Septocaine and Epinephrine

SEPTOCAINE AND EPINEPHRINE- articaine hydrochloride and epinephrine bitartrate injection, solution
Septodont Inc.

1 INDICATIONS AND USAGE

SEPTOCAINE is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage Information

Table 1 summarizes the recommended dosages of SEPTOCAINE administered by intraoral submucosal infiltration or nerve block for various types of anesthetic dental procedures in healthy adults and pediatric patients.

Table 1: Recommended Dosages for Both Strengths

Procedure	Septocaine Injection
	Volume (mL)	Total dose of articaine HCl (mg)
Infiltration	0.5 mL to 2.5 mL	20 mg to 100 mg
Nerve block	0.5 mL to 3.4 mL	20 mg to 136 mg
Oral surgery	1 mL to 5.1 mL	40 mg to 204 mg

The recommended dosages of SEPTOCAINE in healthy adults serve only as a guide to the amount of anesthetic required for most routine dental procedures. The dosages to be used in adults depend on several factors such as type and extent of surgical procedure, depth of anesthesia, degree of muscular relaxation, and condition of the patient. In all cases, administer the lowest dosage that will produce the desired result.
The dosages of SEPTOCAINE to be used in pediatric patients aged 4 to 16 years old are determined by the age and weight of the patient and the type of dental procedure.
For most routine dental procedures, SEPTOCAINE containing epinephrine 1:200,000 is preferred. However, when more pronounced hemostasis or improved visualization of the surgical field are required, SEPTOCAINE containing epinephrine 1:100,000 may be used.
The onset of anesthesia and the duration of anesthesia are proportional to the dosage of the local anesthetic used. Exercise caution when employing large volumes because the incidence of adverse reactions may be dose-related.

2.2 Maximum Recommended Dosages

• Healthy Adults: The maximum recommended dosage of SEPTOCAINE is 7 mg/kg of articaine and 0.0017mg/kg of epinephrine (equivalent to 0.175 mL/kg for either product presentation, articaine HCl and 1:100,000 or 1:200,000 epinephrine).
• Pediatric Patients Ages 4 to 16 Years: The maximum recommended dosage of SEPTOCAINE is 7 mg/kg of articaine and 0.0017mg/kg of epinephrine (equivalent to 0.175 mL/kg for either product presentation, articaine HCl and 1:100,000 or 1:200,000 epinephrine) [see Use in Specific Populations (8.4)].

2.3 Dosage in Specific Populations

Lower dosages or dosage reduction may be required in debilitated patients, acutely ill patients, elderly patients, and pediatric patients commensurate with their age and physical condition. No studies have been performed in patients with renal or liver impairment. Exercise caution when using SEPTOCAINE in patients with severe liver disease. [see Warnings and Precautions (5.2), Use in Specific Populations (8.4, 8.5, and 8.6)]

2.4 Important Administration Instructions

Visually inspect SEPTOCAINE for particulate matter and discoloration prior to administration.
Prior to using the glass cartridges, disinfect by wiping the cap thoroughly with USP grade isopropyl alcohol (70%). Avoid use of isopropyl alcohol, as well as solutions of ethyl alcohol that are not of USP grade because they may contain denaturants that are injurious to rubber. Immersion is not recommended. Discard unused portion.

3 DOSAGE FORMS AND STRENGTHS

Injection (clear, colorless solution), provided in:

• Glass cartridges (single-dose) containing (less than a full cartridge or more than one cartridge may be used for an individual patient):

– Articaine hydrochloride 4% (40 mg/mL) and epinephrine 1:200,000 (as epinephrine bitartrate 0.009 mg/mL)
– Articaine hydrochloride 4% (40 mg/mL) and epinephrine 1:100,000 (as epinephrine bitartrate 0.018 mg/mL)

4 CONTRAINDICATIONS

SEPTOCAINE is contraindicated in patients who are hypersensitive to products containing sulfites. Products containing sulfites may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people [see Warnings and Precautions (5.5)].

5 WARNINGS AND PRECAUTIONS

5.1 Accidental Intravascular Injection

Accidental intravascular injection of SEPTOCAINE may be associated with convulsions, followed by central nervous system or cardiorespiratory depression and coma, progressing ultimately to respiratory arrest. Dental practitioners who employ local anesthetic agents including SEPTOCAINE 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. 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.

Small doses of local anesthetics injected in dental blocks may produce adverse reactions similar to systemic toxicity seen with unintentional intravascular injections of larger doses. Confusion, convulsions, respiratory depression or respiratory arrest, and cardiovascular stimulation or depression have been reported. These reactions may be due to intra-arterial injection of the local anesthetic with retrograde flow to the cerebral circulation. Patients receiving these blocks should be observed constantly. Resuscitative equipment and personnel for treating adverse reactions should be immediately available. Dosage recommendations should not be exceeded [see Dosage and Administration (2.1)].

5.2 Systemic Toxicity

This includes toxicity arising from accidental intravascular injection of SEPTOCAINE discussed in Section 5.1, as well as that related to higher systemic concentrations of local anesthetics or epinephrine [see Warnings and Precautions (5.3)]. Systemic absorption of local anesthetics including SEPTOCAINE can produce effects on the central nervous and cardiovascular systems.

At blood concentrations achieved with therapeutic doses of SEPTOCAINE, changes in cardiac conduction, excitability, refractoriness, contractility, and peripheral vascular resistance are minimal. However, toxic blood concentrations of SEPTOCAINE can depress cardiac conduction and excitability, which may lead to atrioventricular block, ventricular arrhythmias, and cardiac arrest, possibly resulting in fatalities. In addition, myocardial contractility is depressed and peripheral vasodilatation occurs, leading to decreased cardiac output and arterial blood pressure. SEPTOCAINE should also be used with caution in patients with heart block as well as those with impaired cardiovascular function since they may be less able to compensate for functional changes associated with the prolongation of A-V conduction produced by these drugs.

Restlessness, anxiety, tinnitus, dizziness, blurred vision, tremors, depression, or drowsiness may be early warning signs of central nervous system toxicity.

Careful and constant monitoring of cardiovascular and respiratory (adequacy of ventilation) vital signs and the patient’s state of consciousness should be performed after each local anesthetic injection of SEPTOCAINE. Repeated doses of SEPTOCAINE may cause significant increases in blood levels because of possible accumulation of the drug or its metabolites. The lowest dosage that results in effective anesthesia should be used to decrease the risk of high plasma levels and serious adverse effects. Tolerance to elevated blood levels varies with the status of the patient. Resuscitative equipment, oxygen, and other resuscitative drugs should be available for immediate use. Precautions for epinephrine administration, discussed in Section 5.3, should be observed.

Debilitated patients, elderly patients, acutely ill patients, and pediatric patients should be given reduced doses commensurate with their age and physical condition [see Dosage and Administration (2.1, 2.3)]. No studies have been performed in patients with liver impairment, and caution should be used in patients with severe hepatic disease.