CARBOCAINE- mepivacaine hydrochloride injection, solution CARBOCAINE WITH NEO-COBEFRIN- mepivacaine hydrochloride and levonorde

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Caresteam Health, Inc.

INN (Jina la Kimataifa):

Mepivacaine hydrochloride

Tungo:

Mepivacaine hydrochloride 30 mg in 1 mL

Njia ya uendeshaji:

SUBCUTANEOUS

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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.

Bidhaa muhtasari:

CARBOCAINE 3% injection (mepivacaine hydrocholoride injection, USP) is available in cartons containing 5 blisters of 10 × 1.7 mL dental cartridges, 50 per carton (NDC 31382-753-05). CARBOCAINE 2% 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 dental cartridges, 50 per carton (NDC 31382-931-05). 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% 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.

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

CARBOCAINE- MEPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION
CARBOCAINE WITH NEO-COBEFRIN- MEPIVACAINE HYDROCHLORIDE AND
LEVONORDEFRIN INJECTION, SOLUTION
CARESTEAM HEALTH, INC.
----------
CARBOCAINE 3% INJECTION
(MEPIVACAINE HYDROCHLORIDE INJECTION, USP)
CARBOCAINE 2%
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% injection and CARBOCAINE 2% with NEO-COBEFRIN 1:20,000
injection are
sterile solutions for injection.
COMPOSITION:
CARTRIDGE
Each mL contains:
2%
3%
Mepivacaine hydrochloride
20 mg
30 mg
Levonordefrin
0.05mg
-
Sodium chloride
4 mg
6 mg
Potassium metabisulfite
1.2 mg
-
®
®
®
15
22
2
9
13
3
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 uncha