Patient Instructions for Use

Booklet Includes:1-PatientInstructions

2-FullPrescribingInformation

3-MedicationGuide

Dispense the enclosed Medication Guide to each patient.

2

Instructions for Use

NOTE: Dilute the solution concentrate as directed prior to use.

Pour ONE (1) 6-ounce bottle of SUPREP liquid into

the mixing container.

STEP

1

Add cool drinking water to the 16-ounce line on the

container and mix.

STEP

2

FILL LINE

Your doctor has recommended split-dose SUPREP

On the day before your procedure• You may have a light breakfast or have clear liquids ONLY;

please have nothing for dinner• DO NOT drink milk• DO NOT eat or drink anything colored red or purple• DO NOT drink alcoholic beverages

• On the evening before procedure (or when your doctor tells you to begin) complete steps 1 through 4 using one (1) 6-ounce bottle before going to bed

Split-Dose (2-Day) Regimen

3

NOTE: You must finish drinking the final glass of water at least 1 hour, or as directed, before your colonoscopy.

Drink ALL the liquid in the container.

STEP

3

You must drink two (2) more 16-ounce containers

of water over the next 1 hour.

STEP

4

IMPORTANT

Any of the following liquids are OKWaterStrained fruit juices (without pulp) including apple, orange, white grape, or white cranberryLimeade or lemonadeCoffee or tea (DO NOT use any dairy or non-dairy creamer)Chicken brothGelatin desserts without added fruit or topping (NO RED OR PURPLE)

• On the morning of your procedure, repeat steps 1 through 4 using the other 6-ounce bottle

(Both 6-ounce bottles are required for a complete prep.)

4

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use SUPREP Bowel Prep Kit safely and effectively. See full prescribing information for SUPREP Bowel Prep KitSUPREP Bowel Prep Kit (sodium sulfate, potassium sulfate, and magnesium sulfate) Oral Solution Initial U.S. Approval: 08/2010

-------------------- INDICATIONS AND USAGE --------------------SUPREPBowelPrepKitisanosmoticlaxativeindicatedforcleansingofthecoloninpreparationforcolonoscopyinadults(1)----------------- DOSAGE AND ADMINISTRATION -----------------Dilutethesolutionpriortouse.SeeFULLPRESCRIBINGINFORMATIONforcompletedosingandadministrationinstructions(2)SplitDose(2-Day)Regimen• Eveningbeforecolonoscopy:dilute1bottleto16ozwithwater

anddrinkentireamount.• Drink32ozwateroverthenexthour.• Nextmorning:repeatbothstepsusingthesecondbottle.• Completepreparationatleast1hourbeforecolonoscopy.

----------------DOSAGE FORMS AND STRENGTHS ----------------• Two6ozbottlesoforalsolution(3)

---------------------- CONTRAINDICATIONS ----------------------• Gastrointestinalobstruction(4,5.6)• Bowelperforation(4,5.6)• Gastricretention(4)• Ileus(4)• Toxiccolitisortoxicmegacolon(4)• Knownallergiestocomponentsofthekit(4,11)

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----------------- WARNINGS AND PRECAUTIONS -----------------• Riskoffluidandelectrolyteabnormalities,arrhythmias,

seizuresandrenalimpairment–assessconcurrentmedicationsandconsidertestinginsomepatients(5.1,5.2,5.3)

• Patientswithrenalinsufficiency–usecaution,ensureadequatehydrationandconsidertesting(5.4)

• SuspectedGIobstructionorperforation–ruleoutthediagnosisbeforeadministration(4,5.6)

• Patientsatriskforaspiration–observeduringadministration(5.7)

• Notfordirectingestion–diluteandtakewithadditionalwater(5.8)

---------------------- ADVERSE REACTIONS ----------------------Mostcommonadversereactions(≥3%)are:overalldiscomfort,abdominalfullness,nausea,abdominalcramping,andvomiting(6)To report SUSPECTED ADVERSE REACTIONS, contact Braintree Laboratories, Inc. at 1-800-874-6756 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

---------------------- DRUG INTERACTIONS ----------------------• Somedrugsincreaserisksduetofluidandelectrolytechanges

(7.1)• Oralmedicationtakenwithin1hourofstartofeachdosemight

notbeabsorbedproperly(7.2)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised 08/2010

6

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS 5.1 PatientsatRiskforSeriousFluidandElectrolyte

Abnormalities 5.2 RiskofSeizures 5.3 RiskofCardiacArrhythmias 5.4 RiskofRenalImpairment 5.5 RiskofColonicMucosalAphthousUlcerations 5.6 UseinPatientswithSignificantGastrointestinal

