CLINDAMYCIN

Main information

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

Documents

Localization

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

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1334/001/001
  • Authorization date:
  • 04-07-2008
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Clindamycin150mgCapsule

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachcapsulecontainsclindamycinhydrochlorideequivalentto150mgclindamycin.

Alsocontainslactose.Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Capsule,hard.

Acapsulewithalavenderbodyandmarooncapimprintedwith"CL150"inwhite.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Clindamycinisindicatedforthetreatmentofsevereinfectionscausedbysusceptiblegram-positiveaerobicorganisms

orbysusceptibleanaerobicorganisms.

Considerationshouldbegiventoofficialguidanceregardingtheappropriateuseofantibacterialagents.

4.2Posologyandmethodofadministration

Tobetakenorally.ClindamycinCapsulesshouldalwaysbetakenwithaglassofwaterandinanuprightposition.

AbsorptionofClindamycinCapsulesisnotappreciablymodifiedbythepresenceoffood.

Adults(includingtheelderly):

Moderatelysevereinfection:150-300mgeverysixhours

Severeinfections:300-450mgeverysixhours

Children:

3-6mg/kgeverysixhoursdependingontheseverityoftheinfection.

DosageinReneal/HepaticImpairment:

Clindamycindosemodificationisnotnecessaryinpatientswithrenalorhepaticinsufficency.

Note:Incasesofbeta-haemolyticstreptococcalinfections,treatmentwithClindamycinCapsulesshouldcontinueforat

least10daystodiminishthelikelihoodofsubsequentrheumaticfeverorglomerulonephritis.

4.3Contraindications

Clindamyciniscontraindicatedinpatientspreviouslyfoundtobehypersensitivetothisantibiotic.Althoughcross-

sensitisationtolincomycinhasnotbeendemonstrated,itisrecommendedthatclindamycinisnotusedinpatientswho

havedemonstratedlincomycinsensitivity.

4.4Specialwarningsandprecautionsforuse

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thepractitionershouldbearinmindthetypeofinfectionandthepotentialhazardofthediarrhoeathatmaydevelop,

sincecasesofcolitishavebeenreported.Theappearanceofmarkeddiarrhoeashouldberegardedasanindicationthat

thedrugshouldbediscontinuedimmediately,sinceitmayprogresstopseudomembranouscolitis.

Studiesindicateatoxin(s)producedbyclostridia(especiallyClostridiumdifficile)istheprincipalcauseofantibiotic-

associatedcolitis.Thesestudiesalsoindicatethatthistoxigenicclostridiumisusuallysensitiveinvitrotovancomycin.

When125-500mgofvancomycinareadministeredorallyfourtimesaday,thereisarapidobserveddisappearanceof

thetoxinfromfaecalsamplesandacoincidentrecoveryfromthediarrhoea.

CareshouldbeobservedintheuseofClindamycinCapsulesinatopicindividualse.g.asthmaandallergy.

Periodicliverfunctiontestsandbloodcountsshouldbecarriedoutduringprolongedtherapy.Suchmonitoringisalso

recommendedinneonatesandinfants.Safetyandappropriatedosageininfantslessthanonemontholdhavenotbeen

established.

Prolongedadministrationofananti-infectivemayresultinsuper-infectionduetoorganismsresistanttotheanti-

infective.

Thismedicinalproductcontainslactose.Patientswithrarehereditaryproblemsofgalactoseintolerance,theLapp

lactasedeficiencyorglucose-galactosemalabsorptionshouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Clindamycinhasbeenshowntohaveneuromuscularblockingpropertiesthatmayenhancetheactionofother

neuromuscularblockingagents.Therefore,itshouldbeusedwithcautioninpatientsreceivingsuchagents.

Antagonismhasbeendemonstratedbetweenclindamycinanderythromycininvitro.Becauseofpossibleclinical

significance,thesetwodrugsshouldnotbeadministeredconcurrently.

4.6Fertility,pregnancyandlactation

Safetyforuseinpregnancyhasnotyetbeenestablished.

Thisdrugshouldonlybeusedinpregnancyorlactationifconsideredessentialbythephysician.Itcrossestheplacenta

andisexcretedinbreastmilk.Thereisnoevidenceofteratogeniceffectinanimalsnortodateinman.

4.7Effectsonabilitytodriveandusemachines

Nonestated.

