DBL™ Frusemide

New Zealand - English - Medsafe (Medicines Safety Authority)

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Active ingredient:
Furosemide 10 mg/mL; Furosemide 10 mg/mL
Available from:
Hospira NZ Ltd
INN (International Name):
Furosemide 10 mg/mL
Dosage:
20 mg/2mL
Pharmaceutical form:
Solution for injection
Composition:
Active: Furosemide 10 mg/mL Excipient: Sodium chloride Sodium hydroxide Water for injection Active: Furosemide 10 mg/mL Excipient: Sodium chloride Sodium hydroxide Water for injection
Units in package:
Ampoule, glass, 50 x 2ml amp, 50 dose units
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Arandy Laboratories Ltd
Therapeutic indications:
DBL™ Frusemide Injection is indicated in adults, infants and children for the treatment of oedema associated with congestive heart failure, cirrhosis of the liver and renal disease including the nephrotic syndrome. DBL™ Frusemide Injection is particularly useful when an agent with greater diuretic potential than that of those commonly employed is desired. Parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations.
Product summary:
Package - Contents - Shelf Life: Ampoule, glass, 50 x 2ml amp - 50 dose units - 36 months from date of manufacture stored at or below 25°C
Authorization number:
TT50-4198
Authorization date:
1986-03-04

Data Sheet–NewZealand

Hosp3.0 1

DBL™FRUSEMIDEINJECTION

Name ofmedicine

Frusemide

Presentation

DBL™Frusemide Injectionisavailableasa 20 mg/2 mL injection,preparedwith sodiumhydroxidegiving

solutionshaving apHofabout9.

Uses

Actions

Frusemide isa potentdiuretic.Itinhibitssodiumand chloride absorptionin theascending limb ofHenle's

loop and in both theproximalanddistaltubules.

The high degree ofefficacyisdue to thisunique site ofaction.The action on the distaltubule isindependent

ofanyinhibitoryeffecton carbonicanhydrase oraldosterone.

Frusemide mayproduce apromptdiuresisin caseswhich have previouslyproved resistanttootherdiuretics.

Frusemide hasno significantpharmacologicalactionsotherthanon renalfunction.

Pharmacokinetics,

Absorption

Frusemideisrapidlyabsorbedfromthe gastrointestinaltract.Absorption ratesinhealthysubjectshave been

reportedfrom60-69%and from43-46%in patientswith end stage renalfailure.

The onsetofdiuresisfollowingintravenousadministrationiswithin 5minutesand somewhatlaterafter

intramuscularadministration.Thepeakeffectoccurswithinthefirsthalfhour.Thedurationofdiureticeffect

isapproximately2 hours.

Distribution

Frusemide isextensivelyboundtoplasma proteins,mainlytoalbumin.Plasma concentrationsranging from1

to 400 µg/mlare 91 to 99%bound inhealthyindividuals.The unbound fraction averages2.3 to 4.1%at

therapeuticconcentrations.

Metabolism

Recentevidence suggeststhatfrusemide glucuronide istheonly,oratleastthe major,bio-transformation

productoffrusemide in man.

Excretion

In patientswith normalrenalfunction,approximately80%ofan intravenousorintramusculardose is

excreted in the urinewithin 24hours.Urinaryexcretionisaccomplishedbothbyglomerularfiltration and

proximaltubularsecretion,which accountsforroughly66%ofthe ingesteddose,the remainderbeing

excreted in the faeces.Asmallfraction ismetabolisedbycleavage ofthe side chain.

Half Life

Frusemide hasabiphasichalflife intheplasma withT

ranging up to100 minutes.T

isprolonged by

renaland hepaticinsufficiencyandin premature and fullterminfants.

Indications

Oedema

DBL™Frusemide Injectionisindicatedin adults,infantsandchildrenforthetreatmentofoedema associated

with congestive heartfailure,cirrhosisofthe liverandrenaldisease including thenephroticsyndrome.

Data Sheet–NewZealand

Hosp3.0 2

DBL™Frusemide Injectionisparticularlyusefulwhenanagentwithgreaterdiureticpotentialthanthatof

those commonlyemployedisdesired.Parenteraltherapyshould be reserved forpatientsunable to take oral

medicationorforpatientsin emergencyclinicalsituations.

