Index of drugs

Local and dermal local anesthesia in dentistry. Ubistesin is mainly recommended for routine procedures in dentistry, such as single and multiple tooth extractions, development of hard tissue defects and teeth grinding. Ubistesin forte is especially indicated for procedures that require the most effective anesthesia as well as the so-called dry operating field, e.g. surgical operations within the mucous membrane and bones; tooth pulp procedures (amputation and emphysema); dental extractions and trepanning with periodontitis and broken tooth extractions.

1 ml of Ubistesin solution contains 40 mg of articaine hydrochloride and 0.006 mg of epinephrine hydrochloride. 1 ml of Ubistesin forte solution contains 40 mg of articaine hydrochloride and 0.012 mg of epinephrine hydrochloride.

The articaine contained in the preparation is an amide type anesthetic. It causes the reversible inhibition of autonomic, sensory and motor nerve fibers. The probable mechanism of action is to block the voltage-dependent sodium channels in the nerve fiber sheath. Articaine is characterized by a rapid onset of anesthesia - latent period of 1-3 min - strong analgesic effect and good local tolerance. Epinephrine narrows the blood vessels locally, resulting in delayed absorption of articaine. The result is a higher concentration of local anesthetics at the application site, a longer period of time and a reduction in systemic side effects. Following administration, anesthesia persists for at least 75 min in the case of pulp anesthesia and 120-140 min in the case of soft tissue anesthesia. The preparation is quickly and almost completely absorbed. After injection into the gingiva, the maximum concentration of articaine in the plasma is reached after 10-15 minutes. Articaine binds to 95% of plasma proteins. T_0,5 is about 20 minutes. Articaine and its metabolites are mainly excreted in urine. Epinephrine is rapidly catabolized in the liver and other tissues; metabolites are excreted through the kidneys.

Use in children under 4 years. Hypersensitivity to the active substance or any of the excipients.Because of the content of articaine preparation must not be used in cases of: hypersensitivity to amide local anesthetics, severe disturbances of nerve impulses conduction and cardiac conduction system, sudden exacerbations of heart failure (acute heart failure), severe hypotension, patients with known deficiency of plasma cholinesterase activity, hemorrhagic diathesis - especially in case of aortic anesthesia, injections into areas affected by inflammation.Due to the content of epinephrine It must not be used in cases of: heart diseases such as: unstable angina, recently-acquired myocardial infarction, recent coronary artery bypass surgery in cases of refractory arrhythmias, paroxysmal tachycardia or persistent high-frequency arrhythmia , untreated or uncontrolled severe hypertension, untreated or uncontrolled congestive heart failure and concomitant treatment with MAO inhibitors or tricyclic antidepressants.Due to the sulphite content The preparation must not be used in cases of hypersensitivity to sulphates or severe bronchial asthma. The preparation may cause severe allergic reactions with anaphylactic symptoms (eg bronchospasm).

The preparation should be used with extreme caution in cases of: severe renal dysfunction, angina pectoris, arteriosclerosis, severe blood coagulation disorders, thyrotoxicosis, narrow-angle glaucoma, diabetes, lung diseases - especially allergic asthma,pheochromocytoma. Accidental injection may cause convulsions followed by depression o.u.n. or cardiac arrest and respiratory function - resuscitation equipment, oxygen and resuscitation drugs should be available for immediate use.The preparation should be used with caution in patients with liver disease; in patients with severe liver disease there is a greater risk of exceeding the toxic plasma concentration of the preparation. Exercise caution in patients with cardiovascular dysfunction - these patients have reduced ability to compensate for functional changes associated with prolongation of A-V conduction caused by administration of the preparation. The preparation should be used with caution in patients with a history of epilepsy. In patients treated with anticoagulants (eg, Heparin or acetylsalicylic acid) inattentive venipuncture when administering an anesthetic can lead to severe bleeding. Avoid inadvertent administration of the detergent. During the development of cavities or pillar teeth one should take into account the reduced blood flow in the pulp as a result of the adrenaline contained in the preparation - in this case there is a risk of overlooking the exposed pulp. Elderly, the plasma concentration may increase. The risk of accumulation of the preparation increases particularly in the case of repeated applications, e.g. after an additional injection. A similar effect may occur in patients with poor general condition and with severe hepatic and renal impairment (a lower dose is recommended). Phenothiazines may reduce or reverse the hypertensive effect of adrenaline - the simultaneous use of both factors should be avoided; in situations where simultaneous therapy is necessary, the patient should be carefully monitored. Co-administration of non-selective β-blockers may lead to increased blood pressure due to the content of epinephrine in the formulation.

There is no clinical experience regarding use in women during pregnancy and lactation. The safety of local anesthetics during pregnancy has not been investigated for adverse effects on fetal development. During pregnancy, use the preparation only after careful consideration of the risks and benefits of its use. Permeation of articaine and its metabolites into breast milk has not been studied. However, based on preclinical safety data, it can be assumed that articaine does not reach clinically relevant concentrations in breast milk. Therefore, nursing mothers should pour the first portion of milk separated after anesthesia with articaine containing agents.

