AXID

Main information

  • Trade name:
  • AXID Capsules Hard 150 Milligram
  • Dosage:
  • 150 Milligram
  • Pharmaceutical form:
  • Capsules Hard
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AXID Capsules Hard 150 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA1328/071/001
  • Authorization date:
  • 18-05-2007
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PPA1328/071/001

CaseNo:2029763

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

B&SHealthcare

Unit4,BradfieldRoad,Ruislip,Middlesex,HA40NU,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

AXID150mgHardCapsules

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom18/05/2007until17/05/2012.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 26/09/2007 CRN 2029763 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Axid150mgHardCapsules

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachhardcapsulecontains150mgofnizatidine.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Capsule,hard

ProductimportedfromtheUK:

Hardgelatincapsuleswithdarkyellowcapsandpaleyellowbodies,codedFLYNN3144,containinganoff-white

granularpowder.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthetreatmentofthefollowingdiseaseswherereductionofgastricacidisindicated:

Duodenalulcer,

Benigngastriculcer,

Preventionofduodenalorbenigngastriculcerrecurrence,

Gastricand/orduodenalulcerassociatedwithconcomitantuseofnon-steroidalanti-inflammatorydrugs.

4.2Posologyandmethodofadministration

Adults:Fortreatmentofduodenalulcer,therecommendeddailydoseis300mgintheevening.Treatmentshould

continueforfourweeks,althoughthisperiodmaybereducedifhealingisconfirmedearlierbyendoscopy.Mostulcers

willhealwithinfourweeks,butifcompleteulcerhealinghasnotoccurredafterfourweekstherapy,patientsshould

continuetherapyforafurtherfourweeks.

Forthetreatmentofbenigngastriculcer,therecommendeddailydoseis300mgintheeveningforfouror,ifnecessary,

eightweeks.Priortotreatmentwithnizatidine,careshouldbetakentoexcludethepossibilityofgastriccancer.

Ifpreferred,the300mgdailydoseforthetreatmentofduodenalorbenigngastriculcermaybegivenastwodivided

dosesof150mginthemorningandevening.

Forthepreventionofduodenaland/orbenigngastriculcerrecurrence(prophylacticmaintenancetherapy)the

recommendeddailydoseis150mgintheevening.Patientsshouldbekeptunderregularsurveillance.

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Forthetreatmentofgastricand/orduodenalulcerassociatedwithconcomitantuseofnon-steroidalanti-inflammatory

drugs,therecommendeddailydoseis300mgdaily(either300mgatbedtimeor150mgtwicedaily,inthemorningand

intheevening)forupto8weeks.

Inmostpatients,theulcerswillhealwithin4weeks.Duringtreatment,theuseofnon-steroidalanti-inflammatory

drugsmaycontinue.

Theelderly:Agedoesnotsignificantlyinfluenceefficacyorsafety.Normallydosagemodificationisnotrequired

exceptinpatientswhohavemoderatetosevererenalimpairment(creatinineclearancelessthan50m1/min).

Children:Notrecommended,assafetyandefficacyhavenotbeenestablished.

Patientswithimpairedrenalfunction:Nizatidineisprincipallyexcretedviathekidneys.

Forpatientswhohavemoderaterenalimpairment(creatinineclearancelessthan50m1/min)orpatientswhohave

severerenalimpairment(creatinineclearancelessthan20m1/min),thedosageshouldbereducedasfollows

4.3Contraindications

KnownhypersensitivitytoH2-receptorantagonists.

4.4Specialwarningsandprecautionsforuse

Asnizatidineispartiallymetabolisedbytheliverandprincipallyexcretedbythekidneys,patientswithimpairedliver

orkidneyfunctionshouldbetreatedwithcaution(seePosologyandMethodofAdministration’Section).

Symptomaticresponsetonizatidinetherapydoesnotprecludethepresenceofgastricmalignancy.

