Consumer medicine information

3% Citanest Dental with Octapressin

Prilocaine hydrochloride; Felypressin

BRAND INFORMATION

Brand name

3% Citanest Dental with Octapressin

Active ingredient

Prilocaine hydrochloride; Felypressin

Schedule

What is in this leaflet

This leaflet answers some common questions about Citanest DENTAL with Octapressin.

It does not contain all the available information. It does not take the place of talking to your dental practitioner or dental nurse.

All medicines have risks and benefits. Your dental practitioner has weighed the risks of you using this medicine against the benefits they expect it will 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 Citanest DENTAL with Octapressin is used for

Citanest DENTAL with Octapressin is used to prevent or relieve pain during dental procedures, but it will not put you to sleep. This medicine belongs to a group of medicines called local anaesthetics.

It is injected into the gums and works by making the nerves unable to pass pain messages to the brain.

Depending on the amount used, it will either totally stop pain or will cause a partial loss of feeling.

The felypressin makes the blood vessels at the site of injection narrower, which means you bleed less. It is then easier for your dental practitioner to see what is happening.

Ask your dental practitioner if you have any questions about why this medicine has been prescribed for you.

This medicine is not addictive.

Before you are given Citanest DENTAL with Octapressin

When you must not be given it

Do not take Citanest DENTAL with Octapressin if you have an allergy to:

any medicine containing prilocaine
any of the ingredients listed at the end of this leaflet
any other similar medicines, such as other local anaesthetics e.g. Xylocaine.

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.

Do not take Citanest DENTAL with Octapressin if you have any of these medical conditions:

a problem with abnormal blood pigment levels (methaemoglobinaemia).

It may not be safe for you to be given this medicine if you have any of these conditions.

This medicine will only be used if the solution is clear, the package is undamaged and the use by (expiry) date printed on the pack has not been passed.

Before you are given it

Tell your dental practitioner if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your dental practitioner if you have or have had any of the following medical conditions:

problems with your heart beat rhythm or a very slow heart beat
anaemia (a decreased number of red blood cells)
diabetes
nerve problems
liver problems
kidney problems
heart problems
malignant hyperthermia.

Tell your 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.

This medicine has been widely used for dental procedures during pregnancy with no reports of ill effects to the mother or baby.

This medicine may enter breast milk, but in such small amounts that there is generally no risk of affecting the baby.

If you have not told your dental practitioner about any of the above, tell him/her before you are given Citanest DENTAL with Octapressin.

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 Citanest DENTAL with Octapressin may interfere with each other. These include:

medicines used to maintain the normal rhythm of your heart, such as mexilitene
a type of antibiotic medicine, known as sulphonamides, such as sulfamethoxozole
medicines used to treat malaria, such as quinine
medicines called nitric compounds such as nitroglycerin which is used to treat angina.

These medicines may be affected by Citanest DENTAL with Octapressin 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 Citanest DENTAL with Octapressin is given

Follow all directions given to you by your dental practitioner carefully. They may differ from the information contained in this leaflet.

How much you are given

The dosage you will be given will depend on your body size, age and the type of dental work you will be having done.

Your dental practitioner will choose the best dose for you. They will be willing to discuss this decision with you.

How it is given

Citanest DENTAL with Octapressin will be injected by your dental practitioner into your gum near a single nerve, or into an area which contains a large number of nerves.

This will result in an area of numbness at the site or near the site of injection.

Citanest DENTAL with Octapressin should not be injected directly into the blood.

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, if you are particularly sensitive to it, or the dose is accidentally injected directly into your blood, you may develop problems for a short time.

Symptoms of an overdose may include:

a numb feeling in or around the mouth
feeling dizzy or stiff
muscle twitching.

Whenever you are given the medicine, equipment will be available to care for you if an overdose happens.

