MARCAINE- bupivacaine hydrochloride injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Bupivacaine Hydrochloride (UNII: 7TQO7W3VT8) (Bupivacaine - UNII:Y8335394RO)

Available from:

General Injectables & Vaccines, Inc

INN (International Name):

Bupivacaine Hydrochloride

Composition:

Bupivacaine Hydrochloride 5 mg in 1 mL

Administration route:

EPIDURAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

MARCAINE / MARCAINE WITH EPINEPHRINE is indicated in adults 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. Specific concentrations and presentations of MARCAINE / MARCAINE WITH EPINEPHRINE are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see DOSAGE AND ADMINISTRATION (2.2)]. Limitations of Use Not all blocks are indicated for use with MARCAINE / MARCAINE WITH EPINEPHRINE given clinically significant risks associated with use [see DOSAGE AND ADMINISTRATION (2.2), CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.1, 5.4, 5.5, 5.7, 5.9)]. MARCAINE / MARCAINE WITH EPINEPHRINE is contraindicated in: - obstetrical paracervical block anesthesia. Its use in this technique has resulted in fetal bradycardia and death. - intravenous regional anesthesia (Bier Block) [see WARNINGS AND PRECAUTIONS (5.7)]. - patients with a known hyper

Product summary:

Store at 20 °C to 25 °C (68 °F to 77 °F); excursions permitted between 15 °C to 30 °C (59 °F 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. Protect from light. This product is clear and colorless. Do not use the solution if it is discolored or if it contains a precipitate. For single-dose vials: Discard unused portion. MARCAINE with epinephrine 1:200,000 (as bitartrate)—Do not autoclave solutions of MARCAINE that contain epinephrine and protect from light. This product is clear and colorless. Do not use the solution if it is discolored or if it contains a precipitate. For single-dose vials: Discard unused portion.

Authorization status:

New Drug Application

Summary of Product characteristics

MARCAINE- BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINES, INC
REFERENCE LABEL SET ID: 8DB7C501-993A-444D-A819-D1F9DF1D7B62
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HIGHLIGHTS OF PRESCRIBING INFORMATION
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MARCAINE™ AND
MARCAINE™ WITH EPINEPHRINE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
MARCAINE™ AND MARCAINE™ WITH EPINEPHRINE.
MARCAINE™ (BUPIVACAINE HYDROCHLORIDE) INJECTION, FOR INFILTRATION,
PERINEURAL, CAUDAL,
EPIDURAL, OR RETROBULBAR USE
MARCAINE™ WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND
EPINEPHRINE) INJECTION, FOR
INFILTRATION, PERINEURAL, CAUDAL, OR EPIDURAL USE
INITIAL U.S. APPROVAL: 1972
INDICATIONS AND USAGE
MARCAINE contains bupivacaine, an amide local anesthetic, and MARCAINE
WITH EPINEPHRINE is a
combination of bupivacaine, an amide local anesthetic, and
epinephrine, an alpha and beta-adrenergic
agonist. MARCAINE / MARCAINE WITH EPINEPHRINE is indicated in adults
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. For each type
of block indicated to produce local
or regional anesthesia or analgesia, specific concentrations and
presentations are recommended. (1, 2.2)
(2)
Limitations of Use (2)
Not all blocks are indicated for use with MARCAINE / MARCAINE WITH
EPINEPHRINE given clinically
significant risks associated with use. (1, 2.2, 4, 5.1, 5.4, 5.5, 5.7,
5.9) (2)
DOSAGE AND ADMINISTRATION
Not for intrathecal use. (2.1)
Avoid use of solutions containing antimicrobial preservatives (i.e.,
multiple-dose vials) for epidural or
caudal anesthesia. (2.1, 5.4)
Three mL of MARCAINE WITH EPINEPHRINE without antimicrobial
preservative (0.5% bupivacaine with
1:200,000 epinephrine ) is recommended for use as a test dose prior to
caudal and lumbar epidural
blocks when clinical conditions permit. (2.4)
See full prescribing information for:
–
Reco