AKNEMYCIN

Main information

  • Trade name:
  • AKNEMYCIN Ointment 2 %w/ w
  • Dosage:
  • 2 %w/ w
  • Pharmaceutical form:
  • Ointment
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AKNEMYCIN Ointment 2 %w/w
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0043/033/001
  • Authorization date:
  • 21-02-1997
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AknemycinOintment,2%w/w

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Erythromycin2%w/w.

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Ointment

Awhitishcolouredointment.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Themanagementofacnevulgarisparticularlyofthepapularorpustulartype.

4.2Posologyandmethodofadministration

AdultsandtheElderly:Applysparinglytotheaffectedareaonceortwicedailyafterthoroughcleansing.

Children:Notrecommended.

4.3Contraindications

Hypersensitivitytoanyoftheconstituents.

4.4Specialwarningsandprecautionsforuse

Prolongeduseofanti-infectivemayresultinsuperinfectionduetomicro-organismsresistanttothatanti-infective.

Ifthereisnoresponsewithin6-8weeksalternativemeasuresshouldbeconsidered.

Prolongeduseisnotrecommended.Acourseshouldnotnormallyexceed6months.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Concomitantusewithothertopicaltreatmentshouldonlybecarriedoutwithcautioninviewofpossiblecumulative

localadverseeffects.

4.6Pregnancyandlactation

Studiesofuseduringpregnancyhavenotbeenconductednostatementsonsafetycanbemade.

Itisrecommendedthatthepreparationshouldonlybeusedwithcautioninlactatingwomenwhoarebreastfeeding,

Irish Medicines Board

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Date Printed 28/07/2006 CRN 2026147 page number: 1

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Localirritation,erythemaanddrynessmayoccur.Diarrhoeahasbeenreportedrarely.

4.9Overdose

Unlikelyastheamountoferythromycinistoosmalltoinducesystemictoxicity.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Erythromycinactsasabacteriostatonallpathogensthatplayaroleinacne,inparticularonPropionibacteriumacnes

(Corynebacteriumacnes).Itinhibitslipolysisofsebumlipids.Adirectanti-inflammatoryeffectispresumed.Invitro

testsdemonstrateasignificantreductioninPropionibacteriumacnesandmicrococcaceae,aswellastotalpathogens.

5.2Pharmacokineticproperties

Percutaneousabsorptionoftheactiveisnegligiblefollowingtopicalapplicationoftheproducttolargeareasforseveral

weeks.Erythromycinpenetratesthesebaceousglandopeningwhereithasbeenshowntohaveabacteriostaticeffect.

5.3Preclinicalsafetydata

Therearenodatafrompreclinicalstudieswhichprovideanyinformationwhichisinadditiontotheknowneffectsof

erythromycininhumans.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Titaniumdioxide

Talc

Whitesoftparaffin

Hardparaffin

Lightliquidparaffin

Oleicacidoleylester

Cetylstearylalcohol

Cetylstearylpolyglycolphosphate

Laurylpolyglycolphosphate

Sorbitol

Perfumeoil

Purifiedwater

6.2Incompatibilities

Irish Medicines Board

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Date Printed 28/07/2006 CRN 2026147 page number: 2

6.3ShelfLife

Unopened:3years.

Usewithin6monthsafterfirstopening.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

Aluminiumtube,withHDPEscrewcap,containing25g.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Forexternaluseonly.

Avoidcontactwitheyes.

7MARKETINGAUTHORISATIONHOLDER

CrookesHealthcareLimited

1ThaneRoadWest

Nottingham

NG23AA

England

8MARKETINGAUTHORISATIONNUMBER

PA43/33/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:21February1992

Dateoflastrenewal:21February2002

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 28/07/2006 CRN 2026147 page number: 3