LIDOCAINE HCL- lidocaine hydrochloride and epinephrine bitartrate injection, solution

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Pearson Dental

DCI (Denominação Comum Internacional):

Lidocaine Hydrochloride

Composição:

Lidocaine Hydrochloride 20 mg in 1 mL

Via de administração:

SUBCUTANEOUS

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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 Injection 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.

Resumo do produto:

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.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

LIDOCAINE HCL - LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE
INJECTION, SOLUTION
PEARSON DENTAL
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LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, USP
(LIDOCAINE HCL 2% AND EPINEPHRINE 1:100,000 INJECTION)
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- -[(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
2
1:100,000
6.5
1.2
0.25
14
22
2
2
9
13
3
4
6
6
The pH of all solutions are adjusted to USP limits with sodium
hydroxide.
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 approximately 2.5
hours.When used for nerve blocks in dental patients, the time of onset
f