DALACIN T TOPICAL SOLUTION

Main information

  • Trade name:
  • DALACIN T TOPICAL SOLUTION
  • Dosage:
  • 10 Base mg/ml
  • Pharmaceutical form:
  • Cutaneous Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DALACIN T TOPICAL SOLUTION
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0936/080/001
  • Authorization date:
  • 22-05-2001
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

DalacinTTopical10mg/mlCutaneousSolution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlofsolutioncontainsclindamycinphosphateequivalentto10mgofclindamycin.

Excipients:

Propyleneglycol 50mg/ml

Forfulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Cutaneoussolution.

Aclear,colourlesssolutionwithcharacteristicisopropylalcoholodour.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Treatmentofacnevulgaris.

4.2Posologyandmethodofadministration

Topical.

ApplyathinfilmofDalacinTTopicalSolutiontwicedailytotheaffectedareaafterthoroughcleansing.

4.3Contraindications

DalacinTiscontraindicatedinpatientspreviouslyfoundtobehypersensitivetopreparationscontainingclindamycinor

lincomycin.Thisisalsocontra-indicatedinpatientswithahistoryofinflammatoryboweldiseaseorahistoryof

antibiotic-associatedcolitis.

DalacinTshouldnotbeusedinpatientswithsystemicinfectionsforwhichantimicrobialsarebeingused.

4.4Specialwarningsandprecautionsforuse

Oralandparenteralclindamycin,aswellasmostotherantibiotics,havebeenassociatedwithsevere

pseudomembranouscolitis.Post -marketingstudieshaveindicatedaverylowincidenceofcolitiswithDalacinT

TopicalSolution,howeverthephysicianshould,nonetheless,bealerttothedevelopmentofantibiotic -associated

diarrhoeaorcolitis.Ifdiarrhoeaoccurs,theproductshouldbediscontinuedimmediately.

Studiesindicateatoxin(s)producedbyClostridiumdifficileisthemajorcauseofantibiotic -associatedcolitis.Colitis

isusuallycharacterisedbypersistent,severediarrhoeaandabdominalcramps.Endoscopicexaminationmayreveal

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Diarrhea,colitis,andpseudomembranouscolitishavebeenobservedtobeginuptoseveralweeksfollowingcessation

oforalandparentaltherapywithclindamycin.

Vancomyciniseffectiveinthetreatmentofantibiotic -associatedcolitisproducedbyC.difficile.Theusualdoseis

-500mgorallyevery6hoursfor7-10days.Additionalsupportivemedicalcaremaybenecessary.

Mildcasesofcolitismayrespondtodiscontinuationofclindamycinalone.Cholestyramineandcolestipolresinshave

beenshowntobindC.difficiletoxininvitro,andcholestyraminehasbeeneffectiveinthetreatmentofsomemild

casesofantibiotic -associatedcolitis.

Cholestyramineresinshavebeenshowntobindvancomycin;therefore,whenbothcholestyramineandvancomycinare

usedconcurrently,theiradministrationshouldbeseparatedbyatleasttwohours.

DalacinTTopicalSolutioncontainsanalcoholbasewhichcancauseburningandirritationoftheeye.Intheeventof

accidentalcontactwithsensitivesurfaces(eye,abradedskin,mucousmembranes),bathewithcopiousamountsofcool

tapwater.Thesolutionhasanunpleasanttasteandcautionshouldbeexercisedwhenapplyingmedicationaroundthe

mouth.

Ifthereisnoresponsewithinafewweeksalternativetherapyshouldbeconsidered,butaresponsemaynotbeseenfor

-6weeks.

ProlongeduseofDalacinTTopicalSolutionmayresultinsuper-infectionduetomicro -organismsresistantto

clindamycin.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Clindamycinhasbeenshowntohaveneuromuscularblockingpropertiesthatmayenhancetheactionofother

neuromuscularblockingagents.Therefore,itshouldbeusedwithcautioninpatientsreceivingsuchagents.

Concomitantusewithothertopicaltreatmentshouldonlybecarriedoutwithcautioninviewofpossiblelocal

cumulativeeffects.

4.6Fertility,pregnancyandlactation

Safetyforuseinpregnancyhasnotbeenestablished.

ItisnotknownwhetherclindamycinisexcretedinhumanmilkfollowinguseofDalacinTTopicalSolution.The

preparationshouldonlybeusedwithcautioninnursingmothersandshouldnotbeusedonthechest.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Skindrynessisthemostcommonadversereactionseenwiththesolution.Inaddition,thefollowingadverseeffects

havebeenreportedwiththeuseoftopicalclindamycin.

Eyedisorders:stingingoftheeye

Gastrointestinaldisorders:abdominalpain,gastrointestinaldistrubances

Infectionsandinfestations:gram-negativefolliculitis

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4.9Overdose

Topicallyappliedclindamycincanbeabsorbedinsufficientamountstoproducesystemiceffects.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Clindamycinisalincosamideantibioticwhichisachlorinatedderivativeoflincomycin.Theactiveconstituent,

clindamycin,isaknownantibiotic.Whenappliedtopicallyitisfoundincomedonesamplesatsufficientlevelstobe

activeagainstmoststrainsofPropionibacteriumacnes.

5.2Pharmacokineticproperties

Whenappliedtopically,clindamycinhasbeenshowntobeabsorbedfromtheskininsmallamounts.

Verylowlevels,morethan1000timeslowerthanthosefromnormalsystemicdosesofclindamycin,havebeenfound

intheplasma.UsingasensitiveRIAmethodclindamycinhasbeendetectedintheurineatlevelsof<1to53

nanograms/ml,0.15-0.25%ofthecumulativedosebeingrecoveredfromtheurine.Noclindamycinhasbeendetected

intheserumfollowingtopicalapplications.

5.3Preclinicalsafetydata

Nospecialcharacteristics.See"Specialwarningsandprecautionsforuse"forfurtherinformation.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Isopropylalcohol

Propyleneglycol

Purifiedwater

Concentratedhydrochloricacid(forpH-adjustment)

Sodiumhydroxide(forpH-adjustment)

6.2Incompatibilities

Notapplicable.

6.3Shelflife

2years.

6.4Specialprecautionsforstorage

Donotstoreabove25ºC.

6.5Natureandcontentsofcontainer

Bottle–Whitehighdensitypolyethylenebottlecontaining30mlor50ml

Cap–Polypropylene,linerlessscrewcaps

polypropylenescrewcapslinedwithlaminatedfilmsconsistingofp olyethylene,polyvinylidenechloride

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Applicator–Low-densitypolyethyleneapplicatormadebyDab-O-Matic

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Shakeimmediatelybeforeuse.

7MARKETINGAUTHORISATIONHOLDER

PharmaciaIreland

9Riverwalk

NationalDigitalPark

CitywestBusinessCampus

Dublin24

8MARKETINGAUTHORISATIONNUMBER

PA0936/080/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:12April1989

Dateoflastrenewal:22May2006

10DATEOFREVISIONOFTHETEXT

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