Primacaine with adrenaline - instructions for use, dose, side effects, contraindications

Combined drug, the effect of which is due to its constituent components. Articaine - local anesthetic of the amide type of the thiafen group. Epinephrine causes vasoconstriction, especially at the injection site, which makes it difficult to absorb and prolongs the effect. The drug has a local anesthetic effect, has analgesic effect.The effect of the drug begins quickly - after 0.5-3 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 low: 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. The binding of articaine with proteins is 95%. Active substances penetrate to the minimum degree through the placental barrier, practically do not stand out with breast milk. The half-life of articaine with submucous administration 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 any component of the drug;

- hypersensitivity to sulfites;

- bronchial asthma;

- paroxysmal tachycardia and other tachyarrhythmias;

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

- hyperthyroidism;

- severe form of liver failure;

- porphyria;

- use of MAO inhibitors or tricyclic antidepressants;

- In 12-deficient anemia, methemoglobinemia, hypoxia.

Carefully:Cholinesterase deficiency, kidney failure, diabetes, hypertension, children under 4 years of age (efficacy and safety not defined).

Pregnancy and lactation:

The safety of the drug during pregnancy is not established. In this regard, it is recommended to relate the benefits to the mother and the possible risk to the fetus. 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, an additional injection from 1 ml to 1.7 ml of the drug 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 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 premolars of the lower jaw in the absence of inflammation, mandibular anesthesia can be dispensed with, as infiltration anesthesia, provided by injection of 1.7 ml per tooth, is usually sufficient. If this method failed to achieve the desired effect, an additional injection of 1 to 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, 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 the lower molars, the administration of the drug in a dose of 0.5 ml to 1.7 ml per tooth as 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 an intervention can be performed, is 30 to 45 minutes.

For 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 kg 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 1/2 cartridge). 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 1.7 ml (from 1/3 to 1 cartridge). The maximum single dose of the drug should not exceed 1.7 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 epinephrine in the formulation. 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.

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, carry out artificial respiration and, if necessary, endotracheal intubation with controlled ventilation of the lungs. 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, oxygen inhalation and intravenous infusion of balanced electrolyte and plasma-substituting solutions, intravenously injecting glucocorticoids (250-1000 mg of methylprednisolone). In case of threatening vascular collapse and increasing bradycardia, administer 25-100 μg of epinephrine intravenously (0.25-1.0 ml of a solution with a concentration of 100 μg / 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). With the introduction of 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. The local anesthetic effect of articaine is enhanced and lengthened by vasoconstrictive drugs.

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:

The drug can not be administered intravenously. Do not inject into the area of inflammation. To prevent infection (including viral hepatitis), you should not use open cartridges again for other patients.The drug contains sulfites, which can provoke an anaphylactic reaction. Increased sensitivity to sulfites is more often observed in patients with bronchial asthma. In patients with cholinesterase deficiency, the drug can be Use only with urgent indications, as these patients have a possibility of prolongation and sometimes intensifying the action 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 stroke, 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.

Effect on the ability to drive transp. cf. and fur:It is necessary to refrain from driving motor vehicles and engage in potential activities that require increased concentration and speed of psychomotor reactions.

Form release / dosage:

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

Packaging:

1,7 ml in a cartridge of colorless glass of class 1, one side sealed with a plug of elastomer (piston plug) of gray color (from brombutyl rubber) type 1, on the other hand ukuporenny with a seal of elastomer gray (from brombutyl rubber) type 1 with a cap from aluminum.

10 cartridges are placed in a contour mesh box made of a polyvinyl chloride film and an aluminum lacquered foil or paper.

5 contour mesh packages together with instructions for use are placed in a cardboard pack.

Storage conditions:

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

In a place inaccessible to children.

List B.

Shelf life:

2 years

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:П N011701 / 01

Date of registration:08.09.2009

The owner of the registration certificate:Produits Dentaires Pierre RollandProduits Dentaires Pierre Rolland France

Manufacturer: & nbsp

PRODUITS DENTAIRES PIERRE ROLLAND France

Information update date: & nbsp08.09.2009

Illustrated instructions

Instructions

Primacaine with adrenaline (Primacaine adrenaline)