CARBOCAINE Dosage and Administration

(mepivacaine Hydrochloride Injection, USP)

2 DOSAGE AND ADMINISTRATION

     

2.1 Important Dosage and Administration Information

•
CARBOCAINE is not for intrathecal use.
•
CARBOCAINE is supplied both with (multiple-dose vials) and without (single-dose vials) antimicrobial preservatives.
•
Avoid use of CARBOCAINE solutions containing antimicrobial preservatives (i.e., multiple-dose vials) for epidural or caudal anesthesia [see Warnings and Precautions (5.3)].
•
Discard unused portions of solution not containing preservatives, i.e., those supplied in single-dose vials, following initial use.
•
Visually inspect this product for particulate matter and discoloration prior to administration whenever solution and container permit. CARBOCAINE is a clear, colorless solution. Do not administer solutions which are discolored or contain particulate matter.
•
Mixing or the prior or intercurrent use of any other local anesthetic with CARBOCAINE is not recommended because of insufficient data on the clinical use of such mixtures.

Administration Precautions

•
CARBOCAINE is to be administered in carefully adjusted dosages by or under the supervision of experienced clinicians who are well versed in the diagnosis and management of dose-related toxicity and other acute emergencies which might arise from the block to be employed.
•
Use CARBOCAINE only if the following are immediately available: oxygen, cardiopulmonary resuscitative equipment and drugs, and the personnel resources needed for proper management of toxic reactions and related emergencies [see Warnings and Precautions (5.1), Adverse Reactions (6), Overdosage (10)].
•
The toxic effects of local anesthetics are additive. Monitor for neurologic and cardiovascular effects related to local anesthetic systemic toxicity when additional local anesthetics are administered with CARBOCAINE [see Warnings and Precautions (5.1), Drug Interactions (7.1), Overdosage (10)].
•
Avoid puncturing the skin if there are signs of inflammation and/or sepsis in the region of the proposed injection.
•
Aspirate for blood or cerebrospinal fluid (where applicable) prior to injecting CARBOCAINE, both the initial dose and all subsequent doses, to avoid intravascular or intrathecal injection. However, a negative aspiration for blood or cerebrospinal fluid does not ensure against an intravascular or intrathecal injection [see Warnings and Precautions (5.5)].
•
Avoid rapid injection of a large volume of CARBOCAINE and use fractional (incremental) doses when feasible.
•
During major regional nerve blocks, such as those of the brachial plexus or lower extremity, the patient should have an indwelling intravenous catheter to assure adequate intravenous access. The lowest dosage of CARBOCAINE that results in effective anesthesia should be used to avoid high plasma levels and serious adverse reactions.
•
Perform careful and constant monitoring of cardiovascular and respiratory (adequacy of oxygenation and ventilation) vital signs and the patient’s level of consciousness after each local anesthetic injection.

2.2 Recommended Concentrations and Dosages of CARBOCAINE

The dosage of CARBOCAINE 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. Administer the smallest dosage and concentration required to produce the desired result.

Dosing in Adults

The types of block and recommended CARBOCAINE concentrations are shown in Table 1.

Table 1. Types of Block and Recommended CARBOCAINE Concentrations in Adults
✓=indicated use
*
CARBOCAINE 0.5% (prepared via dilution) is also recommended for local infiltration.
†
Avoid use of multiple-dose vials of CARBOCAINE for caudal or epidural anesthesia [see Warnings and Precautions (5.3)].

Type of Block

1%

(10 mg/mL)

1.5%

(15 mg/mL)

2%

(20 mg/mL)

Local infiltration*

✓

Peripheral nerve block

✓

✓

Caudal block†

✓

✓

✓

Epidural block†

✓

✓

✓

The recommended single adult dosage (or the total of a series of doses given in one procedure) of CARBOCAINE for unsedated, healthy, normal-sized individuals should not usually exceed 400 mg. The recommended dosage is based on requirements for the average adult (see Table 2). The dosages in Table 2 are provided as a general guidance for use.

Do not exceed a total daily dosage of 1,000 mg in 24 hours because of slow accumulation of the anesthetic or its derivatives or slower than normal metabolic degradation or detoxification with repeat administration. While maximum doses of 7 mg/kg (550 mg) have been administered in some patients, these are not recommended, except in exceptional circumstances. Under no circumstances should the administration be repeated at intervals of less than 1.5 hours [see Warnings and Precautions (5.1), Clinical Pharmacology (12.3)].

