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:

Hospira, Inc.

INN (International Name):

LIDOCAINE HYDROCHLORIDE

Composition:

LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg in 1 mL

Administration route:

INFILTRATION

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lidocaine Hydrochloride Injection, USP 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.

Product summary:

Lidocaine Hydrochloride Injection, USP is supplied as follows: NDC 0409-4278-01 Tray of 25 Glass Single-dose Teartop Vials 0.5% 250 mg/50 mL (5 mg/mL) NDC 0409-4713-62 Case of 800 Glass Single-dose Ampuls 1% 20 mg/2 mL (10 mg/mL) NDC 0409-4713-65 Case of 800 Glass Single-dose Ampuls 1% 50 mg/5 mL (10 mg/mL) NDC 0409-4279-02 Tray of 25 Glass Single-dose Teartop Vials 1% 300 mg/30 mL (10 mg/mL) NDC 0409-4776-01 Carton of 25 Glass Single-dose Ampuls 1.5% 300 mg/20 mL (15 mg/mL) NDC 0409-4282-02 Carton of 25 Glass Single-dose Ampuls 2% 200 mg/10 mL (20 mg/mL) NDC 0409-4713-02 Bundle of 5 Clamcells containing 5 Single-dose Ampuls per Clamcell 1% 50 mg/5 mL (10 mg/mL) NDC 0409-4713-32 Bundle of 5 Cartons containing 10 Single-dose Ampuls per Carton 1% 20 mg/2 mL (10 mg/mL) NDC 0409-4282-01 Bundle of 5 Clamcells containing 5 Single-dose Ampuls per Clamcell 2% 40 mg/2 mL (20 mg/mL) NDC 0409-4275-01 Tray of 25 Plastic Multiple-dose Fliptop Vials 0.5% 250 mg/50 mL (5 mg/mL) NDC 0409-4276-01 Tray of 25 Plastic Multiple-dose Fliptop Vials 1% 200 mg/20 mL (10 mg/mL) NDC 0409-4276-02 Tray of 25 Plastic Multiple-dose Fliptop Vials 1% 500 mg/50 mL (10 mg/mL) NDC 0409-4277-01 Tray of 25 Plastic Multiple-dose Fliptop Vials 2% 400 mg/20 mL (20 mg/mL) NDC 0409-4277-02 Tray of 25 Plastic Multiple-dose Fliptop Vials 2% 1000 mg/50 mL (20 mg/mL) For single-dose vials and ampuls: Discard unused portion. Single-dose products are preservative-free. Store at 20 to 25°C (68 to 77°F). [see USP Controlled Room Temperature.] Lidocaine Hydrochloride Injection, USP solutions packaged in ampuls and glass teartop vials may be autoclaved one time only. Autoclave at 15 pounds pressure, 121°C (250°F) for 15 minutes. DO NOT AUTOCLAVE PRODUCT IN PLASTIC VIALS.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LIDOCAINE HYDROCHLORIDE- LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION
HOSPIRA, INC.
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LIDOCAINE HYDROCHLORIDE
INJECTION, USP
AQUEOUS SOLUTIONS FOR
INFILTRATION AND NERVE BLOCK
AMPUL
PLASTIC MULTIPLE-DOSE FLIPTOP VIAL
GLASS TEARTOP VIAL
RX ONLY
DESCRIPTION
Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic
solution of lidocaine
hydrochloride in water for injection for parenteral administration in
various
concentrations with characteristics as follows:
CONCENTRATION
0.5%
1%
1.5%
2%
mg/mL lidocaine HCl (anhyd.)
5
10
15
20
mg/mL sodium chloride
8
7
6.5
6
Multiple-dose vials contain 0.1% of methylparaben added as
preservative. May contain
sodium hydroxide and/or hydrochloric acid for pH adjustment. The pH is
6.5 (5.0 to 7.0).
See HOW SUPPLIED section for various sizes and strengths.
Lidocaine is a local anesthetic of the amide type.
Lidocaine Hydrochloride, USP is chemically designated
2-(diethylamino)-N-(2,6-
dimethylphenyl)-acetamide monohydrochloride monohydrate, a white
powder freely
soluble in water. The molecular weight is 288.82. It has the following
structural formula:
The semi-rigid vial used for the plastic vials is fabricated from a
specially formulated
polyolefin. It is a copolymer of ethylene and propylene. The safety of
the plastic has been
confirmed by tests in animals according to USP biological standards
for plastic
containers. The container requires no vapor barrier to maintain the
proper drug
concentration.
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 re