Adin

Main information

  • Trade name:
  • Adin 0.1 mg/mL Nasal spray solution
  • Dosage:
  • 0.1 mg/mL
  • Pharmaceutical form:
  • Nasal spray solution
  • Units in package:
  • Bottle, glass, amber,pre-compression pump 5mL, 5 mL
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • PolyPeptide Laboratories AB

Documents

Localization

  • Available in:
  • Adin 0.1 mg/mL Nasal spray solution
    New Zealand
  • Language:
  • English

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 12010
  • Authorization date:
  • 01-03-2005
  • Last update:
  • 27-09-2017

Summary of Product characteristics: dosage,interactions,side effects

ADINNASALSPRAY

Desmopressinacetate

Presentation

ADIN0.1mg/mlnasalspraysolution.1mlnasalspraysolutioncontains0.1mgdesmopressin

acetateequivalenttodesmopressin0.089mg.Aclear,colourlesssolutioninanamberglass

bottle.

Uses

Actions

Pharmacotherapeuticgroup:vasopressinandanalogues.ATCcode:H01BA02.

ADINnasalspraysolutioncontainsdesmopressin,astructuralanalogueofthenaturalpituitary

hormoneargininevasopressin.Thedifferenceliesinthedesaminationofcysteineand

substitutionofL-argininebyD-arginine.Thisresultsinaconsiderablylongerdurationofaction

andacompletelackofpressoreffectinthedosagesclinicallyused.

Pharmacokinetics

Thebioavailabilityisabout3-5%.Maximumplasmaconcentrationisreachedafterapproximately

onehour.Anintranasaldoseof10-20µgprovidesanantidiureticeffectduring8-12hours.

Desmopressinisexcretedmainlyintheurine.

Indications

ADINnasalspraysolutionisindicatedforthetreatmentofcentraldiabetesinsipidusandfor

establishingrenalconcentrationcapacitytesting.

ADINnasalspraysolutionisalsoindicatedforthetreatmentofprimarynocturnalenuresisin

patients(from5yearsofage)withnormalabilitytoconcentrateurine.

DosageandAdministration

1doseofthesprayprovides0.1ml,whichcorrespondsto10µgdesmopressinacetate.

Centraldiabetesinsipidus

Dosageisindividualaftertesting,butnormaldosageforadultsis10-20µg1-2timesdaily.For

children5-10µg1-2timesdaily.Intheeventofsignsofwaterretention/hyponatremiatreatment

shouldbeinterruptedandthedoseshouldbeadjusted.

Primarynocturnalenuresis

Aclinicallyeffectivedoseisindividualandmayvaryfrom10to40µgadministeredintranasally.A

suitabledoseis20µgintranasallyatbedtime.Startatlowestdose.Increaseprogressivelyand

withcaution.Fluidrestrictionshouldbeobserved,(seeunderWarningsandPrecautions).In

theeventofsignsofwaterretention/hyponatremiatreatmentshouldbeinterrupted.Assessment

ofthenecessityofcontinuedtreatmentshouldbemadeafterthreemonthsduringonesubstance-

freeweek.

Renalfunctiontesting

Toestablishrenalconcentrationcapacity,thefollowingsingledosesarerecommended:

Thenormaldoseforadultsis40µg.

Forchildrenover1year20µg.

Forchildrenunder1year10µg.

AfteradministrationofADINnasalspraysolutionanyurinecollectedwithinonehourisdiscarded.

Duringthenext8hours2portionsofurinearecollectedforosmolalitytesting.Fluidrestriction

shouldbeobserved,seeunderWarningsandPrecautions.

Contraindications

ADINnasalspraysolutioniscontraindicatedincasesof:

habitualorpsychogenicpolydipsia(resultinginaurineproductionexceeding40mL/kg/24

hours)

syndromeofinappropriateADHsecretion(SIADH)

knownhyponatraemia

historyofknownorsuspectedcardiacinsufficiencyandotherconditionsrequiringtreatment

withdiuretics

moderateandsevererenalinsufficiency(creatinineclearancebelow50mL/min)

hypersensitivitytodesmopressinortoanyoftheexcipients

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WarningsandPrecautions

Onlyusenasalsprayinpatientswhereorallyadministeredformulationsarenotfeasible.

ADINnasalspraysolutionshouldbeusedwithcautionin:

veryyoungandelderlypatients

conditionscharacterisedbyfluidand/orelectrolyteimbalance

patientsatriskforincreasedintracranialpressure

Renalconcentrationcapacitytestinginchildrenbelowtheageof1yearshouldonlybeperformed

inhospitalandundercarefulsupervision.Whenusedfordiagnosticpurposesthefluidintake

mustbelimitedtoamaximumof0.5litrestoquenchthirstfrom1hourbeforeuntil8hoursafter

administration.

Whenusedforenuresisthefluidintakemustbelimitedtoaminimumfrom1hourbeforeuntil8

hoursafteradministration.

Ensurethatinchildrenadministrationisunderadultsupervision.

Severebladderdysfunctionandoutletobstructionshouldbeconsideredbeforestartingtreatment

forprimarynocturnalenuresis.

Precautions

Severebladderdysfunctionandoutletobstructionshouldbeconsideredbeforestartingtreatment

forprimarynocturnalenuresis.

