This Jelly is a sterile local anaesthetic product which contains Lidocaine Hydrochloride USP in a water-soluble Jelly base. It is used for topical/surface anaesthesia. The onset of action is 3-5 minutes. It may be rapidly and almost completely absorbed following topical application to mucous membrane and systemic effects may occur.

Pharmacology

Lidocaine acts mainly by inhibiting sodium influx through sodium specific ion channels in the neuronal cell membrane, in particular the so called voltage-gated sodium channels. When the influx of sodium is interrupted, an action potential cannot arise and signal conduction is inhibited. The receptor site is thought to be located at the cytoplasmic (inner) portion of the sodium channel. Lidocaine binds more readily to sodium channels in activated state, thus onset of neuronal blockade is faster in neurons that are rapidly firing. This is referred to as state dependent blockade.

Lidocaine Jelly is indicated for-

• Surface anaesthesia of the male and female urethra
• Topical treatment of painful urethritis
• Anaesthetic lubrication for endotracheal intubation
• Adequate analgesia in endoscopy.

Urethral anaesthesia:

• Surface anaesthesia of the male adult urethra: For adequate analgesia in males 400 mg is required.
• Surface anaesthesia of the female adult urethra: Instil 100-200 mg in small portions to fill the whole urethra. In order to obtain adequate anaesthesia, several minutes should be allowed prior to perform in the urological procedure.

Lubrication for endotracheal intubation: 100 mg applied on the surface of the tube just prior to insertion. Care should be taken to avoid introducing the product into the lumen of the tube.

Endoscopy: Instillation of 200-400 mg is recommended for adequate analgesia and a small amount should be applied on the instrument for lubrication. Debilitated, elderly patients and children should be given doses commensurate with their age and physical condition.

Note: The applicator is sterilized for 5 minutes in boiling water, cooled and attached to the tube. The jelly is instilled slowly as required. The applicator should be detached after each use and keep the tube tightly closed.

It is contraindicated in patients with a known history of hypersensitivity of local anaesthetics of the amide type.

Nervousness, dizziness, blurred vision, tremors, drowsiness, convulsions, unconsciousness, respiratory arrest, hypotension, myocardial depression, bradycardia, cardiac arrest and anaphylactic reactions (cutaneous lesion, urticaria, oedema).

There is no, or inadequate, evidence of safety of the drug in human pregnancy but it has been in wide use for many years without apparent ill consequence. If drug therapy is needed in pregnancy, this drug can be used if there is no safer alternative. Lidocaine enters the mother's milk, but in such small quantities that there is generally no risk of affecting the child at therapeutic dose levels.

Precautions & Warnings

Absorption from wound surfaces and mucous membranes is relatively high, especially in the bronchial tree. Lidocaine Jelly 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 condition, bradycardia, impaired hepatic function and in severe shock.

The use of oropharyngeal 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.