SCANDONEST 2% L- mepivacaine hydrochloride and levonordefrin injection, solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

MEPIVACAINE HYDROCHLORIDE (UNII: 4VFX2L7EM5) (MEPIVACAINE - UNII:B6E06QE59J), LEVONORDEFRIN (UNII: V008L6478D) (LEVONORDEFRIN - UNII:V008L6478D)

Disponible desde:

Septodont, Inc.

Designación común internacional (DCI):

MEPIVACAINE HYDROCHLORIDE

Composición:

MEPIVACAINE HYDROCHLORIDE 20 mg in 1 mL

Vía de administración:

SUBCUTANEOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Mepivacaine is indicated for production of local anesthesia for dental procedures by infiltration or nerve block in adults and pediatric patients. SCANDONEST® is contraindicated in patients with a known hypersensitivity to amide-type local anesthetics.

Resumen del producto:

SCANDONEST® 3% (30 mg/mL) Plain; (Mepivacaine Hydrocholoride Injection USP) (NDC 0362-1098-90) is available in cardboard boxes containing 5 blisters of 10 × 1.7 mL single-dose dental cartridges, 50 per carton. SCANDONEST® 2% (20 mg/mL) L (Mepivacaine Hydrochloride and Levonordefrin Injection; USP) (NDC 0362-1097-80 is available in cardboard boxes containing 5 blisters of 10 × 1.7 mL single-dose dental cartridges, 50 per carton. Both solutions should be stored 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 top flap. The SCANDONEST® 2% (20 mg/mL) L solution should not be used if its color is pinkish or darker than slightly yellow or it contains a precipitate. Cartridge warmers should not be used with SCANDONEST® products. Manufactured for SEPTODONT, Inc., 205 Granite Run Dr., Suite 150, Lancaster, PA, USA 17601 by Novocol Pharmaceutical of Canada Inc., 25 Wolseley Court, Cambridge, Ontario, Canada N1R 6X3 Rev. March 2021 (2558-9)

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

SCANDONEST 2% L- MEPIVACAINE HYDROCHLORIDE AND LEVONORDEFRIN
INJECTION,
SOLUTION
SEPTODONT, INC.
----------
SCANDONEST 3% (30 MG/ML) PLAIN
(MEPIVACAINE HYDROCHLORIDE INJECTION, USP)
SCANDONEST 2% (20 MG/ML) L (WITH LEVONORDEFRIN 1:20,000)
(MEPIVACAINE HYDROCHLORIDE AND LEVONORDEFRIN INJECTION, USP)
​RX ONLY
THESE SOLUTIONS ARE INTENDED FOR DENTAL USE ONLY.
DESCRIPTION:
Mepivacaine Hydrochloride, a tertiary amine used as a local
anesthetic, is 1-methyl-2', 6' -
pipecoloxylidide monohydrochloride with the following structural
formula:
It is a white, crystalline, odorless powder soluble in water, but very
resistant to both acid
and alkaline hydrolysis.
Levonordefrin, a sympathomimetic amine used as a vasoconstrictor in
local anesthetic
solution, is (-)-
-(1-Aminoethyl)-3, 4-dihydroxybenzyl alcohol with the following
structural formula:
It is a white or buff-colored crystalline solid, freely soluble in
aqueous solutions of
mineral acids, but practically insoluble in water;
DENTAL CARTRIDGES MAY NOT BE AUTOCLAVED.
SCANDONEST 3% (30 mg/mL) Plain (mepivacaine hydrochloride injection 3%
(30
mg/mL)) and SCANDONEST 2% (20 mg/mL) L (mepivacaine hydrochloride 2%
(20
mg/mL) with levonordefrin 1:20,000 injection are sterile solutions for
injection.
COMPOSITION: CARTRIDGE
​EACH ML CONTAINS:
2%
3%
Mepivacaine Hydrochloride
20 mg
30 mg
Levonordefrin
0.05 mg
-
Sodium Chloride
4 mg
6 mg
Potassium metabisulfite
1.2 mg
-
Edetate disodium
0.25 mg
-
Sodium Hydroxide q.s. ad pH; Hydrochloric Acid
0.5 mg
-
Water for Injection q.s. ad.
1 mL
1 mL
The pH of the 2% cartridge solution is adjusted between 3.3 and 5.5
with NaOH.
The pH of the 3% cartridge solution is adjusted between 4.5 and 6.8
with NaOH.
CLINICAL PHARMACOLOGY:
SCANDONEST stabilizes the neuronal membrane and prevents the
initiation and
transmission of nerve impulses, thereby effecting local anesthesia.
SCANDONEST is rapidly metabolized, with only a small percentage of the
anesthetic (5
to 10 percent) being excreted unchanged in the urine. SCANDONEST
because of its
amide st