Table 2. Recommended Concentrations and Doses of CARBOCAINE for Adults
*
This is the maximum recommended dose per 90-minute period in obstetrical and non-obstetrical patients. Inject slowly, 5 minutes between sides.
†
Use only single-dose vials which do not contain a preservative.
‡
An equivalent amount of a 0.5% solution (prepared by diluting the 1% solution with Sodium Chloride Injection, USP) may be used for large areas.

Procedure

Concentration

Total Dose

mL

mg

Cervical, brachial, intercostal nerve block

1%

(10 mg/mL)

5 mL to 40 mL

50 mg to 400 mg

2%

(20 mg/mL)

5 mL to 20 mL

100 mg to 400 mg

Pudendal nerve block

1%

(10 mg/mL)

2.5 mL to 20 mL administered on each side

25 mg to 200 mg administered on each side

2%

(20 mg/mL)

2.5 mL to 10 mL administered on each side

50 mg to 200 mg administered on each side

Transvaginal block

(paracervical plus pudendal)

[see Use in Specific Populations (8.1)]

1%

(10 mg/mL)

up to 15 mL

administered on each side

up to 150 mg

administered on each side

Paracervical block*

[see Use in Specific Populations (8.1)]

1%

(10 mg/mL)

up to 10 mL

administered on each side

up to 100 mg

administered on each side

Caudal and epidural block†

[see Dosage and Administration (2.4)]

1%

(10 mg/mL)

15 mL to 30 mL

150 mg to 300 mg

1.5%

(15 mg/mL)

10 mL to 25 mL

150 mg to 375 mg

2%

(20 mg/mL)

10 mL to 20 mL

200 mg to 400 mg

Infiltration‡

1%

(10 mg/mL)

up to 40 mL

up to 400 mg

Therapeutic block

(pain management)

1%

(10 mg/mL)

1 mL to 5 mL

10 mg to 50 mg

2%

(20 mg/mL)

1 mL to 5 mL

20 mg to 100 mg

Dosing in Pediatrics

The pediatric dose should be carefully measured based on weight, and should not exceed 5 mg/kg to 6 mg/kg in pediatric patients, especially those weighing less than 13.6 kg. In pediatric patients under 3 years of age or weighing less than 13.6 kg concentrations less than 2% (e.g., 0.5% to 1.5%) should be employed.

2.3 Use in Epidural Anesthesia

During the administration of epidural anesthesia, it is recommended that a test dose of CARBOCAINE without antimicrobial preservative be administered initially and the effects monitored before the full dose is given. When using a “continuous” catheter technique, test doses should be given prior to both the initial and all supplemental doses [see Dosage and Administration (2.4)].

During epidural administration, administer CARBOCAINE solutions in incremental doses with sufficient time between doses to detect toxic manifestations of unintentional intravascular or intrathecal injection. Administer injections slowly, with frequent aspirations before and during the injection to avoid intravascular injection. Perform syringe aspirations before and during each supplemental injection in continuous (intermittent) catheter techniques. Repeat doses should be preceded by a test dose containing epinephrine if not clinically contraindicated. Use only the single-dose vials for caudal or epidural anesthesia; avoid use of the multiple-dose vials for these procedures, which contain a preservative [see Dosage and Administration (2.1, 2.4), Warnings and Precautions (5.3, 5.5)].

2.4 Test Dose for Caudal and Lumbar Epidural Blocks

CARBOCAINE without antimicrobial preservative is recommended for use as a test dose with epinephrine prior to caudal and lumbar epidural blocks when clinical conditions permit. An effective test dose should contain epinephrine (10 mcg to 15 mcg) to serve as a warning of unintended intravascular injection. The test dose should also contain 45 mg to 50 mg of CARBOCAINE to detect an unintended intrathecal administration. When using a “continuous” catheter technique, test doses should be given prior to both the original and all reinforcing doses, because plastic tubing in the epidural space can migrate into a blood vessel or through the dura. Closely monitor for early clinical signs of toxicity following each test dose [see Warnings and Precautions (5.5)]. Allot adequate time for onset of spinal block to detect possible intrathecal injection. An intravascular or intrathecal 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 Precautions (5.1, 5.5), Overdosage (10)].

