Pioglitazone Hydrochloride Monograph For Professionals - Drugs

20/10/2016 PioglitazoneHydrochlorideMonographforProfessionalsDrugs.
com
PioglitazoneHydrochloride
Class:Thiazolidinediones
ATCClass:A10BG03
VAClass:HS502
ChemicalName:()5[p[2(5Ethyl2pyridyl)ethoxy]benzyl]2,4thiazolidinedionemonohydrochloride
MolecularFormula:C19H20N2O3SClH
CASNumber:112529154
Brands:Actos
Warning(s)
CHF
Thiazolidinediones,includingpioglitazone,causeorexacerbateCHFinsomepatients. 1 27 28Monitorforsignsand
symptomsofCHF(e.g.,dyspnea,rapidandexcessiveweightgain,edema)afterinitiationoftherapyanddosage
titration. 1 27 28IfCHFdevelops,manageaccordingtocurrentstandardsofcareconsiderdiscontinuanceorreductionin
dosageofpioglitazone. 1 27 28
Notrecommendedinpatientswithsymptomaticheartfailure. 1 27 28
InitiationofpioglitazonecontraindicatedinpatientswithNYHAclassIIIorIVheartfailure. 1 27 28(SeeCHFunder
Cautions.)
Introduction
Antidiabeticagentthiazolidinedione(glitazone).18912
UsesforPioglitazoneHydrochloride
DiabetesMellitus
Usedaloneorincombinationwithasulfonylurea,metformin,orinsulinasanadjuncttodietandexerciseto
improveglycemiccontrolinpatientswithtype2(noninsulindependent)diabetesmellitus(NIDDM).12142728
Shouldbeaddedto,notsubstitutedfor,otherantidiabeticagentsinpatientswhoseNIDDMisnotadequately
controlledbytheseagents.13
Maybeaddedtoglyburide/metforminfixedcombinationtherapyifhyperglycemiaisnotadequatelycontrolled
withthefixedcombination.14Maybeusedincombinationwithrepaglinideifhyperglycemiaisnotadequately
controlledwithdiet,exercise,andmonotherapywithanotheroralantidiabeticagent.17
Noteffectiveassoletherapyfortype1diabetesmellitusordiabeticketoacidosis.1
PioglitazoneHydrochlorideDosageandAdministration
Administration
OralAdministration
Administerpioglitazoneoncedailywithoutregardtomeals.1
Administerfixedcombinationofpioglitazoneandimmediatereleasemetforminhydrochloride(ActoPlusMet)
onceortwicedailywithmealstoreducetheGIeffectsofmetformincomponent.27
https://www.drugs.com/monograph/pioglitazonehydrochloride.html 1/13
20/10/2016 PioglitazoneHydrochlorideMonographforProfessionalsDrugs.com
Administerfixedcombinationofpioglitazoneandextendedreleasemetforminhydrochloride(ActoPlusMetXR)
oncedailywiththeeveningmealtoreduceGIeffectsofmetformincomponent.27
Administerfixedcombinationofpioglitazoneandglimepiride(Duetact)oncedailywiththefirstmainmeal.28
Dosage
Availableaspioglitazonehydrochloridedosageexpressedintermsofpioglitazone.1
InitiationordiscontinuanceofaCYP2C8inducerduringpioglitazonetherapymaynecessitatechangesin
antidiabetictherapy.1(SeeInteractions.)
IfapotentCYP2C8inhibitorisusedconcomitantly,reductionofthemaximumdailypioglitazonedosageis
recommended.1(SeeInteractions.)
Adults
DiabetesMellitus
Monotherapy
Oral
Initially,15or30mgoncedaily.1Ifresponseinadequate,increasedosagegraduallyuptomaximumof45mg
daily.1
Allowsufficienttime(812weeks)toevaluateadequacyofresponseasdeterminedbyHbA1cunlessglycemic
controlbasedonfastingplasmaglucosedeteriorates.27
Pioglitazone/ImmediatereleaseMetforminHydrochlorideFixedcombinationTherapy(ActoPlusMet)
Oral
Baseinitialdosageoffixedcombinationonpatient'scurrentdosageofpioglitazoneand/orimmediaterelease
metforminhydrochlorideandonusualinitialdosagesofthesedrugs.27
Initially,15mgofpioglitazoneand500or850mgofimmediatereleasemetforminhydrochlorideonceortwice
