DIAZEPAM

Main information

  • Trade name:
  • DIAZEPAM Tablets 5 Milligram
  • Dosage:
  • 5 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DIAZEPAM Tablets 5 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0565/001/002
  • Authorization date:
  • 18-04-1991
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

DiazepamTabletsBP5mg

2QUALITATIVEANDQUANTITATIVECOMPOSITION

DiazepamB.P.5mg

3PHARMACEUTICALFORM

Round,flat-facedbeigetablets,markedwithascorelineononefaceandDIAZEPAM5"onthereverse.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Anxiety

Insomnia

Benzodiazepinesareonlyindicatedwhenthedisorderissevere,disablingorsubjectingtheindividualto

extremedistress.

Inthecontrolofmusclespasmincludingthatassociatedwithtetanus.

Inthemanagementofepilepsy.

Aspre-operativemedicationinminorsurgery.

4.2Posologyandmethodofadministration

(1) Anxiety

Treatmentshouldbeasshortaspossible.Thepatientshouldbereassessedregularlyandtheneedforcontinued

treatmentshouldbeevaluated,especiallyincasethepatientissymptomfree.Theoveralldurationoftreatment

generallyshouldnotbemorethan4-6weeks,includingataperingoffprocess.

Incertaincasesextensionbeyondthemaximumtreatmentperiodmaybenecessary;ifso,itshouldnottakeplace

withoutreevaluationofthepatient'sstatuswithspecialexpertise.

Recommendeddosage:

(1) Inthemanagementofanxietyandtensionstates:

Adultsonly: SevereanxietyTheusualtotaldailydosageis15to30mgindivideddoses,dependingontheseverity

ofthecondition.

Children: Notrecommended.

(2) Inthemanagementofmusclespasm:

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Children: Theusualtotaldailydosageis2to40mgindivideddoses.

Adults: Theusualtotaldailydosageis2to60mgindivideddoses.

Spasmduetosuchlocalconditionsasfibrositis:

Theusualtotaldailydosageis2to15mgindivideddoses.

Tetanus:

Theusualdosageis3to10mg/kgbodyweightbyduodenaltube,withadjustmentofdosageonthebasisoftheseverity

ofthecondition.

CerebralPalsy

Theusualdosageis2to60mgindivideddoses.

(3) Aspre-operativemedication:

Adults: Theusualdosageis5to20mg.

Children:Theusualdosageis2to10mg.

Intheelderlyordebilitatedpatient,dosesshouldbereducedtohalfthoseoftheadultdosesstatedabove.

Infantsandneonates

Notrecommended

SpecialGroups

Debilitatedpatients

Dosesshouldnotexceedhalfthosenormallyrecommendedforadults.

Treatmentshouldbestartedwiththelowestrecommendeddose.

Themaximumdoseshouldnotbeexceeded.

Thepatientshouldbecheckedregularlyatthestartofthetreatmentinordertodecreaseifnecessary,thedoseor

frequencyofadministrationtopreventoverdoseduetoaccumulation.

4.3Contraindications

Myastheniagravis

Hypersensitivitytobenzodiazepines

Severerespiratoryinsufficiency

Sleepapnoeasyndrome

Severehepaticinsufficiency.

4.4Specialwarningsandprecautionsforuse

Tolerance

Somelossofefficacytothehypnoticeffectsofbenzodiazepinesmaydevelopafterrepeateduseforafewweeks.

Dependence

Useofbenzodiazepinesmayleadtothedevelopmentofphysicalandpsychicdependenceupontheseproducts.The

riskofdependenceincreaseswithdoseanddurationoftreatment;itisalsogreaterinpatientswithahistoryofalcohol

ordrugabuse.

Oncephysicaldependencehasdeveloped,abruptterminationoftreatmentwillbeaccompaniedbywithdrawal

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irritability.Inseverecasesthefollowingsymptomsmayoccur:derealization,depersonalization,hyperacusis,

numbnessandtinglingoftheextremities,hypersensitivitytolight,noiseandphysicalcontact,hallucinationsor

epilepticseizures.

Reboundinsomniaandanxiety:atransientsyndromewherebythesymptomsthatledtotreatmentwitha

benzodiazepinerecurinanenhancedform,mayoccuronwithdrawaloftreatment.Itmaybeaccompaniedbyother

reactionsincludingmoodchanges,anxietyorsleepdisturbancesandrestlessness.

Sincetheriskofwithdrawalphenomena/reboundphenomenaisgreaterafterabruptdiscontinuationoftreatment,itis

recommendedthatthedosageisdecreasedgradually.