While you are being given Citanest DENTAL with Octapressin

Things you must not do

Do not eat or drink anything until the feeling has completely 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 Citanest DENTAL with Octapressin affects you. This medicine may cause dizziness, nervousness, drowsiness, blurred vision or feeling strange/disoriented in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

Side effects

Tell your dental practitioner as soon as possible if you do not feel well while you are being given Citanest DENTAL with Octapressin. This medicine helps most people have pain-free visits to the dental practitioner but it may have unwanted side effects in a few people, although these are rare. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

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 you notice any of the following and they worry you:

nervousness
dizziness
blurred vision
drowsiness
ringing in the ears
numbness
feeling strange (disoriented)
nausea
vomiting
shakes (tremor)
headache.

The above list includes side effects that are usually mild and short lived.

If Citanest DENTAL with Octapressin is given wrongly or you are very sensitive to it, any of the following may happen. Tell your dental practitioner immediately or go to Accident and Emergency at your nearest hospital:

fits
unconsciousness
breathing problems
dizziness
slow heart beat
collapse.

The above list includes very serious side effects. If you have them, you may have had a serious (allergic) reaction to the medicine. You may need urgent medical attention or hospitalisation.

Tell your dental practitioner if you notice anything that is making you feel unwell. Other side effects not listed above may also occur in some people.

After using Citanest DENTAL with Octapressin

Storage

Citanest DENTAL with Octapressin will be stored by your dental practitioner under the recommended conditions.

It should be kept in a cool dry place where the temperature stays below 25°C. Protect from light.

Disposal

Any medicine from a single dose which is not used will be disposed of in a safe manner by your dental practitioner.

Product Description

What it looks like

Citanest DENTAL with Octapressin is a clear, colourless solutions in 2.2 mL and 1.8 mL dental cartridges. Each cartridge is distinctly colour banded for ease of identification with green and gold.

Ingredients

Citanest DENTAL with Octapressin contains 30 mg/mL of prilocaine hydrochloride and 0.54 µg/mL of felypressin as the active ingredients. It also contains:

Sodium chloride
Sodium hydroxide and/or
Hydrochloric acid
Water for Injections.

This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Supplier/Sponsor

Citanest DENTAL with Octapressin is supplied in Australia by:

Dentsply Sirona Pty Ltd
11-21 Gilby Rd
Mount Waverley
Victoria, 3149 Australia

Tel: 1300 55 29 29

Citanest DENTAL with Octapressin is supplied in New Zealand by:

Dentsply Sirona (N.Z.) Limited
c/o- Lowndes Jordan
Level 15, PWC Tower
188 Quay Street
Auckland 1010
New Zealand

Tel: 0800 33 68 77

This leaflet was prepared on 14 December 2018.

Australian Register numbers:

3% Citanest® DENTAL with Octapressin® 2.2 mL injection cartridge

AUST R 220320

3% Citanest® DENTAL with Octapressin® 1.8 mL injection cartridge

AUST R 220319

® Trademarks herein are the property of the AstraZeneca group.

Published by MIMS February 2019

BRAND INFORMATION

Brand name

3% Citanest Dental with Octapressin

Active ingredient

Prilocaine hydrochloride; Felypressin

Schedule

1 Name of Medicine

Prilocaine hydrochloride.
Felypressin.

2 Qualitative and Quantitative Composition

3% Citanest Dental with Octapressin is a clear, colourless sterile aqueous solution contains 30 mg/mL prilocaine hydrochloride and 0.54 micrograms/mL felypressin.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

3% Citanest Dental with Octapressin injection solution in a standard and self-aspirating glass cartridge.
The finished product is a clear and colourless solution packed in a carton containing either 50 or 100 units of 1.8 mL and 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

3% Citanest Dental with Octapressin is indicated for the production of local anaesthesia in routine dental procedures and oral surgery by means of infiltration and nerve block techniques.

4.2 Dose and Method of Administration

The lowest dosage that results in effective anaesthesia should be used. The dosage will also depend on the area of the oral cavity to be anaesthetised, the vascularity of the oral tissues and the technique of anaesthesia. See Table 1.

Note.

