Xylocaine Jelly

Each gram of the jelly contains lidocaine HCl 20 mg. It also contains the following excipients: Hydroxypropyl methylcellulose, sodium hydroxide 2M and/or hydrochloric acid 2M to pH 6.2-6.8, methyl parahydroxybenzoate, propyl parahydroxybenzoate and purified water.

Pharmacotherapeutic Group: Local anaesthetic. ATC Code: N01BB02.
Pharmacology: Xylocaine Jelly provides prompt and profound anaesthesia of mucous membranes and lubrication which reduces friction. Its water-miscible base, characterized by high viscosity and low surface tension, brings the anaesthetic into intimate and prolonged contact with the tissue, giving effective anaesthesia of long duration (approximately 20-30 min). Anaesthesia usually occurs rapidly (within 5 min, depending upon the area of application).
Lidocaine, like other local anaesthetics, causes a reversible blockade of impulse propagation along nerve fibres by preventing the inward movement of sodium ions through the nerve membrane. Local anaesthetics of the amide type are thought to act within the sodium channels of the nerve membrane.
Local anaesthetic drugs may also have similar effects on excitable membranes in the brain and myocardium. If excessive amounts of the drug reach the systemic circulation rapidly, symptoms and signs of toxicity will appear, emanating from the central nervous and cardiovascular systems.
Central nervous system toxicity (see Overdosage) usually precedes the cardiovascular effects as it occurs at lower plasma concentrations. Direct effects of local anaesthetics on the heart include slow conduction, negative inotropism and possibly cardiac arrest.
Pharmacokinetics: Absorption from the mucous membranes is variable but especially high from the bronchial tree. The absorption of lidocaine jelly from the nasopharynx is usually lower than with other lidocaine products. Blood concentrations of lidocaine after instillation of the jelly in the intact urethra and bladder in doses up to 800 mg are fairly low and below toxic levels.

Surface anaesthetic and lubricant for the male and female urethra during cystoscopy, catheterisation, exploration by sound and other endourethral procedures. Nasal and pharyngeal cavities in endoscopic procedures eg, gastroscopy and bronchoscopy; during proctoscopy and rectoscopy; tracheal intubation.
Symptomatic treatment of pain in connection with cystitis and urethritis.
To relieve pain after circumcision in children.

As with any local anaesthetic, the safety and effectiveness of lidocaine depend on the proper dosage, the correct technique, adequate precautions and readiness for emergencies.
The following dosage recommendations should be regarded as a guide. The clinician's experience and knowledge of the patient's physical status are of importance in calculating the required dose.
Urethral Anaesthesia: Surface Anaesthesia of the Male Adult Urethra: For adequate analgesia in males, 20 mL (lidocaine HCl 400 mg) jelly is required. The jelly is instilled slowly until the patient has a feeling of tension or until almost ½ the tube (10 mL=lidocaine HCl 200 mg) has been emptied.
A penile clamp is then applied for several minutes at the corona, after which the rest of the jelly is instilled.
When anaesthesia is especially important eg, during sounding or cystoscopy, a larger quantity of jelly (30-40 mL) may be instilled in 3-4 portions and allowed to act for 10-12 min before insertion of the instrument. The jelly instilled into the bladder is also effective procedures in this region.
Surface Anaesthesia of the Female Adult Urethra: Instil 5-10 mL in small portions to fill the whole urethra. In order to obtain adequate anaesthesia, several minutes should be allowed to elapse prior to performing urological procedures.
Endoscopy: The instillation of 10-20 mL is recommended for adequate analgesia and a small amount may be applied to the lubricating instrument. When combined with other lidocaine products (eg, bronchoscopy), the total dose of lidocaine should not exceed 400 mg.
Proctoscopy and Rectoscopy: Up to 20 mL can be used for anal and rectal procedures. The total dose should not exceed 400 mg lidocaine.
Lubrication for Endotracheal Intubation: About 2 mL applied to the surface of the tube just prior to insertion. Care should be taken to avoid introducing Xylocaine Jelly into the lumen of the tube.
Children <12 years: The dose should not exceed 6 mg/kg.
Debilitated or elderly patients, children >12 years, acutely ill patients or patients with sepsis should be given doses commensurate with their age, weight and physical condition.
Note: No more than 4 doses should be given in a 24-hr period. After use, the jelly is no longer sterile and should be discarded.

