UBISTESIN

What it is

Ubistesin and Ubistesin Forte contain articaine hydrochloride and adrenaline (epinephrine) as solution for injection. Articaine hydrochloride is a local anaesthetic. Adrenaline (epinephrine) is a vasoconstrictor. Ubistesin contains articaine hydrochloride 4% with adrenaline (epinephrine) 1:200,000. Ubistesin Forte contains articaine hydrochloride 4% with adrenaline (epinephrine) 1:100,000. Each 1.7 mL cartridge of Ubistesin contains 68.00 mg articaine hydrochloride and 10.2 micrograms adrenaline (epinephrine) hydrochloride (equivalent to 8.5 micrograms adrenaline). Each 1.7 mL cartridge of Ubistesin Forte contains 68.00 mg articaine hydrochloride and 20.4 micrograms adrenaline (epinephrine) hydrochloride (equivalent to 17.0 micrograms adrenaline).

Approved indications

— Ubistesin is used for local anaesthesia (infiltration and nerve-block anaesthesia) in dentistry during minor procedures in adults, adolescents and children 4 years of age and older. — Ubistesin Forte is used for local and regional anaesthesia (infiltration and nerve-block anaesthesia) in dentistry during minor and complicated procedures in adults, adolescents and children 4 years of age and older.

Dosing overview

The smallest possible volume of solution which will lead to an effective anaesthesia should be used. For most common operations, one infiltration with Ubistesin and Ubistesin Forte 1.7 mL is sufficient. In all cases, the injection must be done slowly (about 1 mL/minute). The maximum recommended dose for normal healthy adults of articaine hydrochloride administered by submucosal infiltration and/or nerve block should not exceed 7 mg/kg of bodyweight. The duration of the anaesthesia during which an operation can be performed is about one hour (pulpal analgesia) depending on the technique used, and on the procedure. Dosages in paediatric patients (over 4 years) should be reduced, commensurate with age, bodyweight and physical condition. The maximum recommended dose for normal healthy children must not exceed 7 mg/kg of bodyweight.

Key safety warnings

Injection should always be made slowly with frequent aspirations to avoid inadvertent intravascular injection, which can produce cerebral symptoms even at low doses. Accidental intravascular injection may cause sudden high levels of adrenaline and articaine in the systemic circulation. This may be associated with severe adverse reactions, such as convulsions, atrioventricular block or ventricular arrhythmias followed by central nervous system and cardiorespiratory depression and coma, progressing to respiratory and cardiac arrest. Accidental intraneural injection may lead the drug to move in retrograde manner along the nerve. In order to avoid intraneural injection and to prevent nerve injuries in connection with nerve blockades, the needle should always be slightly withdrawn if electric shock sensation is felt by the patient during injection or if the injection is particularly painful. Very rare cases of prolonged or irreversible nerve injury and gustatory loss have been reported after mandibular block analgesia. Adrenaline (epinephrine) impairs the flow of blood in the gums, potentially causing local tissue necrosis. Risk of biting trauma (lips, cheeks, mucosa, and tongue) exists, especially in children; the patient should be told to avoid chewing gum or eating until normal sensation is restored.

Contraindications

Contraindications include hypersensitivity to articaine (or any local anaesthetic agent of the amide type) or to adrenaline (epinephrine) or to any of the excipients, phaeochromocytoma, uncontrolled hyperthyroidism, plasma cholinesterase deficiency, and complete heart block not compensated by a pacemaker. Ubistesin contains sodium sulfite, which may cause allergic reactions, including anaphylactic reactions and asthmatic episodes, in susceptible people.

Regulatory history

Ubistesin articaine hydrochloride 4% with adrenaline (epinephrine) 1:200,000 solution for injection cartridge was first listed on the ARTG on 6 June 2011. Ubistesin Forte articaine hydrochloride 4% with adrenaline (epinephrine) 1:100,000 solution for injection cartridge was first listed on the ARTG on 6 June 2011.