Xylocaine Viscous Topical Anaesthesia Solution

Xylocaine Viscous Topical Anaesthesia Solution for the mouth and throat is indicated for the relief of pain and discomfort associated with: irritated or inflamed mucous membranes of the mouth, pharynx and upper gastrointestinal tract, e.g. post-tonsillectomy sore throat, dumping syndrome; introduction of instruments and catheters into the respiratory and gastrointestinal tract. Directions Please refer to Medsafe Data Sheet for more details. As with any local anaesthetic, reactions and complications are best averted by employing the minimal effective dosage. Debilitated, acutely ill or elderly patients and children should be given doses commensurate with their age and physical condition. Shake the bottle well before use. For symptomatic treatment of irritated or inflamed mucous membranes of the mouth and pharynx, the usual adult dose is 15 mL undiluted. For use in the mouth, the solution should be swished around the mouth for approximately 30 seconds and spat out. For use on the pharynx, the solution should be gargled and may be swallowed. This dose should not be administered at intervals of less than three hours. Adults: No more than 15 mL (300 mg lidocaine HCl) every 3 hours or 120 mL in a 24 hour period. Children over 3 years of age: No more than 4 mg/kg (0.2 mL/kg) of bodyweight or 5 mL (100 mg lidocaine HCl), whichever is lower. No more than 4 doses should be given in a 24 hour period. The dose should not be administered at intervals of less than three hours. It is recommended that excess solution is spat out. Children under 3 years of age: No more than 4 mg/kg (0.2 mL/kg) of bodyweight or 1.25 mL (25 mg lidocaine HCl) whichever is lower, accurately measured and applied only to the affected area with a cotton swab. No more than 4 doses should be given in a 24 hour period. This dose should not be administered at intervals of less than three hours. The solution should not be administered to sooth teething pain in infants and children because of safety concerns. Ingredients Each mL of Xylocaine Viscous contains lidocaine hydrochloride monohydrate 21.4 mg (equivalent to lidocaine hydrochloride 20 mg). Excipients: Methyl hydroxybenzoate, propyl hydroxybenzoate, sodium hydroxide, saccharin sodium, cherry flavour, carmellose sodium, citric acid anhydrous and purified water. Warnings Excessive dosage, or short intervals between doses, can result in high levels of lidocaine or its metabolites and serious adverse effects. In order to prevent serious adverse effects, patients should be instructed to strictly adhere to the recommended dosage and administration guidelines. The management of serious adverse reactions may require the use of resuscitative equipment, oxygen and other resuscitative drugs. Patients should not exceed the recommended dose or use Xylocaine Viscous for prolonged periods except on the advice of their physician. The lowest dose that results in effective anaesthesia should be used to avoid high plasma levels and serious adverse effects. Tolerance to elevated blood levels varies with the status of the patient. Excessive dosage or short intervals between doses may result in high plasma levels and serious adverse effects. Following too high or repeated doses, including accidental ingestion of viscous lidocaine in infants and children under the age of three years, serious side effects have been reported involving the cardiovascular and central nervous systems including fatal outcomes. Patients should be instructed to adhere strictly to the recommended dosage. This is especially important in children where the doses vary with weight.