PROMACE VETERINARY

Israel - English - Ministry of Health

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Active ingredient:
ACEPROMAZINE MALEATE 10 MG/ML
Available from:
A.VETERINARY SUPPLY LTD
Pharmaceutical form:
SOLUTION FOR INJECTION
Administration route:
I.M, I.V, S.C
Manufactured by:
FORT DODGE ANIMAL HEALTH, USA
Therapeutic indications:
Dogs and cats: Promace can be used as an aid in controlling intractible animals during examination treatment grooming x-ray and minor surgical procedures to alleviate itching as a result of skin irritation As an antiemetic to control vomiting associated with motion sickness. Promace is particularly useful as a preanesthetic agent (1) to enhance and prolong the effects of barbiturates thus reducing the requirements for general anesthesia (2) as an adjunct to surgery under local anesthesia. Horses: Promace can be used as an aid in controlling fractious animals during examination treatment loading and transportation. Particularly useful when used in conjunction with local anesthesia for firing castration neurectomy removal of skin tumors ocular surgery and applying casts.
Authorization number:
80599216400
Authorization date:
2008-11-01

PhysiciansPrescribing Information

PROMACE VETERINARY

Solution forInjection ; For Veterinary Use Only

NAME OFPRODUCT:PROMACEVETERINARY

DESCRIPTION:Acepromazine maleate,USP,apotentneuroleptic agentwitha loworderoftoxicity, isofparticular

valueinthetranquilizationofdogs,catsandhorses.Itsrapid actionandlackofhypnoticaffectareaddedadvantages.

AccordingtoBaker thescope ofpossible applicationsforthis compound inveterinarypractice isonlylimitedbythe

imaginationofthepractitioner.

CHEMISTRY:Acepromazine[10-[3-(dimethylamino)propyl]phenothiazin-2-yl-methylketone]Maleate,USPhasthe

followingchemical formula:C

S

ACTIONS:PromAceVeterinary hasadepressanteffectonthe centralnervoussystemand,therefore, causes sedation,

muscularrelaxationandareduction inspontaneousactivity. Itactsrapidly, exertingaprompt and pronouncedcalming

effect.

INDICATIONS:

DogsandCats:PromAceVeterinarycanbeusedasanaidincontrollingintractible animalsduringexamination,

treatment, grooming,x-ray and minorsurgicalprocedures toalleviate itchingasaresultofskinirritation;as an

antiemetic tocontrolvomitingassociatedwithmotionsickness. Promace Veterinary isparticularlyuseful as a

preanesthetic agent(1)toenhance and prolong the effectsofbarbiturates, thusreducingtherequirements forgeneral

anesthesia;(2) as anadjunct tosurgery under localanesthesia.

Horses:PromAceVeterinarycanbeusedasan aidin controllingfractiousanimals duringexamination,treatment,

loadingandtransportation. Particularly usefulwhenusedinconjunctionwithlocal anesthesia forfiring,castration,

neurectomy, removalofskin tumors,ocularsurgeryand applyingcasts.

CONTRAINDICATIONS:Phenothiazinesmaypotentiatethetoxicityoforganophosphatesandtheactivityofprocaine

hydrochloride.Therefore,donotusePromAce Veterinary(acepromazinemaleate, USP), to control tremors associated

with organicphosphate poisoning. Do notuseinconjuctionwithorganophospharusvermifuges orectoparasiticides,

including fleacollars.Donotusewithprocaine hydrochloride.

WARNING:Not for usein animalsintendedfor food.

PRECAUTIONS:Tranquilizersare potent central nervoussystemdepressantsand theycancause markedsedation with

suppressionofthe sympathetic nervous system.

Tranquilizerscanproduceprolongeddepressionormotorrestlessnesswhengiven inexcessiveamountsorwhengivento

sensitive animals.

Tranquilizers are additive inaction totheactions ofotherdepressants andwill potentiate general anesthesia.

Tranquilizers should beadministeredinsmaller dosesandwithgreater careduringgeneralanesthesiaandalso to animals

exhibitingsymptomsofstress,debilitation, cardiacdisease,sympatheticblockade,hypovolemiaorshock.PromAce

Veterinary, like otherphenothiazinederivatives, isdetoxifiedinthe liver;therefore, itshouldbeusedwith cautionin

animalswitha previoushistoryofliver dysfunction orleukopenia.

Hypotension canoccur afterrapidintravenousinjection causing cardiovascular collapse.

Epinephrineis contraindicated fortreatmentofacutehypotensionproducedbyphenothiazine-deriavitivetranquilizers

sincefurtherdeprssionofbloodpressurecan occur.Other pressoramines, suchas norepinephrine orphenylophrine,are

thedrugsofchoice.

