📌 COMPOSITION

Each dose (spray) contains: Lidocaine base USP 10 mg.

📌 DESCRIPTION

Lidosol (Lidocaine) is a local anaesthetic characterised by a rapid onset of action which occurs within 1-5 minutes depending on the area of application, and it has an intermediate duration of efficacy which lasts for approximately 10-15 minutes. It causes a reversible blockage of impulse propagation along nerve fibres by preventing the inward movement of sodium ions through the nerve membrane. The absorption rate of lidocaine following topical administration to mucous membranes is faster than that after intratracheal and bronchial administration. The plasma protein binding of lidocaine is dependent on the drug concentration. Lidocaine crosses the blood‑brain and placental barriers by passive diffusion. It is 95% metabolised in the liver, and the elimination half‑life is approximately 90-120 minutes. The unchanged drug is excreted by the kidneys.

📌 INDICATIONS & DOSAGE

Lidosol is a topical anaesthetic used for the prevention of pain associated with the following cases:

• Minor surgical procedures in the oral and nasal cavity, pharynx and epipharynx: 3 doses.
• During the final stages of delivery and before suturing: up to 20 doses.
• Introduction of tubes and catheters during endotracheal intubation and endoscopic procedures of the respiratory and digestive tract, as anaesthetic for mucous membrane in the mouth: up to 20 doses. During prolonged procedures, up to 40 doses may be administered. In addition, when combined with other lidocaine products, the total dose should not exceed 40 doses. If used mainly on the larynx, trachea and bronchi, the total dose should not exceed 20 doses.
• Extraction of deciduous and loose teeth and loose root fragments, before injection, dental impressions, X‑ray photography: 1-5 doses to the mucous membranes.

In children below 12 years of age, the dose should not exceed 3 mg/kg. When used mainly on the larynx and bronchi, the dose should be reduced to 1.5 mg/kg. In children below 3 years of age, less concentrated lidocaine solutions are recommended.

📌 RESTRICTIONS ON USE

Contraindications

Hypersensitivity to lidocaine or other local anaesthetics of the amide type.

Precautions

• Patients with wounds or traumatised mucosa in the region of the proposed application.
• Patients with cardiovascular diseases and heart failure, patients with epilepsy, the elderly and patients in poor general health.
• Patients with advanced liver disease or severe renal dysfunction.
• Avoid contact with eyes.

Effect on ability to drive and use machines

Depending on the dose, lidocaine may have a very mild effect on mental function and may temporarily impair locomotion and coordination.

Use in Pregnancy and Lactation

The safety of lidocaine for use during pregnancy has not been fully established; however, it has been widely used for many years without apparently causing any problem. It should be used with caution during pregnancy if the expected benefit is greater than the risk. This medicine may pass into breast milk, but only in small amounts that are extremely unlikely to be harmful to a nursing infant.

📌 DRUG INTERACTIONS

Lidosol should be used with caution in patients receiving agents structurally related to local anaesthetics such as tocainide and antiarrhythmic drugs.

📌 ADVERSE EFFECTS

Some adverse effects such as local irritation at the application site and allergic reactions may occur. Reversible symptoms such as sore throat, hoarseness and loss of voice may occur after application to the laryngeal mucosa.

📌 OVERDOSAGE

Symptoms: Toxic reactions involve the central nervous system and cardiovascular system. The first symptoms of CNS are paraesthesia, numbness of the tongue, light‑headedness and tinnitus. Visual disturbance and muscular tremors precede the onset of generalised convulsions. Unconsciousness and grand mal convulsions may follow. In severe cases, apnoea may occur. Cardiovascular symptoms such as severe hypotension, bradycardia and arrhythmia occur in cases of high systemic concentration.

Management of overdosage: Oxygen must be given. An anticonvulsant should be given IV if the convulsions do not stop spontaneously in 15-30 seconds. Thiopentone 100-150 mg IV will abort the convulsions rapidly. If cardiovascular depression is evident, ephedrine 5-10 mg IV should be given and repeated, if necessary, after 2-3 minutes. If circulatory arrest occurs, immediate cardiopulmonary resuscitation should be instituted. Adrenaline 0.1-0.2 mg IV or IC should be given as soon as possible.

📌 STORAGE INSTRUCTIONS

Store below 30°C, protect from light.

📌 PHARMACEUTICAL FORMS

• Lidosol Spray: Bottle of 50 ml.