Septocaine
Loading...Septocaine Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
ACCIDENTAL INTRAVASCULAR INJECTION MAY BE ASSOCIATED WITH CONVULSIONS, FOLLOWED BY CENTRAL NERVOUS SYSTEM OR CARDIORESPIRATORY DEPRESSION AND COMA, PROGRESSING ULTIMATELY TO RESPIRATORY ARREST. DENTAL PRACTITIONERS AND/OR CLINICIANS WHO EMPLOY LOCAL ANESTHETIC AGENTS SHOULD BE WELL VERSED IN DIAGNOSIS AND MANAGEMENT OF EMERGENCIES THAT MAY ARISE FROM THEIR USE. RESUSCITATIVE EQUIPMENT, OXYGEN, AND OTHER RESUSCITATIVE DRUGS SHOULD BE AVAILABLE FOR IMMEDIATE USE.
Intravascular injections should be avoided. To avoid intravascular injection, aspiration should be performed before Septocaine® is injected. The needle must be repositioned until no return of blood can be elicited by aspiration. Note, however, that the absence of blood in the syringe does not guarantee that intravascular injection has been avoided.
Septocaine® contains epinephrine that can cause local tissue necrosis or systemic toxicity. Usual precautions for epinephrine administration should be observed.
Septocaine® contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Septocaine® is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental and periodontal procedures.
History
There is currently no drug history available for this drug.
Other Information
Septocaine® injection is a sterile, aqueous solution that contains articaine HCl 4% (40mg/mL) with epinephrine bitartrate in a 1:100,000 strength. Articaine HCl is a local anesthetic, which is chemically designated as 4-methyl-3-[2-(propylamino)-propionamido]-2-thiophene-carboxylic acid, methyl ester hydrochloride and is a racemic mixture. Articaine HCl has a molecular weight of 320.84 and the molecular and structural formulae are displayed below :
Articaine HCl has a partition coefficient in n-octanol/ Soerensen buffer (pH : 7.35) of 17 and a pKa of 7.8.
Epinephrine bitartrate, (-)-1-(3,4-Dihydroxyphenyl)-2-methylamino-ethanol (+) tartrate (1:1) salt, is a vasoconstrictor that is added to articaine HCl in a concentration of 1:100,000 as the free base. It has a molecular weight of 333.3. The molecular and structural formulae are displayed below:
Septocaine® contains articaine HCl (40mg/mL), epinephrine as bitartrate (1:100,000), sodium chloride (1.6 mg/mL), and sodium metabisulfite (0.5 mg/mL). The product is formulated with a 15% overage of epinephrine. The pH is adjusted to 5.0 with sodium hydroxide.
Sources
Septocaine Manufacturers
-
Septodont, Inc.
![Septocaine (Articaine Hydrochloride And Epinephrine Bitartrate) Injection, Solution [Septodont, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Septocaine | Septodont, Inc.
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 PROCEDURE Septocaine® Injection Vol (mL) Total Dose of Articaine (HCl)
(mg) Infiltration 0.5-2.5 20-100 Nerve block 0.5-3.4 20-136 Oral surgery 1.0-5.1 40-204 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 AdultsFor 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 PatientsUse 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 PROCEDURESFor 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.
Login To Your Free Account