Disease 5.7 PatientsatRiskforAspiration 5.8 NotforDirectIngestion

6 ADVERSE REACTIONS 6.1 ClinicalStudiesExperience

7 DRUG INTERACTIONS 7.1 DrugsThatMayIncreaseRisksDuetoFluidand

ElectrolyteAbnormalities 7.2 PotentialforAlteredDrugAbsorption

7

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 NursingMothers 8.4 PediatricUse 8.5 GeriatricUse

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY 12.1 MechanismofAction 12.2 Pharmacodynamics 12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis,Mutagenesis,ImpairmentofFertility 13.2 AnimalToxicologyand/orPharmacology

14 CLINICAL STUDIES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION 17.1 PatientCounseling

*Sectionsorsubsectionsomittedfromthefullprescribinginformationarenotlisted.

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FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE SUPREPBowelPrepKitisindicatedforcleansingofthecolonasapreparationforcolonoscopyinadults.

2 DOSAGE AND ADMINISTRATION SUPREPBowelPrepKitshouldbetakenasasplit-doseoralregimen.

ThedoseforcoloncleansingrequiresadministrationoftwobottlesofSUPREPBowelPrepKit.Eachbottleisadministeredas16ozofdilutedSUPREPsolutionwithanadditional1quartofwatertakenorally.Thetotalvolumeofliquidrequiredforcoloncleansing(usingtwobottles)is3quarts(approximately2.8L)takenorallypriortothecolonoscopyinthefollowingway:

Split-Dose (Two-Day) RegimenDaypriortocolonoscopy:• Alightbreakfastmaybeconsumed,orhaveonlyclearliquids

onthedaybeforecolonoscopy.Avoidredandpurpleliquids,milk,andalcoholicbeverages.

• Earlyintheeveningpriortocolonoscopy:pourthecontentsofonebottleofSUPREPBowelPrepKitintothemixingcontainerprovided.Fillthecontainerwithwatertothe16ozfillline,anddrinktheentireamount.

• Drinktwoadditionalcontainersfilledtothe16ozlinewithwateroverthenexthour.

Dayofcolonoscopy:• Haveonlyclearliquidsuntilafterthecolonoscopy.Avoidred

andpurpleliquids,milk,andalcoholicbeverages.

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• Themorningofcolonoscopy(10to12hoursaftertheeveningdose):pourthecontentsofthesecondbottleofSUPREPBowelPrepKitintothemixingcontainerprovided.Fillthecontainerwithwatertothe16ozfillline,anddrinktheentireamount.

• Drinktwoadditionalcontainersfilledtothe16ozlinewithwateroverthenexthour.

• CompleteallSUPREPBowelPrepKitandrequiredwateratleastonehourpriortocolonoscopy.

3 DOSAGE FORMS AND STRENGTHS Two6ozbottlesoforalsolution. Each6ozbottlecontains:sodiumsulfate17.5g,potassiumsulfate3.13g,magnesiumsulfate1.6g.

4 CONTRAINDICATIONS • Gastrointestinalobstruction• Bowelperforation• Gastricretention• Ileus• Toxiccolitisortoxicmegacolon• Knownallergiestocomponentsofthekit

[see Description (11)]

5 WARNINGS AND PRECAUTIONS 5.1 Serious Fluid and Serum Chemistry Abnormalities

Adviseallpatientstohydrateadequatelybefore,during,andaftertheuseofSUPREPBowelPrepKit.IfapatientdevelopssignificantvomitingorsignsofdehydrationaftertakingSUPREPBowelPrepKit,considerperformingpost-colonoscopylabtests(electrolytes,creatinine,andBUN).Fluidandelectrolytedisturbancescanleadtoseriousadverseeventsincludingcardiacarrhythmias,seizuresandrenalimpairment.

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PatientswithelectrolyteabnormalitiesshouldhavethemcorrectedbeforetreatmentwithSUPREPBowelPrepKit.Inaddition,usecautionwhenprescribingSUPREPBowelPrepKitforpatientswithconditions,orwhoareusingmedications,thatincreasetheriskforfluidandelectrolytedisturbancesormayincreasetheriskofadverseeventsofseizure,arrhythmias,andrenalimpairment.[see Drug Interactions (7.1)]

SUPREPBowelPrepKitcancausetemporaryelevationsinuricacid.[see Adverse Reactions (6.1)].Uricacidfluctuationsinpatientswithgoutmayprecipitateanacuteflare.ThepotentialforuricacidelevationshouldbeconsideredbeforeadministeringSUPREPBowelPrepKittopatientswithgoutorotherdisordersofuricacidmetabolism.

