BUSPAR

Main information

  • Trade name:
  • BUSPAR Tablets 10 Milligram
  • Dosage:
  • 10 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BUSPAR Tablets 10 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0048/041/002
  • Authorization date:
  • 12-12-1988
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACT1995,asamended

MedicinalProducts(ControlofPlacingontheMarket)Regulations,2007,asamended

PA0048/041/002

CaseNo:2060646

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

Bristol-MyersSquibb(Holdings)

T/ABristol-MyersPharmaceuticals,Swords,Co.Dublin,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Buspar10mgTablets

theparticularsofwhicharesetoutintheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsasmaybespecifiedin

thesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom12/12/2008.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 21/06/2010 CRN 2060646 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Buspar10mgTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontain:buspironehydrochloride10mg

Excipients:ContainsLactoseAnhydrousDC111.4mg

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Tablet.

Whitepillow-shapedbiconvextabletswithascorelineand“10”ononeface.

Thescorelineistoallowbreakingforeaseofswallowingonly.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Busparisindicatedfortheshort-termmanagementofanxietydisordersandthereliefofsymptomsofanxietywithor

withoutaccompanyingdepression.Treatmentshouldusuallybelimitedto4-12weeks.

4.2Posologyandmethodofadministration

Adults:

Dosageshouldbeadjustedaccordingtoresponseformaximumeffect.Therecommendedinitialdoseis5mgtwoor

threetimesdailyandthismaybeincreasedeverytwotothreedays.Theusualtherapeuticdoseis15to30mgdailyin

divideddoseswithamaximumrecommendeddoseof45mgdailyindivideddoseswithamaximumrecommended

doseof45mgdailyindivideddoses.

Elderly:

Althoughthereisnoevidencefromkineticandclinicalstudiesthatbuspironewouldbehavedifferentlyintheelderly,

therearelimiteddatabeyond4weeksandatdosesabove30mg/dayinthisagegroup.Thereforeitisrecommended

thatbuspironebeusedforshorttermtreatment(upto4weeks)intheelderlypatient,atamaximumdosenormallynot

exceeding30mgdaily.

RenalandHepaticImpairment

Inpatientswithahistoryofrenalorhepaticimpairment,Busparshouldbeusedwithcaution.Dosageshouldbe

reducedinrenalorhepaticimpairment.

Children:

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4.3Contraindications

1.Patientshypersensitivetoanyoftheingredientsoftheformulation.

2.Useinepilepticpatients.

3.Useinpatientswithsevererenalimpairment,withacreatinineclearanceof20mlperminuteorbelow,oraplasma

creatinineabove200micromoles/litre.

4.Severeliverimpairment.

4.4Specialwarningsandprecautionsforuse

Buspironeshouldonlybeusedwithgreatcautioninpatientswithestablishedorlikelybasalgangliallesion.

Incontrolledstudiesinhealthyvolunteers,buspironeinsingledosesupto20mgcausednosignificantimpairmentof

cognitiveorpsychomotorfunctions,unlikethebenzodiazepines,diazepamorlorazepam.However,patientsshouldnot

driveoroperatemachineryunlessthedrughasbeenshownnottoaffectphysicalormentalability.Theincidenceof

drowsinessincontrolledclinicaltrialshasbeenshowntobecomparabletoplacebounlikethecomparative

benzodiazepine.

Patientswithcompromisedhepaticandrenalfunctionrequiremonitoringandpossibledosageadjustments.

Thisproductcontainslactose.Patientswithrarehereditaryproblemsofgalactoseintolerance,theLapplactase

deficiencyorglucose-galactosemalabsorptionshouldnottakethismedicinalproduct.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Elevatedbloodpressurehasoccurredinpatientsreceivingbothbuspironeandmonoamine

oxidaseinhibitors(phenelzineandtranylcypromine).Concomitantadministrationis

contraindicated.

Concomitantadministrationofnefazodonetohealthyvolunteersresultedinsignificant

increasesinbuspironeC

andAUCanddecreasesinplasmaconcentrationsofbuspirone

metabolite.Itisrecommendedthattheinitialdoseofbuspironebeloweredto2.5mgand

subsequentdoseadjustmentsofeitherproductshouldbebasedontoleranceandclinical

response.

Buspironedoesnotexhibitcross-tolerancewithbenzodiazepinesandothersedative/hypnotic

agentsandwillnotpreventthewithdrawalsyndromeoftenseenwithcessationoftherapywith

theseagents.Beforecommencingtherapywithbuspironeitisadvisabletowithdrawpatients

graduallyfrompriorchronictreatmentwiththesedrugs.

