LIDOCAINE HYDROCHLORIDE injection, solution

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Lifestar Pharma LLC

给药途径:

INFILTRATION

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Lidocaine hydrochloride injection is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and by peripheral nerve block techniques such as brachial plexus and intercostal, 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.

產品總結:

Lidocaine hydrochloride injection, USP is a clear, colorless solution, filled in flint vial with rubber stopper and sealed with aluminium flip off seal, and is supplied as: 1% (20 mg/2 mL) (10 mg/mL):   Carton of 1 Multiple-dose 2 mL Vial             NDC 70756-644-82 Carton of 25 Multiple-dose 2 mL Vials         NDC 70756-644-25 1% (100 mg/10 mL) (10 mg/mL): Carton of 1 Multiple-dose 10 mL Vial           NDC 70756-645-86 Carton of 25 Multiple-dose 10 mL Vials       NDC 70756-645-25 1% (200 mg/20 mL) (10 mg/mL): Carton of 1 Multiple-dose 20 mL Vial           NDC 70756-646-87 Carton of 5 Multiple-dose 20 mL Vials         NDC 70756-646-05 Carton of 10 Multiple-dose 20 mL Vials       NDC 70756-646-10 Carton of 25 Multiple-dose 20 mL Vials       NDC 70756-646-25 1% (500 mg/50 mL) (10 mg/mL): Carton of 1 Multiple-dose 50 mL Vials         NDC 70756-666-90 Carton of 10 Multiple-dose 50 mL Vials       NDC 70756-666-10 Carton of 25 Multiple-dose 50 mL Vials       NDC 70756-666-25 2% (200 mg/10 mL) (20 mg/mL): Carton of 1 Multiple-dose 10 mL Vial           NDC 70756-647-86 Carton of 25 Multiple-dose 10 mL Vials       NDC 70756-647-25 2% (400 mg/20 mL) (20 mg/mL): Carton of 1 Multiple-dose 20 mL Vial           NDC 70756-648-87 Carton of 25 Multiple-dose 20 mL Vials       NDC 70756-648-25 2% (1000 mg/50 mL) (20 mg/mL): Carton of 1 Multiple-dose 50 mL Vial           NDC 70756-667-90 Carton of 10 Multiple-dose 50 mL Vial         NDC 70756-667-10 Carton of 25 Multiple-dose 50 mL Vials       NDC 70756-667-25 All solutions should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Manufactured for: Lifestar Pharma LLC 1200 MacArthur Blvd. Mahwah, NJ 07430 USA Made in India Revised: October 2023, V-04

授权状态:

Abbreviated New Drug Application

产品特点

LIDOCAINE HYDROCHLORIDE- LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION
LIFESTAR PHARMA LLC
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LIDOCAINE HYDROCHLORIDE INJECTION, USP
PRESERVED
LOCAL ANESTHETIC FOR INFILTRATION AND NERVE BLOCK
NOT FOR SPINAL OR EPIDURAL ANESTHESIA
RX ONLY
DESCRIPTION
Lidocaine hydrochloride injection, USP is sterile, nonpyrogenic,
aqueous solution that
contain a local anesthetic agent and is administered parenterally by
injection. See
INDICATIONS AND USAGE section for specific uses.
Lidocaine hydrochloride injection, USP solution contain lidocaine
hydrochloride, USP,
which is chemically designated as acetamide,
2-(diethylamino)-N-(2,6-dimethylphenyl)-,
monohydrochloride and has the molecular wt. 270.8. Lidocaine
hydrochloride, USP
(C14H22N2O • HCl) has the following structural formula:
Lidocaine hydrochloride injection, USP is a clear, colorless, sterile,
nonpyrogenic, isotonic
solution containing sodium chloride. Each mL also contains 1 mg
methylparaben as
antiseptic preservative. The pH of these solutions is adjusted between
5.0 to 7.0 with
sodium hydroxide and/or hydrochloric acid.
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 hydrochloride is completely absorbed following parenteral
administration, its
rat