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:

Hikma Pharmaceuticals USA Inc.

INN (International Name):

CHLOROPROCAINE HYDROCHLORIDE

Composition:

CHLOROPROCAINE HYDROCHLORIDE 20 mg in 1 mL

Administration route:

EPIDURAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Chloroprocaine hydrochloride injection 2% and 3%, in single dose vials, without methylparaben preservative, without EDTA, is indicated for the production of local anesthesia by infiltration, peripheral and central nerve block, including lumbar and caudal epidural blocks. Chloroprocaine hydrochloride injection is not to be used for subarachnoid administration. Chloroprocaine hydrochloride is 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:

Chloroprocaine Hydrochloride Injection, USP, without preservatives and without EDTA, is supplied as follows: 3% solution (NDC 0143-9210-10 ) in 20 mL single dose vials, packaged 10 vials per carton. 2% solution (NDC 0143-9209-10 ) in 20 mL single dose vials, packaged 10 vials per carton. Keep from freezing. Protect from light. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . For Product Inquiry call 1-877-845-0689.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CHLOROPROCAINE HYDROCHLORIDE- CHLOROPROCAINE HYDROCHLORIDE INJECTION,
SOLUTION
HIKMA PHARMACEUTICALS USA INC.
----------
CHLOROPROCAINE HYDROCHLORIDE INJECTION, USP
FOR INFILTRATION AND NERVE BLOCK
RX ONLY
DESCRIPTION
Chloroprocaine Hydrochloride Injection, USP is a sterile non-pyrogenic
local anesthetic.
The active ingredient is chloroprocaine HCl (benzoic acid,
4-amino-2-chloro-2-
(diethylamino) ethyl ester, monohydrochloride), which is represented
by the following
structural formula:
Molecular Formula: C
H
ClN O • HCl M. W.
307.22
Chloroprocaine Hydrochloride Injection, USP is available in a 2% and
3% solution for
infiltration, nerve block, caudal and epidural anesthesia (NOT for
spinal anesthesia).
Each mL of the 20 mg/mL, 2%, solution contains; 20 mg of
Chloroprocaine HCl, USP, 4.7
mg of Sodium Chloride, USP, and Sodium Hydroxide and/or Hydrochloric
Acid to adjust
pH. The pH range is 2.7 to 4.0.
Each mL of the 30 mg/mL, 3%, solution contains; 30 mg of
Chloroprocaine HCl, USP, 3.3
mg of Sodium Chloride, USP, and Sodium Hydroxide and/or Hydrochloric
Acid to adjust
pH. The pH range is 2.7 to 4.0.
Chloroprocaine HCl Injection, USP, 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.
13
19
2
2
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,
contractilit