POLOCAINE- mepivacaine hydrochloride injection, solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

MEPIVACAINE HYDROCHLORIDE (UNII: 4VFX2L7EM5) (MEPIVACAINE - UNII:B6E06QE59J)

Διαθέσιμο από:

Dentsply Pharmaceutical

INN (Διεθνής Όνομα):

MEPIVACAINE HYDROCHLORIDE

Σύνθεση:

MEPIVACAINE HYDROCHLORIDE 30 mg in 1 mL

Οδός χορήγησης:

SUBMUCOSAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

3% (30 mg/mL) Polocaine® DENTAL (Mepivacaine Hydrochloride Injection USP) (NDC 66312-441-16) is available in cardboard boxes containing 5 blisters of 10 × 1.7 mL single-dose dental cartridges, 50 per carton. 2% (20 mg/mL) Polocaine® DENTAL with Levonordefrin 1:20,000 (Mepivacaine Hydrochloride and Levonordefrin Injection USP) (NDC 66312-461-16) 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. For protection from light, retain in box until time of use. Once opened, the box should be reclosed by closing the top flap. The 2% (20 mg/mL) Polocaine® DENTAL with Levonordefrin 1:20,000 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 Polocaine® products.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

POLOCAINE- MEPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION
DENTSPLY PHARMACEUTICAL
----------
3% POLOCAINE DENTAL
MEPIVACAINE HYDROCHLORIDE 3% (30 MG/ML)
(MEPIVACAINE HYDROCHLORIDE INJECTION, USP)
2% POLOCAINE DENTAL WITH LEVONORDEFRIN 1:20,000
MEPIVACAINE HYDROCHLORIDE 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:
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 (-)-α-(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.
3% (30 mg/mL) Polocaine DENTAL (mepivacaine hydrochloride injection 3%
(30
mg/mL)) and 2% (20 mg/mL) Polocaine DENTAL with Levonordefrin 1:20,000
(mepivacaine hydrochloride 2% (20 mg/mL) with levonordefrin 1:20,000
injection) are
sterile solutions for injection.
®
®
®
®
sterile solutions for injection.
COMPOSITION:
CARTRIDGE
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.
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
CLINICAL PHARMACOLOGY
Polocaine stabilizes the neuronal membrane and prevents the initiation
and
transmission of nerve impulses, thereby effecting local anesthesia.
Polocaine is rapidly metabolize