:2007WARNING:,-angiotensinsystemcancauseinjuryandevendeathtothedevelopingfetus.(-------------RECENTMAJORCHANGES---------------------IndicationsandUsage(17/2008DosageandAdministration,InitialTherapy((:•Inpatientsnotadequatelycontrolledonmonotherapy(1•Asinitialtherapyinpatientslikelytoneedmultipledrugstoachievetheirbloodpressuregoals(1.------------DOSAGEANDADMINISTRATION-------------GeneralConsiderations:•Majorityofeffectattainedwithin2weeks(•Maybeadministeredwithotherantihypertensiveagents(•Maybeusedasadd-ontherapyforpatientsnotcontrolledonmonotherapy(•Patientswhoexperiencedose-ponent(•ponents(•Whenusedasinitialtherapy:Initiatewith5/160mg,thentitrateupwardsasnecessarytoamaximumof10/320mgoncedaily(-----------DOSAGEFORMSANDSTRENGTHS------------Tablets(amlodipine/valsartanmg:5/160,10/160,5/320,10/320(3---------------WARNINGSANDPRECAUTIONS------------•Avoidfetalorneonatalexposure(•Assessforhypotension.(•Warnpatientswithsevereobstructivecoronaryarterydiseaseabouttheriskofmyocardialinfarctionorincreasedangina(•Titrateslowlyinpatientswithimpairedhepatic((-------------------ADVERSEREACTIONS----------------------Inplacebo-controlledclinicaltrials,%e-%intheplacebo-(≥2%ofpatientsatahigherincidencethanplaceboincludedperipheraledema,nasopharyngitis,upperrespiratorytractinfectionanddizziness.(6ToreportSUSPECTEDADVERSEREACTIONS,contactNovartisPharmaceuticalsCorporationat1-888-669-6682orFDAat1-800-FDA-------------USEINSPECIFICPOPULATIONS-------------≥75yearsoldorinpatientswithhepaticimpairment.(:etherapy,butnotboth.(-app
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