CITANEST

What it is

CITANEST contains prilocaine hydrochloride as the active substance. Prilocaine is a membrane stabilising agent and a local anaesthetic of the amide type. Prilocaine stabilises the neuronal membrane and reversibly prevents the initiation and conduction of nerve impulses thereby producing local anaesthesia. CITANEST is available in three formulations. 4% CITANEST DENTAL contains prilocaine hydrochloride. 3% CITANEST with ADRENALINE 1:300,000 contains prilocaine hydrochloride and adrenaline acid tartrate as the active substances. 3% CITANEST Dental with OCTAPRESSIN contains prilocaine as prilocaine hydrochloride and felypressin as the active substances. Felypressin is a synthetic hormone with similar properties to vasopressin. It is used as a vasoconstrictor in local anaesthetics when sympathomimetics should be avoided.

Approved indications

— Production of local anaesthesia in routine dental procedures and oral surgery by means of infiltration and nerve block techniques.

Dosing overview

The lowest dosage that results in effective anaesthesia should be used. The dosage will also depend on the area of the oral cavity to be anaesthetised, the vascularity of the oral tissues and the technique of anaesthesia. It is recommended that the dose of prilocaine at any one time should not exceed 6mg/kg (plain solution) or 9mg/kg (ADRENALINE or OCTAPRESSIN containing solutions). For children, the dose may have to be reduced commensurate with body weight. The dosage should be calculated for each patient individually and modified in accordance with the dentist's experience and knowledge of the patient.

Key safety warnings

When any local anaesthetic agent is used, resuscitative equipment and drugs, including oxygen, should be immediately available in order to manage possible adverse reactions involving the cardiovascular, respiratory or central nervous systems. Injection should always be made slowly with frequent aspirations to avoid inadvertent intravascular injection which can produce toxic effects. Multiple injections should be administered at spaced intervals. Methaemoglobinaemia and cyanosis may occur following the administration of prilocaine solutions, particularly following a high dose. This is caused by the metabolite o-toluidine. In patients with hypoxaemia there is the potential for further hypoxic embarrassment as large doses of prilocaine may produce methaemoglobinaemia. Prilocaine should be given with great caution to patients with severe bradycardia, cardiac conduction disturbances or severe digitalis intoxication. Adrenaline-containing solutions should be used with extreme caution in patients with severe or untreated hypertension, arteriosclerotic heart disease, heart block, cerebral vascular insufficiency, thyrotoxicosis or any other pathological condition that might be aggravated by the effects of adrenaline. Adrenaline may induce anginal pain in patients suffering from ischaemic heart disease. The patient should be advised to exert caution to avoid inadvertent trauma to the lips, tongue, cheek mucosa or soft palate when these structures are anaesthetised. The ingestion of food should therefore be postponed until normal function returns.

Contraindications

Allergy or hypersensitivity to amide type local anaesthetics or other components of the injection solution which may be present. Congenital or idiopathic methaemoglobinaemia. Local anaesthetic techniques must not be used when there is inflammation and/or sepsis in the region of the proposed injection.

Regulatory history

TGA approval date: February 28, 2005.