Artikain INIBSA - instructions for use, doses, side effects, contraindications

1 ml of the preparation contains:
Active substances	40 mg / ml + 0.010 mg / ml *	40 mg / ml + 0.005 mg / ml **
Articaine hydrochloride	40 mg	40 mg
Epinephrine hydrotartrate
(in terms of epinephrine)	0.010 mg	0.005 mg

Excipients: sodium chloride, sodium metabisulphite, hydrochloric acid, sodium hydroxide, water for injection up to 1 ml.

* corresponds to the content of epinephrine in a solution of 1: 100,000

** corresponds to the content of epinephrine in a solution of 1: 200,000

Description:Transparent colorless or slightly colored solution, free from mechanical inclusions.

Pharmacotherapeutic group:Local anesthetic + α- and β-adrenomimetic

ATX: & nbsp

N.01.B.B.58 Articaine in combination with other drugs

Pharmacodynamics:

Combined drug, the effect of which is due to its constituent components. Articaine - local anesthetic of the amide type of the thiafen group. Epinephrine vasoconstrictor.Artikain INIBSA has a local anesthetic effect, has analgesic effect. The effect of the drug begins quickly - after 1-3 minutes. The duration of anesthesia is at least 45 minutes. The drug is characterized by good tissue tolerance and minimal vasoconstrictive action.

Due to the low content of epinephrine in the preparation, its effect on the cardiovascular system is poor: almost no increase in blood pressure and an increase in heart rate.

Pharmacokinetics:Articaine with submucosal administration in the oral cavity has a high diffusion capacity. Binding to proteins is 95%. Active substances penetrate to the minimum degree through the placental barrier, practically do not stand out with breast milk. The elimination half-life is 25 minutes.

Indications:

Infiltration and conductive anesthesia in dentistry (especially in patients with concomitant severe physical illnesses), including the following manipulations:

- uncomplicated removal of one or more teeth;

- Preparation of carious cavities and teeth before prosthetics.

Contraindications:

- Hypersensitivity to articaine, epinephrine, sulfites, as well as to any of the auxiliary components of the drug;

- paroxysmal tachycardia and other tachyarrhythmias;

- bronchial asthma with increased sensitivity to sulfites;

- closed-angle glaucoma, simultaneous reception of non-selective beta-blockers;

- severe form of hepatic insufficiency (porphyria);

- hyperthyroidism;

- patients undergoing treatment with MAO inhibitors or tricyclic antidepressants;

- B12-deficiency anemia, methemoglobinemia, hypoxia, intolerance to sulfo groups (especially in bronchial asthma).

Carefully:

Cholinesterase deficiency, renal insufficiency, diabetes mellitus, arterial hypertension, children's age (up to 4 years - effectiveness and safety not determined).

Pregnancy and lactation:Until now, the safety of the drug during pregnancy has not been established. In this regard, when it is used, it is necessary to take into account a possible pregnancy, especially its early months. If it is necessary to use the drug in a nursing mother, there is no need to interrupt feeding,since active substances are not excreted in breast milk in clinically significant amounts.

Dosing and Administration:

With uncomplicated removal of the teeth of the upper jaw, in the absence of inflammation, 1.8 ml of the drug (per tooth) is usually injected into the submucosa in the region of the transitional fold from the vestibular side. In some cases, additional administration of 1 ml to 1.8 ml of the drug may be required to achieve complete anesthesia. In most cases, there is no need to perform painful injections from the palatal side. For anesthesia with palatine incisions and suturing with the purpose of creating a palatine depot, about 0.1 ml of the drug per shot is needed. When several adjacent teeth are removed, the number of injections is usually limited. In the case of removal of the premolars of the lower jaw, in the absence of inflammation, mandibular anesthesia can be dispensed with, as infiltration anesthesia provided by injection of 1.8 ml per tooth is usually sufficient. If this method failed to achieve the desired effect, an additional injection of 1 to 1.8 ml of the drug into the submucosa should be performed in the region of the transitional fold of the lower jaw with a vestibularside. If, in this case, it was not possible to achieve complete anesthesia, it is necessary to blockade the mandibular nerve.

