COMPOSITION :

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

Cetrimide 0.07 mg.

DESCRIPTION :

Lidosol Plus is a local anaesthetic and antiseptic consist of two active substances include Lidocaine which is used as local

anaesthetic, it causes a reversible blockage of impulse propagation along nerve fibers by preventing the inward movement of

sodium ions through the nerve membrane, Cetrimide that is used as antiseptic due to its bactericidal activity against gram positive

species but it has less activity against some gram negative species. The onset of action occurs rapidly within 2 - 5 minutes and the

duration of efficacy lasts for approximately 10 – 20 minutes . Lidocaine is metabolized mainly in the liver and is excreted by the

kidneys . Cetrimide penetrates into the superficial layer of the epidermis , although its absorption through the gastrointestinal tract

is poor, more than 90% of the dose ingested is excreted in the faeces.

INDICATIONS:

Lidosol Plus is a topical anaesthetic and antiseptic used in adults and children above 4 years for the prevention of pain associated

with the following cases :

- Minor surgical procedures in the oral cavity like opening of superficial abscesses .

- 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 .

- Extraction of deciduous and loose teeth and loose root fragments ,before injection , fitting of crown rings , bridges, bands and

dentures.

- To control nausea during taking dental impressions or X-ray photography .

DOSAGE :

1- 2 doses of Lidosol plus spray is usually sufficient to achieve anaesthesia on a particular site . The application of one dose may

be repeated in 4 or 5 different areas of the buccal mucosa.

RESTRICTIONS ON USE :

Contraindications

- Hypersensitivity to the ingredients of the product 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 . It should be used with caution and under

physician supervision especially in the early stages of pregnancy. It should be used with caution for nursing mothers if the

expected benefit is greater than the risk.

DRUG INTERACTIONS :

- Lidosol Plus should be used with caution in patients receiving agents structurally related to local anaesthetics such as tocainide

and antiarrhythmic drugs.

- Concurrent use of Lidocaine with beta-adrenergic blocking agents may slow metabolism of lidocaine and its use with Cimetidine

may inhibit hepatic metabolism of lidocaine, leading to increased risk of lidocaine toxicity, particularly with large doses or

repeated administration.

ADVERSE EFFECTS :

Some adverse effects resulted from the administration of Lidocaine 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 : The symptoms of overdose may occur due to increase the level of lidocaine in the blood ,particularly with large

doses or repeated administration consequently increased risk of lidocaine toxicity . Toxic reactions involve central nervous system

and cardiovascular system . The first symptoms of CNS are nervousness, dizziness, blurred vision and tremors followed by

drowsiness, convulsions, unconsciousness and possibly, respiratory arrest may occur. Cardiovascular symptoms such as

hypotension, bradycardia and possibly, cardiac arrest.

Management of overdosage : Patient must be given Oxygen and anticonvulsant IV if the convulsions do not stop spontaneously

such as Diazepam or Thiopentone. If cardiovascular depression is evident , ephedrine should be given .

STORAGE INSTRUCTIONS :

Store below 30oC, protect from light.

PRESENTATION :

Lidosol Plus spray : Bottle of 50 ml .