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AcarboseMonographforProfessionalsDrugs.com
Acarbose
Class:alphaGlucosidaseInhibitors
VAClass:HS502
ChemicalName:O4,6dideoxy4[[[1S(1,4,5,6)]4,5,6trihydroxy3(hydroxymethyl)2
cyclohexen1yl]amino]dglucopyranosyl(14)Odglucopyranosyl(14)dglucose
MolecularFormula:C25H43NO18
CASNumber:56180940
Brands:Precose
Introduction
Antidiabeticagentanglucosidaseinhibitor.163052
UsesforAcarbose
DiabetesMellitus
Usedasmonotherapyasanadjuncttodietandexerciseforthemanagementoftype2(noninsulindependent)
diabetesmellitus(NIDDM)inpatientswhosehyperglycemiacannotbecontrolledbydietandexercisealone.1614
47
Alsousedasadjuncttodietandexerciseincombinationwithmetformin,asulfonylurea,orinsulinfor
managementoftype2diabetesmellitusinpatientswhosehyperglycemiacannotbecontrolledwithacarbose,
metformin,insulin,orsulfonylureamonotherapy,diet,andexercise.1361423264447
Metformingenerallyrecommendedoverotherantidiabeticagentsforinitialoralantidiabetictherapybecauseof
absenceofweightgainorhypoglycemia,relativelylowerexpenseandgreaterefficacy,andgenerallylow
adverseeffectprofile.110
ADAandotherclinicianspreferadditionofaninsulin,asulfonylurea,orathiazolidinedioneoveranglucosidase
inhibitor(e.g.,acarbose),pramlintide,exenatide,orameglitinide(e.g.,repaglinide,nateglinide)assecondline
therapyinpatientsinadequatelycontrolledonmetforminmonotherapybecauseofrelativelylesserefficacy,
limitedclinicaldata,frequentGIadverseeffects,and/orgreatercostwiththelatteragents.110
Acarboseshouldnotbeusedassoleantidiabetictherapyinpatientswhosediabetesiscomplicatedby
ketoacidosiswithorwithoutcoma(e.g.,type1[insulindependent,IDDM]diabetesmellitus)instead,such
patientsshouldreceiveinsulin.157
AcarboseDosageandAdministration
General
IndividualizetreatmentandadjusttargetbloodglucoseandglycosylatedhemoglobinA1c(HbA1c)
concentrationsbasedonpatientsunderstandingandadherencetothetreatmentregimen,theriskofsevere
hypoglycemia,andotherfactorsthatmayincreaseriskordecreasebenefit(e.g.,veryyoungoroldage,
comorbidconditions,otherdiseasesthatmateriallyshortenlifeexpectancy).162
Goaloftherapyistoreducebothpostprandialblood(orplasma)glucoseandhemoglobinvaluestonormalor
nearnormalusinglowesteffectivedosageofacarboseasmonotherapyorcombinedwithasulfonylurea
antidiabeticagent,metformin,orinsulin.1(Plasmaglucoseconcentrationsgenerally1015%higherthanthose
inwholebloodandmayvaryaccordingtomethodandlaboratoryused.)63Duringtherapyinitiationanddosage
titration,obtain1hourpostprandialglucoseconcentrationtodeterminetherapeuticresponseandminimum
1 14 23 52 62
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effectivedosage.114235262MonitorHbA
1cvaluesatapproximatelyevery3monthstoevaluatelongterm
glycemiccontrol.114235262Monitorglucoseconcentrations12hoursafterthestartofamealinthosewho
haveelevatedHbA1cdespiteadequatepreprandialglucoseconcentrations.62
Administration
OralAdministration
Administerorallyatthebeginning(withthefirstbite)ofeachmainmeal.123Ifadoseismissed,takethenext
doseatthenextmeal.108Donottakeadoubledosetomakeupforthemisseddose.108
Dosage
Adults
DiabetesMellitus
Oral
Initially,25mg3timesdailyatthebeginningofeachmainmeal.123InpatientswithadverseGIeffects,2122334
initiateat25mgoncedailyandincreasedosagegraduallyasnecessaryto25mg3timesdaily.1
