COGENTIN

Main information

  • Trade name:
  • COGENTIN Solution for Injection 1 mg Milligram
  • Dosage:
  • 1 mg Milligram
  • Pharmaceutical form:
  • Solution for Injection
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • COGENTIN Solution for Injection 1 mg Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0035/046/002
  • Authorization date:
  • 01-04-1979
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Cogentin 1mg/mlSolution forInjection.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each sterileinjection of‘Cogentin’contains1.0 mg/mlbenzatropinemesilate. (2mg per2mlampoule)

Forexcipients, see6.1

3PHARMACEUTICALFORM

Solution forInjection.

Aclear, colourless, sterilesolution forinjection.

4CLINICALPARTICULARS

4.1TherapeuticIndications

‘Cogentin’isan anti-parkinsonian agentwith powerfulanticholinergiceffects.

Itisindicated forsymptomatictreatmentofalltypesof‘classical’parkinsonismincluding arteriosclerotic,

post-encephalitic, and idiopathicparkinsonism, and ofextrapyramidalreactionsinduced by phenothiazinesor

reserpine.Itisnotrecommended forusein tardivedyskinesia

4.2Posologyandmethodofadminstration

‘Cogentin’Injection isonly to beused in anemergency orwhen apatientisunableto swallowtablets.

As‘Cogentin’iscumulativein action, treatmentshould begin withalowdosage, which can beincreased by amountsof

0.5 mg atintervalsoffiveto six days, to thesmallestdosagenecessary foroptimalreliefwithoutexcessive

side-effects.Maximumdosage, 6 mg aday.

‘Cogentin’Injection may beused intramuscularly orintravenously in emergencies, orforpatientsunableto swallow

tablets.(Asthereisno significantdifferencein timeofonsetofeffectbetween intramuscularand intravenous

administration, theintravenousrouteisnotusually necessary.)

In emergencies, 1-2 ml(1-2 mg)of‘Cogentin’Injection willnormally providequick relief.Ifsignsofparkinsonism

begin to return, thedosecan berepeated.

Classical’parkinsonism:Usualdosage:1-2 mg aday, with arangeof0.5-6 mg aday.Dosagemustbeadjusted on

an individualbasis, taking into consideration theageand weightofthepatient, and thetypeofparkinsonism.Older

patients, thin patientsand thosewith arterioscleroticparkinsonismusually cannottoleratelargedosages.Mostpatients

with post-encephaliticparkinsonismneed and indeed toleratefairly largedosages.Patientswith apoormentaloutlook

may respond poorly.In arterioscleroticand idiopathicparkinsonism, therapy may beinitiatedwith asingledaily dose

of0.5-1 mg atbedtime.Thisdosagewillbeadequatein somepatients, whereas4-6 mg aday may berequired by

others.In post-encephaliticparkinsonism, therapy may beinitiated in mostpatientswith 2mg aday in oneormore

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Somepatientsobtain greatestreliefby taking theentiredoseatbedtime;othersreactmorefavourably to divided

dosage, two to fourtimesaday.Onedoseaday frequently issufficient;divided dosesmay beunnecessary oreven

undesirable.

Drug-induced parkinsonism:Usualdosagerange:1-4 mg onceortwiceaday.

Acutedystonicreactions:1-2 ml(1-2 mg)by intravenousinjection followed usually by 1-2 mg orally twiceaday.

Extrapyramidalreactionsappearing soon afterstarting phenothiazineorreserpinetherapy arelikely to betemporary,

and areusually controlled in oneortwo daysby 1-2 mg of‘Cogentin’two orthreetimesaday.‘Cogentin’should be

withdrawn afteroneortwo weeksto determineifitisstillneeded.Itcan bereinstated ifnecessary.

Certain extrapyramidalreactionswhich develop slowly (e.g. tardivedyskinesia)do notusually respond to‘Cogentin’.

Paediatricuse:Usewith caution in children over3 yearsold (seesection 4.3‘Contra-indications’).

Usein theelderly:Aswithyoungerpatients, dosageshould bethesmallestpossibleforoptimumreliefofsymptoms.

