CO-TENIDONE BP

Main information

  • Trade name:
  • CO-TENIDONE BP
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CO-TENIDONE BP
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0436/030/002
  • Authorization date:
  • 10-10-1996
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Co-TenidoneTabletsBP100/25mg

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each tabletcontainsAtenolol100mg and Chlorthalidone25mg.

3PHARMACEUTICALFORM

Circular, whitefilmcoated tabletsembossed 'Co-Ten 100' on oneside, plain on thereverse.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Themanagementofhypertension.

4.2Posologyandmethodofadminstration

Adults:

Onetabletdaily.

Olderpatientswith hypertension who do notrespond to lowdosetherapy with asingleagentshould haveasatisfactory

responseto asingletabletdaily ofCo-Tenidone50/12.5mg.Wherehypertensivecontrolisnotachieved, addition ofa

smalldoseofathird agente.g. avasodilatormay beappropriate.

Elderly:

Dosagerequirementsareoften lowerin thisagegroup.Olderpatientswith hypertension who do notrespond to low

dosetherapy with asingleagentshould haveasatisfactory responseto asingletabletdaily ofCo-Tenidone50/12.5mg.

Wherehypertensivecontrolisnotachieved, addition ofasmalldoseofathird agent, e.g. avasodilatormay be

appropriate.

Children:

Thereisno paediatricexperienceofthisdrug and itisthereforenotrecommended forusein children.

RenalFailure:

In patientswith severerenalimpairmentareduction in daily dosageorin frequency ofadministration may be

necessary.

4.3Contraindications

or3 rd

degreeatrioventricularblock

Severebradycardia

Uncontrolled ordigitalis/diureticrefractory heartfailure

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4.4Special warningsandprecautionsforuse

Specialprecautionsforuse

Cardiac

Specialcareshould betaken with patientswhosecardiacreserveispoor.Beta-adrenoceptorblocking drugsshould be

avoided in overtheartfailure.They should only beused with caution in patientswith controlled congestivecardiac

failure.

PulseRate

Oneofthepharmacologicalreactionsofthebeta-adrenoceptorblocking drugsistoreduceheartrate.In therare

instancewheresymptomsmay beattributableto slowheartratethedosemay bereduced.

Hypoglycaemia

Co-Tenidonemodifiesthetachycardiaofhypoglycaemia.

Obstructiveairwaysdisease

Although cardio selectivebetablockersmay havelesseffecton lung function than non selectiveblockersthey should

beavoided in patientswith reversibleobstructiveairwaysdiseaseunlesstherearecompelling reasonsfortheirusein

which casethey may beused with caution.Occasionally someincreasein airwaysresistancemay occurin asthmatic

patientsand thismay usually bereversed by commonly used dosagesofbronchodilatorssuchassalbutamolor

isoprenaline.Betablockersshouldbeused with caution in patientswith afamily history ofasthma.

Sudden withdrawalin ischaemicheartdisease

In patientssuffering fromischaemicheartdiseaseaswith otherbetablocking drugstreatmentshould notbestopped

abruptly.

Metaboliceffects

Themetaboliceffectsofchlorthalidonearedoserelated and atthelowdosein Co-Tenidoneareunlikely to be

troublesome.

Potassiumstatus

Aswithothercombinationsofbetaadrenoceptorblocking drugsand diureticshypokalaemiamay occurwithCo-

Tenidone.In mostpatientsthisappearsto beoflittleclinicalsignificance.Measurementofpotassiumlevelsis

appropriateespecially in theolderpatient, thosereceiving digitalispreparationsforcardiacfailure, taking abnormal

(lowin potassium)dietsorsuffering fromgastrointestinalcomplaints.

Serumuricacid

Co-Tenidoneisgenerally associated with only aminorincreasein serumuricacid.In casesofprolonged elevation the

concurrentuseofauricosuricagentwillreversethehyperuricaemia.

Diabetes

Co-Tenidonecontainschlorthalidonewhich may decreaseglucosetoleranceduringprolonged therapy.Regulartests

forglycosuriashould becarried out.

Sensitivityto Chlorthalidone

Careshould betaken in patientswith ahistory ofsensitivity to chlorthalidone.

Anaesthesia

Careshould betaken in theuseofanaestheticwith chlorthalidone.Theanaesthetistshould beinformedand thechoice

ofanaestheticshould betheagentwith aslittlenegativeinotropicactivity aspossible.

SpecialWarnings

Renalimpairment

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necessary.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Caution should beexercised when transferring patientsfromclonidineto betablocking drugs.Ifbetaadrenoceptor

blocking drugsand clonidinearegiven concurrently clonidineshouldnotbediscontinued untilseveraldaysafter

withdrawalofthebetaadrenoceptorblocking drug.