5.2 Cardiac Arrhythmias Therehavebeenrarereportsofseriousarrhythmias

associatedwiththeuseofionicosmoticlaxativeproductsforbowelpreparation.UsecautionwhenprescribingSUPREPBowelPrepKitforpatientsatincreasedriskofarrhythmias(e.g.,patientswithahistoryofprolongedQT,uncontrolledarrhythmias,recentmyocardialinfarction,unstableangina,congestiveheartfailure,orcardiomyopathy).Pre-doseandpost-colonoscopyECGsshouldbeconsideredinpatientsatincreasedriskofseriouscardiacarrhythmias.

5.3 SeizuresTherehavebeenreportsofgeneralizedtonic-clonicseizures

and/orlossofconsciousnessassociatedwithuseofbowelpreparationproductsinpatientswithnopriorhistoryofseizures.Theseizurecaseswereassociatedwithelectrolyteabnormalities(e.g.,hyponatremia,hypokalemia,hypocalcemia,andhypomagnesemia)andlowserumosmolality.Theneurologicabnormalitiesresolvedwithcorrectionoffluidandelectrolyteabnormalities.

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UsecautionwhenprescribingSUPREPBowelPrepKitforpatientswithahistoryofseizuresandinpatientsatincreasedriskofseizure,suchaspatientstakingmedicationsthatlowertheseizurethreshold(e.g.,tricyclicantidepressants),patientswithdrawingfromalcoholorbenzodiazepines,orpatientswithknownorsuspectedhyponatremia.

5.4 Renal ImpairmentUsecautionwhenprescribingSUPREPBowelPrepKitfor

patientswithimpairedrenalfunctionorpatientstakingconcomitantmedicationsthatmayaffectrenalfunction(suchasdiuretics,angiotensinconvertingenzymeinhibitors,angiotensinreceptorblockers,ornon-steroidalanti-inflammatorydrugs).Advisethesepatientsoftheimportanceofadequatehydration,andconsiderperformingbaselineandpost-colonoscopylaboratorytests(electrolytes,creatinine,andBUN)inthesepatients.

5.5 Colonic Mucosal Ulcerations and Ischemic ColitisAdministrationofosmoticlaxativeproductsmayproduce

colonicmucosalaphthousulcerations,andtherehavebeenreportsofmoreseriouscasesofischemiccolitisrequiringhospitalization.ConcurrentuseofstimulantlaxativesandSUPREPBowelPrepKitmayincreasetheserisks.Thepotentialformucosalulcerationsresultingfromthebowelpreparationshouldbeconsideredwheninterpretingcolonoscopyfindingsinpatientswithknownorsuspectinflammatoryboweldisease(IBD).

5.6 Use in Patients with Significant Gastrointestinal DiseaseIfgastrointestinalobstructionorperforationissuspected,

performappropriatediagnosticstudiestoruleouttheseconditionsbeforeadministeringSUPREPBowelPrepKit.

Usewithcautioninpatientswithsevereactiveulcerativecolitis.

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5.7 AspirationUsewithcautioninpatientswithimpairedgagreflexand

patientspronetoregurgitationoraspiration.SuchpatientsshouldbeobservedduringadministrationofSUPREPBowelPrepKitsolution.

5.8 Not for Direct IngestionEachbottlemustbedilutedwithwatertoafinalvolumeof

16ozandingestionofadditionalwaterasrecommendedisimportanttopatienttolerance.Directingestionoftheundilutedsolutionmayincreasetheriskofnausea,vomiting,dehydration,andelectrolytedisturbances.

6 ADVERSE REACTIONS6.1 Clinical Studies Experience Becauseclinicalstudiesareconductedunderwidelyvaryingconditions,adversereactionratesobservedintheclinicalstudiesofadrugcannotbedirectlycomparedtoratesinclinicalstudiesofanotherdrugandmaynotreflecttheratesobservedinpractice.

Inamulticenter,controlledclinicaltrialcomparingSUPREPBowelPrepKitwithabowelprepcontainingpolyethyleneglycolandelectrolytes(PEG+E)thatwereadministeredinasplit-dose(2-day)regimen,themostcommonadversereactionsafteradministrationofSUPREPBowelPrepKitwereoveralldiscomfort,abdominaldistention,abdominalpain,nausea,vomiting,andheadache;seeTable1,below.LesscommonAdverseReactionsoccurringwereAVBlock(1case)andCKincrease.Inthisstudy,patientsreceivingSUPREPBowelPrepKitwerelimitedtoalightbreakfastfollowedbyclearliquids;patientsreceivingthePEG+Ebowelprepwereallowedtohaveanormalbreakfastandalightlunch,followedbyclearliquids.

