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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.
DOSAGE AND ADMINISTRATION
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.
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).
- 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.
- 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.
- 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
|Surface Area of Treatment Site (cm²)||Length of PLIAGLIS Cream for 1 mm Thickness (cm)||Weight of PLIAGLIS Cream Dispensed (g)|
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].
- 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].
Dosage Forms And Strengths
Each gram of PLIAGLIS Cream contains lidocaine 70 mg and tetracaine 70 mg and is a smooth, white to off-white, viscous cream.
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 0299-6100-30 30 gram tube
(with Child Resistant Cap)
NDC 0299-6100-35 30 gram tube
NDC 0299-6100-60 60 gram tube
NDC 0299-6100-10 100 gram tube
Refrigerate at 2 -8°C (36 -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.
Marketed by: Galderma Laboratories, L.P. Fort Worth, Texas 76177 USA. Manufactured by: G Production Inc., Baie d'Urfé, QC, H9X 3S4 Canada. Made in Canada. Revised: Nov 2013.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/12/2013
Additional Pliaglis Information
- Pliaglis Drug Interactions Center: lidocaine-tetracaine top
- Pliaglis Side Effects Center
- Pliaglis FDA Approved Prescribing Information including Dosage
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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