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Septocaine (Articaine Hydrochloride / Epinephrine Bitartrate Subcutaneous) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Septocaine® is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental and periodontal procedures.

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
PROCEDURESeptocaine® Injection
Vol (mL)Total Dose of Articaine (HCl)
(mg)
Infiltration0.5-2.520-100
Nerve block0.5-3.420-136
Oral surgery1.0-5.140-204
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

Adults

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.

Pediatric Patients

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.

HOW SUPPLIED

Septocaine® (articaine HCl 4% with epinephrine 1:100,000 Injection) is available in 1.7 mL glass cartridges, in boxes or cans of 50 cartridges. The product is formulated with a 15% overage of epinephrine.

NDC 12862-1050-1 Can of 50 cartridges
NDC 12862-1050-2 Box of 50 cartridges

Store at 25°C (77°F) with brief excursions permitted between 15° and 30°C (59°F-86°F) (see USP controlled room temperature). Protect from light.

Manufactured in France by: SEPTODONT, France.

Distributed by: SEPTODONT, Inc.,
245, Quigley Boulevard-Suite C
New Castle, Delaware 19720

® 05 14 228 50 03
02/02

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