Each 100 ml of LIGNORAL Oral Spray contains: Active ingredient: Lidocaine 10 g.
Excipients/Inactive Ingredients: Cetylpyridinum chloride, ethanol, saccharin sodium, banana flavor and polyethylene Glycol 400.
LIGNORAL (lidocaine) is a safe and effective local anaesthetic, belonging to the amide class of local anaesthetics for surface anaesthesia of oral mucous membrane.
Action: Following local application of LIGNORAL oral spray, lidocaine penetrates oral mucous membrane altering cell membrane permeability of ions particularly sodium influx and preventing initiation and conduction of nerve impulses. Clinically, LIGNORAL oral spray provides prompt and profound local anaesthesia that appears within 1 - 5 minutes post application to mucous membrane and lasts for about 15 - 30 minutes.
This is beneficial in instantaneous relief of pain associated with dental practice or before otorhinolaryngology. Also, LIGNORAL action facilitates insertion of instruments during endotracheal intubation and endoscopic procedures of the airways and upper GIT. LIGNORAL oral spray is free of propellant gases and easy to handle besides high safety profille which recommends its use in all disciplines requiring oral mucous membrane surface anaesthesia.
Pharmacokinetics: Following application of LIGNORAL oral spray, absorption of lidocaine from mucous membrane depends upon concentration, total dose administered, the specific site of application and duration of exposure. About 64% of the absorbed lidocaine is bound to plasma proteins. Lidocaine is metabolized rapidly by the liver and excreted in the urine as metabolites and as unchanged drug.
LIGNORAL oral spray is indicated in surface anaesthesia: Before injections in dental practice, dental impressions (especially copperband impression), X-ray photography, removal of calculus.
Before puncture of the maxillary sinus and surgical procedures in the nasal cavity, pharynx and epipharynx paracentesis.
Route of administration: Oral spray for topical use.
In dental practice: 1 - 5 applications to oral mucous membranes. Onset of action is within 1 - 2 minutes.
Puncture of the maxillary sinus and other otorhinolaryngology procedures: 3 applications. Onset of action is within 2 - 3 minutes.
Symptoms of overdosage include drowsiness, confusion, nervousness, ringing in ears, blurred vision, feeling hot or cold, numbness, muscle twitches, slowed breathing or respiratory failure. Treatment is symptomatic and supportive.
Hypersensitivity to lidocaine or any component of the oral spray. Lidocaine must not be used on open wounds or infected areas (local sepsis).
Local anaesthetics must not be applied for prolonged periods or over large areas of mucous membranes or sprayed near or into the eyes. LIGNORAL oral spray must not be used by patients having allergy to local anaesthetics and patients having epilepsy or liver, heart or kidney problems.
No harmful effects have been reported on the use of local anaesthetics during pregnancy and lactation. However, LIGNORAL oral spray should be used during pregnancy under strict medical supervision.
Local adverse reactions might occur with applied lidocaine and include allergic reactions or drowsiness. Other side effects that may rarely occur include dizziness, blurred vision, tremors, nervousness, wheezing or difficulty in breathing, chest pain, severe rash or itching and increased sweating.
LIGNORAL should be used with caution in patients receiving class I antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic.
When LIGNORAL is used concomitantly with other products containing local anaesthetic agents, the amount absorbed from all formulations must be considered.
Interference with Laboratory Tests: None reported with local anaesthetics.
Store at temperature below 30°C.
Keep out of the reach of children.
R02AD02 - lidocaine ; Belongs to the class of local anesthetics used in throat preparations.
Lignoral 10% w/v oral spray
(banana flavour) 15 mL x 1's
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