Bupivacaine Hydrochloride (Page 4 of 4)

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 8.25% dextrose injection, USP Spinal should be reduced for elderly and debilitated patients and patients with cardiac and/or liver disease.

For specific techniques and procedures, refer to standard text books.

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 8.25% dextrose injection, USP Spinal 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 8.25% dextrose injection, USP Spinal 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 8.25% dextrose injection, USP Spinal 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 8.25% dextrose injection, USP Spinal produces complete motor and sensory block.

Unused portions of solutions should be discarded following initial use.

Bupivacaine hydrochloride in 8.25% dextrose injection, USP Spinal 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 ampules of 2 mL (15 mg bupivacaine hydrochloride with 165 mg dextrose), are supplied as follows:

AIN code

NDC No.

Container

Fill

Quantity

AIN00189

36000-092-10

Glass ampule

2 mL

Blister pack of 10

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Bupivacaine hydrochloride in 8.25% dextrose injection, USP 7.5 mg/mL Spinal 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 ampules: Discard the unused portion.

Manufactured for:

Baxter Healthcare Corporation

Deerfield, IL 60015 USA

Manufactured by:

Baxter Pharmaceuticals India Private Ltd

Ahmedabad 382213, India
2018-11-27
1400007319

PRINCIPAL DISPLAY PANEL — 2 mL Carton

NDC 36000-092-10 Rx Only

AIN00189

Bupivacaine Hydrochloride in

8.25% Dextrose Injection, USP

Spinal 0.75%

(15 mg/2 mL)

(7.5 mg/mL)

STERILE HYPERBARIC SOLUTION

FOR SPINAL ANESTHESIA

10 x 2 mL Single-Dose Ampules

Baxter

Each mL contains:

7.5 mg bupivacaine hydrochloride (anhydrous) and 82.5 mg

dextrose (anhydrous). pH adjusted between 4.0 and 6.5 with NaOH

or HCl.

Usual dosage: See insert.

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room

Temperature.]

M. L. No.: G/28/1156

Manufactured for:

Baxter Healthcare Corporation

Deerfield, IL 60015 USA

Manufactured by:

Baxter Pharmaceuticals India Private Ltd

Ahmedabad 382213, India

2018-09-17

1200010234

932685c4-3e47-4872-baa3-eb0ce011a2ce-03
(click image for full-size original)
BUPIVACAINE HYDROCHLORIDE
bupivacaine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36000-092
Route of Administration INTRASPINAL 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
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36000-092-05 5 AMPULE in 1 BLISTER PACK contains a AMPULE
1 2 mL in 1 AMPULE This package is contained within the BLISTER PACK (36000-092-05)
2 NDC:36000-092-10 10 AMPULE in 1 BLISTER PACK contains a AMPULE
2 2 mL in 1 AMPULE This package is contained within the BLISTER PACK (36000-092-10)
3 NDC:36000-092-25 25 AMPULE in 1 BLISTER PACK contains a AMPULE
3 2 mL in 1 AMPULE This package is contained within the BLISTER PACK (36000-092-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207266 08/08/2016
Labeler — Baxter Healthcare Corporation (005083209)
Registrant — Baxter Healthcare Corporation (005083209)
Establishment
Name Address ID/FEI Operations
BAXTER PHARMACEUTICALS INDIA PRIVATE LIMITED 918603338 ANALYSIS (36000-092), STERILIZE (36000-092), LABEL (36000-092), MANUFACTURE (36000-092), PACK (36000-092)

Revised: 01/2020 Baxter Healthcare Corporation

Page 4 of 4 1 2 3 4

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.