Drug Catalog - Product Detail
PLIAGLIS LIDOCAINE-TETRACAINE CREAM 7-7% 30 GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 73575-0009-09 | OBA PHARMACEUTICALS | 30 | 7-7% | CREAM |
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Description
11 DESCRIPTION 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. 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 C 14 H 22 N 2 O. The structural formula is: Tetracaine, an ester local anesthetic, is chemically designated as 2-dimethylaminoethyl 4-n-butyl-aminobenzoate 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 C 15 H 24 N 2 O 2 . The structural formula is: Each gram of PLIAGLIS contains lidocaine 70 mg and tetracaine 70 mg in a 1:1 eutectic mixture and it also contains the following inactive ingredients: anhydrous dibasic calcium phosphate, methylparaben, polyvinyl alcohol, propylparaben, purified water, sorbitan monopalmitate, and white petrolatum. Chemical Structure Chemical Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING PLIAGLIS (lidocaine and tetracaine) Cream (70 mg of lidocaine and 70 mg of tetracaine in 1 gram), 7% / 7%, appears smooth and white to off-white and is available as the following: NDC 73575-009-09 30 gram tube (with Child Resistant Cap) with applicator 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.
Indications & 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 laser-assisted 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