Consumer medicine information

ATO Mepivacaine 3%

Mepivacaine hydrochloride

BRAND INFORMATION

Brand name

ATO Mepivacaine 3%

Active ingredient

Mepivacaine hydrochloride

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using ATO Mepivacaine 3%.

WHAT’S IN YOUR MEDICINE

ATO Mepivacaine contains a local anaesthetic, Mepivacaine hydrochloride.

ATO MEPIVACAINE 3%

Active ingredients

Cartridge 2.2 mL

Mepivacaine hydrochloride 66 mg

Other ingredients:

Sodium chloride, Sodium hydroxide solution, water for injections.

Presentation:

Box of 50 cartridges for single use, containing each 2.2 mL.

WHAT YOUR MEDICINE IS USED FOR AND HOW IT WORKS

ATO MEPIVACAINE 3% contains one active ingredient, Mepivacaine hydrochloride, a local anaesthetic to prevent the pain and is given by injection to cause loss of feeling before and during dental procedures.

ADVICE BEFORE USING THE MEDICINAL PRODUCT

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your dentist will make before treatment.

This product should not be used if any of the following apply to you:

  • You are allergic to mepivacaine, or any local anaesthetic and any other ingredient included in the product
  • You have arterial hypertension (high blood pressure), coronary disease or valvular cardiac disease (heart or circulation problems).
  • You have an over active thyroid gland, whether or not you are treated for this.
  • You have cerebral arteriosclerosis (hardening in the brain arteries).
  • You have inflammation (pain, swelling, redness and heat) or infection in the region of the proposed injection
  • Children under the age of 3 years old.

You must tell your dentist if you have the following conditions:

  • You have problems with your heart, blood vessels, circulation and heart rhythm.
  • You are taking any medicine
  • You have epilepsy.
  • You have hepatic (liver) or renal (kidney) diseases.
  • You have malignant hyperthermia (history or experience of a rapid rise in body temperature to a dangerously high level brought on by general anaesthesia.
  • You have prostatic hypertrophy (enlarged prostate).
  • You are pregnant or breast-feeding. If ATO MEPIVACAINE is used while you are breast-feeding you should not breast-feed for at least 48 hours following use of ATO MEPIVACAINE.
  • You have any other medical conditions.

ATO MEPIVACAINE MAY INTERACT WITH OTHER MEDICINES

It should be used with caution if you are taking:

  • Beta-blockers or Guanethidine (medicines used to lower high blood pressure and/or treat heart problems).
  • Hypoglycaemics (medicine used to treat high blood sugar).
  • Anti-arrhythmic drugs and amiodarone (medicines used to treat irregular heartbeats).
  • Anti-epileptic 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 ATO MEPIVACAINE, or may affect how well it works.

Please make sure that you tell your dentist about all medicines which you are taking, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Your dentist will advise you what to do if you are taking any of these medicines.

HOW THIS MEDICINE WILL BE USED

Your dentist will explain to you why you are being treated with ATO MEPIVACAINE 3% and what dose you will be administered.

Your dentist will inject ATO Mepivacaine into your oral (mouth) cavity. This will result in an area of numbness at the site of injection. One cartridge is usually sufficient but your dentist may give you a greater quantity. He will adjust the dosage according to your age, your health and the dental work to be performed. If only a portion of a cartridge is used the remainder must be discarded.

WHILE YOU ARE affected by ATO MEPIVACAINE

Things you must not do:

  • Do not eat or drink any thing hot 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 ATO Mepivacaine affects you. You may be drowsy and your reflexes may be slow.
  • Do not drink alcohol immediately before or after you are given ATO Mepivacaine.
  • If you drink alcohol while you are being given ATO Mepivacaine, your blood pressure may drop making you feel dizzy and faint.
  • Please talk to your dentist or pharmacist about these possibilities if you think they may bother you.

SIDE EFFECTS

ATO Mepivacaine like most other medicines may cause side effects in some patients.

Although not all of these side effects may occur, if they do occur they may need medical attention. While you are in your dentist’s office, your dentist will carefully follow the effects of ATO Mepivacaine.

However, some effects may not be noticed or appear later. Check with your dentist if any of the following side effects occur:

Common reactions:

  • Infection and pain in the injection site.
  • Tingling and numbness of the hands and feet or increased feeling or sensitivity of the skin.
  • You are feeling nervous, nauseous or dizzy
  • You have a headache
  • You are trembling, have buzzing in the ears, blurred vision or have any abnormal feeling
  • Your breathing is difficult
  • Your heart is beating slowly or irregularly
  • You have facial swelling or inflammation of gums
  • You have skin rash, hives or itching
  • You may have a loss of sensation and muscle function following the injection of ATO Mepivacaine. Resolution occurs generally within two weeks.

