BY-MYCIN

Main information

  • Trade name:
  • BY-MYCIN Capsules Hard 50 Milligram
  • Dosage:
  • 50 Milligram
  • Pharmaceutical form:
  • Capsules Hard
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BY-MYCIN Capsules Hard 50 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0915/024/001
  • Authorization date:
  • 13-03-2009
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACT1995,asamended

MedicinalProducts(ControlofPlacingontheMarket)Regulations,2007,asamended

PA0915/024/001

CaseNo:2085661

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

HelsinnBirexTherapeuticsLtd

Damastown,Mulhuddart,Dublin15,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

By-Mycin50mgCapsules

theparticularsofwhicharesetoutintheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsasmaybespecifiedin

thesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom09/07/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 09/07/2010 CRN 2085661 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

By-Mycin50mgCapsules

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachcapsulecontains:

Doxycyclinebase 50mg

(asdoxycyclinehyclate)

Eachcapsulealsocontains12.13mgofsucrose.

Forafulllistofexcipientsseesection6.1

3PHARMACEUTICALFORM

Capsules,hard.(Capsules).

Size4,opaquepalegreencapandopaquewhitebody,hardgelatincapsulescontainingyellowtoyellowish

microgranules.

4CLINICALPARTICULARS

4.1TherapeuticIndications

By-Mycinhasbeenfoundclinicallyeffectiveinthetreatmentofavarietyofinfectionscausedbysusceptiblestrainsof

Gram-positiveandGram-negativebacteriaandcertainothermicro-organisms.

RespiratoryTractInfections:

PneumoniaandotherlowerrespiratorytractinfectionsduetosusceptiblestrainsofStreptococcuspneumoniae,

Haemophilusinfluenzae,Klebsiellapneumoniae,Branhamellacatarrhalisandotherorganisms.Mycoplasma

pneumoniapneumonia.

Treatmentofchronicbronchitis,sinusitis.

UrinaryTractinfections:

InfectionscausedbysusceptiblestrainsofKlebsiellaspecies,Enterobacterspecies,Escherichiacoli,Streptococcus

faecalisandotherorganisms.

SexuallyTransmittedDisease:

InfectionsduetoChlamydiatrachomatisincludinguncomplicatedurethral,endocervicalorrectalinfections.Non-

gonococcalurethritiscausedbyUreaplasmaurealyticum(T-mycoplasma).By-Mycinisalsoindicatedininfections

duetoCalymmatobacteriumgranulomatis.By-Mycinisanalternativedruginthetreatmentofgonorrhoeaand

syphilis.

Dermatologicalinfections:

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SinceBy-Mycinisamemberofthetetracyclineseriesofantibiotics,itmaybeexpectedtobeusefulinthetreatmentof

infections,whichrespondtoothertetracyclinessuchas.

Ophthalmicinfections:

By-Mycinisindicatedinthetreatmentoftrachoma,althoughtheinfectiousagentisnotalwayseliminated,asjudged

byimmunofluorescence.InclusionconjunctivitismaybetreatedwithoralBy-Mycinaloneorincombinationwith

topicalagents.

Rickettsialinfections:

RockyMountainspottedfever,typhusgroup,QfeverandCoxiellaendocarditis.

Otherinfections:

Psittacosis,brucellosis(incombinationwithstreptomycin),cholera,bubonicplague,louseandtick-bornerelapsing

fever,includingstage1Lymedisease,leptospirosis,tularaemia,glanders,chloroquine-resistantfalciparummalariaand

acuteintestinalamoebiasis(asanadjuncttoamoebicides).InfectionsduetosusceptiblestrainsofBacteroidesspecies,

ListeriaspeciesandBacillusanthracis.

By-Mycinisanalternativedruginthetreatmentofleptospirosis,gasgangreneandtetanus.

By-Mycinisindicatedforprophylaxisinthefollowingconditions:Scrubtyphus,travellers’diarrhoea(enterotoxigenic

Escherichiacoli),leptospirosis,malariaandcholera.

4.2Posologyandmethodofadministration

Adultsandchildrenover50kgb.w.

TheusualdoseofBy-Mycinforthetreatmentofacuteinfectionsisaninitialdoseof200mg(administeredasasingle

doseordividedintotwoequaldoseswitha12hourinterval)followedbyamaintenancedoseof100mg/day.Formore

severeinfections(particularlychronicinfectionsoftheurinarytract)200mgdailyshouldbegiventhroughoutthe

treatmentperiod.