1. Recommended doses.

Toxic doses vary widely between patients and toxic effects may occur after any local anaesthetic procedure. Careful observation of the patient must therefore be maintained. It is recommended that the dose of prilocaine at any one time should not exceed 9 mg/kg. However, the dose administered must be tailored to the individual patient and procedure, and the maximum doses here quoted should be used as a guide only.

2. Safe dose.

The safe dose for people with acute or chronic disease, especially those on medications, may be substantially less.

4.3 Contraindications

1) Allergy or hypersensitivity to amide type local anaesthetics or other components of the injection solution which may be present (see Section 6.5 Nature and Contents of Container, Note). Detection of suspected sensitivity by skin testing is of limited value.
2) Congenital or idiopathic methaemoglobinaemia.
3) Local anaesthetic techniques must not be used when there is inflammation and/or sepsis in the region of the proposed injection.
See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

4.4 Special Warnings and Precautions for Use

1) When any local anaesthetic agent is used, resuscitative equipment and medicines, including oxygen, should be immediately available in order to manage possible adverse effects involving the cardiovascular, respiratory or central nervous systems.
2) Injection should always be made slowly with frequent aspirations to avoid inadvertent intravascular injection which can produce toxic effects. Multiple injections should be administered at spaced intervals.
3) The safety and effectiveness of 3% Citanest Dental with Octapressin depends on proper dosage, correct technique, adequate precautions and readiness for emergencies. Standard textbooks should be consulted for specific techniques and precautions regarding various anaesthetic procedures.
4) Prilocaine should be given with great caution to patients with severe bradycardia, cardiac conduction disturbances or severe digitalis intoxication.
5) Prilocaine and/or its metabolites may accumulate during prolonged or repeated administration in patients with hepatic, renal or cardiac disease, the elderly and patients in poor general condition. However, this is unlikely to occur at the doses normally used in dentistry.
6) Prilocaine should be used with caution in patients with known medicine sensitivities. Patients allergic to ester derivatives of para-aminobenzoic acid (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to agents of the amide type.
7) Prilocaine should be used with caution in patients with genetic predisposition to malignant hyperthermia as the safety of amide local anaesthetic agents in these patients has not been fully established.
8) In patients with hypoxaemia there is the potential for further hypoxic embarrassment as large doses of prilocaine may produce methaemoglobinaemia (see Section 4.8 Adverse Effects (Undesirable Effects)).
9) Although largely free of side effects as an additive to prilocaine, felypressin may cause a rise in blood pressure or coronary constriction if an overdose is given.
10) The patient should be advised to exert caution to avoid inadvertent trauma to the lips, tongue, cheek mucosa or soft palate when these structures are anaesthetised. The ingestion of food should therefore be postponed until normal function returns.
11) In the head and neck area the intravascular injection of even small doses of local anaesthetics may cause systemic adverse effects similar to those seen after the inadvertent intravascular injection of larger doses in other areas.
12) Local anaesthetics should be administered with caution to patients with severe or untreated hypertension, severe heart disease, advanced diabetes, severe anaemia or circulatory failure from whatever cause or any other pathological condition. Local anaesthetics should be avoided when there is inflammation in the region of the proposed injection.

Use in the elderly.

Even if the dose of 3% Citanest Dental with Octapressin used in dental practice is generally small, the elderly may require special attention to reduce the risk of dangerous side effect.

Paediatric use.

For children, the dose may have to be reduced commensurate with bodyweight. The dosage should be calculated for each patient individually and modified in accordance with the dentist's experience and knowledge of the patient.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

1. Antiarrhythmic medicines.

Local anaesthetics of the amide type should be used with caution in patients receiving anti arrhythmic medicines, e.g. mexiletine, since the toxic effects may be additive.

2. Methaemoglobinaemia.

Medicines which may predispose to methaemoglobin formation, e.g. sulfonamides, antimalarials and certain nitric compounds, could potentiate this adverse effect of prilocaine.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category A)
Category A: Medicines which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the foetus having been observed.
Although the safe use of prilocaine during pregnancy has not been established with respect to possible adverse effects upon foetal development, prilocaine has been used extensively for dental procedures during pregnancy with no reports of ill effects to mother or foetus. In large doses prilocaine may cause maternal and foetal methaemoglobinaemia which could lead to foetal hypoxia.
Prilocaine may enter the mother's milk, but in such small amounts that there is generally no risk of this affecting the neonate. It is not known whether felypressin is excreted in breast milk.

