TOLAZINE INJECTION

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Active ingredient:
TOLAZOLINE AS TOLAZOLINE HYDROCHLORIDE
Available from:
AKORN ANIMAL HEALTH INC
INN (International Name):
tolazoline as HCl(100mg/mL)
Pharmaceutical form:
PARENTERAL LIQUID/SOLUTION/SUSPENSION
Composition:
TOLAZOLINE AS TOLAZOLINE HYDROCHLORIDE IMIDAZOLE Active 100.0 mg/ml
Units in package:
100mL
Class:
VM - Veterinary Medicine
Manufactured by:
AKORN ANIMAL HEALTH
Therapeutic group:
HORSE | COLT | DONKEY | ENDURANCE HORSE | FILLY | FOAL | GELDING | HIGH PERFORMANCE HORSES | HORSES AT STUD | MARE | PACER | POL
Therapeutic area:
ANTIDOTES
Therapeutic indications:
REVERSAL OF XYLAZINE BASED SEDATION
Product summary:
Poison schedule: 4; Withholding period: WHP: HORSES: MEAT - DO NOT USE LESS THA N 28 DAYS BEFORE SLAUGHTER FOR HUMAN C ONSUMPTION.; Host/pest details: HORSE: [REVERSAL OF XYLAZINE BASED SEDATION]; Poison schedule: 4; Withholding period: ; Host/pest details: HORSE: [REVERSAL OF XYLAZINE BASED SEDATION]; Xylazine reversing agent and antagonist for use in horses. (Tolazoline should be used in horses when it is desirable to reverse the effects of sedation and analgesia caused by xylazine).The safety of this drug in pregnant mares or horses intended for breeding has not been established. This drug should be administered with care to animals with signs of stress, debilitation, cardiac disease, sympathetic blockage, hypovolemia or shock.
Authorization status:
Stopped
Authorization number:
48033
Authorization date:
2020-07-01

TEXT LABEL: To!azine Injection

Bottle

Label-

Front Panel

Text appearing above the Header and below the Footer lines is not included in the label

6 May 2014

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

TOLAZINE

INJECTION

TOLAZOLINE

100mg/ml

(as Tolazoline

hydrochloride)

Xylazine Reversing Agent and Antagonist for Use

Horses

100ml

48033_54753_Labei_RLP _V02

Approved

Page 1 of 7

TE:XJ

LABEL:

Tolazine

Injection

Bottle

Label

-

back

panel

Text

appearing

above

the

Header

and

below

the

Footer

lines

is

not

included

in

the

label

READ

ENCLOSED

LEAFLET

BEFORE

USING

THIS

PRODUCT.

DOSAGE

AND ADMINISTRATION:

the contents

within

24 hours

first

broaching

vial.

Discard

unused portion.

horses.

Carefully calculate dose and administer by slow intravenous

(IV)

injection.

Dose

rate

per 100kg body weight (0.04

ml/kg)

a single injection.

WITHHOLDING

PERIOD:

less

than

days

before

slaughterfor

human consumption.

FIRST

AID: If poisoning occurs, contact a

doctor

Poisons Information Centre. Phone Australia

131126.

Manufactured for:

Lloyd, Incorporated.

Shenandoah

IOWA 51601

Distributed

Consulvet Pty Ltd

135 Brooke Street

Smythesdale

VICTORIA

3351

Australia

Customer Service: 1300

Storage: Store below 25°C (Air Conditioning). Protect

from

light.

Batch:

Expiry:

APVMA No.: 48033/54753

6

May

2014

48033_54753_Labei_RLP _ V02

Page

2

of

7

TEXT LABEL: Tolazine Injection

Leaflet

Text appearing above the Header and below the Footer lines is not included in the label

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

TOLAZINE

INJECTION

TOLAZOLINE 100mg/mL

(as Tolazoline

hydrochloride)

Xylazine Reversing Agent and Antagonist for Use

Horses

DESCRIPTION:

Tolazine contains tolazoline hydrochloride

with

the chemical name 1H-Imidazole,4,5-

dihydro-2-(phenylmethyl)-monohydrochloride. Tolazoline hydrochloride

a molecular weight

196.68 and

molecular formula

HCI.

Each

contains tolazoline hydrochloride equivalent

lOOmg

base

activity.

PRESENTATION:

100ml

Multidose vial.