Oncedosageof25mg3timesdailyhasbeenreached,increasedosageatintervalsof48weeksastoleratedto
achievethedesired1hourpostprandialglucoseconcentration(i.e.,<180mg/dL).12334415262Maintenance
dosagerangesfrom50100mg3timesdaily.1647
Dosageshigherthan100mg3timesdailyarenotrecommendedsincesuchdosageshavebeenassociatedwith
anincreasedriskofelevatedserumaminotransferaseconcentrations.1101819202223252730374352Ifnofurther
therapeuticbenefitoccursatthemaximumrecommendeddosage,considerloweringthedosage.1
PrescribingLimits
Adults
DiabetesMellitus
Oral
Patients60kg:maximum50mg3timesdaily.123344152
Patients>60kg:maximum100mg3timesdaily.1
CautionsforAcarbose
Contraindications
Knownhypersensitivitytothedrug.1
Diabeticketoacidosis.1
Cirrhosis.1
Inflammatoryboweldisease,coloniculceration,existingpartialintestinalobstructionorpredispositiontothis
condition.1
Chronicintestinaldiseasesassociatedwithmarkeddisordersofdigestionorabsorption.1
Coexistingconditionsthatmaydeteriorateasaresultofincreasedintestinalgasformation.1
Warnings/Precautions
GeneralPrecautions
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MetabolicEffects
Shouldnotcausehypoglycemiawhenadministeredaloneinthefastedorpostprandialstate.1However,
hypoglycemia(rarelyhypoglycemicshock)mayoccurwhenusedconcomitantlywithasulfonylureaantidiabetic
agentand/orinsulin.1Ifhypoglycemiaoccurs,adjustdosageoftheseagentsappropriately.1Useoralglucose
(dextrose)forthetreatmentofmildtomoderatehypoglycemiainsteadofsucrose(tablesugar)1theabsorptionof
oralglucoseisnotinhibitedbyacarbose.1SeverehypoglycemiamayrequiretheuseofeitherIVglucoseor
parenteralglucagon.1
Insulinmayberequiredforcorrectionoftemporaryhyperglycemiathatisnotcontrolledbydietaryregulationor
oralantidiabeticagentsduringperiodsofseverestress(e.g.,acuteinfection,trauma,surgery,fever).15759
HepaticEffects
Elevationsinserumaminotransferase(i.e.,ALT,AST)concentrationsand,inrareinstances,hyperbilirubinemia
mayoccur,particularlywithdosagesexceeding150mgdaily(50mg3timesdaily).123Jaundiceandfatal
hepatitisreportedduringpostmarketingexperience.1
Determineserumaminotransferaseconcentrationsevery3monthsduringthefirstyearoftherapyand
periodicallythereafter.1Ifelevationsinserumaminotransferaseconcentrationsoccur,reducedosage.1Maybe
necessarytowithdrawthedrug,particularlyifelevatedserumaminotransferaseconcentrationspersist.1
AdherencetoPrescribedDiet
Ifprescribeddietnotfollowedclosely,adverseGIeffectsmaybeintensified.1108TominimizeadverseGIeffects,
avoidrichfoods,sauces,andcertainbeverages,includingbeerandcarbonatedsoftdrinks.108Limitintakeofgas
producingfoodssuchasbeans,nuts,brancereals,broccoli,andcabbage.108Consumelowfatmealsand
snacks.108Drinkplentyofwater,especiallyintheearlymorning,midmorning,andafternoon.108Avoidovereating
foodportionsshouldbesmalltomoderateinsize.108Eatfoodslowlyandchewthoroughly.108Keepfooddiaryto
identifyproblemfoods.108
SpecificPopulations
Pregnancy
CategoryB.1
Lactation
Distributedintomilkinrats.1Notknownwhetherdistributedintohumanmilk.1Usenotrecommendedinnursing
women.1
PediatricUse
Safetyandefficacyinchildren<18yearsofagenotestablished.123
GeriatricUse
Safetyandefficacyinthose65yearsofagesimilartothatinyoungeradults.1(SeeSpecialPopulationsunder
Pharmacokinetics:Absorption.)
