DALACIN

Main information

  • Trade name:
  • DALACIN Vaginal Cream 2 Base %w/w
  • Dosage:
  • 2 Base %w/w
  • Pharmaceutical form:
  • Vaginal Cream
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DALACIN Vaginal Cream 2 Base %w/w
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0936/082/001
  • Authorization date:
  • 22-05-2001
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Dalacin2%VaginalCream

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachgramofcreamcontainsclindamycinphosphateequivalentto20mgor2.0%w/wclindamycin.

Excipients:

Forfulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Vaginalcream.

White,semi-solidcream.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Antibioticforuseinthemanagementofbacterialvaginosis.

4.2Posologyandmethodofadministration

Oneapplicatorfull(approximately5grams)intravaginallypreferablyatbedtimefor7consecutivedays.

Inpatientsinwhomashortertreatmentcourseisdesirable,a3dayregimenhasbeenshowntobeeffective.

Childrenandtheelderly:Noclinicalstudieshavebeenconductedinpopulationsyoungerthan15yearsorolderthan

60years.DalacinCreamisnotrecommendedforuseintheseagegroups.

4.3Contraindications

DalacinCreamiscontra-indicatedinpatientspreviouslyfoundtobehypersensitivetopreparationscontaining

clindamycinoranyofthecomponentsofthecreambase(seesection6.1Listofexcipients).Althoughcross-

sensitisationtolincomycinhasnotbeendemonstrated,itisrecommendedthatDalacinCreamshouldnotbeusedin

patientswhohavedemonstratedlincomycinsensitivity.DalacinCream2%isalsocontraindicatedindividualswitha

historyofinflammatorybowldiseaseorahistoryofantibiotic-associatedcolitis.

4.4Specialwarningsandprecautionsforuse

AstherearenodataavailableontheuseofDalacinCreaminpatientsyoungerthan15yearsofageorolderthan60

yearsofage,itshouldnotbeusedinthesepopulations.

TheuseofDalacinVaginalCreammayresultintheovergrowthofnon-susceptibleorganisms,particularlyyeasts.

OrallyandparenterallyadministeredDalacin,similartovirtuallyallantibioticshavebeenassociatedwithdiarrhoea

and,insomecases,pseudomembranouscolitis.Therefore,eventhoughonlyaminimalamountofdrugisabsorbedvia

thevaginalroute,ifsignificantdiarrhoeaoccurs,thedrugshouldbediscontinuedandappropriatediagnosticprocedures

Propyleneglycol 50.0 mg/g

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Aswithallvaginalinfections,sexualintercourseduringtreatmentwithDalacinCreamisnotrecommended.Dalacin

Creamcontainsingredientswhichmayweakentherubberofcondomsanddiaphragmsandmakethemlesseffectiveas

abarriermethodofcontraceptionorasprotectionfromsexuallytransmitteddisease,includingAIDS.Donotrelyon

condomsanddiaphragmswhenusingDalacinCream.

Theuseofothervaginalproducts(suchastamponsanddouches)duringthetreatmentwithDalacinCreamisnot

recommended.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Crossresistancehasbeendemonstratedbetweenclindamycinandlincomycin,anderythromycinandclindamycin.

Antagonismhasbeendemonstratedbetweenclindamycinanderythromycininvitro.

Cindamycinhasbeenshowntohaveneuromuscularblockingpropertiesthatmayenhancetheactionoftheother

neuromuscularblockingagents.Therefore,itshouldbeusedwithcautioninpatientsreceivingsuchagents.

Noinformationisavailableonconcomitantusewithotherintravaginalproducts,whichisnotrecommended.

4.6Fertility,pregnancyandlactation

Pregnancy

Inclinicaltrials,useofvaginallyappliedclindamycinphosphatecreaminpregnantwomenintheirsecondtrimester

andsystemicallyadministeredclindamycinduringtheirsecondandthirdtrimestershasnotbeenassociatedwithill

effects.

Thereare,however,noadequateandwell-controlledstudiesinpregnantwomenduringtheirfirsttrimesterandbecause

animalreproductionstudiesarenotalwayspredictiveofhumanresponse,thisdrugshouldbeusedduringpregnancy

onlyifclearlyneeded.

