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
BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride injection, solution | |||||||||||||||||||||||||||||||||
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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
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