daily.27
Graduallytitratedosagebasedonadequacyoftherapeuticresponse.27Allowsufficienttime(812weeks)to
evaluateadequacyofresponseasdeterminedbyHbA1cunlessglycemiccontrolbasedonfastingplasma
glucosedeteriorates.27
Pioglitazone/ExtendedreleaseMetforminHydrochlorideFixedcombinationTherapy(ActoPlusMetXR)
Oral
Baseinitialdosageoffixedcombinationonpatient'scurrentdosageofpioglitazoneand/orextendedrelease
metforminhydrochlorideandonusualinitialdosagesofthesedrugs.27
Initially,15or30mgofpioglitazoneand1gofextendedreleasemetforminhydrochlorideoncedaily.1
Pioglitazone/GlimepirideFixedcombinationTherapy(Duetact)
Oral
Baseinitialdosageoffixedcombinationonpatient'scurrentdosageofpioglitazoneand/orsulfonylurea(e.g.,
glimepiride).28
Patientscurrentlyreceivingglimepiridemonotherapy:Initially,30mgofpioglitazoneand2or4mgofglimepiride
oncedaily.28
Patientscurrentlyreceivingpioglitazonemonotherapy:Initially,30mgofpioglitazoneand2mgofglimepiride
oncedaily.28
Patientsswitchingfromcombinedtherapywithseparatepioglitazoneandglimepiridepreparations:Usualinitial
dosageofthefixedcombinationisthesameasthepatient'sexistingdosageoftheindividualdrugs.28When
switchingtothefixedcombination,carefullymonitorpatientswithinadequateglycemiccontrolonpioglitazone15
mgdailyincombinationwithglimepiride.28
Patientsswitchingfrommonotherapywithasulfonylureaotherthanglimepiride(e.g.,glyburide,glipizide,
chlorpropamide,tolbutamide,acetohexamide)orfromcombinedtherapywithpioglitazoneplusasulfonylurea
otherthanglimepiride:Initially,30mgofpioglitazoneand2mgofglimepirideoncedailynoexactdosage
relationshipexistsbetweenglimepirideandothersulfonylureas.28
PrescribingLimits
Adults
Maximum45mgdaily(asmonotherapyorincombinationwithasulfonylurea,metformin,orinsulin).12728
SpecialPopulations
HepaticImpairment
Monotherapy
Nodosageadjustmentnecessary.1
Pioglitazone/ImmediateorExtendedreleaseMetforminHydrochlorideFixedcombinationTherapy
Donotinitiateinpatientswithclinicalevidenceofactiveliverdiseaseorelevatedserumaminotransferase
concentrations(ALT>2.5timesULN).27
Pioglitazone/GlimepirideFixedcombinationTherapy
Initially,glimepiride1mgdailyasmonotherapy,followedbyconservativeinitialandmaintenancedosagesofthe
fixedcombinationindividualswithhepaticimpairmentmaybeparticularlysensitivetothehypoglycemiceffectsof
glimepiride.28
Donotinitiateinpatientswithclinicalevidenceofactiveliverdiseaseorelevatedserumaminotransferase
concentrations(ALT>2.5timesULN).28
RenalImpairment
Monotherapy
Donotuseinpatientswithrenalimpairment.27
fixedcombinationindividualswithrenalimpairmentmaybeparticularlysensitivetothehypoglycemiceffectsof
glimepiride.28
GeriatricPatients
Monotherapy
Conservativeinitialandmaintenancedosagesrecommendedgeriatricindividualsareparticularlysensitiveto
hypoglycemiceffects.27Generally,donottitratetomaximumrecommendeddosage.27
fixedcombinationgeriatricindividualsmaybeparticularlysensitivetothehypoglycemiceffectsofglimepiride.28
PatientswithCHF
NYHAclassIIIorIVheartfailure:Usecontraindicated.12728
Monotherapy
NYHAclassIorIIheartfailure:Initially,15mgoncedaily.1Increasedosagegradually,ifneeded,uptomaximum
of45mgdailybasedonHbA1cconcentrations.1Monitorcarefullyforweightgain,edema,orothermanifestations
ofCHFexacerbationfollowinginitiationanddosageincrease.1
Systolicdysfunction:Initially,pioglitazone15mgoncedailyasmonotherapysafelytitratedosageto30mgonce
