Bupivacaine (Bupivacaine Hydrochloride / Dextrose Dental) - Indications and Dosage

INDICATIONS AND USAGE

Bupivacaine Hydrochloride is indicated 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. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia. (See WARNINGS .)

Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of 0.75% concentration of Bupivacaine Hydrochloride in these patients.

Bupivacaine Hydrochloride is not recommended for intravenous regional anesthesia (Bier Block). (See WARNINGS .)

The routes of administration and indicated Bupivacaine Hydrochloride concentrations are:

• local infiltration	0.25%
• peripheral nerve block	0.25% and 0.5%
• retrobulbar block	0.75%
• sympathetic block	0.25%
• lumbar epidural	0.25%, 0.5%, and 0.75% (0.75% not for obstetrical anesthesia)
• caudal	0.25% and 0.5%
• epidural test dose	0.5% with epinephrine 1:200,000

(See DOSAGE AND ADMINISTRATION for additional information.)

Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of Bupivacaine Hydrochloride.

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 should be reduced for elderly and/or debilitated patients and patients with cardiac and/or liver disease. The rapid injection of a large volume of local anesthetic solution should be avoided and fractional (incremental) doses should be used when feasible.

    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 is not approved for this use (see WARNINGS and DOSAGE AND ADMINISTRATION).

    In recommended doses, Bupivacaine Hydrochloride produces complete sensory block, but the effect on motor function differs among the three concentrations.

0.25%─ when used for caudal, epidural, or peripheral nerve block, produces incomplete motor block. Should be used for operations in which muscle relaxation is not important, or when another means of providing muscle relaxation is used concurrently. Onset of action may be slower than with the 0.5% or 0.75% solutions.

0.5% ─  provides motor blockade for caudal, epidural, or nerve block, but muscle relaxation may be inadequate for operations in which complete muscle relaxation is essential.

0.75%  ─  produces complete motor block. Most useful for epidural block in abdominal operations requiring complete muscle relaxation, and for retrobulbar anesthesia. Not for obstetrical anesthesia.

The duration of anesthesia with Bupivacaine Hydrochloride is such that for most indications, a single dose is sufficient.

Maximum dosage limit must be individualized in each case after evaluating the size and physical status of the patient, as well as the usual rate of systemic absorption from a particular injection site. Most experience to date is with single doses of Bupivacaine Hydrochloride up to 225 mg with epinephrine 1:200,000 and 175 mg without epinephrine; more or less drug may be used depending on individualization of each case.

These doses may be repeated up to once every three hours. In clinical studies to date, total daily doses have been up to 400 mg. Until further experience is gained, this dose should not be exceeded in 24 hours. The duration of anesthetic effect may be prolonged by the addition of epinephrine.

The dosages in Table 1 have generally proved satisfactory and are recommended as a guide for use in the average adult. These dosages should be reduced for elderly or debilitated patients. Until further experience is gained, Bupivacaine Hydrochloride is not recommended for pediatric patients younger than 12 years. Bupivacaine Hydrochloride is contraindicated for obstetrical paracervical blocks, and is not recommended for intravenous regional anesthesia (Bier Block).

Use in Epidural Anesthesia: During epidural administration of Bupivacaine Hydrochloride, 0.5% and 0.75% solutions should be administered in incremental doses of 3 mL to 5 mL with sufficient time between doses to detect toxic manifestations of unintentional intravascular or intrathecal injection. In obstetrics, only the 0.5% and 0.25% concentrations should be used; incremental doses of 3 mL to 5 mL of the 0.5% solution not exceeding 50 mg to 100 mg at any dosing interval are recommended. Repeat doses should be preceded by a test dose containing epinephrine if not contraindicated. Use only the single-dose ampuls and single-dose vials for caudal or epidural anesthesia; the multiple-dose vials contain a preservative and therefore should not be used for these procedures.

Test Dose for Caudal and Lumbar Epidural Blocks: The Test Dose of Bupivacaine Hydrochloride (0.5% bupivacaine with 1:200,000 epinephrine in a 3 mL ampul) is recommended for use as a test dose when clinical conditions permit prior to caudal and lumbar epidural blocks. This may serve as a warning of unintended intravascular or subarachnoid injection. (See PRECAUTIONS.) The pulse rate and other signs should be monitored carefully immediately following each test dose administration to detect possible intravascular injection, and adequate time for onset of spinal block should be allotted to detect possible intrathecal injection. An intravascular or subarachnoid injection is still possible even if results of the test dose are negative. The test dose itself may produce a systemic toxic reaction, high spinal or cardiovascular effects from the epinephrine. (See WARNINGS and OVERDOSAGE.)

