DALACIN C

Main information

  • Trade name:
  • DALACIN C
  • Dosage:
  • 150 Base Milligrams
  • Pharmaceutical form:
  • Capsules Hard
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DALACIN C
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0936/068/002
  • Authorization date:
  • 22-05-2001
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

DalacinC150mgHardCapsules.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachcapsulecontainsclindamycinhydrochlorideequivalentto150mgofclindamycinbase.

Excipients:

Lactosemonohydrate 237mg

Forfulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Hardcapsule.

Size1,hardgelatincapsuleswithanopaquewhitebodyandanopaquewhitecap,containingawhitetooff-white

powder.Thecapsuleisimprintedwith‘CLIN150’and‘Pfizer’.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthemanagementofseriousinfectionsduetoorganismssusceptibletothisanti-infective.

4.2Posologyandmethodofadministration

Tobetakenorally.DalacinCCapsulesshouldalwaysbetakenwithaglassofwater.

AbsorptionofDalacinCisnotappreciablymodifiedbythepresenceoffood.

Adults(includingtheelderly):

Moderatelysevereinfection: 150 -300mgeverysixhours

Children(over1monthofage):

Theusualdailydosageis12-24mg/kgin4divideddoses.

Inchildrenunderoneyearofageorweighing10kgorless,theminimumrecommendeddosageis37.5mgeveryeight

hours.

DosageinElderly

Thedosageofclindamycinmayrequirereductioninpatientswithrenalimpairmentduetoprolongationoftheserum

half-lifeofthisdrug.Thisisparticularlyimportantwithparenteraldosage.

DosageinRenalImpairment

Clindamycindosagemodificationisnotnecessaryinpatientswithrenalinsufficiency.

Note:Incasesofbeta-haemolyticstreptococcalinfection,treatmentwithDalacinCshouldcontinueforatleast10

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4.3Contraindications

DalacinCiscontraindicatedinpatientspreviouslyfoundtobehypersensitivetothisantibiotic.Althoughcross-

sensitisationtolincomycinhasnotbeendemonstrated,itisrecommendedthatDalacinCisnotusedinpatientswhohave

demonstratedlincomycinsensitivity.

DalacinCshouldnotbeprescribedconcurrentlywitherythromycin.

DalacinCshouldnotbeusedinpatientswithdiarrhoeaorintestinalinflammatorydisease.

Patientswithrarehereditaryproblemsofgalactoseintolerance,theLapplactasedeficiencyorglucose-galactose

malabsorptionshouldnottakethismedicine.

4.4Specialwarningsandprecautionsforuse

DalacinCshouldonlybeusedinthetreatmentofseriousinfections.Inconsideringtheuseofthisproductthepractitioner

shouldbearinmindthetypeofinfectionandthepotentialhazardofthediarrhoeathatmaydevelop,sincecasesofcolitis

havebeenreported.Theappearanceofmarkeddiarrhoeashouldberegardedasanindicationthatthedrugshouldbe

discontinuedimmediately,sinceitmayprogresstopseudomembranouscolitis.

Studiesindicateatoxin(s)producedbyclostridia(especiallyClostridiumdifficile)istheprincipalcauseof

antibiotic -associatedcolitis.Thesestudiesalsoindicatethatthistoxigenicclostridiumisusuallysensitiveinvitroto

vancomycin.When125 -500mgofvancomycinareadministeredorallyfourtimesaday,thereisarapidobserved

disappearanceofthetoxinfromfaecalsamplesandacoincidentrecoveryfromthediarrhoea.

Clostridiumdifficileassociateddiarrhoea(CDAD)hasbeenreportedwiththeuseofnearlyallantibacterialagents,

includingclindamycin,andmayrangeinseverityfrommilddiarrhoeatofatalcolitis.Treatmentwithantibacterial

agentsaltersthenormalfloraofthecolonleadingtoovergrowthofCdifficile.

C.difficileproducestoxinsAandBwhichcontributetothedevelopmentofCDAD.HypertoxinproducingstrainsofC.

difficilecauseincreasedmorbidityandmortality,astheseinfectionscanberefractorytoantimicrobialtherapyandmay

requirecolectomy.CDADmustbeconsideredinallpatientswhopresentwithdiarrhoeafollowingantibioticuse.

CarefulmedicalhistoryisnecessarysinceCDADhasbeenreportedtooccurovertwomonthsaftertheadministration

ofantibacterialagents.

Antagonismhasbeendemonstratedbetweenclindamycinanderythromycininvitro.Becauseofpossibleclinical

significance,thesetwodrugsshouldnotbeadministeredconcurrently.

CareshouldbeobservedintheuseofDalacinCinatopicindividualse.g.asthmaandallergy.