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Table 1: Treatment-Emergent Adverse Reactions Observed in at Least 2% of Patients on the

Split-Dose (2-Day) Regimen

Symptom

Split-Dose (2-Day) Regimen

SUPREP N=190

PEG + E product N=189

OverallDiscomfort 54% 67%

AbdominalDistension 40% 52%

AbdominalPain 36% 43%

Nausea 36% 33%

Vomiting 8% 4%

Headache 1.1% 0.5%

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Table2showsthepercentagesofpatientswhodevelopednewabnormalitiesofimportantelectrolytesanduricacidaftercompletingthebowelpreparationwitheitherSUPREPBowelPrepKitorPEG+Eadministeredasasplit-dose(2-day)regimen.

Table 2: Patients with Normal Baseline Serum Chemistry with A Shift to an Abnormal Value While on the

Split-Dose (2-Day) RegimenDay of

Colonoscopyn (%)*

Day 30

n (%)*Aniongap(high)† SUPREP 14(8.9) 3(1.9)

PEG+Electrolytes 12(7.6) 2(1.4)Bicarbonate(low) SUPREP 20(12.7) 7(4.4)

PEG+Electrolytes 24(15.2) 4(2.7)Bilirubin,total(high) SUPREP 14(8.5) 0(0)

PEG+Electrolytes 20(11.7) 3(1.9)BUN(high) SUPREP 2(1.6) 14(11.2)

PEG+Electrolytes 4(2.9) 19(14.5)Calcium(high) SUPREP 16(10.4) 8(5.2)

PEG+Electrolytes 6(3.7) 6(3.9)Chloride(high) SUPREP 4(2.4) 6(3.7)

PEG+Electrolytes 20(12.2) 6(3.8)Creatinine(high) SUPREP 3(1.9) 5(3.2)

PEG+Electrolytes 2(1.2) 8(5.2)Osmolality(high) SUPREP 8(5.8) NA

PEG+Electrolytes 19(12.9) NAOsmolality(low) SUPREP 3(2.2) NA

PEG+Electrolytes 2(1.4) NAPotassium(high) SUPREP 3(1.8) 6(3.7)

PEG+Electrolytes 5(2.9) 8(4.9)Sodium(low) SUPREP 5(3.1) 1(0.6)

PEG+Electrolytes 4(2.3) 2(1.2)Uricacid(high) SUPREP 27(23.5) 13(11.5)

PEG+Electrolytes 12(9.5) 20(16.7)

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*Percent(n/N)ofpatientswhereN=numberofpatientswithnormalbaselinewhohadabnormalvaluesatthetimepoint(s)ofinterest.†Patientswithnormalbicarbonateatbaselinewhodevelopedlowbicarbonate(≤21mEq/L)andhighaniongap(≥13mEq/L)onDayofColonoscopyorDay30.

Therewerealso408patientswhoparticipatedinastudyinwhicheitherSUPREPBowelPrepKitorPEG+Ewereadministeredinanevening-only(1-day)regimen.Higherratesofoveralldiscomfort,abdominaldistention,andnauseawereobservedwiththeevening-only(1-day)regimencomparedtothesplit-dose(2-day)regimenforbothpreparations.PatientstreatedwithSUPREPBowelPrepKithadincreasedratesofvomitingwiththeevening-only(1-day)regimen.Anevening-only(1-day)dosingregimenwasassociatedwithhigherratesofabnormalvaluesforsomeelectrolyteswhencomparedtothesplit-dose(2-day)regimenforbothpreparations.ForSUPREPBowelPrepKit,theevening-only(1-day)regimenwasassociatedwithhigherratesoftotalbilirubin(high),BUN(high),creatinine(high),osmolality(high),potassium(high)anduricacid(high)thantheSUPREPBowelPrepKitsplit-dose(2-day)regimen.AdministrationofSUPREPBowelPrepKitinanevening-only(1-day)dosingregimenisnotrecommended.

7 DRUG INTERACTIONS7.1 Drugs That May Increase Risks Due to Fluid and

Electrolyte Abnormalities UsecautionwhenprescribingSUPREPBowelPrepKitforpatientswithconditions,orwhoareusingmedications,thatincreasetheriskforfluidandelectrolytedisturbancesormayincreasetheriskofadverseeventsofseizure,arrhythmias,andprolongedQTinthesettingoffluidandelectrolyteabnormalities.Consideradditionalpatientevaluationsasappropriate[see Warnings (5)]inpatientstakingtheseconcomitantmedications.

