4% Articadent DENTAL with Adrenaline (Epinephrine) 1:100,000

New Zealand - English - Medsafe (Medicines Safety Authority)

Active ingredient:
Adrenaline acid tartrate 18.2 µg/mL equivalent to adrenaline 10 micrograms/ml;  ; Articaine hydrochloride 40 mg/mL
Available from:
Dentsply Sirona (NZ) Limited
INN (International Name):
Adrenaline acid tartrate 10 µg/mL
Pharmaceutical form:
Solution for injection
Composition:
Active: Adrenaline acid tartrate 18.2 µg/mL equivalent to adrenaline 10 micrograms/ml   Articaine hydrochloride 40 mg/mL Excipient: Hydrochloric acid Sodium chloride Sodium hydroxide Sodium metabisulfite Water for injection
Prescription type:
Prescription
Manufactured by:
Boehringer Ingelheim Pharma GmbH & Co KG
Therapeutic indications:
Indicated for local or regional anaesthesia for both simple and complex dental procedures in adults, adolescents and children 4 years of age and older. Indicated only for dental procedures.
Product summary:
Package - Contents - Shelf Life: Cartridge, glass, Type 1, clear, with self-aspirating bromobutyl plunger and aluminium cap, 2.2 mL - 50 dose units - 2 years from date of manufacture stored at or below 25°C protect from light. Do not freeze
Authorization number:
TT50-9940
Authorization date:
2016-02-16

Read the complete document

4% Articadent DENTAL with adrenaline (epinephrine) 1:100,000, Issue No. 3.0

4% Articadent

®

DENTAL with

adrenaline (epinephrine) 1:100,000

articaine hydrochloride with adrenaline (epinephrine)

Consumer Medicine Information

What is in this leaflet?

This leaflet answers some

common questions about 4%

Articadent DENTAL with

adrenaline (epinephrine)

1:100,000. It does not contain

all of the available information.

It does not take the place of

talking to your dental

practitioner.

All medicines have risks and

benefits. Your dental practitioner

has weighed the expected

benefits of you using 4%

Articadent DENTAL with

adrenaline (epinephrine)

1:100,000 against the risks this

medicine could have for you.

If you have any concerns

about being given this

medicine, ask your dental

practitioner.

Keep this leaflet.

You may need to read it again.

What 4% Articadent

DENTAL with

adrenaline

(epinephrine) 1:100,000

is for

4% Articadent DENTAL with

adrenaline (epinephrine)

1:100,000 are given by injection

to cause loss of feeling before

and during dental procedures. It

contains two active ingredients:

Articaine hydrochloride, a local

anaesthetic to prevent the pain,

and adrenaline (epinephrine)

(as acid tartrate), a

vasoconstrictor, which makes it

last longer. Adrenaline

(epinephrine) narrows the blood

vessels at the site of injection,

which keeps the anaesthetic

where it’s needed for a longer

time) and controls bleeding

during the surgery.

4% Articadent DENTAL with

adrenaline (epinephrine)

1:100,000 belongs to a group of

medicines called local

anaesthetics.

Ask your dental practitioner if

you have any questions about

why this medicine has been

prescribed for you.

4% Articadent DENTAL with

adrenaline (epinephrine)

1:100,000 is not addictive.

Before you take 4%

Articadent DENTAL

with adrenaline

(epinephrine) 1:100,000

You must not take 4%

Articadent DENTAL with

adrenaline (epinephrine)

1:100,000 if you have an

allergy to:

adrenaline (epinephrine) or

articaine

any of the ingredients listed

toward the end of this leaflet

(See “Ingredients”)

any other similar medicines,

such as other local

anaesthetics.

Some of the symptoms of an

allergic reaction may include

shortness of breath

wheezing or difficulty

breathing

swelling of the face, lips,

tongue or other parts of the

body

rash, itching or hives on the

skin.

4% Articadent DENTAL with

adrenaline (epinephrine)

1:100,000 should not be used

if any of the following apply to

you:

you are asthmatic or have

broncho-spasmic (difficulty

in breathing) reactions to

sulfites

you have arterial

hypertension (high blood

pressure), coronary disease

or valvular cardiac disease

(heart or circulation

problems)

you have an overactive

thyroid gland, whether or

not treated for this

you have cerebral

arteriosclerosis (hardening

in the brain arteries)

you have an inflammation or

infection in the region of the

proposed injection

you have diabetes

children under the age of 4

years old.

This medicine will only be

used if the package is

undamaged and the use by

date (expiry date) printed on

the pack has not passed.

Tell your doctor if:

Tell your dental practitioner if

you have allergies to foods,

dyes, preservatives or any

other medicines.

Tell you dental practitioner if

you have or have had any of

4% Articadent DENTAL with adrenaline (epinephrine) 1:100,000, Issue No. 3.0

the following medical

conditions:

problems with your heart,

blood vessels or heart

rhythm

epilepsy

hepatic (liver) problems

renal (kidney) problems

malignant hyperthermia

(history or experience of a

rapid rise in body

temperature to a

dangerously high level

brought on by general

anaesthesia)

prostatic hypertrophy

(enlarged prostate)

you have any other medical

conditions.

Tell your dental practitioner if

you are taking any other

medicines, including

medicines you buy without a

prescription.

Tell you dental practitioner if

you are pregnant or plan to

become pregnant or are

breast-feeding.

Your dental practitioner can

discuss with you the risks and

benefits involved.

If this medicine is used when

you are breast-feeding you

should not breast-feed for at

least 48 hours following use of

this medicine.

If you have not told your

dental practitioner about any

of the above, tell him/her

before you are given 4%

Articadent DENTAL with

adrenaline (epinephrine)

1:100,000.

Taking other medicines

Tell your dental practitioner if

you are taking any other

medicines, including any that

you get without a prescription

from your pharmacy,

supermarket or health food

shop.

Some medicines and 4%

Articadent DENTAL with

adrenaline (epinephrine)

1:100,000 may interfere with

each other. These include:

Mono Amine Oxidase

Inhibitors (MAOI) or tricyclic

antidepressants (medicines

used to treat depression), or

have taken this type of

medicine within the last two

weeks.

Phenothiazines (medicines

used to treat mental

illnesses).

Vasopressor drugs

(medicines used to elevate

blood pressure)

Ergot type oxytocic drugs

(medicines used to induce

labour in pregnant women).

