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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.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
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.
Septocaine® is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental and periodontal procedures.
There is currently no drug history available for this drug.
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.