Pliaglis® in Practice
Important Safety Information:
Cream 7% / 7% 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.
Cream is contraindicated in patients with a known history of sensitivity to lidocaine
or tetracaine, or local anesthetics of the amide or ester type and is also contraindicated
in patients with sensitivity to para-aminobenzoic acid (PABA) or any component of
the product. Adverse Events: In clinical studies, the most common local reactions
were erythema (47%), skin discoloration (16%), and edema (14%). The most common
systemic adverse events were headache, vomiting, dizziness, and fever, all of which
occurred with a frequency of <1%. Warnings/Precautions: Methemoglobinemia
has been associated with use of local anesthetics such as tetracaine. PLIAGLIS® Cream should be used with caution
in patients with severe hepatic disease. When using PLIAGLIS®
Cream in conjunction with other local anesthetic agents, the total dose of anesthetic
should be considered due to the potential for additive systemic toxic effects. Contact
with the eyes should be avoided.
You are encouraged to report negative side effects of prescription drugs to the
FDA. Visit www.fda.gov/medwatch
or call 1-800-FDA-1088.