Septocaine (Page 3 of 4)

Geriatric Use

In clinical trials, 54 patients between the ages of 65 and 75 years, and 11 patients 75 years and over received Septocaine™. Among all patients between 65 and 75 years, doses from 0.43 mg/kg to 4.76 mg/kg (0.9 to 11.9 mL) were administered safely to 35 patients for simple procedures and doses from 1.05 mg/kg to 4.27 mg/kg (1.3 to 6.8 mL) were administered safely to 19 patients for complex procedures. Among the 11 patients ≥ 75 years old, doses from 0.78 mg/kg to 4.76 mg/kg (1.3 to 11.9 mL) were administered safely to 7 patients for simple procedures and doses of 1.12 mg/kg to 2.17 mg/kg (1.3 to 5.1 mL) were administered to 4 patients for complex procedures.

No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Approximately 6% of patients between the ages of 65 and 75 years and none of the 11 patients 75 years of age or older required additional injections of anesthetic for complete anesthesia compared with 11% of patients between 17 and 65 years old who required additional injections.

ADVERSE REACTIONS

Reactions to Septocaine^® are characteristic of those associated with other amide-type local anesthetics. Adverse reactions to this group of drugs may also result from excessive plasma levels, which may be due to overdosage, unintentional intravascular injection, or slow metabolic degradation.

The reported adverse events are derived from clinical trials in the US and UK. Of the 1325 patients treated in the primary clinical trials, 882 were exposed to Septocaine^®.

Table 2. Adverse Events in controlled trials with an incidence of 1% or greater in patients administered Septocaine^® (articaine hydrochloride 4% (40 mg/mL) with epinephrine 1:100,000 Injection).

Body system	Septocaine® N (%)
Number of Patients	882 (100%)
Body As A Whole
Face Edema	13 (1%)
Headache	31 (4%)
Infection	10 (1%)
Pain	114 (13%)
Digestive System
Gingivitis	13 (1%)
Nervous system
Paresthesia	11 (1%)

The following list includes adverse and intercurrent events that were recorded in 1 or more patients, but occurred at an overall rate of less than one percent, and were considered clinically relevant.

Body as a Whole — abdominal pain, accidental injury, asthenia, back pain, injection site pain, malaise, neck pain.

Cardiovascular System — hemorrhage, migraine, syncope, tachycardia.

Digestive System — constipation, diarrhea, dyspepsia, glossitis, gum hemorrhage, mouth ulceration, nausea, stomatitis, tongue edemas, tooth disorder, vomiting.

Hemic and Lymphatic System — ecchymosis, lymphadenopathy.

Metabolic and Nutritional System — edema, thirst.

Musculoskeletal System — arthralgia, myalgia, osteomyelitis.

Nervous System — dizziness, dry mouth, facial paralysis, hyperesthesia, increased salivation, nervousness, neuropathy, paresthesia, somnolence.

Respiratory System — pharyngitis, rhinitis.

Skin and Appendages — pruritis, skin disorder.

Special Senses — ear pain, taste perversion.

Urogenital System — dysmenorrhea.

OVERDOSAGE

Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics or to unintended subarachnoid injection of local anesthetic solution (see WARNINGS, PRECAUTIONS General and ADVERSE REACTIONS).

Management of Local Anesthetic Emergencies

The first consideration is prevention, best accomplished by careful and constant monitoring of cardiovascular and respiratory vital signs and the patient’s state of consciousness after each local anesthetic injection. At the first sign of change, oxygen should be administered.

The first step in the management of convulsions, as well as hypoventilation, consists of immediate attention to the maintenance of a patent airway and assisted or controlled ventilation as needed. The adequacy of the circulation should be assessed. Should convulsions persist despite adequate respiratory support, treatment with appropriate anticonvulsant therapy is indicated. The practitioner should be familiar, prior to the use of local anesthetics, with the use of anticonvulsant drugs. Supportive treatment of circulatory depression may require administration of intravenous fluids and, when appropriate, a vasopressor.

If not treated immediately, both convulsions and cardiovascular depression can result in hypoxia, acidosis, bradycardia, arrhythmias and cardiac arrest. If cardiac arrest should occur, standard cardiopulmonary resuscitative measures should be instituted.

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

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.