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PLIAGLIS is a brand name for Lidocaine (also known as Lignocaine), supplied as a cream. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Dosing Considerations PLIAGLIS (lidocaine 7% and tetracaine 7%) cream should only be applied to intact skin. Do not reapply to treated area after the procedure. If your procedure has to be repeated, the treated area must have time to fully recover before using PLIAGLIS again.
PLIAGLIS should be used in the treatment location where the procedure will be performed. Conditions where dosing may require adjustment: in acutely ill, debilitated or elderly patients, and patients with severe hepatic impairment who are more sensitive to systemic effects due to increased blood levels of lidocaine and tetracaine in patients who are administered other local anesthetics or amide type local anesthetics (see DRUG INTERACTIONS) in debilitated patients, or those with impaired elimination, smaller application areas are recommended to avoid toxicity.
PLIAGLIS should only be used for the approved indications because safety and efficacy have not been determined for other uses. PLIAGLIS cream should be applied to skin areas 400cm2 or less and for the time recommended only. For use in adults only.
g. dermal filler injection) or facial laser ablation, apply PLIAGLIS to intact skin for 20-30 minutes prior to the procedure. See Table 2 for instructions on the amount to apply. For superficial dermatological procedures such as laser-assisted tattoo removal, apply PLIAGLIS to intact skin for 60 minutes prior to the procedure.
See Tables 4 and 5 for instructions on the amount to apply. In order to minimize the risk of systemic toxicity, do not exceed the recommended amount of drug to apply or the duration of the application. 3 g of cream per 10 cm2). After the required time, the peel must then be removed from the skin prior to the procedure.
3 g of cream per 10 cm2). After the required time, the peel must then be removed from the skin prior to the procedure. The amount (length) of PLIAGLIS that should be dispensed is determined by the size of the area to be treated (see Table 4).
3 20 6 3 40 12 5 80 24 11 100 30 13 150 46 20 200 61 26 250 76 33 300 91 40 350 106 46 400 121 52 Table 5: Visual Comparator Reference Chart cm2 Area Reference 10 Approximately the size of a two dollar coin (“toonie”). 40 Approximately the size of a credit card.
80 Approximately the size of two credit cards. 200 Approximately the size of a standard postcard. 400 Approximately the size of 2 standard postcards. The maximum application area should not exceed 400 cm2. PLIAGLIS (lidocaine and tetracaine) Product Monograph Page 15 of 30 Administration Squeeze out and measure the amount of PLIAGLIS that approximates the amount required to achieve proper coverage.
Adverse Drug Reaction Overview The total number of patients experiencing adverse reactions in controlled clinical trials was 740 (50%) for the PLIAGLIS (lidocaine 7% and tetracaine 7%) cream treatment group (N = 1480) and 485 (40%) for the placebo group (N = 1229).
The most frequently reported adverse reactions in the PLIAGLIS treatment group in controlled studies were erythema (42%), skin discolouration (12%) and skin oedema (8%). Most adverse reactions were mild and transient in nature. However, one patient withdrew from a controlled study due to burning pain at the treatment site and a second subject withdrew from an open-label study due to severe skin oedema at the treatment site.
Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. In controlled clinical trials, 1480 subjects received PLIAGLIS and 1229 subjects received placebo or vehicle.
The adverse reactions reported in at least 1% of the patients treated with PLIAGLIS in the controlled clinical trials are listed in Table 1 below.
Table 1:
Commonly Reported Adverse Events Reported in Controlled Clinical Trials System Organ Class / Preferred Term PLIAGLISa n=1480 (%) Placebob n=1229 (%) Skin and subcutaneous tissue disorders Erythema Skin Discolouration Skin Oedema (42) (12) (8) (34) (8) (4) a Includes Developmental A PLIAGLIS Formulation, Developmental B PLIAGLIS Formulation, Developmental C PLIAGLIS Formulation, Final PLIAGLIS Formulation (including Final 4-88 and Final 5-88); b Includes 100 subjects that received a Vehicle Control.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Lidocaine in Canada.
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Then spread PLIAGLIS evenly and thinly (approximately 1 mm or the thickness of a dime) across the treatment area using a flat-surfaced tool such as a metal spatula or tongue depressor. After waiting the required application time ensuring that the PLIAGLIS has dried, remove the peel by grasping a free-edge with your fingers and pulling it away from the skin.
If the peel does not pull away freely, the cream may not be completely dried. If this occurs, use a gauze to wipe away any PLIAGLIS cream that has not dried. If skin irritation or a burning sensation occurs during application, remove PLIAGLIS immediately.
