Adrenaline with articaine hydrochloride

STRENGTH SCOPE: only the 1:200,000 adrenaline strength is covered. The page names adrenaline 1:100,000 or 1:200,000, but the pinned SPC dosing is for the 1:200,000 product only; the SPC states that 'Septanest/Artikent/Bartinest/Isonest 1:100,000 is also available and is preferable for use in more complex procedures, such as requiring pronounced hemostasis', and the 1:100,000 product's own SPC is NOT covered here. §4.1 (verbatim): 'Local and loco-regional anaesthesia in dental procedures. Septanest/Artikent/Bartinest/Isonest 1:200,000 is indicated in adults, adolescents and children above 4 years of age (or from 20 kg (44 lbs) of body weight).' §2 (verbatim): 'Per 1.7 ml cartridge Per 2.2 ml cartridge Articaine hydrochloride (INN) 68.000 mg 88.000 mg ... Adrenaline tartrate (expressed in base) 8.50 micrograms (1:200 000) 11.00 micrograms (1:200 000)'. VERBATIM §4.2: 'For professional use by physicians or dentists only.' 'For all populations, the lowest dose leading to effective anaesthesia should be used. The necessary dosage must be determined on an individual basis. For a routine procedure, the normal dose for adult patients is of 1 cartridge, but the contents of less of a cartridge may be sufficient for effective anaesthesia. At the discretion of the dentist, more cartridges may be required for more extensive procedures without exceeding the maximum recommended dose.' 'Septanest/Artikent/Bartinest/Isonest 1:200,000 is indicated for use in most routine dental procedures.' 'In adults and adolescents, the maximum articaine dose is 7 mg/kg with an absolute maximum articaine dose of 500 mg. The maximum articaine dose of 500 mg corresponds to a healthy adult of more than 70 kg body weight.' Printed maximum-dose table (adults and adolescents; body weight, maximum articaine hydrochloride, adrenaline dose, total volume): 40 kg, 280 mg, 0.035 mg, 7.0 ml (4.1 cartridges of 1.7 ml; 3.1 cartridges of 2.2 ml); 50 kg, 350 mg, 0.044 mg, 8.8 ml (5.2; 4); 60 kg, 420 mg, 0.053 mg, 10.5 ml (6.2; 4.7); 70 kg or more, 490 mg, 0.061 mg, 12.3 ml (7.0; 5.5). The table lists 490 mg for 70 kg or more while the text prints an absolute maximum of 500 mg; both are as printed. CONCOMITANT SEDATIVES (§4.2): 'The maximum safe dose of local anaesthetics may be reduced in sedated patients due to an additive effect on central nervous system depression (see section 4.5).' METHOD (§4.2): 'Infiltration and perineural use in oral cavity. Local anaesthetics should be injected with caution when there is inflammation and/or infection at the site of the injection. The rate of injection should be very slow (1 ml/min).' 'When using Septanest/Artikent/Bartinest/Isonest 1:200,000 for infiltration or regional block anaesthesia, injection should always be made slowly and with prior aspiration.' 'This medicinal product should only be used by or under the supervision of physicians or dentists sufficiently trained and familiar with diagnosis and treatment of systemic toxicity. The availability of appropriate resuscitation equipment and medication should be ensured before induction of regional anaesthesia with local anaesthetics to enable prompt treatment of any respiratory and cardiovascular emergencies.' 'The patient's state of consciousness should be monitored after each local anaesthetic injection.' TRUNCATION: §4.2, §4.3, §4.6 and §2 were retrieved in full; the retrieved §4.4 ends part-way through the intravascular-injection precaution, §4.5 ends at the ergot-type oxytocic entry and §4.8 ends part-way through the musculoskeletal entries at the source-fetch limit, so the safety lists below are partial. Paediatric and special-population information is in the paediatric block and the renal / hepatic fields.

As printed in SPC §4.2 (Children 4 to 11 years of age), not scaled from the adult dose. Verbatim: 'The safety of Septanest/Artikent/Bartinest/Isonest 1:200,000 in children aged 4 years and below has not been established. No data are available. The quantity to be injected should be determined by the age and weight of the child and the magnitude of the operation. The average effective dose of articaine is 2 mg/kg and 4 mg/kg for simple and complex procedures, respectively. The lowest dose providing effective dental anaesthesia should be used. In children aged 4 years (or from 20 kg (44 lbs) of body weight) and above, the maximum dose of articaine is 7 mg/kg only with an absolute maximum dose of 385 mg articaine for a healthy child of 55 kg body weight.' Printed maximum-dose table for children (body weight, maximum articaine hydrochloride, adrenaline dose, total volume): 20 kg, 140 mg, 0.018 mg, 3.5 ml (2.1 cartridges of 1.7 ml; 1.5 cartridges of 2.2 ml); 30 kg, 210 mg, 0.026 mg, 5.3 ml (3.1; 2.4); 40 kg, 280 mg, 0.035 mg, 7.0 ml (4.1; 3.1); 55 kg or more, 385 mg, 0.048 mg, 9.6 ml (5.6; 4.3). No dose is given for children aged 4 years and below, or below 20 kg. Risk of biting trauma (lips, cheeks, mucosa and tongue) exists, especially in children (§4.4).