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7.2 Potential for Altered Drug Absorption OralmedicationadministeredwithinonehourofthestartofeachSUPREPBowelPrepKitdosemaybeflushedfromthegastrointestinaltract,andthemedicationmaynotbeabsorbedproperly.

8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy Teratogeniceffects:PregnancyCategoryC.AnimalreproductionstudieshavenotbeenconductedwithSUPREPBowelPrepKit.ItisalsonotknownwhetherSUPREPBowelPrepKitcancausefetalharmwhenadministeredtoapregnantwomanorcanaffectreproductioncapacity.SUPREPBowelPrepKitshouldbegiventoapregnantwomanonlyifclearlyneeded.

8.3 Nursing Mothers Itisnotknownwhetherthisdrugisexcretedinhumanmilk.Becausemanydrugsareexcretedinhumanmilk,cautionshouldbeexercisedwhenSUPREPBowelPrepKitisadministeredtoanursingwoman.

8.4 Pediatric Use Safetyandeffectivenessinpediatricpatientshavenotbeenestablished.

8.5 Geriatric Use Ofthe375patientswhoreceivedSUPREPBowelPrepKitinclinicaltrials,94(25%)were65yearsofageorolder,and25(7%)were75yearsofageorolder.NooveralldifferencesinsafetyoreffectivenessofSUPREPBowelPrepKitadministeredasasplit-dose(2-day)regimenwereobservedbetweengeriatricpatientsandyoungerpatients.GeriatricpatientsreportedmorevomitingwhenSUPREPBowelPrepKitwasgivenasaone-daypreparation.

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11 DESCRIPTION EachSUPREPBowelPrepKitcontainstwo6ozbottlesofsolution.Each6ozbottlecontains:sodiumsulfate17.5g,potassiumsulfate3.13g,magnesiumsulfate1.6g.Inactiveingredientsinclude:sodiumbenzoate,NF,sucralose,malicacidFCC,citricacidUSP,flavoringingredients,purifiedwater,USP.Thesolutionisacleartoslightlyhazyliquid.Thesolutionisclearandcolorlesswhendilutedtoafinalvolumeof16ozwithwater.

SodiumSulfate,USP

ThechemicalnameisNa2SO4.TheaverageMolecularWeightis142.04.Thestructuralformulais:

PotassiumSulfate,FCC,purified

ThechemicalnameisK2SO4.TheaverageMolecularWeightis174.26.Thestructuralformulais:

18

MagnesiumSulfate,USP

ThechemicalnameisMgSO4.TheaverageMolecularWeight:120.37.Thestructuralformulais:

EachSUPREPBowelPrepKitalsocontainsapolypropylenemixingcontainer.

12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action Sulfatesaltsprovidesulfateanions,whicharepoorlyabsorbed.Theosmoticeffectofunabsorbedsulfateanionsandtheassociatedcationscauseswatertoberetainedwithinthegastrointestinaltract.

12.2 Pharmacodynamics Theosmoticeffectoftheunabsorbedions,wheningestedwithalargevolumeofwater,producesacopiouswaterydiarrhea.

12.3 Pharmacokinetics Fecalexcretionwastheprimaryrouteofsulfateelimination.AfteradministrationofSUPREPBowelPrepKitinsixhealthyvolunteers,thetimeatwhichserumsulfatereacheditshighestpoint(Tmax)wasapproximately17hoursafterthefirsthalfdoseorapproximately5hoursaftertheseconddose,andthendeclinedwithahalf-lifeof8.5hours.

Mg2+

O

S

O

O- O-

19

ThedispositionofsulfateafterSUPREPBowelPrepKitwasalsostudiedinpatients(N=6)withmild-moderatehepaticimpairment(Child-PughgradesAandB)andinpatients(N=6)withmoderaterenalimpairment(creatinineclearanceof30to49mL/min).TherenalimpairmentgrouphadthehighestserumsulfateAUCandCmax,followedbythehepaticimpairmentgroup,andthenbyhealthysubjects.Systemicexposureofserumsulfate(AUCandCmax)wassimilarbetweenhealthysubjectsandhepaticimpairmentpatients.Renalimpairmentresultedin54%highermeanAUCand44%highermeanCmaxthanhealthysubjects.ThemeansulfatelevelsofallthreegroupsreturnedtotheirrespectivebaselinelevelsbyDay6afterdoseinitiation.Urinaryexcretionofsulfateover30hours,startingafterthefirsthalfdose,wassimilarbetweenhepaticpatientsandnormalvolunteers,butwasapproximately16%lowerinmoderaterenalimpairmentpatientsthaninhealthyvolunteers.

