LIDOCAINE HYDROCHLORIDE MONOHYDRATE powder

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)

Available from:

SA3, LLC

Administration route:

INTRADERMAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lidocaine Hydrochloride Monohydrate powder intradermal injection system is indicated for use on intact skin to provide topical local analgesia prior to venipuncture or peripheral intravenous cannulation, in children 3–18 years of age. Lidocaine Hydrochloride Monohydrate powder intradermal injection system is indicated for use on intact skin to provide topical local analgesia prior to venipuncture in adults. Lidocaine Hydrochloride Monohydrate is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type. Lidocaine Hydrochloride Monohydrate powder intradermal injection system was not formally evaluated for effects on reproduction. Significant systemic exposure to lidocaine is not expected under recommended conditions of use of Lidocaine Hydrochloride Monohydrate powder intradermal injection system as lidocaine levels were below the limit of detection in human studies. Lidocaine has been previously tested for reproductive toxicity in animal studies, however. The follo

Product summary:

NDC 69420-1230 Lidocaine Hydrochloride Monohydrate powder intradermal injection system contains 0.5 mg of sterile lidocaine hydrochloride monohydrate. Lidocaine HCl Monohydrate injection system is a single-dose device packaged in an individual clear pouch. Twelve pouched devices are placed in labeled cartons. Cartons are stored at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

LIDOCAINE HYDROCHLORIDE MONOHYDRATE- LIDOCAINE HYDROCHLORIDE
MONOHYDRATE POWDER
SA3, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LIDOCAINE HYDROCHLORIDE MONOHYDRATE
POWDER INTRADERMAL INJECTION SYSTEM SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR LIDOCAINE
HYDROCHLORIDE MONOHYDRATE POWDER INTRADERMAL INJECTION SYSTEM.
LIDOCAINE HYDROCHLORIDE MONOHYDRATE 0.5MG
POWDER INTRADERMAL INJECTION SYSTEM
INITIAL U.S. APPROVAL: 1948
RECENT MAJOR CHANGES
Warnings and Precautions, Methemoglobinemia (5.1) 12/2018
INDICATIONS AND USAGE
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Important Limitations:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Lidocaine Hydrochloride Monohydrate powder intradermal injection
system is a sterile, single-use, powder intradermal
injection system containing 0.5 mg lidocaine hydrochloride
monohydrate. (3) Lidocaine Hydrochloride Monohydrate
powder intradermal injection system utilizes a helium-powered delivery
system. (11)
CONTRAINDICATIONS
Lidocaine Hydrochloride Monohydrate powder intradermal injection
system is contraindicated in patients with a known
history of sensitivity to local anesthetics of the amide type. (4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most common adverse reactions (>5%) are skin reactions at the site
of administration: erythema, petechiae, edema,
and pruritus (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT FDA AT 1-800-FDA-1088
OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 12/2018
Lidocaine Hydrochloride Monohydrate powder intradermal injection
system is an amide local anesthetic indicated for
use on intact skin to provide local analgesia prior to venipuncture or
peripheral intravenous cannulation in children 3–
18 years of age. (1)
Lidocaine Hydrochloride Monohydrate powder intradermal injection
system is indicated for use on intact skin to
provide topical local analgesia prior to venipuncture in adults. (1)
For use on intact sk