Cal.D.Forte

New Zealand - English - Medsafe (Medicines Safety Authority)

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Active ingredient:
Colecalciferol 1.25 mg equivalent to 50,000 IU (plus 12% (0.15 mg) overage)
Available from:
PSM Healthcare Ltd trading as API Consumer Brands
INN (International Name):
Colecalciferol 1.25 mg (= 50,000 IU; plus 12% (0.15 mg) overage)
Dosage:
1.25 mg
Pharmaceutical form:
Coated tablet
Composition:
Active: Colecalciferol 1.25 mg equivalent to 50,000 IU (plus 12% (0.15 mg) overage) Excipient: Acacia   Ammonia solution Calcium carbonate   Castor oil Ether Gelatin Hydrated silica Lactose monohydrate Magnesium stearate Maize starch     Methylated spirits Povidone Powdered cellulose Prepared theobroma Purified talc     Purified water Shellac Sucrose   Titanium dioxide White beeswax
Units in package:
Bottle, glass, Amber, with PP cap, 12 tablets
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
DSM Nutritional Products France SAS
Therapeutic indications:
Indicated for treatment of vitamin D deficiency associated with malabsorption in children and/or adult patients. Indicated for prevention and treatment of vitamin D deficiency states.
Product summary:
Package - Contents - Shelf Life: Bottle, glass, Amber, with PP cap - 12 tablets - 18 months from date of manufacture stored at or below 25°C
Authorization number:
TT50-5807
Authorization date:
1996-04-01

DATASHEET

CAL.D.FORTE

(Colecalciferol1.25mg)

PRESENTATION

Cal.D.ForteTabletscontain1.25mgofcolecalciferol.

White,sugar-coated,8mm,biconvextablet.

USES

Actions:

Colecalciferol is avitaminD compoundwhichpossessesthepropertyofpreventing

or treatingrickets.

VitaminD is essentialfor promotingabsorptionandutilisationofcalciumand

phosphateandfor normal calcificationofbone.Alongwithparathyroidhormoneand

calcitonin,itregulatesserumcalciumconcentrations byincreasingserumcalcium

andphosphateconcentrationsas needed.VitaminD stimulates calciumand

phosphateabsorptionfromthesmallintestineandmobilisescalciumfrombone.

Colecalciferol is transferredtotheliverwhere itis convertedtocalcifediol (25-

hydroxycolecalciferol),whichis thentransferredtothekidneys andconvertedto

calcitriol (1,25-dihyroxycolecalciferol,thoughttobethemostactiveform) and24,25-

dihydroxycolecalciferol(physiologic rolenotdetermined).

Calcitriol appears toactbybindingtoaspecific receptor inthecytoplasmofthe

intestinal mucosaandsubsequentlybeingincorporatedintothenucleus,probably

leadingtoformationofthecalcium-bindingproteinwhichresultsinincreased

absorptionofcalciumfromtheintestine.Also,calcitriol mayregulatethetransfer of

calciumionfromboneandstimulatereabsorptionofcalciuminthedistal renal

tubule,therebyeffectingcalciumhomeostasis intheextracellularfluid.

Onset ofaction –Hypercalcaemic: 12to24hours; therapeutic effectmaytake10to

14days.

Duration of action –Followingoral administration:upto6months;repeateddoses

haveacumulativeaction.

Pharmacokinetics:

VitaminD substancesare wellabsorbedfromthegastrointestinal tract.The

presenceofbileisessentialfor adequateintestinal absorption;absorptionmaybe

decreasedinpatientswithdecreasedfatabsorption.

VitaminD anditsmetabolites circulateinthebloodboundtoaspecificalpha-

globulin.VitaminD canbestoredinadiposeandmuscletissuefor longperiodsof

time.Itis slowlyreleasedfromsuchstoragesites andfromtheskinwhere itis

formedinthepresenceofsunlightor ultravioletlight.Ergocalciferoland

colecalciferolhaveaslowonsetandalongdurationofaction;calcitriol andits

analoguealfacalcidol,however, haveamorerapidactionandshorter half-lives.