Lactation

Itisnotknownifclindamycinisexcretedinbreastmilkfollowingtheuseofvaginallyadministeredclindamycin

phosphate.Orallyandparenterallyadministeredclindamycinhasbeenreportedtoappearinbreastmilk;therefore,a

fullassessmentofbenefit-riskshouldbemadewhenconsiderationisgiventousingvaginalclindamycinphosphateina

nursingmother.

4.7Effectsonabilitytodriveandusemachines

Notapplicable.

4.8Undesirableeffects

ThesafetyofDalacinVaginalCreamwasevaluatedinbothnon-pregnantpatientsandpatientsduringtheirsecondand

thirdtrimestersofpregnancy.Adverseeventswerereportedbylessthan10%ofpatientsandarelistedbelow:

Urogential:Vaginalmoniliasis,vulvovaginaldisorder,vulvovaginitis,vulvarirritation,trichomonalvaginitis,

cervicitis/vaginitis/vaginalinfection,menstrualdisorder,vaginalpain,metrorrhagia,dysuria,vaginaldischarge,urinary

tractinfection,abnormallabour,endometriosis,glycosuriaandproteinuria.

Bodyasawhole:Moniliasis(body),fungalinfection,generalisedabdominalpain,localisedabdominalpain,bacterial

infection,abdominalcramps,headache,pelvicpain,halitosis,inflammatoryswelling,upperrespiratoryinfection,

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Gastrointestinal:Diarrhoea,nausea,vomiting,constipation,dyspepsia,heartburn,flatulence,abdominalpainand

gastrointestinaldisorder.

Dermatological:Pruritus(non-applicationsite),rash,maculopapularrash,erythema,pruritus(topicalapplicationsite),

moniliasis(skin),andurticaria.

Centralnervoussystem:Dizziness,headacheandvertigo.

Endocrine:Hyperthyroidism

Respiratory:Epistaxis

SpecialSenses:Tasteperversion

4.9Overdose

Vaginallyappliedclindamycinphosphatevaginalcream2%canbeabsorbedinsufficientamountstoproducesystemic

effects.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Clindamycinisantimicrobialagentwhichhasbeenshowntobeeffectiveinthetreatmentofinfectioncausedby

susceptibleanaerobicbacteriaorsusceptiblestrainsofGrampositiveaerobicbacteria.

5.2Pharmacokineticproperties

Followingonceadaydosingof100mgofvaginallyadministeredDalacinCream,ataconcentrationequivalentto20

mgofclindamycinpergramofcream,peakserumclindamycinlevelsaverage20nanograms/ml(range3-93

nanograms/mlinnormalvolunteers.Approximately4%(range0.6-11%)oftheadministereddoseisabsorbed

systematically.

Inwomenwithbacterialvaginosis,theamountofclindamycinabsorbedfollowingvaginaladministrationof100mgof

DalacinCream(20mg/g)is4%(range0.8-8%),whichisapproximatelythesameasinnormalwomen.

Characteristicsinpatients

Nospecialcharacteristics.Seesection4.4"Specialwarningsandspecialprecautionsforuse"forfurtherinformation.

5.3Preclinicalsafetydata

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sorbitanstearate(TypeI)

Polysorbate60

Propyleneglycol

Stearicacid

Cetostearylalcohol

Mixedfattyacidesters/cetylpalmitate

Mineraloil(viscosity180)

Benzylalcohol

Purifiedwater

6.2Incompatibilities

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6.3Shelflife

2years.

6.4Specialprecautionsforstorage

Donotstoreabove25ºC.Donotfreeze.

6.5Natureandcontentsofcontainer

Collapsible,laminatetube(consistingofLDPE,ethyleneco-polymer,paperandaluminiumfoil)withpolypropylene

capcontaining20gramor40gramofcream,packedtogetherwithaleaflet,inacardboardbox.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

PharmaciaIreland

9Riverwalk

NationalDigitalPark

CitywestBusinessCampus

Dublin24

8MARKETINGAUTHORISATIONNUMBER

PA0936/082/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:15October1993

Dateoflastrenewal:22May2006

10DATEOFREVISIONOFTHETEXT

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