POTASSIUM ORAL SOLUTION

Doctor leaflet

PotassiumOralSolution

Notto beinjected.

Must bediluted beforedrinking.

Dilutethedosein120ml(abouthalf aglass) ofwateror juiceand drinkslowly.

Composition

Activeingredient:Each5ml contains10mEqpotassium(1.4gpotassiumgluconateand

0.43gpotassiumcitrate).

Action

Potassiumis thepredominantcationwithinthecells (approximately150to160mEq/L) and

intracellular sodiumcontentis relativelylow.Highintracellular potassiumconcentrations are

necessaryfor numerous cellular metabolic processes.

Inextracellular fluid,sodiumpredominates andthepotassiumcontentis low(3.5-5mEq/L). A

membrane-boundenzyme,Na+K+ATPase,activelytransports or pumps sodiumoutand

potassiumintocells tomaintaintheseconcentrationgradients.Theintracellular to

extracellular potassiumgradientsare necessaryfor theconductionofnerveimpulsesin

suchspecializedtissues as theheart, brain,andskeletal muscle,andfor themaintenanceof

normal renal functionandacid-basebalance.

Indications

Potassiumoral solutionis indicatedfor thepreventionandtreatmentofhypokalemia.

Contraindications

Donotuseinpatientshypersensitivetoanyingredient.

Exceptunder special circumstances,donotuseinhyperkalemic patients,or inpatients

sufferingfromconditions predisposingtohyperkalemiasuchas:acutemetabolic acidosis,

adrenal insufficiency,acutedehydration,uncontrolleddiabetes mellitus,chronic renal failure

andextensivetissuebreakdown,becausefurther increases inserumpotassiummaycause

cardiacarrest.

Warnings

Cautionis warrantedinpatientssufferingfromsevere or prolongeddiarrhearesultingin

severe dehydration.Theloss offluids incombinationwithuseofpotassiumsupplements

maycauserenal toxicity,whichmayincreasetherisk ofhyperkalemia.Ifpotassium

supplementsare giveninthepresenceofdiarrhea,serumpotassiumlevels shouldbe

monitored.

Adelayinpassageofpotassiumsupplementsthroughthegastrointestinal tractcausedby

stricture or obstructionor peptic ulcer,maycauseor worsengastrointestinal irritation.

Potassiumsupplementsmayaggravatefamilial periodic paralysis or myotoniacongenita,

althoughsomepatientswithfamilial periodic paralysis mayrequire potassium

supplementation.

Careful monitoringofserumpotassiumis warrantedinpatientswithsevere or completeheart

block,especiallyindigitalizedpatients(seeDrugInteractions).

Cautionis warrantedinpatientssufferingfromesophageal compressionordelayedgastric

emptying.

UseinPregnancy:Studieshavenotbeendoneinanimals or inhumans.

FDA PregnancyCategoryC.

UseinBreastfeeding:Problems inhumans havenotbeendocumented.

UseintheElderly:Althoughappropriatestudiesontherelationshipofagetotheeffectsof

potassiumsupplementshavenotbeenperformedinthegeriatric population,nogeriatrics-

specific problems havebeensufficientlydocumentedtodate.However, elderlypatientsare

atgreater risk ofdevelopinghyperkalemiaduetoage-relatedchanges intheabilityofthe

kidneys toexcretepotassium.

UseinPediatrics:Appropriatestudiesontherelationshipofagetotheeffectsofpotassium

supplementshavenotbeenperformedinthepediatric population.However,nopediatrics-

specific problems havebeensufficientlydocumentedtodate.

AdverseReactions

Hyperkalemiasideeffectsare consideredrarewhenoral dosageforms ofpotassiumare

administeredtopatientshavingnormal renal function.Whenhyperkalemiais present,

symptoms include:severe muscleweakness,unusual tiredness,slowor irregular heartbeat,

confusion,numbness or tinglingofthehands,feetor lips,unexplainedanxiety,shortness of

breathor difficultbreathing.

Irritationofthealimentarytractmayoccur whenpotassiumpassageis delayedor is in

contactwithulcerous areas.Symptoms include:continuingabdominal or stomachpain,

cramping,or soreness,chestor throatpain,especiallywhenswallowing,stools containing

freshor digestedblood.

