DOSAGE AND ADMINISTRATION
Table 3 (Recommended Dosages) summarizes the recommended volumes and concentrations of Septocaine® for various types of anesthetic procedures. The dosages suggested in this table are for normal healthy adults, administered by submucosal infiltration and/or nerve block.
Table 3. Recommended Dosages
|Vol (mL)||Total Dose of Articaine (HCl)|
|THE ABOVE SUGGESTED VOLUMES SERVE ONLY AS A GUIDE. OTHER VOLUMES MAY BE USED PROVIDED THE TOTAL MAXIMUN RECOMMENDED DOSE IS NOT EXCEEDED.|
These recommended doses serve only as a guide to the amount of anesthetic required for most routine procedures. The actual volumes to be used depend on a number of factors such as type and extent of surgical procedure, depth of anesthesia, degree of muscular relaxation, and condition of the patient. In all cases, the smallest dose that will produce the desired result should be given. Dosages should be reduced for pediatric patients, elderly patients, and patients with cardiac and/or liver disease. (See PRECAUTIONS, Pediatric Use and Geriatric Use).
The onset of anesthesia, and the duration of anesthesia are proportional to the volume and concentration (i.e., total dose) of local anesthetic used. Caution should be exercised when employing large volumes since the incidence of side effects may be dose-related.
MAXIMUM RECOMMENDED DOSAGES
For normal healthy adults, the maximum dose of articaine HCl administered by submucosal infiltration and/or nerve block should not exceed 7 mg/kg (0.175 mL/kg) or 3.2 mg/lb (0.0795 mL/lb) of body weight.
Use in pediatric patients under 4 years of age is not recommended. The quantity to be injected should be determined by the age and weight of the child and the magnitude of the operation. Do not exceed the equivalent of 7 mg/kg (0.175 mL/kg) or 3.2 mg/lb (0.0795 mL/lb) of body weight.
STERILIZATION, STORAGE, AND TECHNICAL PROCEDURES
For chemical disinfection of the carpule, either isopropyl alcohol (91%) or ethyl alcohol (70%) is recommended. Many commercially available brands of isopropyl (rubbing) alcohol, as well as solutions of ethyl alcohol not of U.S.P. grade, contain denaturants that are injurious to rubber and therefore are not to be used.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.