LIDOCAINE HYDROCHLORIDE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

McKesson Corporation dba SKY Packaging

INN (International Name):

LIDOCAINE HYDROCHLORIDE ANHYDROUS

Composition:

LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 mL

Administration route:

INFILTRATION

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lidocaine Hydrochloride Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed. Lidocaine HCl is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

Product summary:

Product: 63739-469 NDC: 63739-469-21 50 mL in a VIAL, MULTI-DOSE / 5 in a BOX Product: 63739-470 NDC: 63739-470-21 50 mL in a VIAL, MULTI-DOSE / 5 in a BOX

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LIDOCAINE HYDROCHLORIDE- LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION
MCKESSON CORPORATION DBA SKY PACKAGING
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LIDOCAINE HYDROCHLORIDE
INJECTION, USP
AQUEOUS SOLUTIONS FOR
INFILTRATION AND NERVE BLOCK
AMPUL
PLASTIC MULTIPLE-DOSE FLIPTOP VIAL
GLASS TEARTOP VIAL
RX ONLY
DESCRIPTION
Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic
solution of lidocaine hydrochloride
in water for injection for parenteral administration in various
concentrations with characteristics as
follows:
CONCENTRATION
0.5%
1%
1.5%
2%
mg/mL lidocaine HCl (anhyd.)
5
10
15
20
mg/mL sodium chloride
8
7
6.5
6
Multiple-dose vials contain 0.1% of methylparaben added as
preservative. May contain sodium
hydroxide and/or hydrochloric acid for pH adjustment. The pH is 6.5
(5.0 to 7.0). See HOW
SUPPLIED section for various sizes and strengths.
Lidocaine is a local anesthetic of the amide type.
Lidocaine Hydrochloride, USP is chemically designated
2-(diethylamino)-N-(2,6-dimethylphenyl)-
acetamide monohydrochloride monohydrate, a white powder freely soluble
in water. The molecular
weight is 288.82. It has the following structural formula:
The semi-rigid vial used for the plastic vials is fabricated from a
specially formulated polyolefin. It is a
copolymer of ethylene and propylene. The safety of the plastic has
been confirmed by tests in animals
according to USP biological standards for plastic containers. The
container requires no vapor barrier to
maintain the proper drug concentration.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Lidocaine HCl stabilizes the neuronal membrane by inhibiting the ionic
fluxes required for the initiation
and conduction of impulses thereby effecting local anesthetic action.
HEMODYNAMICS
Excessive blood levels may cause changes in cardiac output, total
peripheral resistance, and mean
arterial pressure. With central neural blockade these changes may be
attributable to block of autonomic
fibers, a direct depressant effect of the local anesthetic agent on
various components of the
cardiovascular system, and/o