4% Articadent DENTAL with

adrenaline (epinephrine)

1:100,000 should be used with

caution if you are taking the

following medicines:

Beta-blockers or

guanethidine (medicines

used to lower high blood

pressure and/or treat heart

problems)

Hypoglycaemics (medicines

used to treat irregular

heartbeats)

Antiepileptic drugs

(medicines used to treat

epilepsy)

Cardiac glycosides

(medicines used to treat

heart failure)

Cimetidine (medicine used

to treat reflux and stomach

or duodenal ulcers)

Thyroid hormone

Inhalational anaesthetics.

These medicines may be

affected by 4% Articadent

DENTAL with adrenaline

(epinephrine) 1:100,000 or may

affect how well it works. You

may need different amounts of

your medicines, or you may

need to take different

medicines.

Your dental practitioner and

pharmacist have more

information on medicines to be

careful with or avoid while being

given this medicine.

How 4% Articadent

DENTAL with

adrenaline

(epinephrine) 1:100,000

is given

Your dentist will explain to you

why you are being treated with

4% Articadent DENTAL with

adrenaline (epinephrine)

1:100,000 and what dose you

will be administered.

How it is given

Your dentist will inject 4%

Articadent DENTAL with

adrenaline (epinephrine)

1:100,000 into your oral (mouth)

cavity. This will result in an area

of numbness at the site of the

injection.

How much you are given

One cartridge is usually

sufficient but your dentist may

give you a greater quantity.

He/she will adjust the dosage

according to your age, your

health, your weight and the

dental work to be performed. If

only a portion of a cartridge is

used the remainder must be

discarded.

4% Articadent DENTAL with

adrenaline (epinephrine)

1:100,000 should not be

injected directly into the

blood.

4% Articadent DENTAL with adrenaline (epinephrine) 1:100,000, Issue No. 3.0

If you are given too

much (Overdose)

The dental practitioner giving

you this medicine will be

experienced in the use of local

anaesthetics, so it is unlikely

that you will be given an

overdose.

However, some persons tolerate

articaine and adrenaline

(epinephrine) less well than

others and the signs and

symptoms of too much of these

substances in your blood

include:

nervousness

dizziness

blurred vision nausea

trembling convulsions

slow or irregular heart beat

troubled breathing.

Tell your dentist immediately if

you experience any of these

symptoms during or shortly after

your treatment.

Whenever you are given the

medicine, equipment will be

available to care for you if an

overdose happens.

While you are taking

4% Articadent with

adrenaline

(epinephrine) 1:100,000

Things you must not do

Do not eat or drink anything

until the feeling has returned

to your mouth.

You may burn or bite yourself.

Things to be careful of

Be careful driving or

operating machinery until you

know how 4% Articadent

DENTAL with adrenaline

(epinephrine) 1:100,000

affects you.

This medicine may cause

dizziness, nervousness,

drowsiness, blurred vision or

feeling strange/disoriented in

some people and your reflexes

may be slow. If you have any of

these symptoms, do not drive,

operate machinery or do

anything else that could be

dangerous.

Do not drink alcohol

immediately before or after

you are given 4% Articadent

DENTAL with adrenaline

(epinephrine) 1:100,000.

If you drink alcohol while you

are being given 4% Articadent

with adrenaline (epinephrine)

1:100,000, your blood pressure

may drop, making you feel dizzy

and faint.

Talk to your dentist or

pharmacist about these

possibilities if you think they

may bother you.

What are the side

effects?

Tell your dental practitioner

as soon as possible if you do

not feel well while you are

being given 4% Articadent

DENTAL with adrenaline

(epinephrine) 1:100,000, even

if the problem is not listed

below.

This medicine helps most

people have pain-free visits to

the dental practitioner but like

other medicines, 4% Articadent

DENTAL with adrenaline

(epinephrine) 1:100,000 can

cause some side effects. If they

occur, they are most likely to be

minor and temporary. However,

some may be serious and need

medical attention.

If you are over 65 years of age

you may have an increased

chance of getting side effects.

Do not be alarmed by the

following lists of side effects.

You may not experience any

of them.

Ask your dental practitioner to

answer any questions you may

have.

Tell your dental practitioner if

any of the below side effects

occur.

The most commonly reported

side effects are:

infection and pain in the

injection site

tingling and numbness of the

hand and feet or increased

feeling or sensitivity of the

skin

feeling nervous, nauseous

or dizzy

headache

trembling, buzzing in the

ears, blurred vision or have

any abnormal feeling

difficulty breathing

slow or irregular heart beat

facial swelling or

inflammation of gums

skin rash, hives or itching

loss of sensation and

muscle function following

injection of 4% Articadent

DENTAL with adrenaline

(epinephrine) 1:100,000.

Resolution occurs generally

within two weeks.

Very rare reactions

There are some serious

unwanted reactions, which may

happen if 4% Articadent

DENTAL with adrenaline

(epinephrine) 1:100,000 is given

into the veins or you are very

sensitive to it, it may cause:

fits

unconsciousness

breathing problems

low blood pressure

slow heart beat

4% Articadent DENTAL with adrenaline (epinephrine) 1:100,000, Issue No. 3.0

collapse.

If experiencing any of these, you

may have had a serious

(allergic) reaction to 4%

Articadent with adrenaline

(epinephrine) 1:100,000. You

may need urgent medical

attention or hospitalisation.

Tell your dentist if you notice

anything else that is making

you feel unwell.

You may be hypersensitive to

sulfites and therefore show

allergic symptoms to 4%

Articadent DENTAL with

adrenaline (epinephrine)

1:100,000 such as breathing

difficulties and/or skin

reactions.

If you have problems with

your blood vessels,

circulation or have high blood

pressure, you may react

exaggeratedly to the

vasoconstrictor contained in

4% Articadent DENTAL with

adrenaline (epinephrine)

1;100,000 and develop a small

injury at the site of injection.

This is not a complete list of all

possible side effects. Others

may occur in some people and

there may be some side effects

not yet known.

Do not be alarmed by this list

of possible side effects.

You may not experience any

of them.

Storage of 4%

Articadent DENTAL

with adrenaline

(epinephrine) 1:100,000

It is most unlikely that you will

be asked to look after this

medicine. Your dentist will store

this medicine below 25

He/she will not use this

medicine after the expiry date

printed on the package.

4% Articadent DENTAL with

adrenaline (epinephrine)

1:100,000 must be stored in a

cool, dry place where it stays

below 25°C.

All medicines must be kept in a

safe place out of the reach of

children.

Product description

What 4% Articadent

DENTAL with adrenaline

(epinephrine) 1:100,000

looks like

This medicine is packed in a

carton containing 50, 2.2 mL

glass cartridges.