Periodicliverfunctiontestsandbloodcountsshouldbecarriedoutduringprolongedtherapy.Suchmonitoringisalso

recommendedinneonatesandinfants.Safetyandappropriatedosageininfantslessthanonemontholdhavenotbeen

established.

Prolongedadministrationofananti-infectivemayresultinsuper-infectionduetoorganismsresistanttotheanti-

infective.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Clindamycinhasbeenshowntohaveneuromuscularblockingpropertiesthatmayenhancetheactionofother

neuromuscularblockingagents.Itshould,therefore,beusedwithcautioninpatientsreceivingsuchagents.Antibiotics

canreducetheefficacyoftheoralcontraceptivepill.Additionalcontraceptiveprecautionsshouldbetakenduring

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4.6Fertility,pregnancyandlactation

Assafetyforuseinpregnancyorlacatationhasnotbeenestablished,DalacinCshouldbeusedonlyifconsidered

essentialbythephysician.DalacinCcrossestheplacentainhumans.Aftermultipledoses,amnioticfluid

concentrationswereapproximately30%ofmaternalbloodconcentrations.

CautionshouldbeexercisedwhenDalacinCisadministeredtoanursingmother.DalacinChasbeenreportedto

appearinhumanbreastmilkinrangesfrom0.7to3.8µg/mL.Itisunlikelythatanursinginfantcanabsorba

significantamountofDalacinCfromitsgastro-intestinaltract.

4.7Effectsonabilitytodriveandusemachines

Nonestated.

4.8Undesirableeffects

Gastro-intestinaltract:Nausea,vomiting,oesphagitis,oesophagealulcerabdominalpainanddiarrhoea.Theappearance

ofmarketeddiarrhoeashouldberegardedasanindicationthatthisdrugshouldbediscontinuedimmediately.Usually

C.difficiletoxinhasbeenshownasthecauseofcolitis.

Haemopoietic:Transientneutropenia(leucopenia),eosinophilia,agranulocytosisandthrombocytopeniahavebeen

reported.NodirectaetiologicrelationshiptoconcurrentDalacinCtherapycouldbemadeinanyoftheforegoing.

Skinandmucousmembrane:Pruritus,vaginitisandrareinstancesofexfoliativeandvesiculobullousdermatitishave

beenreported.Rarecasesoftoxicepidermalnecrolysishavebeenreportedduringpost-marketingsurveillance.

Hypersensitivityreactions:Maculopapularrashandurticariahavebeenobservedduringdrugtherapy.Generalisedmild

tomoderatemorbilliform-likeskinrashesarethemostfrequentlyreportedreactions.Rareinstancesoferythema

multiform,someresemblingStevens-johnsonsyndrome,havebeenassociatedwithDalacinC.afewcasesof

anaphylactoidreactionshavebeenreported.

Hepatic:JaundiceandabnormalitiesinliverfunctiontestshavebeenobservedduringDalacinCtherapy.

Nervoussystem:Dysgeusia.

Cardiovascular:Rareinstancesofcardiopulmonaryarrestandhypotensionhavebeenreportedfollowingtoorapid

intravenousadministration.

4.9Overdose

Incasesofoverdosagenospecifictreatmentisindicated.

Theserumbiologicalhalf-lifeofDalacinCis2.4hours.DalacinCcannotreadilyberemovedfromthebloodby

haemodialysisorperitonealdialysis.

Ifanallergicadversereactionoccurs,therapyshouldbewiththeusualemergencytreatments,includingcorticosteroids,

adrenalineandantihistamines.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

DalacincisalincosamideantibioticwithaprimarilybacteriostaticactionagainstGram-positiveaerobesandawide

rangeofanaerobicbacteria.LincosamidessuchasDalacinCbindtothe50Ssubunitofthebacterialribosomesimilarly

tomacrolidessuchaserythromycinandinhibittheearlystagesofproteinsynthesis.TheactionofDalacinCis

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DalacinChasbeenshowntohaveinvitroactivityagainstisolatesofthefollowingorganisms:

Aerobicgram-positivecocci,including:

Staphylococcusaureus:

Staphylococcusepidermidis(penicillinaseandnonpenicillinaseproducingstrains):

Whentestedbyinvitromethodssomestaphylococcalstrainsorigincallyresistanttoerythromycinrapidlydevelop

resistanceofDalacinCphosphate:

Streptococci(exceptStreptococcusfaecalis):

Pnenmococci.

Anaerobicgram-negativebacilli,including:

Bacteroidsspecies(includingBacteroidsfragilisgroupandBacteroidesmelaninogenicusgroup):

Fusobacteriumspecies.

Anaerobicgram-positivenon-sporeformingbacilli,including:

Propionibacterium

Eubacterium

Actinomycesspecies:

Anaerobicandmicroaerophilicgram-positivecocci,including:

Peptococcusspecies:

Peptostreptococcusspecies:

Microaerophilicstreptococci.