By-Mycinshouldbeadministeredwithadequateamountsoffluid.Thisshouldbedoneinthesittingorstanding

positionandwellbeforeretiringatnighttoreducetheriskofoesophagealirritationandulceration.Ifgastricirritation

occurs,itisrecommendedthatBy-Mycinbegivenwithfoodormilk.

StudiesindicatethattheabsorptionofBy-Mycinisnotnotablyinfluencedbysimultaneousingestionoffoodormilk.

Exceedingtherecommendeddosagemayresultinanincreasedincidenceofsideeffects.

Therapyshouldbecontinuedatleast24to48hoursaftersymptomsandfeverhavesubsided.

Whenusedinstreptococcalinfections,therapyshouldbecontinuedfor10daystopreventthedevelopmentof

rheumaticfeverorglomerulonephritis.

Dosagerecommendationsinspecificinfections:

Acnevulgaris:therecommendeddoseis50mgdaily,foraminimumof6weeks.

SexuallyTransmittedDisease:100mgtwicedailyfor7daysisrecommendedinthefollowinginfections:

Uncomplicatedurethral,endocervicalorrectalinfectioncausedbyChlamydiatrachomatis,non-gonococcalurethritis

causedbyUreaplasmaurealyticum.

Uncomplicatedgonococcalinfections(exceptanorectalinfectionsinmen)doxycycline100mgtwicedailyfor7days

togetherwithintramuscularceftriaxone.

Acuteepididymo-orchitiscausedbyChlamydiatrachomatisorNeisseriagonorrhoeadoxycycline100mgtwicedaily

for10daystogetherwithintramuscularceftriaxone.

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Louseandtick-bornerelapsingfeversandlousebornetyphus:Asingledoseof100to200mgaccordingto

severity.

StageOneLymedisease:100mgtwicedailyfor10-30daysaccordingtoclinicalresponse.

Chloroquine-resistantfalciparummalaria:200mgdailyforatleast7days.Duetothepotentialseverityofthe

infection,arapid-actingschizonticidesuchasquinineshouldalwaysbegiveninconjunctionwithBy-Mycin,quinine

dosagerecommendationsvaryindifferentareas.

ProphylaxisofMalaria:100mgdailyinadults.Prophylaxiscanbegin1-2daysbeforetraveltomalariousareas.It

shouldbecontinueddailyduringtravelinthemalariousareasandfor4weeksafterthetravellerleavesthemalarious

area.

Forthetreatmentandselectiveprophylaxisofcholerainadults:300mgasasingledose.

Forthepreventionofscrubtyphus:200mgasingledose,onceweekly.

Forthepreventionoftravellers'diarrhoeaadults:200mgonthefirstdayoftravel(administeredasasingledoseor

as100mgevery12hours)followedby100mgdailythroughoutthestayinthearea.Dataontheuseofthedrug

prophylacticallyarenotavailablebeyond21days.

Forthetreatmentofleptospirosis:100mgtwicedailyfor7days.

Forthepreventionofleptospirosis:200mgonceeachweekthroughoutthestayintheareaand200mgatthe

completionofthetrip.Dataontheuseofthedrugprophylacticallyarenotavailablebeyond21days.

Useintheelderly:By-Mycinmaybeprescribedintheusualdosewithnospecialprecautions.Nodosageadjustment

isnecessaryinthepresenceofrenalimpairment.

Childrenunder50kgb.w.

Aninitialdoseof4mg/kgisfollowedbyadailydoseof2to4mg/kgb.w.

4.3Contraindications

Useinpatientswithhypersensitivitytotetracyclines.

Useduringpregnancyorlactationinwomenbreastfeedinginfants.

Obstructiveoesophagealdisorders,suchasstrictureorachalasia.

4.4Specialwarningsandprecautionsforuse

Tetracyclinesareabsorbedtosomeextentbydevelopingbonesandteethandmayproducestainingandenamel

hypoplasia.Forthisreasonduringthesecondhalfofpregnancylactationandbreastfeedingandinchildrenuptothe

ageofeightyearstetracyclinesshouldonlybeadministeredifconsideredessentialbythephysician,andforasshorta

treatmentperiodasfeasible.Repeatedcoursesshouldbeavoided.Theeffectappearstoberelatedtototaldosagegiven,

andnotonlytodurationoftreatment.

Cross-resistancebetweentetracyclinesmaydevelopinmicro-organismsandcrosssensitisationinpatients.