CLINICAL

PHARMACOLOGY:

Tolazoline belongs

the synthetic group

alpha-adrenergic blocking

agents known

imidazoline derivatives

a mixed alpha-1 and alpha-2 adrenergic receptor

antagonist which competitively reverses the effects ofxylazine.' Tolazoline

also

a direct peripheral

vasodilator that decreases

peripheral resistance and increases venous capacitance. Tolazoline

competitively blocks and antagonises central nervous system depression caused by xylazine

Xylazine,

alpha-2 adrenergic agonist

with

potent

sedative, analgesic and muscle relaxant

properties,

been used extensively

analgesic-sedative restraining agent.

also been

used

a preanaesthetic agent

many general anaesthetics.

central nervous system

depressant effect,

well

other

pharmacologic effects

xylazine,

dose dependent.

Tolazoline

useful

counteract the sedation after standard doses

xylazine.

competitive

selective blocking

alpha-2 adrenergic receptor by tolazoline displaces xylazine

from

these sites

and thereby rapidly cancels the effect

xylazine

INDICATIONS: Tolazoline should

used in horses when

desirable

reverse the effects

sedation and analgesia caused by xylazine.

DIRECTION£

t=OR

!JSE:

Precautions: The safety

TotazolinE

in prEgnant

rnat·es

in horses ir1tended

breeding

been established.

RESTRAINT:

less

than

28 days before slaughter

human consumption.

6 May 2014

48033_54753_Labei_RLP

_ V02

Page

3of7

TEXT LABEL: Tolazine Injection

Leaflet

Text

appearing above the Header

below the Footer lines is

included in the label

This drug should be administered

with

greater

care

animals exhibiting

signs

stress, debilitation,

cardiac disease, sympathetic blockade, hypovolemia

shock. The safety

this drug

been

evaluated in horses

with

metabolically unstable conditions. This drug should be administered

with

extreme care to horses

that

are exhibiting any

type

circulatory compromise, particularly that

associated with blood loss.

In general, all drugs, including Tolazine,

when

given intravenously, should

administered carefully

and at a slow rate to allow venous dilution

occur

prior

the drug reaching

brain and heart.

The drug reverses

analgesic effects

xylazine

well

sedative effects.

animal

given xylazine

its analgesic properties, reversal

result in return

normal pain perception.

Tolazine

not been evaluated

reversing xylazine used

a preanaesthetic

general anaesthetic.

EFFECTS:

Temporary side effects

tolazoline

tachycardia; peripheral vasodilation,

evidenced by bright pink

dark red mucous membranes

gingiva

conjunctiva; and

hyperalgesia

lips, evidenced

licking

flipping

lips even before the injection

completed. Some horses may exhibit piloerection, especially in

rump

neck regions, 4 to

minutes

after

dosing. Clear lachrymal and nasal discharges may

noted.

Some

horses may also

show

signs

apprehensiveness,

this state quickly subsides. All side effects should dissipate

within

30-60 minutes. The potential

adverse effects increases when higher than recommended

doses

administered, or when Tolazine

given

without

prior administration

xylazine.

Dosage and

Administration:

Use contents

within

24 hours

first broaching

vial.

Discard the unused portion.

in horses. Carefully calculate dose and

administer

slow intravenous (IV) injection.

Dose

rate

per 100kg body weight (0.04

ml/kg)

a single injection.

WITHHOLDING

PERIOD:

less

than

28 days before slaughter

human

consumption.

Safety: Tolazine was tolerated in horses at 3

times

(12 mg/kg) and 5 times

mg/kg) the

recommended dose administered

without

prior

xylazine injection at 3 intervals

6 hours.

Lachrymation

most evident when tolazoline was dosed at the

magnitude, and

appeared

that

tolazoline,

when

administered alone, increased

motility

horses

would

attempt

defecate

with

flatulence within minutes

injection. Some horses were uneasy or restless, giving the

appearance

abdomina I discomfort, especially those in the

group. Following

second

third

doses,

horses manifested a

greater

degree

gut motility.

Some

horses had transient

diarrhoea

with

signs

mild colic, i.e. shifting

their

weight, borborygmus

tenesmus. However,

these horses made no

attempt

to lie

down

roll

kick at

their

abdomen.

