BUPIVACAINE HYDROCHLORIDE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BUPIVACAINE HYDROCHLORIDE (UNII: 7TQO7W3VT8) (BUPIVACAINE - UNII:Y8335394RO)

Available from:

Baxter Healthcare Corporation

INN (International Name):

BUPIVACAINE HYDROCHLORIDE

Composition:

BUPIVACAINE HYDROCHLORIDE ANHYDROUS 7.5 mg in 1 mL

Administration route:

INTRASPINAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Bupivacaine hydrochloride in 8.25% dextrose injection Spinal is indicated for the production of subarachnoid block (spinal anesthesia). Standard text books should be consulted to determine the accepted procedures and techniques for the administration of spinal anesthesia. Bupivacaine hydrochloride in 8.25% dextrose injection Spinal is contraindicated in patients with a known hypersensitivity to it or to any local anesthetic agent of the amide-type. The following conditions preclude the use of spinal anesthesia:

Product summary:

Single-dose ampules of 2 mL (15 mg bupivacaine hydrochloride with 165 mg dextrose), are supplied as follows: AIN code NDC No.  Container  Fill  Quantity AIN00189 36000-092-10 Glass ampule 2 mL  Blister pack of 10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Bupivacaine hydrochloride in 8.25% dextrose injection, USP 7.5 mg/mL Spinal solution may be autoclaved once at 15 pound pressure, 121°C (250°F) for 15 minutes. Do not administer any solution which is discolored or contains particulate matter. For single-dose ampules: Discard the unused portion. Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA Manufactured by: Baxter Pharmaceuticals India Private Ltd Ahmedabad 382213, India 2018-11-27 1400007319

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUPIVACAINE HYDROCHLORIDE- BUPIVACAINE HYDROCHLORIDE INJECTION,
SOLUTION
BAXTER HEALTHCARE CORPORATION
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BUPIVACAINE HYDROCHLORIDE IN 8.25% DEXTROSE INJECTION, USP SPINAL
STERILE HYPERBARIC SOLUTION
FOR SPINAL ANESTHESIA
RX ONLY
DESCRIPTION
Bupivacaine hydrochloride is 2-Piperidinecarboxamide,
1-butyl-_N_-(2,6-dimethylphenyl)-,
monohydrochloride, monohydrate, a white crystalline powder that is
freely soluble in 95 percent
ethanol, soluble in water, and slightly soluble in chloroform or
acetone. It has the following structural
formula:
Dextrose is D-glucopyranose monohydrate and has the following
structural formula:
Bupivacaine hydrochloride in 8.25% dextrose injection, USP Spinal is
available in sterile hyperbaric
solution for subarachnoid injection (spinal block).
Bupivacaine hydrochloride is related chemically and pharmacologically
to the aminoacyl local
anesthetics. It is a homologue of mepivacaine and is chemically
related to lidocaine. All three of these
anesthetics contain an amide linkage between the aromatic nucleus and
the amino or piperidine group.
They differ in this respect from the procaine-type local anesthetics,
which have an ester linkage.
Each mL of Bupivacaine hydrochloride in 8.25% dextrose injection, USP
Spinal contains 7.5 mg
bupivacaine hydrochloride (anhydrous) and 82.5 mg dextrose
(anhydrous). The pH of this solution is
adjusted to between 4.0 and 6.5 with sodium hydroxide or hydrochloric
acid.
The specific gravity of Bupivacaine hydrochloride in 8.25% dextrose
injection, USP Spinal is between
1.030 and 1.035 at 25°C and 1.03 at 37°C.
Bupivacaine hydrochloride in 8.25% dextrose injection, USP Spinal does
not contain any preservatives.
Bupivacaine hydrochloride in 8.25% dextrose injection, USP Spinal does
not contain any preservatives.
CLINICAL PHARMACOLOGY
Local anesthetics block 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 r