Scandonest contraindications. Is it possible to carry out local anesthesia for pregnant women

Latin name: scandonest
ATX code: N01BB03
Active substance: mepivacaine
Manufacturer: Septodont, France
Vacation from the pharmacy: On prescription
Storage conditions: t no more than 25 С
Best before date: 3 years

Scandonest is a drug that is used for pain relief during various dental, surgical or therapeutic procedures.

Indications for use

In dentistry, the use of Scandonest is indicated for infiltration or conduction anesthesia.

The drug is used in a simple procedure for removing teeth, as well as during the process of preparing cavities and hygienic treatment of the stump of the teeth before subsequent restoration or installation of orthopedic structures.

An anesthetic is also used if vasoconstrictor drugs are contraindicated.

Composition and forms of release

A 1.8 ml solution (1 cartridge) contains the only component, which is mepivacaine hydrochloride, its mass fraction is 54 mg.

Additional substances are presented:

  • saline solution
  • Sodium hydroxide
  • Purified water.

The solution poured into cartridges is a transparent and almost colorless liquid, no visible inclusions are observed. Inside the contour package is placed 10 or 20 cartridges. A pack may contain 1-6 Comte. packages.

Medicinal properties

Mepivacaine refers to local anesthetics, characterized by a rapid analgesic effect, this is due to the reverse inhibition of ion fluxes that are responsible for conducting nerve impulses. Widely used in dental practice.

The drug begins to act quite quickly (after 1-3 minutes from the moment of injection), while there is a pronounced analgesic effect and high local tolerance.

It should be noted that the mechanism of action is based on the blocking of special stress-dependent sodium channels, which are located inside the membranes of the nerve fiber itself. The analgesic component first penetrates the nerve membrane, and then enters the nerve cell as a base. In this case, the mepivacaine cation after the process of secondary proton addition is the active form. In the case of a reduced pH, which is observed, for example, in the presence of inflamed areas, only a small amount of the active substance is in its primary form, this can reduce the effect of anesthesia.

The duration of action of anesthesia without adrenaline in dentistry is observed for 20-40 minutes, in the case of soft tissue anesthesia, the analgesic effect lasts up to 90 minutes.

Mepivacaine is fairly rapidly absorbed. Communication with plasma proteins is not more than 78%. The half-life is about 2 hours.

After the introduction of the drug into a vein, the volume of distribution is 84 liters, while the clearance is 0.78 l / min.

Metabolic transformations of mepivacaine occur in the liver cells, metabolic products are excreted with the participation of the renal system.

It should be noted that you can buy Scandonest without adrenaline only with a prescription.

Scandonest: instructions for use

Price: from 450 to 570 rubles.

Scandonest without adrenaline will need to be injected exclusively into the tissue, preventing the anesthetic solution from entering the vessels. During the injection, aspiration control should be carried out.

The solution should be administered as slowly as possible, not faster than 0.5 ml over 15 seconds.

Adults are usually prescribed a dosage of 1-4 ml, it is impossible to administer more than 6 ml of anesthetic for 2 hours or exceed a daily dose of 10 ml.

For children over the age of 4 years, the selection of the required dosage is carried out individually, taking into account body weight, as well as the nature of the surgical intervention. The average dosage for children is about 0.5 mg per 1 kg.

Elderly people are shown to administer no more than ½ of the dosage, which is calculated for an adult patient.

When administering the drug, the smallest volume of solution should be used, which will give the necessary analgesic effect.

Use during pregnancy and breastfeeding

During pregnancy, anesthesia without adrenaline is contraindicated, since the pregnant body may react differently to this drug. If you need anesthesia for HB, you do not need to interrupt breastfeeding.

Contraindications and precautions

The use of the drug is contraindicated in case of:

  • Excessive susceptibility to the main component of the solution
  • Pregnancy
  • Severe liver pathologies
  • Childhood and senile age
  • Complicated course of myasthenia gravis.

It will be necessary to be careful during the treatment of persons who have diseases of the cardiovascular system, the renal system, inflammatory diseases, diabetes mellitus, as well as during the delivery period.

It is worth noting that during the use of Scandonest without adrenaline, patient reviews of possible side effects may differ, this is due to the individual reaction of the body.

Before planning anesthesia with Scandonest, some preparatory measures will need to be taken. Approximately 10 days. before the proposed anesthesia, the use of MAO inhibitors, for example, drugs such as Selegiline, Furazolidone, and Procarbazine, should be abandoned. This is due to an unexpected decrease in blood pressure. Pain injections should be given only after consultation with the doctor.

Cross-drug interactions

The risk of hypotension increases with the simultaneous use of MAO inhibitors.