Ingredients

4% Articadent DENTAL with

adrenaline (epinephrine)

1:100,000 contains 40 mg/mL

articaine hydrochloride and 0.01

mg/mL adrenaline (epinephrine)

(as acid tartrate) as the active

ingredients.

It also contains:

Sodium chloride

Sodium metabisulfite

Sodium hydroxide and/or

Hydrochloric acid

solution

Water for Injections.

This medicine does not contain

lactose, sucrose, gluten,

tartrazine or any other azo dyes.

Sponsor

4% Articadent DENTAL with

adrenaline (epinephrine)

1:100,000 is supplied by:

Australia

Dentsply Sirona Pty Ltd

11-21 Gilby Road

Mount Waverley, VIC 3149

Australia

New Zealand

Dentsply Sirona (N.Z.) Limited

c/o Lowndes Jordan

Level 15, PWC Tower

188 Quay Street

Auckland 1010

New Zealand

Where to go for further

information

Only a dentist can administer

this product. Pharmaceutical

companies are not in a position

to give people an individual

diagnosis or medical advice.

This leaflet provides only a

summary of the information

known about 4% Articadent

DENTAL with adrenaline

(epinephrine) 1:100,000. If you

have any questions, want to

know more about this medicine,

or have some doubts, ask your

dental practitioner or

pharmacist.

This leaflet was prepared on

30 August 2018

The information provided

applies only to 4% Articadent

DENTAL with adrenaline

(epinephrine) 1:100,000.

Articadent is a registered

trademark of DENTSPLY

International Inc.

AUST R 231745

TT50-9940

Read the complete document

4% Articadent® DENTAL with Adrenaline (epinephrine)

1:100,000

Data Sheet

Dentsply Sirona (NZ) Ltd

NZ-DS Revision 2.0

Page 1 of 15

NEW ZEALAND DATA SHEET

1

PRODUCT NAME

4% Articadent

DENTAL with Adrenaline (epinephrine) 1:100,000 Injection for Local and

Regional Dental Anaesthesia

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

4% Articadent

DENTAL with Adrenaline (epinephrine) 1:100,000 consists of

Articaine hydrochloride 40 mg/mL and Adrenaline (epinephrine) (as acid tartrate) 10

micrograms/mL.

Articaine hydrochloride: white to almost white powder, odourless.

Articaine hydrochloride is a local anaesthetic and is a racemic mixture. Articaine

hydrochloride has a partition coefficient in n-octanol/ Soerensen buffer (pH 7.35) of 17, a

pKa of 7.8 and is freely soluble in water and in ethanol (96 per cent).

Adrenaline (epinephrine) (as acid tartrate): white or greyish-white or light brownish grey,

odourless, crystalline powder, which slowly darkens on exposure to air and light.

Adrenaline (epinephrine) (as acid tartrate) 1.8 mg is approximately equivalent to 1 mg of

adrenaline (epinephrine). It is freely soluble in water and slightly soluble in ethanol (96 per

cent).

Adrenaline (epinephrine) (as acid tartrate) is a vasoconstrictor.

Chemical structure of articaine hydrochloride

Chemical structure of adrenaline (epinephrine) acid tartrate

4% Articadent® DENTAL with Adrenaline (epinephrine)

1:100,000

Data Sheet

Dentsply Sirona (NZ) Ltd

NZ-DS Revision 2.0

Page 2 of 15

Chemical name:

Articaine hydrochloride:

Methyl 4

methyl

[[(2RS)

2-(propylamino)propanoyl]amino]-

thiophene

carboxylate hydrochloride

Adrenaline (epinephrine) acid tartrate:

(1R)

(3,4

Dihydroxyphenyl)

(methylamino)ethanol hydrogen (2R,3R)

dihydroxybutanedioate

Molecular formula:

Articaine hydrochloride:

C13H20N2O3S.HCl

Adrenaline (epinephrine) acid tartrate: C9H13NO3.C4H6O6

Molecular weight:

Articaine hydrochloride:

320.84

Adrenaline (epinephrine) acid tartrate: 333.3

CAS Registry Number:

Articaine hydrochloride:

23964-57-0

Adrenaline (epinephrine) acid tartrate: 51-42-3

4% Articadent DENTAL with Adrenaline (epinephrine) 1:100,000 injection also contains the

excipients with known effect, sodium metabisulfite. For the full list of excipients, see Section

6.1 List of excipients.

3

PHARMACEUTICAL FORM

4% Articadent

DENTAL with Adrenaline (epinephrine) 1:100,000 is a clear, colourless

sterile aqueous solution that contains articaine hydrochloride 4% (40 mg/mL) with

adrenaline (epinephrine) (as acid tartrate) in a 1:100,000 strength.

The finished product is packed in a carton containing 50, 2.2 mL Type I glass cartridges,

closed on one end with a self-aspirating bromobutyl rubber plunger and at the other end by

a bromobutyl disk covered by an aluminium cap.

4

CLINICAL PARTICULARS

4.1 Therapeutic indications

4% Articadent

DENTAL with Adrenaline (epinephrine) 1:100,000 is indicated for local or

regional anaesthesia for both simple and complex dental procedures in adults, adolescents

and children 4 years of age and older.

4% Articadent

DENTAL with Adrenaline (epinephrine) 1:100,000 is indicated only for

dental procedures.

4.2 Dose and method of administration

One or more cartridges should be used on a single patient on one occasion only during

each session of treatment. If only a portion of a cartridge is used, the remainder must be

discarded.

Administer 4% Articadent DENTAL with Adrenaline (epinephrine) 1:100,000 by submucosal

injection.

Use in Adults

Table 1 summarises the recommended volumes and concentrations of 4% Articadent

DENTAL with Adrenaline (epinephrine) 1:100,000 for various types of anaesthetic

procedures. For most common operations, one infiltration with 4% Articadent DENTAL with

Adrenaline (epinephrine) 1:100,000 is sufficient. In all cases, the injection must be done

slowly (about 1 mL/min).

4% Articadent® DENTAL with Adrenaline (epinephrine)

1:100,000

Data Sheet

Dentsply Sirona (NZ) Ltd

NZ-DS Revision 2.0

Page 3 of 15

For an infiltration in the interdental septum, a quantity of 0.3 to 0.5 mL is generally

sufficient. Higher volumes should rarely be required.

