CHLOROPROCAINE HCI injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

HF Acquisition Co LLC, DBA HealthFirst

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(R) -MPF (CHLOROPROCAINE HCI INJECTION, USP) is supplied in the following dosage forms. NDC 51662-1408-1 NESACAINE(R) -MPF (CHLOROPROCAINE HCI INJECTION, USP) 2% (400mg per 20mL) (20mg per mL) 20mL VIAL NDC 51662-1408-2 NESACAINE(R) -MPF (CHLOROPROCAINE HCI INJECTION, USP) 2% (400mg per 20mL) (20mg per mL) 20mL VIAL, 1 VIAL/POUCH NDC 51662-1408-3 NESACAINE(R) -MPF (CHLOROPROCAINE HCI INJECTION, USP) 2% (400mg per 20mL) (20mg per mL) 20mL VIAL, 1 VIAL/POUCH, 25 POUCHES/CASE HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 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].

Authorization status:

New Drug Application

Summary of Product characteristics

CHLOROPROCAINE HCI- CHLOROPROCAINE HCI INJECTION, SOLUTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
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NESACAINE(R) -MPF (CHLOROPROCAINE HCI INJECTION, USP) 2% (400MG PER
20ML) (20MG PER ML) 20ML VIAL
SPL UNCLASSIFIED
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
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 conduction and excitability, which may lead to
atrioventricular block and
ultimately to cardiac arrest. In addition, with toxic blood
concentrations myocardial
contractility may be depressed and peripheral vasodilation may occur,
leading to
decreased cardiac output and arter