LIDOCAINE HYDROCHLORIDE solution

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

International Medication Systems, Limited

INN (국제 이름):

LIDOCAINE HYDROCHLORIDE

구성:

LIDOCAINE HYDROCHLORIDE ANHYDROUS 40 mg in 1 mL

관리 경로:

TOPICAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Lidocaine HCl Topical Solution, 4% is indicated for the production of topical anesthesia of the mucous membranes of the respiratory tract. Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

제품 요약:

In unit use packages containing one sterile disposable laryngotracheal cannula with attached vial injector, and one disposable single dose vial prefilled with sterile, aqueous solution of lidocaine hydrochloride. STOCK NO. 6300         4 mL         4% LARYNG-O-JET®         76329-6300-5 Twenty-five unit use packages per carton. Manufactured under LARYNG-O-JET® System. Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Tempertaure]. INTERNATIONAL MEDICATION SYSTEMS, LIMITED SOUTH EL MONTE, CA 91733, U.S.A. An Amphastar Pharmaceuticals Company                                                             REV. 10-19 6963000V

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

LIDOCAINE HYDROCHLORIDE - LIDOCAINE HYDROCHLORIDE SOLUTION
INTERNATIONAL MEDICATION SYSTEMS, LIMITED
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LARYNG-O-JET LIDOCAINE HYDROCHLORIDE TOPICAL SOLUTION USP, 4%
DISPOSABLE KIT WITH
LIDOCAINE HYDROCHLORIDE TOPICAL SOLUTION
FOR LARYNGOTRACHEAL ANESTHESIA RX ONLY
DESCRIPTION
Lidocaine HCl Topical Solution USP, 4% is a sterile, aqueous solution
containing a local
anesthetic agent and is administered topically.
Lidocaine hydrochloride is designated chemically as acetamide,
2-(diethylamino)-N-(2, 6-
dimethylphenyl)-monohydrochloride, with the following structural
formula:
COMPOSITION OF LIDOCAINE HCL 4% TOPICAL SOLUTION: Each mL of aqueous
solution
contains lidocaine HCl, 40 mg, and sodium hydroxide and/or
hydrochloric acid to adjust
pH to 5.0 to 7.0. No preservative is added since all or part of the
contents of the syringe
unit is administered as a single dose and the unit should not be
re-used.
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. The onset of action is rapid.
HEMODYNAMICS: Excessive blood levels may cause changes in cardiac
output, total
peripheral resistance, and mean arterial pressure. These changes may
be attributable to
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: Lidocaine may be absorbed following
topical
administration to mucous membranes, its rate and extent of absorption
depending upon
concentration and total dose administered, the specific site of
application, and duration
of exposure. In general, the rate of absorption of local anesthetic
agents following
topical application occurs most rapidly after intratracheal
administration. Lidocaine is also
well-absorbed from the gastrointestinal tract, but little intact drug
appears in t