SCANDINIBSA

The drug may only be used by or under the supervision of dentists, stomatologists or other clinicians adequately trained and familiar with the diagnosis and treatment of systemic toxicities.

The presence of resuscitation equipment and medications as well as that of qualified personnel must be confirmed before performing local anesthesia to ensure immediate management of any respiratory or cardiovascular emergency.

The patient's state of consciousness should be monitored after each injection of local anesthesia.

As the absence of pain depends on the sensitivity of each patient, the lowest effective dose of anesthetic should be used.

During a more extensive procedure, one or more cartridges may be necessary, without exceeding the maximum recommended dose.

In adults, the maximum recommended dose is 4.4 mg per kg of body weight, with the maximum recommended dose being 300 mg in patients weighing more than 70 kg, equivalent to 10 mL of solution.

Please note: the maximum quantity must take into account the patient's body weight.

As each patient has a different weight, the maximum tolerated dose of mepivacaine will be different in each patient.

Additionally, there are individual variations in the onset and duration of the action.

The table below indicates the maximum doses authorized in adults in the most common anesthesia techniques as well as their equivalent in number of cartridges: Body weight (kg) Mepivacaine hydrochloride dose (mg) Volume (mL) Equivalent number of cartridges (1.7 mL) Equivalent number of cartridges (2.2 mL) 50 220 7.3 4.0 3.0 60 264 8.8 5.0 4.0 ≥70 300 10.0 5.5 4.5 SCANDONEST 30 mg/mL, solution for injection for dental use should not be used in children under 4 years of age (i.e. under 20 kg) .

Recommended therapeutic dose

The quantity injected depends on the age, weight of the child and the type of intervention to be performed.

The average dose to be expected is 0.75 mg/kg = 0.025 mL of mepivacaine solution per kilogram of body weight: ~ ¼ cartridge (15 mg of mepivacaine hydrochloride) in a child weighing 20 kg. Maximum recommended dose: The maximum recommended dose in the pediatric population is 3 mg mepivacaine/kg (0.1 mL mepivacaine/kg).

The table below indicates the maximum doses authorized for children as well as their equivalent in number of cartridges: Body weight (kg) Mepivacaine hydrochloride dose (mg) Volume (mL) Equivalent number of cartridges (1.7 mL) Equivalent number of cartridges (2.2 mL) 20 60 2 1.2 0.9 35 105 3.5 2.0 1.5 45 135 4.5 2.5 2.0 In the absence of clinical data, special precautions must be taken to administer the smallest doses that provide effective anesthesia in: the elderly people with renal or hepatic insufficiency.

Mepivacaine is metabolized in the liver and there may be elevated plasma levels in patients with hepatic disorders, especially with repeated use.

If it is necessary to reinject, the patient should be monitored for any signs of relative overdose.

Concomitant use of sedatives to reduce patient anxiety: If a sedative is administered, the maximum tolerated dose of mepivacaine should be reduced due to the additive effect of this combination on central nervous system depression.

Infiltration and perineural route.

Precautions to take before handling or administering the drug This product should not be used if it is cloudy or colored.

The injection rate should not exceed 1 mL of solution per minute Local anesthetics should be injected with caution when there are signs of inflammation and/or infection at the injection site.

The injection speed should be very slow (1 mL/min).

Accidental intravascular injection (i.e. inadvertent intravenous injection into the systemic circulation, intra-arterial or inadvertent intravenous injection in the head or neck region) may be associated with certain severe adverse reactions such as convulsions followed by depression of the central nervous system as well as of the cardiorespiratory system and coma, up to respiratory arrest, resulting from a sudden and elevated rise in blood chloride levels. mepivacaine into the systemic circulation.

Therefore, to ensure that the needle does not enter a blood vessel during the injection, aspiration must be performed before injecting the year.

mg/mL, injectable solution for dental use, is indicated in local or loco-regional anesthesia in odonto-stomatological practice in adults, adolescents and children over 4 years old (i.e. weighing more than 20 kg).

Mepivacaine stabilizes the neuronal membrane and prevents the initiation and transmission of nerve impulses, thereby effecting local anesthesia.

Mepivacaine is rapidly metabolized, with only a small percentage of the anesthetic (5 to 10 percent) being excreted unchanged in the urine.

Mepivacaine because of its amide structure, is not detoxified by the circulating plasma esterases.

The liver is the principal site of metabolism, with over 50 percent of the administered dose being excreted into the bile as metabolites.

Most of the metabolized

Mepivacaine is probably resorbed in the intestine and then excreted into the urine since only a small percentage is found in the feces.

The principal route of excretion is via the kidney.

Most of the anesthetic and its metabolites are eliminated within 30 hours.

It has been shown that hydroxylation and N-demethylation, which are detoxification reactions, play important roles in the metabolism of the anesthetic.

Three metabolites of

Mepivacaine have been identified from adult humans: two phenols, which are excreted almost exclusively as their glucuronide conjugates, and the N-demethylated compound (2’, 6’ - pipecoloxylidide).