dailyasmonotherapybeforeinitiatingthefixedcombinationofglimepiride2mgandpioglitazone30mg.28If
subsequentdosageadjustmentisnecessarywiththefixedcombinationpreparation,monitorcloselyforweight
gain,edema,orothermanifestationsofCHFexacerbation.28
DebilitatedorMalnourishedPatients
Generally,donottitratetomaximumrecommendeddosagetheseindividualsareparticularlysusceptibleto
hypoglycemiceffects.27
fixedcombinationtheseindividualsareparticularlysusceptibletohypoglycemiceffects.28
PatientswithAdrenalorPituitaryInsufficiency
fixedcombinationtheseindividualsareparticularlysusceptibletohypoglycemiceffects.28
CautionsforPioglitazoneHydrochloride
Contraindications
InitiationoftherapyinpatientswithNYHAclassIIIorIVheartfailure.12728(SeeBoxedWarning.)
Knownserious1hypersensitivitytopioglitazoneoranyingredientintheformulation.12728
Warnings/Precautions
Warnings
CHF
Fluidretentionassociatedwithuseofpioglitazone,aloneorincombinationwithotherantidiabeticagents,may
leadtoorexacerbateCHF.1192728303137384041(SeeBoxedWarning.)Useincombinationwithinsulinorin
patientswithNYHAclassIorIIheartfailuremayincreasetherisk.1
MonitorforsignsandsymptomsofCHF(e.g.,dyspnea,rapidweightgain,edema,unexplainedcoughor
fatigue),especiallyduringinitiationoftherapyanddosagetitration.11927283740
IfCHFdevelops,manageaccordingtocurrentstandardsofcare.11927283740Considerdosagereductionor
discontinuanceofpioglitazone.11927283740
Donotinitiatethiazolidinedionetherapyinhospitalizedpatientswithdiabetesmellitusbecauseofdelayedonset
ofactionandpotentialforincreasedvascularvolumeandCHF.34
Edema
FluidretentionreportedmayleadtoorexacerbateCHF.113
UsewithcautioninpatientswithedemaandinthoseatriskforCHF.127ObserveformanifestationsofCHF(e.g.,
dyspnea,rapidweightgain,edema).1(SeeCHFunderCautions.)
WeightGain
Reportedmayinvolvefluidretentionandfataccumulation.1(SeeBoxedWarning.)
OtherWarnings/Precautions
HepaticEffects
Noevidenceofhepatotoxicityinclinicalstudiestodate.11213However,hepatitis,elevationsinhepaticenzymes,
mixedhepatocellularcholestaticliverinjury,15and,veryrarely,hepaticfailureassociatedwithfatalitiesreported
duringpostmarketingexperience.1
Monitorliverfunctiontestspriortoinitiationoftherapy,thenperiodicallythereafteraccordingtoclinician
judgment.112Monitormorefrequentlyifusedinpatientswithmildhepaticimpairment(ALT12.5timestheupper
limitofnormal[ULN]).1(SeeHepaticImpairmentunderCautions.)
RecheckliverfunctionifALTincreasesto>3timestheULNorifmanifestationssuggestiveofhepaticdysfunction
(e.g.,unexplainednausea,vomiting,abdominalpain,fatigue,anorexia,darkurine)occur.1Discontinuetherapyif
ALTremainselevatedat>3timestheULNorifjaundicedevelops.1
MusculoskeletalEffects
Riskofbonelossandfracturesinwomen,andpossiblyinmen,receivingthiazolidinedionetherapy.1293536394750
Fracturesreportedmorefrequentlyinwomenreceivingpioglitazone(5.1%)thaninwomenreceivingplacebo
(2.5%)inlongtermstudy(mean34.5monthsfollowup).12728303233Effectsnotedafterfirstyearoftreatment
andpersistedthroughouttreatment.12728303233Mostfractureswerenonvertebral,occurringinadistallimb
(forearm,hand,wrist,foot,ankle,fibula,tibia).1272829
Inanobservationalstudy,useofpioglitazoneorrosiglitazoneforapproximately1218monthsassociatedwith
twofoldtothreefoldincreaseinfractures,particularlyofhipandwrist.50Overallriskoffracturesimilaramongmen
andwomen.50
