CARBOCAINE- mepivacaine hydrochloride injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Septodont, Inc.

Administration route:

SUBMUCOSAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

CARBOCAINE 3% (30 mg/mL) injection (mepivacaine hydrocholoride injection, USP) is available in cartons containing 5 blisters of 10 × 1.7 mL single-dose dental cartridges, 50 per carton (NDC 0362-0753-05). CARBOCAINE 2% (20 mg/mL) with NEO-COBEFRIN 1:20,000 injection, USP (mepivacaine hydrochloride and levonordefrin injection, USP) is available in cartons containing 5 blisters of 10 × 1.7 mL single-dose dental cartridges, 50 per carton (NDC 0362-0931-05). Both solutions should be stored at controlled room temperature, below 25° C (77° F). Protect from light. Do not permit to freeze. For protection from light, retain in box until time of use. Once opened, the box should be reclosed by closing the flap. The mepivacaine 2% (20 mg/mL) 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 CARBOCAINE products.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CARBOCAINE- MEPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION
SEPTODONT, INC.
----------
CARBOCAINE 3% (30 MG/ML) INJECTION
(MEPIVACAINE HYDROCHLORIDE INJECTION, USP)
CARBOCAINE 2% (20 MG/ML)
WITH NEO-COBEFRIN 1:20,000 INJECTION
(MEPIVACAINE HYDROCHLORIDE AND LEVONORDEFRIN INJECTION, USP)
RX ONLY
THESE SOLUTIONS ARE INTENDED FOR DENTAL USE ONLY.
DESCRIPTION
CARBOCAINE (mepivacaine hydrochloride), a tertiary amine used as a
local anesthetic, is
1-methyl-2', 6' - pipecoloxylidide monohydrochloride with the
following structural
formula:
C
H
N 0.HCl M.W. 282.81
It is a white, crystalline, odorless powder soluble in water, but very
resistant to both acid
and alkaline hydrolysis.
NEO-COBEFRIN, a sympathomimetic amine used as a vasoconstrictor in
local anesthetic
solution, is (-)-
-(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.
CARBOCAINE 3% (30 mg/mL) injection and CARBOCAINE 2% (20 mg/mL) with
NEO-
COBEFRIN 1:20,000 injection are sterile solutions for injection.
COMPOSITION:
CARTRIDGE
Each mL contains:
2%
3%
®
®
®
15
22
2
9
13
3
Mepivacaine hydrochloride
20 mg
30 mg
Levonordefrin
0.05mg
-
Sodium chloride
4 mg
6 mg
Potassium metabisulfite
1.2 mg
-
Edetate disodium
0.25mg
-
Sodium hydroxide q.s. ad pH
Hydrochloric acid
0.5 mg
-
Water for injections 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
CARBOCAINE stabilizes the neuronal membrane and prevents the
initiation and
transmission of nerve impulses, thereby effecting local anesthesia.
CARBOCAINE is rapidly metabolized, with only a small percentage of the
anesthetic (5 to
10 percent) being excreted unchanged in the urine. CARBOCAINE because
of its amide
structure, is not detoxified by the cir