COMPOSITION :

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

DESCRIPTION :

Lidosol (lidocaine) is a local anaesthetic characterized by a rapid onset of action occurs within 1 - 5 minutes depending on the area

of application and it has intermediate duration of efficacy which lasts for approximately 10 - 15 minutes . It causes a reversible

blockage of impulse propagation along nerve fibers by preventing the inward movement of sodium ions through the nerve

membrane. 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 % metabolized in the liver and the

elimination half -life is approximately 90 - 120 minutes and 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 to 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 to 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 anaesthesia of the amide type.

Precautions

- Patients with wounds or traumatized mucosa in the region of the proposed application.

- Patients with cardiovascular diseases and heart failure, the 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 has a very mild effect on mental function and may temporarily impair locomotion and

coordination.

Use in Pregnancy & 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 after application to laryngeal mucosa.

OVERDOSAGE :

Symptoms : Toxic reactions involve 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 generalized convulsions . Unconsciousness and grand mal convulsions may follow. In severe cases apnea 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 , anticonvulsant should be given IV if the convulsions do not stop

spontaneously in 15 - 30 sec. 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 occur ,

immediately cardiopulmonary resuscitation should be instituted. Adrenaline 0.1 – 0.2 mg as IV or IC should be given as soon as

possible .

STORAGE INSTRUCTIONS :

Store below 30oC , protect from light.

PRESENTATION :

Lidosol spray : Bottle of 50 ml .