Considerriskoffracture,particularlyinfemalepatients.12935Assessandmaintainbonehealthaccordingto
currentstandardsofcare.1282930323335
RiskofBladderCancer
Increasedriskofbladdercancer.12728Donotuseinpatientswithactivebladdercancerusewithcautionin
patientswithhistoryofbladdercancer,weighingbenefitsofglycemiccontrolagainstunknownrisksofcancer
recurrence.1272880
Hypoglycemia
Concomitantuseofinsulinorotherantidiabeticdrugs(e.g.,insulinsecretagogues)increasesriskfor
hypoglycemia.12728Mayneedtoreducedosageofconcomitantantidiabeticagenttodecreaseriskof
hypoglycemia.12728(SeeDosageunderDosageandAdministration.)
OcularEffects
Newonsetorworsening(diabetic)macularedemawithdecreasedvisualacuityreportedrarelyconcurrent
peripheraledemareportedfrequently.127283233Symptomsimprovedinsomepatientsfollowingdiscontinuance
ofpioglitazone.127283233
Regulareyeexaminationsbyophthalmologistadvised.12728323334Promptlyreferpatientsreportingvisual
symptomstoophthalmologist,regardlessofotherconcurrenttherapyorphysicalfindings.127283233
OvulatoryEffects
Maycauseovulationinpremenopausalanovulatorywomenriskofpregnancyunlessadequatecontraceptive
measuresinitiated.1
MacrovascularOutcomes
Evidenceofmacrovascularriskreductionwithpioglitazoneoranyotherantidiabeticagenthasnotbeen
conclusivelydemonstratedincontrolledclinicaltrials.1
LaboratoryAbnormalities
Possibledoserelateddecreasesinhemoglobinandhematocritusuallyevidentwithin412weeksoftherapy.1
Mayberelatedtoplasmavolumeexpansion.1Rarelyassociatedwithclinicallyimportanthematologic
manifestations.1
IsolatedelevationsinserumCK>10timesULNnotedrarelyduringclinicaltrials.1Resolvedinmostpatients
withoutapparentsequelaedespitecontinuedtherapywiththedruganyrelationshiptopioglitazonetherapy
unknown.1
UseofFixedCombinations
Whenusedinfixedcombinationwithmetforminhydrochlorideorglimepiride,considerthecautions,precautions,
andcontraindicationsassociatedwiththeconcomitantagent.2728
SpecificPopulations
Pregnancy
CategoryC.1Mostcliniciansrecommendthatinsulinbeusedduringpregnancyinwomenwithdiabetesmellitus.1
Lactation
Distributedintomilkinratsnotknownwhetherdistributedintohumanmilk.1Usenotrecommended.1
PediatricUse
Safetyandefficacynotestablishedinpediatricpatients<18yearsofageusenotrecommended.113
GeriatricUse
Nosubstantialdifferencesinsafetyandefficacyrelativetoyoungeradults.1
HepaticImpairment
Usewithcautioninpatientswithmildhepaticimpairment(ALT12.5timestheULN).112Usenotrecommended
inpatientswithactivehepaticdisease,ALT>2.5timestheULN,ortroglitazoneassociatedjaundice(troglitazone
nolongercommerciallyavailableinUS).112
CommonAdverseEffects
Upperrespiratorytractinfection,headache,sinusitis,myalgia,pharyngitis,edema.1
InteractionsforPioglitazoneHydrochloride
MetabolizedprincipallybyCYP2C8and,toalesserextent,byCYP3A4andotherisoenzymes(e.g.,CYP1A1).1
WeakinducerofCYP3A4.1
DrugsAffectingHepaticMicrosomalEnzymes
PotentCYP2C8inhibitors:IncreasedpioglitazoneAUCandhalflifedonotexceedmaximumpioglitazone
dosageof15mgoncedaily.1
CYP2C8inducers:DecreasedpioglitazoneAUC.1InitiationordiscontinuanceofaCYP2C8inducerduring
pioglitazonetherapymaynecessitatechangesinantidiabetictherapyhowever,donotexceedmaximum
recommendedpioglitazonedosageof45mgdaily.1
SpecificDrugs
Drug Interaction Comments
Antidiabeticagents Additiveeffectspossible Mayneedtoreducedosageofotherantidiabeticagents1

