LIDOCAINE HYDROCHLORIDE- lidocaine hydrochloride anhydrous injection, solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

General Injectables & Vaccines, Inc

INN (Διεθνής Όνομα):

Lidocaine Hydrochloride Anhydrous

Σύνθεση:

Lidocaine Hydrochloride Anhydrous 10 mg in 1 mL

Οδός χορήγησης:

INFILTRATION

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

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. Revised: 4/2016 Hospira, Inc., Lake Forest, IL 60045 USA

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

LIDOCAINE HYDROCHLORIDE- LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION,
SOLUTION
GENERAL INJECTABLES & VACCINES, INC
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LIDOCAINE HCL 1% INJECTION, USP 2 ML SINGLE DOSE AMPULE
DESCRIPTION
Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic
solution of lidocaine
hydrochloride in water for injection for parenteral administraion in
various
concentrations with characteriststics as follows:
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 fafbricated 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 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 me