A prolonged analgesic effect is observed in the case of simultaneous injection with vasoconstrictor drugs.

The negative effect of the anesthetic on the central nervous system may increase during the use of drugs that inhibit the activity of the nervous system.

When combined with anticoagulants, the risk of bleeding increases.

In the case of the procedure for disinfecting the injection site with drugs containing heavy metals, the risk of adverse symptoms increases.

The effect of muscle relaxants can be significantly enhanced in the case of combined use with an anesthetic.

The combination with narcotic analgesics can provoke an additive effect. This combination of drugs is possible in the case of epidural anesthesia, but special care should be taken, as there is a risk of respiratory depression.

The use of antimyasthenic drugs provokes pronounced antagonism, as well as insufficient effectiveness of drugs.

The rate of elimination of mepivacaine is affected by cholinesterase inhibitors.

Side effects and overdose

During the use of an anesthetic drug, the occurrence of a severe headache, combined with dizziness, lethargy, may be recorded. It is possible that there is a violation of the activity of the CCC, the occurrence of a convulsive syndrome, loss of consciousness, as well as pronounced motor restlessness.

In addition, there may be a negative effect of a local anesthetic on the functioning of the excretory system, and manifestations of allergies are possible. In this regard, skin rashes and itching, involuntary frequent urination, Quincke's edema, numbness of some parts of the face cannot be ruled out.

The following symptoms may be observed:

  • Increased muscle tone
  • convulsive syndrome
  • Acidosis
  • Violation of oxygen supply, respiratory function
  • Decreased blood pressure
  • Pathological conditions of the cardiovascular system
  • Change in acid-base balance.

Analogues

Espe Dental AG, Germany

Price from 1420 to 2100 rubles.

The drug, which is used for local anesthesia, its trade name does not match the name of the active substances (epinephrine, articaine). It is used in public clinics and private clinics during various dental procedures. Ubistezin is available in the form of a solution.

Pros:

  • Rapid analgesic effect (for toothache)
  • Can be used during pregnancy
  • It is characterized by low systemic toxicity.

Minuses:

  • Can only be bought with a prescription
  • Should not be combined with tricyclic antidepressants
  • After the injection, the occurrence of local edema is not excluded.

Sanofi Aventis, France

Price from 506 to 5336 rubles.

Means for local anesthesia without adrenaline (adrenaline) and ananephrine. The active ingredients are articaine and epinephrine. It is characterized by the same action as Ubistezin. Ultracain is produced in the form of an injection solution.

Pros:

  • Widely used in dentistry
  • Used during lactation
  • Rarely provokes side effects (according to numerous reviews).

Minuses:

  • You can buy medicines only with a prescription
  • Contraindicated in bronchial asthma
  • High price.
Scandonest

Compound

The basis of Scandonest is a medicinal substance - mepivacaine hydrochloride. Auxiliary components of the drug are sodium chloride and hydroxide, water for injection.


pharmachologic effect

Scandonest has a fast local anesthetic effect. The medicinal effect of the drug is based on the inhibition of ion flows that are involved in the transmission of impulses through neuronal membranes.

Mepivacaine, the main component of Scandonest, has a mild vasoconstrictor effect at the injection site, which allows the use of fewer vasoconstrictors.

With the introduction of the drug, anesthesia develops after 30 minutes and lasts for 30-40 minutes when injected into the pulp, into soft tissues - 2-3 hours.


Indications for use

The solution is indicated for administration before classical operations, single and multiple removals without complications, removal of impacted teeth. Scandonest injections are recommended before trepanation, apical resection, alveolectomy, cyst removal, cavity preparation, pulpectomy.


Mode of application

Scandonest should be injected into the tissues, avoiding contact with the solution from the blood vessel. During the manipulation, aspiration control should be carried out.

The drug should be administered slowly no faster than 0.5 ml in 15 seconds.

For adult patients, a dose of 1 to 4 ml is effective, it is forbidden to administer more than 6 ml of Scandonest within 2 hours or 10 ml per day.

For children from 4 years old, the dose is selected individually, taking into account the weight, age and nature of the operation. The average dose for children is 0.0167 ml of solution (0.5 mg mepivacaine) per 1 kg of body weight.


Side effects

The introduction of Scandonest can cause the patient to develop restlessness, dizziness, headache, weakness, disturbance and loss of consciousness, tachycardia or bradycardia, hypotension, chest pain.

Rarely, the use of the solution causes severe pathologies - convulsions, motor and sensory block, trismus, collapse, arrhythmias, digestive disorders, tremors, diplopia, hallucinations, dilated pupils, nystagmus, involuntary urination and defecation, methemoglobinemia, apnea and dyspnea.