MAXIMUM RECOMMENDED DOSE for normal healthy adults of articaine hydrochloride

administered by submucosal infiltration and/or nerve block should not exceed 7 mg/kg of

body weight. This corresponds, for a subject weighing 60 kg, to five (5) standard 2.2 mL

cartridges (doses of 7 mg/kg were not exceeded in clinical trials). Anaesthesia is obtained

rapidly (1 to 6 minutes).

Table 1. Recommended Dosages in Adults

Procedure

4% Articadent DENTAL with Adrenaline (epinephrine) 1:100,0

Volume (mL)

Total dose of articaine hydrochloride

(mg)

Infiltration

Nerve block

Oral surgery

0.5 – 2.5

0.5 – 3.4

1.0 – 5.1

20 – 100

20 – 136

40 – 204

The above-suggested volumes serve only as a guide for normal healthy adults.

Other volumes may be used provided that the total maximum recommended dose is not

exceeded.

The duration of the anaesthesia during which an operation can be performed is about one

hour (pulpal analgesia) depending on the technique used, and on the procedure.

Use in Children

Safety and effectiveness in paediatric patients below the age of 4 years have not been

established. Dosages in paediatric patients (over 4 years) should be reduced,

commensurate with age, body weight, and physical condition. Please refer to Table 2

below. Use of 4% Articadent DENTAL with Adrenaline (epinephrine) 1:100,000 in children

under 4 years of age is not recommended due to the absence of safety and efficacy data.

MAXIMUM RECOMMENDED DOSE for normal healthy children must not exceed 7 mg/kg of

body weight.

Table 2. Dosage Adjustments for Use in Children

20 Kg child

40 Kg child

Maximum Dose: 0.175 mL/Kg

3.5 mL

(i.e. ~1.5 cartridges of 2.2 mL)

7.0 mL

(i.e. ~3 cartridges of 2.2 mL)

Recommended dose:

0.06 mL/kg for simple procedure

1.2 mL

(i.e.

½ cartridge of 2.2 mL)

2.4 mL

(i.e.

1 cartridge of 2.2 mL)

0.07 mL/kg for complex procedure

1.4 mL

(i.e.

½ cartridge of 2.2 mL)

2.8 mL

(i.e.

1 cartridge of 2.2 mL)

4% Articadent® DENTAL with Adrenaline (epinephrine)

1:100,000

Data Sheet

Dentsply Sirona (NZ) Ltd

NZ-DS Revision 2.0

Page 4 of 15

4.3 Contraindications

These may be of the following types:

Contraindications to articaine:

specific allergies to articaine or to other anaesthetics of the amide type,

hypersensitivity to any local anaesthetic agent.

Contraindications to the vasoconstrictor:

arterial hypertension,

coronary disease,

valvular cardiac disease (particularly sequelae to acute rheumatic fever),

thyrotoxicosis, untreated,

known sensitivity to sympathomimetic amines.

Hypersensitivity to sulfites (sodium metabisulfite is present in the formula as an

antioxidant).

Injection by intravenous route.

Inflammation or sepsis in the region of the proposed injection.

Patients who have experienced bronchospasm after administration of any product,

which contains sulfites, should not be given 4% Articadent DENTAL with Adrenaline

(epinephrine) 1:100,000.

Hypersensitivity to any other component of 4% Articadent DENTAL with Adrenaline

(epinephrine) 1:100,000.

Patients who are known or who have a history, which suggests a deficiency in

plasma cholinesterase activity (see section Section 5.2 Pharmacokinetics

Properties).

Patients receiving monoamine oxidase inhibitors (or who have received such an

agent within two weeks), or tricyclic antidepressants.

Patients in whom there is a possibility that general anaesthesia might be required to

complete the procedure.

Do not use in children under 4 years of age.

4.4 Special warnings and precautions for use

WHEN ANY LOCAL ANAESTHETIC AGENT IS USED, RESUSCITATIVE EQUIPMENT

AND RESUSCITATIVE DRUGS, INCLUDING OXYGEN, SHOULD BE IMMEDIATELY

AVAILABLE IN ORDER TO MANAGE POSSIBLE ADVERSE REACTIONS INVOLVING

THE CARDIOVASCULAR, RESPIRATORY OR CENTRAL NERVOUS SYSTEMS. Because

of the possibility of hypotension and bradycardia following major blocks, an intravenous

cannula should be inserted before the local anaesthetic is injected. Delay in proper

management of dose-related toxicity, under ventilation from any cause and/or altered

sensitivity may lead to the development of acidosis, cardiac arrest and death.

INJECTION SHOULD ALWAYS BE MADE SLOWLY WITH FREQUENT ASPIRATIONS TO

AVOID INADVERTENT INTRAVASCULAR INJECTION, WHICH CAN PRODUCE

CEREBRAL SYMPTOMS EVEN AT LOW DOSES.

Note, however, that the absence of blood in the syringe does not assure that intravascular

injection will be avoided. There should be careful monitoring of cardiovascular and

respiratory vital signs after each injection.

4% Articadent® DENTAL with Adrenaline (epinephrine)

1:100,000

Data Sheet

Dentsply Sirona (NZ) Ltd

NZ-DS Revision 2.0

Page 5 of 15

Intravascular injection is strictly contraindicated. An accidental injection into a blood vessel

may be associated with systemic adverse effects due to the circulating levels of adrenaline

(epinephrine) and/or articaine. Therefore, it is imperative to ensure that the needle being

used for the injection does not go into a blood vessel.

Since amide-type local anaesthetics are also metabolised by the liver, 4% Articadent

DENTAL with Adrenaline (epinephrine) 1:100,000 should be used with caution in patients

with hepatic disease. Patients with severe hepatic disease, because of their inability to

metabolise local anaesthetics normally, are at greater risk of developing toxic plasma

concentration.

Due to the presence of adrenaline (epinephrine), the product is not advised for diabetic

subjects and for patients with thyrotoxicosis.

Use with caution in the following circumstances:

The lowest dosage that results in effective anaesthesia should be used to avoid high

plasma levels and serious adverse effects. Repeated doses may cause significant

increases in blood levels with each repeated dose due to slow accumulation of the

drug or its metabolites. Tolerance to elevated blood levels varies with the status of

the patient. Debilitated, elderly patients, acutely ill patients and children should be

given reduced doses commensurate with their age and physical condition. 4%

Articadent DENTAL with Adrenaline (epinephrine) 1:100,000 should also be used

with caution in patients with heart block.