HepaticImpairment
Contraindicatedinpatientswithcirrhosis.12352Notstudiedinotherconditionsassociatedwithhepatic
impairment.12352
RenalImpairment
Notrecommendedforuseindiabeticpatientswithappreciablerenalimpairment(Scr>2mg/dL).123
CommonAdverseEffects
Flatulence,diarrhea,abdominaldiscomfort/pain.1
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InteractionsforAcarbose
DigestiveEnzymeSupplements
Possiblereductionintheglycemiceffectsofacarbose.1Avoidconcomitantuse.1
IntestinalAdsorbents
Possiblereductionintheglycemiceffectsofacarbose.1Avoidconcomitantuse.1
SpecificDrugs
Drug
Interaction
Comments
Amylase(digestive
enzymepreparation)
Possiblereductioninglycemic
effectsofacarbose1
Avoidconcomitantuse1
Calciumchannel
blockingagents
Potentialtoexacerbate
hyperglycemia,resultinginlossof
glycemiccontrol1
Monitorforlossofglycemiccontrol1
Noeffectofacarboseonthe
pharmacokineticor
pharmacodynamicsofnifedipine1
Whencalciumchannelblockingagentsare
withdrawninpatientsreceivingconcurrent
sulfonylureasorinsulin,monitorforevidence
ofhypoglycemia1
Charcoal(intestinal
adsorbent)
Possiblereductioninglycemic
effectsofacarbose1
Avoidconcomitantuse1
Corticosteroids
Potentialtoexacerbate
hyperglycemia,resultinginlossof
glycemiccontrol1
Monitorforlossofglycemiccontrol1
Potentialexacerbationof
hyperglycemia/lossofglycemic
control1
Monitorforlossofglycemiccontrol1
Digoxin
Decreasedbloodconcentrationsof
digoxin1
Mayrequireincreaseddigoxindosage1
Diuretics(e.g.,thiazides)
Potentialexacerbationof
hyperglycemia,resultinginlossof
glycemiccontrol1
Monitorforlossofglycemiccontrol1
Contraceptives,oral
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Whencorticosteroidsarewithdrawnin
patientsreceivingconcurrentsulfonylureas
orinsulin,monitorforevidenceof
hypoglycemia1
Whenoralcontraceptivesarewithdrawnin
patientsreceivingconcurrentsulfonylureas
orinsulin,observeforevidenceof
hypoglycemia1
Whendiureticsarewithdrawninpatients
receivingconcurrentsulfonylureasorinsulin,
observeforevidenceofhypoglycemia1
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Estrogens
AcarboseMonographforProfessionalsDrugs.com
Potentialtoexacerbate
hyperglycemia,resultinginlossof
glycemiccontrol1
Monitorforlossofglycemiccontrol1
Whenestrogensarewithdrawninpatients
receivingconcurrentsulfonylureasorinsulin,
observeforevidenceofhypoglycemia1
Glyburide
Noeffectonabsorptionor
Pharmacokineticinteractionwithglyburide
dispositionofconcomitantglyburide1 unlikely1
Insulin
Increasedriskofhypoglycemia,
rarelyhypoglycemicshock,with
concomitantinsulin1
Ifhypoglycemiaoccurs,reduceinsulin
dosage1
Isoniazid
Potentialtoexacerbate
hyperglycemia,resultinginlossof
glycemiccontrol1
Monitorforlossofglycemiccontrol1
Metformin
Possibledecreasedpeakplasma
concentrationofmetformin1
Pharmacokineticinteractionnotconsidered
clinicallyimportant1
Nicotinicacid
Potentialtoexacerbatediabetes
mellitus,resultinginlossofglycemic
control1
Monitorforlossofglycemiccontrol1
Pancreatin(digestive
enzymepreparationno
longercommercially
availableintheUS)
Possiblereductioninglycemic
effectsofacarbose1
