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XYLOCAINE is a brand name for Lidocaine (also known as Lignocaine), supplied as a spray, metered dose. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: XYLOCAINE Spray (lidocaine) is indicated for surface anesthesia associated with: nasal procedures, e.g. puncture of the maxillary sinus; procedures in the oropharynx, e.g. gastrointestinal endoscopy; procedures in the upper respiratory tract, above the larynx e.g. insertion of instruments and tubes 1.1…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations General When XYLOCAINE Spray (lidocaine) is used concomitantly with other products containing lidocaine, the total dose contributed by all formulations must be kept in mind. Since absorption is variable and especially high in the trachea and bronchi, the maximum recommended doses vary depending on the area of application.
Each actuation of the metered dose valve delivers 10 mg lidocaine. © 2019 Aspen Group of companies or its licensor. All rights reserved. Page 4 of 19 Special Populations Lidocaine should 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 Spray 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.
2 Recommended Dose and Dosage Adjustment Adults Table 1. g. puncture of the maxillary sinus. g. gastrointestinal endoscopy. g. insertion of instruments and tubes. 50-400 400 600 1 For short procedures the drug is given for less than one minute.
2 For prolonged procedures, the duration of application is more than 5 minutes. Since absorption is variable, the maximum recommended doses vary depending on the area of application (see ACTION AND CLINICAL PHARMACOLOGY, Pharmacokinetics).
, less than 25 kg) should be dosed with caution.
Under 12 years of age:
For upper respiratory tract use, above the larynx, the dose should not exceed 3mg/kg. For nasal and oropharyngeal use, the dose should not exceed 4-5mg/kg. In © 2019 Aspen Group of companies or its licensor. All rights reserved. Page 5 of 19 neonates and infants, less concentrated lidocaine solutions are recommended.
3 Administration When using the spray for the first time, after attaching the nozzle, the pump must be primed by pressing downwards on the actuator five to ten times. When changing to a new nozzle, the pump need not be re-primed but the air in the nozzle must be voided before a full dose is delivered.
1 Adverse Reaction Overview Adverse experiences following the administration of lidocaine are similar in nature to those observed with other amide local anesthetic agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by overdosage or rapid absorption, eg, application to areas below the vocal cords, or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient.
0 μg free base per mL. Serious adverse experiences are generally systemic in nature.
The following types are those most commonly reported:
Central Nervous System: CNS manifestations are excitatory and/or depressant and may be characterized by the following signs and symptoms of escalating severity: circumoral paresthesia, light-headedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, hyperacusis, tinnitus, blurred vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest.
, twitching, tremors, convulsions) may be very brief or may not occur at all, in which case the first manifestation of toxicity may be drowsiness merging into unconsciousness and respiratory arrest. Drowsiness following the administration of lidocaine is usually an early sign of a high lidocaine plasma level and may occur as a consequence of rapid absorption.
Cardiovascular System:
Cardiovascular manifestations are usually depressant and are characterized by bradycardia, hypotension, arrhythmia, and cardiovascular collapse, which may lead to cardiac arrest.
Allergic:
Allergic reactions are characterized by cutaneous lesions, urticaria, edema or, in the most severe cases, anaphylactic shock. 1%) and may occur as a result of sensitivity either to the local anesthetic agent or to other components in the formulation (See DOSAGE FORM, COMPOSITION AND PACKAGING).
General EXCESSIVE DOSAGE, OR SHORT INTERVALS BETWEEN DOSES, CAN RESULT IN HIGH PLASMA LEVELS OF LIDOCAINE OR ITS METABOLITES AND SERIOUS ADVERSE EFFECTS. Absorption from the mucous membranes is variable. Such applications may therefore result in rapidly rising or excessive plasma concentrations, with an increased risk for toxic symptoms, such as convulsions.
This is especially important in children where doses vary with weight. The management of serious adverse reactions may require the use of resuscitative equipment, oxygen and other resuscitative drugs (see OVERDOSAGE). The lowest dosage that results in effective anesthesia should be used to avoid high plasma levels and serious adverse effects.
Tolerance to elevated blood levels varies with the status of the patient. Lidocaine should be used with caution in patients with sepsis and/or traumatized mucosa at the area of application, since under such conditions there is the potential for rapid systemic absorption.
XYLOCAINE Spray (lidocaine) 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. In patients under general anesthesia who are paralyzed, higher plasma concentrations may occur than in spontaneously breathing patients.
Unparalysed patients are more likely to swallow a large proportion of the dose which then undergoes considerable first-pass hepatic metabolism following absorption from the gut. Avoid contact with eyes. Many drugs used during the conduct of anesthesia are considered potential triggering agents for familial malignant hyperthermia.
