BOCATRIOL

Main information

  • Trade name:
  • BOCATRIOL Capsule 0.25 Millilitre
  • Dosage:
  • 0.25 Millilitre
  • Pharmaceutical form:
  • Capsule
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BOCATRIOL Capsule 0.25 Millilitre
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0046/062/001
  • Authorization date:
  • 04-02-2000
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Bocatriol0.25 microgramSoftCapsules

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each capsulecontains0.25 microgramscalcitriol.

Forexcipients, see6.1.

3PHARMACEUTICALFORM

Capsule, soft.

Apink/creamcoloured, egg-shaped capsulecontainingan oily solution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

RenalOsteodystrophy:Correction ofcalciumand phosphatemetabolismabnormalities.

Postmenopausalosteoporosis:Treatmentofestablished postmenopausalosteoporosis.

4.2Posologyandmethodofadminstration

Responseto treatmentispartly dependenton asufficientintakeofcalcium. Dietary modification orsupplementsmay

berequired.

Bocatriolcapsulesarefororaladministration onlyand should beswallowed with alittlewater.

Adults

Renalosteodystrophy

Hypercalcaemiacan beavoided by carefully adjusting thedoseofBocatriolforeach individual, according to the

biologicalresponseto themedicine. Initially, adaily doseof0.25 microgramsofBocatriolisemployed.Adoseof

0.25 microgramson alternativedaysmay beadequateforthosepatientswith normaloronly slightly lowered calcium

levels.Thisdaily dosemay beincreased by 0.25 microgramsafter2-4 weeksifbiochemicaland clinicalresponsesare

considered inadequate.

Ifnecessary thisdosageincrementcan berepeated at2-4 weekly intervals. Whilethedoseisbeing adjusted, serum

calciumlevelsshould bemonitored atleasttwiceeach week.Themajority ofpatientsrespond to adoseofbetween 0.5

microgramsand 1.0 microgramsperday.

PostmenopausalOsteoporosis

Therecommendeddoseofcalcitriolis0.25 microgramstwicedaily.

Elderly

Thesamedoseshould beusedasforotheradults.

Children

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4.3Contraindications

Hypercalcaemiaormetastaticcalcification.

Hypersensitivity to calcitriol(ordrugsofthesameclass)orto any oftheexcipientsin theproduct.

4.4Special warningsandspecialprecautionsforuse

Phosphate-binding agentsmay berequired to controlplasmaphosphatelevels. Wherephosphatebinding agentshave

been employed, doseadjustmentmay benecessary asBocatriolaffectsphosphatetransportin thegastrointestinaltract

and bone.

During treatmentwith Bocatriolavoid allotherproductscontaining vitamin Dmetabolitesand theirderivatives,

including foodstuffswhich may be‘fortified’with vitamin D.

Patientson thistherapy should beunderregularsurveillanceand thosebeing treated forrenalosteodystrophy should be

underthesupervision ofaspecialist, having athisdisposalfacilitiesto monitortheappropriatebiochemicalparameter.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Concurrentadministration ofbarbiturates, phenytoin orotherdrugsstimulating hepaticmicrosomalenzymeswill

interferewith theactivity ofBocatriol.

4.6Pregnancyandlactation

Thesafety ofBocatriolduring pregnancy hasnotbeen established and itshould begiven only when thepotential

benefithasbeen weighed againstthepossiblerisk to thefoetus. Theusualcaution in prescribing any drug forwomen

ofchildbearing ageshould beobserved.

Itisnotknownifcalcitriolisexcreted in human milk.

4.7Effectsonabilitytodriveandusemachines

Presumed to besafeorunlikely to producean effect.

4.8Undesirableeffects

Relativeorabsoluteoverdosagewith Bocatriolwillresultin hypercalcaemiaand hypercalciuria. Hypercalcaemiais

mostlikely to develop in patientswho havetertiary hyperparathyroidism, renalfailure, orthoseon regular

haemodialysis. Thesymptomsofhypercalcaemiaincludeanorexia, nausea, vomiting, headache,weakness, apathy and

somnolence. In moreseverecasesthirst, dehydration, polyuria, nocturia, abdominalpain, paralyticileusand cardiac

arrhythmiasmay occur. Overtpsychosisand metastaticcalcificationmay occurrarely.

