FAST, CLEAN, SIMPLE The first and only self-occluding topical anaesthetic1
New Pliaglis is Fast, Clean, Simple. With 7% lidocaine and 7% tetracaine, Pliaglis contains high concentrations of two anaesthetic ingredients in a single cream.2,3
Pliaglis delivers
long-lasting (mean duration 9 hours) anaesthesia within 30 or 60 minutes to provide sufficient pain relief during dermatological procedures.2,3
The occlusion-free formula‡1 Pliaglis delivers a clean and simple procedure.
References: 1. Alster T. Review of Lidocaine/Tetracaine Cream as a Topical Anaesthetic for Dermatologic Laser Procedures. Pain Ther. 2013 [Epub ahead of print]. 2. Pliaglis EU Summary of Product Characteristics. 3. Alster TS, et al. The Lidocaine/Tetracaine Peel: A Novel Topical Anaesthetic for Dermatological Procedures in Adult Patients. Dermatol Surg. 2007;33:1073-1081.
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Abbreviated Prescribing Information Pliaglis 70mg/g + 70mg/g cream. ATC code: N01BB52. 1 gram of cream contains 70 mg lidocaine and 70 mg tetracaine. Indication: In adults to produce local dermal anaesthesia on intact skin prior to dermatological procedures.
Posology and method of administration: For procedures such as pulsed-dye laser therapy, laser-assisted hair removal, non-ablative laser facial resurfacing, dermal filler injections and vascular access, Pliaglis should be applied at a thickness of 1mm for 30 minutes. †
For procedures such as laser-assisted tattoo removal, and laser leg vein ablation, Pliaglis should be applied at a thickness of 1mm for 60 minutes. After the required time, the peel must then be removed from the skin prior to the procedure. The maximum application area should not exceed 400 cm2 .
Pliaglis is for single patient use. For facial procedures, Pliaglis should be applied by healthcare professionals. For procedures on any other part of the body, Pliaglis should be applied by healthcare professionals or by patients adequately instructed in appropriate application technique. Direct contact with the cream or the skin covered with the cream should be avoided in order to prevent contact dermatitis. Pliaglis should only be applied with a flat surfaced tool such as a spatula or tongue depressor, never with fingers. Hands should be washed immediately after removing and disposal of the peel. The use of Pliaglis is not recommended in children and adolescents.
Contraindications: Hypersensitivity to lidocaine, tetracaine, other anaesthetics of the amide or ester type, to para-aminobenzoic acid (a known by-product of tetracaine metabolism), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216) or to any of the other excipients. Pliaglis should not be used on mucous membranes or on broken or irritated skin.
Warnings and precautions for use: Contact with eyes should be avoided. The treated area should not be occluded before removing Pliaglis from the skin. Pliaglis should not be applied for a longer time than recommended. Rare allergic or anaphylactoid reactions associated with lidocaine, tetracaine or other ingredients in Pliaglis can occur. Several local anaesthetics, including tetracaine, have been associated with methemoglobinemia. It is not recommended to use Pliaglis before injection of live vaccines as Lidocaine has been shown to inhibit viral and bacterial growth. Use with caution in patients with hepatic, renal or cardiac impairment, and in patients with increased sensitivity to systemic circulatory effects of lidocaine and tetracaine, such as the acutely ill or debilitated. Avoid inadvertent trauma to the skin whilst under effects of Pliaglis.
Interactions: No interaction studies have been performed. The risk of additional systemic toxicity should be considered when Pliaglis is applied to patients receiving Class I and III antiarrhythmic medicinal products or other products containing local anaesthetic agents. Interactions following appropriate use are unlikely since only low concentrations of lidocaine and tetracaine are found in the plasma after topical administration of recommended doses. Patients taking drugs associated with drug-induced methemoglobinemia are at greater risk for developing methemoglobinemia.
Pregnancy and breast feeding: Caution should be exercised when used in pregnant women. Pliaglis can be used during breast-feeding as long as Pliaglis is not applied to the breast.
Undesirable effects: Localized skin reactions at the application site were very common adverse events in clinical studies but were generally mild and transient in nature. Reported adverse events include: Very common (≥1/10): erythema, skin discolouration; Common (≥1/100 to <1/10): skin oedema; Uncommon (≥1/1,000 to <1/100:) pruritus, pain of skin, pain; Rare (≥1/10,000 to <1/1,000): paresthesia, eyelid oedema, pallor, skin burning sensation, swelling face, skin exfoliation, skin irritation; Not known (cannot be estimated from the available data): urticaria.
Packagings: Tube with 15g or 30g. POM. Cost: national decision. For full prescribing information refer to Summary of Product Characteristics (SmPC), available by Galderma. Adverse events should be reported. Based on EU SmPC approved 2012-05.
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