4.7 Effects on Ability to Drive and Use Machines

Depending on the dose, local anaesthetics may have a very mild effect on mental function and may temporarily impair locomotion and coordination.

4.8 Adverse Effects (Undesirable Effects)

Reactions to prilocaine are rare in the doses used in dental procedures. If adverse effects occur, they are similar in character to those observed with other local anaesthetics of the amide type. Psychogenic reactions in anticipation of or during the dental procedures are, however, common and may mimic the symptoms of generalised systemic reaction to local anaesthetics.
Adverse effects may be due to high plasma levels as a result of excessive dosage, rapid absorption, delayed elimination or metabolism, or inadvertent intravascular injection. Such reactions are systemic in nature and involve the central nervous system and/or the cardiovascular system (see Section 4.9 Overdose). Pronounced acidosis or hypoxia may increase the risk and severity of toxic reactions.
The following adverse effects are rare when associated with dental use of prilocaine.
Nervousness, dizziness, blurred vision, tremor, drowsiness, tinnitus, numbness, disorientation, nausea, vomiting, headache, palpitations and tachycardia.
More serious reactions that reflect an overdosage of prilocaine are convulsions, unconsciousness, respiratory depression or arrest, hypotension, cardiovascular collapse and bradycardia which may lead to cardiac arrest.
Regarding methaemoglobinaemia, see below.

Allergy.

Allergy to amide type local anaesthetics is very rare but may present as allergic dermatitis, bronchospasm or anaphylaxis.

Methaemoglobinaemia.

Methaemoglobinaemia and cyanosis may occur following the administration of prilocaine solutions, particularly following a high dose. This is caused by the metabolite o-toluidine. Cyanosis of the nails and lips are clinical signs of methaemoglobinaemia.
In the dental dosage of prilocaine (1-5 mL 3% Citanest Dental with Octapressin, i.e. 30-150 mg prilocaine hydrochloride 3% with felypressin 0.03 IU/mL (0.54-2.7 microgram/mL) the occurrence of methaemoglobinaemia in dental practice appears remote. However, gross overdosage in dental practice has been reported to cause methaemoglobinaemia.
A dose response relationship appears to exist between the amount of prilocaine administered and the degree of methaemoglobin formation. In studies conducted in man, the incidence of methaemoglobinaemia at a dose of 400 mg prilocaine is not statistically significant. Cases of cyanosis at doses between 400 mg and 600 mg prilocaine are extremely rare.
At a dose of 600 mg prilocaine, methaemoglobin forms at levels less than 15% of the total haemoglobin content. This degree of methaemoglobinaemia is not associated with any adverse respiratory, cardiovascular or CNS symptoms. However, cyanosis has been reported at this dosage level.
If methaemoglobinaemia does occur, it may be treated by a single intravenous injection of a 1% methylene blue solution, given at a dose of 1 mg/kg bodyweight over a 5 minute period. This dose normally reverses methaemoglobinaemia within 15 minutes and should not be repeated as methylene blue in high concentrations acts as a haemoglobin oxidant.
In most patients receiving doses of 3% Citanest Dental with Octapressin within the recommended range, the appearance of clinical signs and symptoms of hypoxia may be due to cardiac or respiratory insufficiency and should be treated with oxygen and/or other appropriate measures. If cyanosis persists, methaemoglobinaemia should be suspected and methylene blue treatment initiated.
The reduction of the oxygen carrying capacity in normal patients is marginal; hence the cyanosis is usually symptomless. However, in severely anaemic patients it may cause significant hypoxaemia. It is important to rule out other more serious causes of cyanosis such as acute hypoxaemia and/or heart failure.
Even low concentrations of methaemoglobin may interfere with pulse oximetry readings, indicating a false low oxygen saturation.

Neurological reactions.