13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Long-termstudiesinanimalshavenotbeenperformedtoevaluatethecarcinogenicpotentialofSUPREPBowelPrepKit.StudiestoevaluatethepossibleimpairmentoffertilityormutagenicpotentialofSUPREPBowelPrepKithavenotbeenperformed.

13.2 Animal Toxicology and/or Pharmacology Thesulfatesaltsofsodium,potassium,andmagnesiumcontainedinSUPREPBowelPrepKitwereadministeredorally(gavage)toratsanddogsupto28daysuptoamaximumdailydoseof5g/kg/day(approximately0.9and3timesforratsanddogs,respectively,therecommendedhumandoseof44g/dayor0.89g/kgbasedonthebodysurfacearea).Inrats,thesulfatesaltscauseddiarrheaandelectrolyteandmetabolicchanges,includinghypochloremia,hypokalemia,hyponatremia,lowerserumosmolality,andhighserumbicarbonate.Significantrenalchangesincluded

20

increasedfractionalsodiumexcretion,increasedurinarysodiumandpotassiumexcretion,andalkalineurineinbothmalesandfemales.Inaddition,creatinineclearancewassignificantlydecreasedinfemalesatthehighestdose.Nomicroscopicrenalchangeswereseen.Indogs,thesulfatesaltscausedemesis,excessivesalivation,excessivedrinkingofwater,andabnormalexcreta(softand/ormucoidfecesand/ordiarrhea)andincreasedurinepHandsodiumexcretion.

14 CLINICAL STUDIES ThecoloncleansingefficacyofSUPREPBowelPrepKitwasevaluatedinarandomized,single-blind,active-controlled,multicenterstudy.Inthisstudy,363adultpatientswereincludedintheefficacyanalysis.Patientsrangedinagefrom20to84years(meanage55years)and54%werefemale.Racedistributionwas86%Caucasian,9%African-American,and5%other.

Patientswererandomizedtooneofthefollowingtwocolonpreparationregimens:SUPREPBowelPrepKitoramarketedpolyethyleneglycol(PEG)bowelprep.IntheStudySUPREPBowelPrepKitwasadministeredaccordingtoasplit-dosepreparationregimen[see Dosage and Administration (2.1)].ThePEGbowelprepwasalsogivenasasplit-dosepreparationaccordingtoitslabeledinstructions.PatientsreceivingSUPREPBowelPrepKitwerelimitedtoalightbreakfastfollowedbyclearliquidsonthedaypriortothedayofcolonoscopy;patientsreceivingthePEGbowelprepwereallowedtohaveanormalbreakfastandalightlunch,followedbyclearliquids.

Theprimaryefficacyendpointwastheproportionofpatientswithsuccessfulcoloncleansingasassessedbythecolonoscopists,whowerenotinformedaboutthetypeofpreparationreceived.Inthestudy,noclinicallyorstatisticallysignificantdifferenceswereseenbetweenthegrouptreatedwithSUPREPBowelPrepKitandthegrouptreatedwiththePEGbowelprep.SeeTable3below.

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Table 3: Colon Cleansing Response Rates

Treatment Group Regimen N

Responders1

%(95% C. I.)

SUPREP-PEG Difference(95% CI)

SUPREPBowelPrepKit(withlightbreakfast)

Split-Dose 180 97%

(94%,99%) 2%2

(-2%,5%)PEGbowelprep(withnormalbreakfast&lightlunch)

Split-Dose 183 96%

(92%,98%)

1Responderswerepatientswhosecolonpreparationsweregradedexcellent(nomorethansmallbitsofadherentfeces/fluid)orgood(smallamountsoffecesorfluidnotinterferingwiththeexam)bythecolonoscopist.

2Doesnotequaldifferenceintabledresponderratesduetoroundingeffects.

16 HOW SUPPLIED/STORAGE AND HANDLINGEachSUPREPBowelPrepKitcontains:• Two(2)6ozbottlesoforalsolution.• One(1)19ozmixingcontainerwitha16ozfillline.

Storage: Storeat20°to25°C(68°to77°F).Excursionspermittedbetween15°to30°C(59°to86°F).SeeUSPcontrolledroomtemperature.

Keepoutofreachofchildren.

SUPREPBowelPrepKit NDC 52268-012-01

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17 PATIENT COUNSELING INFORMATION See Medication Guide and FDA-Approved Patient Labeling

17.1 Patient Counseling• Askpatientstoletyouknowiftheyhavetrouble

swallowingorarepronetoregurgitationoraspiration.

