Posology : מינונים

4.2 Posology and method of administration                           Other special patient groups
Posology                                                             • Doses should be reduced in patients in poor general Local and regional anaesthesia.                                      condition or in those with reduced protein binding As a matter of principle the smallest possible dose that             capacity (resulting e.g. from renal insufficiency, liver produces adequate anaesthesia should be administered.                insufficiency, cancer, pregnancy).
The dosage should be adjusted individually according to              • In patients with severe renal insufficiency the dose the particulars of each case.                                        may need to be adapted due to reduced clearance and increased half-life of lidocaine (see section 5.2). Patients
Adults:                                                              with liver diseases show reduced tolerance towards When injected into tissues with marked systemic                      amide-type local anaesthetics. This may be due to absorption, without combination with a vasoconstrictor, a            reduced hepatic metabolism and decreased protein single dose of lidocaine Hydrochloride monohydrate                   synthesis resulting in a lower protein binding rate of the should not exceed 4.5 mg/kg body weight (BW) (or 300                 local anaesthetic. Dose reduction is advisable in such mg). If combined with a vasoconstrictor, 7 mg/kg BW (or              cases.
500 mg) of lidocaine Hydrochloride monohydrate per                   • The dose should be reduced in patients showing clinical single dose should not be exceeded.                                  signs of cardiac insufficiency. Nevertheless, local or regional nerve blockage can be the anaesthetic method
For the clinical uses listed below, recommendations for              of choice in such patients.
single doses and strengths of the injection solution to be           • During pregnancy, the dose may need to be reduced administered to adults with average body weight (70 kg)              depending on the type of anaesthesia. Regional are as follows:                                                      anaesthetic blocks in which usually large doses are Usual
Type of              Concentration volume    Maximum dose [mg] required should be avoided during the first trimester.
anaesthesia          [%]                                              For use in anaesthetic blocks in which smaller doses are [ml]
300                      administered, the dosage may need to be reduced Infiltration         0.5-1                                            because of the altered anatomical and physiological 500 (with epinephrine)
Major nerve blocks   1-2            30-50    500 (with epinephrine)   characteristics in late pregnancy.
Minor nerve blocks   1              5-20     200
Antiarrhythmic therapy
Epidural             1-2            15-30*   500 (with epinephrine)   Adults Spinal
1.5 or 5 in
1-2      100                      The dosage must be adjusted according to individual 7.5% glucose                                     requirements and the therapeutic effect.
Intravenous regional anaesthesia (IVRA) 0.5              40
- upper limb         0.25           50-100
Bolus:
-lower limb                                                           Usual loading doses are 50 - 100 mg or 1 - 1.5 mg/kg *1.5 ml per segment in average                                     BW of lidocaine Hydrochloride monohydrate as direct intravenous injection, corresponding to approximately
2.5 - 5 ml or 0.05 ‑ 0.075 ml/kg BW of LIDOCAINE                monitored for toxic effects caused by accumulation of
HYDROCHLORIDE S.A.L.F. 20 mg/ml. The rate of                    active metabolites.
injection should not exceed 25-50 mg/min,
corresponding to approximately 1.25 – 2.5 ml/min                In cases of severe renal insufficiency the dose may LIDOCAINE HYDROCHLORIDE S.A.L.F. 20 mg/ml.                      need to be adapted (see also section 5.2).
If the therapeutic effect of the first dose is insufficient within the first 5 – 10 minutes, the initial dose may be        Method of administration repeated once or twice up to a maximum dose of                  Local and regional anaesthesia 200 - 300 mg in 1 hour.                                         Intradermal, intramuscular, subcutaneous, or submucosal use (infiltration), perineural (injection into
Maintenance:                                                    the surroundings of peripheral nerves), epidural or To maintain therapeutic plasma lidocaine concentrations         spinal use.
(1.5 ‑ 5 microgram/ml), lidocaine Hydrochloride                 Intravenous use regarding intravenous regional monohydrate is infused at a rate of 20 ‑ 50 microgram/kg        anaesthesia (Bier`s block).
BW/min (about 1-4 mg/min), corresponding to                     Every local anaesthetic procedure should only be approximately 0.001 – 0.0025 ml/kg BW/min.                      carried out by personnel adequately skilled in the Infusions can be prepared by adding 1000 mg of                  respective anaesthetic technique.
lidocaine Hydrochloride monohydrate, corresponding to 50 ml LIDOCAINE HYDROCHLORIDE S.A.L.F.                       Antiarrhythmic therapy 20 mg/ml, to 500 ml of glucose 5% solution or                   Intravenous use physiological saline.                                           Administer as slow intravenous injection or intravenous The infusion should be terminated as soon as the                infusion after dilution in a suitable vehicle solution.
patient's basic cardiac rhythm appears to be stable or          Because of the relatively short duration of action of at the earliest signs of toxicity. It should rarely be          lidocaine, the injection should be followed by necessary to continue the infusion beyond 24 hours.             continuous infusion, if possible, using an infusion As soon as possible, patients should be changed to an           pump.
oral antiarrhythmic agent for maintenance therapy.