BIRAVID

Main information

  • Trade name:
  • BIRAVID Film Coated Tablet 200 Milligram
  • Dosage:
  • 200 Milligram
  • Pharmaceutical form:
  • Film Coated Tablet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BIRAVID Film Coated Tablet 200 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0915/008/001
  • Authorization date:
  • 29-10-2004
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACT1995,asamended

MedicinalProducts(ControlofPlacingontheMarket)Regulations,2007,asamended

PA0915/008/001

CaseNo:2086658

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

HelsinnBirexTherapeuticsLtd

Damastown,Mulhuddart,Dublin15,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Biravid200mgFilm-Coatedtablets

theparticularsofwhicharesetoutintheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsasmaybespecifiedin

thesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom30/07/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 30/07/2010 CRN 2086658 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Biravid200mgFilm-Coatedtablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachfilm-coatedtabletContains200mgofloxacin

Excipients:Eachtabletcontains108.9mglactosemonohydrate.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Film-coatedtablets{shortterm:tablets}

White,round,film-coatedtablets11mmindiameter,scoredonbothsides.Onesideofthetabletdebossed‘FXN’on

onesideofthebreak-lineand‘200’ontheotherside.

Thetabletcanbedividedintoequalhalves.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Ofloxacinisasynthetic4-fluoroquinoloneantibacterialagent.ItiseffectiveinvitroagainstawiderangeofGram-

negativeandGram-positiveorganisms.Itisindicatedforthetreatmentofthefollowinginfectionswhencausedby

sensitiveorganisms:

Respiratorytract:Acute,chronicorrecurrentrespiratorytractinfections(bronchitis)causedbyHaemophilus

influenzaeorotherGram-negativeormulti-resistantpathogens,aswellasbyStaphylococcusaureus.Inrespiratory

tractinfectionofloxacinisnotrecommendedasfirst-linetherapyforthetreatmentofpneumococcalpneumonia.

Streptococcuspneumoniaeisthemostfrequentpathogenresponsibleforcommunityacquiredpneumonia.

UrinaryTract:Acuteandchroniclowerurinarytractinfections;acuteandchronicupperurinarytractinfections

(pyelonephritis).Uncomplicatednon-gonococcalgonorrhoea,non-gonococcalurethritisandcervicitis

Biravidtabletsarealsoindicatedforinfectionprophylaxisinneutropenicpatients.

Skinandsofttissueinfection.

4.2Posologyandmethodofadministration

Generaldosagerecommendations:Biravidtabletsshouldbeswallowedwithliquid;theyshouldnotbetakenwithin

twohoursofmagnesium/aluminiumcontainingantacids,sucralfateorironpreparationssincereductionofabsorption

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Thedoseofofloxacinisdeterminedbythetypeandseverityoftheinfection.Thedosagerangeforadultsis200mgto

800mgdaily.Upto400mgmaybegivenasasingledose,preferablyinthemorning.

Dailydosesofmorethan400mgmustbedividedintotwoseparatedosesandbegivenatapproximatelyequal

intervals.

Respiratorytractinfection:400mgdailyistherecommendeddoseforthetreatmentofinfectionscausedbysensitive

organisms.

Ofloxacinisnotrecommendedasfirst-linetreatmentforpneumococcalpneumoniabutincircumstanceswherea

physicianconsidersisappropriatetouseofloxacininpatientswithpneumococcalpneumonia,adoseof800mgdaily

shouldbeused.Inthesecases,thedrugshouldbegivenastwodivideddosesdaily.

Lowerrespiratorytractinfection:400mgdailyincreasing,ifnecessary,to400mgtwicedaily.

Lowerurinarytractinfection:200-400mgdaily.

Upperurinarytractinfection:200-400mgdailyincreasing,ifnecessary,to400mgtwiceaday.

Uncomplicatedurethralandcervicalgonorrhoea:Asingledoseof400mg.

Non-gonococcalurethritisandcervicitis:400mgdailyinsingleordivideddoses.

Infectionprophylaxisinneutropenia:400-800mgdailyforupto2monthsasrequired.

Skinandsofttissueinfections:Oral400mgtwiceaday.

Impairedrenalfunction:ThedosageofBiravidshouldbeadjustedaccordingtothedegreeofrenalimpairment.

