LIGNAGEL 2% W/W

Active substance: LIDOCAINE HYDROCHLORIDE MONOHYDRATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
LIGNAGEL 2% w/w

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of gel contains 2.14% (w/w) lidocaine hydrochloride equivalent to 2% (w/w)
lidocaine hydrochloride (anhydrous).
For excipients see 6.1.

3

PHARMACEUTICAL FORM
Gel
Viscous clear and colourless and free from particulate material.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For surface anaesthesia and lubrication:
- The male urethra during cystoscopy, cathertisation, exploration by sound and other
endouretheral operations.
- Nasal and pharyngeal cavities in endoscopic procedures such as gastroscopy and
bronchoscopy
- Intubation

4.2

Posology and method of administration
As with any local anaesthetic, reactions and complications are best averted by
employing the minimal effective dosage. In view of the potential risks associated with
systemic adsorption no more than 4 doses should be given in any 24 hour period.
Debilitated and elderly patients should be given reduced doses commensurate with
their age and physical condition. Children should not receive more than 6 mg/kg.
Urethral anaesthesia:
Surface anaesthesia of the male adult urethra: for adequate analgesia in males, 20m1,
equivalent to 400mg lidocaine hydrochloride of the gel is required. The gel is instilled
slowly until approximately 10ml has been instilled. A penile clamp is then applied for
several minutes at the corona, released and a further 10ml of the gel instilled.
To provide effective analgesia, the gel should be instilled not less than 15 minutes
prior to instrumentation.
When anaesthesia is especially important e.g. during sounding or cystology, a larger
quantity of the gel, for example 30-40ml may be instilled in 3-4 portions and allowed
to work for not less than 15 minutes before insertion of the instrument.
Endoscopy:
Instillation of 10-20ml of the gel is recommended for adequate analgesia and a small
amount should be applied to the instrument for lubrication.
Lubrication for endotracheal intubation:
Apply approximately 5ml to the surface of the tube just prior to insertion. Care should
be taken to avoid introducing the product into the lumen of the tube.

4.3

Contraindications
Known history of hypersensitivity to local anaesthetics of the amide type or other
component in the gel.

4.4

Special warnings and precautions for use
Precautions:

Adsorption of lidocaine from wound surfaces and mucous membranes is relatively
high, especially in the bronchial tree. Lignagel 2% w/w should be used with caution
in patients with traumatised mucosa and/or sepsis in the region of the proposed
application.
If the dose or site of administration is likely to result in high blood levels, lidocaine,
in common with other local anaesthetics, should be used cautiously in patients with
epilepsy, impaired cardiac conditions, brachycardia, impaired hepatic function and in
severe shock.
The use of oral topical anaesthetic agents may interfere with swallowing and thus
enhance the danger of aspiration. This is particularly important in children because of
their frequency of eating. Numbness of the tongue or buccal mucosa may increase the
danger of biting trauma.
When used for endotracheal tube lubrication, care must be taken to avoid introduction
of the gel into the lumen of the tube. The gel may dry out on the inner surface leaving
a residue which tends to clump with flexion, narrowing the lumen. There have been
rare reports in which this residue has caused the lumen to occlude.
Care must be taken to avoid instillation of excess amounts of Lignagel 2%w/w into
the rectum. This is of particular importance in children and infants. Systemic
adsorption of lidocaine may occur from the rectum and large doses may result in CNS
side-effects. On rare occasions convulsions have occurred in children.

4.5

Interaction with other medicinal products and other forms of interaction
Lidocaine should be used with caution in patients receiving antiarrhythmic drugs
since the toxic effects are additive.

4.6

Pregnancy and lactation
Pregnancy:
Although there is no evidence from animal studies of harm to the foetus, as with all
drugs Lignagel 2%w/w should not be used in early pregnancy unless the benefits
outweigh the risks.
Lactation:

Lidocaine enters the mother’s milk, but in such low concentrations that at therapeutic
dose levels, there is generally no risk to the child.

4.7

Effects on ability to drive and use machines
None known.