Durationoftreatment

Thedurationoftreatmentshouldbeasshortaspossible(seePosology)dependingontheindication,butshouldnot

exceed4weeksforinsomniaandeighttotwelveweeksincaseofanxiety,includingtaperingoffprocess.Extension

beyondtheseperiodsshouldnottakeplacewithoutreevaluationofthesituation.

Itmaybeusefultoinformthepatientwhentreatmentisstartedthatitwillbeoflimiteddurationandtoexplain

preciselyhowthedosagewillbeprogressivelydecreased.Moreoveritisimportantthatthepatientshouldbeawareof

thepossibilityofreboundphenomena,therebyminimisinganxietyoversuchsymptomsshouldtheyoccurwhilethe

medicinalproductisbeingdiscontinued.Thereareindicationsthat,inthecaseofbenzodiazepineswithashort

durationofaction,withdrawalphenomenacanbecomemanifestwithinthedosageinterval,especiallywhenthedosage

ishigh.Whenbenzodiazepineswithalongdurationofactionarebeinguseditisimportanttowarnagainstchanging

toabenzodiazepinewithashortdurationofaction,aswithdrawalsymptomsmaydevelop.

Amnesia

Benzodiazepinesmayinduceanterogradeamnesia.Theconditionoccursmostoftenseveralhoursafteringestingthe

productandthereforetoreducetheriskpatientsshouldensurethattheywillbeabletohaveanuninterruptedsleepof

7-8hours(seealsoUndesirableEffects).

Psychiatricand`paradoxical'reactions

Reactionslikerestlessness,agitation,irritability,aggressiveness,delusion,rages,nightmares,hallucinations,psychoses,

inappropriatebehaviourandotheradversebehaviouraleffectsareknowntooccurwhenusingbenzodiazepines.Should

thisoccur,useofthedrugshouldbediscontinued.Theyaremorelikelytooccurinchildrenandtheelderly.

Specificpatientgroups

Benzodiazepinesshouldnotbegiventochildrenwithoutcarefulassessmentoftheneedtodoso;thedurationof

treatmentmustbekepttoaminimum.Elderlyshouldbegivenareduceddose(seePosology).Alowerdoseisalso

recommendedforpatientswithchronicrespiratoryinsufficiencyduetotheriskofrespiratorydepression.

Benzodiazepinesarenotindicatedtotreatpatientswithseverehepaticinsufficiencyastheymayprecipitate

encephalopathy.

Benzodiazepinesarenotrecommendedfortheprimarytreatmentofpsychoticillness.

Benzodiazepinesshouldnotbeusedalonetotreatdepressionoranxietyassociatedwithdepression(suicidemaybe

precipitatedinsuchpatients).

Benzodiazepinesshouldbeusedwithextremecautioninpatientswithahistoryofalcoholordrugabuse.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Notrecommended Concomitantintakewithalcohol

Thesedativeeffectmaybeenhancedwhentheproductisusedincombinationwithalcohol.Thisaffectstheabilityto

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Takeintoaccount CombinationwithCNSdepressants

Enhancementofthecentraldepressiveeffectmayoccurincasesofconcomitantusewithantipsychotics(neuroleptics),

hypnotics,anxiolytics/sedatives,antidepressantagents,narcoticanalgestics,anti-epilepticdrugs,anaestheticsand

sedativeantihistamines.

Inthecaseofnarcoticanalgesicsenhancementoftheeuphoriamayalsooccurleadingtoanincreaseinpsychic

dependence.

Compoundswhichinhibitcertainhepaticenzymes(particularlycytochromeP450)mayenhancetheactivityof

benzodiazepines.Toalesserdegreethisalsoappliestobenzodiazepinesthataremetabolizedonlybyconjugation.

4.6Pregnancyandlactation

Animalstudieswithbenzodiazepineshaveshownminoreffectsonthefoetuswhileafewstudieshavereportedlate

behaviouraldisturbancesinoffspringexposedinutero.

Iftheproductisprescribedtoawomanofchildbearingpotential,sheshouldbewarnedtocontactherphysician

regardingdiscontinuanceoftheproductifsheintendstobecomeorsuspectsthatsheispregnant.

If,forcompellingmedicalreasons,theproductisadministeredduringthelatephaseofpregnancy,orduringlabour,

effectsontheneonate,suchashypothermia,hypotoniaandmoderaterespiratorydepression,canbeexpected,dueto

thepharmacologicalactionofthecompound.

Moreover,infantsborntomotherswhotookbenzodiazepineschronicallyduringthelatterstagesofpregnancymay

havedevelopedphysicaldependenceandmaybeatsomeriskfordevelopingwithdrawalsymptomsinthepostnatal

period.