It has been shown that the use of amide local anesthetics in malignant hyperthermia is safe. However, there is no guarantee that neural blockade will prevent the development of malignant hyperthermia during surgery. It is also difficult to predict the need for supplemental general anesthesia.
XYLOCAINE
Spray is contraindicated in: patients with a known hypersensitivity to local anesthetics of the amide type or to any of the ingredients in the formulation. For a complete listing, see DOSAGE FORMS, COMPOSITION, AND PACKAGING. patients undergoing a procedure where sterile topical anesthesia is required
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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This usually requires two actuations. The spray nozzle is already bent to its final configuration for use. No further manipulations should be made to the spray nozzle before use. The nozzle must not be shortened, otherwise the spray function will be destroyed.
XYLOCAINE Spray should be used in the upright position to ensure proper function. Nozzles should not be reused and should be discarded immediately after use.
© 2019 Aspen Group of companies or its licensor. All rights reserved.
Page 11 of 19 Local Reactions:
Local irritation at the application site has been described.
Therefore a standard protocol for the management of malignant hyperthermia should be available. When topical anesthetics are used in the mouth, the patient should be aware that the production of topical anesthesia may impair swallowing and thus enhance the danger of aspiration.
Numbness of the tongue or buccal mucosa may enhance the danger of unintentional biting trauma. Food or chewing gum should not be taken while the mouth or throat area is anesthetized.
See also Part III:
Patient Medication Information. XYLOCAINE Spray is ineffective when applied to intact skin. Lidocaine has been shown to be porphyrinogenic in animal models. XYLOCAINE Spray should © 2019 Aspen Group of companies or its licensor. All rights reserved.
Page 8 of 19 only be prescribed to patients with acute porphyria on strong or urgent indications, when they can be closely monitored. Appropriate precautions should be taken for all porphyric patients. Carcinogenesis and Mutagenesis Genotoxicity tests with lidocaine showed no evidence of mutagenic potential.
A metabolite of lidocaine, 2,6-dimethylaniline, showed weak evidence of activity in some genotoxicity tests. A chronic oral toxicity study of the metabolite 2,6-dimethylaniline (0, 14, 45, 135 mg/kg) administered in feed to rats showed that there was a significantly greater incidence of nasal cavity tumors in male and female animals that had daily oral exposure to the highest dose of 2,6-dimethylaniline for 2 years.
The lowest tumor-inducing dose tested in animals (135 mg/kg) corresponds to approximately 45 times the amount of 2,6-dimethylaniline to which a 50 kg subject would be exposed following the application of 40x10 mg/metered dose of lidocaine non- aerosol spray for 24 hours on the mucosa, assuming the highest theoretical extent of absorption of 100%, and 80% conversion to 2,6-dimethylaniline.
Based on a yearly exposure (once daily dosing with 2,6-dimethylaniline in animals and 5 treatment sessions with 40x10 mg/metered dose of lidocaine non-aerosol spray in humans), the safety margins would be approximately 3400 times when comparing the exposure in animals to man.
Cardiovascular Lidocaine should be used with caution in patients with bradycardia or impaired cardiovascular function since they may be less able to compensate for functional changes associated with the prolongation of A-V conduction produced by amide-type local anesthetics.
Lidocaine should be used with caution in patients with severe shock. , amiodarone) anti-arrhythmic drugs should be under close surveillance and ECG monitoring should be considered, since cardiac effects may be additive (see DRUG INTERACTIONS).
Driving and Operating Machinery Due caution should be exercised when driving or operating a vehicle or potentially dangerous machinery. Hepatic Because amide-type local anesthetics such as lidocaine are metabolized by the liver, these drugs, especially repeated doses, should be used cautiously in patients with hepatic disease.
Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at greater risk of developing toxic plasma concentrations.
Neurologic Epilepsy:
The risk of central nervous system side effects when using lidocaine in patients with epilepsy is very low, provided that the dose recommendations are followed (See DOSAGE AND ADMINISTRATION).
Locomotion and Coordination:
Topical lidocaine formulations generally result in low plasma © 2019 Aspen Group of companies or its licensor. All rights reserved. Page 9 of 19 concentrations because of a low degree of systemic absorption. However, depending on the dose, local anesthetics may have a very mild effect on mental function and coordination even in the absence of overt CNS toxicity and may temporarily impair locomotion and alertness.
Renal Lidocaine is metabolized primarily by the liver to monoethylglycinexylidine (MEGX, which has some CNS activity), and then further to metabolites glycinexylidine (GX) […]