Initialdosageshould be0.5-1 mgpreferably atnight, increasing untiloptimumeffectisseen.Olderpatientsusually

cannottoleratelargedoses.

4.3Contraindications

Becauseoftheatropine-likesideeffects,‘Cogentin’iscontra-indicated in children under3 yearsold and should be

used with caution in olderchildren.‘Cogentin’iscontra-indicated in patientswho arehypersensitiveto thisproductor

who haveprostatichypertrophy, pyloricstenosis, paralyticileusorclosed angleglaucoma.

4.4Special warningsandspecialprecautionsforuse

Continued supervision ofpatientsisrecommended as‘Cogentin’hasacumulativeaction.Patientswith atendency

towardstachycardiaandthosewithprostatichypertrophy, should becloselyobserved.

Patientswith mentaldisordersshould becarefully supervised when‘Cogentin’isused to controldrug-induced

extrapyramidalreactions, especially whentherapy isstarted orthedosageof‘Cogentin’isincreased.Intensification of

mentalsymptomsmay occasionally occur.‘Cogentin’should betemporarily withdrawn ifthereactionsaresevere.

‘Cogentin’hasanticholinergiceffects, and glaucomaisapossibility.Although‘Cogentin’doesnotappearto haveany

adverseeffectonsimpleglaucoma, itsuseisprobably notadvisablein narrow-angleglaucoma.Itmay cause

anhidrosis;thisshould bebornein mind, particularly in hotweather, especially when given concomitantly with other

atropine-likedrugsto thechronically ill, alcoholics, orpatientswith acentralnervoussystemdiseaseand thosewho do

manuallabourin ahotenvironment.‘Cogentin’should beused cautiously in patientswith orproneto abnormalitiesof

sweating.

Ifthereisevidenceofanhidrosis, thepossibility ofhyperthermiashould beconsidered.Dosageshould bedecreased as

necessary to maintain body heatequilibriumby theaction ofperspiration.Severeanhidrosisand fatalhyperthermia

haveoccurred.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Theanticholinergiceffectsofthisproductarelikely to beincreased by concomitantuseofamantadine, anti-histamines,

phenothiazines, butyrophenones, tricyclicanti-depressantsand otherdrugswith anticholinergicorantidopaminergic

effects.Extracareshould betaken when‘Cogentin’isgivenconcomitantly with thesemedications.Patientsshould be

advised to reportgastro-intestinalcomplaints, feverorheatintolerancepromptly.

Paralyticileus, sometimesfatal, hasoccurred in patientstaking anticholinergic-typeanti-parkinsonian drugs, including

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Tardivedyskinesiamay appearin somepatientson long-termtherapy with phenothiazinesorrelated agents,after

discontinuation ofsuch therapy.Anti-parkinsonian agentsdo notusually alleviatesymptomsoftardivedyskinesia, and

in somecasesmay aggravateorunmask them.‘Cogentin’isnotrecommended in tardivedyskinesia.

4.6Pregnancyandlactation

Itisnotknownwhether‘Cogentin’can causefoetalharmwhen administered to apregnantwomanorcan affect

reproductivecapacity.‘Cogentin’should begiven to apregnantwoman only ifclearly needed.

Breast-feedingmothers:itisnotknown whetherthisdrug isexcretedin human milk.Becausemany drugsare

excreted in human milk, caution should beexercised when‘Cogentin’isadministered to abreast-feeding mother.

4.7Effectsonabilitytodriveandusemachines

‘Cogentin’may impairthementalalertnessand physicalability required fortheperformanceofsuch hazardoustasks

asdriving acaroroperating machinery.

4.8Undesirableeffects

Sideeffects, mostofwhich areanticholinergicorantihistaminicin naturearelisted belowby body systemin orderof

decreasing severity.

Cardiovascular

Tachycardia.

Digestive

Constipation, dry mouth, nausea, vomiting.

Ifdry mouth isso severethatthereisdifficulty in swallowing orspeaking, orlossofappetiteand weightoccur, reduce

dosage, ordiscontinuethedrug temporarily.

