BUPIVACAINE HYDROCHLORIDE injection, solution

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

AuroMedics Pharma LLC

Tuyến hành chính:

INFILTRATION

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Bupivacaine hydrochloride injection USP is indicated for the production of local or regional anesthesia or analgesia for surgery, 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                     0.25% - lumbar epidural                         0.25%, 0.5%, and 0.75% (0.75% not for obstetrica

Tóm tắt sản phẩm:

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 0.25% (2.5 mg/mL)    50 mL Multiple Dose Vials in a Carton of 25                                  NDC 55150-249-50 Bupivacaine hydrochloride injection USP 0.5% (5 mg/mL)    50 mL Multiple Dose Vials in a Carton of 25                                  NDC 55150-250-50 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] The vial stoppers are not made with natural rubber latex. Sterile, Nonpyrogenic Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad - 500038 India Revised: March 2019

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

BUPIVACAINE HYDROCHLORIDE - BUPIVACAINE HYDROCHLORIDE INJECTION,
SOLUTION
AUROMEDICS PHARMA LLC
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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 and 1
mg methylparaben as antiseptic preservative. 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
cardiovascul