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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, Inc.

INN (International Name):

BUPIVACAINE HYDROCHLORIDE

Composition:

BUPIVACAINE 2.5 mg in 1 mL

Administration route:

INFILTRATION

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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: ∙ local infiltration                                                                                 0.25% ∙ peripheral nerve block                                                                      0.25% and 0.5% ∙ retrobulbar block                                                                              0.75% ∙ sympathetic block                                                      

Product summary:

These solutions are not for spinal anesthesia. Store at 20 to 25°C (68 to 77°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. Revised: 10/2011   Printed in USA                           EN-2916         Hospira, Inc., Lake Forest, IL 60045 USA Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, Oklahoma       74146

Authorization status:

New Drug Application

Summary of Product characteristics

MARCAINE - BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION
MARCAINE WITH EPINEPHRINE - BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
BITARTRATE INJECTION, SOLUTION
PHYSICIANS TOTAL CARE, 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
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 an