hypoglycemia1
Atorvastatin Decreasedplasma
concentrationsandAUC
foratorvastatinand
pioglitazone1
Digoxin Pharmacokinetic
interactionunlikely1
Fexofenadine Pharmacokinetic
Gemfibrozil Increasedpioglitazone Donotexceedmaximumpioglitazonedosageof15mg

AUCandhalflife127 oncedaily
Ketoconazole Increasedserum
concentrationsandAUC
forpioglitazone11327
Midazolam Decreasedmidazolam
AUCandpeakplasma
concentrations1
Nifedipine,extended Decreasedpeakplasma Clinicalimportanceunknown1

release nifedipineconcentrations
andAUC1
Oralcontraceptives, Smalldecreasesinpeak Clinicalimportanceunknown1

hormonal(ethinyl plasmaethinylestradiol
estradiol/norethindrone) concentrationsand
AUC1
Ranitidine Pharmacokinetic
Rifampin Decreasedpioglitazone Mayrequirechangeinantidiabetictherapyifrifampin

AUC127 initiatedordiscontinuedduringpioglitazonetherapy,but
donotexceedmaximumpioglitazonedosageof45mg
daily127
Theophylline Pharmacokinetic
Warfarin Pharmacokineticor
pharmacologic
interaction(e.g.,effect
onPT)unlikely1
PioglitazoneHydrochloridePharmacokinetics
Absorption
Bioavailability
Peakserumconcentrationsattainedwithin2hours.1
Absolutebioavailabilityis83%.81
Food
Fooddelaystimetopeakserumconcentrationto34hoursbutdoesnotaffectextentofabsorption.1
SpecialPopulations
Inpatientswithhepaticimpairment(ChildPughclassBorC),peakpioglitazoneconcentrationisdecreasedby
45%.1
Ingeriatricpatients,AUCofpioglitazoneisincreasednotclinicallyrelevant.1
Infemales,peakserumconcentrationandAUCareincreasedby2060%.1
Distribution
Extent
Distributedintomilkinrats.1Notknownwhetherthedrugdistributesintohumanmilk.1
PlasmaProteinBinding
>99%(mainlyalbumin).1
Elimination
Metabolism
Extensivelymetabolized,principallybyCYP2C8and,toalesserextent,byCYP3A4andotherisoenzymes(e.g.,
CYP1A1).1
EliminationRoute
Excretedinurine(1530%)andinfeces,primarilyasmetabolites.1
Halflife
37hours(forpioglitazone)or1624hours(forpioglitazoneandmetabolites).1
SpecialPopulations
Ingeriatricpatients,terminalhalflifeisprolongednotclinicallyrelevant.1
Stability
Storage
Oral
Tablets
Tightcontainersat25C(maybeexposedto1530C).1Protectfrommoistureandhumidity.1
Actions
Structurallyandpharmacologicallyrelatedtorosiglitazoneandtroglitazone(nolongercommerciallyavailable
intheUS)189112unrelatedtootherantidiabeticagents(e.g.,sulfonylureas,biguanides,glucosidase
inhibitors).112
Aperoxisomeproliferatoractivatedreceptor(PPAR)agonistincreasestranscriptionofinsulinresponsive
genes.1
Increasesinsulinsensitivityintargettissuesanddecreaseshepaticgluconeogenesis.1Amelioratesinsulin
resistanceassociatedwithtype2diabetesmellituswithoutincreasinginsulinsecretionfrompancreatic
cells.1Doesnotlowerglucoseconcentrationsbeloweuglycemia.1
Ineffectiveinabsenceofinsulin.1
AdvicetoPatients
Importanceofreadingmedicationguideprovidedbymanufacturerbeforestartingpioglitazoneandeachtime
prescriptionisrefilled.1
Importanceofinformingpatientsofpotentialrisksandadvantagesoftherapyandofalternativetherapies.28
Discusspotentialforalterationsindosagerequirementsduringperiodsofstress(e.g.,fever,trauma,infection,
surgery)importanceofcontactingaclinicianpromptly.127
Importanceofinformingpatientsthatpioglitazonemustnotbeusedinpatientswithsevereheartfailure
(NYHAclassIIIorIV).1ImportanceofimmediatelyinformingclinicianifpotentialmanifestationsofCHF(e.g.,
rapidweightgain,edema,unusualfatigue,troublebreathing,shortnessofbreath)occur.12728
Importanceofinformingpatientsthatliverfunctiontestswillbeperformedpriortoinitiationoftherapyand
periodicallythereafter.1(SeeHepaticEffectsunderCautions.)Advisepatientstoinformclinicianifpotential
manifestationsofhepaticdysfunction(e.g.,unexplainednausea,vomiting,abdominalpain,fatigue,anorexia,
darkurine,yellowingofskinorwhitesofeyes)occur.12728
Increasedriskofbladdercancer.12728Importanceofpatientnottakingpioglitazoneifreceivingtreatmentfor
bladdercancer.12728Importanceofpatientreportinganysignofmacroscopichematuriaorsymptomssuchas
dysuriaorurinaryurgencythatdeveloporincreaseduringpioglitazonetreatment.12728
Importanceoftakingexactlyasprescribed.12728Ifadoseismissedononeday,takethenextdoseas
prescribedunlessotherwiseinstructedbycliniciandonotdoublethedosetomakeupforthemisseddose.127
28 27 28
28Importanceofchangingdosagewithcautionandonlyundermedicalsupervision.2728Importanceof
immediatelycontactingaclinicianorgoingtothenearesthospitalemergencydepartmentifaccidental
overdosageoccurs.1
Importanceofadvisingpatientnottochew,cut,orcrushthecombinationpreparationcontainingpioglitazone
andextendedreleasemetforminhydrochloride(ActoPlusMetXR)mustswallowthisdosageformwhole.27
Advisepatientsthatbiologicallyinertcomponentsoftheextendedreleasecombinationtabletmayoccasionally
beeliminatedinfecesasasoftmassthatmayresembleoriginaltablet.27
Riskofhypoglycemiainpatientsreceivingconcomitantinsulinorotherantidiabetictherapy.1Provide
instructionsregardingmanagementofhypoglycemia,includingrecognitionofsymptoms,predisposing
conditions,andtreatment.1
Riskofpregnancyinpremenopausalanovulatorywomen.12728Advisepatientstoutilizeeffective
contraceptionduringtherapy.12728
Importanceofadheringtodietandexerciseregimen.1Importanceofregularmonitoring(preferablyself
monitoring)ofbloodglucoseandofHbA1c.127
Riskoffractures(e.g.,hand,upperarm,foot)inwomen.150
Importanceofregulareyeexaminations.1Importanceofreportingchangesinvision.1
Importanceofinformingcliniciansofexistingorcontemplatedconcomitanttherapy,includingprescriptionand
OTCdrugs,aswellasanyconcomitantillnesses.127
Importanceofwomeninformingtheirclinicianiftheyareorplantobecomepregnantorplantobreastfeed.127
28
Importanceofinformingpatientsofotherimportantprecautionaryinformation.127(SeeCautions.)
Preparations
Excipientsincommerciallyavailabledrugpreparationsmayhaveclinicallyimportanteffectsinsomeindividuals
consultspecificproductlabelingfordetails.
PleaserefertotheASHPDrugShortagesResourceCenterforinformationonshortagesofoneormoreof
thesepreparations.
PioglitazoneHydrochloride
Routes DosageForms Strengths BrandNames Manufacturer
Oral Tablets,filmcoated 15mg(ofpioglitazone) Actos Takeda
30mg(ofpioglitazone) Actos Takeda
45mg(ofpioglitazone) Actos Takeda
PioglitazoneHydrochlorideCombinations
Routes DosageForms Strengths Brand Manufacturer
Names
Oral Tablets 15mg(ofpioglitazone)with Actoplus Takeda