• Instructpatientsthateachbottleneedstobedilutedinwaterbeforeingestionandthattheyneedtodrinkadditionalwateraccordingtotheinstructions.Directingestionoftheundilutedsolutionmayincreasetheriskofnausea,vomiting,anddehydration.

• InformpatientsthatoralmedicationsmaynotbeabsorbedproperlyiftheyaretakenwithinonehourofstartingeachdoseofSUPREPBowelPrepKit.

• TellpatientsnottotakeotherlaxativeswhiletheyaretakingSUPREPBowelPrepKit.

DistributedbyBraintreeLaboratories,Inc.Braintree,MA02185

U.S.Patent6,946,149

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Medication Guide

SUPREP® (Soo-prêp) Bowel Prep Kit(sodiumsulfate,potassiumsulfateandmagnesiumsulfate)OralSolution

ReadthisMedicationGuidebeforeyoustarttakingSUPREPBowelPrepKit.Thisinformationdoesnottaketheplaceoftalkingwithyourhealthcareprovideraboutyourmedicalconditionoryourtreatment.

What is the most important information I should know about SUPREP Bowel Prep Kit? SUPREP Bowel Prep Kit and other osmotic bowel prepara-tions can cause serious side effects, including: Serious loss of body fluid (dehydration) and changes in blood salts (electrolytes) in your blood. These changes can cause:•abnormal heartbeats that can cause death•seizures.Thiscanhappenevenifyouhaveneverhadaseizure.•kidney problemsYour chance of having fluid loss and changes in body salts with SUPREP Bowel Prep Kit is higher if you: •haveheartproblems•havekidneyproblems•takewaterpillsornon-steroidalanti-inflammatorydrugs

(NSAIDS)

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Medication GuideTell your healthcare provider right away if you have any of these symptoms of a loss of too much body fluid (dehydration) while taking SUPREP Bowel Prep Kit: • vomitingthatpreventsyoufromkeepingdowntheadditional

prescribedamountofwaterlistedintheInstructionsforUseinthePatientInstructionsforUseBooklet

•dizziness•urinatinglessoftenthannormal•headacheSee Section “What are the possible side effects of SUPREP Bowel Prep Kit?” for more information about side effects.What is SUPREP Bowel Prep Kit? SUPREPBowelPrepKitisaprescriptionmedicineusedbyadultstocleanthecolonbeforeacolonoscopy.SUPREPBowelPrepKitcleansyourcolonbycausingyoutohavediarrhea.Cleaningyourcolonhelpsyourhealthcareproviderseetheinsideofyourcolonmoreclearlyduringyourcolonoscopy.ItisnotknownifSUPREPBowelPrepKitissafeandeffectiveinchildren.Who should not take SUPREP Bowel Prep Kit? Do not take SUPREP Bowel Prep Kit if your heathcare provider has told you that you have:•ablockageinyourbowel(obstruction)• anopeninginthewallofyourstomachorintestine(bowel

perforation)• problemswithfoodandfluidemptyingfromyourstomach

(gastricretention)• averydilatedintestine(bowel)• anallergytoanyoftheingredientsinSUPREPBowelPrepKit.

SeetheendofthisleafletforacompletelistofingredientsinSUPREPBowelPrepKit.

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What should I tell my healthcare provider before taking SUPREP Bowel Prep Kit? Before you take SUPREP Bowel Prep Kit, tell your healthcare provider if you:•haveheartproblems•havestomachorbowelproblems•haveulcerativecolitis•haveproblemswithswallowingorgastricreflux•havegout•haveahistoryofseizures•arewithdrawingfromdrinkingalcohol•havealowbloodsalt(sodium)level•havekidneyproblems•anyothermedicalconditions• arepregnant.ItisnotknownifSUPREPBowelPrepKitwill

harmyourunbornbaby.Talktoyourdoctorifyouarepregnantorplantobecomepregnant.

• arebreastfeedingorplantobreastfeed.ItisnotknownifSUPREPBowelPrepKitpassesintoyourbreastmilk.YouandyourhealthcareprovidershoulddecideifyouwilltakeSUPREPBowelPrepKitwhilebreastfeeding.

Tell your healthcare provider about all the medicines you take, includingprescriptionandnon-prescriptionmedicines,vitamins,andherbalsupplements.SUPREPBowelPrepKitmayaffecthowothermedicineswork.Medicinestakenbymouthmaynotbeabsorbedproperlywhentakenwithin1hourbeforethestartofeachdoseofSUPREPBowelPrepKit.

