A3080-27 SPINAL - regional anesthesia kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Smiths Medical ASD, Inc.

INN (International Name):

BUPIVACAINE HYDROCHLORIDE

Composition:

BUPIVACAINE HYDROCHLORIDE ANHYDROUS 7.5 mg in 1 mL

Therapeutic indications:

Bupivacaine Spinal is indicated for the production of subarachnoid block (spinal anesthesia). Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of spinal anesthesia. Bupivacaine Spinal (Bupivacaine in Dextrose Injection, USP) 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: Severe hemorrhage, severe hypotension or shock and arrhythmias, such as complete heart block, which severely restrict cardiac output. Local infection at the site of proposed lumbar puncture. Septicemia. Lidocaine Hydrochloride Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, wh

Product summary:

Bupivacaine Spinal (Bupivacaine in Dextrose Injection, USP) is supplied in 2 mL ampuls (15 mg bupivacaine hydrochloride with 165 mg dextrose anhydrous) packaged in cartons of 10 (NDC No. 0409-3613-01). Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Revised: 01/2013 EN-3185 Hospira, Inc., Lake Forest, IL 60045 USA

Authorization status:

Premarket Notification

Summary of Product characteristics

A3080-27 SPINAL - REGIONAL ANESTHESIA KIT
SMITHS MEDICAL ASD, INC.
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Bupivacaine HCl 0.75% in Dextrose
8.25% Injection
Sterile Hyperbaric Solution for
Spinal Anesthesia
Rx only
Bupivacaine hydrochloride is 1-Butyl-2΄ 6΄-pipecoloxylidide
monochloride, 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 Spinal (Bupivacaine in Dextrose Injection, USP) 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 1 mL of Bupivacaine Spinal contains 7.5 mg bupivacaine
hydrochloride, anhydrous and 82.5 mg
dextrose, anhydrous. The pH of this solution is adjusted to 5.5 (4.0
to 6.5) with sodium hydroxide
and/or hydrochloric acid.
The specific gravity of Bupivacaine Spinal is between 1.030 and 1.035
at 25°C and 1.03 at 37°C.
Bupivacaine Spinal does not contain any preservatives.
Solutions of bupivacaine hydrochloride may be autoclaved if they do
not contain epinephrine.
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 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)