Withacreatinineclearanceof20-50ml/minute(serumcreatinine1.5-5.0mg/dl)adoseof200mgshouldbe

administeredinitiallyfollowedby100-200mgevery24hours.Ifcreatinineclearanceislessthan20ml/minute(serum

creatininegreaterthan5mg/dl)adoseof200mgshouldbegiveninitiallyandthenreducedto100mgandadministered

every48hours.

Inpatientsundergoinghaemodialysisorperitonealdialysis,100mgshouldbegivenevery24hours.

4.3Contraindications

Ofloxacinmustnotbeusedinpatientswithknownhypersensivitytoofloxacinorothersimilarquinolonedrugsand

anyoftheexcipients.

Inchildrenoradolescentinthegrowthphase,duringpregnancy,inwomenatriskofpregnancyorduringlactation

because,judgingfromanimalexperiments,ariskofdamagetothegrowth-platecartilageinthegrowingorganism

cannotbeentirelyexcluded.

Itshouldnotbeusedinpatientswithahistoryofquinolone-inducedtendondisordersorinpatientswithepilepsy.

Inpatientswithpre-existingCNSlesionsinvolvingaloweredconvulsionsthreshold.

4.4Specialwarningsandprecautionsforuse

Clostridiumdifficile-associateddisease

Diarrhoea,particularlyifsevere,persistentand/orbloody,duringoraftertreatmentwithofloxacin,maybe

symptomaticofpseudo-membranouscolitis.

Ifpseudo-membranouscolitisissuspected,ofloxacinmustbestoppedimmediately.

Appropriatespecificantibiotictherapymustbestartedwithoutdelay(e.g.oralvancomycin,oralteicoplaninor

metronidazole).Productsinhibitingtheperistalsisarecontraindicatedinthisclinicalsituation.

Patientspredisposedtoseizures

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Tendinitis

Tendinitis,rarelyobservedwithquinolones,mayoccasionallyleadtoruptureinvolvingAchillestendoninparticular.

Elderlypatientsaremorepronetotendinitis.Theriskoftendonrupturemaybeincreasedbycoadministrationof

corticosteroids.

Iftendinitisissuspected,oratthefirstsignsofpainorinflammation,treatmentwithofloxacinmustbehalted

immediately.Appropriatetreatment(e.g.immobilisation)mustbeinitiatedfortheaffectedtendon.

Patientswithrenalimpairment

Sinceofloxacinismainlyexcretedbythekidneys,thedoseofofloxacinshouldbeadjustedinpatientswithrenal

impairment.(seesection4.2Posologyandmethodofadministration).

Preventionofphotosensitization

Becauseoftheriskofphotosensitization,exposuretostrongsunlightandUVradiationshouldbeavoidedduring

treatmentwithofloxacin.

SecondaryInfection

Aswithotherantibiotics,theuseofofloxacin,especiallyifprolonged,mayresultintheovergrowthofnon-susceptible

organisms.Repeatedevaluationofthepatientsconditionsisessential.Ifsecondaryinfectionoccurs,appropriate

measuresshouldbetaken.

Patientswithlatentoractualdefectsinglucose-6-phosphatedehydrogenaseactivitymaybepronetohaemolytic

reactionswhentreatedwithquinoloneantibacterialagents.

Patientswithrarehereditaryproblemsofgalactoseintolerance,theLapplactasedeficiencyorglucose-galactose

malabsorptionshouldnottakethismedicine.

Cautionisrecommendedifthedrugistobeusedinpsychoticpatientsorinpatientswithahistoryofpsychiatric

disease.

Usewithgreatcautioninpatientswithpre-existingcentralnervoussystemdisorders.

Patientswithpre-existingsignificantrenalorhepaticdisordersshouldbecarefullymonitoredtodetectany

deteriorationinfunction.Areductionindosagemayberequired.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Antacids

Antacidscontainingaluminium(includingsucralfate)andmagnesiumhydroxides,aluminiumphosphate,zinc,ironare

liabletoreducetheabsorptionofofloxacintablets.Ofloxacinshouldbeadministeredapproximately2hoursapartfrom

antacids.

