BUPIVACAINE HYDROCHLORIDE injection, solution

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Asclemed USA, Inc.

Laluan pentadbiran:

INTRACAUDAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Bupivacaine hydrochloride injection, USP is indicated for the production of local or regional anesthesia or analgesia for surgery, oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia. (See WARNINGS .) Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of 0.75% concentration of bupivacaine hydrochloride injection, USP in these patients. Bupivacaine hydrochloride injection, USP is not recommended for intravenous regional anesthesia (Bier Block). See WARNINGS . The routes of administration and indicated bupivacaine hydrochloride injection, USP concentrations are: - local infiltration                          0.25% - peripheral nerve block               0.25% and 0.5% - retrobulbar block                       0.75% - sympathetic block                     0.2

Ringkasan produk:

These solutions are not for spinal anesthesia. Bupivacaine hydrochloride injection, USP — Solution of bupivacaine hydrochloride injection, USP may be autoclaved. Autoclave at 15-pound pressure, 121°C (250°F) for 15 minutes. Bupivacaine hydrochloride injection, USP is a clear, colorless, sterile isotonic solution and is available as follows: Bupivacaine hydrochloride injection, USP 0.5% (5 mg/mL) 10 mL Single Dose Vials   NDC 76420-008-10 (relabeled from NDC 55150-169-10) Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Discard unused portion. This container closure is not made with natural rubber latex. Sterile, Nonpyrogenic Relabeled by: Enovachem PHARMACEUTICALS Torrance, CA 90501

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

BUPIVACAINE HYDROCHLORIDE- BUPIVACAINE HYDROCHLORIDE INJECTION,
SOLUTION
ASCLEMED USA, INC.
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BUPIVACAINE HYDROCHLORIDE INJECTION, USP
RX ONLY
DESCRIPTION
Bupivacaine hydrochloride USP is 2-Piperidinecarboxamide, 1-butyl-
_N_-(2,6-
dimethylphenyl)-, monohydrochloride, monohydrate, a white, odorless,
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:
Bupivacaine hydrochloride injection, USP is available in sterile
isotonic solution for
injection via local infiltration, peripheral nerve block, and caudal
and lumbar epidural
blocks. Solution of bupivacaine hydrochloride injection, USP may be
autoclaved. Solution
is clear and colorless.
Bupivacaine 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.
Bupivacaine hydrochloride injection, USP — Sterile isotonic solution
containing sodium
chloride. The pH of the solution is adjusted to between 4 and 6.5 with
sodium hydroxide
or hydrochloric acid.
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 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 (CNS). At blood c