MARCAINE SPINAL- bupivacaine hydrochloride in dextrose injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hospira, Inc.

INN (International Name):

BUPIVACAINE HYDROCHLORIDE

Composition:

BUPIVACAINE HYDROCHLORIDE ANHYDROUS 7.5 mg in 1 mL

Administration route:

SUBARACHNOID

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

MARCAINE SPINAL is indicated for subarachnoid injection in adults for the production of subarachnoid block (spinal anesthesia). MARCAINE SPINAL is contraindicated in: Risk Summary The available data on the use of MARCAINE SPINAL in pregnant women do not establish the presence or absence of developmental toxicity related to the use of MARCAINE SPINAL. In animal studies, embryo-fetal lethality was noted when bupivacaine was administered subcutaneously to pregnant rabbits during organogenesis and decreased pup survival was observed in a rat pre- and post-natal developmental study (dosing from implantation through weaning). These effects were observed at dose levels approximately 30 times the daily maximum recommended human dose (MRHD) on a body surface area (BSA) basis. Based on animal data, advise pregnant women of the potential risk to a fetus (see Data ). Local anesthetics rapidly cross the placenta, and when used for epidural, caudal, or pudendal block anesthesia, can cause varying degrees of maternal, fetal

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 SPINAL solution may be autoclaved once at 15 pound pressure, 121°C (250°F) for 15 minutes. This product is clear and colorless. Do not use the solution if it is discolored or contains particulate matter. Single-dose ampules of 2 mL MARCAINE SPINAL (bupivacaine hydrochloride in dextrose injection) (15 mg bupivacaine hydrochloride with 165 mg dextrose) are supplied as follows: NDC 0409-1761-02 Carton of 10 Uni-Amp™ single-dose ampules 15 mg/2 mL (7.5 mg/mL) NDC 0409-1761-10 Carton of 2 clamcells each containing 5 single-dose ampules 15 mg/2 mL (7.5 mg/mL) NDC 0409-1761-62 Case of 800 single-dose ampules 15 mg/2 mL (7.5 mg/mL) Discard the unused portion.

Authorization status:

New Drug Application

Summary of Product characteristics

MARCAINE SPINAL- BUPIVACAINE HYDROCHLORIDE IN DEXTROSE INJECTION,
SOLUTION
HOSPIRA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MARCAINE SPINAL
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MARCAINE
SPINAL.
MARCAINE SPINAL (BUPIVACAINE HYDROCHLORIDE IN DEXTROSE INJECTION) FOR
SUBARACHNOID
INJECTION
INITIAL U.S. APPROVAL: 1984
INDICATIONS AND USAGE
MARCAINE SPINAL is an amide-local anesthetic indicated in adults for
subarachnoid injection for the
production of subarachnoid block (spinal anesthesia). (1)
DOSAGE AND ADMINISTRATION
The dosage of MARCAINE SPINAL administered varies with the anesthetic
procedure, the vascularity of the
tissues, the number of neuronal segments to be blocked, the depth of
anesthesia and degree of muscle
relaxation required, the duration of anesthesia desired, individual
tolerance, and the physical condition of
the patient. Administer the smallest dosage and concentration required
to produce the desired result. The
following are general dosage guidelines:
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Injection: 15 mg/2 mL (7.5 mg/mL) in single-dose glass ampules. (3)
CONTRAINDICATIONS
•
•
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
®
®
®
MARCAINE SPINAL 6 mg is generally adequate for vaginal delivery. (2.2)
MARCAINE SPINAL 7.5 mg is generally adequate for spinal anesthesia for
lower extremity and perineal
procedures. (2.2)
MARCAINE SPINAL 12 mg is generally adequate for lower abdominal
procedures. (2.2)
MARCAINE SPINAL 7.5 mg to 10.5 mg is generally adequate for Cesarean
section. (2.2)
Intravenous regional anesthesia (Bier Block). (4)
Septicemia. (4)
Severe hemorrhage, severe hypotension or shock, and arrhythmias, such
as complete heartblock,
which severely reduce cardiac output. (4)
Known hypersensitivity to bupivacaine or to any local anesthetic agent
of the amide-type or to other
components of MARCAINE SPINAL. (4)
Local infection at the site of proposed lumbar puncture. (4)
U