Clostridia:clostridiaaremostresistantthanmostanaerobestoDalacinC.MostClostridiumperfringensaresusceptible,

butotherspeciese.g.,ClostridiumsporogenesandClostridiumtertiumarefrequentlyresistanttoDalacinC.

Mostgram-negativeaerobicbacteria,includingtheenterobacteriaceae,areresistanttoDalacinC.DalacinC

demonstratescross-resistancewithlimcomycin.Whentestedbyinvitromethods,somestaphylococcalstrains

originallyresistanttoerythromycinrapidlydevelopedresistancetoDalacinC.themechanismsforresistancearethe

sameasforerythromycin,namelymethylationoftheribosomalbindingsite,chromosomalmutationoftheribosomal

proteinandinafewstaphylococcalisolatesenzymicinactivationbyaplasmid-mediatedadenyltransferase.

5.2Pharmacokineticproperties

Serumlevelstudieswitha150mgoraldoseofDalacinCin24normaladultvolunteersshowedthatDalacinCwas

rapidlyabsorbedafteroraladministration.Anaveragepeakserumlevelof2.5mcg/mLwasreachedin45minutes:

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

complete(90%)andtheconcomitantadministrationoffooddosenotappreciablymodifytheserumconcentrations;

serumlevelshavebeenuniformandpredictablefrompersontopersonanddosetodose.Serumlevelsstudiesfollowing

multipledoseofDalacinCforupto14daysshownoevidenceofaccumulationoralteredmetabolismofdrug.Serum

half-lifeofDalacinCisincreasedslightlyinpatientswithmarkedlyreducedrenalfunction.Haemodialysisand

peritonealdialysisarenoteffectiveinremovingDalacinCfromtheserum.ConcentrationsofDalacinCintheserum

increasedlinearlywithincreaseddose.SerumlevelsexceedtheMIC(minimuminhibitoryconcentrations)formost

indicatedorganismsforatleastsixhoursfollowingadministrationoftheusuallyrecommendeddoses.Dalacinis

widelydistributedinbodyfluidsandtissues(includingbones).Theaveragebiologicalhalf-lifeis2.4hours.

Approximately10%ofthebioactivityisexcretedintheurineand3.6%inthefaeces;theremainderisexcretedas

bioinactivemetabolites.Dosesofupto2gramsofDalacinCperdayfor14dayshavebeenwelltoleratedbyhealthy

volunteers,exceptthattheincidenceofgastrointestinalsideeffectsisgreaterwiththehigherdoses.Nosignificant

levelsofDalacinCareattainedinthecerebrospinalfluid,eveninthepresenceofinflamedmeninges.Pharmacokinetic

studiesinelderlyvolunteers(61-79years)andyoungeradults(18-39years)indicatethatagealonedoesnotalter

DalacinCpharmakinetics(clearance,eliminationhalf-life,volumeofdistribution,andareaundertheserum

concentrationstimecurve)afterIVadministrationofDalacinCphosphate.AfteroraladministrationofDalacinC,

eliminationhalf-lifeisincreasedtoapproximately4.0hours(range3.4-5.1h)intheelderlycomparedto3.2hours

(range2.1-4.2h)inyoungeradults.Theextentofabsorptionhowever,isnotdifferentbetweenagegroupsandno

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5.3Preclinicalsafetydata

Thereisnoevidenceofteratogeniceffectinanimalsnortodateinman.

Carcinogenesis:longtermstudiesinanimalshavenotbeenperformedwithDalacinCtoevaluatecarcinogenicpotential.

Mutagenesis:GenotoxicitytestperformedincludedaratmicronucleustestandanAmesSalmonellareversiontest.Both

testswerenegative.

ImpairmentofFertility:Fertilitystudiesinratstreatedorallywithupto300mg/kg/day(approximately1.1timesthe

highestrecommendedadulthumandosebasedonmg/m²)revealednoeffectsonfertilityormatingability.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate

Maizestarch

Talc

Magnesiumstearate

Capsules:

Gelatin

Titaniumdioxide(E171)

Printingink:

Shellac

Soyalecithin

Dimeticone(AntifoamDC1510)

Blackironoxide

Propyleneglycol

6.2Incompatibilities

Notapplicable.

6.3Shelflife

5years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

DalacinC150mgHardCapsulesareavailableinblisterpacks(aluminiumfoil/PVC)of24and100capsules.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfromsuchmedicinalproduct

andotherhandlingoftheproduct.

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7MARKETINGAUTHORISATIONHOLDER

PharmaciaIreland

9Riverwalk

NationalDigitalPark

CitywestBusinessCampus

Dublin24

8MARKETINGAUTHORISATIONNUMBER

PA0936/068/002

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:10May1977

Dateoflastrenewal:22May2006

10DATEOFREVISIONOFTHETEXT

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