BUPIVACAINE HYDROCHLORIDE injection, solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Medical Purchasing Solutions, LLC

Pot uporabe:

PERINEURAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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        

Povzetek izdelek:

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

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

BUPIVACAINE HYDROCHLORIDE- BUPIVACAINE HYDROCHLORIDE INJECTION,
SOLUTION
MEDICAL PURCHASING SOLUTIONS, 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