Colecalciferol andergocalciferol arehydroxylatedintheliver bytheenzymevitamin

D 25-hydroxylasetoform25-hydroxycolecalciferol (calcifediol)and25-

hydroxyergocalciferol respectively.Thesecompounds undergofurther hydroxylation

inthekidneys bytheenzymevitaminD 1-hydroxylasetoformtheactivemetabolites

1,25-dihydroxycolecalciferol (calcitriol)and1,25-dihydroxyergocalciferol respectively.

Furthermetabolismalsooccurs inthekidneys,includingtheformationofthe

1,24,25-trihydroxyderivatives.Ofthesynthetic analogues,alfacalcidol is converted

rapidlyintheliver tocalcitriol,anddihydrotachysterol is hydroxylated,alsointhe

liver, toitsactiveform25-hydroxydihydrotachysterol.

VitaminD compoundsandtheirmetabolites are excretedmainlyinthebileand

faeceswithonlysmallamountsappearinginurine,there issomeenterohepatic

recyclingbutit is consideredtohaveanegligiblecontributiontovitaminD status.

CertainvitaminD substancesmaybedistributedintobreastmilk.

Indications:

Colecalciferol is indicatedfor treatmentofvitaminD deficiencyassociatedwith

malabsorptioninchildrenand/or adultpatients.

Colecalciferol is indicatedfor preventionandtreatmentofvitaminDdeficiency

states.VitaminD deficiencymayoccur asaresult ofinadequatenutrition,intestinal

malabsorption,or lackofexposuretosunlight,butdoes notoccur inhealthy

individuals receivinganadequatebalanceddietandexposuretosunlight.

Requirementsmaybeincreasedand/or supplementationmaybenecessaryinthe

followingpersons or conditions(althoughclinical deficienciesareusuallyrare).

Alcoholism.

Dark-skinnedindividuals.

Hepatic-bilarytractdisease –hepaticfunctionimpairment,cirrhosis,obstructive

jaundice.

Infants,breast-fed,withinadequateexposuretosunlight.

Intestinal disease –celiac,tropical sprue,regionalenteritis,persistentdiarrhoea.

Lack ofexposuretosunlightcombinedwithreducedvitaminD intake.

Renalfunctionimpairment.

Ingeneral,vitaminD absorptionwill beimpairedinanyconditioninwhichfat

malabsorption(steatorrhoea)occurs.

Someunusual diets,(e.g.,strictvegetariandietswithnomilk intakesuchasvegan-

vegetarianor macrobiotic,or reducingdiets thatdrasticallyrestrictfoodselection)

maynotsupplyminimumdailyrequirementsofvitaminD.Supplementationmaybe

necessaryinpatientsreceivingtotal parenteral nutrition(TPN)or undergoingrapid

weightlossor inthosewithmalnutrition,becauseofinadequatedietaryintake.

Congenital ricketshavebeenreportedinnewbornswhosemothershadlowserum

levels ofvitaminD.

DOSAGEANDADMINISTRATION

1) Moderate/Severe VitaminD insufficiencyis less than

10micrograms/litreofserum25hydroxyVitaminD concentration

Dosage= 1xColecalciferol tabletadayfor10days (loading), then

1xColecalciferoltabletamonth(maintenance)

2) For Mild/ModerateVitaminDinsufficiency,i.e.10mcg/Lorhigher

Dosage= 1xColecalciferol tabletamonth

BeforevitaminD therapyis begun,elevatedserumphosphateconcentrationsmust

becontrolled.

Clinical responsetovitaminDdepends onadequatedietarycalcium.

Becauseofindividual variationinsensitivitytoitseffects,dosageofvitaminDmust

beadjustedonthebasis ofclinical response.Someinfantsarehyper reactiveto

evensmalldoses.Careful titrationisnecessarytoavoidoverdosage,whichinduces

hypercalcaemiaandcancausehypercalciuriaandhyperphosphataemia.