DBL™FrusemideInjectionisalsoindicatedasadjunctivetherapyinacutepulmonaryoedemaandcerebral

oedemawhereintenseandrapid onsetofdiuresisisdesired.Ifgastrointestinalabsorptionisimpairedororal

medicationisnotpracticalforanyreason,Frusemideisindicatedbytheintravenousroute.Parenteraluse

should bereplacedwith oralFrusemide assoonaspractical.

Dosageand administration

ParenteraltherapywithDBL™Frusemide Injectionshould be usedonlyin patientsunable to take oral

medicationorinemergencysituationsand should be replacedwithoraltherapyissoon aspractical.

Oedema

Adults:TheusualinitialdoseofDBL™FrusemideInjectionis20to40mggivenasasingledose,injected

intramuscularlyorintravenously.Theintravenousdoseshouldbegivenslowly(seePRECAUTIONS).

Ordinarilya promptdiuresisensues.Ifneeded,anotherdose maybe administered in the samemanner2

hourslater,orthedosemaybeincreased.Thedosemayberaisedby20mg,andgivennotsoonerthan2

hoursafterthe previousdose,untilthe desireddiureticeffecthasbeenobtained.Thisindividually

determined single dose shouldthen begiven once ortwice daily.

Therapyshould be individualised according to patientresponse to gain maximaltherapeuticresponse and to

determine the minimaldose needed to maintain thatresponse.Closemedicalsupervision isnecessary.If

the physician electsto useDBL™Frusemide Injectionparenteraltherapy,addDBL™Frusemide Injection to

eitherSodiumChlorideInjection,LactatedRinger'sInjection,orDextrose(5%)InjectionafterpHhasbeen

adjustedtoabove5.5.Administerasacontrolledintravenousinfusionataratenotgreaterthan4mg/min.

DBL™Frusemide Injectionisa buffered alkalinesolution.

AcutePulmonaryOedema

The usualinitialdose ofDBL™Frusemide Injection is40 mg injected slowlyintravenously(see

PRECAUTIONS).Ifasatisfactoryresponsedoesnotoccurwithin1hour,thedosemaybeincreasedto80

mg injected slowlyintravenously.Ifnecessary,additionaltherapy(e.g.digitalis,oxygen)maybe

administered concomitantly.

CerebralOedema

The followingprocedureisrecommended,pending furtherexperience:

Intravenousinjectionof20 to 40 mg threetimesdaily.

Amore uniformdiureticactionisobtainedifthe same dosesare infused.The rateofinfusion mustbe

determinedindividuallyin accordancewith the diureticactionand the neurologicalfindings.

Infantsandchildren:Parenteraltherapyshouldonlybeusedinpatientsunabletotakeoralmedicationorin

emergencysituations,andshould bereplacedwith oraltherapyassoon aspractical.

The recommended initialdose ofDBL™Frusemide Injection (intravenouslyorintramuscularly)in infantsand

childrenis1mg/kgbodyweightandshouldbegivenslowlyunderclosemedicalsupervision.Ifthediuretic

response to theinitialdoseisnotsatisfactory,dosagemaybeincreasedby1mg/kg notsoonerthan2 hours

afterthe previousdose,untilthedesired diureticeffecthasbeen obtained.

Dosesgreaterthan 6 mg/kg bodyweightare notrecommended.

DBL™Frusemide Injection should beinspectedvisuallyforparticulate matterand discolouration before

administration.Do notuseifsolution isdiscoloured.

Use intheelderly

No requirementexistsforspecialdosage recommendationsintheelderly.

Data Sheet–NewZealand

Hosp3.0 3

Contraindications

Knownhypersensitivitytofrusemideorsulphonamidesoranyoftheinactiveingredients.Patientsallergicto

sulphonamides(e.g.sulfonamide antibioticsorsulfonylureas)mayshowcrosssensitivityto furosemide.

Complete renalshutdown.

Ifincreasing azotaemia and oliguriaoccurduring treatmentofsevere progressiverenaldisease,discontinue

frusemide.

Severehypokalaemia,hyponatraemia,hypovolaemiaorhypotensionmustberegardedascontraindications

untilserumelectrolytes,fluid balanceand blood pressure havebeen restored tonormallevels.

