These highlights do not include all the information needed to use PLIAGLIS safely and effectively. See full prescribing information for PLIAGLIS.
PLIAGLIS ® (lidocaine and tetracaine) Cream, for topical use
Initial U.S. Approval: 2006
INDICATIONS AND USAGE
PLIAGLIS Cream 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
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Apply PLIAGLIS Cream to intact skin 20-30 minutes prior to the procedure for dermal filler injection, ablative laser facial resurfacing, or pulsed-dye laser therapy. (2.1)
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For superficial dermatological procedures such as laser-assisted tattoo removal, apply PLIAGLIS Cream to intact skin for 60 minutes prior to the procedure. (2.1)
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Amount of cream to apply is determined by size of treatment area. (2.2)
DOSAGE FORMS AND STRENGTHS
Cream: 70 mg of lidocaine and 70 mg of tetracaine per gram (7%; 7%). (3)
CONTRAINDICATIONS
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Known history of sensitivity to lidocaine or tetracaine, or local anesthetics of the amide or ester type. (4)
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Para-aminobenzoic acid (PABA) hypersensitivity. (4)
WARNINGS AND PRECAUTIONS
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Use with caution in patients who may be more sensitive to systemic effects of lidocaine and tetracaine, including acutely ill or debilitated. (5.1)
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When used concomitantly with other products containing local anesthetic agents, amount absorbed from all formulations should be considered since systemic toxic effects are thought to be additive and potentially synergistic with lidocaine and tetracaine. (5.1)
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Do not apply to mucous membranes or broken or inflamed skin. Use only on intact skin. (5.1)
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Do not apply for longer times than those recommended or over larger surface areas than those recommended, which could result in absorption of lidocaine and tetracaine at doses that could lead to serious adverse effects. (5.1)
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Keep PLIAGLIS Cream away from children and pets due to the risk of accidental exposure and resulting toxicity. (5.2)
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Tetracaine has been associated with methemoglobinemia. Risk o
