri 1993. My 1933 ri rmMkaM. (In I H6S BOL) Concoroitani administration of astemiiole wit) H JANSSEN KUIWACCUnCA 1*rjtf U>MUB THEN I WOKE UP ID HISMANAL" With HISMANAL, you get relief of your runny nose, sneezing, and itchy/watery eyes...without getting drowsy. In fact, HISMANAL causes no more drowsiness than a sugar pill.* What's more, r you only have to take HISMANAL once a day for a full 24 hours' worth of relief. HISMANAL is available by prescription only. So ask your doctor today about HISMANAL. And wake up to a different kind of allergy relief. WARNING: HISMANAL should be taken only as directed, one tablet a day. Do not increase the dose in an attempt to speed the action of HISMANAL It may take a few days of regular use to feel the action of HISMANAL 'The reported incidence of drowsiness with HISMANAL (7.1%) in clinical studies involving more than 1600 patients did not differ significantly from that reported in patients receiving placebo (6.4%). FOR A FREE HELPFUL BOOKLET CALL 18005568867 medicines itraconazole (Sporanox®) or ketoconazole (Nizoral*) tablets, or the prescription antibiotics erytivomycin orclarithromycin. People with serious liver disease should not take HISMANAL HISMANAL has been associated with rare occurrences of abnormal heartbeats and heart attacks. In very rare cases, this could be fatal. Tell your doctor before taking HISMANAL if you have any liver or heart problems. It's also important to tell your doctor if you ever become faint, dizzy, or have irregular heartbeats while you are taking HISMANAL Ask your doctor today aboot PRESCRSPTIQ WiY HISMflnflL OKTG1IZOL0 10mg Tablets © Janssen Pharmaceutica Inc.. 1995 JPI-HS-241 Please see adjacent important precautionary information.

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