In hepaticcoma orpre-coma and conditionsproducingelectrolytedepletion,frusemide therapyshouldnotbe

instituted untilthe underlying conditionshave been corrected orameliorated.

In breastfeedingwomen.

Do notadministerfrusemide to newbornspresenting jaundice ortoinfantswith conditionswhich might

inducehyperbilirubinaemiaorkernicterus(e.g.Rhesusincompatibility,familialnon-haemolyticjaundiceetc.)

becauseoffrusemide's'in vitro'potentialto displace bilirubin fromalbumin.

Warningsand precautions

Excessivediuresismayresultindehydrationand reductioninbloodvolume with circulatorycollapseandwith

the possibilityofvascularthrombosisand embolism,particularlyin elderlypatients.

Excessivelossofpotassiumin patientsreceiving cardiacglycosidesmayprecipitate digitalistoxicity.

In patientswithhepaticcirrhosisandascites,initiation oftherapyandDBL™Frusemide Injectionisbest

carried outin hospital.

Sudden alterationsoffluid and electrolyte balance inpatientswith cirrhosismayprecipitate hepaticcoma,

therefore,strictobservationisnecessaryduring theperiod ofdiuresis.

Casesofreversibleorirreversible tinnitusorhearingimpairmenthave been reported.

Usually,reportsindicatethatfrusemideototoxicityisassociatedwithrapidinjectionorinfusion,severerenal

impairment,hypoproteinaemia,dosesexceedingseveraltimestheusualrecommendeddose,or

concomitanttherapywith aminoglycosideantibiotics,ethacrynicacid,orotherototoxicmedicines.

Inpatientswithhypoproteinameia,e.g.associatedwithnephroticsyndrome,theeffectoffrusemidemaybe

weakened anditsototoxicitypotentiated.Cautiousdose titration isrequired.

IfthephysicianelectstouseHighDoseparenteraltherapy,controlledintravenousinfusionisadvisable(for

adultswithnormalrenalfunction,an infusion ratenotexceeding4 mgDBL™Frusemide Injectionperminute

mustbeused;foradultswithimpairedrenalfunction[creatinine >5mg/dL],aninfusionrateofnogreater

than2.5 mg/minmustbe used).

Cautionshouldbeexercisedwhenadministeringcurareoritsderivativestopatientsundergoingfrusemide

therapy.Itisalso advisableto discontinuefrusemide foroneweekpriortoanyelectivesurgery.

Rigid sodiumrestrictionisconducive tobothhyponatraemia and hypokalaemia,thusstrictrestrictionof

sodiumintake isnotadvisableinpatientsreceiving frusemide.

Frusemide should be usedwith care,especiallyin the initialstages,in patientswith impairmentofmicturition

(eg.prostatichypertrophy).Urinaryoutflowmustbesecured.Particularlycarefulmonitoringisrequiredin

patientswithgout,patientswithpartialobstructionofurinaryoutflow,inpatientsatriskformhypotension (eg,

patientswith coronaryarterystenosis),inpatientswith hepatorenalsyndrome orin patientswith

hypoproteinaemia(eg.associatedwithnephroticsyndrome).Dosetitration,especiallyinthislattercase,is

required.

Data Sheet–NewZealand

Hosp3.0 4

In premature infants,there isthe possible developmentofnephrocalcinosis/nephrolithiasisand therefore

renalfunctionmustbe monitoredand renalultrasonographyperformed.

In premature infants,frusemide administeredduringthe firstfewweeksoflife mayincreasetheriskof

persistenceofBotallo'sduct.

Aswith anyeffectivediuretic,electrolytedepletion mayoccurduringtherapywith Frusemide,especiallyin

patientsreceivinghigherdosesandarestrictedsaltintake.Periodicdeterminationsofserumelectrolytesto

detectpossible imbalanceshould be performed atappropriate intervals,aswellascreatinine,blood urea

and CO

content.

Allpatientsreceiving Frusemide therapyshould beobserved forsignsoffluidorelectrolyte imbalance;

namelyhyponatraemia,hypochloraemicalkalosis,and hypokalaemia.