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Dosage and Administration

2 DOSAGE AND ADMINISTRATION

     

2.1 Important Dosage and Administration Information

•
CARBOCAINE is not for intrathecal use.
•
CARBOCAINE is supplied both with (multiple-dose vials) and without (single-dose vials) antimicrobial preservatives.
•
Avoid use of CARBOCAINE solutions containing antimicrobial preservatives (i.e., multiple-dose vials) for epidural or caudal anesthesia [see Warnings and Precautions (5.3)].
•
Discard unused portions of solution not containing preservatives, i.e., those supplied in single-dose vials, following initial use.
•
Visually inspect this product for particulate matter and discoloration prior to administration whenever solution and container permit. CARBOCAINE is a clear, colorless solution. Do not administer solutions which are discolored or contain particulate matter.
•
Mixing or the prior or intercurrent use of any other local anesthetic with CARBOCAINE is not recommended because of insufficient data on the clinical use of such mixtures.

Administration Precautions

•
CARBOCAINE is to be administered in carefully adjusted dosages by or under the supervision of experienced clinicians who are well versed in the diagnosis and management of dose-related toxicity and other acute emergencies which might arise from the block to be employed.
•
Use CARBOCAINE only if the following are immediately available: oxygen, cardiopulmonary resuscitative equipment and drugs, and the personnel resources needed for proper management of toxic reactions and related emergencies [see Warnings and Precautions (5.1), Adverse Reactions (6), Overdosage (10)].
•
The toxic effects of local anesthetics are additive. Monitor for neurologic and cardiovascular effects related to local anesthetic systemic toxicity when additional local anesthetics are administered with CARBOCAINE [see Warnings and Precautions (5.1), Drug Interactions (7.1), Overdosage (10)].
•
Avoid puncturing the skin if there are signs of inflammation and/or sepsis in the region of the proposed injection.
•
Aspirate for blood or cerebrospinal fluid (where applicable) prior to injecting CARBOCAINE, both the initial dose and all subsequent doses, to avoid intravascular or intrathecal injection. However, a negative aspiration for blood or cerebrospinal fluid does not ensure against an intravascular or intrathecal injection [see Warnings and Precautions (5.5)].
•
Avoid rapid injection of a large volume of CARBOCAINE and use fractional (incremental) doses when feasible.
•
During major regional nerve blocks, such as those of the brachial plexus or lower extremity, the patient should have an indwelling intravenous catheter to assure adequate intravenous access. The lowest dosage of CARBOCAINE that results in effective anesthesia should be used to avoid high plasma levels and serious adverse reactions.
•
Perform careful and constant monitoring of cardiovascular and respiratory (adequacy of oxygenation and ventilation) vital signs and the patient’s level of consciousness after each local anesthetic injection.

2.2 Recommended Concentrations and Dosages of CARBOCAINE

The dosage of CARBOCAINE 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. Administer the smallest dosage and concentration required to produce the desired result.

Dosing in Adults

The types of block and recommended CARBOCAINE concentrations are shown in Table 1.

Table 1. Types of Block and Recommended CARBOCAINE Concentrations in Adults
✓=indicated use
*
CARBOCAINE 0.5% (prepared via dilution) is also recommended for local infiltration.
†
Avoid use of multiple-dose vials of CARBOCAINE for caudal or epidural anesthesia [see Warnings and Precautions (5.3)].

Type of Block

1%

(10 mg/mL)

1.5%

(15 mg/mL)

2%

(20 mg/mL)

Local infiltration*

✓

Peripheral nerve block

✓

✓

Caudal block†

✓

✓

✓

Epidural block†

✓

✓

✓

The recommended single adult dosage (or the total of a series of doses given in one procedure) of CARBOCAINE for unsedated, healthy, normal-sized individuals should not usually exceed 400 mg. The recommended dosage is based on requirements for the average adult (see Table 2). The dosages in Table 2 are provided as a general guidance for use.

Do not exceed a total daily dosage of 1,000 mg in 24 hours because of slow accumulation of the anesthetic or its derivatives or slower than normal metabolic degradation or detoxification with repeat administration. While maximum doses of 7 mg/kg (550 mg) have been administered in some patients, these are not recommended, except in exceptional circumstances. Under no circumstances should the administration be repeated at intervals of less than 1.5 hours [see Warnings and Precautions (5.1), Clinical Pharmacology (12.3)].

