AKNEMIN

Main information

  • Trade name:
  • AKNEMIN Capsule 100 Milligram
  • Dosage:
  • 100 Milligram
  • Pharmaceutical form:
  • Capsule
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AKNEMIN Capsule 100 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0557/002/002
  • Authorization date:
  • 14-06-1994
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Aknemin100

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Minocyclinebase100mg(asthehydrochloridePh.Eur.)percapsule.

3PHARMACEUTICALFORM

Capsule,hard.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Minocyclineisanantibioticwithaspectrumofactivitysimilartoothertetracyclinesbutmoreactiveagainst

StaphylococcusaureusandNocardiaspp.

Itisindicatedforthetreatmentofdiseasesassociatedwithorganismssensitivetotetracyclinessuchasacne,respiratory

infections.gonorrhoea,nocardiosis,staphylococcalinfections;thechemoprophylaxisofmeningococcalinfections.

4.2Posologyandmethodofadministration

Fororaladministration

Adults

Routineantibioticuse:200mgdailyindivideddoses.

Acne:100mgoncedaily

Gonorrhoea:Inadultmales,200mginitiallyfollowedby100mgeveryl2hoursforaminimumof4dayswith

post-therapycultureswithin2-3days.Adultfemalesmayrequiremoreprolongedtherapy.

Prophylaxisofmeningococcalinfections:100mgtwicedailyfor5days,usuallyfollowedbyacourseof

rifampicin.

Children

Aknemin100isnotrecommendedforchildrenunder12yearsold.Forchildrenabove12yearsoldtherecommended

doseis50mgevery12hours.

TheElderly

Aknemin100maybeusedatthenormalrecommendeddosageinelderlypatientsbutcautionisadvisedinpatientswith

renalimpairment.

Thetreatmentofacneshouldbecontinuedforaminimumof6weeks.

4.3Contraindications

Hypersensitivitytotetracyclines,systemiclupuserythematosus,completerenalfailure,childrenunder12yearsold,

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4.4Specialwarningsandprecautionsforuse

Aknemin100shouldbeusedwithcautioninpatientswithhepaticdysfunctionandinconjunctionwithalcoholand

otherhepatotoxicdrugs,andinpatientswithsevererenalimpairment.Incasesofsevererenalinsufficiency,reduction

ofdoseandmonitoringofrenalfunctionmayberequired.

Cross-resistancebetweentetracyclinesmaydevelopinmicro-organismsandcross-sensitisationinpatients.Aknemin

100shouldbediscontinuediftherearesignsorsymptomsofovergrowthofresistantorganisms,e.g.enteritis,glossitis,

stomatitis,vaginitis.pruritusaniorstaphylococcalenteritis.

Patientstakingoralcontraceptivesshouldbewarnedthatifdiarrhoeaorbreakthroughbleedingoccursthereisa

possibilityofcontraceptivefailure.

CautionshouldbeexercisedinpatientswithMyastheniaGravisastetracyclinescancauseweakneuromuscular

blockade.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Tetracyclinesdecreaseplasmaprothrombinactivity;reduceddosesofconcomitantanticoagulantsmaythereforebe

required.Aknemin100shouldnotbeusedwithpenicillins.TheabsorptionofAknemin100isimpairedbyconcomitant

administrationofantacids,andpreparationscontainingiron,calcium,aluminium,ormagnesium.

4.6Pregnancyandlactation

Aknemin100shouldnotbeusedinpregnancyunlessessential.Yellow-browndiscolourationoftheteethandenamel

hypoplasiacanoccurwhendrugsofthetetracyclinegroupareadministeredafterthefirsttrimesterofpregnancy.

Aknemin100shouldnotbegiventolactatingwomen.

4.7Effectsonabilitytodriveandusemachines

Patientsshouldbewarnedofthehazardsofdrivingoroperatingmachineryuntiltheeffectoftreatmentisknown(See

4.8).

4.8Undesirableeffects

Headache,dizziness,vertigo,ataxia,andtinnitusmayoccur,Thesedisturbancesarereversiblewithin3-48hoursof

discontinuingtherapyandoccurlessfrequentlywhenalowdoseisgiven.Gastrointestinaldisturbancesmayoccur.

Dermatologicalreactionsarerarebuterythemamultiforme,Stevens-Johnsonsyndrome,exfoliativedermatitis.and

photosensitivityhavebeenreported.

Hypersensitivityreactionscanincludeurticaria,fever,arthralgia,angioneuroticoedema,anaphylaxisandanaphylactoid

purpura.Rarelypericarditisandpulmonaryinfiltrationhavebeenreported.

Isolatedcasesofsystemiclupuserythematosus(SLE)andexacerbationofpre-existingSLEhavebeenreported.

Aswithothertetracyclines,bulgingfontanellesininfantsandbenignintracranialhypertensioninadultshavebeen

reported.Treatmentshouldbestoppedifevidenceofraisedintracranialpressuredevelops.

Haemolyticanaemia,thrombocytopenia.neutropeniaandeosinophiliahavebeenreportedwithtetracyclines.In

commonwithothertetracyclines.transientincreasesinliverfunctiontestvaluesandrarely,hepatitishavebeen

reported.Therehavebeenisolatedincidencesofpancreatitis.

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ofthyroidtissue;noabnormalitiesoffunctionareknowntooccur.

Hyperpigmentationofskinordiscolourationofteethandbuccalmucosahasbeenreportedoccasional]y.Theseare

generallyreversibleoncessationoftherapy.Thereareisolatedcasesofdiscolourationofconjunctiva,lacrimal

secretions.breastsecretionsandperspiration.(See4.6).

4.9Overdose

Thereisnospecificantidote.Treatmentisgastriclavagewithappropriatesupportivetreatment.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Minocyclineisanantibioticwithaspectrumofactivitysimilartoothertetracyclinesbutismoreactiveagainst

StaphylococcusaureusandNocardiaspp.

5.2Pharmacokineticproperties

Minocyclineisalmostcompletelyabsorbedafteroraladministration.

Absorptionisnotsignificantlyaffectedbythepresenceoffoodormilk.Dosesof200mgfollowedby100mgevery12

hoursproduceplasmaconcentrationsof1to4mgperml.

Plasmahalflifeis12-16hoursinpatientswithnormalrenalfunctionbutincreasedinrenalimpairment.

Minocyclineiswidelydistributedinbodyfluidsandtissue.Itcrossestheplacentaandisexcretedinbreastmilk.

5.3Preclinicalsafetydata

Norelevantpreclinicalsafetydatahavebeengenerated.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Macrogol

Erythrosine(E127)

Redironoxide(E172)

Yellowironoxide(E172)

Titaniumdioxide(E171)

Gelatin

6.2Incompatibilities

Nonestated.

6.3ShelfLife

24months.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

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6.5Natureandcontentsofcontainer

PVC/aluminiumfoilblisterof14inacardboardoutercontaining56or112capsules.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nonestated.

7MARKETINGAUTHORISATIONHOLDER

SurtechInternationalLtd.

TheWindrush

HighStreet

Moreton-In-Marsh

Gloucestershire

GL560LH

England

8MARKETINGAUTHORISATIONNUMBER

PA0557/002/002

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:14June1994

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