Instudiesinhealthyvolunteers,buspironedidnotpotentiatethepsychomotorimpairment

producedbyalcohol,incontrasttoacomparativebenzodiazepine.However,nodatais

availableonconcomitantuseofalcoholandbuspironeatsingledosesgreaterthan20mg.

Thereforealcoholshouldnotbeusedwhilethepatientistakingbuspirone.

Invitrostudieshaveshownthatbuspironedoesnotdisplacewarfarinphenytoinorpropranolol

fromplasmaproteins.

Inastudyinnormalvolunteers,nointeractionwithamitriptylinewasobserved.Asimilar

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4.6Pregnancyandlactation

Insomestudies,administrationofhighdosesofbuspironetopregnantanimalsproducedeffectsonsurvival,birthand

weanlingweights,althoughtherewasnoeffectonfoetaldevelopment.Sincetherelevanceofthisfindinginhumans

hasnotbeenestablished,Buspariscontraindicatedinpregnancyandinlactation.

4.7Effectsonabilitytodriveandusemachines

PatientsshouldbecautionedaboutdrivingorusingcomplexmachineryuntiltheyarereasonablycertainthatBuspar

doesnotaffectthemadversely.

4.8Undesirableeffects

Sideeffectsincludeheadache,dizziness,nervousness,excitement,lightheadedness,nauseaanddiarrhoea.

Tachycardia,palpitations,chestpain,drowsiness,confusion,drymouth,fatigueandsweatinghavealsobeenreported

rarely.Inpaediatrictrialslightheadednessandsomnolenceoccurredmorefrequentlythanwithplacebo.

4.9Overdose

ThereisnospecificantidotetoBuspar.Busparisnotremovedbyhaemodialysis.Thestomachshouldbeemptiedas

quicklyaspossible.Treatmentshouldbesymptomaticandsupportive.Theingestionofmultipleagentsshouldbe

suspected.

Deathbydeliberateoraccidentaloverdosehasnotbeenobserved.Adoseof375mgperdayinhealthyvolunteers

producednosignificantadverseeffects.Asmaximumdoselevelsarereachedsymptomsmostcommonlyobserved

are:nausea,vomiting,dizziness,drowsinessandmiosis.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Busparisanazaspirodecanedione.TheexactmechanismofBuspar’sanxioselectiveactionisnotfullyknown.Itdoes

notactonbenzodiazepinereceptorsitesandlackssedative,anticonvulsantandmusclerelaxantproperties.

Fromanimalstudiesitisknowntointeractwithserotonin,noradrenaline,acetylcholineanddopaminesystemsofthe

brain.Busparenhancestheactivityofspecificnoradrenergicanddopaminergicpathways,whereastheactivityof

BuspironehasbeenshownInvitrotobemetabolisedbycytochromeP4503A4(CYP3A4).

Thisisconsistentwiththeinteractionobservedbetweenbuspironeandsubstancesthatinhibit

thisisoenzyme,e.g.erythromycin,itraconazoleandgrapefruitjuice.IncaseswhereBusparis

likelytobeusedwithapotentinhibitorofCYP3A4alowerdoseofbuspirone(e.g.2.5mg

b.i.d.)shouldbeused.

Concomitanttreatmentwitheitherdiltiazemorverapamilhasbeendemonstratedtoincrease

plasmabuspironeconcentration.SubsequentdoseadjustmentsofeitherBusparorthecalcium

antagonistshouldbebasedonclinicalresponse.

CoadministrationofrifampicinwithBusparhasbeenshowntodecreasetheplasma

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5.2Pharmacokineticproperties

Busparisrapidlyabsorbedwhengivenorally.Itisthensubjecttoconsiderablefirst-passmetabolism.Peakplasma

levelsoccur60-90minutesafterdosing.Plasmaconcentrationislinearlyrelatedtodose.Followingmultipledosing

steadystateplasmaconcentrationsareachievedwithin2days.Busparis95%proteinbound.Buspariseliminated

primarilybylivermetabolism.Inpharmacokineticstudiesmeanplasmahalf-livesvariedfrom2to11hours.

5.3Preclinicalsafetydata

Nofurtherrelevantinformation.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactoseanhydrous

Sodiumstarchglycollate

Microcrystallinecellulose

Collodialanhydroussilica

Magnesiumstearate

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

Thetabletsarepackedinbottlescontaining50or100tablets;blisterscontaining21,30,60,84,90tablets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecificrequirements.

7MARKETINGAUTHORISATIONHOLDER

Bristol-MyersSquibbHoldingsLtd

t/aBristol-MyersPharmaceuticals

Swords

Irish Medicines Board

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8MARKETINGAUTHORISATIONNUMBER

PA48/41/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:12 th

December1988

Dateoflastrenewal:12 th

December2008

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 21/06/2010 CRN 2060646 page number: 6