Ifhypercalcaemiaoccursduring treatment, thedoseofBocatriolshould bereduced ordiscontinued untilserumcalcium

hasreturned to normal. Calcitriolhasarelatively shortbiologicalhalf-lifeand following cessation oftreatmentwith

Bocatriol, serumcalciumlevelswillreturn to normalwithin 2-7 days. Transientelevation in liverenzymelevels

(SGOT, SGPT)hasbeen noted in afewpatientstreated with calcitriolbuttherehavebeen no reportsofpathological

changesintheliver.

4.9Overdose

Gastriclavageshould beconsidered assoon afteringestion aspossible, provided thatthedrug wastaken within the

previoussix to eighthours. Hypercalcaemiacan bereversedby stopping Bocatrioltreatmentuntilcalciumlevelshave

returned to normal. Alowcalciumdietwillspeed thisreversal. Bocatriolmay then berestarted, eitheratalowerdose

orgiven atthesamedosebutlessfrequently. In severehypercalcemiarehydration, treatmentwith diureticsand general

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resorption isincreased. Intermittenthaemodialysisusing adialysatewith alowconcentration ofcalciummay alsobe

employed to treatsomepatients.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Calcitriol(1,25-dihydroxycholecalciferol)isusually formed by renal1-hydroxylation ofitsimmediateprecursor,

25-hydroxycholecalciferol. Itisthemostbiologically activeofthevitaminDcompounds.Itenhancestheintestinal

absorption ofcalciumand phosphateand also playsan importantrolein controlling bonemineralisation. In chronic

renalfailureproduction ofcalcitriolisimpaired and thiscontributesto thedisturbancesin mineralmetabolismwhich

arecharacteristicofthedisease. Endogenouscalcitriolproduction decreaseswhen theglomerularfiltration ratefalls

below30ml/min.Oraladministration ofBocatriolcompensatesforthedecreaseby restoring homeostasisand thus

reversing thesignsand symptomsofbonedisease.

In patientswith established postmenopausalosteoporosis, Bocatriolincreasescalciumabsorption and reducesthe

incidenceofvertebralfracture.

Theonsetand reversaloftheeffectsofBocatriolarerapid and dosagemodificationscan beachieved quickly.

5.2Pharmacokineticproperties

Following an oraldose, calcitriolisefficiently absorbed leading to peakserumlevelsafter4-6 hours. Thehalf-lifeof

calcitriolisintherangeof3-6 hours, althoughpharmacologicalactivity persistsforabout3-5 days. In normalsubjects

given a1µg radiolabelled doseofcalcitriol, about10%ofthetotalradioactivity appearsin theurinewithin 24 hours.

Calcitriolisalso excreted in thebileand issubjectto enterohepaticrecirculation.

5.3Preclinical safetydata

Thereareno preclinicaldataofrelevanceto theprescriberthatareadditionalto thatalready presented in othersections

oftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Butylhydroxyanisole(E320)

Mediumchain triglycerides

Gelatin,

Glycerol

Red iron oxide(E172)

Titaniumdioxide(E171)

Purified Water

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

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6.4Special precautionsforstorage

Do notstoreabove25 o

6.5Natureandcontentsofcontainer

Strip blisterpacksof30, 50 and 100 capsulesconsisting ofan aluminium/PVCblisterwith apolyamide/aluminiumlid

material.

Notallpack sizesmay bemarketed.

6.6Instructionsforuseandhandling

No specialrequirements.

7MARKETINGAUTHORISATIONHOLDER

LEOLaboratoriesLimited

CashelRoad

Dublin 12

8MARKETINGAUTHORISATIONNUMBER

PA46/62/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:4 th

February 2000

Dateoflastrenewal:4 th

February 2005

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Issued 09/09/2005 CRN 2014644 page number: 4