CALCIUM GLUCONATE

Main information

  • Trade name:
  • CALCIUM GLUCONATE
  • Dosage:
  • 10 %w/ v, 1 Grams
  • Pharmaceutical form:
  • Solution for Injection
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CALCIUM GLUCONATE
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0073/115/001
  • Authorization date:
  • 01-09-1988
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CalciumGluconateInjectionBP10%w/v,10ml

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each10mlofsolutioncontains2.25millimolesofCa 2+

ascalciumgluconate(975mg/10ml).

Eachmlofsolutioncontains0.225millimolesofCa 2+

ascalciumgluconate(95.7mg/ml).

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Solutionforinjection

Clear,colourless,sterilesolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Parenteraladministrationisindicatedwherethepharmacologicalactionofahighcalciumionconcentrationis

required,asinacutehypocalcaemiaandhypocalcaemictetany.

4.2Posologyandmethodofadministration

Forintravenousorintramuscularinjection.

Adults:Theusualdoseis5-10ml(1.125-2.25mmolor2.25-4.5mEqCa ++

)byslowI.V.injectionorbydeep

I.M.injectionintotheglutealregion.Thedosecanberepeateddailyoreveryseconddayasrequired.

Children:Theusualdoseis2.5-5.0ml(0.562-1.125mmolor1.125-2.25mEqCa ++

)byslowI.V.injection.The

intramuscularrouteisnotrecommendedforchildren.

Elderly:Asperadults,butelderlypatientsshouldbecarefullysupervised(SeeWarningsandPrecautions).

4.3Contraindications

Useinpatientswithhypercalcaemiaandhypercalciuria(e.g.inhyperparathyroidism,hypervitaminosisD,neoplastic

diseasewithdecalcificationofbone,immobilisationosteoporosis,sarcodiosis).

Useinpatientswithrenalinsufficiency.

Useinpatientswithmilk-alkalisyndrome.

4.4Specialwarningsandprecautionsforuse

Calciumsaltsshouldbeusedwithcautioninpatientswithimpairedrenalfunction,orwithnephrocalcinosis,orin

theelderly.

Patientsreceivingcalciumsaltsshouldbemonitored,carefully,toensuremaintenanceofcorrectcalciumbalance

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parenteralcalciumisadministered.

Solutionscontainingcalciumshouldbeadministeredslowlytominimiseperipheralvasodilationandcardiac

depression.

Extravasationshouldbeavoided.

HighVitaminDintakeshouldbeavoided.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Theeffectsofdigoxinandothercardiacglycosidesmaybeaccentuatedbycalcium,resultinginserioustoxicity.

4.6Pregnancyandlactation

Calciumcrossestheplacentaandisexcretedinbreastmilkandthisshouldbeborneinmindwhenconsideringthe

useofcalciumduringpregnancyorlactation.

4.7Effectsonabilitytodriveandusemachines

Nil.

4.8Undesirableeffects

Calciumsaltsareirritantandcancauselocalreactionsfollowingintramuscularinjectionorifextravasationoccurs

duringintravenousadministration.Excessiveamountsofcalciummayleadtohypercalcaemia(SeeOverdose).

4.9Overdose

Possiblesymptomsofhypercalcaemiaincludenausea,vomiting,polydipsia,polyuria,muscleweakness,bonepain,

drowsinessand,inseverecases,cardiacarrhythmiasandcoma.Ifintravenousinjectionistoorapid,symptomsof

hypercalcaemiamayoccuraswellasachalkytaste,hotflushesandhypotension.

Treatmentshouldbeaimedatloweringtheelevatedplasmacalciumconcentration.Initialmanagementshould

includerehydrationand,inseverehypercalcaemia,itmaybenecessarytoadministersodiumchloridebyi.v.infusion

toexpandtheextracellularfluid.Frusemidemaybeadministeredtoincreasecalciumexcretionbutthiazidediuretics

shouldbeavoidedastheymayincreaserenalabsorptionofcalcium.Phosphateshavebeenusedtolowerplasma

calciumconcentrationsbutprecipitationofcalciumphosphateinthetissuesmayresultinnephrocalcinosisand

impairedrenalfunction.Haemodialysisorperitonealdialysismaybeconsideredwhereothermeasureshavefailed

andwherethepatientremainsacutelysymptomatic.Serumelectrolytesshouldbecarefullymonitoredthroughout

treatmentofoverdosage.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

CalciumGluconateInjectionBPisareadilyavailablesourceofcalciumionsforthetreatmentofacute

hypocalcaemiaandhypocalcaemictetany.

5.2Pharmacokineticproperties

Calciumisabsorbedfromthesmallintestine.Plasmalevelsofcalciumarenormallymaintainedwithintherange85-

105mgperlitre(2.1-2.6mmolperlitre).About50%ofthetotalplasmacalciumisinthephysiologicallyactive

ionisedform,about45%isboundtoproteins,mainlyalbumin,and5%iscomplexedwithanions.Excretionof

calciumoccursintheurinealthoughalargeproportionundergoesrenaltubularreabsorption.Calciumisalso

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5.3Preclinicalsafetydata

NofurtherrelevantinformationotherthanthatwhichisincludedinothersectionsoftheSummaryofProduct

Characteristics.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Calciumd-Saccharate

WaterforInjections

6.2Incompatibilities

Calciumsaltscanformcomplexeswithmanydrugsandthismayresultinaprecipitate.Calciumsaltsare

incompatiblewithoxidizingagents,citrates,solublecarbonates,bicarbonates,phosphates,tartrates,sulphates.

Physicalincompatibilityhasalsobeenreportedwithamphotericin,cephalothinsodium,cephazolinsodium,

cephamandolenafate,novobiocinsodium,dobutaminehydrochloride,prochlorperazineandtetracyclines.

6.3ShelfLife

Unopened:3years.

Theproductshouldbeusedimmediatelyafteropening.

6.4Specialprecautionsforstorage

Donotstoreabove25 o

Keeptheampoulesintheoutercarton.

6.5Natureandcontentsofcontainer

10ml,clearglassampoules,glasstypeIPh.Eur.borosilicateglass,packedincardboardcartonstocontain10x10

mlampoules.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Forsingleuseonly.

Solutionscontainingvisiblesolidparticlesshouldnotbeused.

Ifonlypartofthecontentsofanampouleisused,theremainingsolutionshouldbediscarded.

7MARKETINGAUTHORISATIONHOLDER

AntigenPharmaceuticalsLtd.

Roscrea

Co.Tipperary

8MARKETINGAUTHORISATIONNUMBER

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9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:01September1988

Dateoflastrenewal:01September2003

10DATEOFREVISIONOFTHETEXT

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