Bupivacaine Hydrochloride with Dextrose (Page 5 of 5)

DOSAGE AND ADMINISTRATION

The dose of any local anesthetic administered varies with the anesthetic procedure, the area to be anesthetized, 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. The smallest dose and concentration required to produce the desired result should be administered. Dosages of Bupivacaine Hydrochloride in Dextrose Injection, USP should be reduced for elderly and debilitated patients and patients with cardiac and/or liver disease.

For specific techniques and procedures, refer to standard textbooks.

There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures. Bupivacaine Hydrochloride in Dextrose Injection, USP is not approved for this use (see WARNINGS and DOSAGE AND ADMINISTRATION).

The extent and degree of spinal anesthesia depend upon several factors including dosage, specific gravity of the anesthetic solution, volume of solution used, force of injection, level of puncture, and position of the patient during and immediately after injection.

Seven and one-half mg (7.5 mg or 1 mL) Bupivacaine Hydrochloride in Dextrose Injection, USP has generally proven satisfactory for spinal anesthesia for lower extremity and perineal procedures including TURP and vaginal hysterectomy. Twelve mg (12 mg or 1.6 mL) has been used for lower abdominal procedures such as abdominal hysterectomy, tubal ligation, and appendectomy. These doses are recommended as a guide for use in the average adult and may be reduced for the elderly or debilitated patients. Because experience with Bupivacaine Hydrochloride in Dextrose Injection, USP is limited in patients below the age of 18 years, dosage recommendations in this age group cannot be made.

Obstetrical Use:

Doses as low as 6 mg bupivacaine hydrochloride have been used for vaginal delivery under spinal anesthesia. The dose range of 7.5 mg to 10.5 mg (1 mL to 1.4 mL) bupivacaine hydrochloride has been used for Cesarean section under spinal anesthesia.

In recommended doses, Bupivacaine Hydrochloride in Dextrose Injection, USP produces complete motor and sensory block.

Unused portions of solutions should be discarded following initial use.

Bupivacaine Hydrochloride in Dextrose Injection, USP should be inspected visually for discoloration and particulate matter prior to administration; solutions which are discolored or which contain particulate matter should not be administered.

HOW SUPPLIED

Single-dose, clear, colorless solution that is packaged in an ampoule of 2 mL (15 mg bupivacaine hydrochloride with 165 mg dextrose), is packaged 10 per carton as follows:

NDC Description Container/ Fill
0264-9379-88 Bupivacaine Hydrochloride 0.75% with Dextrose 8.25% 2 mL ampoule

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.]

Bupivacaine Hydrochloride in Dextrose Injection, USP solution may be autoclaved once at 15 pound pressure, 121°C (250°F) for 15 minutes. Do not administer any solution which is discolored or contains particulate matter.

For single-dose ampoules and vials: Discard the unused portion.

Rx only

Revised: January 2019

A4805964-1

Manufactured for:

B. Braun Medical Inc.

Bethlehem, PA 18018-3524 USA

Prepared in Germany.
API from Switzerland.

Manufactured by:

Solupharm Pharmazeutische Erzeugnisse GmbH

PRINCIPAL DISPLAY PANEL

LD-560-1

NDC 0264-9379-88

Bupivacaine HCl 0.75%

in Dextrose 8.25%

Injection, USP

SPINAL

Contains 7.5 mg bupivacaine HCl (anhydrous) and 82.5 mg dextrose (anhydrous) per mL. pH adjusted between 4.0 and 6.5 with NaOH or HCl.

2 mL

Rx only

Manufactured for:

B. Braun Medical Inc.

Bethlehem, PA 18018-3524 USA

Prepared in Germany.
API from Switzerland.

LOT

EXP

2 mL Ampoule Container label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL 2mL CARTON

10 x 2 mL Single-dose Ampoules

NDC 0264-9379-88

Rx only

STERILE HYPERBARIC SOLUTION FOR SPINAL ANESTHESIA

Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP

SPINAL 0.75%
(15 mg/2 mL)
(7.5 mg/mL)

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.]
Each mL contains 7.5 mg bupivacaine HCl (anhydrous) and 82.5 mg dextrose
(anhydrous) per mL. pH adjusted between 4.0 and 6.5 with NaOH or HCl.
These ampoules bear a color band signifying that they are Easy Break Ampoules.
The tops snap off at constriction, regardless of the position of the color band.
Usual dosage: See Insert.

LD-618-1

Manufactured for:

B. Braun Medical Inc.

Bethlehem, PA 18018-3524 USA

1-800-227-2862

Prepared in Germany.
API from Switzerland.

Bupivacaine HCl 0.75%
in Dextrose 8.25%
Injection, USP
SPINAL

LOT

EXP

10 x 2 mL Carton
(click image for full-size original)
BUPIVACAINE HYDROCHLORIDE WITH DEXTROSE
bupivacaine hydrochloride with dextrose injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0264-9379
Route of Administration SUBARACHNOID DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE) BUPIVACAINE HYDROCHLORIDE ANHYDROUS 7.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DEXTROSE 82.5 mg in 1 mL
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0264-9379-88 10 AMPULE in 1 CARTON contains a AMPULE
1 2 mL in 1 AMPULE This package is contained within the CARTON (0264-9379-88)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209087 04/02/2019
Labeler — B. Braun Medical Inc. (002397347)

Revised: 04/2019 B. Braun Medical Inc.

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