Avoidconcomitantuse1
Phenothiazines
Potentialtoexacerbate
hyperglycemia,resultinginlossof
glycemiccontrol1
Monitorforlossofglycemiccontrol1
Potentialtoexacerbate
hyperglycemia,resultinginlossof
glycemiccontrol1
Monitorforlossofglycemiccontrol1
Phenytoin
Whenisoniazidiswithdrawninpatients
receivingconcurrentsulfonylureasorinsulin,
monitorforevidenceofhypoglycemia1
Whennicotinicacidiswithdrawninpatients
receivingconcurrentsulfonylureasorinsulin,
observeforevidenceofhypoglycemia1
Whenphenothiazinesarewithdrawnin
patientsreceivingconcurrentsulfonylureas
orinsulin,monitorforevidenceof
hypoglycemia1
Whenphenytoiniswithdrawninpatients
receivingconcurrentsulfonylureasorinsulin,
monitorforevidenceofhypoglycemia1
Pramlintide
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Delayedgastricemptyingcausedby
glucosidaseinhibitorsmayalter
effectsofpramlintideonGI
absorptionofnutrients112
Propranolol
Pharmacokineticor
pharmacodynamicinteraction
unlikely1
Ranitidine
Pharmacokineticor
pharmacodynamicinteraction
unlikely1
Rosiglitazone
Reducedextentofabsorptionand
prolongedhalflifeofrosiglitazone113
Avoidconcomitantpramlintide
safety/efficacyofcombinationtherapynot
established112
Pharmacokineticinteractionnotconsidered
clinicallyimportant113
Potentialforalteredglycemiccontrol
isuncertain114
Sulfonylureas
Increasedriskofhypoglycemia,
hypoglycemicshockwith
sulfonylureas1
Ifhypoglycemiaoccurs,reducesulfonylurea
dosage1
Sympathomimetic
agents
Potentialtoexacerbate
hyperglycemia,resultinginlossof
glycemiccontrol1
Monitorforlossofglycemiccontrol1
Thyroidagents
Potentialtoexacerbate
hyperglycemia,resultinginlossof
glycemiccontrol1
Monitorforlossofglycemiccontrol1
Whensympathomimeticagentsare
withdrawninpatientsreceivingconcurrent
sulfonylureasorinsulin,monitorforevidence
ofhypoglycemia.1
Whenthyroidagentsarewithdrawnin
patientsreceivingconcurrentsulfonylureas
orinsulin,monitorforevidenceof
hypoglycemia1
AcarbosePharmacokinetics
Absorption
Bioavailability
Lowsystemicbioavailabilityofparentcompound<2%ofdoseisabsorbedasactivedrug(parentcompoundand
activemetabolite).1Peakplasmaconcentrationsofactivedrugattainedatapproximately1hour.1Approximately
34%ofdoseabsorbedasnumerousmetabolites.1
Onset
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Satisfactorycontrolofbloodglucoseconcentrationsachievedwithinafewdaysafterdosageadjustment
however1823maximumresponsemaybedelayedforupto2weeks.1823
SpecialPopulations
Ingeriatricpatients,meanAUCandpeakbloodconcentrationsofthedrugwerehighercomparedwithyounger
adults1differencesnotstatisticallysignificant.1
Inindividualswithsevererenalimpairment(CLcr<25mL/minute),peakplasmadrugconcentrationsandAUC
increasedcomparedwiththosevaluesinindividualswithnormalrenalfunction.1
Distribution
Extent
Distributedintomilkinrats.1
Elimination
Metabolism
MetabolizedexclusivelyinGItract,principallybyintestinalbacteriabutalsobydigestiveenzymestonumerous
metabolites,oneofwhichisactive.1
EliminationRoute
Excretedprincipallyinfeces(51%ofdose)asunabsorbeddrugandinurineasmetabolites(34%ofdose).1No
accumulationwithrecommendeddosingfrequency.1
