Adults ( > 18 years of age):

XYLOCAINE Viscous 2% (lidocaine hydrochloride) is indicated to provide relief of pain and discomfort in connection with:

• Irritated or inflamed mucous membranes of the mouth and pharynx, e.g. lesions following tonsillectomy;
• Introduction of instruments and catheters into the respiratory and digestive tracts, e.g. bronchoscopy, esophagoscopy;
• Painful diseases of the upper gastrointestinal tract e.g. esophagitis.

Geriatrics ( > 65 years of age)

Elderly patients should be given reduced doses commensurate with their age and physical condition (see DOSAGE AND ADMINISTRATION-Special Populations).

Pediatrics ( < 18 years of age)

Children should be given reduced doses commensurate with their age, weight and physical condition (see DOSAGE AND ADMINISTRATION-Special Populations).

Lidocaine should be used with caution in children younger than two years of age as there are insufficient data to support the safety and efficacy of this product in this patient population at this time (see WARNINGS AND PRECAUTIONS-Special Populations).

Dosing Considerations

General

When XYLOCAINE Viscous 2% (lidocaine hydrochloride) is used concomitantly with other products containing lidocaine, the total dose contributed by all formulations must be kept in mind.

The degree of absorption from mucous membranes is variable but especially high from the bronchial tree. The degree of systemic absorption depends on whether the lidocaine viscous is swallowed or expectorated. It is therefore important to expectorate in order to avoid unnecessary absorption. After a swallowed single dose of 300 mg (15 mL) of lidocaine viscous, the resulting blood concentrations are low.

Special Populations

Lidocaine should also be used with caution in patients with epilepsy, impaired cardiac conduction, bradycardia, impaired hepatic or renal function and in severe shock (See WARNINGS AND PRECAUTIONS).

Debilitated, elderly patients, acutely ill patients, patients with sepsis, and children should be given reduced doses commensurate with their age, weight and physical condition.

XYLOCAINE Viscous 2% should be used with caution in children under the age of 2 as there is insufficient data to support the safety and efficacy of this product in this patient population at this time.

Mode of Administration

Xylocaine Viscous 2%

XYLOCAINE VISCOUS 2% IS FOR TOPICAL USE ONLY AND MUST NOT BE USED FOR INJECTION (see WARNINGS AND PRECAUTIONS).

For oral analgesia, the solution should be swished around in the mouth and spat out or swallowed slowly.

For use in the pharynx, the solution should be gargled and may be swallowed.

Recommended Dose and Dosage Adjustment

Adults

For treatment of pain from irritated or inflamed mucous membranes of the mouth and throat, 5-10 mL of lidocaine viscous (100 - 200 mg lidocaine) is recommended. Six doses may be given in 24 hours. Total dosage of XYLOCAINE Viscous 2% in 24 hours should not exceed 60 mL or 1200 mg lidocaine.

For topical anesthesia before introduction of instruments and catheters into the upper respiratory or digestive tracts, 10 - 15 mL of lidocaine viscous (200 - 300 mg lidocaine) is recommended. When combined with other lidocaine products (e.g. for bronchoscopy), the total dosage of lidocaine should not exceed 400 mg.

For diseases of the upper gastrointestinal tract, 5 - 15 mL of lidocaine viscous (100 - 300 mg of lidocaine) should be swallowed quickly in one gulp. Six doses may be given in 24 hours. Total dosage of XYLOCAINE Viscous 2% in 24 hours should not exceed 60 mL or 1200 mg lidocaine.

Children (Under 12 Years)

In children under the age of 12, for treatment of irritated or inflamed mucous membranes of the mouth and throat, the dose should not exceed 4 mg/kg. It is recommended that excess lidocaine viscous solution is spat out. No more than four doses should be given during 24 hours.

For children over 12 years of age doses should be commensurate with weight and physical condition.

Children (Under 3 Years)

In children under the age of 3, the dose should be accurately measured and applied to the affected area with a cotton tip applicator. The same procedure is also recommended for older children having problems in expectorating. No more than four doses should be given during 24 hours.

At the present time there is not enough documentation to allow recommendations for a more prolonged use of viscous lidocaine in children under the age of 3.

Storage And Stability

Store at 15 - 30°C. Protect from freezing.

HOW SUPPLIED

Dosage Forms, Composition And Packaging

Dosage Forms

XYLOCAINE Viscous 2% (lidocaine hydrochloride) is a clear to almost clear slightly coloured viscous liquid with an odour of cherries.

XYLOCAINE Viscous 2% has a low surface tension which provides for an even film over the mucous membrane. Prolonged contact is possible due to its high viscosity.

Composition
lidocaine hydrochloride 20 mg/mL
methylparaben
propylparaben
cherry essence
saccharin sodium
sodium carboxymethylcellulose to adjust viscosity.
sodium hydroxide to adjust pH to 6.0 - 7.0.
purified water

Packaging

XYLOCAINE Viscous 2% is supplied in 100 mL plastic bottles.

This leaflet was prepared by: AstraZeneca Canada Inc. Mississauga, Ontario L4Y 1M4. Last revised: April 2, 2008. FDA revision date: 5/31/1996

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