Slightreduction in dosagemay controlnauseaand stillgivesufficientreliefofsymptoms.Vomiting may becontrolled

by temporary discontinuation, followed by resumption atalowerdosage.

Nervoussystem

Toxicpsychosis, including confusion, disorientation, memory impairment, visualhallucinations;exacerbation of

pre-existing psychoticsymptoms;nervousness;depression;listlessness;numbnessoffingers.

SpecialSenses

Blurred vision, dilated pupils.

Urogenital

Urinaryretention, dysuria.

Metabolic/Immuneand Skin

Occasionally, an allergicreaction, e.g.,skin rash, develops.Ifthiscannotbecontrolled by dosagereduction, the

medication should bediscontinued.

Other

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4.9Overdose

Symptomsmay beany ofthoseseen in atropinepoisoning orantihistamineoverdosage:Centralnervoussystem(CNS)

depression, preceded orfollowed by stimulation;confusion;nervousness;listlessness;intensification ofmental

symptomsortoxicpsychosisin patientswith mentalillnessbeing treated with neurolepticdrugs(e.g. phenothiazines);

hallucinations(especially visual);dizziness;muscleweakness;ataxia;dry mouth;mydriasis;blurred vision;

palpitations;tachycardia;nausea;vomiting;dysuria;numbnessoffingers;dysphagia, allergicreactions, e.g. skin rash;

headache;hot, dry, flushed skin;delirium;coma;shock;convulsions;respiratory arrest;anhidrosis;hyperthermia;

glaucoma;constipation.

Physostigminesalicylate(1-2 mg, subcutaneously orintravenously)isreported to reversesymptomsofanticholinergic

intoxication.Asecondinjection may begiven aftertwo hoursifneeded.Otherwise, treatmentissymptomaticand

supportive.

Ashort-acting barbituratemay beused forCNSexcitement, butwith caution to avoid subsequentdepression.

SupportivecareforCNSdepression may berequired (suchconvulsantstimulantsaspicrotoxin, leptazolorbemegride

should beavoided).In severerespiratory depression, artificialrespiration may berequired.Also needed may bea

localmioticformydriasisandcycloplegia, icebagsorothercold applicationsand alcoholspongesforhyperpyrexia, a

vasopressorand fluidsforcirculatory collapse, and adarkened roomforphotophobia.

Dataon themetabolismofbenzatropinemaleatearenotavailableatpresent;butadeath wasrecorded 1½hoursafter

ingestion.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Anticholinergicdrugsexerttheiranti-parkinsonian effectby correcting therelating cholinergicexcesswhich isthought

to occurin parkinsonismasaresultofdopaminedeficiency.

Thedeficiencyofdopaminein thestriatumofpatientswith parkinsonismintensifiestheexcitatory effectsofthe

cholinergicsystemwithin thestriatum.Anticholinergicsaid such patientsby bluntingthiscomponentofthe

nigrostriated pathway.

5.2Pharmacokineticproperties

Following i.m. injection,theclinicaleffectsofbenzatropineareapparentwithin 10 minutesand themaximumeffectis

seen within 30 minutes.

Benzatropinehasacumulativeeffectand aprolonged duration ofaction when compared with otheranticholinergic

agentsused in thetreatmentofParkinson’sitmay takeup to seven daysbeforeallevidenceofdrug-related effects

haveceased.

5.3Preclinical safetydata

No relevantinformation.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sodiumchloride

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6.2Incompatibilities

Noneknown.

6.3ShelfLife

3 years.

6.4Special precautionsforstorage

Do notstoreabove25°C.Do notfreeze.

Keepthevialin theoutercarton.

6.5Natureandcontentsofcontainer

TypeIglassampoulescontaining 2mlsofsolution.

6.6Instructionsforuseandhandling

Forsingleuseonly.Discardany unused contents.

7MARKETINGAUTHORISATIONHOLDER

MerckSharp &DohmeLimited

Hertford Road,

Hoddesdon,

Hertfordshire

EN11 9BU,

United Kingdom

8MARKETINGAUTHORISATIONNUMBER

PA35/46/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:1 st

April1979

Dateoflastrenewal:1 st

April2004

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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