The onset of action is rapid (30 to 120 seconds in the upper jaw; 1 to 4 minutes in the lower jaw) and Mepivacaine HCl 3% (30 mg/mL) will ordinarily provide operating anesthesia of 20 minutes in the upper jaw and 40 minutes in the lower jaw.

HCl 2% (20 mg/mL) with Levonordefrin 1:20,000 provides anesthesia of longer duration for more prolonged procedures, 1 hour to 2.5 hours in the upper jaw and 2.5 hours to 5.5 hours in the lower jaw.

Mepivacaine does not ordinarily produce irritation or tissue damage.

Levonordefrin is a sympathomimetic amine used as a vasoconstrictor in local anesthetic solutions.

It has pharmacologic activity similar to that of Epinephrine but it is more stable than Epinephrine.

In equal concentrations, Levonordefrin is less potent than Epinephrine in raising blood pressure, and as a vasoconstrictor.

Pharmacotherapeutic group

Nervous System / Anesthetics / Local anesthetics / Amides / Mepivacaine, ATC code: N01BB03.

Mepivacaine is an amide local anesthetic.

Mepivacaine reversibly inhibits nerve conduction by reducing or blocking sodium (Na+) flow during nerve action potential propagation.

As anesthesia settles along the nerve, the threshold of electrical excitability gradually increases, the elevation of the action potential and the propagation of the nerve impulse decrease.

Mepivacaine has a short onset of action, high anesthetic potency and low toxicity.

Mepivacaine shows mild vasoconstrictor properties leading to a longer duration of action than other local anesthetics administered without vasoconstrictors.

These vasoconstrictor properties have been demonstrated by several studies.

They would be beneficial when the injection of a vasoconstrictor is contraindicated.

Several factors such as tissue pH, pKa, lipid solubility, concentration of the local anesthetic, nerve diffusion of the local anesthetic, etc., can influence the occurrence and duration of local anesthesia.

In cases of dental peripheral nerve block, the effect of mepivacaine sets in quickly (usually within 3-5 minutes).

Pulp anesthesia generally lasts 25 minutes after maxillary infiltration and approximately 40 minutes after a lower alveolar block while soft tissue anesthesia will be maintained until 90 minutes after maxillary infiltration and approximately 165 minutes after a lower alveolar block.

Bioavailability is 100% at the site of action.

following administration of SCANDONEST 30 mg/mL are similar to those observed with other amide local anesthetics.

These adverse effects are mainly dose dependent and result from high plasma levels following overdose, rapid absorption or accidental intravascular injection.

They can also occur in cases of hypersensitivity, idiosyncrasy or reduced tolerance.

Severe adverse effects are usually systemic.

Reported adverse reactions come from spontaneous reports and publications.

The frequency classification follows this convention

Very common (≥1/10), Common (≥1/100 - <1/10), Uncommon (≥1/1,000 - <1/100), Rare (≥1/10,000 - <1/1,000) and Very rare (<1/10,000), “Not known (frequency cannot be estimated from the available data). »

In the presence of these signs, patients should be asked to hyperventilate and rigorous monitoring should be instituted 4 Certain neurological disorders may occur with various symptoms of abnormal sensations (i.e., paresthesia, hypoesthesia, dysesthesia, hyperesthesia, etc). of the lips, tongue, and oral tissues.

These data come from post-MAD reports, especially following nerve blocks of the jaw, involving different branches of the trigeminal nerve 5 This occurs mostly in patients with an underlying heart condition or taking certain medications; 6 This survives.

Hypersensitivity to the active substance (or to any other amide-type local anesthetic) or to one of the excipients mentioned in section 6.1 Children under 4 years old (less than 20 kg) Severe atrioventricular conduction disorders not stabilized by a pacemaker, Uncontrolled epilepsy.

Reactions resulting in fatality have occurred on rare occasions with the use of local anesthetics, even in the absence of a history of hypersensitivity.

Fatalities may occur with use of local anesthetics in the head and neck region as the result of retrograde arterial flow to vital CNS areas even when maximum recommended doses are observed.

The practitioner should be alert to early evidence of alteration in sensorium or vital signs.

The solution which contains a vasoconstrictor (Mepivacaine HCl 2% (20 mg/mL)) should be used with extreme caution for patients whose medical history and physical evaluation suggest the existence of hypertension, arteriosclerotic heart disease, cerebral vascular insufficiency, heart block, thyrotoxicosis and diabetes, etc.

The solution which contains a vasoconstrictor (Mepivacaine HCl 2% (20 mg/mL)) also contains potassium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and lifethreatening or less severe asthmatic episodes in certain susceptible people.

The overall prevalence of sulfite sensitivity in the general population is unknown and probably low.

Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.

HCl 3% (30 mg/mL) is SULFITE FREE.

Mepivacaine, along with other local anesthetics, is capable of producing methemoglobinemia.

The clinical signs of methemoglobinemia are cyanosis of the nail beds and lips, fatigue and weakness.

If methemoglobinemia does not respond to administration of oxygen, administration of methylene blue intravenously 1-2 mg/kg body weight over a 5 minute period is recommended.

Association has made the following recommendations regarding the use of local anesthetics with vasoconstrictors in patients with ischemic heart disease: “Vasoconstrictor agents should be used in local anesthesia solutions during dental practice only when it is clear that the procedure will be shortened or the analgesia rendered more profound.

