NESACAINE- chloroprocaine hydrochloride injection, solution NESACAINE MPF- chloroprocaine hydrochloride injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CHLOROPROCAINE HYDROCHLORIDE (UNII: LT7Z1YW11H) (CHLOROPROCAINE - UNII:5YVB0POT2H)

Available from:

Fresenius Kabi USA, LLC

Administration route:

INFILTRATION

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Nesacaine 1% and 2% Injections, in multidose vials with methylparaben as preservative, are indicated for the production of local anesthesia by infiltration and peripheral nerve block.  They are not to be used for lumbar or caudal epidural anesthesia. Nesacaine-MPF 2% and 3% Injections, in single dose vials without preservative and without EDTA, are indicated for the production of local anesthesia by infiltration, peripheral and central nerve block, including lumbar and caudal epidural blocks. Nesacaine and Nesacaine-MPF Injections are not to be used for subarachnoid administration. Nesacaine and Nesacaine-MPF Injections are contraindicated in patients hypersensitive (allergic) to drugs of the PABA ester group. Lumbar and caudal epidural anesthesia should be used with extreme caution in persons with the following conditions: existing neurological disease, spinal deformities, septicemia, and severe hypertension.

Product summary:

NESACAINE ® (chloroprocaine HCl Injection, USP) with preservatives is supplied as follows: NESACAINE ® -MPF (chloroprocaine HCl Injection, USP) without preservatives and without EDTA is supplied as follows: For single-dose vials: Discard unused portion. Keep from freezing.  Protect from light.  Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. All trademarks are the property of Fresenius Kabi USA, LLC.

Authorization status:

New Drug Application

Summary of Product characteristics

NESACAINE- CHLOROPROCAINE HYDROCHLORIDE INJECTION, SOLUTION
NESACAINE MPF- CHLOROPROCAINE HYDROCHLORIDE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
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NESACAINE
(CHLOROPROCAINE HCL INJECTION, USP)
NESACAINE -MPF
(CHLOROPROCAINE HCL INJECTION, USP)
_For Infiltration and Nerve Block_
DESCRIPTION
Nesacaine and Nesacaine-MPF Injections are sterile non-pyrogenic local
anesthetics. The
active ingredient in Nesacaine and Nesacaine-MPF Injections is
chloroprocaine HCl
(benzoic acid, 4-amino-2-chloro-2-(diethylamino) ethyl ester,
monohydrochloride), which
is represented by the following structural formula:
TABLE 1: COMPOSITION OF AVAILABLE INJECTIONS
FORMULA (MG/ML)
PRODUCT
IDENTIFICATION
CHLORO-
PROCAINE
HCL
SODIUM
CHLORIDE
DISODIUM
EDTA
DIHYDRATE
METHYLPARABEN
Nesacaine 1%
Nesacaine 2%
Nesacaine-MPF 2%
Nesacaine-MPF 3%
10
20
20
30
6.7
4.7
4.7
3.3
0.111
0.111
-
-
1
1
-
-
The solutions are adjusted to pH 2.7 to 4.0 by means of sodium
hydroxide and/or
hydrochloric acid. Filled under nitrogen.
Nesacaine and Nesacaine-MPF Injections should not be resterilized by
autoclaving.
CLINICAL PHARMACOLOGY
Chloroprocaine, like other local anesthetics, blocks the generation
and the conduction of
nerve impulses, presumably by increasing the threshold for electrical
excitation in the
nerve, by slowing the propagation of the nerve impulse and by reducing
the rate of rise
of the action potential. In general, the progression of anesthesia is
related to the
®
®
diameter, myelination and conduction velocity of affected nerve
fibers. Clinically, the
order of loss of nerve function is as follows: (1) pain, (2)
temperature, (3) touch, (4)
proprioception, and (5) skeletal muscle tone.
Systemic absorption of local anesthetics produces effects on the
cardiovascular and
central nervous systems. At blood concentrations achieved with normal
therapeutic
doses, changes in cardiac conduction, excitability, refractoriness,
contractility, and
peripheral vascular resistance are minimal. However, toxic blood
concentrations
depress cardiac conductio