Lidocaine and Tetracaine

PLIAGLIS is indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal. PLIAGLIS is a combination of lidocaine, an amide local anesthetic, and tetracaine, an ester local anesthetic, indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal.

Lidocaine is an amide-type local anesthetic agent and tetracaine is an ester-type local anesthetic agent. Both lidocaine and tetracaine block sodium ion channels required for the initiation and conduction of neuronal impulses which, in certain instances, results in local anesthesia. When applied to intact skin, PLIAGLIS provides local dermal analgesia by the release of lidocaine and tetracaine from the peel into the skin.

Apply only to intact skin. Do not exceed the recommended dose of drug or duration of application. Recommended duration of application: For dermal filler injection ablative laser facial resurfacing, or pulsed-dye laser therapy 20-30 minutes prior to procedure For superficial dermatological procedures such as laserassisted tattoo removal 60 minutes prior to procedure See Full Prescribing Information for amount to apply based upon treatment site surface area.

PLIAGLIS is contraindicated in patients with a known history of sensitivity to lidocaine or tetracaine, local anesthetics of the amide or ester type, or to any other component of the product. PLIAGLIS is contraindicated in patients with para-aminobenzoic acid (PABA) hypersensitivity. Known history of sensitivity to lidocaine or tetracaine, or local anesthetics of the amide or ester type. Para-aminobenzoic acid (PABA) hypersensitivity.

Methemoglobinemia: Cases of methemoglobinemia have been reported in association with local anesthetic use. Overexposure: To avoid overexposure that could lead to adverse effects, do not use for longer duration or over larger surface areas than recommended. consider total amount of local anesthetics absorbed from all formulations. do not apply to mucous membranes or broken or inflamed skin. use with caution in patients who may be more sensitive to systemic effects of PLIAGLIS, including acutely ill or debilitated or those with severe hepatic disease or pseudocholinesterase deficiency. Risk of Secondary Exposure to Children and Pets: Store and dispose of PLIAGLIS out of reach of children and pets due to the risk of accidental exposure and resulting toxicity. Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs. Eye Irritation: Avoid contact with eyes.

The following adverse reactions are described elsewhere in the labeling: Methemoglobinemia Overexposure Risks of Secondary Exposure in Children and Pets Anaphylactic Reactions Eye Irritation Most common local reactions were erythema (47%), skin discoloration (16%), and edema (14%).

Antiarrhythmic Drugs: Use with caution in patients receiving Class I antiarrhythmic drugs (such as tocainide and mexiletine) because the systemic toxic effects are thought to be additive and potentially synergistic with lidocaine and tetracaine.

Refrigerate at 2 to 8°C (36 to 46°F). Do not freeze. PLIAGLIS can be stored at room temperature for up to 3 months. Discard PLIAGLIS after storing at room temperature for 3 months.