LIDOCAINE- lidocaine hydrochloride and epinephrine bitartrate injection, solution

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987), Epinephrine Bitartrate (UNII: 30Q7KI53AK) (Epinephrine - UNII:YKH834O4BH)

Pieejams no:

Henry Schein

SNN (starptautisko nepatentēto nosaukumu):

LIDOCAINE HYDROCHLORIDE

Kompozīcija:

LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 mL

Ievadīšanas:

SUBCUTANEOUS

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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.

Produktu pārskats:

Dental Cartridges: - Lidocaine Hydrochloride 2% and Epinephrine 1:50,000 injection is available in carboard boxes containing 5 blisters of 10 x 1.7 mL cartridges cartridges (NDC 0404-6500-15). Lidocaine Hydrochloride 2% and Epinephrine 1:100,000 injection is available in cardboard boxes containing 5 blisters of 10 x 1.7 mL cartridges (NDC 0404-6512-05). Dental Injector: -Lidocaine HCl 2% and Epinephrine, 1:100,000 with Monoject Disposable Dental Injector (Lidocaine Hydrochloride and Epinephrine Injection, USP) is available in 2 needle gauges: 27G Long x 1-1/4” (0.406 mm x 32 mm) and 30G Short x 3/4” (0.305 mm x 19 mm). It is packaged in cardboard boxes containing 30 disposable single dose dental injectors, each containing a single 1.7 mL cartridge (NDC 0404-6512-30). 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. 1. Cartridges should not be autoclaved, because the closures employed cannot withstand autoclaving temperatures and pressures. 2. Certain metallic ions (mercury, zinc, copper, etc.) have been related to swelling and edema after local anesthesia in dentistry. Therefore, chemical disinfectants containing or releasing these ions are not recommended. Antirust tablets usually contain sodium nitrite or some similar agents that may be capable of releasing metal ions. Because of this, aluminium sealed cartridges should not be kept in such solutions. 3. Quaternary ammonium salts, such as benzalkonium chloride, are electrolytically incompatible with aluminium. Cartridges of Lidocaine and Epinephrine Injections are sealed with aluminium caps and therefore should not be immersed in any solution containing these salts. 4. Store at controlled room temperature, below 25°C (77°F). Do not permit to freeze. Protect from light. Limited only to cartridges when sold without the dental injector: 5. If chemical disinfection of anesthetic cartridges is desired, either isopropyl alcohol (91%) or 70% ethyl alcohol is recommended. Many commercially available brands of rubbing alcohol, as well as solutions of ethyl alcohol not of U.S.P grade, contain denaturants that are injurious to rubber and, therefore, are not to be used. It is recommended that chemical disinfection be accomplished just prior to use by wiping the cartridge cap thoroughly with a pledge of cotton that has been moistened with recommended alcohol. 6. To avoid leakage of solutions during injection, be sure to penetrate the center of the rubber diaphragm when loading the syringe. An off-center penetration produces an oval shaped puncture that allows leakage around the needle. Other causes of leakage and breakage include badly worn syringes, aspirating syringes with bent harpoons, the use of syringes not designed to take 1.7 mL cartridges, and inadvertent freezing. 7. Cracking of glass cartridges is most often the result of an attempt to use a cartridge with an extruded plunger. An extruded plunger loses its lubrication and can be forced back into the cartridge only with difficulty. Cartridges with extruded plungers should be discarded.

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

LIDOCAINE - LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE
INJECTION, SOLUTION
HENRY SCHEIN
----------
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
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)
14
22
2
2
9
13
3
4
6
6
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 approximately 2.5
hours.When used for nerve