Hypersensitivity after the introduction of Scandonest can be manifested by local (edema, redness, rash, itching) and general reactions (bronchospasm, angioedema and anaphylactic shock).


Contraindications

Scandonest is forbidden to use for porphyria, severe stages of liver failure and myasthenia gravis.

The drug is contraindicated in people with allergies to the components of the drug.

It is forbidden to use Scandonest for children under 4 years old.

With caution, the drug for anesthesia is used for diseases in which hepatic blood flow decreases - diabetes mellitus, chronic heart failure. With caution, Scandonest is administered to patients suffering from hepatic pathologies, pseudocholinesterase deficiency, inflammation or infiltration at the injection site of the solution, renal failure, and the elderly.


Pregnancy

It is forbidden to use Scandonest for women during pregnancy. When using the drug during the lactation period, breastfeeding can be continued.


drug interaction

The likelihood of developing hypotension increases when Scandonest is used with MAO inhibitors (selegiline, furazolidone, procarbazine).

The action of Scandonest is prolonged when administered with vasoconstrictors (epinephrine, phenylephrine, methoxamine).

The negative effect of Scandonest on the central nervous system increases when used with drugs that depress the nervous system.

The likelihood of bleeding increases when Scandonest is used with anticoagulants.

When disinfecting the injection site of Scandonest with heavy metal preparations, the risk of developing local side effects increases.

The action of muscle relaxants is enhanced when used together with Scandonest.

With the introduction of Scandonest with narcotic analgesics, an additive effect is observed. The combination of drugs is used for epidural anesthesia, but requires special care due to the risk of respiratory depression.

When Scandonest is used with antimyasthenic drugs, pronounced antagonism and low efficacy of drugs are observed.

The elimination time of mepivacaine from the body increases during treatment with cholinesterase inhibitors.


Overdose

Exceeding the recommended dose of Scandonest can be manifested by anaphylactic shock, convulsions, increased muscle tone, loss of consciousness, hypotension, hypoxia, apnea, dyspnea, hypercapnia, arrhythmia, cardiac arrest, metabolic and respiratory acidosis.


Release form

Scandonest is available in the form of a solution of 30 mg of mepivacaine in 1 ml of the drug. The drug is poured into 1.8 ml cartridges sealed with butyl rubber stoppers. Cartridges are packaged in 10 or 20 pcs. in contour packs. One package may contain 20, 30, 40, 50, 60, 80, 100 or 120 solution cartridges.


Storage conditions

At room temperature. Do not allow the drug to freeze.

An open cartridge cannot be stored.

) - dentist therapist, orthodontist. Engaged in the diagnosis and treatment of anomalies in the development of teeth, malocclusion. Also installs braces and plates.

Painkillers are actively used in medical practice to relieve pain. Scandonest belongs to the group of local anesthetics. The drug is used in dentistry and gynecology during planned operations in patients with adrenaline intolerance.

Scandonest without adrenaline is produced in blisters of 10 ampoules each. The drug is intended for professional use, is administered by injection into soft tissues.

  • mepivacaine hydrochloride;
  • sodium hydroxide;
  • sodium chloride;
  • saline.

The active ingredient in Scandonest is mepivacaine hydrochloride, which acts by blocking the nerve impulses responsible for pain. Unlike other painkillers, Scandonest is characterized by a vasoconstrictive effect. This is fundamentally opposite to the action of drugs that expand the lumen of blood vessels.

Note! Scandonest is used to anesthetize patients for whom adrenaline is contraindicated.

The anesthetic effect lasts at least 30 minutes and occurs 3-4 minutes after the administration of the drug. After 1.5 hours, the drug is partially excreted from the body. However, it should be borne in mind that no more than 10% of the drug is excreted by the kidneys, the main blow is taken by the liver. Therefore, any pathological changes in the liver can lead to problems.

Note! When using local anesthetics, the patient is conscious and adequately responds to the situation.

The result of the use of Scandonest is a loss of sensitivity to pain. Even unpleasant sensations do not arise. Before the injection of the medicine, the dentist freezes the area so that there is no discomfort during the injection. After the onset of the drug, therapy takes place in a calm environment.

Application in pediatric dentistry

Scandonest is used in pediatric dentistry, as it provides 100% pain relief and does not cause negative side effects. This is especially true for young patients under five years of age, for whom adrenaline is contraindicated. After the age of five, children can be anesthetized with drugs containing adrenaline, for example, the drug. The dosage of the medicine corresponds to the age of the small patient.

The work of a dentist with a child should be carried out with the full confidence of the baby in the doctor. After anesthesia, the child is imbued with confidence in the dentist and allows you to carry out the necessary therapy.

