Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
lidocaine (UNII: 98PI200987) (lidocaine - UNII:98PI200987), tetracaine (UNII: 0619F35CGV) (tetracaine - UNII:0619F35CGV)
Taro Pharmaceuticals U.S.A., Inc.
lidocaine
lidocaine 70 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
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
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.
New Drug Application
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 Прочитајте комплетан документ