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:

Safco Dental Supply Co.

INN (International Name):

Mepivacaine Hydrochloride

Composition:

Mepivacaine Hydrochloride 30 mg in 1 mL

Administration route:

SUBMUCOSAL

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. Mepivacaine is contraindicated in patients with a known hypersensitivity to amide-type local anesthetics.

Product summary:

Mepivacaine HCl 3% (30 mg/mL); (Mepivacaine Hydrocholoride Injection USP) is available in cardboard boxes containing 5 blisters of 10 × 1.7 mL single-dose dental cartridges, 50 per carton. Mepivacaine HCl 2% (20 mg/mL) (Mepivacaine Hydrochloride and Levonordefrin Injection; USP) is available in cardboard boxes containing 5 blisters of 10 × 1.7 mL single-dose 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% (20mg/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 Mepivacaine HCl injection USP products.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MEPIVACAINE HYDROCHLORIDE- MEPIVACAINE HYDROCHLORIDE INJECTION,
SOLUTION
SAFCO DENTAL SUPPLY CO.
----------
MEPIVACAINE HCL 3% (30 MG/ML)
(MEPIVACAINE HYDROCHLORIDE INJECTION, USP)
MEPIVACAINE HCL 2% (20 MG/ML)
(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:
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.
Levonordefrin, 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.
Mepivacaine hydrochloride injection 3% (30 mg/mL) and Mepivacaine
hydrochloride 2%
(20 mg/mL) with levonordefrin 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
0.05
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
struct