LIDOCAINE- lidocaine hydrochloride and epinephrine bitartrate injection, solution

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987), Epinephrine Bitartrate (UNII: 30Q7KI53AK) (Epinephrine - UNII:YKH834O4BH)

Dostupné s:

CareStream Health, Inc.

INN (Mezinárodní Name):

Lidocaine Hydrochloride

Složení:

LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 mL

Podání:

SUBCUTANEOUS

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Lidocaine and Epinephrine Injection, USP solutions are indicated for the production of local anesthesia for dental procedures by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended. Lidocaine and Epinephrine Injection,USP is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to any components of the injectable formulations.

Přehled produktů:

Store at controlled room temperature, below 25°C (77°F). Protect from light. Do not permit to freeze. BOXES : For protection from light, retain in box until time of use. Once opened, the box should be reclosed by closing the end flap. Do not use if color is pinkish or darker than slightly yellow or if it contains a precipitate.

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

LIDOCAINE - LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE
INJECTION, SOLUTION
CARESTREAM HEALTH, INC.
----------
LIDOCAINE HCL 2% AND EPINEPHRINE 1:50,000 INJECTION
LIDOCAINE HCL 2% AND EPINEPHRINE 1:100,000 INJECTION
(LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, USP)
RX ONLY
SOLUTIONS FOR LOCAL ANESTHESIA IN DENTISTRY
DESCRIPTION
Sterile isotonic solution containing a local anesthetic agent,
Lidocaine Hydrochloride, and a
vasoconstrictor, Epinephrine (as bitartrate) and are administered
parenterally by injection. Both solutions
are available in single dose cartridges of 1.7 mL (See INDICATIONS AND
USAGE for specific
uses). The solutions contain lidocaine hydrochloride which is
chemically designated as acetamide, 2-
(diethylamino)-N-(2,6-dimethylphenyl)-monohydrochloride, and has the
following structural formula :
C
H N 0•HCL• H 0 M.W. 288.8
Epinephrine is ( - )-3,4-Dihydroxy-α-[(Methylamino) methyl] benzyl
alcohol and has the following
structural formula :
C H NO •C H 0 M.W. 333.3
COMPOSITION OF AVAILABLE SOLUTIONS
PRODUCT IDENTIFICATION
FORMULA
SINGLE DOSE CARTRIDGE
LIDOCAINE
HYDROCHLORIDE
EPINEPHRINE
(AS THE BITARTRATE)
SODIUM CHLORIDE
POTAS S IUM
METABIS ULFITE
EDETATE DISODIUM
CONCENTRATION %
DILUTION
(MG/ML)
(MG/ML)
(MG/ML)
2
1:50,000
6.5
1.2
0.25
14
22
2
2
9
13
3
4
6
6
The pH of the lidocaine hydrochloride and epinephrine injection, USP
solutions are adjusted to USP
limits with sodium hydroxide.
2
1:100,000
6.5
1.2
0.25
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Lidocaine stabilizes the neuronal membrane by inhibiting the ionic
fluxes required for the initiation and
conduction of nerve impulses, thereby effecting local anesthetic
action.
ONSET AND DURATION OF ANESTHESIA
When used for infiltration anesthesia in dental patients, the time of
onset averages less than two minutes
for each of the two forms of Lidocaine hydrochloride and Epinephrine
Injection, USP. Lidocaine HCl
2% and epinephrine 1:50,000 or lidocaine HCL 2% and epinephrine
1:100,000 provide an average pulp
anesthesia of at leas