LIDOCAINE HYDROCHLORIDE injection, solution LIDOCAINE HYDROCHLORIDE- lidocaine hydrochloride injection, solution

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987)

Tilgængelig fra:

Camber Pharmaceuticals, Inc.

Indgivelsesvej:

INFILTRATION

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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

Produkt oversigt:

Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic, clear, colorless, isotonic solution and is supplied as follows: Lidocaine Hydrochloride Injection USP, 1% (10 mg/mL): 25 x 2 mL Single-Dose Carton                                      NDC 31722-117-31 25 x 5 mL Single-Dose Carton                                      NDC 31722-117-32 Lidocaine Hydrochloride Injection USP, 2% (20 mg/mL): 25 x 2 mL Single-Dose Carton                                        NDC 31722-118-31 25 x 5 mL Single-Dose Carton                                        NDC 31722-118-32 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Discard unused portion. Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 Manufactured by: Aspiro Pharma Limited Survey No. 321, Biotech Park, Phase – III Karkapatla Village, Markook (Mandal) Siddipet, Telangana-502281, India. Issued: 11/2021

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

LIDOCAINE HYDROCHLORIDE- LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION
LIDOCAINE HYDROCHLORIDE - LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION
CAMBER PHARMACEUTICALS, INC.
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FOR INFILTRATION AND NERVE BLOCK INCLUDING CAUDAL AND EPIDURAL USE.
PRESERVATIVE-FREE
DESCRIPTION
Lidocaine hydrochloride injection, USP is sterile, nonpyrogenic,
aqueous solution that
contains a local anesthetic agent and is administered parenterally by
injection. See
INDICATIONS AND USAGE section for specific uses.
Lidocaine hydrochloride injection, USP contains lidocaine
hydrochloride, which is
chemically designated as acetamide,
2-(diethylamino)-N-(2,6-dimethylphenyl)-,
monohydrochloride and has the molecular weight 270.8. Lidocaine
hydrochloride (C
H
N
O.HCl) has the following structural formula:
Lidocaine hydrochloride injection, USP is a sterile, nonpyrogenic,
isotonic solution
containing sodium chloride. The pH of the solution is adjusted to
approximately 6.5 (5.0
to 7.0) with sodium hydroxide and/or hydrochloric acid.
DOSAGE FORMS LISTED AS LIDOCAINE HYDROCHLORIDE INJECTION USP,
(METHYLPARABEN FREE) INDICATE SINGLE DOSE SOLUTIONS THAT ARE METHYL
PARABEN
FREE.
CLINICAL PHARMACOLOGY
_MECHANISM OF ACTION_
Lidocaine hydrochloride 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-
adrenergic receptor stimulating action of epinephrine when present.
The net effect is
normally a modest hypotension when the recommended dosages are not
exceeded.
_PHARMACOKINETICS AND METABOLISM_
Information derived from diverse formulations, concentrations and
usages reveals that
lidocaine hydrochlorid