Very rare reactions:

There are some serious unwanted reactions, which may happen if ATO Mepivacaine 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.
  • Collapse.

If experiencing any of these, you may have had a serious (allergic) reaction to ATO Mepivacaine.

You may need urgent medical attention or hospitalisation.

Tell your dentist if you notice anything else that is making you feel unwell.

Some people may get other side effects while using ATO Mepivacaine.

IN CASE OF OVERDOSE

Your dentist will determine the amount of solution, which is needed to provide pain control during your treatment, and it is very unlikely that you would receive too much ATO Mepivacaine.

However, some persons tolerate mepivacaine less well than others and the signs and symptoms of too much of this substance 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.or contact the Poisons Information Centre (Australia 13 11 26, New Zealand 0800 764 766

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

STORAGE CONDITIONS

It is most unlikely that you will be asked to look after this medicine.

Your dentist will keep it below 25°C and protected from light.

He will not use this medicine after the expiry date printed on the package.

All medicines must be kept in a safe place out of the reach of children.

FURTHER INFORMATION

Only a dentist can administer this product. This leaflet provides only a summary of the information known about ATO Mepivacaine.

If you have any questions, want to know more about this medicine, or have some doubts, ask your dentist.

SPONSOR

Specialites Septodont T/A ATO Zizine, 14 Cliffbrook Crescent, EMU PLAINS, NSW 2750, Australia.

DATE OF INFORMATION

25 Aug 2008

ATO Mepivacaine 3% INJECTION

  • 50 cartridges of 2.2 mL of solution : AUST R 150494

CMI version: 4.0

Published by MIMS February 2022

BRAND INFORMATION

Brand name

ATO Mepivacaine 3%

Active ingredient

Mepivacaine hydrochloride

Schedule

S4

 

1 Name of Medicine

Mepivacaine hydrochloride.

2 Qualitative and Quantitative Composition

ATO Mepivacaine 3%.

See Table 1.
Contains no anti-microbial agent.
Mepivacaine hydrochloride is a local anaesthetic.
Contains mepivacaine hydrochloride 3% (30 mg/mL).

3 Pharmaceutical Form

ATO Mepivacaine 3% is a sterile aqueous injection, solution.

4 Clinical Particulars

4.1 Therapeutic Indications

ATO Mepivacaine 3% 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

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.
The lowest dosage that results in effective anaesthesia for the planned treatment should be used.
The dosage will depend upon the area of the oral cavity to be anaesthetised, the vascularity of the oral tissues and the technique of anaesthesia.
Toxic doses vary widely between patients and toxic effects may occur after any local anaesthetic procedure.
Careful observation of the patient must be maintained after administration of the local anaesthetic.
The product is injected either locally or in the vicinity of a dental nervous trunk.
The safe dose for people with acute or chronic disease may be substantially less than that for healthy individuals.

Adults.

A single cartridge (2.2 mL) is generally sufficient. Do not exceed three cartridges (6.6 mL).

Adolescents between 14 and 17 years.

The usual dosage is one cartridge (2.2 mL). Do not exceed 2 cartridges (4.4 mL) in general cases.

Children between 6 and 14 years.

The usual dose is 1.35 mL. Do not exceed 2.7 mL in usual cases.

Children between 3 and 6 years.

Do not exceed the maximum recommended dose of 1.8 mL.
Do not use on children under three years of age.

4.3 Contraindications

These include:
a) contraindications to mepivacaine (ATO Mepivacaine 3%): specific allergies to mepivacaine or to other anaesthetics of amide type, allergies of cross type procaine - mepivacaine.
b) injection by intravenous route is strictly contra-indicated;
c) inflammation or sepsis in the region of the proposed injection;
d) hypersensitivity to any other component of ATO Mepivacaine 3%;
e) patients receiving monoamine oxidase inhibitors (or who have received such an agent within two weeks) or tricyclic antidepressants;
f) patients in whom there is a possibility that general anaesthesia might be required to complete the procedure.
Do not use on children under three years of age.

4.4 Special Warnings and Precautions for Use

Warnings.