Local anaesthetic solutions containing a vasoconstrictor should be used with caution

in areas of the body supplied by end arteries or having otherwise compromised blood

supply. Patients with peripheral vascular disease and those with hypersensitive

vascular disease may exhibit exaggerated vasoconstrictor response. Ischaemic injury

or necrosis may result. 4% Articadent DENTAL with Adrenaline (epinephrine)

1:100,000 containing a vasoconstrictor should be used with caution in patients during

or following the

administration of potent general anaesthetic agents, since cardiac

arrhythmias may occur under such conditions.

Many drugs used during the conduct of anaesthesia are considered potential

triggering agents for familial malignant hyperthermia. Since it is not known whether

amide-type local anaesthetics may trigger this reaction, and since the need for

supplemental general anaesthesia cannot be predicted in advance, it is suggested

that a standard protocol for management should be available.

Solutions containing adrenaline (epinephrine) should be used with caution in patients

with hypertension, cardiac disease, and/or cerebrovascular insufficiency.

Prostatic hypertrophy.

4% Articadent DENTAL with Adrenaline (epinephrine) 1:100,000 should be

administered with caution to subjects with cardiovascular disease,

abnormalities of

cardiac conduction, or a history of epilepsy.

4% Articadent DENTAL with Adrenaline (epinephrine) 1:100,000 should not be used

in patients with a deficiency of plasma cholinesterase activity.

Systemic absorption of local anaesthetics can produce effects on the central nervous and

cardiovascular systems. At blood concentrations achieved with therapeutic doses, changes

in cardiac conduction, excitability, refractoriness, contractility, and peripheral vascular

resistance are minimal.

However, toxic blood concentrations depress cardiac conduction and excitability, which may

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lead to atrioventricular block, ventricular arrhythmias, and cardiac arrest, sometimes resulting

in fatalities. In addition, myocardial contractility is depressed and peripheral vasodilation

occurs, leading to decreased cardiac output and arterial blood pressure.

Careful and constant monitoring of cardiovascular and respiratory (adequacy of ventilation)

vital signs and the patient’s state of consciousness should be accomplished after each local

anaesthetic injection. It should be kept in mind at such times that restlessness, anxiety,

tinnitus, dizziness, blurred vision, tremors, depression, or drowsiness may be early warning

signs of central nervous system toxicity.

Small doses of local anaesthetics injected in dental blocks may produce adverse reactions

similar to systemic toxicity seen with unintentional intravascular injections of larger doses.

Confusion, convulsions, respiratory depression and/or respiratory arrest, and cardiovascular

stimulation or depression have been reported. These reactions may be due to intra-arterial

injection of the local anaesthetic with retrograde flow to the cerebral circulation. Patients

receiving these blocks should be

observed constantly. Resuscitative equipment and

personnel for treating adverse reactions should be immediately available. Dosage

recommendations should not be exceeded.

The patient should be informed in advance of the possibility of temporary loss of sensation

and muscle function following infiltration and nerve block injections.

Use in hepatic impairment

In vitro studies show that about 5% to 10% of articaine is metabolised by the human liver

microsomal P450 isoenzyme system. However because no studies have been performed in

patients with liver dysfunction, caution should be used in patients with severe hepatic

disease. 4% Articadent DENTAL with Adrenaline (epinephrine) 1:100,000 should also be

used with caution in patients with impaired cardiovascular function since they may be less

able to compensate for functional changes associated with the prolongation of

atrioventricular (AV) conduction produced by these drugs.

Use in the elderly

No overall differences in safety or effectiveness were observed between elderly subjects and

younger subjects, and other reported clinical experience has not identified differences in

responses between the elderly and younger patients, but greater sensitivity of some older

individuals cannot be ruled out. Approximately 6% of patients between the ages of 65 and 75

years and none of the 11 patients 75 years of age or older required additional injections of

anaesthetic for complete anaesthesia compared with 11% of patients between 17 and 65

years old who required additional injections. See Section 5.1 Pharmacodynamic Properties –

Clinical Trials for description of studies in the elderly.

Paediatric use

4% Articadent DENTAL with Adrenaline (epinephrine) 1:100,000 should not be used in

children younger than 4 years of age as safety and effectiveness has not been established

in this age group.

See Section 5.1 Pharmacodynamic Properties – Clinical trials for description of studies in

children and adolescents (4 years of age to 16 years of age). See also Section 4.2 Dose

and Method of Administration.

Effects on laboratory test

No data available.

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4.5 Interaction with other medicines and other forms of interaction

No drug interaction studies have been performed.

Due to the possibility that clinically significant increases in circulating adrenaline

(epinephrine) concentrations may occur post-injection, 4% Articadent DENTAL with

Adrenaline (epinephrine) 1:100,000 should be administered with caution to any patient

receiving drugs with sympathomimetic properties or with agents whose therapeutic actions

may be antagonized by adrenaline (epinephrine).

The administration of local anaesthetic solutions containing adrenaline (epinephrine) to

patients receiving monoamine oxidase inhibitors, tricyclic antidepressants or phenothiazines

may produce severe prolonged hypotension or hypertension. Phenothiazines and

butyrophenones may reduce or reverse the pressor effect of adrenaline (epinephrine).

Concurrent use of these agents should generally be avoided. In situations when concurrent

therapy is necessary, careful patient monitoring is essential. Concurrent administration of

vasopressor drugs and ergot-type oxytocic drugs may cause severe, persistent hypertension

or cerebrovascular accidents.

4% Articadent DENTAL with Adrenaline (epinephrine) 1:100,000 should be administered with

caution to patients under the following treatments:

Hypoglycaemics: adrenaline (epinephrine)-induced hyperglycaemia may lead to loss

of blood sugar control in diabetic patients treated with hypoglycaemics.

Anti-arrhythmic agents (e.g. procainamide, mexilitine, disopyramide).

Antiepileptic skeletal muscle relaxant.

Cardiac glycosides (e.g. digoxin): adrenaline (epinephrine) may interact with cardiac

glycosides resulting in cardiac arrhythmias.

Adrenergic neuron blocking agents (e.g. guanethidine) since the product contains

adrenaline (epinephrine).

Quinidine: combination with adrenaline (epinephrine) may lead to cardiac

arrhythmias.

Cimetidine.

Amiodarone.

Phenytoin and other antiepileptic drugs such as phenobarbitone, primidone and

carbamazepine.

Inhalational anaesthetics: serious cardiac arrhythmias may occur if preparations

containing adrenaline (epinephrine) are employed in patients following the

administration of inhalational anaesthetics.

Beta adrenoreceptor antagonists - Propranolol and metoprolol, timolol. Administration

of adrenaline (epinephrine) may result in dose-dependent hypertension and

bradycardia with possible heart block.