Table 2. Recommended Concentrations and Doses of CARBOCAINE for Adults
*
This is the maximum recommended dose per 90-minute period in obstetrical and non-obstetrical patients. Inject slowly, 5 minutes between sides.
†
Use only single-dose vials which do not contain a preservative.
‡
An equivalent amount of a 0.5% solution (prepared by diluting the 1% solution with Sodium Chloride Injection, USP) may be used for large areas.

Procedure

Concentration

Total Dose

mL

mg

Cervical, brachial, intercostal nerve block

1%

(10 mg/mL)

5 mL to 40 mL

50 mg to 400 mg

2%

(20 mg/mL)

5 mL to 20 mL

100 mg to 400 mg

Pudendal nerve block

1%

(10 mg/mL)

2.5 mL to 20 mL administered on each side

25 mg to 200 mg administered on each side

2%

(20 mg/mL)

2.5 mL to 10 mL administered on each side

50 mg to 200 mg administered on each side

Transvaginal block

(paracervical plus pudendal)

[see Use in Specific Populations (8.1)]

1%

(10 mg/mL)

up to 15 mL

administered on each side

up to 150 mg

administered on each side

Paracervical block*

[see Use in Specific Populations (8.1)]

1%

(10 mg/mL)

up to 10 mL

administered on each side

up to 100 mg

administered on each side

Caudal and epidural block†

[see Dosage and Administration (2.4)]

1%

(10 mg/mL)

15 mL to 30 mL

150 mg to 300 mg

1.5%

(15 mg/mL)

10 mL to 25 mL

150 mg to 375 mg

2%

(20 mg/mL)

10 mL to 20 mL

200 mg to 400 mg

Infiltration‡

1%

(10 mg/mL)

up to 40 mL

up to 400 mg

Therapeutic block

(pain management)

1%

(10 mg/mL)

1 mL to 5 mL

10 mg to 50 mg

2%

(20 mg/mL)

1 mL to 5 mL

20 mg to 100 mg

Dosing in Pediatrics

The pediatric dose should be carefully measured based on weight, and should not exceed 5 mg/kg to 6 mg/kg in pediatric patients, especially those weighing less than 13.6 kg. In pediatric patients under 3 years of age or weighing less than 13.6 kg concentrations less than 2% (e.g., 0.5% to 1.5%) should be employed.

2.3 Use in Epidural Anesthesia

During the administration of epidural anesthesia, it is recommended that a test dose of CARBOCAINE without antimicrobial preservative be administered initially and the effects monitored before the full dose is given. When using a “continuous” catheter technique, test doses should be given prior to both the initial and all supplemental doses [see Dosage and Administration (2.4)].

During epidural administration, administer CARBOCAINE solutions in incremental doses with sufficient time between doses to detect toxic manifestations of unintentional intravascular or intrathecal injection. Administer injections slowly, with frequent aspirations before and during the injection to avoid intravascular injection. Perform syringe aspirations before and during each supplemental injection in continuous (intermittent) catheter techniques. Repeat doses should be preceded by a test dose containing epinephrine if not clinically contraindicated. Use only the single-dose vials for caudal or epidural anesthesia; avoid use of the multiple-dose vials for these procedures, which contain a preservative [see Dosage and Administration (2.1, 2.4), Warnings and Precautions (5.3, 5.5)].

2.4 Test Dose for Caudal and Lumbar Epidural Blocks

CARBOCAINE without antimicrobial preservative is recommended for use as a test dose with epinephrine prior to caudal and lumbar epidural blocks when clinical conditions permit. An effective test dose should contain epinephrine (10 mcg to 15 mcg) to serve as a warning of unintended intravascular injection. The test dose should also contain 45 mg to 50 mg of CARBOCAINE to detect an unintended intrathecal administration. When using a “continuous” catheter technique, test doses should be given prior to both the original and all reinforcing doses, because plastic tubing in the epidural space can migrate into a blood vessel or through the dura. Closely monitor for early clinical signs of toxicity following each test dose [see Warnings and Precautions (5.5)]. Allot adequate time for onset of spinal block to detect possible intrathecal injection. An intravascular or intrathecal 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 Precautions (5.1, 5.5), Overdosage (10)].
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