Ubistezin forte - instructions for use, dose, side effects, contraindications

Pharmacodynamics:Ubistezin forte is a combined preparation for local anesthesia in dentistry. Included in its composition articaine - local anesthetic of the amide type of the thiafen group. The effect of the drug begins quickly, after 1-3 minutes.

The duration of anesthesia is at least 75 minutes. Wound healing proceeds without complications, which is due to good tissue tolerance and minimal vasoconstrictive effect.

Pharmacokinetics:Articaine with submucosal introduction in the oral cavity has a high diffuse capacity. The connection with 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 conduction anesthesia in dentistry (especially in patients with concomitant severe medical conditions), including the following manipulations:

uncomplicated removal of one or more teeth;

filling of carious cavities, teeth grinding before preparation;

operations on the mucous membranes of the mouth or bone, requiring a more pronounced effect of ischemia;

Conduella-Luke operation;

cystectomy;

percutaneous osteosynthesis.

Contraindications:-Increased sensitivity to articaine, epinephrine, sulfites, as well as to any of the auxiliary components of the drug;

- Known or congenital deficiency of cholinesterase activity;

-patients with hemorrhagic diathesis;

-heavy form of liver failure, porphyria, hyperthyroidism;

-cross-angle glaucoma;

heart disease (unstable angina, recently transferred myocardial infarction, post-coronary artery bypass grafting, uncontrolled severe arterial hypertension, uncontrolled congestive heart failure), severe arterial hypotension, paroxysmal tachycardia and other tachyarrhythmias, severe or uncontrolled conduction disorders of the heart (including atrioventricular blockade of II and III degree, bradycardia;

- bronchial asthma with hypersensitivity to sulfites;
inflammation in the area of suspected anesthesia;

-cardiogenic shock;

- simultaneous reception of nonselective beta-blockers, concomitant therapy with monoamine oxidase inhibitors or tricyclic antidepressants;

-baby age to 4 years (due to lack of relevant clinical data).

Carefully:- pheochromocytoma;

- coagulation disorders;

-diabetes;

-epilepsy;

- arterial hypertension, angina pectoris, atherosclerosis, intraventricular and atrioventricular blockade of I degree, chronic heart failure;

-bronchial asthma;

-liver failure;

- kidney failure;

- simultaneous reception of phenothiazine, cardioselective beta-blockers, anticoagulants and antiplatelet agents;

-Heavy general condition, weakened patients;

-elderly age.

Pregnancy and lactation:There are not enough clinical observations on the use of the drug during pregnancy and lactation. At present, there is no information on the safety of the drug during pregnancy with respect to the effects on fetal development. Therefore, the use of the drug in pregnancy is possible only if the expected benefit to the mother from its use exceeds the potential risk to the fetus.
It is not known whether articaine and epinephrine with breast milk. During the period of breastfeeding, they are used only if the intended benefit to the mother exceeds the potential risk for the child.

At preservation of thoracal feeding after anesthesia with articaine it is recommended to pass one breast feeding {to express and not to use milk), having replaced it on artificial.

Dosing and Administration:

Adults

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 on the palatine side. For anesthesia with palatine incisions and suturing with the goal 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 premolars of the lower jaw in the absence of inflammation, you can do without mandibular anesthesia. infiltration anesthesia, provided by injection of 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 of the tooth for sealing or treatment 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 by type infiltration anesthesia from the vestibular side. 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 intrapulpic anesthesia is at least 75 minutes, the duration of anesthesia of soft tissues is from 120 to 240 minutes. Elderly patients An increase in the concentration of the drug in the blood plasma can be caused by a decrease in metabolic processes and a decrease in the volume of distribution. In particular, the risk of cumulation of the drug increases after repeated administration. It is required to reduce the dose for diseases of the heart and liver. Patents with hepatic impairment Articaine is metabolized by the liver. A dose reduction may be required to achieve sufficient depth of anesthesia and systemic accumulation. Patients with renal insufficiency Basically articaine and its metabolites are excreted in the urine.A dose reduction may be required to achieve sufficient depth of anesthesia and systemic accumulation. Dose reduction is required for angina pectoris, atherosclerosis and other diseases listed in the "With caution" section.