Careshould betaken when prescribing abetaadrenoceptorblocking drug with classIantidysrhythmicagentssuch as

disopyramide.Betaadrenoceptorblocking drugsshould beused with caution in combination with verapamilin

patientswith impaired ventricularfunction.Thiscombination should notbegiven to patientswith conduction

abnormalities.Preparationscontaining lithiumgenerally should notbegiven with diureticsbecauseitmay reduceits

renalclearance.

4.6Pregnancyandlactation

Co-Tenidoneshould notbegiven during pregnancy and lactation unlessconsidered essentialby thephysician.

4.7Effectsonabilitytodriveandusemachines

Co-Tenidoneisunlikely to resultin any impairmentoftheability ofthepatientto driveorto operatemachinery.

4.8Undesirableeffects

Co-Tenidoneisgenerally welltolerated.Sideeffectsassociated with itaregenerally mild and infrequent.Minorside

effectsincludecold extremities, muscularfatigueand in isolated casesbradycardia.Sleep disturbancesofthetype

noted with otherbetaadrenoceptorblocking drugshaverarely been reported.Therehavebeen reportsofskin rashes

and/ordry eyesassociated with theuseofbetaadrenergicblocking drugs.Thereported incidenceissmalland in most

casesthesymptomshaveclearedon withdrawalofthedrug. Discontinuationofthedrug should beconsidered ifsuch

reactionsareotherwiseinexplicable.Cessationoftherapy with betaadrenoceptorblocking drugsshouldbegradual.

Nauseaand dizzinesshavebeen reported occasionally with chlorthalidoneand idiosyncraticdrug reactionssuch as

thrombocytopeniaand leucopeniahaveoccurred rarely.

4.9Overdose

Excessivebradycardiamay becountered with atropine1-2mg i.v. followed ifnecessary by abolusdoseof10mg

glucagon intravenously.Ifnecessary thismay berepeated orfollowed by an intravenousinfusion ofglucagon 1-

10mg/hourdepending on response.Ifno responseto glucagon occursorifitisunavailableabetaadrenoceptor

stimulantsuch asprenalterol5mg intravenously, followed ifnecessary by an intravenousinfusion of5mg/houror,

dobutamine2.5-10µg/kg/minuteby intravenousinfusion may begiven.Any risk ofhypotension occurring following

theuseofabetaadrenoceptoragonistwillbereduced by theuseofmoreselectiveagents, e.g. prenalterolor

dobutamine.Excessivediuresisshould becountered by maintaining normalfluid and electrolytebalance.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Co-Tenidonecombinestheanti-hypertensiveactivity oftwo agents, abetaadrenergicreceptorblocking agent

(atenolol)and adiuretic(chlorthalidone).Atenololpredominantly blocksbetareceptorsand doesnotpossess

membranestabilising orintrinsicsympathomimetic(partialagonistactivities).

Themechanismoftheantihypertensiveactivity ofatenololhasnotbeen established.Chlorthalidonea

monosulphamoyldiureticincreasestheexcretionofsodiumand chloride.Natriuresisisaccompanied by somelossof

potassium.Themechanismby which chlorthalidoneworksusually doesnotdecreasenormalblood pressure.The

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eitherdrug used aloneasan anti-hypertensiveagent.

5.2Pharmacokineticproperties

Co-administration ofatenololand chlorthalidonehaslittleeffecton thepharmacokineticsofeitherdrug.

Approximately 50%ofan oraldoseofatenololand 60%ofan oraldoseofchlorthalidoneisabsorbed fromthe

gastrointestinaltract.Atenololisonly poorly boundto plasmaproteins.Chlorthalidoneis75%plasmaprotein bound.

TheT

foratenololisthreehoursand theT

forchlorthalidoneistwelvehours.Metabolismofatenolol, occursto

only aminorextentand both atenololand pharmacologically activemetaboliteofatenololispresentin man but

representsonly 2%ofthedose.Thismetaboliteisnotdetected in plasma.Theelimination halflifeofatenololis6-9

hoursand thatforchlorthalidoneisapproximately 50 hours.

5.3Preclinical safetydata

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Heavy magnesiumcarbonate

Maizestarch

Gelatin

Sodiumlaurylsulphate

Magnesiumstearate

Hypromellose

Macrogol

Talc

Titaniumdioxide

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3 years.

6.4Special precautionsforstorage

Do notstoreabove25°C.Storein theoriginalcontainer.

6.5Natureandcontentsofcontainer

Polypropylenetubeswith lowdensity polyethylenecapscontaining 30, 100, 500 or1000 tablets.

PVdC/Alblisterpackscontaining 28, 30 and 100 tablets.

6.6Instructionsforuseandhandling

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7MARKETINGAUTHORISATIONHOLDER

Norton Waterford

IDAIndustrialEstate

Cork Road

Waterford

8MARKETINGAUTHORISATIONNUMBER

PA436/30/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 10 October1996

Dateoflastrenewal:10 October2001

10DATEOFREVISIONOFTHETEXT

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