SCANDONEST L- mepivacaine hydrochloride and levonordefrin injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Novocol Pharmaceutical of Canada, Inc

INN (International Name):

MEPIVACAINE HYDROCHLORIDE

Composition:

MEPIVACAINE HYDROCHLORIDE 20 mg in 1 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

SCANDONEST® 3% Plain; (Mepivacaine Hydrocholoride Injection USP) (NDC 12862-1098-9 and NDC 51004-1098-9) is available in cardboard boxes containing 5 blisters of 10 × 1.7 mL dental cartridges, 50 per carton. SCANDONEST 2% L (Mepivacaine Hydrochloride and Levonordefrin Injection; USP) (NDC 12862-1097-8 and NDC 51004-1097-8) is available in cardboard boxes containing 5 blisters of 10 × 1.7 mL 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% 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, Louisville, CO 80027 by Novocol Pharmaceutical of Canada, Inc., Cambridge, Ontario, Canada N1R 6X3

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SCANDONEST L- MEPIVACAINE HYDROCHLORIDE AND LEVONORDEFRIN INJECTION,
SOLUTION
NOVOCOL PHARMACEUTICAL OF CANADA, 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.
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% Plain (mepivacaine hydrochloride injection 3%) and
SCANDONEST 2% L
(mepivacaine hydrochloride 2% 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 structure, is not
detoxified by the circulating pla