Thyroid hormones: may potentiate the actions of adrenaline (epinephrine).

4.6 Fertility, pregnancy and lactation

Effects on Fertility

No effects on male or female fertility were observed in rats given articaine hydrochloride with

adrenaline (epinephrine) subcutaneously from prior to mating until mating (males) or early

gestation (females) at doses up to 80 mg/kg/day (approximately twice the maximum

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recommended human dose on a mg/m

basis).

Use in pregnancy

Category B3

[Definitions of the Australian categories for prescribing medicines in pregnancy for

Category B3

Drugs which have been taken by only a limited number of pregnant women and women of

childbearing age, without an increase in the frequency of malformation or other direct or

indirect harmful effects on the human fetus having been observed.

Studies in animals have shown evidence of an increased occurrence of fetal damage, the

significance of which is considered uncertain in humans.]

No clinical experience of the use in pregnancy and lactating women is available. Safe use of

local anaesthetics during pregnancy has not been established with respect to adverse

effects on fetal development. The product should only be used in pregnancy when the

benefits are considered to outweigh the risks.

No effects on embryofetal development were observed when articaine hydrochloride with

adrenaline (epinephrine) was administered subcutaneously throughout organogenesis at

doses up to 40 mg/kg/day in rabbits and 80 mg/kg/day in rats (approximately 2 times the

maximum recommended human dose on a mg/m

basis). In rabbits, fetal death and

increased fetal skeletal variations were observed at the maternotoxic dose of 80 mg/kg

(approximately 4 times the maximum recommended human dose on a mg/m

basis).

When articaine hydrochloride alone was administered subcutaneously to rats throughout

gestation and lactation, 80 mg/kg/day (approximately 2 times the maximum recommended

human dose on a mg/m

basis) increased the number of stillbirths, delayed eye opening, and

adversely affected passive avoidance, a measure of learning, in pups, along with maternal

toxicity were observed. A dose of 40 mg/kg/day (approximately the maximum recommended

human dose on a mg/m

basis) did not produce these effects. A similar study using articaine

hydrochloride with adrenaline (epinephrine) produced maternal toxicity, but no effects on the

offspring.

Use in lactation

The excretion of articaine or its metabolites in human milk is unknown. As many drugs are

excreted in human milk, caution should be exercised when 4% Articadent DENTAL with

Adrenaline (epinephrine) 1:100,000 is administered to a nursing woman. If administered,

nursing women should not breast feed for at least 48 hours following anaesthesia with 4%

Articadent DENTAL with Adrenaline (epinephrine) 1:100,000.

For effects of articaine hydrochloride in rat pups being suckled, see Section 4.6 Fertility,

Pregnancy and Lactation - Use in pregnancy.

4.7 Effects on ability to drive and use machine

In a controlled study on healthy volunteers articaine was shown to have no effect on the level

of attentiveness, reaction time to visual stimulations or motor co-ordination.

Patients who experience systemic adverse effects during or immediately following

administration of 4% Articadent DENTAL with Adrenaline (epinephrine) 1:100,000 should be

advised to avoid driving or operating machinery until resolution of signs or symptoms.

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4.8 Undesirable effects

Articaine and adrenaline (epinephrine) may reach sufficient concentrations in blood to

provoke systemic adverse effects. Reactions to 4% Articadent DENTAL with Adrenaline

(epinephrine) 1:100,000 are characteristic of those associated with other amide-type local

anaesthetics. Adverse reactions to this group of drugs may also result from excessive

plasma levels, which may be due to overdosage, unintentional intravascular injection, or slow

metabolic degradation.

Adverse Reactions from Clinical Trials:

The reported adverse events are derived from clinical trials in the US and UK.

Of the 1,325 patients treated in the primary clinical trials, 882 were exposed to articaine

hydrochloride 4% (40 mg/mL) with epinephrine (adrenaline) 1:100,000 injection.

Table 3. Adverse events in controlled trials with an incidence of 1% or greater in

patients administered articaine hydrochloride 4% (40 mg/mL) with

epinephrine (adrenaline) 1:100,000 injection

Body system

Articaine hydrochloride 4% with

adrenaline (epinephrine) 1:100,000

injection

N (%)

Number of Patients

882 (100%)

Body as a whole

Face oedema

Headache

Infection

Pain

13 (1%)

31 (4%)

10 (1%)

114 (13%)

Digestive system

Gingivitis

13 (1%)

Nervous system

Paraesthesia

11 (1%)

The following list includes adverse and concurrent events that were recorded in 1 or more

patients, but occurred at an overall rate of less than 1%, and were considered clinically

relevant.

Body as a Whole - abdominal pain, accidental injury, asthenia, back pain, injection

site pain, malaise, neck pain.

Cardiovascular System - hemorrhage, migraine, syncope, tachycardia.

Digestive System - constipation, diarrhea, dyspepsia, glossitis, gum hemorrhage,

mouth ulceration, nausea, stomatitis, tongue edemas, tooth disorder, vomiting.

Hemic and Lymphatic System - ecchymosis, lymphadenopathy.

Metabolic and Nutritional System - edema, thirst.

Musculoskeletal System - arthralgia, myalgia, osteomyelitis.

Nervous System - dizziness, dry mouth, facial paralysis, hyperesthesia, increased

salivation, nervousness, neuropathy, paresthesia, somnolence.

Respiratory System - pharyngitis, rhinitis.

Skin and Appendages - pruritis, skin disorder.

Special Senses - ear pain, taste perversion.

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Urogenital System - dysmenorrhea.

Adverse Reactions Due to Articaine:

Toxic reactions (showing an abnormally high concentration of local anaesthetic in the blood)

may appear either immediately, by accidental intravascular injection or later, by true

overdose following an injection of an excessive quantity of anaesthetic solution.

Symptoms include:

Symptoms showing effects on the central nervous system: nervousness, shaking,

yawning, trembling, apprehension, nystagmus, logorrhoea, headache, nausea,

buzzing in the ears. These signs, when they appear, require rapid corrective

measures to prevent possible worsening.

Respiratory symptoms: tachypnoea, then bradypnoea, which could lead to apnoea.

Cardiovascular signs: reduction in the contractile power of the myocardium, lowering

of heart rate and drop in blood pressure.

Common ≥ 1% and <10%

Headache, facial oedema, gingivitis.

Disruption of nerve transmission (para-, hypo- and dysaesthesia) may appear after articaine

administration. Resolution usually occurs within two weeks.