Indications and contraindications

Scandonest is widely used in dentistry for the treatment and extraction of teeth, surgical manipulations on the oral mucosa, during operations on the jaw.

Absolute contraindications:

  • intolerance to the ingredients of the drug;
  • severe diseases of internal systems;
  • pathology of hemoglobin formation (porphyria);
  • muscle weakness (myasthenia gravis);
  • children under the age of five.

Relative contraindications:

  • pregnancy and breastfeeding;
  • renal/liver failure;
  • cardiovascular pathology;
  • elderly patients after 65 years;
  • inflammatory processes at the injection site.

The dosage of the therapeutic agent depends on the age of the patient and the nature of the therapeutic manipulations. For patients after 65 years, the measure of administration is half the usual.

Scandonest during pregnancy is prescribed with great care after the approval of the gynecologist. The active substance is easily absorbed by the placenta and penetrates into the fetus. When feeding, you need to take into account the time of excretion of the substance from the body. The active ingredients can pass into breast milk, but in small quantities.

Side effects

Any medicinal substance can cause negative effects of varying severity. In the case of using Scandonest, these may be reactions of different body systems.

  • drowsiness and lethargy;
  • dysmotility;
  • failure of tactile sensations;
  • dizziness, headache;
  • excessive excitability, anxiety;
  • trembling of the limbs;
  • pupil dilation;
  • loss of consciousness.

Vascular system:

  • arrhythmia, tachycardia;
  • pressure drop;
  • bradycardia;
  • pain in the chest.

The patient may experience nausea and vomiting, fecal and urinary incontinence, respiratory depression may occur. In some cases, allergy symptoms may occur - hives, itching, rashes, swelling at the injection site. Numbness and a feeling of coldness at the injection site (as well as lips and tongue) are common manifestations. Severe manifestations of the side effect include the shock state of the patient.

Important! The appearance of side effects requires qualified medical care.

Scandonest slows down motor reactions, therefore, after application, it is not recommended to drive a vehicle and work with equipment that requires concentration and precise movements.

Precautions

To avoid the occurrence of allergic reactions, it is recommended to do a trial test by introducing a small amount of the drug - 5%.

Patients should not eat or chew gum until tissue sensation is fully restored. There is a certain risk of biting through the lip, cheek or tongue.

Analogues

Scandonest analogues contain one or more substances that have the same effect. In medical practice, the following substitutes are used:

  • Isocaine;
  • mepivacaine;
  • Mepivastezin;
  • Mepidont;
  • Mepicatone;
  • Scandinavian;
  • Ultracain DS;
  • Artikain.

isocaine

Isocaine produced in Canada is a local anesthetic drug for blocking pain. The active ingredient is mepivacaine. The drug is produced in injection ampoules intended for professional use. For local anesthesia, a 3% solution of the drug is administered, the dosage depends on the nature of the intervention.

mepivacaine

Mepivacaine is a synonym for Scandonest, fully consistent with its composition and action. The drug is less toxic than, and also less effective. Mepivacaine is not recommended for patients with poor blood clotting. During surgery on soft tissues, severe blood loss is possible, which can only be stopped by vasoconstrictor adrenaline. In some cases, patients are prescribed blood-thinning drugs a few days before the introduction of Mepivacaine.

Mepivastezin

Mepivastezin is a submucosal injection used in dentistry and surgery. The drug has a local anesthetic and immunomodulatory effect. The active substance is mepivacaine. Mepivastezin is not recommended for patients with poor health, with severe pathologies of the kidneys / liver. The tool is not recommended for use in early pregnancy due to its toxic effects on the fetus, breastfeeding can be continued one day after the administration of the drug dose.

Mepidont

Mepidont is made in Italy. This is a complex drug, which includes mepivacaine and epinephrine. Epinephrine has a vasoconstrictive effect and enhances the properties of mepivacaine. The drug is intended for professional use, prior consultation with a doctor is necessary before administration. Side effects are similar to other drugs based on mepivacaine, allergic reactions are not excluded. Mepidont does not combine well with certain drugs, therefore, on the eve of treatment, the use of drugs should be discontinued.

scandinibsa

Scandinibsa produced in Spain based on mepivacaine has a local anesthetic property and is administered by injection into soft tissues. Mepivacaine enhances the healing properties of other drugs that block the sensitivity of the central nervous system. Side effects occur with sensitivity to the constituent substances of the drug. With a pronounced syndrome of side effects, medical attention should be provided. Eating is allowed only after the restoration of the sensitivity of nerve endings.

Ultracain

Ultracaine is often used during treatment in the dental office. This drug does not cause severe side effects and contraindications. With the help of Ultracaine, a wide variety of dental procedures are carried out, the patient does not feel pain. The drug is also used in pediatric dentistry, but after the age of four.

