Lignocaine Hydrochloride 2% and Adrenaline 1:80,000
A loco-regional anaesthetic for dental use

Properties:

LIGNOSPAN SPECIAL is a lignocaine based anaesthetic in strile injectable form.

Lignocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of nerve impulses, thereby effecting local anaesthetic action.

Lignocaine is metabolized mainly in the liver and extracted via the kidneys. Approximately 90 % of lignocaine administered is excreted in the form of various metabolites, and less than 10 % is excreted unchanged.

The presence of adrenaline, a vasoconstrictor, in the formulation prolongs the action of the anaesthetic in localizing the latter to the site of injection. Therefore the rate at which the anaesthetic passes into the bloodstream is reduced. In addition, the vasoconstrictor reduces haemorrhaging during surgical procedures in the vicinity of the injection, thus facilitating clinical care.

Onset duration of anaesthesia:

- When used for infiltration anaesthesia in dental patients, the time of onset averages less than two minutes.

LIGNOSPAN SPECIAL provides an average pulp anaesthesia of at least sixty minutes with an average duration of soft tissue anaesthesia of approximately two and a half hours.

- When used for nerve blocks in dental patients, the time of onset averages two to four minutes. LIGNOSPAN SPECIAL provides pulp anaesthesia averaging at least ninety minutes with an average duration of soft tissue anaesthesia of three to three and a quarter hours.

Indications: LIGNOSPAN SPECIAL is indicated for the production of local anaesthesia for dental procedures by infiltration or nerve block injection.

Contra-Indications:

LIGNOSPAN SPECIAL is contra-indicated in patients with a known history of hypersensitivity to local anaesthetics of the amide type or to any components of the injectable formulation.

LIGNOSPAN SPECIAL, due to the presence of a vasoconstrictor (adrenaline) in the formula, is contra-indicated for patients suffering from :

- arterial hypertension,

- coronary disease,

- valvular cardiac disease (particularly sequelae to acute rheumatic fever).

LIGNOSPAN SPECIAL should not be used or only in extreme caution in patients with bradycardia, AV block, severe hypotension or myasthenia gravis., paroxysmal tachycardia, high-frequency continuous arrhythmia, coronary insufficiency, high-grade arteriosclerosis, severe hypertension, thyrotoxicosis, decompensated diabetes, narrow-angle glaucoma, Graves disease or other endocrine disorders.

The drug is contraindicated by any route when the area or site of injection is infected or inflamed and should be used with extreme caution in patients with skin infections anywhere on the body.

Interactions with Other Medicaments:

- As in the case of all other local anaesthetic solutions containing adrenaline, the administration of LIGNOSPAN SPECIAL in patients receiving MAOI (monoamine oxidase inhibitors), tricyclic antidepressants or phenothiazines may produce severe prolonged hypotension or hypertension.

- Concurrent use of these agents should generally be avoided. In situations when concurrent therapy is necessary, careful patient monitoring is essential.

- Concurrent administration of vasopressor drugs and ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents.

- If sedatives are employed to reduce patient apprehension, reduced doses of anaesthetic solution should be used since local anaesthetic agents, like sedatives, are central nervous system depressants which in combination may have an additive effect.

- Concurrent use of beta-adrenergic blocking agents with an anaesthetic solution containing a vasoconstrictor, may result in dose dependent hypertension and bradycardia.

Adverse Reactions:

Adverse experiences following the administration of lignocaine are similar in nature to those observed with other amide local anaesthetic agents, these adverse experiences are, in general, dose-related and may result from high plasma levels

caused by excessive dosage, rapid absorption or unintended intra-vascular injection, or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature. The following types are those most commonly reported :

- Central Nervous System:

CNS manifestations are excitatory and/or depressant and may be characterized by lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest. The excitatory manifestations may be very brief or may not occur at all, in which case the first manifestation of toxicity may be drowsiness merging into unconsciousness and respiratory arrest. Drowsiness following the administration of lignocaine is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption.

- Cardiovascular system:

Cardiovascular manifestations are usually depressant and are characterized by bradycardia, hypotension, and cardiovascular collapse, which may lead to cardiac arrest.  Signs and symptoms of depressed cardiovascular function may commonly result from a vasovagal reaction, particularly if the patient is in an upright position less commonly, they may result from a direct effect of the drug. Failure to recognize the premonitory signs such as sweating, a feeling of faintness, changes in pulse or sensorium may result in progressive cerebral hypoxia and seizure or serious cardiovascular catastrophe. Management consists of placing the patient in the recumbent position and ventilation with oxygen. Supportive treatment of circulatory depression may require the administration of intravenous fluids and, when appropriate, a vasopressor (e.g., ephedrine) as directed by the clinical situation.

- Allergic reactions:

Allergic reactions are characterized by cutaneous lesions, urticaria, edema or anaphylactoid reactions. Allergic eactions as a result of sensitivity to lignocaine are extremely rare and, if they occur, should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value.  Adverse reactions resulting from administration of epinephrine-containing solutions include anxiety, palpitations, dizziness, headache, restlessness, tremors, tachycardia, anginal pain, and hypertension. In extreme cases, pulmonary edema and ventricular fibrillation may occur.