Thefollowingsideeffectsrequiremedical attentiononlyiftheycontinueor arebothersome:

diarrhea,nausea,stomachpain,discomfort, flatulenceor mildvomiting.(Thesesideeffects

occur more frequentlywhenthemedicationis nottakenwithfoodor is notdilutedproperly.)

Precautions

Patientsmustbewarnednottotakesalt substitutes or low-salt foods,unlessapprovedby

theirphysician,topreventexcess intakeofpotassium.

Adequaterenal functionis essential for therapywithpotassiumsupplements,sincethe

kidneys maintainnormal potassiumbalance.Monitoringofrenal function,potassiumserum

concentrations andECG is recommendedatperiodic intervals duringoral therapy.The

risk/benefit ofpotassiumsupplementshouldbeconsideredinanypatientwithahigher-than-

normal serumcreatinineconcentration.

Patientsmustbewarnednottobeginanystrenuous physical exercise,ifoutofcondition,to

preventpossibleexercise-inducedhyperkalemia.

DrugInteractions:

Digitalis glycoside,inthepresenceofheart block:potassiumsupplementsare not

recommendedfor concurrentuseinanydigitalizedpatientwithsevere or completeheart

block;however, ifpotassiumsupplementsmustbeusedtopreventor correcthypokalemiain

adigitalizedpatient,careful monitoringofserumpotassiumconcentrations is extremely

important.Abruptdiscontinuationofsupplemental potassiumtoapatientsuffering

concurrentpotassiumlosses,andalsoreceivingdigitalis preparations mayresult indigitalis

toxicity.

AmphotericinB,corticosteroidsespecially withsignificantmineralocorticoidactivity,

corticotropin(ACTH),gentamicin,penicillinsor polymyxinB:potassiumrequirementsmaybe

increasedinpatientsreceivingthesemedications duetorenal potassiumwasting.Close

monitoringofserumpotassiumis recommended.

Angiotensin-convertingenzymeinhibitors, beta-adrenergic blockingagents,potassium

sparingdiuretics, heparin,cyclosporin,non-steroidal anti-inflammatory drugs (NSAIDS):

concurrentusewithpotassiumsupplementsmayincreaseserumpotassiumconcentrations,

whichmaycausesevere hyperkalemiaandleadtocardiacarrest,especiallyinrenal

insufficiency.

Thiazidediuretics:there isanincreasedrisk ofhyperkalemiawhenapotassium-wasting

diuretic is discontinuedafter concurrentusewithapotassiumsupplement.

Low-salt milk,salt substitutes,potassium-containingmedications:concurrentusewith

potassiumsupplementsmayincreaseserumpotassiumconcentrations,whichmaycause

severe hyperkalemiaandleadtocardiacarrest,especiallyinrenal insufficiency.Mostsalt

substitutes containsubstantial amountsofpotassium(low-salt milk maycontainpotassium

upto60mEq/L).

Bloodfrombloodbank:bloodfrombloodbank maycontainpotassiumupto30mEq/Lof

plasmaor upto65mEq/Lofwholebloodwhenstoredfor more than10days.

Parenteral calciumsalts:potassiumsupplementsshouldbeusedcautiouslyinpatients

receivingparenteral calciumsalts becauseofthedanger ofprecipitatingcardiacarrhythmias.

Exchangeresins,sodiumcycle,suchas sodiumpolystyrenesulfonate:whether these

medications are administeredorallyor rectally,serumpotassiumconcentrations are reduced

bysodiumreplacementofthepotassium;fluidretentionmayoccur insomepatientsbecause

oftheincreasedsodiumintake.

Insulinor sodiumbicarbonate:concurrentuseofthesemedications withpotassium

decreases serumpotassiumconcentrations bypromotingashiftofpotassiumionintothe

cells.

Laxatives:chronic useor overuseoflaxatives mayreduceserumpotassiumconcentrations

bypromotingexcessivepotassiumloss fromtheintestinal tract.

Anticholinergics or other medications withanticholinergic activity:concurrentusemay

increaseseverityofgastrointestinal lesions producedbypotassiumchloridealone.If

symptoms develop,patientsshouldbecarefullymonitoredendoscopicallyfor evidenceof

lesions.

Dosageand Administration

Each5ml PotassiumOral Solutioncontains10mEqpotassium.