When a vasoconstrictor is indicated, extreme care should be taken to avoid intravascular injection.

The minimum possible amount of vasoconstrictor should be used.” (Kaplan, EL, editor: Cardiovascular disease in dental practice, Dallas 1986, American Heart Association). Methemoglobinemia: Cases of methemoglobinemia have been reported in association with local anesthetic use; MEPIVACAINE, along with other local anesthetics, is capable of producing this condition.

Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition.

If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended.

Signs of methemoglobinemia may occur immediately or may be delayed some hours after exposure, and are characterized by cyanosis of the skin, nail beds and lips, and/or abnormal coloration of the blood, fatigue and weakness.

Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death.

MEPIVACAINE and any other oxidizing agents.

Depending on the severity of the signs and symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydration.

If methemoglobinemia does not respond to administration of oxygen, a more severe clinical presentation may require treatment with methylene blue exchange transfusion, or hyperbaric oxygen.

Mepivacaine is contraindicated in patients with a known hypersensitivity to amide-type local anesthetics.

As with all local anesthetics, the dose varies and depends upon the area to be anesthetized, the vascularity of the tissues, individual tolerance and the technique of anesthesia.

The lowest dose needed to provide effective anesthesia should be administered.

For specific techniques and procedures refer to standard dental manuals and textbooks.

For infiltration and block injections in the upper or lower jaw, the average dose of 1 cartridge will usually suffice.

Each cartridge contains 1.7 mL (34 mg of 2% or 51 mg of 3%). 5.3 cartridges (180 mg of the 2% solution or 270 mg of the 3% solution) are usually adequate to effect anesthesia of the entire oral cavity.

Whenever a larger dose seems to be necessary for an extensive procedure, the maximum dose should be calculated according to the patient's weight.

A dose of up to 3 mg per pound of body weight may be administered.

At any single dental sitting the total dose for all injected sites should not exceed 400 mg in adults.

The maximum pediatric dose should be carefully calculated.

Maximum dose for pediatric population = Child's Weight (lbs). 150 × Maximum Recommended Dose for Adults (400 mg) The following table, approximating these calculations, may also be used as a guide.

This table is based upon a recommended maximum for larger pediatric population of 5.3 cartridges (the maximum recommended adult dose) during any single dental sitting, regardless of the pediatric patient's weight or (for 2% mepivacaine) calulated maximum amount of drug: Maximum Allowable Dosage 3% Mepivacaine 2% Mepivacaine 1:20,000 Levonordefrin 3 mg/lb 3mg/lb (270 mg max). (180 mg max). Weight (lb). mg Number of Cartridges mg Number of Cartridges 20 60 1.2 60 1.8 30 90 1.8 90 2.6 40 120 2.3 120 3.5 50 150 2.9 150 4.4 60 180 3.5 180 5.3 80 240 4.7 180 5.3 100 270 5.3 180 5.3 120 270 5.3 180 5.3 Adapted from Malamed, Stanley F. Handbook of medical emergencies in the dental office, ed. 2, St.

Louis, 1982.

When using Mepivacine HCl Injection

USP for infiltration or regional block anesthesia, injection should always be made slowly and with frequent aspiration.

Any unused portion of a cartridge should be discarded.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

HCl 3% (30 mg/mL); (Mepivacaine Hydrocholoride Injection USP) is available in cardboard boxes containing 5 blisters of 10 x 1.7 mL single-dose dental cartridges, 50 per carton.

HCl 2% (20 mg/mL) (Mepivacaine Hydrochloride and Levonordefrin Injection; USP) is available in cardboard boxes containing 5 blisters of 10 x 1.7 mL single-dose dental cartridges, 50 per carton.

Both solutions should be stored at controlled room temperature, below 25° C (77° F).

Protect from light.

Do not permit to freeze.

For protection from light, retain in box until time of use.

Once opened, the box should be reclosed by closing the top flap.

Mepivacaine 2% (20 mg/mL) solution should not be used if its color is pinkish or darker than slightly yellow or it contains a precipitate.

Cartridge warmers should not be used with Mepivacaine HCl Injection USP products.

Both solutions should be stored at controlled room temperature, below 25° C (77° F).

Protect from light.

Do not permit to freeze.

For protection from light, retain in box until time of use.

Once opened, the box should be reclosed by closing the top flap.

Mepivacaine 2% (20 mg/mL) solution should not be used if its color is pinkish or darker than slightly yellow or it contains a precipitate.

Cartridge warmers should not be used with Mepivacaine HCl Injection USP products.

Animal reproduction studies have not been conducted with this solution.

It is also not known whether this solution can cause fetal harm when administered to a pregnant woman or can effect reproductive capacity.

This solution should be given to a pregnant woman only if clearly needed.

It is not known whether this drug is excreted in human milk.

Because many drugs are excreted in human milk, caution should be exercised when this solution is administered to a nursing woman.

Great care must be exercised in adhering to safe concentrations and dosages for pedodontic administration See DOSAGE AND ADMINISTRATION.