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:

Innovida Pharmaceutique Corporation

INN (International Name):

lidocaine

Composition:

lidocaine 70 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lidocaine and tetracaine cream 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. - Lidocaine and tetracaine cream 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) ]. - Lidocaine and tetracaine cream is contraindicated in patients with para-aminobenzoic acid (PABA) hypersensitivity. Risk Summary There are no available data on lidocaine and tetracaine cream 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-a

Product summary:

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: Refrigerate at 2 to 8°C (36 to 46°F). Do not freeze. Lidocaine and tetracaine cream can be stored at room temperature for up to 3 months. Discard lidocaine and tetracaine cream after storing at room temperature for 3 months.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

LIDOCAINE AND TETRACAINE- LIDOCAINE AND TETRACAINE CREAM
INNOVIDA PHARMACEUTIQUE CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LIDOCAINE AND
TETRACAINE CREAM SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR LIDOCAINE
AND TETRACAINE CREAM.
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
Lidocaine and tetracaine cream 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,