DosageofvitaminDfromdietaryandother sourcesshouldbeevaluatedin

determiningthetherapeutic dosage.

Theserumcalciumtimesphosphorus(CaXP,inmg/dL) productshouldnotexceed

60.

Tocontrol elevatedserumphosphateconcentrations inpatientsundergoingdialysis,

aphosphatebindingagentshouldbeused.Thedosageofthebindingagentmay

needtobeincreasedduringvitaminD therapysincephosphateabsorptionis

enhanced.

Deficiencyduetomalabsorptionstatesor liver diseaseoftenrequires higher doses

for treatment,ofupto1mg(40000units) daily.Doses ofupto2.5mg(100000

units) dailymaybeusedinthetreatmentofhypocalcaemiadueto

hypoparathyroidism.

Colecalciferol doesnotneedtobeadministeredwithfood.

Patient monitoring:

Thefollowingmaybeespeciallyimportantinpatientmonitoring(other testsmaybe

warrantedinsomepatients,dependingoncondition.

Bloodureanitrogen(BUN) and

Cretonne,serum

(determinationrecommendedatperiodic intervals inpatientsreceiving

therapeuticdoses)

Alkalinephosphataseconcentrations,serum,and

Phosphorusconcentrations,serum, and

Calciumconcentrations,urinary,24-hour, and

Calcium/creatinine,urinaryratio

(determinationrecommendedevery1to3monthsduringtherapy,as longas

thepatientremainsstable)

Calciumconcentrations,serum,or ionisedcalciumconcentration,serum

(determinations recommendedatleastonceweeklyinearlyperiodof

treatmenttoaidindosageadjustmentbecauseofnarrowtherapeutic range,

thenatperiodic intervals duringtherapyinpatientsreceivingtherapeutic

doses;serumcalciumconcentrations shouldbemaintainedat8.8to10.3mg

per 100mL,dependingonlabvariability;serumionisedcalcium

concentrations arepreferabletodeterminefreeandboundcalcium,butmay

notbereadilyavailable)

X-rays ofbones

(recommendedbysomeclinicians every3to6months until patientis stable,

thenyearlytodeterminewhentreatmentoffamilial hypophosphataemiaor

hypoparathyroidismis sufficient)

CONTRAINDICATIONS

Colecalciferol is contraindicatedinpatientswithhypersensitivitytoanycomponentof

this product.

Exceptunder special circumstances,thismedicationshouldnotbeusedwhenthe

followingmedical problemsexist:

Hypercalcaemia

Hypervitaminosis D

Renal osteodystrophywithhyperphosphataemia

(risk ofmetastatic calcification;however, vitaminD therapycanbeginonce

serumphosphatelevels havestabilised).

Risk-benefit shouldbeconsideredwhenthefollowingmedical problemsexist:

Arteriosclerosis or

Cardiacfunctionimpairment

(conditionsmaybeexacerbatedduetopossibilityofhypercalcaemiaand

elevatedserumcholesterol concentrations).

HypersensitivitytoeffectsofvitaminD

(maybeinvolvedincausingidiopathic hypercalcaemiaininfants).

Renalfunctionimpairment

(toxicitymayoccur inpatientsreceivingvitaminDfor non-renal problems,

althoughtoxicityis alsopossibleduringtreatmentofrenal osteodystrophy

becauseofincreasedrequirementsanddecreasedrenalfunction).

Sarcoidosis,andpossiblyother granulomatous diseases

(increasedsensitivitytoeffectsofvitaminD).

WARNINGSANDPRECAUTIONS

Mutagenicity:

Studieswithcalcitriol havefoundnoevidenceofmutagenicity.

Usein Pregnancy:

Pregnancy –Problemsinhumans havenotbeendocumentedwithintakeofnormal

dailyrequirements.Maternalhypercalcaemiaduringpregnancyinhumansmaybe

associatedwithincreasedsensitivitytoeffects ofvitaminD,suppressionof

parathyroidfunction,orasyndromeofpeculiar (elfin)faces,mental retardationand

congenitalaortic stenosis ininfants.

