Active Ingredient: Levobupivacaine
Small doses of local anaesthetics injected into the head and neck area, including retrobulbar, dental and stellate ganglion blocks, may produce adverse reactions similar to systemic toxicity seen with unintentional intravascular injections of larger doses. The injection procedures require the utmost care. Reactions may be due to intraarterial injection of the local anaesthetic with retrograde flow to the cerebral circulation. They may also be due to puncture of the dural sheath of the optic nerve during retrobulbar block with diffusion of any local anaesthetic along the subdural space to the midbrain. Patients receiving these blocks should have their circulation and respiration monitored and be constantly observed. Resuscitative equipment and personnel for treating adverse reactions should be immediately available.
For this indication, competent medicine agencies globally authorize below treatments:
Infiltration
2.5 - 150 mg
From 2.5 To 150 mg once every day
The table below is a guide to dosage for the more commonly used blocks. For analgesia (e.g. epidural administration for pain management), the lower concentrations and doses are recommended. Where profound or prolonged anaesthesia is required with dense motor block (e.g. epidural or peribulbar block), the higher concentrations may be used. Careful aspiration before and during injection is recommended to prevent intravascular injection.
There is limited safety experience with levobupivacaine therapy for periods exceeding 24 hours. In order to minimise the risk for severe neurological complications, the patient and the duration of administration of levobupivacaine should be closely monitored (see section 4.4).
Aspiration should be repeated before and during administration of a bolus dose, which should be injected slowly and in incremental doses, at a rate of 7.5–30 mg/min, while closely observing the patient’s vital functions and maintaining verbal contact.
If toxic symptoms occur, the injection should be stopped immediately.
The maximum dosage must be determined by evaluating the size and physical status of the patient, together with the concentration of the agent and the area and route of administration. Individual variation in onset and duration of block does occur. Experience from clinical studies shows onset of sensory block adequate for surgery in 10-15 minutes following epidural administration, with a time to regression in the range of 6-9 hours.
The recommended maximum single dose is 150 mg. Where sustained motor and sensory block are required for a prolonged procedure, additional doses may be required. The maximum recommended dose during a 24 hour period is 400 mg. For post-operative pain management, the dose should not exceed 18.75 mg/hour.
Table of doses:
| Concentration (mg/ml)1 | Dose | Motor Block | |
|---|---|---|---|
| Surgical Anaesthesia | |||
| Local Infiltration – Adults | 2.5 | 1-60 ml (2.5-150 mg max) | Not applicable |
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