DALACIN T TOPICAL LOTION 10 MG/ ML CUTANEOUS EMULSI

Main information

  • Trade name:
  • DALACIN T TOPICAL LOTION 10 MG/ ML CUTANEOUS EMULSI
  • Dosage:
  • 10 Base mg/ ml
  • Pharmaceutical form:
  • Cutaneous Emulsion
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DALACIN T TOPICAL LOTION 10 MG/ML CUTANEOUS EMULSI
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0936/080/002
  • Authorization date:
  • 03-01-2001
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

DalacinTTopicalLotion10mg/mlCutaneousEmulsion

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmillilitreofemulsioncontainsclindamycinphosphateequivalentto10mgclindamycin.

Excipients:Cetostearylalcohol25mg/ml

Methylparahydroxybenzoate(E218)3mg/ml

Forfulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Cutaneousemulsion.

Smooth,whitetooff-whiteemulsion.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Treatmentofacnevulgaris.

4.2Posologyandmethodofadministration

ApplyathinfilmofDalacinTTopicalLotiontwicedailytotheaffectedarea.

4.3Contraindications

DalacinTiscontraindicatedinpatientspreviouslyfoundtobehypersensitivetopreparationscontainingclindamycinor

lincomycin.Thisisalsocontra-indicatedinpatientswithahistoryofinflammatoryboweldiseaseorahistoryof

antibiotic-associatedcolitis.

DalacinTshouldnotbeusedinpatientswithsystemicinfectionsforwhichantimicrobialsarebeingused.

4.4Specialwarningsandprecautionsforuse

Oralandparenteralclindamycin,aswellasmostotherantibiotics,havebeenassociatedwithsevere

pseudomembranouscolitis.However,post-marketingstudieshaveindicatedaverylowincidenceofcolitiswith

DalacinTLotion.Thephysicianshould,nonetheless,bealerttothedevelopmentofantibiotic-associateddiarrhoeaor

colitis.Ifdiarrhoeaoccurs,theproductshouldbediscontinuedimmediately.

Studiesindicateatoxin(s)producedbyClostridiumdifficileisthemajorcauseofantibiotic-

associatedcolitis.Colitisisusuallycharacterizedbypersistent,severediarrhoeaandabdominalcramps.Endoscopic

examinationmayrevealpseudomembranouscolitis.StoolcultureforC.difficileand/orassayforC.difficiletoxinmay

behelpfultodiagnosis.

Diarrhea,colitis,andpseudomembranouscolitishavebeenobservedtobeginuptoseveralweeksfollowingcessation

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 27/10/2011 CRN 2106783 page number: 1

Mildcasesofcolitismayrespondtodiscontinuanceofclindamycinalone.

Ifthereisnoresponsewithinafewweeksalternativetherapyshouldbeconsidered,butaresponsemaynotbeseenfor

4-6weeks.

DalacinTTopicalLotionismoresuitableforuseindryorsensitiveskin.Thisisbecausethesolutioncontainsalcohol,

whichmaymaketheskindrier.

ProlongeduseofDalacinTmayresultinsuper-infectionduetomicro-organismsresistanttoclindamycin.

Thelotionhasanunpleasanttasteandcautionshouldbeexercisedwhenapplyingmedicationaroundthemouth.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Clindamycinhasbeenshowntohaveneuromuscularblockingpropertiesthatmayenhancetheactionofother

neuromuscularblockingagents.Therefore,itshouldbeusedwithcautioninpatientsreceivingsuchagents.

Concomitantusewithothertopicaltreatmentshouldonlybecarriedoutwithcautioninviewofpossiblelocal

cumulativeeffects.

4.6Fertility,pregnancyandlactation

Safetyforuseinpregnancyhadnotbeenestablished.Theproductshouldonlybeusedduringpregnancyifconsidered

essentialbythephysician.

ItisnotknownwhetherclindamycinisexcretedinhumanmilkfollowinguseofDalacinT.Breastfeedingshouldnot

beundertakenwhileapatientisusingDalacinT.

4.7Effectsonabilitytodriveandusemachines

None

4.8Undesirableeffects

Skindrynessisthemostcommonadversereactionseenwiththesolution.Inaddition,thefollowingadverseeffects

havebeenreportedwiththeuseoftopicalclindamycin.

Eyedisorders:stingingoftheeye

Gastrointestinaldisorders:abdominalpain,gastrointestinaldistrubances

Infectionsandinfestations:gram-negativefolliculitis

Skinandsubcutaneousskindisorders:skinirritation,contactdermatitis,skinoiliness,urticaria

4.9Overdose

Topicallyappliedclindamycincanbeabsorbedinsufficientamountstoproducesystemiceffects.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Theactiveconstituent,clindamycin,isaknownantibiotic.Whenappliedtopicallyitisfoundincomedonesamplesat

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 27/10/2011 CRN 2106783 page number: 2

5.2Pharmacokineticproperties

Whenappliedtopicallyinanalcoholicsolution,clindamycinhasbeenshowntobeabsorbedfromtheskininsmall

amounts.Verylowlevels,morethan1,000timeslowerthanthosefromnormalsystemicdosesofclindamycin,have

beenfoundintheplasma.UsingasensitiveRIAmethod,clindamycinhasbeendetectedintheurineatlevelsof<1to

53ng/ml,0.15-0.25%ofthecumulativedosebeingrecoveredfromtheurine.Noclindamycinhasbeendetectedinthe

serumfollowingtopicalapplication.

5.3Preclinicalsafetydata

Nospecialcharacteristics.See"Specialwarningsandprecautionsforuse"forfurtherinformation.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Glycerol

Sodiumlauroylsarcosinate

Stearicacid50

GlycerylstearateSE

Cetostearylalcohol

Isostearylalcohol

Methylparahydroxybenzoate(E218)

Purifiedwater

6.2Incompatibilities

Notapplicable.

6.3Shelflife

2years.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

6.5Natureandcontentsofcontainer

LDPEbottlewithpolypropylenedispensingcapcontaining30mlofDalacinTTopicalLotion.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Shakewellbeforeuse.

7MARKETINGAUTHORISATIONHOLDER

PharmaciaIreland

9Riverwalk

NationalDigitalPark

CitywestBusinessCampus

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 27/10/2011 CRN 2106783 page number: 3

8MARKETINGAUTHORISATIONNUMBER

PA936/80/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 3 rd

January1991

Dateoflastrenewal: 22 nd

May2006

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 27/10/2011 CRN 2106783 page number: 4