MARCAINE WITH EPINEPHRINE- bupivacaine hydrochloride and epinephrine bitartrate injection, solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

BUPIVACAINE HYDROCHLORIDE (UNII: 7TQO7W3VT8) (BUPIVACAINE - UNII:Y8335394RO), EPINEPHRINE BITARTRATE (UNII: 30Q7KI53AK) (EPINEPHRINE - UNII:YKH834O4BH)

Διαθέσιμο από:

General Injectables & Vaccines, Inc.

Οδός χορήγησης:

INFILTRATION

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

MARCAINE 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 MARCAINE in these patients. MARCAINE is not recommended for intravenous regional anesthesia (Bier Block). See WARNINGS . The routes of administration and indicated MARCAINE 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 MARCAINE. MARCAINE is contraindicated in obstetrical paracervical block anesthesia. Its use in this technique has resulted in fetal bradycardia and death. MARCAINE is contraindicated in patients with a known hypersen

Περίληψη προϊόντος:

These solutions are not for spinal anesthesia. 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.] MARCAINE ―Solutions of MARCAINE that do not contain epinephrine may be autoclaved. Autoclave at 15-pound pressure, 121°C (250°F) for 15 minutes. MARCAINE with epinephrine 1:200,000  (as bitartrate)―Solutions of MARCAINE 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. For single-dose vials: Discard unused portion. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1178-2.0 Revised: 11/2018

Καθεστώς αδειοδότησης:

New Drug Application

Αρχείο Π.Χ.Π.

MARCAINE WITH EPINEPHRINE- BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
BITARTRATE INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINES, INC.
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MARCAINE™
BUPIVACAINE HYDROCHLORIDE INJECTION, USP
MARCAINE™
WITH EPINEPHRINE 1:200,000 (AS BITARTRATE)
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, USP
RX ONLY
PAA118781
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-α-[(methylamino)methyl] benzyl
alcohol. It has the
following structural formula:
MARCAINE 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 MARCAINE 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.
_MARCAINE_—Sterile isotonic solutions containing sodium chloride. In
multiple-dose vials,
each mL also contains 1 mg methylparaben as antiseptic preservative.
The pH of these
solutions is adjusted to between 4 and 6.5 with sodium hydroxide or
hydrochloric acid.
_MARCAINE with epinephrine 1:200,000_ (as bitartrate)—Sterile
isotonic solutions
containing sodium chloride. Each mL contains bupivacaine hydrochloride
and 0.0091 mg
epinephrine bitartrate, with 0.5 mg sodium metabisulfite, 0.001 mL
monothioglycerol,
and 2 mg ascorbic acid as antioxidants, 0.0017 mL 60% sodium lactate
bu