Serumandurine electrolytedeterminationsareparticularlyimportantwhenthepatientisvomiting

excessivelyorreceivingparenteralfluids.Warning signs,irrespectiveofcause,include drynessofmouth,

thirst,weakness,lethargy,drowsiness,restlessness,muscle painsorcramps,muscularfatigue,hypotension,

oliguria,tachycardia,arrhythmia,andgastrointestinaldisturbancessuchasnauseaandvomiting.

Hypovolaemia ordehydration aswellasanysignificantelectrolyte and acid-base disturbancesmustbe

corrected.ThismayrequiretemporarydiscontinuationofDBL™Frusemide Injection.

Duringlong-termtherapy,ahighpotassiumdietisrecommended(leanmeat,potatoes,banana,tomatoes,

cauliflower,spinach,driedfruitetc.).Potassiumsupplementsmayberequired,especiallywhenhighdoses

are used forprolongedperiods.Particularcautionwith potassiumisnecessarywhen the patientison

digitalisglycosides,potassiumdepleting steroidsorin the caseofinfantsand children.Potassium

supplementation,diminution indose,ordiscontinuation offrusemide therapymaybe required.

Periodiccheckson urineand bloodglucoseshouldbemade indiabeticsandeven those suspected oflatent

diabeteswhenreceivingDBL™Frusemide Injection.

Increasesinbloodglucoseand alterationsinglucose tolerance testswith abnormalitiesofthe fasting and 2-

hourpostprandialsugarhave been observed,and rare casesofprecipitationofdiabetesmellitushave been

reported.

DBL™FrusemideInjectionmaylowercalciumlevels,andrarecasesoftetanyhavebeenreported.

Accordingly,periodicserumcalciumlevelsshouldbeobtained.

In children,urge to defecate,complaintsofabdominalpain and cramping have been reported afterIV

frusemide.Anassociationofthesesymptomswithalowserumcalciumand/oralowcalcium/proteinratiois

possible.

Reversible elevationsofblood urea maybe seen.These have been observedin associationwith

dehydration,which shouldbe avoided,particularlyin patientswithrenalinsufficiency.

Frusemideincreasescholesterolandtriglyceridesshort-term.Itisnotclearwhetherthiseffectpersistslong-

term;however,the currentevidence doesnotindicatethis.

Aswith manyothermedicines,patientsshouldbeobserved regularlyforthepossibleoccurrence ofblood

dyscrasias,liverdamage,orotheridiosyncraticreactions.

Renalcalcifications(frombarelyvisibleonX-raytostaghorn)haveoccurredin some severelypremature

infantstreatedwithintravenousDBL™FrusemideInjectionforoedemaduetopatentductusarteriosusand

hyaline membrane disease.

The concurrentuseofchlorothiazideshasbeenreportedtodecreasehypercalciuria andtodissolve some

calculi.

The possibilityexistsofexacerbation oractivationofsystemiclupuserythematous.

Data Sheet–NewZealand

Hosp3.0 5

Asymptomatichyperuricaemia can occurand rarely,goutmaybeprecipitated.

WhenDBL™Frusemide Injectionisadministered parenterally,a maximuminjectionorinfusion rate of4

mg/min(innormalrenalfunction)or2.5mg/min(inimpairedrenalfunction)shouldbeusedtominimisethe

riskofototoxicity.

Intramuscularadministration ofDBL™Frusemide Injection mustbe limited toexceptionalcaseswhere

neitheroralnorintravenousadministrationsare feasible.Intramuscularadministrationisnotsuitable for

acute conditionssuch aspulmonaryoedema.

Pregnancyand Lactation

Frusemide mustnotbe given during pregnancyunlessthere are compelling medicalreasons.Treatment

during pregnancyrequiresmonitoringoffoetalgrowth.

Thiazides,relateddiureticsandloopdiureticsenterthefoetalcirculationandmaycauseelectrolyte

disturbances.Neonatalthrombocytopaeniahasbeen reportedwith thiazidesand relateddiuretics.

Loopdiuretics,likefrusemideandbumetanide,areprobablyalsoassociatedwiththisrisk.Duringthelatter

partofpregnancy,productsofthistype shouldonlybegiven onsoundindications,andthen inthelowest

effective dose.

The use offrusemideinlactatingmothersshouldbeavoidedasitpassesinto thebreastmilkandinhibits

lactation.

Use inElderly

No requirementexistsforspecialdosage recommendationsintheelderly.