The incidence of adverse neurological reactions directly caused by the use of local anaesthetics is very low.
Neurological reactions may be related to the total dose of the local anaesthetic administered and are also dependent upon the particular medicine used, the route of administration and the physical status of the patient. Many of these effects may be related to local anaesthetic techniques, with or without contribution from the medicine.
Neurological reactions following regional nerve blocks have included persistent numbness, paraesthesia and sensory disturbances.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia) and 0800 764 766 (New Zealand).
Systemic toxicity is initially manifested as CNS excitation and may be characterised by nervousness, dizziness, blurred vision and tremors followed by drowsiness, convulsions, unconsciousness and possibly respiratory arrest.
Toxic cardiovascular reactions to local anaesthetics are usually depressant in nature, may occur rapidly and with little warning and can lead to peripheral vasodilation, hypotension, myocardial depression, bradycardia and possibly cardiac arrest.

Treatment of overdosage.

Treatment of a patient with toxic symptoms consists of ensuring a patent airway and supporting ventilation with oxygen and assisted or controlled respiration as required. This usually will be sufficient in the management of most reactions.
Further treatment depends on diagnosis. Medical assistance should be summoned.
If ventricular fibrillation or cardiac arrest occurs, effective cardiovascular resuscitation treatment must be instituted and maintained for a prolonged period if necessary.
For treatment of reactions caused by adrenaline, consult standard textbooks.
For treatment of methaemoglobinaemia, see Section 4.8 Adverse Effects (Undesirable Effects).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Prilocaine is a membrane stabilising agent and a local anaesthetic of the amide type. Prilocaine stabilises the neuronal membrane and reversibly prevents the initiation and conduction of nerve impulses thereby producing local anaesthesia.
Prilocaine has a similar time of onset and potency to lignocaine. Prilocaine has a lower toxicity than lignocaine.
The onset and duration of anaesthesia depend on the route of administration, status of the patient and the dosage (volume and concentration) employed. The addition of felypressin reduces the rate of absorption of prilocaine from the site of injection thereby increasing its duration of action.
Felypressin is a synthetic hormone with similar properties to vasopressin. In contrast to adrenaline, felypressin does not produce ischaemia distal to or at the injection site. 3% Citanest Dental with Octapressin is therefore indicated for routine use. It is particularly suitable for use in patients for whom the use of solutions containing sympathomimetic agents is contraindicated.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

3% Citanest Dental with Octapressin contains the excipients sodium chloride and water for injections and may also contain sodium hydroxide and/or hydrochloric acid for pH adjustment to 3.5-5.2.

6.2 Incompatibilities

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

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

3% Citanest Dental with Octapressin should be stored below 25°C. Protect from light.
Local anaesthetics react with certain metals and cause the release of their respective ions which, if injected, may cause severe local irritation. Adequate precautions should be taken to avoid prolonged contact between 3% Citanest Dental with Octapressin solutions and metal surfaces, e.g. cartridges should not be preloaded and connected to needles until just prior to use.
Cartridges showing discolouration or cracks should be discarded. 3% Citanest Dental with Octapressin solutions should not be autoclaved. Surface sterilisation using pure, undiluted isopropyl alcohol (91%) or 70% ethyl alcohol (USP) may be carried out if desired.

6.5 Nature and Contents of Container

See Table 2.
Not all pack sizes/presentations are being distributed.

Note.

1. All Dentsply Sirona dental cartridges are paraben free and for single use in a single patient only. Remaining unused contents should be discarded.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Prilocaine hydrochloride.

The chemical name of prilocaine hydrochloride is 2-(propylamino)-o-propionotoluidide hydrochloride; and it is also known as propitocaine hydrochloride. It has a molecular weight of 256.8.

Chemical structure.

CAS number.

1786-81-8.

Felypressin.

The chemical name of the vasoconstrictor octapressin is 2-(phenylalanine)-8-lysine vasopressin; also known as felypressin. It has a molecular weight of 1040.2.

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3% Citanest Dental with Octapressin

Prilocaine hydrochloride; Felypressin

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