Important! Ultracaine is approved for use by pregnant women, but with the permission of the gynecologist.

The composition of the drug contains adrenaline, but in very small quantities. Ultracaine can be used to anesthetize patients with high blood pressure and cardiovascular pathologies. With severe pain syndrome, an increase in the dose of the drug is allowed.

Dentists give the benefits of Ultracaine, which is several times higher than the action of Lidocaine. The analgesic effect lasts a minimum of 20 minutes and can last up to 40 minutes. Ultracain forte anesthetizes tissues for 1 hour 15 minutes.

Outcome

Extraction of a tooth, elimination of pulpitis and operations on the soft tissues of the oral cavity should be performed under local anesthesia. Scandonest in dentistry is a new generation anesthetic based on mepivacaine, which does not contain adrenaline. It can be administered to patients who are sensitive to the action of adrenaline and who have contraindications to the use of Lidocaine. Also, this drug is used in gynecology and in the treatment of other diseases.

Sources used:

  • Solovieva A. A. (2015) Fundamentals of anesthesiology. Local and general anesthesia
  • Anesthesiology and resuscitation, ed. Dolina O. A., M. GEOTAR-Media, 2006
  • Bernardsky Yu. I. Fundamentals of maxillofacial surgery and surgical dentistry. - M.: Medical literature, 2000.

Compound

Active substance: Mepivacaine hydrochloride, 3,000g/100ml

Other Ingredients: Sodium chloride, sodium hydroxide, water for injection.

One cartridge of 1.8 ml solution for injection contains 54,000 mg of mepivacaine hydrochloride.

SCANDONEST contains less than 1 mmol sodium (23 mg) per cartridge, i.e. practically "sodium-free".

Description

Clear colorless solution. The pH was adjusted to 6.4 with sodium hydroxide.

pharmachologic effect

SCANDONEST contains mepivacaine, which is an amide-type local anesthetic. Mepivacaine reversibly blocks nerve impulses through its action on ion transport across the cell membrane. Mepivacaine has a fast onset of action, a high rate of anesthesia, and low toxicity.

Start of action

After blockade of the peripheral nerve, the action of mepivacaine begins within 5 minutes.

Duration of anesthesia

Pulp anesthesia typically lasts 25 min after maxillary infiltration and 40 min after mandibular alveolar nerve anesthesia, while soft tissue anesthesia is maintained for 90 min and 165 min after maxillary infiltration and 40 min after mandibular alveolar nerve anesthesia. nerve, respectively.

Pharmacokinetics

Suction

The rate of systemic absorption of mepivacaine in humans depends mainly on the total dose and concentration of the drug administered, on the route of administration, the presence of blood vessels at the injection site, and the combined use of vasoconstrictors that reduce the rate of absorption.

Distribution

Mepivacaine is rapidly distributed in tissues. Although local anesthetics reach all tissues, the highest concentrations are in more perfused organs such as the lungs and kidneys.

Metabolism

Like all local anesthetics of the amide type, mepivacaine is predominantly metabolized in the liver by microsomal enzymes. Over 50% is excreted as metabolites in the bile, but it is likely that they pass through the enterohepatic circulation, since only small amounts are present in the faeces.

breeding

The plasma half-life in adults is 1.9 hours. Metabolites are excreted in the urine, with less than 10% of mepivacaine excreted unchanged.

Indications for use

SCANDONEST is a local anesthetic for infiltration and conduction anesthesia during dental operations in adults, adolescents and children over 4 years of age (approximately 15 kg (33 lb) body weight).

SCANDONEST is particularly indicated in cases where there are contraindications to the use of vasoconstrictors.

Contraindications

Hypersensitivity to mepivacaine (or any other amide-type local anesthetic) or any of the excipients;

Severe forms of atrioventricular blockade;

uncontrolled epilepsy;

Acute intermittent porphyria;

Children under 4 years of age (weighing approximately 20 kg)

Pregnancy and lactation

Fertility

There are no relevant data on the toxic effects of mepivacaine in animals. To date, no human data are available. Pregnancy

Clinical studies in pregnant women have not been conducted, and there are no descriptions in the literature of cases of the administration of mepivacaine 30 mg / ml to pregnant women. Animal studies have shown no direct or indirect harmful effects in terms of reproductive toxicity. Therefore, as a precautionary measure, it is preferable to avoid the use of SCANDONEST during pregnancy.

lactation period

Breastfeeding mothers were not included in the clinical trials of SCANDONEST. There are only data in the literature on the passage of lidocaine into milk, which does not pose a risk. However, given the lack of data on mepivacaine, a risk to neonates/infants cannot be excluded. Therefore, breastfeeding mothers are advised not to breastfeed for 10 hours after anesthesia with SCANDONEST.