However,the smallerpeakeffectofasingle dose togetherwith a delayin itseffectin conjunctionwith

reduced renalfunction,aswellaspossibleneed forclosermonitoringofwaterand electrolyte balancesin

the elderly,mustbe taken into consideration.

Effectsonabilitytodriveandusemachines

Some adverse effects(e.g.an undesirable pronounced fallinbloodpressure)mayimpairthe patient'sability

to concentrate and reactand therefore constitute ariskin situationswhere these abilitiesare ofspecial

importance (e.g.operatinga vehicle ormachinery).

Adverse effects

Aswith otherdiuretics,electrolytesand waterbalancemaybe disturbed duringtherapywithfrusemide,

especiallyin patientsreceivinghigh dosesfora prolongedperiod.

Excessivediuresismaygiveriseespeciallyinelderlypatientsandchildren,tocirculatorydisturbancessuch

asheadache,dizziness,drymouthorvisualimpairment,assymptomsofhypovolaemia.Inextremecases,

hypovolaemia and dehydration maylead to hypotension,circulatorycollapseand in elderlypatientsin

particular,thrombophilia.However,withindividualiseddosage,acutehaemodynamicreactionsaregenerally

notto beexpected,although diuresissetsin rapidly.

Allsalureticsmaycause hypokalaemia,mainlyincasesoflowpotassiumdiet,vomiting orchronicdiarrhoea.

Factorssuch asunderlyingdiseases(livercirrhosis,cardiacfailure),concomitantmedication(see

INTERACTIONS)ornutritionalinadequacies(excessive restriction ofsaltintake),mayleadto sodiumor

otherelectrolyte orfluid deficiencieswhich mayproduce a fallin orthostaticblood pressure,calfmuscle

spasms,anorexia,weakness,dizziness,drowsiness,apathy,vomiting and confusion.

Frusemidemaylowertheserumcalciumlevel.Thismaytriggerastateofincreasedneuromuscular

irritability.Inveryrarecases,tetanyhasbeenobserved.Inprematureinfants,calciumsaltsmaybe

depositedintherenaltissue (nephrocalcinosis).

Data Sheet–NewZealand

Hosp3.0 6

Hypomagnesaemiaandinrarecases,tetanyorcardiacarrhythmiahavebeenobservedasaconsequence

ofincreased renalmagnesiumlosses.

Treatmentwith frusemide maylead to transitoryincreasesin blood creatinineand urea levelsand toan

increaseincholesterolandtriglycerideserumlevels.Serumlevelsofuricacidmayincreaseandattacksof

goutmayoccur.

Hepatic System:Isolatedcasesofacute pancreatitisandincreasesinlivertransaminaseshave been

observed.Additionally,intrahepaticcholestasisand jaundice have been reported,however,relationshipto

the medicinehasnotbeenestablished.Frusemidemayincreasethe bile flowanddistendthe biliarytree,

whichisalreadyobstructed.

CentralNervousSystem:Reactionssuchasdizziness,vertigo,paraesthesia,headacheandblurredvision

occasionallyaccompanyDBL™Frusemide Injection induced diuresis.Tinnitus,reversible impairmentand

rarely,permanentimpairmentofhearing have beenobservedwith markedlyreduced renalfunction or

hypoproteinaemia.(e.g.innephroticsyndrome).

Thisoccursparticularlywhen the recommended rate ofinjection orinfusion of4mg/min (normalrenal

function)or2.5mg/min(impairedrenalfunction)isexceeded,orinpatientswhoarealsoreceiving

medicinesknownto be ototoxic.

Dermatologic:Allergicreactionsmayoccasionallyoccurinthe formofdermatitis,including rash,urticaria

and rare casesofexfoliative dermatitis,necrotisingangitis,bullouseruption,erythemamultiforme and

purpuraandpruritus.

Photosensitivityreactionshaveoccasionallybeen reported.

Haematologic:The followingrare adverse reactionshavebeen reported:eosinophilia,thrombophlebitis,

haemolyticoraplasticanaemia,leucopoenia,thrombocytopaenia,agranulocytosis.Vasculitismayalso

occur.

UrinarySystem:Excessive diuresisanddehydrationcouldcause transientelevationofcreatinineandBUN

and reductionofGFR.Inelderlymenwithprostatichypertrophy,acuteurinaryretentionwithoverflow

incontinence mayoccur.Interstitialnephritishasalso been reportedwith frusemide use.

