LIDOCAINE HYDROCHLORIDE AND DEXTROSE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987), DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)

Available from:

Hospira, Inc.

INN (International Name):

LIDOCAINE HYDROCHLORIDE

Composition:

LIDOCAINE HYDROCHLORIDE ANHYDROUS 50 mg in 1 mL

Administration route:

INTRASPINAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

5% Lidocaine Hydrochloride and 7.5% Dextrose Injection, USP is indicated for the production of spinal anesthesia when the accepted procedures for this technique as described in standard textbooks are observed. Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type. The following conditions preclude the use of spinal anesthesia: - Severe hemorrhage, shock or heart block - Local infection at the site of proposed puncture - Septicemia - Known sensitivity to the local anesthetic agent.

Product summary:

5% Lidocaine Hydrochloride and 7.5% Dextrose Injection, USP, is supplied in the following: Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LIDOCAINE HYDROCHLORIDE AND DEXTROSE- LIDOCAINE HYDROCHLORIDE AND
DEXTROSE INJECTION, SOLUTION
HOSPIRA, INC.
----------
5% LIDOCAINE HYDROCHLORIDE AND 7.5% DEXTROSE
INJECTION, USP
AMPUL
SINGLE-DOSE CONTAINER
Rx only
DESCRIPTION
5% Lidocaine Hydrochloride and 7.5% Dextrose Injection, USP is a
sterile, nonpyrogenic,
hyperbaric solution for use in spinal anesthesia.
5% Lidocaine Hydrochloride and 7.5% Dextrose Injection, USP contains
lidocaine HCl,
which is chemically designated as
2-(diethylamino)-N-(2,6-dimethylphenyl)-acetamide
monohydrochloride, monohydrate and Dextrose (D-Glucose monohydrate)
which have
the following structural formulas:
Lidocaine Hydrochloride (monohydrate)
Dextrose (hydrous)
5% Lidocaine Hydrochloride and 7.5% Dextrose Injection, USP contains
50 mg/mL of
lidocaine hydrochloride, anhydrous with 75 mg/mL of dextrose, hydrous
in water for
injection. May contain sodium hydroxide and/or hydrochloric acid for
pH adjustment. pH
6.5 (6.0 to 7.0). The osmolar concentration is 0.75 mOsmol/mL (calc.).
The specific
gravity is 1.030 to 1.035.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Lidocaine stabilizes the neuronal membrane by inhibiting the ionic
fluxes required for the
initiation and conduction of impulses, thereby effecting local
anesthetic action.
ONSET AND DURATION OF ANESTHESIA
The onset of action is rapid. The duration of perineal anesthesia
provided by 1 mL (50
mg) 5% Lidocaine Hydrochloride and 7.5% Dextrose Injection, USP
averages 100
minutes, with analgesia continuing for an additional 40 minutes. The
duration of surgical
anesthesia provided by 1.5 to 2 mL (75 to 100 mg) of this agent is
approximately two
hours.
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, or 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