Dosage and administration

For professional use by dentists.

adults

As with all anesthetics, doses vary and depend on the area being anesthetized, the degree of tissue vascularity, the number of nerve segments blocked, individual tolerance (the degree of muscle relaxation and the patient's condition), as well as the technique and depth of anesthesia. The lowest dose that provides effective anesthesia should be used. The required dosage must be determined on an individual basis.

It is possible to use different volumes, provided that they do not exceed the maximum recommended dose.

For healthy adults weighing 70 kg, the maximum dose of mepivacaine used for submucosal infiltration and/or nerve block should not exceed 4.4 mg/kg (0.15 ml/kg) body weight with an absolute dose of 300 mg mepivacaine per session.

Children aged 4 years (weighing approximately 20 kg) and older (see "Contraindications"),

The amount to be administered should be determined depending on the age and weight of the child, as well as the extent of the surgical intervention. The average dose is 0.75 mg / kg = 0.025 ml of mepivacaine solution per kg of body weight.

Must not exceed the equivalent of 3 mg mepivacaine/kg (0.1 ml mepivacaine/kg) body weight

Special patient groups

Due to the lack of clinical data, special care should be taken when determining the lowest dose that provides effective anesthesia:

In the elderly

In patients with renal and hepatic insufficiency

in case of hypoxia, hyperglycemia or metabolic acidosis.

Infiltration and conduction anesthesia in the oral cavity.

The rate of injection should not exceed 1 ml per minute.

Side effect

Adverse reactions after using SCANDONEST are similar to reactions to other local anesthetics of the amide type. These adverse reactions are generally dose-dependent and may be caused by high plasma levels resulting from overdose, rapid absorption, or accidental intravascular injection. They can also be caused by hypersensitivity, individual intolerance or reduced tolerance in the patient. Serious adverse reactions are usually systemic.

Information on registered adverse reactions is obtained from spontaneous reports and literature.

The classification of the frequency of occurrence corresponds to the convention: Very common (> 1/10), frequent (> 1/100 -<1/10), нечастые (>1/1,000 - <1/100), редкие (>1/10,000 - <1/1,000) и очень редкие (<1/10,000). «Неизвестные (невозможно вычислить частоту на основании имеющихся данных)».

In the following table, the severity of adverse reactions is classified from 1 (most serious) to 3 (less serious):

) Description of selected adverse reactions

1 laryngo-pharyngeal edema may be accompanied by hoarseness and / or dysphagia;

2 bronchospasm may be accompanied by shortness of breath;

3 neural pathologies that may be accompanied by various symptoms of abnormal sensations (eg, paresthesia, hypoesthesia, dysesthesia, increased pain sensitivity, etc.) of the lips, tongue or oral tissues. These data are obtained from post-marketing reports, mainly such reactions follow blockade of the nerves of the mandible, including different branches of the trigeminal nerve;

4 mostly in patients with underlying heart disease or on certain medications;

5 in patients with a predisposition or risk factors for coronary heart disease;

6 hypoxia and hypercapnia are secondary to respiratory depression and/or seizures and persistent muscle tension;

when accidentally biting or chewing the lips or tongue during the action of anesthesia.

Overdose

Types of overdose

Local anesthetic overdose is often used broadly to describe:

An absolute overdose

Relative overdose, for example:

accidental injection into a blood vessel, or

abnormal rapid absorption into the systemic circulation, or

Slow metabolism and excretion of SCANDONEST. _______________________________________________

Symptoms

Symptoms are dose dependent and may increase in severity within the range of neurological manifestations followed by vascular toxicity, respiratory toxicity and finally cardiotoxicity (detailed in section 4.8).

Overdose treatment

Before anesthesia in dentistry using local anesthetics, resuscitation equipment should be ensured.

If acute toxicity is suspected, the injection of SCANDONEST must be stopped immediately.

Oxygen should be given promptly and assisted ventilation should be used if necessary. If necessary, move the patient to the supine position.

In the event of cardiac arrest, emergency cardiopulmonary resuscitation should be performed.

Interaction with other drugs

Habituation Interactions with other local anesthetics: The toxicity of local anesthetics is addictive. This is not related to doses for anesthesia in dentistry and blood levels, but is relevant to children. The total dose of mepivacaine administered should not exceed the maximum recommended dose.

H2 blockers of histamine receptors (cimetidine); There have been cases of increased levels of amide anesthetics in the blood serum when used together with cimetidine.

Sedatives (central nervous system depressants): Due to the additive effect, reduced doses of SCANDONEST should be used.

