Product Dossier

CITANEST

Product Dossier for CITANEST (felypressin, prilocaine hydrochloride, Dentsply Sirona). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.

What it is

Citanest Dental with Octapressin is a 3% solution containing prilocaine hydrochloride and felypressin as active substances. Prilocaine is a local anaesthetic of the amide type that stabilises the neuronal membrane and reversibly prevents the initiation and conduction of nerve impulses thereby producing local anaesthesia. Prilocaine has a similar time of onset and potency to lignocaine but has lower toxicity than lignocaine. The addition of felypressin reduces the rate of absorption of prilocaine from the site of injection thereby increasing its duration of action. Felypressin is a synthetic hormone with similar properties to vasopressin and, in contrast to adrenaline, does not produce ischaemia distal to or at the injection site.

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 dose of prilocaine at any one time should not exceed 9 mg/kg. For the average, healthy, 70 kg adult patient, the suggested dose is 1 mL for infiltration with onset of action approximately 2 minutes and duration of 40 minutes in the pulp and 2.5 hours in soft tissue, or 1.5–2 mL for nerve block with onset of action approximately 4 minutes and duration of 90 minutes in the pulp and 3.5 hours in soft tissue.

Key safety warnings

Resuscitative equipment and medicines, including oxygen, should be immediately available in order to manage possible adverse effects involving the cardiovascular, respiratory or central nervous systems. Injection should always be made slowly with frequent aspirations to avoid inadvertent intravascular injection, and multiple injections should be administered at spaced intervals. In patients with hypoxaemia there is the potential for further hypoxic embarrassment as large doses of prilocaine may produce methaemoglobinaemia. 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, and the ingestion of food should therefore be postponed until normal function returns. Although largely free of side-effects as an additive to prilocaine, felypressin may cause a rise in blood pressure or coronary constriction if an overdose is given.

Contraindications

Allergy or hypersensitivity to amide type local anaesthetics or other components of the injection solution. 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

Citanest Dental with Octapressin 2.2 mL injection cartridge was first registered on the ARTG on 13 August 1991. The 1.8 mL injection cartridge variant was first listed on 21 May 2008. The product information was most recently amended on 7 July 2014.