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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hikma Pharmaceuticals USA Inc.

INN (International Name):

LIDOCAINE HYDROCHLORIDE

Composition:

LIDOCAINE HYDROCHLORIDE 10 mg in 1 mL

Administration route:

INFILTRATION

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lidocaine HCl Injections are indicated for production of local 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 HCl is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

Product summary:

Lidocaine Hydrochloride Injection, USP is preserved with 0.1% methylparaben and is available in the following concentrations: 1% (10 mg/ mL)    2 mL Multiple Dose Vials packaged in 25s (NDC 0143-9579-25)    30 mL Multiple Dose Vials packaged in 10s (NDC 0143-9578-10)    50 mL Multiple Dose Vials packaged in 10s (NDC 0143-9577-10) 2% (20 mg/ mL)    2 mL Multiple Dose Vials packaged in 25s (NDC 0143-9576-25)    50 mL Multiple Dose Vials packaged in 10s (NDC 0143-9575-10) 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LIDOCAINE- LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION
HIKMA PHARMACEUTICALS USA INC.
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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 a sterile, nonpyrogenic,
aqueous, isotonic solution that
contains a local anesthetic agent and is administered parenterally by
injection. See INDICATIONS
AND USAGE for specific uses.
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:
Each mL of the 1% solution contains lidocaine hydrochloride 10 mg,
sodium chloride 7 mg and 1 mg
methylparaben as antiseptic preservative. Each mL of the 2% solution
contains lidocaine hydrochloride
20 mg, sodium chloride 6 mg and 1 mg methylparaben as antiseptic
preservative. The pH of these
solutions 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. 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 vari