Cytokartin - instructions for use, doses, side effects, contraindications

Active Ingredients:	in ml	in the cartridge
Articaine hydrochloride, mg	40	68
L-adrenaline (epinephrine) hydrotartrate, in terms of adrenaline (epinephrine) base μg	10(5)	17(8,5)
Excipients:
Sodium chloride, mg	1	1,7
Sodium disulphite, mg	0,5	0,85
Water for injections q.s.	1	1,7

Auxiliary components not indicated on the label Hydrochloric acid 1 N

Nitrogen

Description:

Transparent colorless solution without foreign particles.

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. Cytokartin 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 tolerability and minimal vasoconstrictive effect. Due to the low content of epinephrine in the preparation, its effect on the cardiovascular system is poor: almost no increase in arterial pressure and increased 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 hypersensitivity 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;
In 12-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:

Possible use of the drug during pregnancy.

If it is necessary to use the drug in a nursing mother, there is no need to interrupt feeding, since the 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, 1.7 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 to 1.7 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 the infiltration anesthesia provided by injecting 1.7 ml per tooth is usually sufficient. If this method fails to achieve the desired effect, an additional injection of 1-1.7 ml of the drug into the submucosa should be performed in the region of the transitional fold of the lower jaw from the vestibular side. If, however, 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 to 1.7 ml per tooth according to the type of infiltration anesthesia from the vestibular side is indicated. The exact amount depends on the desired depth 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 the intervention can be performed, is 30-45 minutes.

Side effects:

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

From the side of the central nervous system: depending on the dose applied, cases of violation consciousness up to its loss; disturbances of breathing until it stops; muscular tremor; involuntary twitching 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, manifested in lowering blood pressure, tachycardia or bradycardia, inhibiting 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,angioneurotic edema of varying severity (including edema of the upper and / or lower lip and / or neck, glottis with difficulty swallowing, 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), are extremely rare. Very rarely, a random intravascular injection can lead to the development of ischemic zones at the site of administration, sometimes progressing to tissue necrosis.

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, hold artificial respiration ("mouth to nose") and, if necessary, endotracheal intubation with controlled ventilation. The use of analeptic drugs of central action is contraindicated. In case of involuntary muscular twitching or generalized convulsions, intravenous administration of barbiturates of short or ultrashort action is indicated. 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,to carry out inhalation of oxygen 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 (1 ml of 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 such type is described for adrenalin and noradrenalin, when used as a vasoconstrictor at a concentration of 1: 25,000 and 1: 80,000 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:

Cytokartin contains sulfites, which can enhance the anaphylactic reaction. Increased sensitivity to sulfites is more often observed in patients with bronchial asthma.

The drug can not be administered intravenously. Do not inject into the area of inflammation. In patients with cholinostaris deficiency, the drug can be used only for urgent indications, as these patients have a chance of prolonging and sometimes enhancing the effect of the drug.

Patients with diseases of the cardiovascular system (chronic heart failure, coronary artery disease, angina pectoris, rhythm disturbances, myocardial infarction in history, arterial hypertension), cerebrovascular disorders, history of paralysis, chronic bronchitis, emphysema, diabetes, hyperthyroidism,and also in the presence of expressed anxiety, it is advisable to use a preparation containing a smaller amount of epinephrine.

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

In special tests, there was no 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 surgical intervention can influence the effectiveness of the activity, the dentist must individually, in each case, decide whether the patient is allowed to operate the vehicle or work with the mechanisms.

Form release / dosage:

Solution for injection (with epinephrine) 40 mg + 5 mg / ml, 40 mg + 10 mg / ml.

Packaging:Solution for injection (with epinephrine) 40 mg + 5 mkg / ml, 40 mg + 10 mkg / ml in cartridges of 1.7 ml in cartridges of transparent neutral glass. 10 cartridges per contour cell packaging made of PVC film brownish-yellow color and aluminum foil. For 5 contour squares with instructions for use in cardboard pack.

Storage conditions:

In a place protected from light, at a temperature of 4 to 25 ° C.

In a place inaccessible to children.

Shelf life:2 years.Do not use after expiration date indicated on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N012062 / 01

Date of registration:14.10.2008

The owner of the registration certificate:MOLTENI FARMACEUTICI, S.p.A. MOLTENI FARMACEUTICI, S.p.A. Italy

Manufacturer: & nbsp

COSMO, S.p.A. Italy

Representation: & nbspPHARMONYX PHARMONYX Russia

Information update date: & nbsp17.06.2011

Illustrated instructions

Instructions

Cytokartin (Citocartin)