PRELIDOPINE PRE-OPERATIVE SYSTEM- lidocaine hydrochloride kit

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

IT3 Medical LLC

INN (International namn):

LIDOCAINE HYDROCHLORIDE

Sammansättning:

LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 mL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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. First Aid Antiseptic For preparation of the skin prior to an injection - Do not use with electrocautery procedures - Do not use in the eyes - Do not apply to irritated skin - Stop use if pain, irritation, redness, or swelling occurs, discontinue use and consult a physician. - Keep out from reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Produktsammanfattning:

Lidocaine Hydrochloride Injection, USP is supplied as follows: Store in a cool dry place at 20 to 25°C (68 to 77°F). Excursions permitted to 15-30°C (59-86°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. Hospira, Inc., Lake Forest, IL 60045 USA 4/2016 EN-4268 Assembled and Distributed by IT3 Medical, LLC 190 E Stacy Rd, Ste 306-298, Allen, TX 75002 For questions or comments: [e-mail], www.IT3-Medical.com

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

PRELIDOPINE PRE-OPERATIVE SYSTEM- LIDOCAINE HYDROCHLORIDE
IT3 MEDICAL LLC
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PRELIDOPINE PRE-OPERATIVE SYSTEM
LIDOCAINE HYDROCHLORIDE
INJECTION, USP
AQUEOUS SOLUTIONS FOR
INFILTRATION AND NERVE BLOCK
PLASTIC MULTIPLE-DOSE FLIPTOP 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 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 recepto