LIDOCAINE HYDROCHLORIDE injection, solution

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Lifestar Pharma LLC

Vartojimo būdas:

EPIDURAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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

Produkto santrauka:

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: Preservative-Free 1% (20 mg/2 mL) (10 mg/mL): Carton of 1 Single-dose 2 mL Vial                     NDC 70756-640-82 Carton of 10 Single-dose 2 mL Vials                 NDC 70756-640-10 Carton of 25 Single-dose 2 mL Vials                 NDC 70756-640-25 1% (50 mg/5 mL) (10 mg/mL): Carton of 1 Single-dose 5 mL Vial                     NDC 70756-641-85 Carton of 10 Single-dose 5 mL Vials                 NDC 70756-641-10 Carton of 25 Single-dose 5 mL Vials                 NDC 70756-641-25 2% (40 mg/2 mL) (20 mg/mL): Carton of 1 Single-dose 2 mL Vial                     NDC 70756-642-82 Carton of 10 Single-dose 2 mL Vials                 NDC 70756-642-10 Carton of 25 Single-dose 2 mL Vials                 NDC 70756-642-25 2% (100 mg/5 mL) (20 mg/mL): Carton of 1 Single-dose 5 mL Vial                     NDC 70756-643-85 Carton of 10 Single-dose 5 mL Vials                 NDC 70756-643-10 Carton of 25 Single-dose 5 mL Vials                 NDC 70756-643-25 Discard unused portion. All solutions should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. To report SUSPECTED ADVERSE REACTIONS, contact Lifestar Pharma LLC at 1-888-995-4337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured for: Lifestar Pharma LLC 1200 MacArthur Blvd. Mahwah, NJ 07430 USA Made in India Revised: February 2023, V-02

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

LIDOCAINE HYDROCHLORIDE- LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION
LIFESTAR PHARMA LLC
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LIDOCAINE HYDROCHLORIDE INJECTION, USP
FOR INFILTRATION AND NERVE BLOCK
PRESERVATIVE-FREE
RX ONLY
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 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
(C
H
N O•HCl) has the following structural formula:
Lidocaine hydrochloride injection, USP is a clear, colorless, sterile,
nonpyrogenic, isotonic
solution containing sodium chloride. The pH of this solution is
adjusted to approximately
5.0 to 7.0 with sodium hydroxide and/or hydrochloric acid.
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-
14
22
2
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 HCl is completely absorbed following parenteral
administration, its rate of
absorption depending, for example, upon various factors such as the
site of
administration and the presence or absence o