SCANDONEST 3% PLAIN- mepivacaine hydrochloride injection, solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

Mepivacaine Hydrochloride (UNII: 4VFX2L7EM5) (Mepivacaine - UNII:B6E06QE59J)

Διαθέσιμο από:

Septodont, Inc.

INN (Διεθνής Όνομα):

Mepivacaine Hydrochloride

Σύνθεση:

Mepivacaine Hydrochloride 30 mg in 1 mL

Οδός χορήγησης:

SUBMUCOSAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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.

Περίληψη προϊόντος:

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.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

SCANDONEST 3% PLAIN- MEPIVACAINE HYDROCHLORIDE 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:
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, qs. 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
structure