Halflife
Approximately2hours.1
Stability
Storage
Oral
Tablets
25C.1Protectfrommoisture.1
Actions
Smallinhibitoryeffectonglucosidaseenzymes(e.g.,glucoamylase,sucrase,maltase,isomaltase)that
hydrolyzeoligosaccharides,trisaccharides,anddisaccharidestoglucoseandothermonosaccharidesinthe
intestinalbrushborder.261424293052Smallinhibitoryeffectonpancreaticamylase,whichhydrolyzesstarch
intomaltose,maltotriose,anddextrinsinthelumenofthesmallintestine.2143033Noinhibitoryeffectonlactase
andwouldnotbeexpectedtoproducelactoseintolerance.1
Delayscarbohydratebreakdownandglucoseabsorptionandreducespostprandialhyperglycemiaindiabetic
patients.12671014232430
Reducesfluctuationsinthedailybloodglucoseconcentrationtimeprofileinpatientswithtype2diabetes
mellitusandinleanorobesenondiabeticindividuals.12367192021232435373947Fastingbloodglucose
concentrationseithernotaffectedormildlydecreased.12367192021232435373947
Incontrasttosulfonylureaantidiabeticagents,acarbosedoesnotenhanceinsulinsecretion.1Doesnot
producehypoglycemiawhengivenasmonotherapyinfastingindividuals.1
Whenusedincombinationwithsulfonylureaantidiabeticagentsareusedincombination,acarbosereduces
theinsulinotropicandweightincreasingeffectsofsulfonylureas.1Noclinicallyimportantlossofcaloriesor
weightlossoccursineitherdiabeticornondiabeticindividuals.26131418212328353739
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AdvicetoPatients
Importanceofadherencetodietandexerciseregimen.12354
ImportanceofadherencetodietaryprecautionsdesignedtominimizeadverseGIeffects.1108Importanceof
consultingaclinicianfordosageadjustmentsifadverseGIeffectsoccurdespiteadherencetosuchdietary
precautions.1(SeeAdherencetoPrescribedDietunderCautions.)
Importanceofregularmonitoringofbloodglucoseconcentrations.114235262
Importanceofavoidinginfection.23
Provideinstructiononthemanagementofhyperglycemiaorhypoglycemia.2362Adviseoftheriskof
hypoglycemia,itssymptoms,andconditionsthatpredisposetothedevelopmentofhypoglycemia.1Importance
ofkeepingareadilyavailablesourceofglucose(dextrose)totreatsymptomsofhypoglycemiawhenusedin
combinationwithasulfonylureaagentorinsulin.1
Importanceofinformingcliniciansofexistingorcontemplatedconcomitanttherapy,includingprescriptionand
OTCdrugs.1
Importanceofwomeninformingcliniciansiftheyareorplantobecomepregnantorplantobreastfeed.1
Importanceofadvisingpatientsofotherimportantprecautionaryinformation.1(SeeCautions.)
Preparations
Excipientsincommerciallyavailabledrugpreparationsmayhaveclinicallyimportanteffectsinsomeindividuals
consultspecificproductlabelingfordetails.
PleaserefertotheASHPDrugShortagesResourceCenterforinformationonshortagesofoneormoreof
thesepreparations.
Acarbose
Routes
DosageForms
Strengths
BrandNames
Manufacturer
Oral
Tablets
25mg
Precose
Bayer
50mg
Precose
Bayer
100mg
Precose
Bayer
AHFSDIEssentials.Copyright,2016,AmericanSocietyofHealthSystemPharmacists,Inc.,7272WisconsinAvenue,Bethesda,Maryland20814.
Lastreviewed:March23,2012
Datemodified:February08,2016
Datepublished:May01,2004
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