Since compatibility studies have not been conducted, SCANDONEST must not be mixed with any other medicinal products

Application features

special instructions

SCANDONEST should be used with caution:

Patents with cardiovascular disorders:

Peripheral vascular disease

Arrhythmias, in particular of ventricular origin

Heart failure

hypotension

SCANDONEST should be used with caution in patients with impaired cardiac function, as they may be less able to compensate for changes due to slowing atrioventricular conduction.

Patents suffering from epilepsy: “

Since all local anesthetics are capable of causing convulsions, they should be used with great caution.

For information on patients with epilepsy who are under insufficient supervision, see the section "Contraindications".

Patents with liver disease:

The smallest dose that provides effective anesthesia should be used, see section "Method of application and doses".

Patients. being treated with antithrombotic drugs / anticoagulants:

The increased risk of severe bleeding after accidental vessel puncture and during maxillofacial surgery should be taken into account. In patients taking anticoagulants, control of the international normalized ratio (INR) should be strengthened.

Patient with porphyria:

SCANDONEST should be used with caution.

Patients with hemorrhagic diathesis due to needle/technique/surgery.

Elderly Patients:

In elderly patients over the age of 70 years, reduction of vines is required (lack of clinical data).

SCANDONEST must be used safely and effectively under appropriate conditions:

The local anesthetic effect may be reduced when SCANDONEST is injected into an inflamed or infected area.

There is a risk of biting (lips, cheeks, mucous membranes and tongue), especially in children; the patient should be warned not to chew gum or eat food until normal sensation is restored.

SCANDONEST contains less than 1 mmol sodium (23 mg) per cartridge, i.e. considered to be practically "sodium-free".

Athletes should be warned that the presence of SCANDONEST in the blood may give a positive result in the doping test that professional athletes undergo.

Precautions for use Before using SCANDONEST it is important to:

find out information about allergic reactions, current treatment and patient history; maintain verbal contact with the patient. have resuscitation equipment on hand (see Adverse Reactions section).

Risk associated with accidental intravascular injection:

Accidental intravascular injection (eg, accidental intravenous injection into the systemic circulation, accidental intravenous or intraarterial injection into the head or neck) may be associated with severe adverse reactions, such as seizures followed by central nervous system depression or cardiorespiratory depression and coma, eventually progressing to respiratory arrest associated with a sudden high level of mepivacaine in the systemic circulation.

Thus, aspiration should be performed prior to administering the drug to prevent needle puncture of the blood vessel during injection. However, the absence of blood in the syringe does not guarantee that an intravascular injection has not been made.

Risk associated with accidental intraneural injection:

Accidental intraneural injection may result in retrograde movement of the drug along the nerve.

To avoid intraneural injection and to prevent nerve damage associated with nerve blocks, the needle should always be slightly retracted if the patient feels an electric shock during the injection or if the injection is particularly painful. In case of nerve injury with a needle, the neurotoxic effect may be enhanced by the potential chemical neurotoxicity of mepivacaine, as it may adversely affect the perineural blood supply and prevent local washout of mepivacaine.

The combined use of other drugs may require careful monitoring (see section "Interaction with other drugs").

In patients who have received an injection of SCANDONEST, the speed of the psychomotor reaction may change, which affects the ability to drive a car and work with mechanisms.

Patients should not leave the dental office for 30 minutes after using SCANDONEST.

Release form

The drug is a clear, colorless solution. Packaged in a glass cartridge sealed at one end with a synthetic rubber stopper held in place by a metal cap and a movable piston at the other end.

Storage conditions

Keep the drug out of the reach of children.

Do not use this medicine after the expiry date which is stated on the cartridge label and carton. The expiration date means the last day of the specified month.

Store at a temperature not exceeding 25 ° C in a place protected from light. Do not freeze.

To protect from light, store the cartridge in the outer carton tightly closed. Do not use this drug if you notice that the solution has become opaque and / or has acquired any color.

The cartridge is intended for single use. If only part of the cartridge has been used, the rest should be discarded.

Do not dispose of medicines down the drain or with household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

With various dental procedures, anesthesia is indispensable. Most often, operations in the oral cavity are performed using local anesthesia. To do this, drugs are used in which a person remains conscious, and there is a loss of tissue sensitivity in only a certain zone. One of these anesthetics is Scandonest from the French company Septodont. This is a local anesthetic, which is produced in the form of a solution for injection.

Description and composition of the drug

"Scandonest" is a colorless, transparent solution for injection, an amide-type anesthetic. 1 ml of the drug contains 30 mg of the active substance - mepivacaine hydrochloride. The product is packaged in 1.8 ml cartridges. One ampoule contains mepivacaine 54 mg, NaCl - 10.8 mg, water. There are 10 or 50 cartridges in 1 carton.