4.8Undesirableeffects

Anaphylaxisandanaphylactoidreactionshavebeenreported.

Gastro-intestinaltract:Nausea,vomiting,abdominalpainanddiarrhoea(seeWarnings).Diarrhoeaoccursinupto

20%ofpatients;itmaycommenceduringtreatmentormaybedelayeduntilsometimeaftertherapyhasbeen

completed.Thismayprogresstocolitis,includingpseudomembraneouscolitis,whichmayhavelife-threatening

complications.Fatalitieshavebeenreported.

Haemopoietic:Transientneutropenia(leucopenia),eosinophilia,agranulocytosisandthrombocytopeniahavebeen

reported.

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beenreportedinupto10%ofrecipients.Generalisedmildtomoderatemorbilliform-likeskinrashesarethemost

frequentlyreportedreactions.Vesicobullouseruptionsmayalsooccur.Rareinstancesoferythemamultiformeandof

Stevens-Johnsonsyndromehavebeenreported.

Vaginitishasbeenreported.

Hepatic:Jaundiceandabnormalitiesinliverfunctiontestshavebeenobservedduringclindamycintherapy.

Renal:renaldysfunction,orworseningofrenalinsufficiency,hasbeenreported.

Musculoskeletal:polyarthritishasbeenreported.

Nervoussystem:tastedisorder.

4.9Overdose

Symptomsfromoverdosingarenausea,vomitinganddiarrhoea.

Incasesofoverdosagethatmayhaveledtoadversereactions,therapyshouldbediscontinuedandtheusualemergency

treatment,includingcorticosteroids,adrenalineandantihistamines,instituted.

Theserumbiologicalhalf-lifeofclindamycinis2.4hours.Clindamycincannotreadilyberemovedfromthebloodby

dialysisorperitonealdialysis.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Clindamycinisalincosamideantibioticwithaprimarilybacteriostaticaction.Clindamycinbindstothe50Ssubunitof

thebacterialribosomeandinhibittheearlystagesofproteinsynthesis.

Breakpoints:

ThefollowingMICshavebeenproposedtoseparatesusceptiblefromintermediatelysusceptibleandresistant

organisms.

Susceptible: <1.6µg/ml

Intermediate:>1.6-<4.8µg/ml

Resistant: >4.8µg/ml

TheBSAC-recommendedbreakpointsforstaphylococciareS:<0.5µg/ml;

R:>1.0µg/ml

Susceptibility:

Thefollowingtablelistsorganismsaccordingtotheirinherentsusceptibilitytoclindamycin.Theprevalenceof

acquiredresistancemayvarygeographicallyandwithtimeforselectedspeciesandlocalinformationonresistanceis

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*Upto50%ofmethicillin-susceptibleS.aureushavebeenreportedtoberesistanttoclindamycininsomeareas.

Morethan90%ofmethicillin-resistantS.aureus(MRSA)areresistanttoclindamycinandclindamycinshouldnotbe

usedwhileawaitingsusceptibilitytestresultsifthereisanysuspicionofMRSA.

Resistance:

Resistancetoclindamycinusuallyoccursviamacrolide-lincosamide-streptograminB(MLSB)typeofresistance,which

maybeconstitutiveorinducible.Thisismediatedbyavarietyofacquiredgenesthatencodemethylasestargetedatthe

peptidyltransferasecenterof23SribosomalRNA.Methylationimpedesbindingofantibacterialstotheribosomeand

givesrisetocross-resistancetomacrolides(allmacrolideswhenconstitutive),lincosamides(clindamycinand

lincomycin)andtypeBstreptogramins,butnottotypeAstreptogramins.

5.2Pharmacokineticproperties

Serumlevelstudieswitha150mgoraldoseofclindamycinin24normaladultvolunteersshowedthatclindamycinwas

rapidlyabsorbedafteroraladministration.Anaveragepeakserumlevelof2.5mcg/mLwasreachedin45minutes:

serumlevelsaveraged1.51mcg/mLat3hoursand0.70mcg/mLat6hours.Absorptionofanoraldoseisvirtually

complete(90%)andtheconcomitantadministrationoffooddoesnotappreciablymodifytheserumconcentrations;

serumlevelshavebeenuniformandpredictablefrompersontopersonanddosetodose.Serumlevelsstudiesfollowing

Species

Susceptible

Gram-positiveaerobesandanerobes

Staphylococcusaureus*

Staphylococcusepidermidis

Streptococcuspneumoniae

Streptococcuspyogenes

Streptococcusviridans

Gram-negativeanaerobes

Bacteriodesfragilisgroup

Bacteroidesmelaninogenicus

Fusobacteriumspp.