Symptoms: Acute Systemic Toxicity: Toxic reactions originate mainly in the CNS and the cardiovascular system.
Central nervous system toxicity is a graded response, with symptoms and signs of escalating severity. The first symptoms are circumoral paraesthesia, numbness of the tongue, lightheadedness, hyperacusis and tinnitus. Visual disturbance and muscular tremors are more serious and precede the onset of generalised convulsions. Unconciousness and grand mal convulsions may follow, which may last for a few secs to several min. Hypoxia and hypercarbia occur rapidly following convulsions due to the increased muscular activity, together with the interference with normal respiration. In severe cases, apnoea may occur. Acidosis increases the toxic effects of local anaesthetics.
Recovery is due to re-distribution and metabolism of the local anaesthetic drug from the CNS. Recovery may be rapid unless large amounts of the drug has been administered.
Cardiovascular effects are only seen with high systemic concentrations. Severe hypotension, bradycardia, arrhythmia and cardiovascular collapse may be the result in such cases.
Cardiovascular toxic effects are generally preceded by signs of toxicity in the CNS, unless the patient is receiving a general anaesthetic or is heavily sedated with drugs eg, benzodiazepine or barbiturate.
Treatment: Should symptoms of systemic toxicity occur, the signs are anticipated to be similar in nature to those following the administration of local anaesthetics by other routes. Local anaesthetic toxicity is manifested by symptoms of nervous system excitation and, in severe cases, central nervous and cardiovascular depression.
Severe neurological symptoms (convulsions, CNS depression) must be treated symptomatically by respiratory support and the administration of anticonvulsive drugs.
Should circulatory arrest occur, immediate cardiopulmonary resuscitation should be instituted. Optimal oxygenation, ventilation and circulatory support as well as treatment of acidosis are of vital importance, since hypoxia and acidosis will increase the systemic toxicity of local anaesthetics.

Known hypersensitivity to local anaesthetics of the amide type, or other components of the jelly. Hypersensitivity to methyl and/or propyl parahydroxybensoate (methyl-/propyl paraben), or to their metabolite para amino benzoic acid (PABA). Formulations of lidocaine containing parabens should be avoided in patients allergic to ester local anaesthetics or their metabolite PABA.

Excessive doses of lidocaine or short intervals between doses, can result in high plasma levels and serious adverse effects. Patients should be instructed to adhere strictly to the recommended dosage (the management of serious adverse reactions may require the use of resuscitative equipment, oxygen and other resuscitative drugs). (See Overdosage.)
Absorption from wound surfaces and mucous membranes is relatively high and especially high in the bronchial tree. The absorption of lidocaine jelly from the nasopharynx is variable but usually lower than with other lidocaine products. Following instillation in the urethra and bladder, adsorption is low. Lidocaine jelly should be used with caution in patients with traumatized mucosa and/or sepsis in the region of the proposed application.
The oropharyngeal use of topical anaesthetic agents may interfere with swallowing and thus, enhance the danger of aspiration. Numbness of the tongue or buccal mucosa may increase the danger of biting trauma.
When used for endotracheal tube lubrication, care should be taken to avoid introduction of the jelly into the lumen of the tube. The jelly may dry 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.
If the dose or administration is likely to result in high blood levels, some patients require special attention to prevent potentially dangerous side effects eg, patients with partial or complete heart block, the elderly and patients in poor general health and patients with advanced liver disease or severe renal dysfunction.
Xylocaine jelly 20 mg/mL is probably porphyrinogenic and should only be prescribed to patients with acute porphyria on strong or urgent indications. Appropriate precautions should be taken for all porphyric patients.
Effects on the Ability to Drive or Operate Machinery: Depending on the dose, local anaesthetics may have a very mild effect on mental function and may temporarily impair locomotion or coordination.
Use in pregnancy & lactation: It is reasonable to assume that a large number of pregnant women and women of childbearing age have been given lidocaine. No specific disturbances to the reproductive process have so far been reported eg, no increased incidence of malformations.
Like other local anaesthetics, lidocaine may enter the mother's milk but in such small amounts that there is generally no risk of this affecting the neonate.

Use in pregnancy & lactation: It is reasonable to assume that a large number of pregnant women and women of childbearing age have been given lidocaine. No specific disturbances to the reproductive process have so far been reported eg, no increased incidence of malformations.
Like other local anaesthetics, lidocaine may enter the mother's milk but in such small amounts that there is generally no risk of this affecting the neonate.

Local Reactions: An increased incidence of postoperative "sore throat" has been reported following endotracheal tube lubrication with lidocaine jelly.
Allergic Reactions: Allergic reactions (in most severe instances, anaphylactic shock) to local anaesthetics of the amide type are rare. Other constituents of the jelly eg, methyl parahydroxybenzoate and propyl parahydroxybenzoate may also cause this type of reaction.
Acute Systemic Toxicity: Lidocaine may have acute toxic effects if high systemic levels occur due to fast absorption or overdosage. (See Pharmacology under Actions and Overdosage.)

Lidocaine should be used with caution in patients receiving agents structurally related to local anaesthetics eg, tocainide, since the toxic effects are additive. Specific interaction studies with local anaesthetics and class III antiarrhythmic drugs have not been carried out, but caution should be observed.
Drugs that reduce the clearance of lidocaine (eg, cimetidine or β-blockers) may cause potentially toxic plasma concentrations when lidocaine is given in repeated high doses over a long time period. Such interactions should be of no clinical importance following short term treatment with lidocaine at recommended doses.

Do not store above 25°C. Avoid freezing.
Shelf-Life: Please see outer packaging.

Anaesthetics - Local & General

N01BB02 - lidocaine ; Belongs to the class of amides. Used as local anesthetics.

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