LIDOCAINE HYDROCHLORIDE- 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:

Cardinal Health

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 is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

Product summary:

Lidocaine Hydrochloride Injection, USP is supplied as follows: Unit of Sale Concentration Each Multiple-dose: NDC 55154-6969-5 2% 400 mg/20 mL (20 mg/mL) Overbagged with 5 x 20 mL Multiple-Dose Fliptop vials Single-dose products are preservative-free. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Lidocaine Hydrochloride Injection, USP solutions packaged in ampuls and glass teartop vials may be autoclaved one time only. Autoclave at 15 pounds pressure, 121°C (250°F) for 15 minutes. DO NOT AUTOCLAVE PRODUCT IN PLASTIC VIALS. Revised: 1/2015                                                                               EN-3679 Hospira, Inc., Lake Forest, IL 60045 USA                                                                                   Repackaged By: Cardinal Health Zanesville, OH 43701 L40688131016

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LIDOCAINE HYDROCHLORIDE- LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION
CARDINAL HEALTH
----------
LIDOCAINE
Rx only
HYDROCHLORIDE
INJECTION, USP
AQUEOUS SOLUTIONS FOR
INFILTRATION AND NERVE BLOCK
AMPUL
PLASTIC MULTIPLE-DOSE FLIPTOP VIAL
GLASS TEARTOP VIAL
_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 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/or the beta-adrene