Unused portions of solution not containing preservatives, i.e., those supplied in single-dose ampuls and single-dose vials, should be discarded following initial use.

This product should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Solutions which are discolored or which contain particulate matter should not be administered.

Table 1.

Recommended Concentrations and Doses of Bupivacaine Hydrochloride
Type of		Each Dose		Motor
Block	Conc.	(mL)	(mg)	Block1
Local infiltration	0.25%4	up to max.	up to max.	─
Epidural	0.75%2,4	10-20	75-150	complete
	0.5%4	10-20	50-100	moderate to complete
	0.25%4	10-20	25-50	partial to moderate
Caudal	0.5%4	15-30	75-150	moderate to complete
	0.25%4	15-30	37.5-75	moderate
Peripheral nerves	0.5%4	5 to max.	25 to max.	moderate to complete
	0.25%4	5 to max.	12.5 to max.	moderate to complete
Retrobulbar3	0.75%4	2-4	15-30	complete
Sympathetic	0.25%	20-50	50-125	─
Epidural3	0.5%	2-3	10-15	─
Test Dose	w/epi		(10-15 micrograms epinephrine)
1With continuous (intermittent) techniques, repeat doses increase the degree of motor block. The first repeat dose of 0.5% may produce complete motor block. Intercostal nerve block with 0.25% may also produce complete motor block for intra-abdominal surgery. 2For single-dose use, not for intermittent epidural technique. Not for obstetrical anesthesia. 3See PRECAUTIONS. 4Solutions with or without epinephrine.

HOW SUPPLIED

These solutions are not for spinal anesthesia.

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

Bupivacaine Hydrochloride ─ Solutions of Bupivacaine Hydrochloride that do not contain epinephrine may be autoclaved. Autoclave at 15-pound pressure, 121°C (250°F) for 15 minutes. Do not autoclave product packaged in Abboject^® Syringes.

Conc.	Size	pH	Package	NDC No.
0.25%	30 mL	4.0 to 6.5	Ampul	0409-1158-01
	50 mL	4.0 to 6.5	Ampul	0409-1158-02
0.25%	20 mL	4.0 to 6.5	Sterile Pack Ampul	0409-4272-01
0.25%	10 mL	4.0 to 6.5	Teartop Vial	0409-1159-01
	30 ml	4.0 to 6.5	Teartop Vial	0409-1159-02
0.25%	50 mL	4.0 to 6.5	Fliptop Vial (Multiple-dose)	0409-1160-01
0.5%	30 mL	4.0 to 6.5	Ampul	0409-1161-01
0.5%	20 mL	4.0 to 6.5	Sterile Pack Ampul	0409-4273-01
0.5%	50 mL	4.0 to 6.5	Fliptop Vial (Multiple-dose)	0409-1163-01
0.5%	10 mL	4.0 to 6.5	Teartop Vial	0409-1162-01
	30 mL	4.0 to 6.5	Teartop Vial	0409-1162-02
0.75%	20 mL	4.0 to 6.5	Sterile Pack Ampul	0409-4274-01
0.75%	30 mL	4.0 to 6.5	Ampul	0409-1164-01
0.75%	10 mL	4.0 to 6.5	Teartop Vial	0409-1165-01
	30 mL	4.0 to 6.5	Teartop Vial	0409-1165-02
0.25%	20 mL	4.0 to 6.5	Ampul	0409-5622-01
0.75%	2 mL	4.0 to 6.5	Ampul	0409-5623-02
0.5%	20 mL	4.0 to 6.5	Ampul	0409-5757-01
0.5%	20 mL	4.0 to 6.5	AbbojectTM Syringe	0409-5758-01

Bupivacaine Hydrochloride with epinephrine 1:200,000 (as bitartrate) ─ Solutions of Bupivacaine Hydrochloride that contain epinephrine should not be autoclaved and should be protected from light. Do not use the solution if its color is pinkish or darker than slightly yellow or if it contains a precipitate.

                        Concentration

                        Bupivacaine  

HCl	Size	pH	Package	NDC No.
0.25%	10 mL	3.3 to 5.5	Teartop Vial	0409-9042-01
0.25%	30 mL	3.3 to 5.5	Teartop Vial	0409-9042-02
0.25%	50 mL	3.3 to 5.5	Fliptop Vial (Multiple-dose)	0409-9043-01
0.5%	10 mL	3.3 to 5.5	Teartop Vial	0409-9045-01
0.5%	30 mL	3.3 to 5.5	Teartop Vial	0409-9045-02
0.5%	50 mL	3.3 to 5.5	Fliptop Vial (Multiple-dose)	0409-9046-01

Revised: February, 2010

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