Uncommon ≥ 0.1% and <1%

Nausea

Other Adverse Reactions:

Serious adverse experiences following the administration of articaine are similar in nature to

those observed with other amide local anaesthetic agents. These adverse experiences are,

in general, dose-related and may result from high plasma levels caused by excessive

dosage, rapid absorption, unintended intravascular injection or may result from

hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. Serious

adverse experiences are generally systemic in nature.

The following types are those most commonly reported:

Central nervous system: CNS manifestations are excitatory and/or depressant and

may be characterised by light-headedness, nervousness, apprehension, euphoria,

confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting,

sensations of heat, cold or numbness, agitation, difficulty in swallowing and slurred

speech, twitching, tremors, convulsions, unconsciousness, respiratory depression

and arrest which are less common.

The excitatory manifestations may be very brief or may not occur at all, in which case

the first manifestation of toxicity may be drowsiness merging into unconsciousness

and respiratory arrest.

Cardiovascular system: Cardiovascular manifestations are usually depressant and

are characterised by bradycardia, hypotension, and cardiovascular collapse, which

may lead to cardiac arrest. Signs and symptoms of depressed cardiovascular function

may commonly result from a vasovagal reaction, particularly if the patient is in an

upright position.

Less commonly, they may result from a direct effect of the drug. Failure to recognize

the premonitory signs such as sweating, a feeling of faintness, changes in pulse or

sensorium may result in progressive cerebral hypoxia and seizure or serious

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cardiovascular catastrophe. Management consists of placing the patient in the

recumbent position and ventilation with oxygen. Supportive treatment of circulatory

depression may require the administration of intravenous fluids and resuscitative

drugs as directed by the clinical situation.

Hypersensitivity: One may observe manifestations of hypersensitivity to articaine as

rash, pruritis, urticaria or anaphylaxis.

The administration of large doses of articaine may produce methaemoglobinaemia in

patients with subclinical methaemoglobinaemia.

Allergic reactions: Allergic reactions are characterised by cutaneous lesions, urticaria,

oedema or anaphylactoid reactions.

Allergic reaction to sulfites: Allergic-type reactions may occur in patients with

bronchial asthma due to hypersensitivity to the sulfite component and may be

manifested by dermatologic reactions, oedema, urticaria and other allergy symptoms.

Reporting of suspected adverse effects

Reporting suspected adverse reactions after authorization of the medicine is important. It

allows continued monitoring of the benefit/risk balance of the medicine. Healthcare

professionals are asked to report any suspected adverse reactions

https://nzphvc.otago.ac.nz/reporting/

4.9 Overdose

For advice on the management of overdose please contact the National Poisons Centre on

0800 POISON (0800 764766).

The most serious effects of articaine intoxication are on the CNS and cardiovascular

system. The type of toxic reaction is unpredictable and depends on such factors as dosage,

rate of absorption, and clinical status of the patient. Two types of reactions that effect

stimulation and/or depression of the central cortex and medulla may result from systemic

absorption.

Symptoms

Slow onset symptoms following overdose include stimulation leading to nervousness,

dizziness, blurred vision, nausea, tremors, convulsions, hypotension, cardiovascular

depression, and respiratory arrest.

Rapid onset symptoms following overdose include depression, leading primarily to

respiratory arrest, cardiovascular collapse, and cardiac arrest. Since cardiac arrest

symptoms may occur rapidly and with little warning, treatment should be readily available.

Treatment of overdose

For all symptoms: If acute toxicity occurs the injection should be stopped immediately. A

patent airway should be established and maintained, oxygen should be administered, and

assisted or controlled ventilation should be provided as required.

Circulatory collapse: toxic cardiovascular reactions can include peripheral vasodilation,

hypotension, bradycardia and cardiac arrest. Immediately resuscitate with oxygen and

commence cardiovascular resuscitation procedures as appropriate.

Convulsions: Appropriate medication for the management of convulsions should be used.

If not treated immediately, both convulsions and cardiovascular depression may result in

hypoxia, acidosis, bradycardia, arrhythmia and cardiac arrest.

Supportive treatment should be given; standard cardiopulmonary resuscitative therapy,

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including respiratory support may be required to counter adverse effects on the

cardiovascular and/or respiratory systems and to control convulsions. There is no specific

antidote.

5

PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Amides, ATC code: N01BB58

Mechanism of action

Articaine is a local anaesthetic of the amide type. Preclinical pharmacodynamic studies show

that the mechanism of action of articaine is similar to that of other commonly used

anaesthetics (lidocaine, procaine, prilocaine). Inhibition of the generation and the conduction

of the action potential but no change in resting potential is shown.

Articaine blocks sodium channels and, with lower sensitivity, potassium channels at neutral

pH. Inhibition of muscle activation after nerve stimulation and depression of cardiac

electrophysiologic measurements demonstrate that articaine has the same pharmacologic

activities as other local

anaesthetics. When injected close to sensitive nerve filaments,

articaine has the reversible effect of blocking the conduction of painful sensations.

Adrenaline (epinephrine) added to the solution reduces bleeding during surgery, slows down

the passage of articaine into the general circulation and thus ensures the prolonged

maintenance of an active tissue concentration.

Adrenaline (epinephrine) acts on both adrenergic receptors of tissue innervated by

sympathetic nerves, except for the sweat glands and arteries of the face. It is the most

important alpha receptor activator. Adrenaline (epinephrine) stimulates the heart to increase

output, raises the systolic blood pressure, lowers the diastolic blood

pressure, relaxes

bronchial spasm and mobilises liver glycogen, resulting in hyperglycaemia and possibly

glycosuria.

The mean time to onset of anaesthesia after administration of articaine 4% with adrenaline

(epinephrine) 1:100,000 is about 3.5 minutes with a range of 1 to 6 minutes, and the mean

duration of anaesthesia is about 68 minutes with a range of 20 to 175 minutes. The pulpal

analgesia lasts 75 minutes and the bleeding during surgery is significantly reduced.

Clinical trials

Three randomized, double-blind, active-controlled studies were designed to evaluate the

effectiveness of articaine hydrochloride 4% with adrenaline (epinephrine) 1:100,000 injection

as a dental anaesthetic. A total of 882 patients received articaine hydrochloride 4% with

adrenaline (epinephrine) 1:100,000 injection. Of these, 7% were between 4 and 16 years

old, 87% were between 17 and 65 years old, and 6% were at least 65 years old. In addition,

53% of patients were female and 47% were male, with a racial/ethnic distribution of 73%

white, 11% Hispanic, 8% black, 5% Asian and 3% ‘other’ races/ethnicities.

