PLIAGLIS- lidocaine and tetracaine cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

lidocaine (UNII: 98PI200987) (lidocaine - UNII:98PI200987), tetracaine (UNII: 0619F35CGV) (tetracaine - UNII:0619F35CGV)

Available from:

Taro Pharmaceuticals U.S.A., Inc.

INN (International Name):

lidocaine

Composition:

lidocaine 70 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 contraindicated in patients with a known history of sensitivity to lidocaine or tetracaine, local anesthetics of the amide or ester type, or to any other component of the product [see Warnings and Precautions (5.4) ]. - PLIAGLIS is contraindicated in patients with para-aminobenzoic acid (PABA) hypersensitivity. Risk Summary There are no available data on PLIAGLIS use in pregnant women to determine a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Available data from an epidemiologic study and case series with parenteral lidocaine use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Published data on tetracain

Product summary:

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 51672-5305-2 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.

Authorization status:

New Drug Application

Summary of Product characteristics

PLIAGLIS- LIDOCAINE AND TETRACAINE CREAM
TARO PHARMACEUTICALS U.S.A., INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
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
RECENT MAJOR CHANGES
Dosage and Administration, Important Dosage and Administration
Instructions (2.1)
12/2018
Dosage and Administration, Recommended Dosage (2.3)
12/2018
Warnings and Precautions, Methemoglobinemia (5.1)
11/2018
INDICATIONS AND USAGE
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
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 laserassisted tattoo
removal
60 minutes prior to procedure
See Full Prescribing Information for amount to apply based upon
treatment site surface area. (2.3)
DOSAGE FORMS AND STRENGTHS
Cream: 70 mg of lidocaine and 70 mg of tetracaine per gram (7%; 7%).
(3)
CONTRAINDICATIONS
Known history of sensitivity to lidocaine or tetracaine, or local
anesthetics of the amide or ester type. (4)
Para-aminobenzoic acid (PABA) hypersensitivity. (4)
WARNINGS AND PRECAUTIONS
Methemoglobinemia: Cases of methemoglobinemia have been reported in
association with local anesthetic use. (5.1)
Overexposure: To avoid overexposure that could lead to adverse
effects,
–
–
–
–
Risk of Secondary Exposure to Children and Pets: Store and dispose of