To prepare the cavity or prepare for the crown of any tooth, with the exception of lower molars, the administration of the drug in a dose of 0.5 ml to 1.8 ml per tooth according to the type of infiltration anesthesia from the vestibular side is shown. The exact amount depends on the desired depth and duration of the procedure. When performing one treatment procedure, adults can administer up to 7 mg of articaine per 1 kg of body weight. The duration of anesthesia during which an intervention can be performed is 30-45 minutes.

Children the drug is administered in amounts that depend on their age, body weight and method of anesthesia. Do not use the drug for children under 4 years.

For children aged 4 to 12 years, the dose of the drug administered is not more than 5 mg of articaine per kilogram of body weight.

For children with a body weight of 20 to 30 kg, the recommended dose of the drug is from 0.25 to 1 ml (from 1/6 to / 4 cartridges). The maximum single dose of the drug should not exceed 1.5 ml. The daily dose should not exceed 2.5 ml.

For children with a body weight of 30 to 45 kg, the recommended dose of the drug is from 0.5 to 2 ml (from 1/3 to 1 cartridge).The maximum single dose of the drug should not exceed 2 ml. The daily dose should not exceed 5 ml.

Side effects:

The drug is usually well tolerated by patients, however, the following side effects may occur:

From the central nervous system: Depending on the dose applied, cases of impaired consciousness are described, right up to its loss; disturbances of breathing until it stops; muscular tremor; involuntary jerking of the muscles, sometimes progressing up to generalized seizures; nausea, vomiting.

From the side of the organ of vision: occasionally - blurred vision, transitory blindness, diplopia.

From the cardiovascular system: moderately severe disorders hemodynamics appearing in the reduction of arterial pressure, tachycardia or bradycardia, oppression of cardiovascular activity, which in extreme manifestation can lead to collapse and cardiac arrest, which threatens the patient's life.

Allergic reactions: edema or inflammation at the injection site, in other areas - redness of the skin, itching, conjunctivitis, rhinitis, angioedema, of varying severity (including edema of the upper and / or lower lip and / or cheeks, swallowing difficulty, hives, difficulty breathing) .All these phenomena can progress to the development of anaphylactic shock.

Local reactions: swelling or inflammation at the injection site.

Other: headaches are often associated, probably with the presence of a preparation of an epinephrine. Other side effects caused by the action of epinephrine (tachycardia, arrhythmia, increased blood pressure), appear extremely rarely. Extremely rare random intravascular injection can lead to the development of ischemic zones at the site of administration, sometimes progressing to tissue necrosis. Nerve damage (up to the development of paralysis) - occurs only when the technique of injection is disturbed.

Overdose:

When the first signs of the development of side effects or toxic effects (dizziness, motor anxiety, impaired consciousness), it is necessary to urgently stop the injection and give the patient a horizontal position. Careful monitoring of the parameters of hemodynamics (pulse, arterial pressure) and patency of the respiratory tract is necessary. Even if the symptoms do not seem heavy, you should prepare everything you need for intravenous infusion and, at the very least, carry out venipuncture.Depending on the degree of disturbance of breathing, oxygen, lead artificial respiration ("mouth to nose") and, if necessary, endotracheal intubation with controlled ventilation of the lungs. The use of analeptic drugs of central action is contraindicated. With involuntary muscle twitching or generalized convulsions showed intravenous administration of barbiturates of short or ultrashort action. The introduction should be carried out slowly, under the constant control of parameters of hemodynamics and respiration. At the same time, intravenous fluid infusion through a pre-established cannula should be performed. You should also give the patient oxygen.