Patientsreceivingprophylacticmaintenancetherapyshouldbekeptunderregularsurveillancebytheprescribing

physician.Treatmentshouldnotbeformorethanoneyearwithoutmedicalreviewtodeterminetheneedforcontinued

treatment.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Nointeractionhasbeenobservedbetweennizatidineandaminophylline,theophylline,chlordiazepoxide,diazepam,

lignocaine,phenytoin,ibuprofen,metoprolol,warfarinorlorazepam.Nizatidinedoesnotinhibitthehepatic

cytochromeP450-linkeddrugmetabolisingenzymesystembutmayincreaseabsorptionofsalicylateswhentheyare

usedinveryhighdosage.However,nizatidineandotherhistamineH2-receptorantagonistscanreducethegastric

absorptionofdrugswhoseabsorptionisdependentonanacidicgastricpH.Approximately35%ofnizatidineisbound

toplasmaprotein.Warfarin,diazepam,paracetamol,propantheline,phenobarbitoneandpropranololdidnoteffect

plasmaproteinbindingofnizatidineinvitro.

Nizatidinehasnosignificanteffectontheserumconcentrationsofgonadotrophins,prolactin,growthhormone,

antidiuretichormone,cortisol,tri-iodothyronine,thyroxine,testosterone,5alpha-dihydrotestosterone,androstenedione

DOSAGERECOMMENDED

NoRenalImpairment Moderate Renal Impairment

(creatinine clearance 20

50m1/min) Severe Renal Impairment

(creatinine clearance

<20m1/min)

300mgdailydose

150mgdailydose 150mgintheevening

150mgonalternatedays 150mgonalternatedays

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Experienceinclinicaltrialsindicatesthatnizatidinehasnogreaterpotentialthanplaceboforantiandrogeniceffects.

Absorptionofnizatidineisnotclinicallysignificantlyaffectedbyfoodintake,anticholinergicagentsorantacids.

Charcoaladministrationmayreduceabsorptionupto20percent.

4.6Pregnancyandlactation

Usageinpregnancy:Thesafetyofnizatidineforuseduringpregnancyhasnotbeenestablished.Animalstudieshave

shownnoevidenceofimpairedfertilityorteratogenicityattributabletonizatidine.Nizatidineshouldonlybeusedin

pregnantwomen,orinthoseplanningpregnancy,ifconsideredabsolutelynecessary,andthenwithcaution.

Usageinlactation:Studiesconductedinlactatingwomenhaveshownthat0.1%oftheadministeredoraldoseof

nizatidineissecretedinhumanmilkinproportiontoplasmaconcentrations.Becauseofthegrowthdepressioninpups

rearedbylactatingratstreatedwithnizatidine.Axidshouldbeadministeredtonursingmothersonlyifconsidered

absolutelynecessary.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Inlargescaleclinicaltrials,sweatingandurticariaweresignificantlymorecommoninnizatidinetreatedpatientswhen

comparedwithplacebo.

Inthesametrials,patientstreatedwithbothnizatidineandplacebohadmild,transient,asymptomaticelevationsof

transaminasesoralkalinephosphatase;rareinstancesofmarkedelevations(>500iu/l)occurredinnizatidinetreated

patients.Theoverallrateofoccurrencesofelevatedliverenzymesandelevationsto3timestheupperlimitofnormal,

however,didnotdiffersignificantlyfromplacebo.Allabnormalitieswerereversibleafterdiscontinuationofnizatidine.

Sinceintroduction,hepatitisandjaundicehavebeenreported.Rarecasesofcholestaticormixedhepatocellularand

cholestaticinjurywithjaundicehavebeenreported,withreversalofabnormalitiesafterdiscontinuation.

Thefollowingeffectshavealsobeenrarelyreported,althoughacausalrelationshiphasnotalwaysbeenestablished:

thrombocytopenicpurpura,fatalthrombocytopenia,exfoliativedermatitis,vasculitis,arthralgia,myalgia,

gynaecomastia,impotence,hyperuricaemia,fever,nauseaandreversiblementalconfusion.

Rareepisodesofhypersensitivityreactions(e.g.,bronchospasm,laryngealoedema,rash,pruritusandeosinophilia),

serumsicknessandanaphylaxishavebeenreported.

