scandonest plain- Mepivacaine hydrochloride injection, solution scandonest l- Mepivcaine hydrochloride and Levonordefrin inject

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Septodont, Inc.

INN (International Name):

Mepivacaine hydrochloride

Pharmaceutical form:

INJECTION, SOLUTION

Composition:

30 mg in 1 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

- SCANDONEST 2% L (Mepivacaine Hydrochoride and Levonordefrin injection, USP), is available in cardboard boxes containing 5 blisters of 10 × 1.7 mL dental cartridges, 50 per cartons (NDC 12862-1097-8). - SCANDONEST 3%Plain (Mepivacaine hydrochoride injection, USP), is available in cardboard boxes containing 5 blisters of 10 × 1.7 mL dental cartridges, 50 per cartons (NDC 12862-1098-9). Store at room temperature, below 25°C (77°F). Protect from light. Do not permit to freeze. CANS : For protection from light, retain in can until time of use. Once opened, the can should be reclosed using the plastic cap. BOXES : For protection from light, retain in box until time of use. Once opened, the box should be reclosed by closing the top flap. SCANDONEST 2%L should not be use if color is pinkish or darker than slightly yellow or if it contains a precipitate. Cartridge warmers should not be used with SCANDONEST products.

Summary of Product characteristics

SCANDONEST PLAIN- MEPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION
SCANDONEST L- MEPIVCAINE HYDROCHLORIDE AND LEVONORDEFRIN INJECTION,
SOLUTION
SEPTODONT, INC.
----------
SCANDONEST 3% PLAIN
(MEPIVACAINE HYDROCHLORIDE INJECTION, USP)
SCANDONEST 2% L
(WITH LEVONORDEFRIN 1:20,000)
(MEPIVACAINE HYDROCHLORIDE AND LEVONORDEFRIN INJECTION, USP)
RX ONLY
THESE SOLUTIONS ARE INTENDED FOR DENTAL USE ONLY.
DES CRIPTION
Mepivacaine hydrochloride, a tertiary amide used as a local
anesthetic, is 1-methyl-2', 6'-
pipecoloxylidide monohydrochloride with the following structural
formula :
C
H N O. HCL M.W. 282.81
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 solutions, is (-)-
a-(1- Aminoethyl)- 3, 4-dihydroxybenzyl alcohol with the following
structural formula :
C H NO M.W. 183.21
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% PLAIN (mepivacaine hydrochloride injection 3%) and
SCANDONEST 2% L
®
®
15
22
2
9
13
3
(mepivacaine hydrochloride 2% with levonordefrin 1:20,000 injection)
are sterile solutions for
injection.
COMPOS ITION
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 injections 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 unchan