The effect of the solution is due to the fact that it prevents the appearance of impulses in the nerve endings, which leads to blocking of sodium channels. "Scandonest" has a strong anesthetic effect for different types of anesthesia:

  • conductive;
  • infiltration;
  • terminal.

After the agent blocks the peripheral nerve, it begins to act for 5 minutes. The anesthetic acts on the pulp for an average of 25-40 minutes. Anesthesia of soft tissues lasts 1.5-3 hours.

The active substance is quickly absorbed into the tissues. Its highest concentration is observed in the kidneys and lungs. The absorption rate of the drug depends on its concentration and dosage, as well as on the injection site and the presence of vessels there. The active ingredient is well metabolized in the liver. More than 50% of the substance is excreted in the bile. A small amount may be present in the feces. The elimination half-life from the blood is about 2 hours. Less than 10% of "Scandonest" is displayed unchanged.

Indications and contraindications

"Scandonest" is used for local anesthesia during various surgical interventions in the oral cavity, as well as for the treatment of mucous membranes during tracheal incubation, tonsillectomy. Scandonest can be used by children from 4 years of age (from 15 kg).

Contraindications

  • myasthenia gravis;
  • high sensitivity to amide-type anesthetics;
  • porphyria.

Use with caution when:

  • hepatitis;
  • liver failure;
  • impaired renal function;
  • acidosis;
  • breastfeeding;
  • over 65 years of age.

Important! Pregnant women "Scandonest" can be prescribed only if the result of its use will exceed the risks for the child. Mepivacaine can cause narrowing of the uterine artery and fetal hypoxia.

Possible side effects

In case of accidental intravascular injection or overdose of the drug, adverse reactions of the body may occur:

  • allergies in the form of Quincke's edema, urticaria, itching, chills, high fever;
  • violation of swallowing function;
  • involuntary urination;
  • headache;
  • violation of hematopoiesis;
  • bradycardia;
  • hypotension;
  • convulsions;
  • heart failure.

Also among the side effects are vomiting, nausea, depression of the respiratory center, numbness of the lips and tongue.

Interaction with other drugs

If vasoconstrictors (Metoxamine) are used simultaneously with Scandonest, the anesthetic effect of the injection can be prolonged. With the simultaneous administration of mepivacaine with MAO inhibitors (Furazolidol, Selegiline) or Mecamelamine, there is a risk of lowering blood pressure.

The likelihood of bleeding occurs when using Scandonest together with anticoagulants (Heparin, Ardeparin).

If the anesthetic injection site is treated with local antiseptics containing heavy metals, there is a risk of swelling and pain. The metabolism of mepivacaine is reduced when used with cholinesterase inhibitors.

Instructions for use

The dose and amount of the drug is calculated individually. It depends on the nature of the manipulation and the type of anesthesia.

For conduction and infiltration anesthesia, the average dosage is 1-3 ml of a 3% solution. Per 1 kg of weight, it is allowed to use 4.4 mg as much as possible, but not more than 300 mg per administration. For a child, the maximum allowed dose is 6 mg / kg.

The rate of administration of the drug should be no more than 1 ml per minute.

Use with extreme caution in patients over 65 years of age. For them, the dosage should be ½ of the dose of an adult.

Before administering the drug, it is necessary to clarify the likelihood of an allergy to the drug. To do this, you need to conduct a trial injection, introducing 5% of the anesthetic from the required dosage.

When using Scandonest, athletes may have a positive reaction to narcotic substances during doping control.

Preliminarily (10 days before anesthesia), you need to stop taking MAO inhibitors, which, when interacting with Scandonest, help lower blood pressure.

In the presence of a focus of infection and inflammation, the introduction of the solution can reduce its anesthetic properties. You can not eat after the injection, chew gum until the sensitivity returns. Otherwise, there is a risk of biting the tongue, cheeks, lips.

Before opening the solution cartridge, its septum must be disinfected with 70% - 90% alcohol. An open ampoule should not be reused.

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Cost and analogues

"Scandonest" can be purchased at a pharmacy for an average of 2,500 rubles. In the absence of a drug on sale, it can be replaced with similar injection solutions with the same structural composition:

  • "Mepivastezin";
  • "Scandinibsa";
  • "Isocaine";
  • "Mepivacaine";
  • "Mepidont".

Replacement of the drug must be agreed with the doctor.

Scandonest is an effective anesthetic that can be used in dental practice. The decision to use this remedy should be made by the attending physician, taking into account all factors and risks. It is imperative to take into account the contraindications and side effects that Scandonest can cause.