4.9Overdose

Thereislittleexperienceofoverdoseinhumans.Testedatveryhighdosesinanimals,nizatidinehasbeenshowntobe

relativelynon-toxic.Animalstudiessuggestthatcholinergic-typeeffects,includinglacrimation,salivation,emesis,

miosisanddiarrhoea,mayoccurfollowingverylargeoraldoses.

Treatment:Symptomaticandsupportivetherapyisrecommended.Activatedcharcoalmayreducenizatidine

absorption.Theabilityofhaemodialysistoremovenizatidinefromthebodyhasnotbeenconclusivelydemonstrated.

However,thismethodisnotexpectedtobeefficient,sincenizatidinehasalargevolumeofdistribution.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Nizatidineisapotent,selective,competitiveandfullyreversiblehistamineH2-receptorantagonistwitharapidonsetof

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Itsignificantlydecreasesacidandpepsinconcentration,togetherwiththevolumeofbasalandstimulatedgastric

secretion.Inclinicaltrials,nizatidineusuallyabolishedulcerpainwithinthefirstweekoftherapy.Nizatidine300mgat

bedtimesignificantlyreducedovernightgastricsecretion,butdidnotincreasesubsequentbasalormealstimulated

gastrinproduction.Intrinsicfactorisnotdecreasedinsubjectsadministerednizatidine.

5.2Pharmacokineticproperties

Bioavailabilityoforallyadministerednizatidineisnotsignificantlyinfluencedbyfoodorantacids.

Absorptionofnizatidineafteroraladministrationisrapidandpeakplasmaconcentrations(700-1800micrograms/1after

150mgdose;1400-3600microgramsg/lafter300mgdose)areachievedwithin3hours.Oralbioavailabilityexceeds

70%,andtheeliminationhalf-lifeis1to2hours,whileplasmaclearanceis40to601/h.Approximately35%of

nizatidineisboundtoplasmaprotein.Thevolumeofdistributionis0.8to1.51/kg.Minorfirstpasshepaticmetabolism

occurs(6%).butnizatidineisprincipallyexcretedviathekidneys.about60%asunchangeddrug.Theprinciple

metaboliteisdesmethylnizatidine,withsmallerquantitiesofsulphoxideandn-oxidealsobeingformed.Desmethyl

nizatidineisanactivemetabolite,oflimitedpotency.Morethan90%ofanoraldoseofnizatidine(including

metabolites)isexcretedintheurinewithin12hours.

Moderatetosevererenalimpairmentsignificantlyprolongsthehalf-lifeanddecreasestheclearanceofnizatidine.In

individualswhoarefunctionallyanephric,thehalf-lifeis3.5to11hours,andtheplasmaclearanceis7to14

1/h.

5.3Preclinicalsafetydata

Therearenopre-clinicaldataofrelevancetotheprescriberinadditiontothatsummarisedinothersectionsofthe

SummaryofProductCharacteristics.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Maizestarch

Pregelatinisedstarch

Dimeticone

Magnesiumstearate

Capsuleshell:

Yellowironoxide(E172)

Titaniumdioxide(E171)

Gelatin

Blackedibleprintingink,including:

Shellac

Blackironoxide(E172)

Soyalecithin

Polydimethylsiloxane

6.2Incompatibilities

Irish Medicines Board

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6.3ShelfLife

Theshelf-lifeexpirydateofthisproductshallbethedateshownonthecontainerandouterpackageoftheproducton

themarketinthecountryoforigin.

6.4Specialprecautionsforstorage

Donotstoreabove25°C

6.5Natureandcontentsofcontainer

OpaqueortransparentPVC/aluminiumfoilblisters.

Packscontain30hardcapsules.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7ParallelProductAuthorisationHolder

B&SHealthcare

Unit4

BradfieldRoad

Ruislip

MiddlesexHA40NU

UnitedKingdom

8ParallelProductAuthorisationNumber

PPA1328/71/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

18thMay2007

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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