National Geographic : 2006 Jan
TOPROL-XL® (metoprolol succinate) Tablets Adverse EventsOccurring intheMERIT-HF StudyatanIncidence >1% intheTOPROL-XL GroupandGreater ThanPlacebobyMoreThan0.5% TOPROL-XL Placebo N=1990 N=2001 %ofpatients %ofpatients Dizziness/vertigo 1.8 1.0 Bradycardia 1.5 0.4 Accident and/orinjury 1.4 0.8 Otheradverseeventswithan incidence of>1%onTOPROL-XL andascommon onplacebo (within0.5%)included myocardial infarction, pneumonia, cerebrovascular disorder, chestpain, dspneaMdyspnea aggravated, syncope,coronaryarterydisorder,ventricular tachycardia/ arrhythmia aggravated, hypotension, diabetesmellitus/diabetes mellitusaggravated, abdominal pain,andfatigue.Post-Marketing Experience: Thefollowing adversereactionshavebeen reportedwithTOPROL-XL in worldwidepost-marketing use, regardlessof causality: Cardiovascular: 2nd and3rd degreeheartblock;Gastrointestinal: hepatitis,vomiting; Hematologic: thrombocytopenia; Musculoskeletal: arthralgia;NervousSystem/Psychiatric: anxiety/nervousness, hallucinations, paresthesia; Reproductive, male:impotence; Skin:increased sweating,photosensitivity, urticaria;SpecialSense Organs:tastedisturbances. OVERDOSAGE AcuteToxicity: Therehavebeena fewreportsofoverdosage withTOPROL-XL andnospecific overdosage information wasobtained withthisdrug,withtheexception ofanimaltoxicology data. However, sinceTOPROL-XL (metoprolol succinate salt)contains thesameactivemoiety, meto prolol, as conventional metoprolol tablets(metoprolol tartratesalt),therecommendations on overdosageformetoprlol conventional tabletsareapplicable to TOPROL-XL Signsand Symptoms: Overdosage ofTOPROL-XL mayleadtoseverehypotension, sinusbradycardia, atri oventricular block,heartfailure,cardiogenic shock,cardiacarrest,bronchospasm, impairment of consciousness/coma, nausea, vomiting, andcyanosis. Treatment: Ingeneral,patients withacute or recentmyocardial infarction or congestiveheartfailuremaybe morehemodynamically unstablethanotherpatientsandshouldbetreatedaccordingly. Whenpossiblethepatientshould betreatedunderintensive careconditions. Onthebasisofthepharmacologic actionsofmeto prolol,thefollowinggeneralmeasures shouldbeemployed: Elimination oftheDrug:Gastric lavageshouldbeperformed.Bradycardia: Atropine shouldbeadministered. Ifthereis no response to vagalblockade, isoproterenoal shouldbeadministered cautiously, Hypotension: A vasopressor shouldbeadministered, eg,levarterenol ordopamine. Bronchospasm:Abeta2-stim ulating agentand/ora theophylline derivative shouldbeadministered. CardiacFailure: Adigitalis glycosideanddiureticsshouldbeadministered. Inshockresultingfrominadequate cardiac contractility, administration ofdobutamine, isoproterenol, orglucagon maybeconsidered. DOSAGE AND ADMINISTRATION TOPROL-XL isanextended releasetabletintendedforoncedailyadministration. Fortreatment of hypertension andangina, whenswitching fromimmediate releasemetoprolol toTOPROL-XL, the sametotaldailydoseofTOPROL-XL shouldbeused.Dosages ofTOPROL-XL shouldbeindivid ualized andtitration maybeneededinsomepatients. TOPROL-XL tabletsarescoredandcanbe divided;however, thewholeorhalftabletshouldbeswallowed wholeandnotchewed orcrushed. Hypertension: Theusualinitialdosageis25to 100mgdailyina singledose,whether used aloneoraddedto a diuretic. Thedosagemaybeincreased atweekly(orlonger)intervals until optimum bloodpressurereduction isachieved.Ingeneral,themaximum effectofanygiven dosagelevelwillbeapparent after1 weekoftherapy.Dosages above400mgperdayhavenot beenstudied.Angina Pectoris: ThedosageofTOPROL-XL shouldbeindividualized. Theusual initialdosageis100mgdaily,giveninasingledose.Thedosagemaybegradually increased at weeklyintervals untiloptimumclinical responsehasbeenobtainedorthereis a pronounced slowing oftheheartrate.Dosages above400mgperdayhavenotbeenstudied,Iftreatmentisto bediscontinued, thedosageshouldbereducedgradually overa periodof1-2 weeks(seeWARN INGS).Heart Failure: Dosage mustbeindividualized andclosely monitored duringup-titration, Priorto initiation ofTOPROL-XL, thedosingofdiuretics, ACEinhibitors, anddigitalis(ifused) shouldbestabilized. Therecommended startingdoseofTOPROL-XL is25mgoncedailyfortwo weeksinpatientswithNYHA classIIheartfailureand12.5mgoncedailyinpatientswithmore severeheartfailure. Thedoseshouldthenbedoubled everytwoweekstothehighestdosagelevel tolerated bythepatientorupto200mgofTOPROL-XL . Iftransientworsening ofheartfailure occurs,itmaybetreatedwithincreased dosesofdiuretics, anditmayalsobenecessary tolower thedoseofTOPROL-XL ortemporarily discontinue it.ThedoseofTOPROL-XL shouldnotbe increased untilsymptoms ofworseningheartfailurehavebeenstabilized. Initialdifficulty with titration shouldnotprecludelaterattemptstointroduce TOPROL-XL. Ifheartfailurepatients expe riencesymptomatic bradycardia, thedoseofTOPROL-XL shouldbereduced. HOW SUPPLIED Tablets containing metoprolol succinate equivalentto theindicated weightofmetoprolol tartrate, USP,arewhite,biconvex, film-coated, andscored. Bottleof UnitDose 100 Packages of Tablet Shape Engraving NDC 100 0186- NDC0186 25mg* Oval A 1088-05 1088-39 50mg Round A 1090-05 1090-39 m0 100mg Round A 1092-05 1092-39 ms 200mg Oval A 1094-05 N/A my *The25-mgtabletis scoredonbothsides. Storeat25°C(77'F).Excursions permitted to 15-30°C(59-86°F).(SeeUSPControlled Room Temperature.) NOTE: Thissummary providesimportant information aboutTOPROL-XL. FormoreInforma tion,pleaseaskyourdoctor orhealthcareprofessional aboutthefullPrescribing Information anddiscussitwiththem. TOPROL-XL isaregistered trademark oftheAstraZeneca groupofcompanies @AstraZeneca 2002,2004,2005 Manufactured for:AstraZeneca LPWilmington, DE19850 By:AstraZeneca ABS-15185Stdertalje, Sweden MadeinSwedenA 30015-01 Rev02/05 235235 AstraZeneca SaveHundreds ofDollaronthe BELLOHOWELL 10.0 MegaPixel Digital Camera 16M. a,,ilt- Supeadvanced digital camera This camera has 3X the detail-resolu tion of many digital cameras. Ittakes astoundingly beautiful photographs from a macro detail-shot of a flower up to an 8X digital zoom portrait to a distant panorama on select settings. Color is richer and more brilliant. Clarity isknife-edge sharp, and tones are incredibly true to life. Never run out of batteries Many digital cameras require expen sive, hard to find batteries. 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