OverdosageofvitaminD hasbeenassociatedwithfoetal abnormalities inanimals.

Animal studies haveshowncalcitriol tobeteratogenic whengivenindoses4and15

times thedoserecommendedforhumanuse.Excessivedosesof

dihydrotachysterol arealsoteratogenic inanimals. Animal studieshavealsoshown

calcifediol tobeteratogenicwhengivenindoses of6to12times thehumandose.

FDA PregnancyCategoryC

Usein Lactation:

OnlysmallamountsofvitaminD metabolitesappear inhumanmilk.Infantswhoare

totallybreast-fedandhavelittleexposure tothesunmayrequirevitaminD

supplementation.

VitaminD shouldnotbeadministeredtopatientswithhypercalcaemia.Itshouldbe

administeredwithcautiontoinfantsas theymayhaveincreasedsensitivitytoits

effectsandshouldbeusedwithcare inpatientswithrenal impairmentor calculi,or

heartdisease,whomightbeatincreasedrisk oforgandamageifhypercalcaemia

occurred.PlasmaphosphateconcentrationsshouldbecontrolledduringvitaminD

therapytoreducetherisk ofectopic calcification.

Itis advisedthatpatientsreceivingpharmacological dosesofvitaminD shouldhave

theirplasma-calciumconcentrationmonitoredatregular intervals, especiallyinitially

andifsymptoms suggesttoxicitysimilar monitoringis recommendedininfantsifthey

are breastfedbymothers receivingvitaminD.

Growthmaybearrestedinchildren,especiallyafterprolongedadministrationof

45mcg(1800units)ofcolecalciferoladay.

Usein Elderly:

Studieshaveshownthattheelderlymayhaveanincreasedneedfor vitaminD due

toapossibledecreaseinthecapacityoftheskintoproducepre-vitaminD

,or a

decreaseinexposure tothesunor impairedrenalfunctionor impairedvitaminD

absorption.

Effects on abilityto driveand usemachines:

Presumedtobesafeor unlikelytoproduceaneffectontheabilitytodriveor use

machinery.

ADVERSEEFFECTS

Note:IngestionofexcessivedosesofvitaminD either asanacuteoverdoseor over

prolongedperiodscanresult insevere toxicity.

Chronic vitaminD-inducedhypercalcaemiamayresult ingeneralisedvascular

calcification,nephrocalcinosis, andother softtissuecalcificationthatmayleadto

hypertensionandrenalfailure.Theseeffectsare more likelytooccur whenthe

hypercalcaemiais accompaniedbyhyperphosphataemia.

Growthmaybearrestedinchildren,especiallyafterprolongedadministrationof

45mcg(1800units)ofcolecalciferolper day.

Deathmayoccuras aresult ofrenalor cardiovascular failurecausedbyvitaminD

toxicity.

Dosagenecessarytocausetoxicityvarieswithindividual sensitivity,butin

individuals withoutmalabsorptionproblems,250mcg(10,000units) adayfor more

thanseveral weeks or months is themaximumdose.

Toxicitymayoccur withtherapeutic dosesofcalcitriol.

Thefollowingside/adverseeffectshavebeenselectedonthebasisoftheir

potential clinical significance(possiblesignsandsymptoms inparentheses where

appropriate) –notnecessarilyinclusive.

Thoseindicating need for medicalattention

Earlysymptoms ofvitaminD toxicityassociatedwithhypercalcaemia

Constipation –usuallymorefrequentinchildrenandadolescents;diarrhoea;dryness

ofmouth;headache,continuing;increasedthirst;increaseinfrequencyofurination,

especiallyatnight,or inamountofurine;lossofappetite;metallic taste;nauseaor

vomiting –usuallymorefrequentinchildrenandadolescents;unusual tiredness or

weakness.

