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Pliaglis

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Uses

PLIAGLIS Cream is a combination of lidocaine, an amide local anesthetic, and tetracaine, an ester local anesthetic, and 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.

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History

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Other Information

PLIAGLIS (lidocaine and tetracaine) Cream 7% / 7% is a topical local anesthetic cream that forms a pliable peel on the skin when exposed to air. The drug formulation is an emulsion in which the oil phase is a 1:1 eutectic mixture of lidocaine 7% and tetracaine 7%. The eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals.

The net weight of lidocaine is 2.1 g and of tetracaine is 2.1 g per 30 g tube.

The net weight of lidocaine is 4.2 g and of tetracaine is 4.2 g per 60 g tube.

The net weight of lidocaine is 7.0 g and of tetracaine is 7.0 g per 100 g tube.

Lidocaine, an amide local anesthetic, is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl) and has an octanol:water partition ratio of 182 at pH 7.3.

The molecular weight of lidocaine is 234.3, and the molecular formula is C14H22N2O. The structural formula is:

pliaglis-structure-1

Tetracaine, an ester local anesthetic, is chemically designated as 2-dimethylaminoethyl 4-n-butylaminobenzoate and has an octanol:water partition ratio of 5370 at pH 7.3. The molecular weight of tetracaine is 264.4, and the molecular formula is C15H24N2O2. The structural formula is:

pliaglis-structure-2

Each gram of PLIAGLIS Cream contains lidocaine 70 mg and tetracaine 70 mg in a 1:1 eutectic mixture and it also contains the following inactive ingredients: dibasic calcium phosphate, methylparaben, petrolatum, polyvinyl alcohol, propylparaben, purified water, and sorbitan monopalmitate.

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Pliaglis Manufacturers

  • Galderma Laboratories, L.p.
    Pliaglis | Galderma Laboratories, L.p.
    No Recall

    Pliaglis | Galderma Laboratories, L.p.

    Pliaglis | Galderma Laboratories, L.p.


    2.1 General Dosing Information

    PLIAGLIS Cream should only be applied to intact skin.

    For use in adults only.

    • For superficial dermatological procedures such as dermal filler injection, non-ablative laser facial resurfacing, or pulsed-dye laser therapy, apply PLIAGLIS Cream to intact skin for 20-30 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 Cream to intact skin for 60 minutes prior to the procedure. See Table 1 for instructions on the amount to apply.

    The dose of PLIAGLIS Cream 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.

    2.2 Dosage Information

    Determine the amount of drug to apply.

    The amount (length) of PLIAGLIS Cream that should be dispensed is determined by the size of the area to be treated (see Table 1).

    (a) Using the ruler supplied on the carton, squeeze out and measure the amount of PLIAGLIS Cream that approximates the amount required to achieve proper coverage.

    (b) Spread PLIAGLIS Cream 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.

    (c) After waiting the required application time, remove the PLIAGLIS Cream by grasping a free-edge with your fingers and pulling it away from the skin.

    Table 1. Amount of PLIAGLIS Cream According to Treatment Site Surface Area

    2.3 Important Dosage and Administration Instructions

    Important Dosage and Administration instructions include:

    Remove PLIAGLIS Cream 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 contact with PLIAGLIS Cream. Wash hands after handling PLIAGLIS Cream. Upon removal from the treatment site, discard the used PLIAGLIS Cream in a location that is out of the reach of children and pets. Access to PLIAGLIS Cream by children or pets should be prevented during usage and storage of the product [see Warnings and Precautions (5.2)].
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