Theophylline,fenbufenorsimilarnon-steroidalanti-inflammatorydrugs

Nopharmacokineticinteractionsofofloxacinwerefoundwiththeopohyllineinaclinicalstudy.However,a

pronouncedloweringofthecereberalseizurethresholdmayoccurwhenquinolonesaregivenconcurrentlywith

theopohylline,non-steroidalanti-inflammatorydrugs,orotherdrugs,whichlowertheseizurethreshold.

VitaminKantagonists

CoagulationtestsshouldbemonitoredinpatientstreatedwithvitaminKantagonistsbecauseofapossibleincrease

intheeffectofcoumarinderivatives.

Probenecid,cimetidine,furosemideormethotrexate

Particularlyincaseofhighdosetherapy,mutualimpairmentofexcretionandanincreaseinserumlevelsmustbe

consideredwhenquinolonesareadministeredtogetherwithotherdrugsthatalsoundergorenaltubularsecretion.

SuddenreductioninbloodpressuremayoccurwhenBiravidisadministeredwithhypotensiveagents.Insuchcases,

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Concurrentadministrationwithanticoagulanttherapymayrequireadjustmentofthedoseofthelatterasprolonged

ofbleedingtimehasbeenreported.Inastudywithphencourmarinnointeractionswerenoted.

Ofloxacinmaycauseaslightincreaseinserumconcentrationsofglibenclamideadministrationconcurrently;patients

treatedwiththiscombinationshouldbecloselymonitored.

Concomitantusewithsomephenylpropionicacidderivednon-steroidalanti-inflammatorydrugsmayleadtotoxicity

possiblybecauseofrenaleffects.

Ofloxacinmayinhibitthegrowthofmycobacteriumtuberculosis,andtherefore,maygivefalse-negativeresultsinthe

bacteriologicaldiagnosisoftuberculosis.

Determinationofopiatesorporphyrinsinurinemaygivefalse-positiveresultsduringtreatmentwithofloxacin.

4.6Pregnancyandlactation

Ofloxacinmustnotbeprescribedinpregnancyorinwomenatriskofpregnancy.Becauseofloxacinisexcretedin

humanbreastmilk,eitherbreast-feedingortreatmentofthemothermustbestoppedbecauseoftherisktothechild.

(see4.3Contraindications).

4.7Effectsonabilitytodriveandusemachines

Someadversereactions(e.g.dizziness/vertigo,drowsiness,visualdisturbance)mayimpairthepatient’sabilityto

concentrateandreact,andthereforemayconstituteariskinsituationswheretheseabilitiesareofspecialimportance

(e.g.drivingacaroroperatingaspecialmachine).

4.8Undesirableeffects

Theinformationgivenbelowisbasedondatafromclinicalstudiesandonextensivepostmarketingexperience.

Thefollowingfrequencyratinghasbeenused:

Verycommon:morethan10%

Common:1%to10%

Uncommon:0.1%to1%

Rare:0.01%to0.1%

Veryrare:lessthan0.01%

Isolatedcases

Anaphylactic/oidreactions,mucocutaneousreactions

Uncommon:Symptomssuchaspruritus,rash,burningeyes,ticklingcough,nasalcatarrh.

Rare:Anaphylactic/oidreactionssuchasurticaria,angio-edema,dyspnoea/bronchospasm,hotflushes,sweating,

pustulareruption.

Veryrare:Anaphylactic/oidshock,erythemamultiforme,toxicepidermalnecrolysis,photosensitisation,fixed

drugeruption,vascularpurpura,vasculitiswhichcanleadinexceptionalcasestoskinnecrolisis.

Isolatedcases:Steven-Johnsonsyndrome;severedyspnoea.

Gastrointestinal,metabolism

Uncommon:Abdominalpain,diarrhoea,nauseaandvomiting.

Rare:Anorexia,enterocolitiswhichmay,inisolatedcasesbehaemorrhagic.

Veryrare:Pseudomembranouscolitis.

Isolatedcases:Hypoglycaemiaindiabeticstreatedwithhypoglycaemicagents.

Neurological

Uncommon:Agitation,dizziness/vertigo,headache,sleepdisorders/insomnia.

Rare:Psychoticreactions(withe.g.hallucination),anxiety,confusion,nightmares,depression,

drowsiness/somnolence,peripheralsensorydisturbancesuchasparesthesia,tasteandsmell

disorders,visualdisorders.