If PLIAGLIS comes into contact with your eye, immediately rinse your eye with water or salt solution. Protect the eye and avoid rubbing until feeling returns. OVERDOSAGE For management of a suspected drug overdose, contact your regional Poison Control Centre.
Systemic adverse effects of lidocaine and tetracaine are similar in nature to those observed with other amide and ester local anesthetic agents, including CNS excitation and/or depression (light- headedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensation of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest).
Excitatory CNS reactions may be brief or not occur at all, in which case the first manifestation may be drowsiness merging into unconsciousness. The toxicity of co-administered local anesthetics is thought to be at least additive. In the absence of massive topical overdose or oral ingestion, other etiologies for the clinical effects or overdosage from other sources of lidocaine, tetracaine or other local anesthetics should be considered.
The management of overdosage includes close monitoring, supportive care and symptomatic treatment. Dialysis is of negligible value in the treatment of acute overdosage of lidocaine or tetracaine.
Methemoglobinemia:
Mild methemoglobinemia is characterized by tissue cyanosis, a bluish-grey or brownish discoloration of the skin, especially around the lips and nail beds, which is not reversed by breathing 100% oxygen. Clinical signs may also include pallor and marbleization.
Severe methemoglobinemia (MetHb concentrations above approximately 25%) is associated with signs of hypoxemia, ie. dyspnea, tachycardia and depression of consciousness. Drug-induced methemoglobinemia may occur with the use of drugs including but not limited to sulfonamides, acetanilid, aniline dyes, benzocaine, chloroquine, dapsone, naphthalene, nitrates and nitrites, nitrofurantoin, […]
Less Common Clinical Trial Adverse Drug Reactions (<1%) The following less common adverse events have been experienced with PLIAGLIS in clinical trials. 1%) 0 a Includes Developmental A PLIAGLIS Formulation, Developmental B PLIAGLIS Formulation, Developmental C PLIAGLIS Formulation, Final PLIAGLIS Formulation (including Final 4-88 and Final 5-88); b Includes 100 subjects that received a Vehicle Control.
Systemic Events Across all trials, 19 subjects experienced a systemic adverse event, 15 of who were treated with PLIAGLIS and 4 with placebo. 3%). The most common systemic adverse events were headache, vomiting, dizziness, and fever, all of which occurred with a frequency of <1%.
Other systemic events were syncope, nausea, confusion, dehydration, hyperventilation, hypotension, nervousness, paresthesia, pharyngitis, stupor, pallor, and sweating. Overall, systemic adverse reactions following appropriate use of PLIAGLIS are unlikely to occur, due to the small dose absorbed (see ACTION AND CLINICAL PHARMACOLOGY, Pharmacokinetics) Post-Market Adverse Drug Reactions Table 3 is based on post-market spontaneous adverse event reports.
The percentages shown are calculated by dividing the number of adverse events reported to the company by the estimated number of patients exposed to the drug during the same time period. The causal relationship between PLIAGLIS and the emergence of these events has not been established.
01% Eye disorders Corneal epithelium defect X Eye pain X Eye swelling X Keratitis X Vision blurred X Immune system disorders Anaphylactic shock X Infections and infestations Keratitis herpetic X Injury, poisoning and procedural complications Eye burns X Investigations Blood pressure increased X DRUG INTERACTIONS Overview No drug-drug interaction studies have been conducted on PLIAGLIS (lidocaine 7% and tetracaine 7%) cream.
Since PLIAGLIS is for short duration topical administration, it is less likely that metabolic drug- drug interactions of clinical significance can occur due to the resultant low systemic exposure to lidocaine and tetracaine. Ester derivatives such as tetracaine that are hydrolysed to para-aminobenzoic acid may antagonise the activity of aminosalicylic acid or sulfonamides.
Lidocaine has been found to potentiate the neuromuscular blocking effects of suxamethonium (succinylcholine) in both human and animal studies.
Drug-Drug Interactions Antiarrhythmic Drugs:
There is an increased risk of myocardial depression when amide-type local anaesthetics such as lidocaine are given with antiarrhythmics. PLIAGLIS should be used with caution in patients receiving Class I antiarrhythmic drugs (such as tocainide and mexiletine) since the systemic toxic effects are thought to be additive and potentially synergistic with lidocaine and tetracaine.
Caution is advised when using Class III antiarrhythmic drugs concomitantly with PLIAGLIS due to potential pharmacodynamic or pharmacokinetic interactions, or both. g. amiodarone) PLIAGLIS (lidocaine and tetracaine) Product Monograph Page 12 of 30 should be kept under close […]