Cautionmustbeobservedintheattempttocorrecthypokalemiainorder toavoid

overcompensationandaresultanthyperkalemiawithaccompanyingcardiacarrhythmias

Adults:theusual adult andadolescentdoseis 20mEqofpotassium(10ml)dilutedin120

ml(abouthalf aglass)ofcold wateror juicetwotofour times aday.Adjustthedoseas

neededandtolerated.Donotexceed100mEqofpotassiumaday.

Pediatric:theusual pediatric doseis 20-40mEqofpotassiumper square meter ofbody

surfaceor 2-3mEqper kgofbodyweightaday,administeredindivideddoses andmust be

welldiluted inwateror juice.

This medicationmustbetakenwithor immediatelyafter food,and,after dilution,shouldbe

sippedslowly.

Thenormal adult concentrationofserumpotassiumis 3.5-5mEq/Lwith4.5mEqoftenbeing

usedfor areferencepoint.Potassiumconcentrations exceeding5.5mEq/Lare dangerous

becauseofpossibleinitiationofcardiacarrhythmias.(Normal potassiumconcentrations tend

tobehigher inneonates [7.7mEq/L]thaninadults.)

Serumpotassiumconcentrations donotnecessarilyindicatethetruebodypotassium

content.AriseinplasmapH (alkalosis)andchronic acidosis maydecreaseplasma

potassiumconcentrationbypromotingpotassiumexcretionandincreasetheintracellular

potassiumconcentration.Conversely,adecreaseinbloodpH (acuteacidosis)cancausean

increaseinserumpotassiumbyinhibitingpotassiumexcretion.However, it isnecessaryto

attempttorestore serumpotassiumtonormalinfamilial periodic paralysis, eventhough

there isnototal bodypotassiumdepletion.(It maybeadvisabletomonitor serumpH

periodicallyduringtreatment.)

Overdosage

Treatmentofhyperkalemia:

Ifappropriate,discontinuebloodproducts,foodsandmedicationthatcontain

potassium,as wellas ACEinhibitors, betablockingagents,nonsteroidal anti-

inflammatorydrugs,heparin,cyclosporinandpotassium-sparingdiuretics.

Administer 10%dextrosecontaining10to20units ofinsulinper liter atarateof

300to500ml ofsolutionper hour. This will facilitateashiftofpotassiumintothecells.

Correctanyexistingacidosis with50mEqintravenous sodiumbicarbonateover 5

minutes.Thedosemayberepeatedin10to15minutes ifneeded.This willfacilitatea

shiftofpotassiumintothecells.

Administer acalciumsalt (calciumgluconate,0.5to1gram,over a2minuteperiod)

toantagonizethecardiotoxic effectsinpatientswhoseECG showabsentPwaves,or

abroadQRScomplex,andwhoare notreceivingdigitalis glycosides.Doses maybe

repeatedafter 2-minuteintervals.

Useexchangeresins toremoveexcess potassiumfromthebodybyadsorption

and/or exchangeofpotassium.Theoral doseofsodiumpolystyrenesulfonateis 20to

50grams oftheresindissolvedin100to200ml of20%sorbitol. Thedosemaybe

givenevery4hours uptofour or fivedailydoses until potassiumlevels return to

normal. Itmayalsobegivenas aretentionenemabymixing8grams ofsodium

polystyrenesulfonateand50grams ofsorbitol in200ml ofwater. Theretention

enemaexchanges potassiumfaster thantheoral sodiumpolystyrenesulfonate.

Usehemodialysis or peritoneal dialysis toreduceserumpotassiumconcentrations.

This maybenecessaryinpatientswithrenalfunctionimpairment.

Ascertainadequateurineoutputand,ifnotcontraindicatedbytheclinical condition

ofthepatient,maintainahighurineoutputwithnormal salinesolutions andloop

diuretics.

Cautionmustbeobservedwhentreatinghyperkalemiainadigitalizedpatient,sincerapid

reductionofserumpotassiumconcentrations mayinducedigitalis toxicity.

List ofexcipients

Ethanol,citric acidanhydrous,sodiumcyclamate,saccharinsodium,tutti frutti flavor,methyl

hydroxybenzoate,propyl hydroxybenzoate,purifiedwater.

PharmaceuticalPrecautions

Store below25 ˚C.

After firstopening,themedicinecouldbeusedfor6months.

Presentation

Bottlecontaining200ml.

RafaLaboratoriesLtd.,P.O.Box405,Jerusalem9100301

עעבקנהז ןולע טמרופ " ודילע רשואוקדבנונכותותואירבהדרשמ י .