Sincebenzodiazepinesarefoundinthebreastmilk,benzodiazepinesshouldnotbegiventobreastfeedingmothers.

4.7Effectsonabilitytodriveandusemachines

Sedation,amnesia,impairedconcentrationandimpairedmuscularfunctionmayadverselyaffecttheabilitytodriveor

tousemachines.Ifsufficientsleepdurationoccurs,thelikelihoodofimpairedalertnessmaybeincreased(seealso

Interactions).

4.8Undesirableeffects

Drowsiness(whentheproductisusedasahypnoticitshouldbestatedexplicitly:drowsinessduringtheday),numbed

emotions,reducedalertness,confusion,fatigue,headache,dizziness,muscleweakness,ataxiaordoublevision.These

phenomenaoccurpredominantlyatthestartoftherapyandusuallydisappearwithrepeatedadministration.

Othersideeffectslikegastrointestinaldisturbances,changesinlibidoorskinreactionshavebeenreportedoccasionally.

Amnesia

Anterogradeamnesiamayoccurusingtherapeuticdosages,theriskincreasingathigherdosages.Amnesticeffectsmay

beassociatedwithinappropriatebehaviour.(seeWarningsandprecautions).

Depression

Pre-existingdepressionmaybeunmaskedduringbenzodiazepineuse.

Psychiatricand`paradoxical'reactions

Reactionslikerestlessness,agitation,irritability,aggressiveness,delusion,rages,nightmares,hallucinations,psychoses,

inappropriatebehaviourandotheradversebehaviouraleffectsareknowntooccurwhenusingbenzodiazepineor

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Dependence

Use(evenattherapeuticdoses)mayleadtothedevelopmentofphysicaldependence:discontinuationofthetherapy

mayresultinwithdrawalorreboundphenomena(seeWarningsandPrecautions).Psychicdependencemayoccur.

Abuseofbenzodiazepineshasbeenreported.

4.9Overdose

Aswithotherbenzodiazepines,overdoseshouldnotpresentathreattolifeunlesscombinedwithotherCNS

depressants(includingalcohol).

Inthemanagementofoverdosewithanymedicinalproduct,itshouldbeborneinmindthatmultipleagentshavebeen

taken.

Followingoverdosewithanymedicinalproduct,vomitingshouldbeinduced(withinonehour)ifthepatientis

consciousorgastriclavageundertakenwiththeairwayprotectedifthepatientisunconscious.Ifthereisnoadvantage

inemptyingthestomach,activatedcharcoalshouldbegiventoreduceabsorption.Specialattentionshouldbepaidto

respiratoryandcardiovascularfunctionsinintensivecare.

Overdoseofbenzodiazepinesisusuallymanifestedbydegreesofcentralnervoussystemdepressionrangingfrom

drowsinesstocoma.Inmildcases,symptomsincludedrowsiness,mentalconfusionandlethargy,inmoreserious

cases,symptomsmayincludeataxia,hypotonia,hypotension,respiratorydepression,rarelycomaandveryrarelydeath.

Flumazenilmaybeusefulasanantidote.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Abenzodiazepinewithanxiolytic,sedative,musclerelaxantandanticonvulsantproperties.

5.2Pharmacokineticproperties

Diazepamisreadilyandcompletelyabsorbedfromthegastro-intestinaltract,peakplasmaconcentrations

occurringwithinabout30to90minutesoforaladministration;therateofabsorptionisage-relatedandtendstobe

delayedintheelderly.Diazepamhasabiphasichalf-lifewithaninitialrapiddistributionphasefollowedbya

prolongedterminaleliminationphaseof1or2days;itsactionisfurtherprolongedbytheevenlongerhalf-lifeof

2to5daysofitsprincipalactivemetabolite,desmethyldiazepam(Nordazepam),therelativeproportionofwhich

increasesinthebodyonlong-termadministration.Diazepamisveryextensivelyboundtoplasmaproteins.

5.3Preclinicalsafetydata

None.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactose,potatostarch,primojel(sodiumstarchglycollate),talc(E533(b))andmagnesiumstearate(E572),iron

oxideyellow(E172)andsnowflake12701.

6.2Incompatibilities

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6.3ShelfLife

5years.

6.4Specialprecautionsforstorage

Storebelow25 o

Cinadryplace.

6.5Natureandcontentsofcontainer

Polyethylenebottleswithscrew-cap,100and1,000tablets.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

None.

7MARKETINGAUTHORISATIONHOLDER

WorldwidePharmaceuticalResearchLimited,

Unit222WesternIndustrialEstate,

NaasRoad,

Dublin12

8MARKETINGAUTHORISATIONNUMBER

PA0565/001/002

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:18April1991

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