DOSAGE AND ADMINISTRATION
Table 1 (Recommended Dosages) summarizes the recommended volumes and concentrations of Lidocaine HCI Injection, USP for various types of anesthetic procedures. The dosages suggested in this table are for normal healthy adults and refer to the use of epinephrine-free solutions. When larger volumes are required only solutions containing epinephrine should be used except in those cases where vasopressor drugs may be contraindicated.
These recommended doses serve only as a guide to the amount of anesthetic required for most routine procedures. The actual volumes and concentrations to be used depend on a number of factors such as type and extent of surgical procedure, depth of anesthesia, and degree of muscular relaxation required, duration of anesthesia required, and the physical condition of the patient. In all cases the lowest concentration and smallest dose that will produce the desired result should be given. Dosages should be reduced for children and for elderly and debilitated patients and patients with cardiac and/or liver disease.
The onset of anesthesia, the duration of anesthesia, and the degree of muscular relaxation are proportional to the volume and concentration (i.e. total dose) of local anesthetic used. Thus an increase in volume and concentration of Lidocaine HCI Injection, USP will decrease the onset of anesthesia, prolong the duration of anesthesia, provide a greater degree of muscular relaxation and increase the segmental spread of anesthesia. Although the incidence of side effects with lidocaine is quite low, caution should be exercised when employing large volumes and concentrations since the incidence of side effects is directly proportional to the total dose of local anesthetic agent injected.
MAXIMUM RECOMMENDED DOSAGES: NOTE: The products accompanying this insert do not contain epinephrine.
ADULTS: For normal healthy adults, the individual maximum recommended dose of Lidocaine HCI with epinephrine should not exceed 7 mg/kg (3.2 mg/lb) of body weight, and, in general, it is recommended that the maximum total dose not exceed 500 mg. When used without epinephrine the maximum individual dose should not exceed 4.5 mg/kg (2 mg/lb) of body weight, and, in general, it is recommended that the maximum total dose does not exceed 300 mg. The maximum recommended dose per 90 minute period of lidocaine hydrochloride for paracervical block in obstetrical and non-obstetrical patients is 200 mg total. One half of the total dose is usually administered to each side. Inject slowly five minutes between sides (See also discussion of paracervical block in PRECAUTIONS).
CHILDREN: It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children over 3 years of age who have a normal lean body mass and normal body development, the maximum dose is determined by the child's age and weight. For example a child of 5 years weighing 50 lbs, the dose of lidocaine HCI should not exceed 75-100 mg (1.5-2 mg/lb). The use of even more dilute solutions (i.e., 0.25-0.5%) and total dosages not to exceed 3 mg/kg (1.4 mg/lb) are recommended for induction of intravenous regional anesthesia in children.
In order to guard against systemic toxicity, the lowest effective concentration and lowest effective dose should be used at all times. In some cases it will be necessary to dilute available concentrations with 0.9% sodium chloride injection in order to obtain the required final concentration.
NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit. Solutions that are discolored and/or contain particulate matter should not be used.
TABLE 1 Recommended Dosages | PROCEDURE | Conc (%) | Lidocaine Hydrochloride Solution
(without epinephrine)
Vol (mL) | Total Dose (mg) |
Infiltration
Percutaneous |
0.5 or 1.0 |
1-60 |
5-300 |
Peripheral Nerve Blocks e.g.
Brachial
Dental
Intercostal
Paravertebral
Pudendal (each side) |
1.5
2.0
1.0
1.0
1.0 |
15-20
1-5
3
3-5
10 |
225-300
20-100
30
30-50
100 |
Paracervical
Obstetrical analgesia (each side) |
1.0 |
10 |
100 |
Sympathetic Nerve Blocks e.g.
Cervical (stellate ganglion) |
1.0 |
5 |
50 |
| Lumbar | 1.0 | 5-10 | 50-100 |
THE ABOVE SUGGESTED CONCENTRATIONS AND VOLUMES SERVE ONLY AS A GUIDE. OTHER VOLUMES AND CONCENTRATIONS MAY BE USED PROVIDED THE TOTAL MAXIMUM RECOMMENDED DOSE IS NOT EXCEEDED.
STERILIZATION, STORAGE AND TECHNICAL PROCEDURES: Disinfecting agents containing heavy metals which cause release of respective ions (mercury, zinc, copper etc.) should not be used for skin or mucous membrane disinfection as they have been related to incidents of swelling and edema. When disinfection of multi-dose vials is desired either isopropyl alcohol (91%) or 70% ethyl alcohol is recommended. Many commercially available brands of rubbing alcohol, as well as solutions of ethyl alcohol not of USP grade, contain denaturants which are injurious to rubber and therefore are not to be used.
FOR INFILTRATION AND NERVE BLOCK. NOT FOR EPIDURAL OR CAUDAL USE.
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