Symptomsofexisting obstructed micturition in patientswith conditionssuch asuretostenosisor

hydronephrosismaybetriggeredoraggravated bypronounced diuresis.

Cardiovascular:Orthostatichypotension mayoccurand maybe aggravatedbyalcohol,narcoticsand

barbiturates.Ischaemiccomplicationshave also beenreported in elderlypatients.

Other:Restlessness,fever,rise in serumcholesteroland triglyceride,transientpain atthe injection site

followingintramuscularinjection.TreatmentwithFrusemidehasoccasionallycausedreducedglucose

toleranceanddeteriorationincasesofmanifestdiabetes,ormade latentdiabetesmanifest.Pre-existing

metabolicalkalosis(e.g.duetodecompensatedlivercirrhosis)maybeaggravatedduringfrusemide

treatment.Uricaemia mayoccurandlead togoutattacksin predisposedpatients(seePRECAUTIONS).

Rarely,feverorparaesthesiaeandoccasionallyphotosensitivitymayoccur.

In premature infants,Frusemide mayprecipitatenephrocalcinosis/nephrolithiasis.IfFrusemide is

administeredtopremature infantsduringthefirstweeksoflife,itmayincreasetheriskofpersistenceof

patentductusarteriosus.

Followingintramuscularinjection,localreactionssuchaspain mayoccur.

Duetothepossibilityofsideeffectssuchashypotension,patientsabilitytodriveoroperatemachinerymay

be impaired,especiallyatthe commencementoftherapy.

Anaphylacticshockisrare,butisacutelylife-threatening ifitdoesoccur.

Data Sheet–NewZealand

Hosp3.0 7

Wheneveradverse reactionsare moderateorsevere,Frusemide doseshould bereducedortherapy

withdrawn.

Interactions

Whenacardiacglycosideisadministeredconcurrently,itshouldberememberedthatpotassiumor

magnesiumdeficiencyincreasesthesensitivityofthemyocardiumtodigitalisandmayincreasethetoxicity

ofdrugs,whichinduce QTintervalprolongation syndrome.When a glucocorticoid isadministeredduring

diuretictreatment,thepotassium-loweringeffectofthesteroidshouldbeborneinmind(See

PRECAUTIONS).Carbenoxolone,corticosteroids,prolonged use oflaxativesoringestion ofliquorice in

large amountsmayalso predispose apatienttohypokalaemia.

Patientsreceivinghighdosesofsalicylates,asinrheumaticdisease,inconjunctionwithDBL™Frusemide

Injectionmayexperience salicylate toxicityatlowerdosesbecause ofcompetitiverenalexcretorysites.

Interactionsbetweenfrusemide andneuromuscularblocking agentshavebeen reported.Theseappeartobe

dependentonthedoseoffrusemideandtheneuromuscularblockingagentinvolved.Lowdosesof

frusemide (0.1 to10 µg/kg)enhance the neuromuscularblockade oftubocurarineand succinylcholine.

Highdoses(1to5 mg/kg)offrusemide have atendencytoantagonise the skeletalmuscle relaxingeffectof

tubocurarinebutmaypotentiate the actionofsuccinylcholine.The clinicalrelevanceofthese findingsis

uncertain.

Lithiumgenerallyshouldnotbegivenwithdiureticsbecausetheyreduceitsrenalclearanceandaddahigh

riskoflithiumtoxicity.Ifgiven,lithiumlevelsshould bemonitored.

DBL™FrusemideInjectionmayincreasetheototoxicpotentialofantibiotics,especiallyinthepresenceof

impaired renalfunction.Exceptinlife-threatening situations,avoid thiscombination.DBL™Frusemide

Injectionshouldnotbeused concomitantlywithethacrynicacidorcisplatin because ofthe possibilityof

ototoxicity.Inaddition,nephrotoxicityofcisplatinmaybeenhancedifFrusemideisnotgiven inlowdoses

(e.g.40 mg in patientswith normalrenalfunction)andwith positive fluid balance when used to achieve

forced diuresisduring cisplatintreatment.