MetforminHydrochloride500mg Met
Takeda
15mg(ofpioglitazone)with Actoplus
MetforminHydrochloride850mg Met
30mg(ofpioglitazone)with Duetact Takeda

Glimepiride2mg
30mg(ofpioglitazone)with Duetact Takeda

Glimepiride4mg
Oral Tablets,extendedrelease 15mg(ofpioglitazone)with Actoplus Takeda

(metforminhydrochloridecore) MetforminHydrochloride1g MetXR
30mg(ofpioglitazone)with Actoplus Takeda

MetforminHydrochloride1g MetXR
AHFSDIEssentials.Copyright,2016,AmericanSocietyofHealthSystemPharmacists,Inc.,7272WisconsinAvenue,Bethesda,Maryland20814.
Datemodified:February08,2016
Lastreviewed:February09,2015
Datepublished:May01,2004
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Drug Interaction Comments

Antidiabeticagents Additiveeffectspossible Mayneedtoreducedosageofotherantidiabeticagents1

Gemfibrozil Increasedpioglitazone Donotexceedmaximumpioglitazonedosageof15mg

Nifedipine,extended Decreasedpeakplasma Clinicalimportanceunknown1

Oralcontraceptives, Smalldecreasesinpeak Clinicalimportanceunknown1

Rifampin Decreasedpioglitazone Mayrequirechangeinantidiabetictherapyifrifampin

Oral Tablets,filmcoated 15mg(ofpioglitazone) Actos Takeda

30mg(ofpioglitazone) Actos Takeda

45mg(ofpioglitazone) Actos Takeda

Oral Tablets 15mg(ofpioglitazone)with Actoplus Takeda

30mg(ofpioglitazone)with Duetact Takeda

30mg(ofpioglitazone)with Duetact Takeda

Oral Tablets,extendedrelease 15mg(ofpioglitazone)with Actoplus Takeda

30mg(ofpioglitazone)with Actoplus Takeda

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