Thursday, February 17, 2005

Articaine/Septocaine Parasthesia?


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.

  • Articaine/Septocaine is the newest addition to the local anesthetic arsenal and was approved by the Food and Drug Administration in April 2000. It has been in use in Europe since 1976 and in Canada since 1983. Its approval in the US has been delayed by the FDA due to the presence of a preservative which the agency said was unnecessary in single use carpules and was a potential allergen. It was approved when the French company Septodent finally removed the preservative from American shipments.

    Yet today controvery exists whether articiane/septocaine causes parasthesias in either inferior alveolar blocks and/or infiltrations of the mandible. Dental bulletin boards like Dental Town and the Internet Dental Forum have been filled with case reports of either transient or more permanet parasthesias.

    Dr. Stan Malamed, Professor and Chair of the Section of Anesthesia and Medicine
    at the USC School of Dentistry and a well-known and respected dental anesthesiologist author has stated the latest on a post at Dental Town:

    " On February 17, 2005 at 12:24:39 AM 'malamed' posted....

    Very interesting because I AM THE MALAMED you refer to and I have NOT published any study within the past week, or EVER, stating that articaine is associated with a higher rate pf paresthesia. Indeed there is NO scientific valid evidence EVER published that demonstrates a higher rate for articaine or other 4% drugs. All we hear is ANECDOTAL . . . this is NOT scientific evidence. SFM"

    So, from where is the parasthesia information/anecdotes coming?

    Is anyone conducting the research?

    1 comment:

    1. Anonymous4:50 PM

      My wife received five injections of septocaine and two monthes later she still can not move here lower jaw. Beware!!