ADCORTYL IN ORABASE 0.1% W/W OROMUCOSAL PASTE

Main information

  • Trade name:
  • ADCORTYL IN ORABASE 0.1% W/W OROMUCOSAL PASTE
  • Dosage:
  • 0.1 %w/w
  • Pharmaceutical form:
  • Oromucosal Paste
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ADCORTYL IN ORABASE 0.1% W/W OROMUCOSAL PASTE
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0002/018/001
  • Authorization date:
  • 01-04-1978
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0002/018/001

CaseNo:2055949

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

Bristol-MyersSquibbPharmaceuticalsLtd

Swords,Co.Dublin,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

AdcortylinOrabase0.1%w/woromucosalpaste

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom16/12/2008.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 16/12/2008 CRN 2055949 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AdcortylinOrabase0.1%w/woromucosalpaste

2QUALITATIVEANDQUANTITATIVECOMPOSITION

TriamcinoloneAcetonide0.1%w/w.

Forafulllistofexcipientsseesection6.1

3PHARMACEUTICALFORM

Oromucosalpaste.

Smooth,uniform,whitetolighttanoromucosalpastewithcharacteristicodour.

4CLINICALPARTICULARS

4.1TherapeuticIndications

AdcortylinOrabaseisindicatedforaphthousulcers,ulcerativestomatitis,denturestomatitis,desquamative

gingivitis,erosivelichenplanusandlesionsoftheoralmucosaoftraumaticorigin.

4.2Posologyandmethodofadministration

Adults,ChildrenandtheElderly:Application2to4timesdailyorasdirectedbythephysician.

4.3Contraindications

Inpatientswithahistoryofhypersensitivitytotheproductcomponents.

Useinthepresenceofuntreatedinfectionsofbacterial,viral,tuberculousorfungalorigin.

4.4Specialwarningsandprecautionsforuse

Continuoustreatmentforlongerthanthreeweeksshouldbeavoidedinpatientsundertheageofthreeyearsbecause

ofthepossibilityofadrenocorticalsuppressionorofgrowthsuppression.

Prolongeduseofuninterruptedocclusionorusewithextensiveocclusivedressingsmaysuppressadrenocortical

function.

Donotuseonchildrenunder12yearsofagewithoutmedicalsupervision.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

None.

4.6Pregnancyandlactation

Irish Medicines Board

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Date Printed 16/12/2008 CRN 2055949 page number: 2

animalsshowedteratogeniceffects.Thereisasyetnoevidenceofasimilareffectinhumanbeings.

4.7Effectsonabilitytodriveandusemachines

None.

4.8Undesirableeffects

Triamcinoloneacetonideinanoralpasteiswelltolerated.Thepossibilityofthesystemiceffectswhichare

associatedwithallsteroidtherapyshouldbeconsidered.

4.9Overdose

Topicallyappliedcorticosteroidscanbeabsorbedinsufficientamountstoproducesystemiceffects(seeundesirable

effects).

Intheeventofaccidentalingestion,thepatientshouldbeobservedandtreatedsymptomatically.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Triamcinoloneacetonideisapotentfluorinatedcorticosteroidwithrapidanti-inflammatory,antipruriticandanti-

allergicactions.

Whenappliedtolargeareasorwhentheskinisbroken,orwhenadministeredunderocclusivedressings,triamcinolone

maybeabsorbedinsufficientamountstocausesystemiceffects.

5.2Pharmacokineticproperties

Triamcinolonehasaplasmahalf-lifeofaroundfivehours.

5.3Preclinicalsafetydata

See4.6"Pregnancyandlactation".

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Gelatin

Liquidparaffin

Pectin

Polyethyleneresin

Carmellosesodium

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Irish Medicines Board

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6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

Linedaluminiumtubes,withpolyethylenecap,containing10gpaste.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

Bristol-MyersSquibbPharmaceuticalsLtd

Swords

CountyDublin

8MARKETINGAUTHORISATIONNUMBER

PA2/18/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:1April1978

Dateoflastrenewal:1April2008

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 16/12/2008 CRN 2055949 page number: 4