Because of the content of articaine: rare: decreased heart rate, hypotension, decreased blood pressure, impulse conduction in the heart, bradycardia, asystole, cardiovascular function, metallic taste, tinnitus, dizziness, nausea, vomiting, anxiety, anxiety, yawning , tremor, nervousness, nystagmus, retinopathy, headache, increased respiratory rate, paresthesia (loss of sensation, burning, tingling) of the lip, tongue or both, increase and then decrease in the respiratory rate that can lead to apnea; very rare or not known: hypersensitivity to articaine (rash, pruritic edema, pruritus, erythema, nausea, diarrhea, wheezing, anaphylaxis). In patients with delayed hypersensitivity to prilocaine, cross-sensitivity to articaine was observed. In patients with no clinical signs of methemoglobinemia, high doses of articaine can cause methemoglobinemia.Due to the content of epinephrine: rarely: heat sensation, sweating, palpitations, migraine-like headache, increased blood pressure, angina pectoris, tachycardia, tachyarrhythmia, cardiovascular arrest or acute thyroid edema.Due to the sulphite content in very rare cases, allergic reactions or hypersensitivity may occur, especially in the case of bronchial asthma, which are manifested in the form of vomiting, diarrhea, wheezing, an acute attack of asthma, clouding of consciousness or shock.Due to the content of articaine and epinephrine: 2 weeks after the use of articaine and / or epinephrine the occurrence of facial nerve paralysis, which persisted after 6 months, has been described. Disorders of the clinical picture may be the result of simultaneous appearance of various complications and side effects.

Preparation for injections within the oral mucosa. Always use the smallest volume of fluid that will lead to effective anesthesia.Ubistesin. In the extractions of the teeth of the jaw, under anesthesia of a single tooth, in most cases, it is enough to administer 1.7 ml of the preparation, however, painful injection on the side of the palate can be dispensed with. In the case of multiple neighboring teeth extractions it is often possible to reduce the amount of injectable solution to 1-2 amps. In the case of incision or stitching of the palatal tissues, it is recommended to perform a palatine injection of 0.1 ml on the puncture. In simple extractions of the premolars in the mandible, 1.7 ml is usually sufficient for sowing with an anesthetic anesthesia. In individual cases, an additional injection of 1-1.7 ml of buccal anesthesia is required. In rare cases, it may be necessary to inject into the mandibular region. The 0.5-1.7 ml atrial injection with the right tooth enables defects to be developed and the abutment of the abutment teeth. For the extraction of molars in the mandible, it is advisable to perform aortic anesthesia. If the preparation is used in children, the amount of solution for injection should be reduced according to the child's weight. The amount of solution for injection in one treatment should not exceed 1.5 ml in children at birth. 20-30 kg; whereas in children about the month of 30-45 kg, respectively, 2-5 ml. Generally in children with b. approx. 20-30 kg is sufficient with 0.25-1 ml of solution; in children about the month of 30-45 kg of 0.5-2 ml solution. In adults, healthy patients, the maximum dose of the active substance articaine is 7 mg / kg. (500 mg for a 70 kg patient); it is the equivalent of 12.5 ml of the preparation. The maximum dose is 0.175 ml of the final solution / kg. In children, the amount of solution injected depends on the age and weight of the child and the extent of the treatment. Do not use a dose greater than the equivalent of 5 mg articaine / kg body weight. In the case of long-term treatments and if there is a risk of significant bleeding in the treatment area, Ubistesin Forte can also be used.Ubistesin forte. In the extractions of the teeth of the jaw, under anesthesia of a single tooth, in most cases, it is enough to administer 1.7 ml of the preparation, however, painful injection on the side of the palate can be dispensed with. In the case of multiple extractions of adjacent teeth, it is often possible to reduce the amount of solution for injection. In the case of incision or stitching of the palatal tissues, it is recommended to perform a palatine injection of 0.1 ml on the puncture. In simple extractions of the premolars in the mandible, 1.7 ml is usually sufficient for sowing with an anesthetic anesthesia. In individual cases, an additional injection of 1-1.7 ml of buccal anesthesia is required. In rare cases, it may be necessary to inject into the mandibular region. The 0.5-1.7 ml atrial injection with the right tooth enables defects to be developed and the abutment of the abutment teeth. For the extraction of molars in the mandible, it is advisable to perform aortic anesthesia. For all surgical procedures, the dose of Ubistesin forte should be determined individually, depending on the type and duration of the procedure and the patient's condition. If the preparation is used in children, the amount of solution for injection should be reduced according to the child's weight. The amount of solution for injection in one treatment should not exceed 1.5 ml in children at birth. 20-30 kg, or 2.5 ml in 24 hours; in children about the month of 30-45 kg, respectively, 2 ml or 5 ml. Generally in children with b. approx. 20-30 kg is sufficient with 0.25-1 ml of solution; in children about the month of 30-45 kg of 0.5-2 ml solution. In adults, healthy patients, the maximum dose of the active substance articaine is 7 mg / kg. (500 mg for a 70 kg patient); it is the equivalent of 12.5 ml of the preparation. In children, the amount of solution injected depends on the age and weight of the child and the extent of the treatment. Do not use a dose greater than the equivalent of 5 mg articaine / kg body weight. In the case of short procedures and if the bleeding in the surgical field is not significant, Ubistesin may also be used.
In elderly patients, in patients with poor general condition and with severe hepatic and renal impairment and in patients with some existing diseases (angina pectoris, hardening of the arteries) a lower dose is recommended (the minimum amount necessary to obtain an adequate depth of anesthesia) .
Preparation for use only during dental anesthesia. To avoid accidental intravascular administration, always carefully aspirate at least in two positions (needle rotation 180 degrees). A negative aspiration result does not exclude the possibility of unintentional and unnoticed injection into the dish. The injection speed should not exceed 0.5 ml within 15 seconds, i.e. 1 amp / min. Aspirin slowly inject 0.1-0.2 ml. The remaining part of the product should be given no earlier than after 20-30 s. Open ampoules should not be used in other patients.