SEPTANEST

What it is

SEPTANEST is articaine hydrochloride with adrenaline (epinephrine) acid tartrate, where articaine hydrochloride is a local anaesthetic and adrenaline (epinephrine) acid tartrate is a vasoconstrictor. Two strengths are available: SEPTANEST 1:100,000 containing articaine hydrochloride 40 mg/mL with adrenaline (epinephrine) 10µg/mL, and SEPTANEST 1:200,000 containing articaine hydrochloride 40 mg/mL with adrenaline (epinephrine) 5µg/mL. Both strengths are supplied as clear, not opalescent, colourless solutions for injection in cartridges. Cartridges are available in 1.7 mL or 2.2 mL volumes.

Approved indications

— SEPTANEST 1:100,000 is indicated for local or regional anaesthesia for both simple and complex dental procedures in adults, adolescents and children 4 years of age and older. — SEPTANEST 1:200,000 is indicated for local anaesthesia for simple dental procedures in adults, adolescents and children 4 years of age and older.

Dosing overview

For most common operations in adults, one infiltration with 1.7 mL SEPTANEST 1:200,000 or SEPTANEST 1:100,000 is sufficient. The injection must be done slowly at about 1 mL/min. The maximum recommended dose for normal healthy adults administered by submucosal infiltration and/or nerve block should not exceed 7 mg/kg of body weight, which corresponds for a 60 kg subject to six standard 1.7 mL cartridges or five standard 2.2 mL cartridges. Anaesthesia is obtained rapidly within 1 to 6 minutes. The duration of anaesthesia during which an operation can be performed is about one hour. Dosages in paediatric patients over 4 years should be reduced, commensurate with age, body weight, and physical condition. The maximum recommended dose for normal healthy children must not exceed 7 mg/kg of body weight. Safety and effectiveness in paediatric patients below the age of 4 years have not been established, and use in children under 4 years of age is not recommended due to the absence of safety and efficacy data.

Key safety warnings

One or more cartridges should be used on a single patient on one occasion only during each session of treatment, and if only a portion of a cartridge is used, the remainder must be discarded. The solution for injection should not be mixed with any other product into the same syringe, and no opened cartridge of anaesthetic solution should be reused.

Regulatory history

SEPTANEST 1:100,000 in 1.7 mL and 2.2 mL cartridge formulations were first registered on the ARTG on 21 May 2004. SEPTANEST 1:200,000 in 1.7 mL and 2.2 mL cartridge formulations were first registered on the ARTG on 7 October 2016.