"The U.S. Food and Drug Administration today approved the MemoryShape Breast Implant to increase breast size (augmentation) for use in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age. The MemoryShape B"...
Septocaine® (articane hcl and epinephrine injection) , an amide local anesthetic containing a vasoconstrictor, is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures.
DOSAGE AND ADMINISTRATION
General Dosing Information
Table 1 (below) summarizes the recommended volumes and concentrations of Septocaine® (articane hcl and epinephrine injection) for various types of anesthetic procedures. The dosages suggested in this table are for normal healthy adults, administered by submucosal infiltration or nerve block.
Table 1: Recommended Dosages for Both Strengths
|Volume (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 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.
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 because the incidence of side effects may be dose-related.
For most routine dental procedures, Septocaine® (articane hcl and epinephrine injection) containing epinephrine 1:200,000 is preferred. However, when more pronounced hemostasis or improved visualization of the surgical field are required, Septocaine® (articane hcl and epinephrine injection) containing epinephrine 1:100,000 may be used.
Maximum Recommended Dosages
- Adults: For normal healthy adults, the maximum dose of articaine HCl administered by submucosal infiltration or nerve block should not exceed 7 mg/kg (0.175 mL/kg).
- Pediatric Patients Ages 4 to 16 Years: The quantity of articaine HCl in children ages 4 to 16 years of age to be injected should be determined by the age and weight of the child and the magnitude of the operation. The maximum dose of articaine HCl 4% should not exceed 7 mg/kg (0.175 mL/kg) [see Use in Specific Populations].
- Safety and effectiveness of Septocaine® (articane hcl and epinephrine injection) in pediatric patients below the age of 4 years have not been established.
Dosing in Special Populations
Dose 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 dysfunction. Caution should be used in patients with severe liver disease. [see WARNINGS AND PRECAUTIONS, Use in Specific Populations]
Dosage Forms And Strengths
Injection (clear colorless solution), containing:
- 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)
Septocaine® (articaine HCl and epinephrine) Injection is available in 1.7 mL single use glass cartridges, packaged in boxes of 50 cartridges in the following two strengths:
Septocaine® (articane hcl and epinephrine injection) containing articaine HCl 4% (40 mg/mL) and epinephrine 1:200,000 (as epinephrine bitartrate 0.009 mg/mL) (NDC 0362-9048-02)
Septocaine® (articane hcl and epinephrine injection) containing articaine HCl 4% (40 mg/mL) and epinephrine 1:100,000 (as epinephrine bitartrate 0.018 mg/mL) (NDC 0362-9049-02)
Storage and Handling
Store at controlled room temperature 25°C (77°F) with brief excursions permitted between 15° and 30°C (59°F-86°F) [see USP Controlled Room Temperature]. Protect from light. Do Not Freeze.
For 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.
Manufactured for Septodont Louisville, CO 80027 by NOVOCOL Pharmaceutical of Canada Inc. Cambridge, Ontario, Canada N1R 6X3
Last reviewed on RxList: 3/12/2010
This monograph has been modified to include the generic and brand name in many instances.
Additional Septocaine Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.