ARTG Entry
XYLONOR
ARTG entry for XYLONOR (cetrimide, lidocaine), ARTG 20752 — Product Information, dosage form, registration history. Compiled by arcimedes.
- Sponsor: Specialites Septodont
- Active ingredient: cetrimide, lidocaine
- Therapeutic area: Pain Management
What it is
XYLONOR is a topical anaesthetic containing lidocaine and cetrimide. It is an association of a powerful anaesthetic (lidocaine) and a bactericide (cetrimide), in a non-irritant, water-soluble excipient. The surface anaesthetic effect reaches its peak within two to five minutes of application and is complemented by a disinfectant action. XYLONOR is supplied in three formulations. The spray contains lidocaine 15 g and cetrimide 0.15 g per 100 g, and contains saccharin and alcohol. The gel contains lidocaine 5 g and cetrimide 0.15 g per 100 mL, and contains saccharin. The pellets contain lidocaine 5 g and cetrimide 0.15 g per 100 mL, with one impregnated pellet containing approximately 100 mg of the solution.
Approved indications
XYLONOR is indicated for topical anaesthesia and disinfection of the oral mucosa before injections, extraction of mobile, deciduous or permanent teeth, extraction of teeth due to pyorrhoea, adjusting and fitting of crowns and bridges, lancing of abscesses, and scaling. The gel formulation is also indicated for prevention of gagging during impression taking.
Dosing overview
For the gel formulation, the previously dried mucosa is massaged with a cotton pellet impregnated with gel, with anaesthesia occurring shortly after application and taking full effect within two to five minutes. For the pellets formulation, the previously dried mucosa is massaged with a selected pellet, left in situ for a few seconds, with anaesthesia obtained within two to five minutes. For the spray formulation, the nozzle tip is placed about 2 cm from the area to be anaesthetised and pressed vertically to cover an area of about 1 cm in diameter. This procedure may be repeated in 4 or 5 different areas of the buccal mucosa during the same sitting. Each actuation of the valve releases approximately 10 mg of lidocaine.
Key safety warnings
Patients should hold their breath whilst the spray is being used on surface tissue. Patients should be cautioned to expectorate any excess anaesthetic, whatever form is used, to avoid excess absorption.
Contraindications
XYLONOR is contraindicated in patients known to be hypersensitive to local anaesthetics of the amide type, or to cetrimide.
Regulatory history
XYLONOR GEL and XYLONOR PELLETS were first approved on 3 October 1991. XYLONOR SPRAY SOLUTION was first approved on 13 July 1994.