Precautionstoavoidhyponatraemia,includingcarefulattentiontofluidrestrictionandmore

frequentmonitoringofserumsodium,mustbetakenincaseofconcomitanttreatmentwith

medicines,whicharesuspectedtoinduceSIADH,e.g.tricyclicantidepressants,selective

serotoninreuptakeinhibitors,chlorpromazineandcarbamazepineandincaseofconcomitant

treatmentwithNSAID.

Treatmentwithdesmopressinshouldbeinterruptedduringacuteintercurrentillness

characterisedbyfluidand/orelectrolyteimbalance(suchassystemicinfections,fever,

gastroenteritis).

Useinpregnancyandlactation

Pregnancy

Publisheddataonalimitednumber(n=53)ofexposedpregnanciesinwomenwithdiabetes

insipidusindicatenoadverseeffectsofdesmopressinonpregnancyoronthehealthofthe

foetus/newbornchild.Todate,nootherrelevantepidemiologicaldataareavailable.Animal

studiesdonotindicatedirectorindirectharmfuleffectswithrespecttopregnancy,

embryonal/foetaldevelopment,parturitionorpostnataldevelopment.Cautionshouldbe

exercisedwhenprescribingtopregnantwomen.

Lactation

Resultsfromanalysesofmilkfromnursingmothersreceivinghighdosedesmopressin(300µg

intranasal),indicatethattheamountsofdesmopressinthatmaybetransferredtothechildare

considerablylessthantheamountsrequiredtoinfluencediuresis.

Effectsonabilitytodriveandusemachines

None.

AdverseEffects

Common(>1/100)

General

Headache.

Stomachpain,nausea.

Upperrespiratory

Nasalcongestion/rhinitis,epistaxis.

Treatmentwithoutconcomitantreductionoffluidintakemayleadtowaterretention/hyponatremia

withaccompanyingsignsandsymptoms(headache,nausea/vomiting,decreasedserumsodium,

weightgain,andinseriouscases,convulsions).

Postmarketingexperience:

Veryrarecasesofemotionaldisturbancesinchildrenhavebeenreported.

Isolatedcasesofallergicskinreactionsandmoreseveregeneralallergicreactionshave

beenreported.

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Postmarketingexperience

Hyponatraemiaisaninfrequentbutseriousadverseeventwhichhasbeenreportedatarateof

approximately15casesper100,000patientyearsofexposureforintranasalsolutionsand6

casesper100,000yearsfororalformulations.

Interactions

Substances,whichareknowntoinduceSIADH,e.g.tricyclicantidepressants,selectiveserotonin

reuptakeinhibitors,chlorpromazineandcarbamazepine,maycauseanadditiveantidiureticeffect

leadingtoanincreasedriskofwaterretention/hyponatremia.

Indomethacinincreasestheurineconcentratingeffectofdesmopressinwithoutinfluencingthe

duration.Theeffectisprobablywithoutanyclinicalsignificance.

NSAIDsmayinducefluidretention/hyponatraemia.

Overdosage

OverdoseofADINnasalspraysolutioncanleadtowaterretentionwithhyponatremia.

Treatment

Althoughthetreatmentofhyponatremiashouldbeindividualised,thefollowinggeneral

recommendationscanbegiven.Asymptomatichyponatremiaistreatedbydiscontinuingthe

desmopressintreatmentandfluidrestriction.Infusionofisotonicorhypertonicsodiumchloride

maybeaddedincaseswithsymptoms.Whenthewaterretentionissevere(convulsionsand

unconsciousness)treatmentwithfurosemideshouldbeadded.

PharmaceuticalPrecautions

Listofexcipients

SodiumChloride,CitricAcidmonohydrate,DisodiumPhosphatedihydrate,Benzalkonium

Chloride,PurifiedWater.

Incompatibilities

Notapplicable.

Shelf-life

ADINnasalsprayisstableforthreeyearswhenstoredunopenedatroomtemperature(max

25°C).Afteropening,discardafter2months.

Specialprecautionsforstorage

ADINnasalspraysolutionshouldbestoredatroomtemperature(upto25ºC).

Instructionsforuse/handling

BeforeADINnasalspraysolutionisusedforthefirsttime,primethepumpbypressingdownward

4timesoruntilanevensprayisobtained.Ifthesprayhasnotbeenusedforaweekitis

necessarytoprimethepumpagainbypressingitdownwardsonceoruntilanevensprayis

obtained.

Atadministrationitisimportantthattheendofthetubeinsidethebottleissubmergedinthe

liquid.Theheadistobetippedslightlybackwhileinsertingtheapplicatorstraightintothenostril.

Instructionsforuseareenclosedwiththepackage.

Thespraybottleshouldalwaysbestoredinanuprightposition.

MedicineClassification

PrescriptionMedicine.

PackageQuantities

BrownTypeIglassvial.Fill-volume:5ml,6ml.

ADINnasalsprayisactuatedbyamanualdosepumpwithoutpropellant.Thespraypumpis

designedtodeliver100µlsolution(=10µgdesmopressinacetate)perdose.

FurtherInformation

Pre-clinicalsafetydata

Therewerenounusualfindingsduringtheexaminationofthesafetyandsafetyprofileof

desmopressin.

NameandAddress

FerringPharmaceuticalsA/S

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NZdistributor:

Pharmaco(NZ)Ltd

POBox4079

Auckland

Telephone:(09)377-3336

DateofPreparation

20November2007

(CDSNov.05Rev3;Nov2005)

There are no safety alerts related to this product.