BUPIVACAINE HYDROCHLORIDE WITH DEXTROSE injection

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

B. Braun Medical Inc.

Manustamisviis:

SUBARACHNOID

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Bupivacaine Hydrochloride in Dextrose Injection, USP 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 Hydrochloride 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.

Toote kokkuvõte:

Single-dose, clear, colorless solution that is packaged in an ampoule of 2 mL (15 mg bupivacaine hydrochloride with 165 mg dextrose), is packaged 10 per carton as follows: Store at 20 to 25°C (68 to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Bupivacaine Hydrochloride in Dextrose Injection, USP 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 ampoules and vials: Discard the unused portion.

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

BUPIVACAINE HYDROCHLORIDE WITH DEXTROSE- BUPIVACAINE HYDROCHLORIDE
WITH
DEXTROSE INJECTION
B. BRAUN MEDICAL INC.
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BUPIVACAINE HYDROCHLORIDE IN DEXTROSE INJECTION, USP
STERILE HYPERBARIC SOLUTION FOR SPINAL ANESTHESIA
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 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 mL of Bupivacaine Hydrochloride in Dextrose Injection, USP
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 Dextrose
Injection, USP is between 1.030 and
1.035 at 25°C and 1.03 at 37°C. Bupivacaine Hydrochloride in
Dextrose Injection, USP does not contain
any preservatives.
CLINICAL PHARMACOLOGY
Local anesthetics block the generation and the conduction of nerve
impulses, presumably by increasing
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
progressio