When any local anaesthetic agent is used, resuscitative equipment and 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 IV 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 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.
Intra-vascular injection is strictly contra-indicated. An accidental injection into a blood vessel may be associated with systemic adverse effects due to the circulating levels of adrenaline and mepivacaine. Therefore, it is imperative to ensure that the needle being used for the injection does not go into a vessel.
Since amide-type local anaesthetics are also metabolised by the liver and excreted via kidneys, ATO Mepivacaine 3% should be used with caution in patients with hepatic or renal disease. Patients with severe hepatic disease or renal impairment, because of their inability to metabolise or excrete local anaesthetics normally, are at greater risk of developing toxic plasma concentration.
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.

Use with caution in the following circumstances.

Local anaesthetic procedures should be used with caution when there is inflammation and/or sepsis in the region of proposed injection.
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. However, this is unlikely to occur at the doses normally used in dentistry. 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.
Mepivacaine should be used with caution in patients with epilepsy, bradycardia, digitalis intoxication, severe shock or heart block. Mepivacaine should also be used with caution in patients with impaired cardiovascular function as they may be less able to compensate for functional changes associated with prolongation of AV conduction produced by the drug. In patients with Stoke-Adams syndrome or Wolff-Parkinson-White syndrome care should be taken to avoid accidental arterio-venous injection.
The patient should be advised to exert caution to avoid inadvertent trauma to the lips, tongue, check mucosa or soft palate when these structures are anaesthetised. Eating and drinking hot liquids should therefore be postponed until normal function returns.

Precautions due to the presence of mepivacaine.

Inadvertent intravascular injection of small doses of mepivacaine injected into the head or neck area, including retrobulbar, dental and stellate injection blocks, may produce adverse effects similar to systemic toxicity seen with unintentional intravascular injection of larger doses.
Mepivacaine should be used with caution in patients with hepatic or renal disease, since amide-type local anaesthetics are metabolised by the liver and excreted via kidneys. Patients with hepatic or renal impairment, because of their inability to metabolise or excrete local anaesthetics normally, are at greater risk of developing toxic plasma concentrations.
Mepivacaine should be used with caution in persons with known drug sensitivities. Patients allergic to para-aminobenzoic acid derivatives (procaine, benzocaine, etc.) have not shown cross sensitivity to mepivacaine.
The safety and effectiveness of mepivacaine depend on the proper dosage, correct technique and adequate precautions. Standard textbooks should be consulted regarding specific techniques and precautions for various anaesthetic procedures.

Use in hepatic impairment.

Since amide-type local anaesthetics are also metabolised by the liver, ATO Mepivacaine 3% should be used with caution in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolise or excrete local anaesthetics normally, are at greater risk of developing toxic plasma concentration.

Use in renal impairment.

Since amide-type local anaesthetics are also excreted via kidneys, ATO Mepivacaine 3% should be used with caution in patients with renal disease. Patients with severe renal impairment, because of their inability to metabolise or excrete local anaesthetics normally, are at greater risk of developing toxic plasma concentration.

Use in the elderly.

Elderly patients should be given reduced doses commensurate with their age and physical condition.

Paediatric use.

Do not use in children under 3 years of age. Children should be given reduced doses commensurate with their age and physical condition (see Section 4.3 Contraindications; Section 4.2 Dose and Method of Administration).

Effects on laboratory tests.

The intramuscular injection of mepivacaine may result in an increase in creatine phosphokinase levels. Thus, the use of this enzyme determination without isoenzyme separation, as a diagnostic test for the presence of acute myocardial infarction may be compromised by the intramuscular injection of mepivacaine.

4.5 Interactions with Other Medicines and Other Forms of Interactions

ATO Mepivacaine 3% should be administered with caution to patients under the following treatments:

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

Mepivacaine may increase their effects.

Skeletal muscle relaxant (suxamethonium).

Combination with mepivacaine may lead to excessive neuro-muscular block.

Cimetidine.

Increased serum levels of mepivacaine have been reported after concurrent cimetidine and mepivacaine administration.

Amiodarone.

Combination with mepivacaine may reduce the clearance of mepivacaine and seizures, sinus bradycardia and a long sinoatrial arrest have been reported. Patients receiving the combination should be carefully monitored.
Phenytoin and other antiepileptic drugs such as phenobarbitone, primidone and carbamazepine appear to enhance the metabolism of mepivacaine but the significance of this is not known. Phenytoin and mepivacaine have additive cardiac depressant effects.

Structurally related local anaesthetics.

Mepivacaine should be used with caution in patients receiving agents structurally related to local anaesthetics.

Beta-adrenoreceptor antagonists.