Prolongeduseofananti-infectivemayresultinthedevelopmentofinfectionduetomicro-organismsresistanttothe

anti-infective.

Ifusedforthetreatmentofgonorrhoeathepossibilityofconcomitantsyphilisshouldbekeptinmindandadequate

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Doxycyclineshouldonlybeusedwithcautioninpatientswithhepaticdysfunction.

Studiestodatehaveindicatedthatadministrationofdoxycyclineattheusualrecommendeddosesdoesnotleadto

accumulationoftheantibioticinpatientswithrenalimpairment.Haemodialysisdoesnotaltertheserumhalf-lifeof

doxycycline.

Theantianabolicactionofthetetracyclinesmaycauseanincreaseinbloodurea.Studiestodateindicatethatthisdoes

notoccurwithdoxycyclineinpatientswithimpairedrenalfunction.

Casesofoesophagealinjuries(oesophagitisandulceration),sometimesserious,havebeenreported.Patientsshouldbe

instructedtotakedoxycyclinewithplentyofwater(atleast100ml),remainuprightandnottaketheirtreatmentbefore

goingtobed(seesection4.2).Withdrawalofdoxycyclineandinvestigationofoesophagealdisordershouldbe

consideredifsymptomssuchasdyspepsiaorretrosternalpainoccur.Cautionisrequiredinthetreatmentofpatients

withknownoesophagealrefluxdisorders.

Patientswithrarehereditaryproblemsoffructoseintolerance,glucose-galactosemalabsorptionorsucrase-isomaltase

insufficiencyshouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Administrationoftetracyclineswithantacids,calciumorironpreparationsmayaffectabsorption.

Tetracyclinesmayprolongtheactionofcoumarinanti-coagulantsandpersedelaycoagulation.

Concurrentuseofbarbiturates,phenytoinorcarbamazepinemaydecreaseplasmalevelsofdoxycycline.

Sincebacteriostaticdrugsmayinterferewiththebactericidalactionofpenicillin,itisadvisabletoavoidgiving

doxycyclineinconjunctionwithpenicillin.

Theconcurrentuseoftetracyclinesandmethoxyfluranehasbeenreportedtoresultinfatalrenaltoxicity.

4.6Pregnancyandlactation

Doxycyclinecrosstheplacentaandispresentinthemilkoflactatingwomen,itshouldnotbeusedinpregnantwomen

andinnursingmothers.

4.7Effectsonabilitytodriveandusemachines

Patientsonthisdrugshouldnotdriveoroperatemachineryunlessthedoxycyclinehasbeenshownnottoaffecttheir

physicalability.

4.8Undesirableeffects

Gastrointestinaldisturbances,includingdiarrhoea,candidasuperinfection.

Photosensitivitymanifestedbyanexaggeratedsunburnreactionhasbeenobservedinsomeindividualstaking

tetracyclines.Patientslikelytobeexposedtodirectsunlightorultravioletlightshouldbeadvisedthatthisreactioncan

occurwithtetracyclinedrugsandtreatmentshouldbediscontinuedatthefirstevidenceofskinerythema.

4.9Overdose

Acuteoverdosagewithantibioticsisrare.Toxiceffectsareusuallyduetohypersensitivityreactionsandshouldbe

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Doxycyclinehasamodeofactionandaspectrumofanti-infectiveactivitysimilartobutslightlybroaderthanthatof

tetracycline.

5.2Pharmacokineticproperties

Afteroraldosingitisabsorbedreadily,withorwithoutthepresenceoffoodandisexcretedslowlyinurinewithahalf-

lifeofabout14-25hours.Thedrugislipidsoluble.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sucrose

Maizestarch

Crospovidone

EudragitE100

(Poly[butylmethacrylate(2-dimethylaminoethyl)meth-acrylateMethylmethacrylate]1:2:1)

Talc

Capsuleshell

Gelatine

Titaniumdioxide(E171)

Indigocarmine(E132)

Quinolineyellow(E104)

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

Doxycyclinecapsulesarepackedinblisterpacksmadeofonesheetof200micronrigid,opaquewhitepolyvinyl

chlorideandasecondsheetof20micronaluminium.

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Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

HelsinnBirexTherapeuticsLtd.

Damastown

Mulhuddart

Dublin15

8MARKETINGAUTHORISATIONNUMBER

PA915/24/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:8 th

September1994

Dateoflastrenewal:8 th

September2009

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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