Gram-positiveanerobes

Bifdobacteriumspp.

Eubacteriumspp.

Propionibacteriumspp.

Anaerobes

Clostirdiumperfringens

Peptococcusspp.

Peptostreptococcusspp.

Veillonellaspp.

Resistant

Gram-positiveaerobesandanaerobes

Enterococci

Clostridiaspp.

Gram-negativeaerobes

Gram-negativeanaerobes

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Serumhalf-lifeofclindamycinisincreasedslightlyinpatientswithmarkedlyreducedrenalfunction.Haemodialysis

andperitonealdialysisarenoteffectiveinremovingclindamycinfromtheserum.Concentrationsofclindamycininthe

serumincreasedlinearlywithincreaseddose.SerumlevelsexceedtheMIC(minimuminhibitoryconcentrations)for

mostindicatedorganismsforatleastsixhoursfollowingadministrationoftheusuallyrecommendeddoses.

Clindamyciniswidelydistributedinbodyfluidsandtissues(includingbones).Theaveragebiologicalhalf-lifeis2.4

hours.Approximately10%ofthebioactivityisexcretedintheurineand3.6%inthefaeces;theremainderisexcreted

asbioinactivemetabolites.Dosesofupto2gramsofclindamycinperdayfor14dayshavebeenwelltoleratedby

healthyvolunteers,exceptthattheincidenceofgastrointestinalsideeffectsisgreaterwiththehigherdoses.No

significantlevelsofclindamycinareattainedinthecerebrospinalfluid,eveninthepresenceofinflamedmeninges.

Pharmacokineticstudiesinelderlyvolunteers(61-79years)andyoungeradults(18-39years)indicatethatagealone

doesnotalterclindamycinpharmakinetics(clearance,eliminationhalf-life,volumeofdistribution,andareaunderthe

serumconcentrationstimecurve)afterIVadministrationofclindamycinphosphate.Afteroraladministrationof

clindamycin,eliminationhalf-lifeisincreasedtoapproximately4.0hours(range3.4-5.1h)intheelderlycomparedto

3.2hours(range2.1-4.2h)inyoungeradults.Theextentofabsorptionhowever,isnotdifferentbetweenagegroups

andnodosagealterationisnecessaryfortheelderlywithnormalhepaticfunctionandnormal(age-adjusted)renal

function.

5.3Preclinicalsafetydata

Thereisnoevidenceofteratogeniceffectinanimalsnortodateinman.

Carcinogenesis:

Longtermstudiesinanimalshavenotbeenperformedwithclindamycintoevaluatecarcinogenicpotential.

Mutagenesis:

GenotoxicitytestsperformedincludedaratmicronucleustestandanAmesSalmonellareversiontest.Bothtestswere

negative.

ImpairmentofFertility:

Fertilitystudiesinratstreatedorallywithupto300mg/kg/day(approximately1.1timesthehighestrecommended

adulthumandosebasedonmg/m2)revealednoeffectsonfertilityormatingability.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

CapsuleContents

Lactosemonohydrate

MaizeStarch

Magnesiumstearate

Purifiedtalc

CapsuleBody

Gelatin

Erythrosin(E127)

IndigocarmineFD&CBlue(E132)

CapsuleCap

Gelatin

Erythrosin(E127)

IndigocarmineFD&CBlue(E132)

Titaniumdioxide(E171)

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Lecithin.

6.2Incompatibilities

Notapplicable

6.3Shelflife

3years

6.4Specialprecautionsforstorage

Nospecialprecautionsforstorage.

6.5Natureandcontentsofcontainer

BlisterpackscomposedofPVC/PE/PVdCaluminiumfoil;packsizes:4,8,16,20,24,30,32,40and100.

Polypropylenecontainerswithpolyethylenetamperevidentlids;packsize:100.Notallpacksizesmaybe

marketed.

6.6Specialprecautionsfordisposal

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

ChanelleHealthcareLtd.

Loughrea

Co.Galway

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA1334/1/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

DateofFirstAuthorisation:4thJuly2008.

10DATEOFREVISIONOFTHETEXT

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