LatesymptomsofvitaminD toxicityassociatedwithhypercalcaemia

Bonepain;cloudyurine;highbloodpressure;increasedsensitivityofeyes tolightor

irritationofeyes;irregular heartbeat;itchingofskin;lethargy(drowsiness); muscle

pain;nauseaor vomitingandpancreatitis (stomachpain,severe); psychosis, overt

(moodormental changes);

-rare;weightloss.

Thefollowingreactionshavebeenreportedas causallyrelatedtovitaminD intake:

faceoedema,genital oedema,pruritus,dryskin,naildisorder,erythematosus rash,

decreasedprothrombin(druginteraction),purpuric rash,choking,anddysphagia.

Thedecreasedprothrombinwas assessedassevere andasarisingduetoa

possibleinteractionofVitaminD withwarfarinandcalciumcarbonate.

INTERACTIONS

There isanincreasedrisk byhypercalcaemiaifvitaminD is co-administeredwith

thiazidediureticsandcalcium.Plasma-calciumconcentrationsshouldbemonitored

inpatientsreceivingthedrugs concurrently.Someantiepilepticsmayincrease

vitaminD requirements (e.g.carbamazepine,phenobarbitone,phenytoin,and

primidone).

Requirementsmaybeincreasedbythefollowingmedications:Barbiturates,

cholestyramine,colestipol, hydantoinanticonvulsants,mineral oil,andprimidone.

Acaseofseverelydecreasedprothrombinhas beenreportedasduetoapossible

interactionofvitaminDwithwarfarinandcalciumcarbonate.

OVERDOSAGE

ExcessiveintakeofvitaminD leadstothedevelopmentofhypercalcaemiaandits

associatedeffectsincludinghypercalciuria,ectopic calcification,andrenaland

cardiovascular damage.Symptoms ofoverdosageincludeanorexia,lassitude,

nauseaandvomiting,diarrhoea,polyuria,sweatingheadache,thirstandvertigo.

Inter-individual tolerancetovitaminD varies considerably;infantsandchildrenare

generallymore susceptibletoitstoxic effects.

Recommendedtreatmentincludesthefollowing:

Hypervitaminosis D is treatedbywithdrawal ofthevitamins,low-calciumdiet,and

generousfluidintake.

Ifhypercalcaemiapersists,alow-calciumdietandprednisonemaybestarted.

Severe hypercalcaemiamaybetreatedwithcalcitonin,etidronate,pamidronate,or

galliumnitrate.

Hypercalcaemic crisis requires vigorous hydrationwithintravenoussalinetoincrease

calciumexcretion,withor withoutaloopdiuretic.

Cardiacarrhythmiasmaybetreatedwithsmalldosesofpotassiumwithcontinuous

cardiacmonitoring.

Therapymaybereinstitutedatalower dosewhenserumcalciumconcentrations

return tonormal.Serumorurinarycalciumlevels shouldbeobtainedtwiceweekly

after dosagechanges.

PHARMACEUTICALPRECAUTIONS

Shelflife18months.

Storebelow25

C

MEDICINECLASSIFICATION

PrescriptionMedicine

PACKAGEQUANTITIES

12Tablets

FURTHERINFORMATION

Cal.D.Fortehas beengrantedProvisionalconsentfor distributionunder Section23

oftheMedicines Act.

Cal.D.ForteTabletscontainthefollowingexcipients:

Castor Oil

CalciumCarbonate

Povidone

TitaniumDioxide

Sucrose

Acacia

MaizeStarch

Beeswax

Shellac

Gelatin

MagnesiumStearate

HydratedSilica

PurifiedTalc

PreparedTheobroma(CocoaPowder)

PowderedCellulose

Lactose

Sucrose(IcingSugar)

NAMEANDADDRESSOFSPONSOR

PSMHealthcare Ltdtradingas APIConsumer Brands

POBox76401

ManukauCity

Auckland

Phone09-279-7979

DATEOFPREPARATION

September2012

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