LIDOCAINE HYDROCHLORIDE injection, solution LIDOCAINE HYDROCHLORIDE injection, solution

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Hikma Pharmaceuticals USA Inc.

INN (Међународно име):

LIDOCAINE HYDROCHLORIDE

Састав:

LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg in 1 mL

Пут администрације:

EPIDURAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Lidocaine HCl Injections are 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 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.

Резиме производа:

Lidocaine Hydrochloride Injection, USP is available as: Preservative-Free 1% (50 mg/5 mL) (10 mg/ mL)     5 mL Single Dose Vials packaged in 25s (NDC 0143-9595-25) 2% (100 mg/5 mL) (20 mg/ mL)     5 mL Single Dose Vials packaged in 25s (NDC 0143-9594-25) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].    To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . For Product Inquiry call 1-877-845-0689.

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

LIDOCAINE HYDROCHLORIDE- LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION
HIKMA PHARMACEUTICALS USA INC.
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LIDOCAINE HYDROCHLORIDE INJECTION, USP
PRES ERVATIVE-FREE
FOR INFILTRATION AND NERVE BLOCK
RX ONLY
DESCRIPTION
Lidocaine Hydrochloride Injections are sterile, nonpyrogenic, aqueous,
isotonic solutions that contain a
local anesthetic agent and are administered parenterally by injection.
See INDICATIONS AND
USAGE for specific uses.
Each mL of the 1% solution contains lidocaine hydrochloride 10 mg and
sodium chloride 7 mg. Each
mL of the 2% solution contains lidocaine hydrochloride 20 mg and
sodium chloride 6 mg. The pH of
these solutions is adjusted to approximately 5.0 to 7.0 with sodium
hydroxide and/or hydrochloric acid.
Lidocaine Hydrochloride Injection solutions contain lidocaine
hydrochloride which is chemically
designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-,
monohydrochloride and has the
molecular wt. 270.8. Lidocaine HCl (C
H N O • HCl) has the following structural formula:
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-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
14
22
2
completely absorbed following parenteral administration, its rate of
absorption depending, for example,
upon various factors such as the site of admini