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 |
|
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 |
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)].