BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Bupivacaine Hydrochloride (UNII: 7TQO7W3VT8) (Bupivacaine - UNII:Y8335394RO), Epinephrine Bitartrate (UNII: 30Q7KI53AK) (Epinephrine - UNII:YKH834O4BH)

Available from:

Henry Schein, Inc.

Administration route:

INFILTRATION

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Bupivacaine Hydrochloride is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and 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 in these patients. Bupivacaine Hydrochloride is not recommended for intravenous regional anesthesia (Bier Block). (See WARNINGS .) The routes of administration and indicated Bupivacaine Hydrochloride concentrations are: (See DOSAGE AND ADMINISTRATION for additional information.) Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of Bupivacaine Hydrochloride. Bupivacaine Hydrochloride is contraindicated in obstetrical paracervical block anesthesia. Its use in this technique ha

Product summary:

These solutions are not for spinal anesthesia. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Bupivacaine Hydrochloride ─ Solutions of Bupivacaine Hydrochloride that do not contain epinephrine may be autoclaved. Autoclave at 15-pound pressure, 121°C (250°F) for 15 minutes. Bupivacaine Hydrochloride with epinephrine 1:200,000  (as bitartrate) - Solutions of Bupivacaine Hydrochloride that contain epinephrine should not be autoclaved and should be protected from light. Do not use the solution if its color is pinkish or darker than slightly yellow or if it contains a precipitate. Revised: 3/2016 EN-4179 Hospira, Inc. Lake Forest, IL 60045 USA

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE- BUPIVACAINE HYDROCHLORIDE
AND EPINEPHRINE INJECTION, SOLUTION
HENRY SCHEIN, INC.
----------
0.25% BUPIVACAINE HCL AND EPINEPHRINE 1:200,000 INJECTION, USP 30 ML
SINGLE DOSE VIAL
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:
Epinephrine is (-)-3,4-Dihydroxy-a-[(methylamino)methyl] benzyl
alcohol. It has the
following structural formula:
Bupivacaine Hydrochloride is available in sterile isotonic solutions
with and without
epinephrine (as bitartrate) 1:200,000 for injection via local
infiltration, peripheral nerve
block, and caudal and lumbar epidural blocks. Solutions of Bupivacaine
Hydrochloride
may be autoclaved if they do not contain epinephrine. Solutions are
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 is available in sterile,
isotonic solutions
containing bupivacaine hydrochloride in water for injection with
characteristics as
follows:
May contain sodium hydroxide and/or hydrochloric acid for pH
adjustment. (See HOW
SUPPLIED section for pH information.)
Multiple-dose vials contain methylparaben 1 mg/mL added as a
preservative.
Bupivacaine and Epinephrine Injection, USP is available in sterile,
isotonic solutions
containing bupivacaine hydrochloride and epinephrine 1:200,000 with
characteristics as
follows:
Sodium metabisulfite 0.1 mg/mL added as antioxidant and edetate
calcium disodium,
anhydrous 0.1 mg/mL added a