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Medication GuideEspecially tell your healthcare provider if you take:• medicinesforbloodpressureorheartproblems• medicinesforkidneyproblems• medicinesforseizures• waterpills(diuretics)• non-steroidalanti-inflammatorymedicines(NSAID)pain

medicines• laxativesAskyourhealthcareproviderorpharmacistforalistofthesemedicinesifyouarenotsureifyouaretakinganyofthemedicineslistedabove.Knowthemedicinesyoutake.Keepalistofthemtoshowyourhealthcareproviderandpharmacistwhenyougetanewmedicine.

How should I take SUPREP Bowel Prep Kit? See the Instructions for Use in the Patient Instructions for Use Booklet for dosing instructions. You must read, understand, and follow these instructions to take SUPREP Bowel Prep Kit the right way. •TakeSUPREPBowelPrepKitexactlyasyourhealthcareprovider

tellsyoutotakeit.• Do not drink SUPREP Bowel Prep Kit solution that has not

been mixed with water (diluted), it may increase your risk of nausea, vomiting and fluid loss (dehydration).

•EachbottleofSUPREPBowelPrepKitmustbemixedwithwater(diluted)beforedrinking.

•ItisimportantforyoutodrinktheadditionalprescribedamountofwaterlistedintheInstructionsforUsetopreventfluidloss(dehydration).

•DonottakeotherlaxativeswhiletakingSUPREPBowelPrepKit.•DonoteatsolidfoodswhiletakingSUPREPBowelPrepKit.Only

clearliquidsareallowedwhiletakingSUPREPBowelPrepKit.

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What are the possible side effects of SUPREP Bowel Prep Kit? SUPREPBowelPrepKitcancauseserioussideeffects,including:• See Section “What is the most important information I should

know about SUPREP Bowel Prep Kit?” • changes in certain blood tests.Yourhealthcareprovidermaydo

bloodtestsafteryoutakeSUPREPBowelPrepKittocheckyourbloodforchanges.Tellyourhealthcareproviderifyouhaveanysymptomsoftoomuchfluidloss,including:

• vomiting • nausea • bloating • dizziness • stomach(abdominal)cramping • headache • urinatelessthanusual • troubledrinkingclearliquid• heart problems. SUPREP Bowel Prep Kit may cause irregular

heartbeats.• seizures• ulcers of the bowel or bowel problems• worsening gout

ThemostcommonsideeffectsofSUPREPBowelPrepKitinclude:• discomfort• bloating• stomach(abdominal)cramping• nausea• vomiting

Tellyourhealthcareproviderifyouhaveanysideeffectthatbothersyouorthatdoesnotgoaway.

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Medication GuideThesearenotallthepossiblesideeffectsofSUPREPBowelPrepKit.Formoreinformation,askyourhealthcareproviderorpharmacist.

Callyourdoctorformedicaladviceaboutsideeffects.YoumayreportsideeffectstoFDAat1-800-FDA-1088.

How should I store SUPREP Bowel Prep Kit? • StoreSUPREPBowelPrepKitatroomtemperature,between

59°Fto86°F(15°Cto30°C). Keep SUPREP Bowel Prep Kit and all medicines out of the reach of children.

General information about the safe and effective use of SUPREP Bowel Prep Kit. MedicinesaresometimesprescribedforpurposesotherthanthoselistedinaMedicationGuide.DonotuseSUPREPBowelPrepKitforaconditionforwhichitwasnotprescribed.DonotgiveSUPREPBowelPrepKittootherpeople,eveniftheyaregoingtohavethesameprocedureyouare.Itmayharmthem.ThisMedicationGuidesummarizesimportantinformationaboutSUPREPBowelPrepKit.Ifyouwouldlikemoreinformation,talkwithyourhealthcareprovider.Youcanaskyourpharmacistorhealthcareproviderforinformationthatiswrittenforhealthcareprofessionals.Formoreinformation,gotowww.braintreelabs.comorcall1-800-874-6756.

What are the ingredients in SUPREP Bowel Prep Kit? Active ingredients:sodiumsulfate,potassiumsulfateandmagne-siumsulfateInactive ingredients:sodiumbenzoate,sucralose,malicacid,citricacid,flavoringingredients,purifiedwater

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BraintreeLaboratories,Inc.Braintree,MA02185,USAThisMedicationGuidehasbeenapprovedbytheU.S.FoodandDrugAdministration.Revised08/2010

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U.S. Patent 6,946,149

©2010BraintreeLaboratories,Inc. SP-8412 08/2010