ISOCAINE- mepivacaine hydrochloride injection, solution

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Novocol Pharmaceutical of Canada, Inc.

INN (Medzinárodný Name):

Mepivacaine Hydrochloride

Zloženie:

Mepivacaine Hydrochloride 30 mg in 1 mL

Spôsob podávania:

SUBCUTANEOUS

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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

Prehľad produktov:

Mepivacaine HCl 3%; (Mepivacaine Hydrocholoride Injection USP) is available in cardboard boxes containing 5 blisters of 10 × 1.7 mL dental cartridges, 50 per carton. Mepivacaine HCl 2% (Mepivacaine Hydrochloride and Levonordefrin Injection; USP) 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 Mepivacaine 2% 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 Mepivacaine HCl injection USP products.

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

ISOCAINE- MEPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION
NOVOCOL PHARMACEUTICAL OF CANADA, INC.
----------
MEPIVACAINE HCL 3%
(MEPIVACAINE HYDROCHLORIDE INJECTION, USP)
MEPIVACAINE HCL 2%
(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.
Mepivacaine hydrochloride injection 3% and 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, 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
Mepivacaine stabilizes the neuronal membrane and prevents the
initiation and transmission of nerve
impulses, thereby effecting local anesthesia.
Mepivacaine is rapidly metabolized, with only a small percentage of
the anesthetic (5 to 10 percent)
being excreted unchanged in the urine. Mepivacaine because of its
amide structure, is not detoxified by
the circulating plasma esterases. The liver is the principal site of
metabolism,