LIDOCAINE HYDROCHLORIDE- lidocaine hydrochloride anhydrous injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

General Injectables & Vaccines, Inc

INN (International Name):

LIDOCAINE HYDROCHLORIDE

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 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: 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. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1118-4.0 02/2019

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LIDOCAINE HYDROCHLORIDE- LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION,
SOLUTION
GENERAL INJECTABLES & VACCINES, INC
----------
LIDOCAINE HCL 2% 20 MG/ML INJECTION, USP MULTI DOSE VIAL
SPL UNCLASSIFIED
Lidocaine
Hydrochloride
Injection, USP
Rx only
AQUEOUS SOLUTIONS FOR
INFILTRATION AND NERVE BLOCK
Ampul
Plastic Multiple-dose Fliptop Vial
Glass Teartop Vial
Hospira
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:
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/or the beta-
a