Inhorses,paralysis oftheretractorpenis muscle hasbeenassociatedwiththe useofphenothiazine-derivative

tranquilizers.Such caseshaveoccurredfollowing theuseofPromAce Veterinary. This riskshouldbedulyconsidered

priortotheadministrationofPromAce Veterinarytomalehorses (castratedand uncastrated).Whengiven, thedosage

shouldbecarefullylimited tothe minimumnecessary for thedesiredeffect. At the timeoftranquilization,itis not

possible to differentiate betweenreversibleprotrusionofthe penis (anormalclinicalsignof narcosis) andtheirreversible

paralysis oftheretractormuscle. Thecauseofthis sidereactionhas notbeendetermined. Ithasbeenpostulatedthatsuch

paralysis mayoccurwhen atranquilizer is usedinconjunctionwithtestosterone(or installions).

Accidentalintracarotidinjection inhorsescanproduceclinicalsignsranging fromdisorientationtoconvulsiveseizures

and death.

CAUTION:Afewrarebut serious occurrences ofidiosyncratic reactionstoacepromazinemay occurin dogsfollowing

oralorparenteral administration.Thesepotentiallyseriousadversereactionsincludebehavioral disorders indogssuchas

aggression, biting/chewing,and nervousness.

ADMINISTRATIONANDDOSAGE:Thedosageshouldbeindividualized, dependinguponthedegree of

tranquilizationrequired.Asageneral rule, the dosagerequirement inmg/lb ofbody weightdecreasesastheweightof the

animalincreases.

PromAceVeterinary(AcepromazineMaleate Injection,USP) Maybegivenintravenously, intramuscularly or

subcutaneous.ThefollowingschedulemaybeusedasaguidetoIV,IMorSCinjections:

Dogs:0.25-0.5mg/lbofbodyweight=0.55-1.10mg/kgofbodyweight.

Cats:0.5-1mg/lbofbodyweight=1.10-2.21mg/kgofbodyweight.

Horses:2-4mg/100lb of bodyweight= 4.41-8.82mg/100kgof body weight.

IVdosesshouldbe administrated slowly, andaperiodofatleast 15 minutes shouldbeallowedforthedrug totakefull

effect.

[Comparisontablets:1lb= 0.454 kg;1kg = 2.205lb]

HOW SUPPLIED:Each mLcontains10 mg acepromazine maleate, USP.Alsocontainssodiumcitrate 0.36%, citric

acid0.075%,benzylalcohol1% andWaterforinjuction,USP, in50mLvials.

Storedatcontrolled roomtemperature,inacoolplace, below 25°C.

TOXICOLOGY:Acuteand chronictoxicityhaveshownaveryloworderoftoxicity.

Acute toxicity:TheLD50doseofPromAceVeterinary inmice wasdeterminedbymeansofaprobittransformation

withthefollowingresults:Intravenous route - 61.37mg/kg ; Subcutaneousroute -130.5mg/kg;Oral route - 256.8

mg/kg

ChronicToxicity:Testsinrats revealednodeleteriouseffects onrenalorhepatic functionoronhemopoetic activity. In

severalgroupsof twomale andtwofemale beaglehoundstreated for sixmonthswithdaily oraldosesof20to40 mg/kg,

nountowardeffects were encountered. Hematologicstudiesandurinalysis gavevalueswithinnormallimits.Another

group offourdogs,givengraduallyincreasingoraldosesupto a levelof220 mg/kgdaily andreaching atotal dailydose

of2.2gperdog,showedsomesignsofpulmonaryedemaandhypernemiaoftheinternalorgans,butnoanimaldied.

Whenadministered intramuscularly,PromAce Veterinary(acepromazine maleate, USP)causesabriefsensationof

stingingcomparable withthat observedwith other phenothiazinetranquilazers.

CLINICALDATA:ControlledclinicalstudiesintheUnitedStates andCanadahavedemonstratedtheeffectivenessand

safetyofPromAce asa tranquilizer.

Good toexcellentresultswere reported indogs,cats andhorsesgiven PromAce Veterinaryinjectablefor restraintduring

examination,treatment andminor surgeryandforpreanesthetic sedation.Indogs,thedrugreportedly helps control

convulsionsassociatedwith distemper.

Inhorses,Bauman hadgoodresultsusingthe drugasanaid in the control ofpainful spasmsduetocolic.

Other practitionersfoundthe drugusefulasapreanestheticsedativefornervousoraggressive horses, butit hadtobe

administeredwhile the animals werequite andnot inanexcitedstate. Inatrialonmore than200horseswithawide

variety ofdisorders, PromAceVeterinaryInjectalbe provedtobeboth effective andsafe.

ISRAELIDRUGREGISTRATIONNUMBER:080-59-92164-00

MANUFACTURER:FORTDODGEAnimalHealth,USA

AGENT& IMPORTER:A.VeterinarySupply Ltd., 10 Lishanskystreet, RishonLezion75650

Date of(partial)revisionoftext: 13.2.2003

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