Veryrare:Auditorydisturbancesliketinnitusandlossofhearing,seizures,extra-pyramidal

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Isolatedcases:Psycoticreactionswithself-endangeringbehaviourincludingsuicidalideationoracts.

Cardiovascular

Rare:Hypotension,tachycardia.

Duringtheinfusionofofloxacin,tachycardiaandadecreaseinbloodpressuremayoccur.

Suchadecreaseinbloodpressuremay,inveryrarecases,besevere.Intheeventofaconspicuous

dropinbloodpressure,theinfusionmustbehaltedimmediately.

Musculo-skeletal

Rare:Tendinitis.

Veryrare:Arthralgia,myalgia.

Tendonrupture(e.g.Achillestendon);aswithotherfluoroquinolonesthisundesirableeffectmay

occurwithin48hoursofstartingtreatmentandmaybebilateral.

Isolatedcases:Rhabdomyolysisand/ormyopathy.

Muscleweaknesswhichmaybeofspecialimportanceinpatientswithmyastheniagravis.

Liver

Rare:Increaseinenzymes(ALAT,ASAT,LDH,gamma-GTand/oralkalinephosphatase)

and/orbilirubin.

Veryrare:Cholestaticjaundice.

Isolatedcases:Hepatitis,whichmaybesevere.

Kidney

Rare:Increaseinserumcreatinine.

Veryrare:Acuterenalfailure.

Isolatedcases:Acuteinterstitialnephritis.

Blood

Veryrare:Anaemia,haemolyticanaemia,leukopenia,eosinophilia,thrombocytopenia.

Isolatedcases:Agranulocytosis,pancytopenia,bonemarrowdepression.

Others

Uncommon:Developmentofresistantmicro-organismsandfungalovergrowth.

Isolatedcases:Allergicpneumonitis,attacksofporphyriainpatientswithporphyria.

4.9Overdose

ThemostimportantsignstobeexpectedfollowingacuteoverdoseareCNSsymptomssuchasconfusion,dizziness,

impairmentofconsciousnessandseizuresaswellasgastrointestinalreactionssuchasnauseaandmucosalerosions.

Treatmentofoverdosageshouldthereforebesymptomatic,withroutinemeasuressuchasgastriclavagecarriedout

assoonaspossible.Eliminationofofloxacinmaybeincreasedbyforceddiuresis.Nospecificantidoteexists.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticsgroup:Fluoroquinoloneantibiotic,ATCcode:J01MA01

Ofloxacinisaquinolone-carbolicacidderivativewithawiderangeofantibacterialactivityagainstbothgramnegative

andgrampositiveorganisms.ItinhibitsbacterialDNAreplicationbyblockingDNAtopo-isomerases,inparticular

DNAgyrase.

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5.2Pharmacokineticproperties

Ofloxacinisanoxyquinoloneanti-infectivethatiswellabsorbed,widelydistributed,slightlymetabolisedinliverto

inactivemetabolitesandexcretedinurinarytractwithT ½ of6-8hours.

5.3Preclinicalsafetydata

Toxicologicalstudieshaveshownthatadministrationofoxoquinoloneantibacterialagentsatdoseshigherthanthe

therapeuticrangecanproduceerosionofthecartilageinweight-bearingjointsinimmatureanimalsofsomespecies.

Nosuchlesionshavebeenshowntooccurinmantodate.Thisproductshouldnotbeprescribedforchildren.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

TabletCore:

LactoseMonohydrate

PregelatinisedStarch

Hypromellose

Croscarmellosesodium

Colloidalanhydroussilica

Magnesiumstearate

FilmCoat:

Hypromellose

TitaniumDioxide(E171)

LactoseMonohydrate

Macrogol3000

Triacetin

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years

6.4Specialprecautionsforstorage

Thismedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5Natureandcontentsofcontainer

PVC/PVdC/aluminiumblisterpacksof10,14,20and50tablets.

PVC/PVdC/aluminiumblistermedicalsamplepackof3tablets

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6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

HelsinnBirexTherapeuticsLtd,

Damastown,

Mulhuddart,

Dublin15,

Ireland.

8MARKETINGAUTHORISATIONNUMBER

PA0915/008/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:29October2004

Dateoflastauthorisation:29October2009

10DATEOFREVISIONOFTHETEXT

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