LIDOCAINE- lidocaine hydrochloride and epinephrine bitartrate injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Patterson Dental

INN (International Name):

Lidocaine Hydrochloride

Composition:

LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 mL

Administration route:

SUBMUCOSAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lidocaine and Epinephrine Injection, USP is 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 Injections 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.

Product summary:

- Lidocaine Hydrochloride 2% (34 mg/1.7 mL) (20 mg/mL) and Epinephrine 1:50,000 injection is available in cardboard boxes containing 5 blisters of 10 x 1.7 mL single-dose cartridges. - Lidocaine Hydrochloride 2% (34 mg/1.7 mL) (20 mg/mL) and Epinephrine 1:100,000 injection is available in cardboard boxes containing 5 blisters of 10 x 1.7 mL single-dose cartridges. 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LIDOCAINE - LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE
INJECTION,
SOLUTION
PATTERSON DENTAL
----------
LIDOCAINE HCL 2% (34 MG/1.7 ML) (20 MG/ML) AND EPINEPHRINE 1:50,000
INJECTION
LIDOCAINE HCL 2% (34 MG/1.7 ML) (20 MG/ML) AND EPINEPHRINE 1:100,000
INJECTION
(LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, USP)
RX ONLY
SOLUTIONS FOR LOCAL ANESTHESIA IN DENTISTRY
DESCRIPTION
Lidocaine Hydrochloride and Epinephrine, USP is a 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 M.W. 183.21
14 22 2
2
9 13
3
COMPOSITION OF AVAILABLE SOLUTIONS
PRODUCT IDENTIFICATION
FORMULA
SINGLE DOSE CARTRIDGE
LIDOCAINE
HYDROCHLORIDE
EPINEPHRINE
(AS THE
BITARTRATE)
SODIUM
CHLORIDE
POTASSIUM
METABISULFITE
EDETATE DISODIUM
CONCENTRATION
%
DILUTION
(MG/ML)
(MG/ML)
(MG/ML)
The pH of all solutions are adjusted to USP limits with sodium
hydroxide.
2
1:50,000
6.5
1.2
0.25
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 Lidocaine and Epinephrine Injections. Lidocaine
and Epinephrine
Injections provide an average pulp anesthesia of at least 60 minutes
with an average
duration of soft tissue anesthesia of a