Profuse sweating was

noted

with

some

horses following

their

third dose. Fine localised

muscle tremors were seen

the neck and

rump

horses.

with

other

side effects

they

were

transient. Tolazoline, when administered

high doses, exerted either a direct

indirect

negative

dromotropic

effect (slowing

conduction)

in the heart. All side effects had dissipated

within

60 minutes, and

hours all horses appeared

completely normal. Horses that

were

given xylazine

prior

tolaz:oline

administration

demonstrated no clinical signs

diarrhoea

colic at

dosages. Avoid giving overdoses

this drug, especially

animals

with

cardiac or

circulatory compromise.

FIRST

AID:

poisoning occurs contact a

doctor

Poisons Information Centre. Phone Australia

126.

2014

48033_54753_labei_RLP

_V02

Page 4

TEXT

LABEL:

Tolazine

Injection

Leaflet

Text

appearing

above

the

Header

and

below

the

Footer

lines

is

not

included

in

the

!abel

Disposal:

Dispose

empty containers and

outer

packaging by wrapping

with

paper and putting in

garbage. Discarded needles should immediately

placed

a designated and appropriately labelled

'sharps

1

container.

Storage:

Store below 25°C (Air Conditioning). Protect from light. Use

contents

within

hours

first

broaching

vial. Discard

unused portion.

Manufactured for:

Distributed

LLOYD

Shenandoah, IOWA

51601-0086

Consulvet Pty

135 Brooke Street

Smythesdale

VICTORIA

3351

Australia

customer

Service: 1300

APVMA Approval

No.:

48033/54753

REFERENCES:

Adams,

H.R.

Veterinarv Pharmacology and Therapeutics. IOWA State University

Press,

AMES,

7'h

1995:104-108.

Short,

Ed.:

Principles and Practice

Veterinary Anaesthesia. Williams and Wilkins,

Baltimore, MD, 1987.

Tranquilli,

W.J.

and Thurmon,

J.C.

Alpha adrenoceptor pharmacology. JAVMA 1984;184:1400-

1402.

LLOYD,

Inc. Research, 1989-1995.

6 May 2014

48033_54753_Labei_RLP

_ V02

Page 5 of 7

TEXT

LABEL: Tolazine Injection

Carton

Label-

Front Panel

Text

appearing above the Header and below the

Footer

lines is

included

the label

6May2014

PRESCRIPTION

ANIMAL

REMEDY

KEEP

REACH

CHILDREN

ANIMAL TREATMENT

ONLY

Tolazine

INJECTION

Active Constituents:

Tolazoline

mg/ml

Tolazoline hydrochloride)

Xylazine Reversing Agent and Antagonist

in Horses

lOOmL

48033_54753_Labei_RLP

_ V02

Page 6 of 7

TEXT LABEL: Tolazine Injection

Carton Label -

Andl!ary panels

Text appearing above the Header and below the Footer lines is

included in the label

Tolazoline

a mixed alpha-1 and alpha-2 adrenergic antagonist which competitively inhibits alpha-

adrenoceptors.

INDICATIONS: Tolazoline should be

used

horses when

desirable

reverse

effects of

sedation and analgesia caused by xylazine.

DIRECTIONS

USE:

READ

ENCLOSED

LEAFLET

BEFORE

USING

THIS

PRODUCT.

Precautions:

safety ofTolazoline

pregnant mares or

horses intended

breeding

been established.

general, all drugs, including Tolazine, when given intravenously, should

administered carefully

and at

slow rate

allow venous dilution

occur prior to

drug reaching the brain and heart.

Dosage and Administration:

the contents within 24 hours

first broaching

the vial.

Discard the unused portion.

For use

horses. Carefully calculate dose and administer

slow intravenous

(IV)

injection.

Dose

rate

per 100kg body weight (0.04

ml/kg)

a single injection.

WITHHOLDING

PERIOD:

less

than

days

before slaughter

human consumption.

FIRST

AID: If poisoning occurs contact a

doctor

Poisons Information Centre. Phone Australia 131

126.

Distributed by:

Consulvet Pty

135 Brooke Street

Smythesdale

VICTORIA

3351

Australia

Customer Service: 1300 553 193

Disposal:

Dispose

empty containers and

outer

packaging by wrapping with paper and putting in

garbage. Discarded needles should immediately be placed

a designated and appropriately labelled

!sharps'

container.

Storage: Store below 25°C (Air Conditioning). Protect from light.

Use the

contents

within

24 hours

first

broaching

vial. Discard

unused

portion.

Batch:

Expiry:

6 May 2014

48033_54753_Labei_RLP _ V02

Page 7

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