With tachycardia, bradycardia, or a marked decrease in blood pressure, the patient should be given a horizontal position with raised legs. With severe circulatory disturbances and shock, injection of the drug should be discontinued. Provide the patient with a horizontal position with raised legs, oxygen inhalation and intravenous infusion of balanced electrolyte and plasma-substituting solutions, intravenously injecting glucocorticoids (250-1000 mg of methylprednisolone).In the case of threatening vascular collapse and growing bradycardia enter 25-100 ug epinephrine intravenously (0.25-1.0 ml of a solution with a concentration of 100 ug / ml). Introduction is carried out slowly, under the control of pulse and blood pressure. Do not administer more than 100 μg of epinephrine (1ml solution per time). When adding additional amounts of epinephrine it should be added to the infusion solution. The infusion rate should correlate with the heart rate and blood pressure level.

Severe forms of tachycardia and tachyarrhythmias can be eliminated by the use of antiarrhythmic drugs, however, non-selective beta-blockers should not be used. In these cases, the use of oxygen and monitoring of hemodynamic parameters is necessary. With an increase in blood pressure in patients with arterial hypertension should, if necessary, use peripheral vasodilators.

Interaction:

The hypertensive effect of sympathomimetic amines such as epinephrine can be enhanced by tricyclic antidepressants and monoamine oxidase inhibitors. Interaction of this type is dangerous for epinephrine and norepinephrine when used as vasoconstrictors in concentrations of 1: 25,000 and 1: 80000, respectively.

Do not prescribe the drug on the background of treatment with non-selective beta-blockers, since in this case the risk of hypertensive crisis and severe bradycardia is high.

Special instructions:

Articaine contains sulfites, which can enhance the anaphylactic reaction. Increased sensitivity to sulfites is more often observed in patients with bronchial asthma. The drug should not be administered intravenously, to avoid intravascular injection, an aspiration test should be performed. Do not use open cartridges for other patients. Do not use a damaged cartridge. Do not inject into the area of inflammation. In patients with cholinesterase deficiency, the drug can be used only with urgent indications, as these patients have a chance of prolonging and sometimes enhancing the effect of the drug. In patients with cardiovascular disease (chronic heart failure, coronary artery disease, angina pectoris, rhythm disturbance, history of myocardial infarction, arterial hypertension), cerebrovascular disorders, history of paralysis, chronic bronchitis, emphysema, diabetes, hyperthyroidism,as well as in the presence of severe anxiety, it is advisable to use a preparation containing a smaller amount of epinephrine.

Regional and local anesthesia should be performed by experienced specialists in a suitably equipped room, with availability of equipment ready for immediate use and preparations needed for cardiac monitoring and resuscitation. Personnel performing anesthesia should be qualified and trained in the technique of performing anesthesia, should be familiar with the diagnosis and treatment of systemic toxic reactions, adverse events and reactions, and other complications.

Effect on the ability to drive transp. cf. and fur:

AT Special tests did not reveal a clear effect of the drug on operator activity. However, due to the fact that the preoperative anxiety of the patient and the stress caused by surgery can influence the effectiveness of the activity, the dentist must individually, in each case, decide whether to admit the patient to transport management or work with mechanisms.

Form release / dosage:

Solution for injection 40 mg / ml + 0.005 mg / ml, 40 mg / ml + 0.01 mg / ml.

Packaging:

For 1.8 ml of the drug in a cartridge of colorless borosilicate glass type 1 EF, which is glued on the label. The cartridge on one end has a gray plunger made of elastomer, on the other end a disk made of elastomer and corresponding to running in with an aluminum cap with anodized coating. 10 cartridges are placed in a contour mesh box made of transparent thermoplastic and paper with laminated coating, hermetically sealed.

10 contour mesh packages together with the instruction for use are placed in a cardboard box.

Storage conditions:

In a dry, the dark place at a temperature of no higher than 25 ° C.

In a place inaccessible to children.

Shelf life:

2 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N014371 / 01

Date of registration:05.03.2009 / 18.10.2016

Expiration Date:Unlimited

The owner of the registration certificate:Laboratory of Inibes SALaboratory of Inibes SA Spain

Manufacturer: & nbsp

LABORATORY INIBSA, S.A. Spain

Representation: & nbspPharmacy, LLCPharmacy, LLCRussia

Information update date: & nbsp25.09.2017

Illustrated instructions

Instructions

Articaine INIBSA (Articaine INIBSA)