Children (from 4 years to 18 years)

In patients of child age (over 4 years) the dose of the drug is selected depending on the age and body weight of the child. Recommended dose drug depends on body weight:

Body mass

Recommended dose

articaine / mg / child

drug / ml / child

20-<30

10-40

0.25 ml - 1 ml

30-<40

20-80

0.5 ml - 2 ml

40-<45

Do not exceed the dose equivalent to 7 mg of articaine / kg body weight! Maximum recommended doses for children:

Body weight (kg) (corresponds to the age groups of children according to ± norms of growth tables)

The maximum permitted dose at the rate of 7 mg / kg body weight

articaine

mg / child

a drug

ml / child

20- <30

140

3,5

30- <40

210

5,25

40- <45

280

7,0

45 - <50

315

7,9

50-<60

350

8,7

60-<70

420

10,5

70 - <80

490

12,2

Due to articaine rapidly diffuses into tissues and bone tissue density in children is lower compared to adults, infiltrative anesthesia may be used for children instead of conductive anesthesia.

Side effects:

The drug is usually well tolerated by patients, but the following side effects are possible:

From the central nervous system (depends on the magnitude of the applied dose): headache, loss of consciousness until its loss, breathing disorders until it stops, muscle tremor, involuntary twitching of the muscles, sometimes progressing up to generalized seizures;

On the part of the digestive system: nausea, vomiting, diarrhea;

From the side of the organ of vision: rarely - "clouding" in the eyes, transient blindness, diplopia.

From the side of 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 - reddening of the skin, itching, conjunctivitis, rhinitis, angioedema of various degrees (including edema of the upper and / or lower lip and / or cheeks, glottis swallowing difficulty, hives, difficulty breathing). All these phenomena can progress to the development of anaphylactic shock.

Local reactions: edema or inflammation at the injection site; the appearance of ischemic zones at the injection site (up to the development of tissue necrosis - with a random intravascular injection);

Other: often there are headaches associated, probably, with the presence of epinephrine in the formulation; other side effects caused by the action of epinephrine (tachycardia, arrhythmia, increased blood pressure), are extremely rare; nerve damage (up to the development of paralysis) - occurs only when the technique of injection is disturbed.

Overdose:

Symptoms: dizziness, motor anxiety, impaired consciousness, lowering blood pressure, tachycardia, bradycardia.

Treatment: at the appearance of the first signs of an overdose during the injection, it is necessary to stop the drug administration, give the patient a horizontal position, provide free patency of the airways, control the heart rate and blood pressure. If there is a violation of breathing - oxygen, endotracheal intubation, artificial ventilation of the lungs (central analeptics are contraindicated); with convulsions - intravenously slowly barbiturates of short action with simultaneoussupply of oxygen and control of hemodynamics; with severe circulatory disturbances and shock - intravenous infusion of solutions of electrolytes and plasma substitutes, glucocorticosteroids, albumin; with vascular collapse and increasing bradycardia - intravenously slowly epinephrine 0.1 mg, then intravenously drip under the control of heart rate and blood pressure; with severe tachycardia and tachyarrhythmia - intravenous beta-blockers (selective); with increased blood pressure - peripheral vasodilators.

Oxygenotherapy and monitoring of circulatory parameters are necessary in all cases.

Interaction:

The hypertensive effect of sympathomimetic amines such as epinephrine can be enhanced by tricyclic antidepressants and monoamine oxidase inhibitors. Interactions of this type are described for epinephrine and norepinephrine when used as vasoconstrictors at concentrations 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.

The local anesthetic effect of articaine is enhanced and lengthened by vasoconstrictive drugs.

Special instructions:

Ubistezin forte contains sulfites, which can enhance the anaphylactic reaction.

The drug can not be administered intravenously.

Do not inject into the area of inflammation. Eating is possible only after restoration of sensitivity.

To prevent infection (including hepatitis), it is always necessary to use new sterile syringes and needles every time you take a solution from vials or ampoules. Open cartridges can not be used again for other patients (hepatitis risk). Do not use a damaged cartridge.

Effect on the ability to drive transp. cf. and fur:In special tests, there was no clear effect of the drug on the concentration of attention and the speed of motor reactions. 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 the management of transport or work with the mechanisms.

Form release / dosage:

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

Packaging:By 1.7 ml in cartridges of colorless neutral glass, ukuporenny with two ends of stoppers made of brombutyl rubber. The plug closing the neck of the cartridge is protected by an aluminum foil ring. For 50 cartridges with instructions for use in a tin can, sealed with an extra translucent plastic lid.

Storage conditions:

Store in a dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 of the year. Do not use at the end of the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N016047 / 01

Date of registration:25.11.2009

The owner of the registration certificate:3M Deutschland GmbH3M Deutschland GmbH

Manufacturer: & nbsp

3M Deutschland GmbH Germany

Representation: & nbsp3M Russia ZAO3M Russia ZAO

Information update date: & nbsp11.09.2012

Illustrated instructions

Instructions

Ubistezin forte (Ubistesine forte)