These patients underwent simple dental procedures, single apical resections and single

crown procedures, and complex dental procedures such as multiple extractions, multiple

crowns and/or bridge procedures, multiple apical resections, alveolectomies, muco-gingival

operations, and other surgical procedures on the bone.

Articaine hydrochloride 4% with adrenaline (epinephrine) 1:100,000 injection was

administered as submucosal infiltration and/or nerve block. Efficacy was measured

immediately following the procedure by having the patient and investigator rate the patient’s

procedural pain using a 10 cm visual analog scale (VAS), in which a score of zero

represented no pain, and a score of 10 represented the worst pain imaginable.

Mean patient and investigator VAS pain scores were 0.3 - 0.4 cm for simple procedures and

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0.5 - 0.6 cm for complex procedures. These values are summarized in Table 4 below.

Table 4. Summary of VAS Pain Scores

Articaine HCl 4% with adrenaline (epinephrine) (as

acid tartrate) 1:100,000

Simple procedures

Complex procedures

Number of patients

Investigator score (cm)

Mean

Median

Range

0 – 9.0

0 – 7.3

Patient score (cm)

Mean

Median

Range

0 – 8.0

0 – 8.7

In clinical trials, 61 paediatric patients between the ages of 4 and 16 years received articaine

hydrochloride 4% with adrenaline (epinephrine) 1:100,000 injection. Among these paediatric

patients, doses from 0.76 mg/kg to 5.65 mg/kg (0.9 to 5.1 mL) were administered safely to

51 patients for simple procedures and doses between 0.37 mg/kg and 7.48 mg/kg (0.7 to 3.9

mL) were administered safely to 10 patients for complex procedures.

However, there was insufficient exposure to articaine hydrochloride 4% with adrenaline

(epinephrine) 1:100,000 injection at doses greater than 7.00 mg/kg in

order to assess its

safety in paediatric patients. No unusual adverse events were noted in these patients.

Approximately 13% of these paediatric patients required additional injections of anaesthetic

for complete anaesthesia.

In the clinical trials 54 patients between the ages of 65 and 75 years, and 11 patients 75

years and over received articaine hydrochloride 4% with adrenaline (epinephrine) 1:100,000

injection. Among all patients between 65 and 75 years, doses from 0.43 mg/kg to 4.76 mg/kg

(0.9 to 11.9 mL) were administered safely to 35 patients for simple procedures and doses

from 1.05 mg/kg to 4.27 mg/kg (1.3 to 6.8 mL) were administered safely to 19 patients for

complex procedures. Among the 11 patients ≥ 75 years old, doses from 0.78 mg/kg to 4.76

mg/kg (1.3 to 11.9 mL) were administered safely to 7 patients for simple procedures and

doses of 1.12 mg/kg to 2.17 mg/kg (1.3 to 5.1 mL) were administered to 4 patients for

complex procedures.

5.2 Pharmacokinetic properties

Absorption

Following dental injection by the submucosal route of a 4% articaine solution containing

1:200,000 adrenaline (epinephrine), articaine reaches peak blood concentration about 25

minutes after a single dose injection and 48 minutes after three doses. Peak plasma levels

of articaine achieved after 68 minutes and 204 mg doses are 385 and 900 ng/mL,

respectively.

Distribution

Approximately 60 to 80% of articaine hydrochloride is bound to human serum albumin and

globulins at 37˚C in vitro.

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Metabolism

Articaine hydrochloride is rapidly metabolized by plasma carboxyesterase to its primary

metabolite, articainic acid which is inactive. Articainic acid concentration reaches its peak

about 30 to 60 minutes following the peak in articaine concentration. In vitro studies show

that the human liver microsome P450

isoenzyme system metabolises approximately 5% to

10% of the available articaine with nearly quantitative conversion to articainic acid.

Excretion

The elimination half-life of articaine is about 1.8 hours and that of articainic acid is about 1.5

hours. Articaine is excreted primarily through urine with 53 - 57% of the administered dose

eliminated in the first 24 hours following submucosal administration. Articainic acid is the

primary metabolite in urine. A minor metabolite, articainic acid glucuronide, is also excreted

in urine. Articaine constitutes only 2% of the total dose in excreted urine.

Special Populations

Effect of Age: No pharmacokinetic data is available in the following populations: elderly,

children.

Race: No pharmacokinetic data is available for different racial groups.

Renal and Hepatic Insufficiency: No pharmacokinetic data is available for patients with

hepatic or renal impairment.

5.3 Preclinical safety data

Genotoxicity

Articaine was negative in bacterial and mammalian assays for gene mutation and a

chromosomal aberration test in Chinese hamster ovary cells. In vivo clastogenicity (mouse

micronucleous) assays with articaine alone and with adrenaline (epinephrine) were negative

at a low subcutaneous dose (same as the maximal recommended clinical dose on a mg/m

basis).

Carcinogenicity

Studies to evaluate the carcinogenic potential of articaine hydrochloride in animals have not

been conducted.

6

PHARMACEUTICAL PARTICULARS

6.1 List of excipients

4% Articadent DENTAL with Adrenaline (epinephrine) 1:100,000 injection contains the

excipients sodium chloride, sodium metabisulfite, water for injection. Hydrochloric acid

and/or sodium hydroxide may be present and are used to adjust the pH of the solution

during manufacture.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this

medicine.

6.3 Shelf Life

24 months

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6.4 Special precautions for storage

Store below 25˚C. Protect from light. Do not freeze.

6.5 Nature and contents of container <and special equipment for

use, administration or implantation>

Each carton consists of 50 x 2.2 mL Type I glass cartridges.

6.6 Special precautions for disposal <and other handling>

Any unused medicine or waste material should be disposed of in accordance with local

requirements.

7

MEDICINE SCHEDULE

Prescription Medicine

8

SPONSOR

Dentsply Sirona (N.Z.) Limited

c/o- Lowndes Jordan

Level 15, PWC Tower

188 Quay Street

Auckland 1010

New Zealand

Telephone: 0800 33 68 77

www.dentsplysirona.co.nz

9

DATE OF FIRST APPROVAL

27 October 2016

10 DATE OF REVISION OF THE TEXT

18 December 2018

Articadent is a registered trademark of DENTSPLY International Inc.

SUMMARY TABLE OF CHANGES

Section changed

Summary of new information

All sections

Updated Data Sheet format according to the new

requirements

Updated expression of the Drug Product and Drug

Substance to ensure consistency of the ingredient name

with the International Nonproprietary Name for therapeutic

substances

Section 8

Updated sponsor information

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