Propranolol and metoprolol reduce the metabolism of intravenous mepivacaine. It is possible that this effect may also occur with other beta-adrenoceptor antagonists. If these drugs are used concurrently then the patient should be closely observed for the signs of mepivacaine toxicity.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

See Section 5.3 Preclinical Safety Data.
(Category A)
Drugs 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.
The safe use of mepivacaine during pregnancy has not been established. Mepivacaine has however been used extensively for dental procedure during pregnancy with no proven increase in frequency of malformations or of harmful effects to mother or foetus.
 It is not known whether mepivacaine or its metabolites appear in breast milk. Therefore, the use of ATO Mepivacaine 3% is not recommended during lactation.

4.7 Effects on Ability to Drive and Use Machines

Depending on the dosage, or, if given inadvertently intravenously, local anaesthetics may have a mild effect on mental function and may temporarily impair locomotion and coordination.

4.8 Adverse Effects (Undesirable Effects)

Common reactions (≥ 1% and < 10%).

Excluding postprocedural dental pain, local reactions at the injection site are the most common adverse events: infection, gingivitis, pain and oedema. Headache, paresthesia and hyperaesthesia are also reported after use of anaesthetic injections during dental procedures.

Uncommon (≥ 0.1% and < 1%).

Serious adverse experiences following the administration of mepivacaine 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 lightheadedness, 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.
Drowsiness following the administration of mepivacaine is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption.

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 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, when appropriate, a vasopressor (e.g. ephedrine) as directed by the clinical situation.

Allergic reactions.

Allergic reactions are characterised by cutaneous lesions, urticaria, oedema or anaphylactoid reactions. Allergic reactions as a result of sensitivity to mepivacaine are extremely rare and, if they occur, should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value.
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

Most systemic reactions to local anaesthetics are from overdose and in dentistry would most frequently be caused by accidental intravascular injection (for symptoms, see Section 4.8 Adverse Effects (Undesirable Effects)).
If unusual reactions develop resuscitative and/or supportive measures should be started promptly.

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, 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.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Mepivacaine is a local anaesthetic of the amide type. It stabilises the neuronal membrane by decreasing its permeability to sodium ions and reversibly blocks the initiation and conduction of nerve impulses thereby producing local anaesthesia.
The onset - considered as rapid - and duration of anaesthesia (2 to 3 hours) depend on the route of administration and the dosage (volume and concentration) employed.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Information derived from diverse formulations, concentrations and usages reveals that mepivacaine is completely absorbed following parenteral administration. Its rate of absorption depends for example, upon various factors such as the site of administration and the presence or absence of a vasoconstrictor agent.
Except for intravascular administration, the highest blood levels are obtained following intercostal nerve block and the lowest after subcutaneous administration.

Distribution.

Mepivacaine is highly bound to plasma protein. The plasma half-life has been reported to be about 2 to 3 hours in the adult. Mepivacaine crosses the blood-brain and placental barriers, presumably by passive diffusion.
The degree of plasma protein binding in the foetus is less than that of the mother. The free mepivacaine concentration will be the same. Consequently, the total plasma concentration in the foetus will be greater than in the mother.

Metabolism.

Mepivacaine is rapidly metabolised by the liver.

Excretion.

Less than 10% of a dose of mepivacaine is reported to be excreted unchanged in the urine.
Several metabolites are also excreted via kidneys, including glucuronide conjugates of hydroxy compounds and an N-demethylated compound, 2',6'-pipecoloxylidide.
Over 50% of a dose of mepivacaine is excreted as metabolites into the bile but these probably undergo enterohepatic circulation as only small amounts are excreted in the faeces.

5.3 Preclinical Safety Data

Genotoxicity.

Studies of mepivacaine in animals to evaluate the mutagenic potential or the effect on fertility have not been conducted.

Carcinogenicity.

Studies of mepivacaine in animals to evaluate the carcinogenic potential or the effect on fertility have not been conducted.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition.

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

Store below 25°C.
Protect from light.

6.5 Nature and Contents of Container

Box containing 5 blister trays of 10 x 2.2 mL (glass cartridge) with rubber closure, AUST R 150494.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

Mepivacaine hydrochloride.

Chemical name: (1-Methyl-2-piperidyl)formo-2',6'-xylidide hydrochloride.
Chemical formula: C15H22N2O,HCl.
Molecular Weight: 282.81.

CAS number.

Mepivacaine hydrochloride: 1722-62-9.
Mepivacaine hydrochloride is a white crystalline powder, freely soluble in water and in alcohol, very slightly soluble in dichloromethane. It is a racemic mixture.

7 Medicine Schedule (Poisons Standard)

S4, Prescription Only Medicine.

Summary Table of Changes