PLIAGLIS

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE 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. ( 1 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION Apply only to intact skin. ( 2.1 ) Do not exceed the recommended dose of drug or duration of application. ( 2.1 ) Recommended duration of application ( 2.2 ): 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. ( 2.3 ) 2.1 Important Dosage and Administration Instructions For use in adults only. PLIAGLIS should only be applied to intact skin. PLIAGLIS should not be applied to a procedure site after the procedure has been performed. Remove PLIAGLIS if skin irritation or a burning sensation occurs during application. 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 [see Overdosage (10) ] . Avoid eye and lip contact with PLIAGLIS. Wash hands after handling PLIAGLIS. Upon removal from the treatment site, discard the used PLIAGLIS in a location that is out of the reach of children and pets. Access to PLIAGLIS by children or pets should be prevented during usage and storage of the product [see Warnings and Precautions (5.2) ] . Use only as directed. 2.2 Recommended Dosing Duration For superficial dermatological procedures, such as dermal filler injection, non-ablative laser facial resurfacing, or pulsed-dye laser therapy, apply PLIAGLIS to intact skin for 20 to 30 minutes prior to the procedure. See Table 1 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 Table 1 for instructions on the amount to apply. 2.3 Recommended Dosage The dose of PLIAGLIS that provides effective local dermal analgesia depends on the duration of the application. Although not specifically studied, a shorter duration of application may result in a less complete dermal analgesia or a shorter duration of adequate dermal analgesia. Determine the amount of drug to apply The amount (length) of PLIAGLIS that should be dispensed is determined by the size of the area to be treated (see Table 1 ). Using the ruler on the applicator included in the carton, squeeze out and measure the amount of PLIAGLIS that approximates the amount required to achieve proper coverage. 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, remove the PLIAGLIS by grasping a free-edge with your fingers and pulling it away from the skin. Table 1. Amount of PLIAGLIS According to Treatment Site Surface Area Surface Area of Treatment Site (inch 2 ) Length of PLIAGLIS for 1 mm Thickness (inch) Weight of PLIAGLIS Dispensed (g) 2 1 1 3 2 3 6 5 5 12 9 11 16 12 13 23 18 20 31 24 26 39 30 33 47 36 40 54 42 46 62 48 53 Warnings and cautions 5 WARNINGS AND PRECAUTIONS Methemoglobinemia : Cases of methemoglobinemia have been reported in association with local anesthetic use. ( 5.1 ) Overexposure : To avoid overexposure that could lead to adverse effects, do not use for longer duration or over larger surface areas than recommended. ( 5.2 ) consider total amount of local anesthetics absorbed from all formulations. ( 5.2 ) do not apply to mucous membranes or broken or inflamed skin. ( 5.2 ) 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. ( 5.2 ) 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. ( 5 ) Anaphylactic Reactions : Seek emergency help if an anaphylactic reaction occurs. ( 5.4 ) Eye Irritation : Avoid contact with eyes. ( 5.5 ) 5.1 Methemoglobinemia Cases of methemoglobinemia have been reported in association with local anesthetic use. Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase defi