Sincefrusemidemayenhancenephrotoxicityofcertainantibiotics(e.g.aminoglycosides,cephaloridine),the

simultaneousadministration ofthese medicinesisnotadvisable.

The combinationoffrusemide and amphotericin mayresultinan excessivelossofpotassium.

DBL™Frusemide Injectionmaydecrease arterialresponsivenessto noradrenaline.Thisdiminution isnot

sufficientto precludeeffectivenessofthe pressoragentfortherapeuticuse.

The action ofotherantihypertensive medicinesmaybe potentiated byDBL™Frusemide Injection,especially

in combinationwith ACEInhibitors.

The administrationofACEInhibitorstopatientspretreatedwithfrusemide maylead toadeteriorationinrenal

function ormayresultin severehypotension.

Non-steroidalanti-inflammatorymedicines(e.g.indomethacin,acetylsalicylicacid)mayreduce thenatriuretic

and antihypertensive effectsofDBL™Frusemide Injection in some patientsbyinhibiting prostaglandin

synthesis.NSAIDsmayalso cause renalfailure in case ofpre-existing hypovolaemia.Phenytoin ordrugs

whichundergosignificantrenaltubularsecretionsuchasmethotrexateandprobenecid,mayattenuatethe

effectsoffrusemide.

Conversely,Frusemide maydecrease renalelimination ofthese drugs.In caseofhighdose treatment(in

particularofbothfrusemideandtheotherdrugs),thismayleadtoincreasedriskofadverseeffectsdueto

Frusemide orthe concomitantmedication.

IVfrusemidewasshowntoincreasethesteadystateconcentration oftheophyllineby20%ina smallnumber

ofasthmaticpatients;hence itisappropriate to measure serumtheophylline levelswhen both medicinesare

given together.

Data Sheet–NewZealand

Hosp3.0 8

Anticonvulsantsmaydecreasetheresponsetofrusemide.AcombinationofDBL™FrusemideInjectionand

chloralhydrate maylead to diaphoresis,sensationofheat,flushes,nausea,tachycardia andelevationof

blood pressure.Asaresult,thiscombinationisnotrecommended.

Itshould be bornein mind thatthe effectofantidiabeticsorofpressoramines,(e.g.adrenaline,

noradrenaline)maybe attenuated byfrusemide (SeePRECAUTIONS).

Administrationoffrusemideandsucralfatewithintwohoursofeachothershouldbeavoided,assucralfate

reducestheabsorption offrusemide and,hence,weakensitseffect.

Overdosage

The clinicalpicture inacute orchronicoverdose dependprimarilyon theextentand consequencesof

electrolyte and fluidloss;e.g.dehydration,bloodvolume reduction,hypotension,electrolyteimbalance,

cardiacarrhythmias(including A-Vblockand ventricularfibrillation),hypokalaemia and hypochloraemic

alkalosis,andextensionsofitsdiureticaction.Symptomsofthesedisturbancesincludeseverehypotension

(progressingtoshock),acuterenalfailure,thrombosis,deliriousstates,flaccidparalysis,apathyand

confusion.The acute toxicityofFrusemide hasbeendetermined in mice,ratsanddogs.

The intravenousLD

ranged from300 to 680 mg/kg.

The concentrationofFrusemide in biologicalfluidsassociatedwith toxicityordeath isnotknown.

No specificantidoteto Frusemide isknown.

Treatmentofoverdosageissupportive.Serumelectrolytes,carbondioxidelevelandbloodpressureshould

bedeterminedfrequently.Adequatedrainagemustbeassuredinpatientswithurinarybladderoutlet

obstruction (such asprostatichypertrophy).Haemodialysisdoesnotaccelerate frusemide elimination.

Pharmaceuticalprecautions

SpecialPrecautionsforStorage(light storage)

Store below25 °C.Protectfromlight.

Medicine classification

Prescription Medicine.

Package Quantities

DBL™Frusemide Injectionisavailableasa 20 mg/2 mL injectioninpacksof50 ampoules.

FurtherInformation

Frusemide is4-Chloro-N-furfuryl-5-sulphamoylanthranilicacidhaving amolecularformula ofC

S

and amolecularweightof330.7.

Nameandaddress

HospiraNZLimited

23 HainingStreet

TeAro

Wellington

NewZealand

Dateof preparation

22 June 2012

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