4.8

Undesirable effects
In extremely rare cases, local anaesthetic preparations have been associated with
allergic reactions (in the most severe instances anaphylactic shock).
Systemic adverse reactions are rare and may result from high plasma concentrations
due to excessive dosage, rapid absorption or hypersensitivity, idiosyncrasy or
diminished tolerance on the part of the patient. Such reactions involve the central
nervous system and/or the cardiovascular system.
CNS reactions are excitatory and/or depressant and may be characterised by
nervousness, dizziness, convulsions, unconsciousness and possibly respiratory arrest.
The excitatory reactions may be brief, or may not occur at all, in which case the first
manifestations of toxicity may be drowsiness, merging into unconsciousness and
respiratory arrest.
Cardiovascular reactions are depressant and may be characterised by hypotension,
myocardial depression, bradycardia and possibly cardiac arrest.

4.9

Overdose
Treatment of the patient with toxic manifestations consists of ensuring adequate
ventilation and arresting convulsions. Ventilation should be maintained with oxygen
by assisted or controlled ventilation as required. If convulsions occur, they should be
treated rapidly by intravenous administration of succinylcholine 50-100 mg and/or 515 mg diazepam. As succinylcholine will arrest respiration, it should only be used if
the clinician has the ability to perform endotracheal intubation and to manage a fully
paralysed patient. Thiopentone 100-200 mg may also be used to abort convulsions. If
ventricular fibrillation or cardiac arrest occurs, effective cardiovascular resuscitation
must be instituted. Adrenaline in repeated doses and sodium bicarbonate should be
given as rapidly as possible.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Lidocaine is both a class I anti-arrythmic agent and an amide type local anaesthetic.
Its effect as an anaesthetic is produced by penetration of the lipoprotein nerve sheath
impairing the generation and conduction of nerve impulses by slow depolarisation at
or near the site of the application thereby producing a local anaesthetic action. This
action occurs as a result of blocking the large transient increase in cell membrane
permeability to sodium ions that normally follow initial depolarisation. Lidocaine
also reduces the permeability of the resting axon to potassium and sodium ions. It
acts on a specific receptor site within the sodium channel.

5.2

Pharmacokinetic properties
Lidocaine is rapidly taken up from the oral mucous membranes and from the
respiratory tract. Following absorption, there is a rapid distribution to all body tissues.
Distribution of lidocaine follows a two- compartment model initially via the highly
vascular tissues and secondly those poorly perfused. Approximately 65% of the
absorbed lidocaine is protein bound and the compound readily crosses the blood/brain
barrier and has a foetal/maternal plasma ratio of 0.5-0.7.
The liver appears to be the primary site of metabolism for lidocaine. It is metabolised
to monoethylglycinexylidide, glycinexylidide, 3- hydroxy-lidocaine, 3 -hydroxymonoethylglycinexylidide and 2,6- xylidine.
Studies on the excretion of lidocaine have shown that very little, between 3 and 11%
of the dose is excreted in the urine.
Plasma concentrations in excess of 5µg/ml cause general toxic symptoms.
Peak plasma concentrations of lidocaine in patients receiving endourethral doses of
lidocaine in the form of an aqueous gel containing 2% w/w (either 20ml or 40ml)
were 0.06 and 0.15µg/ml respectively.
Peak plasma concentrations of lidocaine in patients resulting from the lubrication of
endotracheal tubes with a 2% lidocaine gel did not exceed 0.2µg/ml.

No bioavailability studies have been carried out with Lignagel formulation.

5.3

Preclinical safety data
There are no preclinical data of relevance to the prescribed additional to that already
mentioned in previous sections of the SPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Glycerol
Hydroxyethyl cellulose
Purified water

6.2

Incompatibilities
No incompatibilities are known

6.3

Shelf life
12 months from the date of manufacture of the unopened container. Discard any
unused material after opening.

6.4

Special precautions for storage
Do not store above 25°C. Do not refrigerate or freeze

6.5

Nature and contents of container
The container consists of a syringe, plunger and end piece, all fabricated from
medical grade polyethylene (low density).The pack sizes are 6ml and 11ml.

6.6

Special precautions for disposal
To be used only by healthcare professionals. Keep out of the reach of children.

7

MARKETING AUTHORISATION HOLDER
ESSEX PHARMACEUTICALS LIMITED
BROCKET COTTAGE
WILLINGALE
ONGAR
ESSEX
CM5 0QS
UNITED KINGDOM

8

MARKETING AUTHORISATION NUMBER(S)
PL 16138/0001

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
1 February 2004

10

DATE OF REVISION OF THE TEXT

10/06/2008

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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