Section 4.8 – Additional Text

The adverse reaction profile for Xylocaine with adrenaline is similar to those of other amide local anaesthetics. Adverse reactions caused by the drug per se are difficult to distinguish from the physiological effects of the nerve block (e.g. decrease in blood pressure, bradycardia), events caused directly (e.g. nerve trauma) or indirectly by the needle puncture.

Section 5.3

Additional information regarding genotoxicity and carcinogenicity:

Genotoxicity tests with lidocaine showed no evidence of mutagenic potential. A metabolite of lidocaine, 2,6-dimethylaniline, showed weak evidence of activity in some genotoxicity tests. The metabolite 2,6-dimethylaniline has been shown to have carcinogenicity potential in preclinical toxicological studies evaluating chronic exposure. Risk assessments comparing the calculated maximum human exposure from intermittent use of lidocaine, with the exposure used in preclinical studies, indicate a wide margin of safety for clinical use.

Section 10

Date of revision of text: 31^st January 2011

Section 4.2 and Section 4.4

Change of text relating to the use of solutions containing preservative:

Preservative containing solutions i.e. those supplied in multidose vials should not be used when:

-      The volume to be injected in a single dose exceeds 15 ml, unless otherwise justified.

-      The preparation is intended for administration by routes where, for medical reasons, an antimicrobial preservative is not acceptable, such as intracisternally, epidurally, intrathecally or by any route giving access to the cerebrospinal fluid, or intra- or retro-bulbary.

Section 4.4

Additional text to include a warning regarding reports of chondrolysis in patients receiving post operative intra-articular continuous infusion of local anaesthetics:

-   There have been post-marketing reports of chondrolysis in patients receiving post-operative intra-articular continuous infusion of local anaesthetics. The majority of reported cases of chondrolysis have involved the shoulder joint. Due to multiple contributing factors and inconsistency in the scientific literature regarding mechanism of action, causality has not been established. Intra-articular continuous infusion is not an approved indication for Xylocaine.

Section 4.8

Undesirable effects:

Addition of word “hypertension” in Common, first sentence, “Vascular disorders: Hypotension, hypertension”.

Additional word “vomiting” in Common, second sentence, “Gastrointestinal disorders: Nausea, vomiting”.

Section 10

Revised date:  4^th March 2009

Update to Sections 4.1, 4.2 and 4.4 to include a Ph Eur restriction regarding the use of solutions containing preservatives

Section 4.1

Deleted text:  Epidural block

Section 4.2

Additional text second paragraph:

The figures reflect the expected average dose range needed. Standard textbooks should be consulted for factors affecting specific block techniques and for individual patient requirements.

Changes to Table

Deletion of text relating to Surgical Anaesthesia

Field Block section of table  - Change of text

Infiltration doses changed from 40 ml to 15 ml and  from 400 to 150 mg

Intercostals dose

Additional text:  2‑5 max 15ml     
20-50mg   max 150mg

Major nerve block

Deletion of text relating to Brachial plexus: Axillary

Deletion of text relating to Supraclavicular, intrascalene and subclavian perivascular

Change of dose to Sciatic   from 20 to 15ml   and  400 to 300 mg

Additional text immediately after table:

Please note: Preservative containing solutions i.e. those supplied in multidose vials should not be used for intrathecal and epidural anaesthesia or in doses more than 15 ml for other types of blockades.

Deletion of text at end of section 4.2 relating to section on Paediatric patients 1 to 12 years of age

Section 4.4

Deletion of text:

-               Central nerve blocks may cause cardiovascular depression, especially in the presence of hypovolaemia, and therefore epidural anaesthesia should be used with caution in patients with impaired cardiovascular function.

-                Retrobulbar injections may rarely reach the cranial subarachnoid space, causing serious / severe reactions, including cardiovascular collapse, apnoea, convulsions and temporary blindness.

-               Retro- and peribulbar injections of local anaesthetics carry a low risk of persistent ocular muscle dysfunction. The primary causes include trauma and/or local toxic effects on muscles and/or nerves.

The severity of such tissue reactions is related to the degree of trauma, the concentration of the local anaesthetic and the duration of exposure of the tissue to the local anaesthetic. For this reason, as with all local anaesthetics, the lowest effective concentration and dose of local anaesthetic should be used. Vasoconstrictors may aggravate tissue reactions and should be used only when indicated.

Deletion of text

Epidural anaesthesia may lead to hypotension and bradycardia. This risk can be reduced by preloading the circulation with crystalloidal or colloidal solutions. Hypotension should be treated promptly with e.g. ephedrine 5-10 mg intravenously and repeated as necessary.

Additional text at end of section

Preservative containing solutions, i.e. those supplied in multidose vials should not be used for intrathecal and epidural anaesthesia or in doses more than 15 ml for other types of blockades.

Section 10